TRILURON

Fidia Farmaceutici S.p.A.

INDICATION FOR USE: Treatment of pain in osteoarthritis (OA) of the knee in
patients who have failed to respond adequately to conservative nonpharmacologic therapy, and to simple analgesics, e.g., acetaminophen

DESCRIPTION:

• Viscous solution consisting of a high molecular weight (500,000–730,000 daltons) fraction of purified sodium hyaluronate (Hyalectin®) in buffered
  physiological sodium chloride, having a pH of 6.8-7.
• The sodium hyaluronate is extracted from rooster combs
•  Hyaluronic acid is a natural complex sugar of the glycosaminoglycan family and is a long-chain polymer containing repeating disaccharide units of Naglucuronate-N-acetylglucosamine
• Administered by intra-articular injection

EFFECTIVENESS AND SAFETY:

• Retrospective analysis of data prospectively collected from two randomized, controlled trials to determine the effectiveness of TRILURON vs. Hyalgan (control device)
• Both have identical chemical formulation and differ only in that a lower
  dose is injected (3 weekly injections for TRILURON™ compared to 5 weekly injections of Hyalgan)
• Primary effectiveness endpoint: Mean change from baseline at 26 weeks in WOMAC Pain scores: TRILURON was non-inferior to Hyalgan
• Primary evidence of safety of Hyalgan is directly applicable to TRILURON and has already been established

REG PATHWAY: PMA

• Device Procode: MOZ

LABEL

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LOADPRO™ Intraoperative Rod Strain Sensor

Intellirod Spine, Inc

INDICATION FOR USE: Intraoperative surgical tool that allows surgeons to measure unidirectional rod microstrain on posterior rods in the sagittal plane when performing spine surgery.

Adjunct to surgeon tactile feedback and is not intended to replace a surgeon’s clinical judgment.

Single use, disposable tool to be used in conjunction with X-Spine Systems Fortex Pedicle Screw System for 5.5mm diameter titanium (ASTM F136) or cobalt chrome (ASTM F1537) rod configurations.

GENERIC DEVICE TYPE: Intraoperative orthopedic strain sensor

• Adjunct tool intended to measure strain on an orthopedic implant in the intraoperative setting only
• Not intended to provide diagnostic information or influence clinical decision-making.

RISKS & MITIGATIONS (SPECIAL CONTROLS):

• Prolonged operative time due to device error or use error: Usability Testing, Non-clinical Performance Testing, Software verification, validation, and hazard analysis, Labeling 
• Electrical shock or device failure due to interference from other devices: Electromagnetic compatibility testing, Electrical safety testing 
• Infection: Sterilization validation, Reprocessing validation, Shelf life testing
  Labeling 
• Adverse tissue reaction: Biocompatibility evaluation

REGULATORY PATHWAY: De Novo request 

• Regulation Number: 21 CFR 888.3090
• Regulation Name: Intraoperative orthopedic strain sensor
• Regulatory Class: Class II
• Product Code: QFP

CLASSIFICATION ORDER

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PLENITY device for weight management and/or weight loss

Gelesis, Inc.

INDICATION FOR USE: To aid in weight management in overweight and obese adults with a Body Mass Index (BMI) of 25 – 40 kg/m2, when used in conjunction with diet and exercise

GENERIC DEVICE TYPE: Ingested, transient, space occupying device for weight management and/or weight loss

• Ingested material that transiently occupies space in the stomach
• Device passes from the body via the natural gastrointestinal tract

RISKS & MITIGATIONS (SPECIAL CONTROLS):

• Device related gastrointestinal adverse events, including:  Obstruction,  Dilation,  Diarrhea, Constipation, Dehydration: Clinical performance testing, Non-clinical performance testing, Labeling, Shelf life testing
• Weight gain: Clinical performance testing, Labeling 
• Interaction with medication: Clinical performance testing, Non-clinical performance testing, Labeling 
• Adverse tissue reaction: Biocompatibility evaluation
• Infection: Non-clinical performance testing. Shelf life testing

REGULATORY PATHWAY: De Novo request

• Regulation Number: 21 CFR 876.5982
• Regulation Name: Ingested, transient, space occupying device for weight management and/or weight loss
• Regulatory Class: Class II
• Product Code: QFQ

CLASSIFICATION ORDER

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Leica FL400 surgical microscope accessory filter

Leica

INDICATION FOR USE: Surgical microscope accessory filter set for viewing fluorescence of fluorophores comprising an excitation filter for blue spectral range 380 nm – 430 nm and an  observation filter comprising the long-wave blue, green, yellow and red spectrum in the spectral band greater than 444 nm.

Surgical microscope accessory used in fluorescent visualization of suspected grade III or IV gliomas during neurosurgery.

GENERIC DEVICE TYPE: Diagnostic neurosurgical microscope filter

• Device intended for use during neurosurgery to visualize fluorescence and enhance visualization of tissue associated with a specific disease or condition

RISKS and MITIGATIONS (SPECIAL CONTROLS):

•  False positive: visualization of fluorescence when in fact no target fluorophore is present: Non-clinical performance testing and Labeling
• False negative: no visualization of fluorescence when in fact the target fluorophore is present:  Non-clinical performance testing and Labeling

REG PATHWAY: De Novo request for Accessory

• Microscope cleared via 510(k) pathway
• De novo request for filter as ‘accessory’
• Regulation Number: 21 CFR 882.4950
• Regulation Name: Diagnostic neurosurgical microscope filter
• Regulatory Class: Class II
• Product Code: QFX

CLASSIFICATION ORDER

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Image credits: Fidia, Intellirod Spine, Gelesis, Leica