(60 days)
No
The summary describes a mechanical fixation device made of titanium and focuses on its physical properties and performance in strength and elongation tests. There is no mention of software, algorithms, image processing, or any terms related to AI/ML.
Yes
The device is described as being used for "fixation of ligaments and tendons in patients requiring ligament or tendon repair", which directly indicates a therapeutic purpose.
No
The device is described as being used for the "fixation of ligaments and tendons," which is a treatment or repair function, not a diagnostic one.
No
The device description explicitly states the devices are made from medical grade titanium, indicating a hardware component.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for the fixation of ligaments and tendons in patients requiring ligament or tendon repair. This is a surgical procedure performed directly on the patient's body.
- Device Description: The device is a physical implant made of medical grade titanium, designed for surgical fixation.
- Lack of IVD Characteristics: An IVD is a medical device used to perform tests on samples taken from the human body (like blood, urine, tissue) to provide information about a person's health. This device does not perform any such tests on biological samples.
The device is a surgical implant used for mechanical support within the body, not for diagnostic testing of biological samples.
N/A
Intended Use / Indications for Use
The Parcus GFS Naked 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 Naked devices are designed for use in the fixation of ligaments and tendons in patients requiring ligament or tendon repair. The devices are made from medical grade titanium and 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 Naked were evaluated and testing was conducted on the worst case configurations. Devices were assembled with suture per the DFU 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 is a black and white logo for the U.S. Department of Health and Human Services. The logo features a stylized image of an eagle with three human profiles incorporated into its design. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular pattern around the eagle.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
November 20, 2015
Parcus Medical, LLC Mr. Paul Vagts RA/QA Manager 6423 Parkland Drive Sarasota, Florida 34243
Re: K152711
Trade/Device Name: Parcus GFS Naked Regulation Number: 21 CFR 888.3040 Regulation Name: Smooth or threaded metallic bone fixation fastener Regulatory Class: Class III Product Code: MBI Dated: October 21, 2015 Received: October 22, 2015
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 Parts 801); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set
1
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 Industry and Consumer Education 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. 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/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 Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely yours,
Mark N. Melkerson -S
Mark N. Melkerson Director Division of Orthopedic Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
2
Indications for Use
| 510(k) Number (if known): | K152711 |
|---|---|
| Device Name: | Parcus GFS Naked |
Indications for Use:
The Parcus GFS Naked are indicated for use in the fixation of ligaments and tendons in patients requiring ligament or tendon repair.
AND/OR Prescription Use __ X __
Over the Counter Use _________________________________________________________________________________________________________________________________________________________
(Part 21 CFR 801 Subpart D)
(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)
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K152711 Page 1 of 1
510(k) Summ
| Submitter: | Parcus Medical, LLC
6423 Parkland Dr
Sarasota, FL 34243 |
|----------------------|---------------------------------------------------------------------------------------------------------|
| Company Contact: | Paul Vagts
Phone: (941)755-7965
Fax: (941)755-6543 |
| Date Prepared: | September 17, 2015 |
| Device Trade Name: | Parcus GFS Naked |
| Common Name: | Ligament 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 GFS II Standard, GFS II Large
and GFS Mini, K133757, February 4, 2014. |
Device Description:
The Parcus GFS Naked devices are designed for use in the fixation of ligaments and tendons in patients requiring ligament or tendon repair. The devices are made from medical grade titanium and are provided sterile.
Intended Use:
The GFS Naked are indicated for use in the fixation of ligaments and tendons in patients requiring ligament or tendon repair.
Substantial Equivalence Summary:
The GFS Naked are very similar to the predicate Parcus Medical GFS, GFS II and GFS Mini devices in that they are comprised of the same materials, are intended for the same indications and utilize similar designs. While the GFS Naked are offered in both smaller and larger sizes, testing has shown that this does not raise any concerns regarding the safety or efficacy of the device.
Summary Performance Data:
The GFS Naked were evaluated and testing was conducted on the worst case configurations. Devices were assembled with suture per the DFU 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.