(66 days)
Not Found
No
The 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 described as being used for "fixation of ligaments and tendons in patients requiring ligament or tendon repair," which directly addresses an injury or disease and restores function, thus classifying it as a therapeutic device.
No
This device is not a diagnostic device. It is an implantable device used for the fixation of ligaments and tendons, as indicated by its "Intended Use" and "Device Description", which describe it as being "designed for use in the fixation of ligaments and tendons in patients requiring ligament or tendon repair" and made from "medical grade titanium and UHMWPE suture". Diagnostic devices are used to detect or identify a disease or condition, which is not the function of this device.
No
The device description explicitly states the device is made from medical grade titanium and UHMWPE suture, indicating it is a physical implant, not software.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In vitro diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections. They are used to provide information for diagnosis, monitoring, or screening.
- Device Description and Intended Use: The description clearly states the device is a physical implant ("made from medical grade titanium and UHMWPE suture") used for the "fixation of ligaments and tendons in patients requiring ligament or tendon repair." This is a surgical implant used in vivo (within the body) for structural support and repair.
- Lack of Biological Sample Testing: There is no mention of the device being used to test biological samples or provide diagnostic information based on such testing.
Therefore, based on the provided information, the Parcus GFS BTB is a surgical implant, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
The Parcus GFS BTB are 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)
MBI
Device Description
The Parcus GFS BTB is 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 UHMWPE suture and are intended on being used in conjunction with other Parcus Medical devices such as the GFS Ultimate, GFS Mini and GFS II. The GFS BTB is 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 (study type, sample size, AUC, MRMC, standalone performance, key results)
The GFS BTB was evaluated and testing was conducted on the worst case configurations. Devices were assembled per the IFU 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 (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.
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Image /page/0/Picture/0 description: The image contains two logos. On the left is the Department of Health & Human Services logo. On the right is the FDA (U.S. Food & Drug Administration) logo.
February 7, 2019
Parcus Medical, LLC Paul Vagts Director of Regulatory Affairs 6423 Parkland Drive Sarasota, Florida 34243
Re: K183331
Trade/Device Name: Parcus GFS BTB Regulation Number: 21 CFR 888.3040 Regulation Name: Smooth or threaded metallic bone fixation fastener Regulatory Class: Class II Product Code: MBI Dated: January 7, 2019 Received: January 8, 2019
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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrl/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, 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
1
801); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/CombinationProducts/GuidanceRegulatoryInformation/ucm597488.html; good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
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 comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
Laurence D. Coyne -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
Form Approved: OMB No. 0910-0120 Expiration Date: 06/30/2020 See PRA Statement below.
510(k) Number (if known) K183331
Device Name Parcus GFS BTB
Indications for Use (Describe)
The Parcus GFS BTB are indicated for use in the fixation of ligaments and tendons in patients requiring ligament or tendon repair.
Type of Use (Select one or both, as applicable)
X Prescription Use (Part 21 CFR 801 Subpart D)
Over-The-Counter Use (21 CFR 801 Subpart C)
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DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.
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Surgical Innovation | Customer Driven
510(k) Summary
| 510(k): | K183331 |
|---|---|
| 510(k) Owner: | Parcus Medical, LLC |
| 6423 Parkland Dr | |
| Sarasota, FL 34243 | |
| Company Contact: | Paul Vagts |
| Phone: (941)755-7965 | |
| Fax: (941)755-6543 | |
| Date Prepared: | January 7, 2019 |
| Device Trade Name: | GFS BTB |
| 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 Parcus GFS |
| Ultimate, K162198, cleared November 18th, 2016, | |
| and the Parcus GFS II and GFS Mini, K133757, | |
| cleared February 4, 2014. |
Device Description:
The Parcus GFS BTB is 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 UHMWPE suture and are intended on being used in conjunction with other Parcus Medical devices such as the GFS Ultimate, GFS Mini and GFS II. The GFS BTB is provided sterile.
Intended Use:
The GFS Ultimate are indicated for use in the fixation of ligaments and tendons in patients requiring ligament or tendon repair.
Substantial Equivalence Summary:
The GFS BTB is very similar to the predicate Parcus Medical GFS devices in that it is comprised of the same materials, intended for the same indications and utilizes similar designs. LAL testing was conducted on a representative device comprised of the same materials and general construction. The results of this testing met the
PARCUSMEDICAL.COM 6423 Parkland Drive, Sarasota, FL 34243
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Surgical Innovation | Customer Driven
acceptance criteria described in the FDA recognized standard and therefore it was concluded that the GFS BTB does not raise any additional concerns regarding pyrogenicity. While the GFS BTB is used in addition to other GFS devices and secures the graft to it, testing has shown that this does not raise any concerns regarding the safety or efficacy of the device.
Summary Performance Data:
The GFS BTB was evaluated and testing was conducted on the worst case configurations. Devices were assembled per the IFU 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.