PANALOK RC QUICKANCHOR PLUS, MODEL 212130, 212730; DUAL SUTURE PANALOK RC QUICKANCHOR PLLUS, MODELS 212132, 212732 by Depuy Mitek

The Panalok RC QuickAnchor Plus and Dual Suture Panalok RC QuickAnchor Plus are intended for fixation of USP size #2 suture to bone for the indication listed below. Shoulder: Rotator cuff repair.

Device Description

The PANALOK RC QuickAnchor Plus is a preloaded disposable anchor/inserter assembly system designed to facilitate the fixation of USP size #2 suture to bone. The absorbable polylactic acid (PLA) anchor is the identical anchor as that of the Mitek Toggle Anchor, and the sutures are similar to those used in the Mitek Toggle Anchor System and other Mitek Anchor systems. The Panacryl and Ethibond sutures are manufactured by Ethicon, Inc. The absorbable anchor is a one-piece suture anchor constructed of molded Poly(1 - lactide) polymer.

The Dual Suture PANALOK RC QuickAnchor Plus is preloaded disposable anchor/inserter assembly system designed to facilitate the fixation of USP size #2 suture to bone. The absorbable polylactic acid (PI.A) anchor is similar to the Mitek Toggle Anchor; the only change is a dimensional change to accommodate two strands of suture instead of onc. The sutures are similar to those used in the Mitck Toggle Anchor System and other Mitek Anchor systems. The Panacryl and Ethibond sutures are manufactured by Ethicon, Inc. The absorbable anchor is a one-piece suture anchor constructed of molded Poly(Llactide) polymer.

AI/ML Overview

This document is a 510(k) Premarket Notification for the Panalok RC QuickAnchor Plus and Dual Suture Panalok RC QuickAnchor Plus. It is not an AI/ML device, therefore, the requested information pertaining to AI/ML device studies and performance metrics cannot be found or fabricated from the provided text.

The document describes a medical device, its intended use, and its classification, and asserts its substantial equivalence to a previously marketed device (Mitek Absorbable Toggle Anchor K964013).

Here's the information that can be extracted from the provided text, related to the device and its assessment:

1. Acceptance Criteria and Reported Device Performance:

The document primarily focuses on establishing "substantial equivalence" to a predicate device rather than defining new, specific performance acceptance criteria or reporting detailed performance metrics for this particular device in a table format.

Substantial Equivalence Basis: The core "acceptance criterion" for this 510(k) submission is that the Panalok RC QuickAnchor Plus and Dual Suture Panalok RC QuickAnchor Plus are substantially equivalent to the original Mitek Absorbable Toggle Anchor (K964013). This equivalence is based on:
- Representing the "same fundamental scientific technology."
- The Panalok RC QuickAnchor Plus uses an "identical anchor" to the Mitek Toggle Anchor.
- The Panalok RC QuickAnchor Plus uses "similar" sutures to those in the Mitek Toggle Anchor System.
- The Dual Suture Panalok RC QuickAnchor Plus is similar, with a "dimensional change to accommodate two strands of suture instead of one."
Safety "Performance":
- Biocompatibility: "Biocompatibility studies have demonstrated the Panalok RC QuickAnchor Plus and Dual Suture Panalok RC QuickAnchor Plus Anchors to be non-toxic, non-irritating, and non-cytotoxic." This is a key safety performance aspect, indicating the device meets biological safety requirements.

A table of acceptance criteria and reported device performance cannot be generated as the document does not contain this specific type of data for novel device performance, but rather a claim of substantial equivalence to a predicate device.

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective):

The document does not provide information on specific test set sample sizes or data provenance for performance testing. Biocompatibility studies are mentioned, but details of those studies (sample size, design, origin) are not included in this summary. The 510(k) process often relies on existing data or equivalence to predicate devices, and full study reports are typically not included in these summaries.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

Not applicable. This is a medical device submission, not a study evaluating an AI/ML system where expert ground truth for interpretation would be established.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:

Not applicable. This is a medical device submission, not a study requiring adjudication of expert interpretations for an AI/ML system.

5. 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. This is a medical device submission for a physical implantable device, not an AI/ML diagnostic tool.

6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done:

Not applicable. This is a medical device submission for a physical implantable device, not an AI/ML algorithm.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):

For the biocompatibility claims, the ground truth would be based on validated laboratory testing methods for toxicity, irritation, and cytotoxicity, rather than expert consensus on images or pathology in the context of an AI study.
For the substantial equivalence claim, the "ground truth" is the performance and safety profile of the predicate device (Mitek Absorbable Toggle Anchor K964013), established through its own regulatory clearance and post-market experience.

8. The sample size for the training set:

Not applicable. This is a physical medical device, not an AI/ML system requiring a training set.

9. How the ground truth for the training set was established:

Not applicable. This is a physical medical device, not an AI/ML system.

Summary

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MAY 2 8 2004

pg 1 of 2 K041117

510(k) Summary – Panalok RC QuickAnchor Plus and Dual Suture Panalok RC QuickAnchor Plus

Submitter's Name andAddress:	DePuy Miteka Johnson & Johnson Company249 Vanderbilt AvenueNorwood, MA 02062
Contact Person	Allyson BarfordRegulatory Affairs AssociateDePuy Miteka Johnson & Johnson Company249 Vanderbilt AvenueNorwood, MA 02062Telephone:Facsimile:e-mail:	781-251-2794781-278-9578abarford@dpyus.jnj.com
Name of Medical Device	Classification Name:	Screw, Fixation, Bone Staple
	Common/Usual Name:	Appliance for reconstruction of bone tosoft tissue
	Proprietary Name:	Panalok RC QuickAnchor PlusDual Suture Panalok RC QuickAnchor Plus
Device Classification	Screw, Fixation, Bone Staple devices have been classified as Class IIGAM and MAI according to 21 CFR 888.3030. No performancestandards have been established under Section 514 of the Food, Drugand Cosmetic Act for Screw, Fixation, Bone Staple devices.
Indications for Use	The Mitek Panalok RC QuickAnchor Plus and Dual Suture PanalokRC QuickAnchor Plus Anchors are intended for fixation of USP size#2 suture to bone for the indication listed below.Shoulder: Rotator cuff repair.
Device Description	The PANALOK RC QuickAnchor Plus is a preloaded disposableanchor/inserter assembly system designed to facilitate the fixation ofUSP size #2 suture to bone. The absorbable polylactic acid (PLA)anchor is the identical anchor as that of the Mitek Toggle Anchor, andthe sutures are similar to those used in the Mitek Toggle Anchor
Special 510(k) Premarket Notification: Panalok RC QuickAnchor Plus andDual Suture Panalok RC QuickAnchor Plus		CONFIDENTIAL

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pg 2 of 2

System and other Mitek Anchor systems. The Panacryl and Ethibond sutures are manufactured by Ethicon, Inc. The absorbable anchor is a one-piece suture anchor constructed of molded Poly(1 - lactide) polymer.

Substantial Equivalence Based on the degree of changes being made to the original Mitek Absorbable Toggle Anchor (K964013) and the fact that the Panalok RC QuickAnchor Plus and Dual Suture Panalok RC QuickAnchor Plus represent the same fundamental scientific technology as the original Mitek Absorbable Toggle Anchor; Mitek believes that the Panalok RC QuickAnchor Plus and Dual Suture Panalok RC Ouick Anchor Plus are substantially equivalent to the Mitek Absorbable Toggle Anchor manufactured by DePuy Mitek.

Biocompatibility studies have demonstrated the Panalok RC Safety QuickAnchor Plus and Dual Suture Panalok RC QuickAnchor Plus Anchors to be non-toxic, non-irritating, and non-cytotoxic.

CONFIDENTIAL

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/2/Picture/1 description: The image is a seal or logo. It features a circular design with text around the perimeter. The text reads "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA". Inside the circle is a symbol consisting of three curved lines that resemble a stylized caduceus or a similar emblem representing health or medicine. The overall design is simple and professional, likely used to represent a government agency or organization related to health and human services in the United States.

Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

MAY 2 8 2004

Allyson Barford Regulatory Affairs Associate Depuy Mitek a Johnson & Johnson Company 249 Vanderbilt Avenue Norwood, Massachusetts 02062

Rc: K041117 Trade/Device Name: Panalok RC QuickAnchor Plus Dual Suture Panalok RC QuickAnchor Plus Regulation Number: 21 CFR 888.3030 Regulation Name: Single/multiple component metallic bone fixation appliances and accessories Regulatory Class: II Product Code: JDR Dated: April 5, 2004 Received: April 29, 2004

Dear Ms. Barford:

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, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.

If your device is classified (see above) into cither 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 l'ederal 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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This letter will allow you to begin marketing your device as described in your Section 510(k) I mis letter will and wyour he FDA finding of substantial equivalence of your device to a legally marketed predicated 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 If you desire specific acries in 301) 594-4659. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the Division of Small other gollord 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,

Sincerely, John,

L. Mark A. Millman

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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INDICATIONS FOR USE

510(k) Number (if known): K041117

Device Names:

Panalok RC QuickAnchor Plus Dual Suture Panalok RC Quick Anchor Plus

Indications for Use:

The Panalok RC QuickAnchor Plus and Dual Suture Panalok RC QuickAnchor Plus are intended for fixation of USP size #2 suture to bone for the indication listed below. Shoulder: Rotator cuff repair.

Mark N Milhason

and Neurological Devices

510(k) Number K041117

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

X Prescription Use _

Over-the-Counter Use_

Special 510(k) Premarket Notification: Panalok RC QuickAnchor Plus and Dual Suture Panalok RC QuickAnchor Plus DePuy Mitek

CONFIDENTIAL

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.