(111 days)
Not Found
No
The summary describes a mechanical device for meniscal repair and does not mention any software, algorithms, or data processing that would indicate the use of AI or ML.
Yes
The device is described as an "all-inside meniscal repair device" intended for "meniscal repair procedures" and is identified as a "suture retention device to facilitate endoscopic soft tissue procedures," indicating its use in treating a medical condition.
No
Explanation: The device is described as a "suture retention device to facilitate endoscopic soft tissue procedures" and an "all-inside meniscal repair device," directly indicating its therapeutic purpose (repair) rather than a diagnostic one (identifying a condition). Its function is to deploy implants for meniscal repair, not to detect or assess a medical condition.
No
The device description clearly outlines physical components (implants, sutures, needle delivery system, depth penetration limiter) and performance studies focus on physical characteristics and testing, indicating it is a hardware medical device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states it's a "suture retention device to facilitate endoscopic soft tissue procedures" and is "indicated for use in meniscal repair procedures." This describes a surgical implant and delivery system used in vivo (within the body) during a surgical procedure.
- Device Description: The description details a physical device with implants, sutures, and a needle delivery system. This is consistent with a surgical tool and implant, not a device used to test samples in vitro (outside the body).
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue, etc.), detecting analytes, or providing diagnostic information based on laboratory testing.
IVD devices are used to examine specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes. The FiberStitch™ device is a surgical tool and implant used to repair tissue directly within the body.
N/A
Intended Use / Indications for Use
The FiberStitch™ Meniscal Repair Device is intended for use as a suture retention device to facilitate endoscopic soft tissue procedures.
The FiberStitch™M Meniscal Repair Device is indicated for use in meniscal repair procedures.
Product codes (comma separated list FDA assigned to the subject device)
MBI
Device Description
The FiberStitch™ devices are an all-inside meniscal repair device. The devices include two non-absorbable polyester implants, pre-tied with #2-0 non-absorbable sutures and preloaded into a needle delivery system. The adjustable depth penetration limiter is preset to approximately 18mm from the tip of the needle. It can be adjusted down in 2 (mm) increments to approximately 10mm.
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)
Nonclinical testing was completed to demonstrate that the FiberStitch™ Implant, Curved with two Polyester Implants and 2-0 FiberWire® and FiberStitch™ Implant, Straight with two Polyester Implants and 2-0 FiberWire® meets the established performance characteristics, and to verify that design requirements are satisfied. Testing included biocompatibility evaluation per ISO 10993-1, ethylene oxide sterilization validation, and package qualification. Device testing included surface/visual, dimensional, mechanical and functional testing. It was concluded that the FiberStitch™ Implant, Curved with two Polyester Implants and 2-0 FiberWire® and the FiberStitch™ Implant, Straight with two Polyester Implants and 2-0 FiberWire® are as safe and effective as 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.
K121861, K111564, K132043, K943949
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/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: a symbol on the left and the FDA name and title on the right. The symbol on the left is a stylized representation of a human figure, while the text on the right reads "FDA U.S. FOOD & DRUG ADMINISTRATION" in blue letters.
T.A.G. Medical Products Corporation, Ltd. Anat Rozen RA Manager Gaaton 2513000, Israel
Re: K190125
Trade/Device Name: FiberStich™ Implant, Curved with two Polyester Implants and 2-0 FiberWire® FiberStitch™ Implant, Straight with two Polyester Implants and 2-0 FiberWire® Regulation Number: 21 CFR 888.3040 Regulation Name: Smooth or threaded metallic bone fixation fastener Regulatory Class: Class II Product Code: MBI Dated: April 3, 2019 Received: April 8, 2019
Dear Anat Rozen:
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/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, 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
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, fi 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, Ph.D. Assistant Director DHT6C: Division of Stereotaxic. Trauma and Restorative Devices OHT6: Office of Orthopedic Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known) K190125
Device Name
FiberStitch™ Implant, Curved with two Polyester Implants and 2-0 FiberWire® FiberStitch™ Implant, Straight with two Polyester Implants and 2-0 FiberWire®
Indications for Use (Describe)
The FiberStitch™ Meniscal Repair Device is intended for use as a suture retention device to facilitate endoscopic soft tissue procedures.
The FiberStitch™M Meniscal Repair Device is indicated for use in 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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K190125 Page 1 of 2
510(k) Summary
Pursuant to CFR 807.92, the following 510(k) Summary is provided:
| 1. | Submitter Address: | Shlomi Dines
T.A.G. Medical Products Corporation, Ltd.
Gaaton 2513000, ISRAEL
www.tag-med.com |
|----|----------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| | Mfg. Phone: | Tel.: 972-4-9858400 |
| | Contact Person: | Anat Rozen |
| | Date: | April 03, 2019 |
| 2. | Device & Classification
Name: | Suture Anchor, class II, 21 CFR 888.3040 Fastener, Fixation, Nondegradable, Soft
Tissue, product code MBI
FiberStitch™ Implant, Curved with two Polyester Implants and 2-0 FiberWire®
FiberStitch™ Implant, Straight with two Polyester Implants and 2-0 FiberWire® |
| 3. | Predicate Devices: | K121861- Smith & Nephew - ULTRA FAST-FIX Meniscal Repair System
K111564- Biomet Sports Medicine - Maxfire Marxmen Meniscal Repair Device
K132043- Arthrex Inc. - Arthrex SpeedCinch
K943949- LOOK – Polyviolene Surgical Suture |
| 4. | Description: | The FiberStitch™ devices are an all-inside meniscal repair device. The devices
include two non-absorbable polyester implants, pre-tied with #2-0
non-absorbable sutures and preloaded into a needle delivery system. The
adjustable depth penetration limiter is preset to approximately 18mm from the
tip of the needle. It can be adjusted down in 2 (mm) increments to
approximately 10mm. |
| 5. | Intended Use: | The FiberStitch™ Meniscal Repair Device is intended for use as a suture
retention device to facilitate endoscopic soft tissue procedures.
The FiberStitch™ Meniscal Repair Device is indicated for use in meniscal
repair procedures. |
| 6. | Comparison of
Technological
Characteristics: | With respect to its indication for use, the FiberStitch™ Implant, Curved
with two Polyester Implants and 2-0 FiberWire® and FiberStitch™
Implant, Straight with two Polyester Implants and 2-0 FiberWire® are
substantially equivalent to its predicate devices in their design which allows for the
devices to be endoscopically delivered from a single access point as the proposed
FiberStitch™ Implant, Curved with two Polyester Implants and 2-0 FiberWire® and
the FiberStitch™ Implant, Straight with two Polyester Implants and 2-0 FiberWire®
devices. Sutures material is similar to Maxfire Marxmen Meniscal Repair Device.
The clinical use is similar; devices are considered all-inside meniscal repair devices.
Conversely, FiberStitch™ Implant, Curved with two Polyester Implants and 2-0
FiberWire® and the FiberStitch™ Implant, Straight with two Polyester Implants and
2-0 FiberWire® are different than their predicate devices in geometry and details of
the operating mechanism while general dimensions are same. The deployment of
the sutures in FiberStitch™ Implant, Curved with two Polyester Implants and 2-0
FiberWire® and the FiberStitch™ Implant, Straight with two Polyester Implants and
2-0 FiberWire® is accomplished by rotating the wheel while for the predicate |
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MEDICAL PRODUCTS
devices deployment of sutures is accomplished by pushing the dedicated trigger. Suture materials are different albeit they are biocompatible. Nonclinical test discussion:
Nonclinical testing was completed to demonstrate that the FiberStitch™ Implant, Curved with two Polyester Implants and 2-0 FiberWire® and FiberStitch™ Implant, Straight with two Polyester Implants and 2-0 FiberWire® meets the established performance characteristics, and to verify that design requirements are satisfied. Testing included biocompatibility evaluation per ISO 10993-1, ethylene oxide sterilization validation, and package qualification. Device testing included surface/visual, dimensional, mechanical and functional testing. It was concluded that the FiberStitch™ Implant, Curved with two Polyester Implants and 2-0 FiberWire® and the FiberStitch™ Implant, Straight with two Polyester Implants and 2-0 FiberWire® are as safe and effective as the predicate devices.