(55 days)
Not Found
No
The 510(k) summary describes a mechanical device for ligament and tendon fixation and does not mention any AI or ML components or functionalities.
Yes
The device is indicated for fixation of ligaments and tendons, which directly addresses a medical condition (ligament/tendon repair) and aids in restoring normal function.
No
The device is described as "designed for use in the fixation of ligaments and tendons," which indicates a therapeutic or surgical function, not a diagnostic one. It doesn't mention identifying, assessing, or monitoring a disease or condition.
No
The device description explicitly states the devices are made from Ultra High Molecular Weight Polyethylene (UHMWPE) and titanium, indicating they are physical hardware components, not software only.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices used to examine specimens taken from the human body (like blood, urine, tissue) to provide information about a person's health. This testing is done outside of the body (in vitro).
- Device Description: The Parcus GFS II and GFS Mini are described as devices for the fixation of ligaments and tendons within the body during surgical repair. They are made of materials like UHMWPE and titanium and are implanted.
- Intended Use: The intended use is for surgical repair of ligaments and tendons, not for testing biological samples.
The description clearly indicates a surgical implant used in vivo (within the body), not a device for in vitro testing of samples.
N/A
Intended Use / Indications for Use
The GFS II and GFS Mini are indicated for use in the fixation of ligaments and tendons in patients requiring ligament or tendon repair.
Product codes
MBI
Device Description
The Parcus GFS II and GFS Mini are designed for use in the fixation of ligaments and tendons in patients requiring ligament or tendon repair. The devices are made from Ultra High Molecular Weight Polyethylene (UHMWPE) and titanium. The GFS II and GFS Mini are provided sterile.
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
The GFS II and GFS Mini were evaluated and testing was conducted on the worst case configurations. Devices were assembled with simulated grafts and placed in a test fixture. Devices were evaluated for strength and elongation under cycle loading and ultimate failure conditions. Results were compared with test data for the predicate device and demonstrated substantial equivalency.
Key Metrics
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
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.
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Image /page/0/Picture/1 description: The image shows the logo for PARCUS MEDICAL, LLC. The logo is in black and has a stylized font. The date "FEB - 4 2014" is to the right of the company name.
510(k) Summary
| Submitter: | Parcus Medical, LLC
6423 Parkland Dr
Sarasota, FL 34243 |
|----------------------|---------------------------------------------------------------------------------------|
| Company Contact: | Paul Vagts
Phone: (941)755-7965
Fax: (941)755-6543 |
| Date Prepared: | December 6, 2013 |
| Device Trade Name: | GFS II Standard
GFS II Large
GFS Mini |
| Common Name: | Suture Retention Device |
| Device Class: | Class II |
| Classification Name: | Fastener, Fixation, Non-Degradable, Soft Tissue 21 CFR
888.3040 - Product Code MBI |
| Predicate Device: | The predicate devices are the Parcus Graft Fixation System,
K090923 June 30, 2009 |
Device Description:
The Parcus GFS II and GFS Mini are designed for use in the fixation of ligaments and tendons in patients requiring ligament or tendon repair. The devices are made from Ultra High Molecular Weight Polyethylene (UHMWPE) and titanium. The GFS II and GFS Mini are provided sterile.
Intended Use:
The GFS II and GFS Mini are indicated for use in the fixation of ligaments and tendons in patients requiring ligament or tendon repair.
Substantial Equivalence Summary:
The GFS II and GFS Mini are very similar to the predicate Parcus Medical GFS device in that they are comprised of the same materials, are intended for the same indications and utilize similar designs. While the GFS II and GFS Mini are offered in more suture loop configurations than the predicate GFS device, testing has shown that this does not raise any concerns regarding the safety or efficacy of the device
Summary Performance Data:
The GFS II and GFS Mini were evaluated and testing was conducted on the worst case configurations. Devices were assembled with simulated grafts and placed in a test fixture. Devices were evaluated for strength and elongation under cycle loading and ultimate failure conditions. Results were compared with test data for the predicate device and demonstrated substantial equivalency.
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Image /page/1/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized depiction of an eagle or bird-like figure with three curved lines representing its wings or body. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the bird-like figure.
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
February 4, 2014
Parcus Medical, LLC Mr. Paul Vagts Regulatory Affairs / Quality Assurance Manager 6423 Parkland Drive Sarasota, Florida 34243
Re: K133757
Trade/Device Name: Parcus GFS II and GFS Mini Regulation Number: 21 CFR 888.3040 Regulation Name: Smooth or threaded metallic bone fixation fastener Regulatory Class: Class II Product Code: MBI Dated: January 07, 2014 Received: January 08, 2014
Dear Mr. Vagts:
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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
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
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Page 2 - Mr. Paul Vagts
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.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Small Manufacturers, International and Consumer Assistance at its tollfree number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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/MedicalDevices/Safety/ReportaProblem/default.htm 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 (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.
Sincerely vours.
Vincen Digevlin -S
- for
Mark N. Melkerson Director Division of Orthopedic Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Indications for Use
K133757 510(k) Number (if known): Device Name: Parcus GFS II and GFS Mini
Indications for Use:
The Parcus GFS II and GFS Mini are indicated for use in the fixation of ligaments and tendons in patients requiring ligament or tendon repair.
Prescription Use ___________ AND/OR (Part 21 CFR 801 Subpart D)
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)
Casey L. Hanley, Ph.D.
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Division of Orthopedic Devices
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