(84 days)
No
The summary describes a mechanical implant and its intended use and testing, with no mention of AI or ML.
Yes
The device is described as a "suture retention device to facilitate endoscopic soft tissue procedures" and is "indicated for use in rotator cuff and meniscal repair procedures," which are therapeutic interventions.
No
The FiberStitch™ Implant is described as a "suture retention device to facilitate endoscopic soft tissue procedures" and is indicated for "rotator cuff and meniscal repair procedures." This indicates it is a surgical implant used in treatment, not for diagnosis.
No
The device is described as an "Implant" and mentions "cadaveric evaluation and biomechanical tensile strength testing," which are indicative of a physical medical device, not software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states the device is for "use as a suture retention device to facilitate endoscopic soft tissue procedures" and is indicated for "rotator cuff and meniscal repair procedures." This describes a surgical implant used in vivo (within the body) during a procedure.
- IVD Definition: In Vitro Diagnostics (IVDs) are medical devices used to perform tests on samples taken from the human body, such as blood, urine, or tissue, to provide information about a person's health.
- Lack of IVD Characteristics: The description does not mention any testing of biological samples, analysis of bodily fluids, or diagnostic purposes.
Therefore, the FiberStitch™ Implant is a surgical device, not an IVD.
N/A
Intended Use / Indications for Use
The FiberStitch™ Implant is intended for use as a suture retention device to facilitate endoscopic soft tissue procedures. The FiberStitch™ Implant Device is indicated for use in rotator cuff and meniscal repair procedures.
Product codes (comma separated list FDA assigned to the subject device)
MBI
Device Description
Not Found
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
rotator cuff, meniscal
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)
Nonclinical testing discussion: To mitigate the risks of usability and functionality of the device due to the additional indication of rotator cuff repair, validation via cadaveric evaluation and biomechanical tensile strength testing was performed on the subject and reference 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.
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
September 7, 2022
Image /page/0/Picture/1 description: The image shows the logo for the U.S. Food and Drug Administration (FDA). The logo consists of two parts: on the left, there is an emblem representing the Department of Health & Human Services - USA, and on the right, there is the text "FDA U.S. FOOD & DRUG ADMINISTRATION" in blue. The word "FDA" is in a larger, bolder font, and the words "U.S. FOOD & DRUG" are stacked above the word "ADMINISTRATION".
T.A.G. Medical Products Corporation, Ltd Shlomi Dines RA/QA Director Gaaton 2513000, ISRAEL
Re: K221731
Trade/Device Name: FiberStitch™ Implant Regulation Number: 21 CFR 888.3040 Regulation Name: Smooth Or Threaded Metallic Bone Fixation Fastener Regulatory Class: Class II Product Code: MBI Dated: June 10, 2022 Received: June 15, 2022
Dear Shlomi Dines:
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/cdrh/cfdocs/cfpmp/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, 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 of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see
1
https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) 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 https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
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/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). 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 (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
For:
Laura C. Rose, Ph.D. Assistant Director DHT6C: Division of Restorative, Repair, and Trauma Devices OHT6: Office of Orthopedic Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
2
DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration
Indications for Use
510(k) Number (if known)
Device Name FiberStitch™ Implant
Indications for Use (Describe)
The FiberStitch™ Implant is intended for use as a suture retention device to facilitate endoscopic soft tissue procedures. The FiberStitch™ Implant Device is indicated for use in rotator cuff and meniscal repair procedures.
| Type of Use (Select one or both, as applicable) | |
|---|---|
| ☑ Prescription Use (Part 21 CFR 801 Subpart D) | ☐ Over-The-Counter Use (21 CFR 801 Subpart C) |
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3
510(k) Summary
Pursuant to CFR 807.92, the following 510(k) Summary is provided:
| 1. | Submitter Address: | T.A.G. Medical Products Corporation, Ltd.
Gaaton 2513000, ISRAEL
www.tag-med.com |
|----|----------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| | Mfg. Phone: | Tel.: 972-4-9858400 |
| | Contact Person: | Shlomi Dines |
| | Date: | September 1, 2022 |
| 2. | Device & Classification
Name: | Suture Anchor, class II, 21 CFR 888.3040 Fastener, Fixation, Nondegradable, Soft
Tissue, product code MBI
FiberStitch™ Implant |
| 3. | Predicate Device: | K190125 FiberStitch™ Implant, Curved with two Polyester Implants and 2-0
FiberWire®, FiberStitch™ Implant, Straight with two Polyester Implants and 2-0
FiberWire® |
| 4. | Reference Device: | K203117 TissueTak device |
| 5. | Indications for Use: | The FiberStitch™ Implant is intended for use as a suture retention device to
facilitate endoscopic soft tissue procedures. The FiberStitch™ Implant Device is
indicated for use in rotator cuff and meniscal repair procedures. |
| 6. | Comparison of
Technological
Characteristics: | In comparison to the predicate device, the FiberStitch™ Implant is
identical in design, materials and methods of manufacturing, shelf life,
sterilization and packaging. Bacterial endotoxin per USP was conducted to
demonstrate that the device meets pyrogen limit specifications. The proposed
device is labeled with an additional indication, rotator cuff repair. |
| | | In comparison to the absorbable reference predicate, the subject device is made
of nondegradable polyester. The reference predicate is manufactured from
PLGA8218. Both devices are indicated for rotator cuff repair. |
| | | Nonclinical testing discussion:
To mitigate the risks of usability and functionality of the device due to the
additional indication of rotator cuff repair, validation via cadaveric evaluation
and biomechanical tensile strength testing was performed on the subject and
reference devices. |
| | | Based on the testing conducted and comparison of technological characteristics
and intended use, it is concluded that the FiberStitch™ Implant is as safe and
effective as the predicate devices. |