The intended use of the Meniscal Dart is intended for use in the arthroscopic fixation of longitudinal, vertical meniscus lesions (bucket handle lesions) in the vascularized area of the meniscus (red-red and red-white areas).

Device Description

The Meniscal Dart is a device fabricated from L-PLA which is intended for meniscal repair. The device consists of a molded device with a back tab and barbs along its length. The device is inserted into the meniscus with the aid of an inserter instrument. Additional instruments include calibration instruments to measure the depth of the tear. The Meniscal Dart is provided in 3 sizes, 10, 11 and 13mm.

AI/ML Overview

The provided document describes the Innovasive Meniscal Dart, a bioabsorbable orthopedic fixation device. The 510(k) summary focuses on establishing substantial equivalence to a predicate device, the Biofix Arrow, rather than presenting a performance study with defined acceptance criteria and specific outcomes like sensitivity, specificity, or accuracy.

Therefore, many of the requested categories (e.g., specific acceptance criteria, sample sizes for test sets/training sets, expert qualifications, adjudication methods, MRMC studies, standalone performance, and ground truth methodologies) are not available in the provided text, as these are typically part of a comprehensive performance study. The document primarily reports on bench and animal testing comparing the device to a predicate.

Here's an analysis of the available information:

Acceptance Criteria and Device Performance

Acceptance Criteria	Reported Device Performance
Bench Testing:
- Fatigue Strength	Comparable to predicate device (Biofix Arrow) in vitro
- Performance under constant load	Assessed
- Weight loss	Assessed
- Intrinsic Viscosity	Assessed
Animal Testing:
- Efficacy	Demonstrated efficacy
- Functionality	Confirmed to function adequately to meet intended use

Study that Proves Device Meets Acceptance Criteria:

The document refers to two types of testing:

Bench Testing: This involved in vitro comparison of the Meniscal Dart's fatigue strength against a predicate device (Biofix Arrow). It also assessed the device's performance under constant load, weight loss, and intrinsic viscosity. The implicit acceptance criterion for fatigue strength would be non-inferiority or equivalence to the predicate device. For the other parameters, the "assessment" implies that the results were within acceptable ranges, though specific numerical criteria are not provided.
Animal Testing: This testing aimed to demonstrate the efficacy and confirm the adequate function of the Innovasive Meniscal Dart for its intended use. The implicit acceptance criteria here would be the successful repair of meniscal tears in an animal model, demonstrating the device's ability to hold the repair and that it functions as intended without adverse events that would preclude its use.

Detailed Information Not Available in the Provided Text:

Sample sizes used for the test set and the data provenance: Not specified.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable, as this was not a human observer study.
Adjudication method for the test set: Not applicable.
If a multi-reader multi-case (MRMC) comparative effectiveness study was done: No, this type of study was not mentioned.
If a standalone (i.e., algorithm only without human-in-the-loop performance) was done: Not applicable, as this is a physical medical device, not an AI algorithm.
The type of ground truth used:
- Bench Testing: Engineering measurements and comparisons to a predicate device's measured performance.
- Animal Testing: Histopathological and gross pathological examinations, clinical observations of repair success in an animal model.
The sample size for the training set: Not applicable, as this is not an AI/algorithm.
How the ground truth for the training set was established: Not applicable.

Summary

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K981340

JUN 2 2 1998

510(K) SUMMARY

1. SUBMITTER:

Innovasive Devices, Inc. 734 Forest St. Marlborough, MA 01752 Telephone: 508-460-8229

Contact: Eric Bannon, Vice President of Regulatory Affairs, Quality Assurance Date Prepared: April 10, 1998

2. DEVICE:

Innovasive Meniscal Dart Innovasive Momisear Dia .
Classification Name: Bioabsorbable Orthopedic Fixation Device Classification Namessive Devices Meniscal Dart

3. PREDICATE DEVICE:

The predicate devices used to determine substantial equivalence for the I he predicale devices used to Beterwas the Biofix Arrow marketed by Bioscience Ltd, Malvern, PA

4. DEVICE DESCRIPTION:

The Meniscal Dart is a device fabricated from L-PLA which is is intended for The Meniscal Dart is a device consists of a molded device with a back tab and barbs meniscal repair. The device is inserted into the meniscus with the aid of an inserter along its length. The device is inserted into the the the measure the mentiscus,
instrument. Additional instruments include calibration to 10, 11 and 12mm instrument. Additional misuallents mortue values canded in 3 sizes, 10, 11 and 13mm.

5. INTENDED USE:

The intended use of the Meniscal Dart is intended for use in the arthroscopic I he intended use of the Membed Date (bucket handle lesions (bucket handle lesions) IXXIIOn of longitudinal. Versive meniscus (red-red and red-white areas).
in the vascularized area of the meniscus (red-red and red-white areas).

6. COMPARISON OF CHARACTERISTICS:

The Meniscal Dart is fabricated from L-PLA, the same material as the Biotix The Meniscal Dart is lableated from II + Li , art using barbs along its length to hold Arrow. The design is also similar with the Dat asting of the gold be and

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Arrow in that the device is placed across the tear and the device used to approximate the tear. The Arrow does use a needle and cannula to place the device where the Dart does not.

The indications for use of the two devices are identical.

7. PERFORMANCE DATA:

The following performance data was provided in support of the substantial equivalence determination:

1. Bench Testing: Comparison of the fatigue strength of the Meniscal Dart in vitro compared to the predicate device. In addition, the performance of the device was assessed under constant load as was the weight loss and intrinsic viscocity.
1. Animal Testing: The testing demonstrated the efficacy of the Innovasive Meniscal Dart and confirmed that the device functions adequately to meet its intended use.

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Image /page/2/Picture/1 description: The image shows the logo for the Department of Health & Human Services (HHS). The logo consists of a stylized depiction of an eagle or bird-like figure with three curved lines representing its wings or feathers. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" is arranged in a circular fashion around the bird symbol.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

JUN 22 1998

Mr. Eric Bannon Vice President of Regulatory Affairs and Quality Assurance Innovasive Devices, Inc. 734 Forest Street Marlborough, Massachusetts -01752

Re: K981340 Innovasive Device Meniscal Dart Repair System Requlatory Class: II Product Codes: MAI and GAM Dated: April 10, 1998 Received: April 13, 1998

Dear Mr. Bannon:

We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to 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). 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.

If your device is classified (see above) into either class II (Special Controls) or class III (Premarket Approval), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 895. A substantially equivalent determination assumes compliance with the current Good Manufacturing Practice requirement, as set forth in the Quality System Regulation (QS) for Medical Devices: General requlation (21 CFR Part 820) and that, through periodic (QS) inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory In addition, FDA may publish further announcements action. concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.

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Page 2 - Mr. Eric Bannon

This letter will allow you to begin marketing your device as described in your 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your markets and thus, permits your device to proceed to the market.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4659. Additionally, for questions on oompriation and advertising of your device, please contact che office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to
premarket notification" (21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its internet address "http://www.fda.gov/cdrh/dsmamain.html".

Sincerely yours,

Celia M. Witten, Ph.D., M.D. Director Division of General and Restorative Devices Office of Device Evaluation Center for Devices and Radioloqical Health

Enclosure

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INDICATIONS FOR USE

The intended use of the Meniscal Screw is intended for use in the arthroscopic fixation of longitudinal vertical meniscus lesions (bucket handle lesions) located in the vascularized area of the meniscus (red-red and red-white areas).

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(Division Sign-Off) Division of General Restorative Devices 510(k) Number_KAK1340

Prescription Use .. (Per 21 CFR 801.109)

Regulation Number and Section

§ 888.3030 Single/multiple component metallic bone fixation appliances and accessories.

(a)
Identification. Single/multiple component metallic bone fixation appliances and accessories are devices intended to be implanted consisting of one or more metallic components and their metallic fasteners. The devices contain a plate, a nail/plate combination, or a blade/plate combination that are made of alloys, such as cobalt-chromium-molybdenum, stainless steel, and titanium, that are intended to be held in position with fasteners, such as screws and nails, or bolts, nuts, and washers. These devices are used for fixation of fractures of the proximal or distal end of long bones, such as intracapsular, intertrochanteric, intercervical, supracondylar, or condylar fractures of the femur; for fusion of a joint; or for surgical procedures that involve cutting a bone. The devices may be implanted or attached through the skin so that a pulling force (traction) may be applied to the skeletal system.(b)
Classification. Class II.