The RAPIDLOC-PDS Meniscal Repair System 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).

Device Description

The RAPIDLOC-PDS Meniscal Repair System consists of a two piece (polydiaxonone tophat and polylactic acid backstop) bioabsorbable meniscal tissue fixation implant mounted on a 2/0 pre-knotted PANACRYL braided long-term absorbable suture. It is applied using a cannulated needle and arthroscopic pusher.

AI/ML Overview

The provided text describes a 510(k) premarket notification for the Mitek RAPIDLOC-PDS Meniscal Repair System. This is a medical device, not a software algorithm or AI. Therefore, the questions related to acceptance criteria, study details for AI/software performance, ground truth, sample sizes for training/test sets, MRMC studies, and standalone algorithm performance are not applicable.

The submission focuses on demonstrating substantial equivalence to predicate devices based on non-clinical testing and shared technological characteristics.

Here's a summary of the relevant information provided:

Device: Mitek RAPIDLOC-PDS Meniscal Repair System

Device Type: Biodegradable Fixation Fastener for meniscal repair.

Intended Use: Arthroscopic fixation of longitudinal vertical meniscus lesions (bucket-handle lesions) located in the vascularized area of the meniscus (red-red and red-white areas).

Acceptance Criteria and Reported Device Performance:

Acceptance Criteria (Implied)	Reported Device Performance
Substantial equivalence to predicate devices (RAPIDLOC Meniscal Repair System and Mitek "H"-Fix Meniscal Fastener)	"Testing conducted to characterize performance of the RAPIDLOC-PDS Meniscal Repair System has demonstrated that it is substantially equivalent to the predicate devices and is suitable for the intended use specified."
Similar technological characteristics, design, and configuration to predicate devices.	"The proposed device has similar technological characteristics and is similar in design and configuration compared to the predicate devices."
Safety and performance acceptable for intended use.	"Based on 1) safety and performance data, and 2) similarities in design, operating principles, biocompatibility and sterilization method, The Mitek RAPIDLOC-PDS Meniscal Repair System has been shown to be substantially equivalent to predicate devices..."

Study that Proves the Device Meets Acceptance Criteria:

A "Summary of Non-clinical Test" was conducted. The document states: "Testing conducted to characterize performance of the RAPIDLOC-PDS Meniscal Repair System has demonstrated that it is substantially equivalent to the predicate devices and is suitable for the intended use specified."

Regarding AI/Software Specific Questions:

Sample size used for the test set and the data provenance: Not applicable, as this is a physical medical device, not an AI/software. No specific "test set" in the AI sense is mentioned.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable.
Adjudication method for the test set: Not applicable.
If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance: Not applicable.
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable.
The type of ground truth used: Not applicable. The "ground truth" for a physical device like this would be its physical and mechanical properties, biocompatibility, and functional performance, which are assessed through non-clinical testing.
The sample size for the training set: Not applicable.
How the ground truth for the training set was established: Not applicable.

Clinical Data:

The document explicitly states: "Clinical Data: Not Applicable". This indicates that the device's substantial equivalence and suitability for its intended use were established through non-clinical testing and comparison to predicate devices, without requiring new human clinical trials for this 510(k) submission.

Summary

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DEC 2 7 2002

23388

510(k) Summary (page 1 of 2)

Submitter's Name and Address:

Mitek Worldwide 249 Vanderbilt Avenue Norwood, MA 02062 Registration #1221934

Petra Smit, RAC, Sr. Project Manager Regulatory Affairs

781-251-3196 781-278-9578

October 8, 2002

Date Summary Prepared:

Device Trade Name:

Contact Person:

Phone Number:

Telefax Number:

Common name:

Classification Name:

Predicate Device(s):

Device Description:

Intended Use:

Mitek RAPIDLOC-PDS Meniscal Repair System

Biodegradable Fixation Fastener

Fastener, Fixation, Biodegradable Soft Tissue (Class II, 21 CFR 888.3030, Product code: 87 MAI)

RAPIDLOC Meniscal Repair System (K002406) Mitek "H"-Fix Meniscal Fastener (K970119)

The RAPIDLOC-PDS Meniscal Repair System is intended for use in the arthroscopic fixation of longitudinal vertical meniscus lesions (buckethandle lesions) located in the vascularized area of the meniscus (red-red and red-white areas).

SPECIAL 510(K)-PREMARKET NOTIFICATION: DEVICE MODIFICATION MITEK RAPIDLOC-PDS MENISCAL REPAIR SYSTEM

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510(k) Summary (page 2 of 2)

Technological Characteristics:	The proposed device has similar technologicalcharacteristics and is similar in design andconfiguration compared to the predicate devices.
Summary of Non-clinical Test:	Testing conducted to characterize performanceof the RAPIDLOC-PDS Meniscal RepairSystem has demonstrated that it is substantiallyequivalent to the predicate devices and issuitable for the intended use specified.
Clinical Data:	Not Applicable
Conclusion:	Based on 1) safety and performance data, and 2)similarities in design, operating principles,biocompatibility and sterilization method, TheMitek RAPIDLOC-PDS Meniscal RepairSystem has been shown to be substantiallyequivalent to predicate devices under the.

SPECIAL 510(K)-PREMARKET NOTIFICATION: DEVICE MODIFICATION MITEK RAPIDLOC-PDS MENISCAL REPAIR SYSTEM

Federal Food, Drug and Cosmetic Act.

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/2/Picture/1 description: The image shows the seal of the Department of Health & Human Services (HHS) of the United States. The seal features an abstract eagle design, with three stylized lines forming the body and wings. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular pattern around the eagle.

Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

OFC 2 7 2002

Ms. Petra C. Smit Sr. Project Manager, Regulatory Affairs Mitek Worldwide 249 Vanderbilt Avenue Norwood, Massachusetts 02062

Re: K023388

Trade/Device Name: Mitek RAPIDLOC-PDS Meniscal Repair System Regulation Number: 21 CFR 888.3030 Regulation Name: Single/Multiple Component Metallic Bone Fixation Appliances and Accessories Regulatory Class: Class II Product Code: JDR Dated: December 5, 2002 Received: December 6, 2002

Dear Ms. Smit:

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. Iisting 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 (PMA), 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 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); good manufacturing practice requirements as set 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.

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Page 2 - Ms. Petra Smit

This letter will allow you to begin marketing your device as described in your Section 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 device 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), please contact the Office of Compliance at (301) 594-4659. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html

Sincerely yours,

Mark M. Mulkerson

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

Enclosure

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Page 1 of 1

510(k) Number (if known):

Device Name: RAPIDLOC-PDS Meniscal Repair System

Indications for Use:

(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Mark N. Mellema

Division of General, Restorative and Neurological Decrees

510(k) Number: K023388

Prescription Use 7 4 (Per 21 CFR 801.109)

Over-the-Counter Use No

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.