(90 days)
The Parcus GFS is indicated for use in the fixation of ligaments and tendons in patients requiring ligament or tendon repair.
The Parcus GFS is a titanium implant assembled with #5 suture threaded through four holes. The loops created by this process vary in length from 10mm and are used to suspend the graft. The titanium portion of the assembly is supplied in sizes, Standard and Large, to accommodate tunnels of different diameters.
The provided text describes the Parcus GFS, a suture retention device, and its substantial equivalence to predicate devices, focusing on mechanical performance. However, the document does not contain details about acceptance criteria, the specific study design, or many of the specific information points requested in the prompt (e.g., sample sizes for test/training sets, expert qualifications, etc.). The information provided is primarily a 510(k) summary for regulatory approval.
Here's the information that can be extracted or inferred from the provided text, along with a clear indication of what is not available:
1. Table of Acceptance Criteria and Reported Device Performance:
| Acceptance Criteria (Inferred from "Substantially Equivalent") | Reported Device Performance |
|---|---|
| Mechanical properties (e.g., pull-out strength) comparable to predicate devices. | Pull-out strength for both Standard and Large GFS was measured. "Results of the pull-out testing demonstrated that the Parcus GFS is substantially equivalent to the predicate devices." |
Explanation of Inference: The core of a 510(k) submission for this type of device often revolves around demonstrating mechanical equivalence to legally marketed predicate devices. While explicit numerical acceptance criteria are not given, the statement "substantially equivalent" implies that the tested performance met the unstated, expected mechanical performance profile of the predicate devices.
2. Sample size used for the test set and the data provenance:
- Sample Size for Test Set: Not specified.
- Data Provenance: The testing was conducted by Parcus Medical, LLC as part of their 510(k) submission. The exact location of the testing is not stated, but the company is based in Sturgeon Bay, WI, USA. The data is retrospective in the sense that it's presented to justify an existing device for market approval, but it represents prospective testing performed specifically for the submission.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Number of Experts: Not applicable/not specified. The "ground truth" for this type of device is its mechanical performance (e.g., pull-out strength), which is measured objectively, not established by expert consensus.
- Qualifications of Experts: Not applicable.
4. Adjudication method for the test set:
- Adjudication method: Not applicable. Mechanical test results do not involve adjudication by experts.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:
- MRMC Study: No, this type of study is not relevant to a mechanical orthopedic device like the Parcus GFS, which is not an AI-powered diagnostic tool. The document describes mechanical testing, not a clinical study involving human readers or AI.
- Effect Size of AI Improvement: Not applicable.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Standalone Performance: Not applicable. This device is not an algorithm or AI.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- Type of Ground Truth: Objective mechanical test results, specifically "pull-out strength."
8. The sample size for the training set:
- Sample Size for Training Set: Not applicable. This device is not an AI/machine learning model that requires a training set. The "training" for such a device would be its manufacturing and quality control processes.
9. How the ground truth for the training set was established:
- Ground Truth Establishment for Training Set: Not applicable. (See #8)
In summary, the provided document is a regulatory submission for a physical medical device (suture retention device) and describes its mechanical performance by comparing it to predicate devices. It does not involve AI, diagnostic imaging, or expert-driven evaluations as typically seen in studies for AI-powered medical devices. Therefore, much of the requested information is not present or relevant to this specific HWC/MBI product code.
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Image /page/0/Picture/1 description: The image shows the logo for PARCUS Medical, LLC. The word "PARCUS" is in large, bold, black letters. To the right of the word "PARCUS" and slightly below it, the words "Medical, LLC" are written in a smaller, lighter font.
SURGICAL INNOVATION >> VALUE DRIVEN
JUN 30 2009
510(k) Summary
| Submitter: | Parcus Medical, LLC839 South Neenah Ave.Sturgeon Bay, WI 54234 |
|---|---|
| Company Contact: | Barton BracyPhone: (920) 746-2972Fax: (920) 746-8665 |
| Date Prepared: | March 30, 2009 |
| Trade Name: | Parcus GFS |
| Common Name: | Suture Retention Device |
| Classification Name: | Fastener, Fixation, Non-Degradable, Soft Tissue21 CFR 888.3040 - Product Code HWC and MBI |
Predicate Devices:
Device Description:
The Parcus GFS is a titanium implant assembled with #5 suture threaded through four holes. The loops created by this process vary in length from 10mm and are used to suspend the graft. The titanium portion of the assembly is supplied in sizes, Standard and Large, to accommodate tunnels of different diameters.
Intended Use:
The Parcus GFS is indicated for use in the fixation of ligaments and tendons in patients requiring ligament or tendon repair.
Substantial Equivalence Summary:
The Parcus GFS is substantially equivalent to the predicate device listed above in which the basic features and intended uses are the same. Any differences between the GFS and the predicate device are considered minor and do not raise questions concerning safety and effectiveness.
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1-877-746-2972
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Image /page/1/Picture/0 description: The image shows the logo for PARCUS Medical, LLC. The logo is in black and white, with the word "PARCUS" in large, bold letters. To the right of the word "PARCUS" is the text "Medical, LLC" in a smaller font. The logo is simple and professional.
Surgical Innovation >> Value Driven
Summary Performance Data:
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The pull out strength was measured for both the Standard and Large GFS. Side by side comparisons were done with the predicate devices and results of the pull-out testing demonstrated that the Parcus GFS is substantially equivalent to the predicate devices.
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839 S NEENAH AVE., STURGEON BAY, WI 54235
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1-877-746-2972
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DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a stylized eagle with its wings spread, and the words "DEPARTMENT OF HEALTH & HUMAN SERVICES, USA" arranged in a circle around the eagle. The eagle is depicted in a simple, abstract style, with bold lines forming its shape. The text is in a sans-serif font and is arranged to follow the curve of the circle.
Public Health Service
JUN 30 2009
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Parcus Medical, LLC % Mr. Barton Bracy VP Marketing and Product Development 839 South Neenah Avenue Sturgeon Bay, Wisconsin 54234
Re: K090923
Trade/Device Name: Parcus GFS Regulation Number: 21 CFR 888.3040 Regulation Name: Smooth or threaded metallic bone fixation fastener Regulatory Class: II Product Codes: MBI, GAT Dated: March 30, 2009 Received: April 1, 2009
Dear Mr. Bracy:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations. Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act . or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
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Page 2 - Mr. Barton Bracy
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to http://www.fda.gov/cdrh/mdr/ for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours,
Stabara Buchun
Mark N. Melkerson Director Division of Surgical, Orthopedic, and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known): K090223
Device Name: _Parcus GFS
Indications for Use:
The Parcus GFS is indicated for use in the fixation of ligaments and tendons in patients requiring ligament or tendon repair.
Prescription Use __ X_ (Part 21 CFR 801 Subpart D) AND/OR
Over the Counter Use _ (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE – CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
| Jonetr | |
|---|---|
| for (Division Sign-Off) | |
| Division of Surgical, Orthopedic, | |
| and Restorative Devices |
| 510(k) Number | K090923 |
|---|---|
| --------------- | --------- |
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§ 888.3040 Smooth or threaded metallic bone fixation fastener.
(a)
Identification. A smooth or threaded metallic bone fixation fastener is a device intended to be implanted that consists of a stiff wire segment or rod made of alloys, such as cobalt-chromium-molybdenum and stainless steel, and that may be smooth on the outside, fully or partially threaded, straight or U-shaped; and may be either blunt pointed, sharp pointed, or have a formed, slotted head on the end. It may be used for fixation of bone fractures, for bone reconstructions, as a guide pin for insertion of other implants, or it may be implanted through the skin so that a pulling force (traction) may be applied to the skeletal system.(b)
Classification. Class II.