(90 days)
Not Found
No
The device description and performance studies focus on the mechanical properties and substantial equivalence to predicate devices, with no mention of AI or ML.
Yes
The device is implanted to fixate ligaments and tendons requiring repair, which is a therapeutic intervention.
No
Explanation: The device is described as a titanium implant for the fixation of ligaments and tendons, and its performance studies focus on pull-out strength, not on diagnosing any condition.
No
The device description clearly states it is a "titanium implant assembled with #5 suture," indicating it is a physical hardware device, not software only.
Based on the provided information, the Parcus GFS is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states "fixation of ligaments and tendons in patients requiring ligament or tendon repair." This describes a surgical implant used in vivo (within the body) for structural support.
- Device Description: The description details a titanium implant with suture, designed to be surgically placed to suspend grafts. This is consistent with a surgical device, not a diagnostic test performed in vitro (outside the body) on biological samples.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue, etc.), detecting specific analytes, or providing diagnostic information about a patient's condition.
Therefore, the Parcus GFS is a surgical implant, not an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The Parcus GFS is indicated for use in the fixation of ligaments and tendons in patients requiring ligament or tendon repair.
Product codes (comma separated list FDA assigned to the subject device)
HWC, MBI, GAT
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
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.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 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.
0
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, LLC
839 South Neenah Ave.
Sturgeon Bay, WI 54234 |
|----------------------|-----------------------------------------------------------------------------------------------|
| Company Contact: | Barton Bracy
Phone: (920) 746-2972
Fax: (920) 746-8665 |
| Date Prepared: | March 30, 2009 |
| Trade Name: | Parcus GFS |
| Common Name: | Suture Retention Device |
| Classification Name: | Fastener, Fixation, Non-Degradable, Soft Tissue
21 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
1
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:
.
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.
:
839 S NEENAH AVE., STURGEON BAY, WI 54235
1
1-877-746-2972
:
.
:
2
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.
3
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
4
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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