The Modified Mitek 3.5mm Absorbable Suture Anchor System is intended for use in soft tissue to bone fixation in association with adequate post-operative immobilization.
The Mitek PANALOK 3.5mm Absorbable Anchor System is indicated for use in soft tissue to bone fixation in association with adequate post-operative immobilization as follows: OPEN PROCEDURES SHOULDER: 1. Bankart repair 2. SLAP lesion repair 3. Rotator cuff repair 4. a. Capsule shift/capsulo-labral reconstruction at the lesser tuberosity of the humerus b. Capsule shift/capsulo-labral reconstruction at the lesser tuberosity of the humerus 5. Biceps tenodesis 6. Acromio-clavicular separation ELBOW: 1. Biceps tendon/reattachment ANKLE: 1. Achilles tendon repair/reconstruction 2. Lateral stabilization 3. Medial stabilization at the medial talus site KNEE: 1. Medial collateral ligament repair 2. Lateral collateral ligament repair 3. Join capsule closure to anterior proximal tibia 4. Posterior oblique ligament or joint capsule to tibia repair 5. Extra capsular reconstruction/ITB tenodesis 6. Patellar ligament and tendon avulsion repairs ARTHROSCOPIC PROCEDURES SHOULDER: - Bankart repair 1. - 2. SLAP lesion repair - 3. Rotator cuff repair - Capsule shift repair (glenoid rim) 4.

Device Description

The Modified Mitek PANALOK 3.5mm Absorbable Suture Anchor System is designed to implant within a pre-drilled bone hole site and provide a means for firmly securing soft tissue to bone using sutures. The Modified Mitek PANALOK 3.5mm Absorbable Suture Anchor System includes a PLL (homopolymer poly (L(-)-lactide) anchor pre-threaded with ETHICON Absorbable poly (Llactide/glycolide) Surgical Suture, Undyed, two pre-attached surgical needles, and a pre-assembled disposable inserter. The system is supplied sterile and ready for use. Mitek instruments, drill and drill guide, are to be used to install the Mitek PANALOK 3.5mm Absorbable Suture Anchor. The drill bit creates a hole 3.5mm in diameter by 18mm deep. Poly (L(-)-lactide) polymer is nonpyrogenic.

AI/ML Overview

This submission describes a medical device, the Modified Mitek 3.5mm Absorbable Suture Anchor System, and its substantial equivalence to a predicate device, the Mitek 3.5mm Absorbable Suture Anchor System.

Here's an analysis of the provided text in relation to your request:

1. Table of Acceptance Criteria and Reported Device Performance

The provided text does not contain a table of acceptance criteria or specific quantitative performance metrics for the modified device. It makes a general statement about substantial equivalence.

2. Sample Size Used for the Test Set and Data Provenance

The document states: "Nonclinical laboratory testing was performed to assess the in vitro and in vivo strength and failure modes." However, it does not specify the sample size for this testing, nor does it provide details on data provenance (e.g., country of origin, retrospective or prospective).

3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications

This information is not mentioned in the provided document. The study described is non-clinical laboratory testing, not a study involving human expert assessment of a test set in the context of AI or diagnostic imaging.

4. Adjudication Method for the Test Set

This information is not applicable as the described study is non-clinical laboratory testing and does not involve human readers or adjudication processes.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

A Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not conducted or described in this document. The device is a surgical anchor, not an AI or diagnostic imaging system.

6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study

This concept is not applicable to the device described. The "device" is a physical surgical implant, not an algorithm.

7. Type of Ground Truth Used

The "ground truth" for the non-clinical laboratory testing would be the measured physical properties and performance characteristics of the Suture Anchor System (e.g., strength, failure modes) under specific experimental conditions. It's based on engineering and biomechanical principles, not expert consensus, pathology, or outcomes data in the traditional sense of diagnostic or AI studies.

8. Sample Size for the Training Set

There is no mention of a training set in this document. The device is a physical product, not an AI model that requires training data.

9. How the Ground Truth for the Training Set Was Established

As there is no training set mentioned, this information is not applicable.

Summary of the Study that Proves the Device Meets Acceptance Criteria (Based on Provided Text):

The provided text states:

"Nonclinical laboratory testing was performed to assess the in vitro and in vivo strength and failure modes."
"The modified device has the same technological characteristics as the predicate device. There are no changes in chemistry, material or composition. When compared to the predicate device, it only differs in that the ETHICON Absorbable poly (Llactide/glycolide) Surgical Suture, Undyed is being attached to its anchor system."
"Based on the 510(k) summaries and 510(k) statements (21 CFR 807) and the information provided herein, we conclude that the modified device is substantially equivalent to the predicate device under the Federal Food, Drug. and Cosmetic Act."

Interpretation:

The "acceptance criteria" appear to be broadly defined by the performance of the legally marketed predicate device. The study performed was non-clinical laboratory testing to evaluate the in vitro and in vivo strength and failure modes of the modified device. The conclusion of substantial equivalence is based on:

The modified device having the same technological characteristics (chemistry, material, composition) as the predicate.
The only difference being the specific suture being attached.
The results of the non-clinical laboratory testing demonstrating comparable strength and failure modes.

Therefore, the study proves substantial equivalence by showing that despite a minor modification (the specific suture), the core performance characteristics (strength, failure modes) are maintained through laboratory testing, aligning with the predicate device's established safety and effectiveness. The specific quantitative results of this testing, which would form the basis of the "reported device performance" against implied acceptance criteria, are not detailed in this summary.

Summary

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SECTION 7

SUMMARY OF SAFETY AND EFFECTIVENESS K970896

510(k) Summary of Safety and Effectiveness Information supporting claims of substantial equivalence, as defined under the Federal Food, Drug and Cosmetic Act, respecting safety and effectiveness is summarized below. For the convenience of the Reviewer, this summary is formatted in accordance with the Agency's final rule " ... 510(k) Summaries and 510(k) Statements..." (21 CFR 807) and can be used to provide a substantial equivalence summary to anyone requesting it from the Agency.

NEW DEVICE NAME: Modified Mitek 3.5mm Absorbable Suture Anchor System

PREDICATE DEVICE NAME: Mitek 3.5mm Absorbable Suture Anchor System

510(k) SUMMARY

Device Description

The Modified Mitek PANALOK 3.5mm Absorbable Suture Anchor System is designed to implant within a pre-drilled bone hole site and provide a means for firmly securing soft tissue to bone using sutures.

The Modified Mitek PANALOK 3.5mm Absorbable Suture Anchor System includes a PLL (homopolymer poly (L(-)-lactide) anchor pre-threaded with ETHICON Absorbable poly (Llactide/glycolide) Surgical Suture, Undyed, two pre-attached surgical needles, and a pre-assembled disposable inserter. The system is supplied sterile and ready for use. Mitek instruments, drill and drill guide, are to be used to install the Mitek PANALOK 3.5mm Absorbable Suture Anchor. The drill bit creates a hole 3.5mm in diameter by 18mm deep.

Poly (L(-)-lactide) polymer is nonpyrogenic.

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SUMMARY OF SAFETY AND EFFECTIVENESS, Continued)

Intended Use	The Modified Mitek 3.5mm Absorbable Suture Anchor Systemis intended for use in soft tissue to bone fixation in associationwith adequate post-operative immobilization.
Indications Statement	The Mitek PANALOK 3.5mm Absorbable Anchor System isindicated for use in soft tissue to bone fixation in associationwith adequate post-operative immobilization as follows:
OPEN PROCEDURES
SHOULDER:
	1.	Bankart repair
	2.	SLAP lesion repair
	3.	Rotator cuff repair
	4.	a. Capsule shift/capsulo-labral reconstruction at thelesser tuberosity of the humerus
		b. Capsule shift/capsulo-labral reconstruction at thelesser tuberosity of the humerus
	5.	Biceps tenodesis
	6.	Acromio-clavicular separation
ELBOW:
	1.	Biceps tendon/reattachment
ANKLE:
	1.	Achilles tendon repair/reconstruction
	2.	Lateral stabilization
	3.	Medial stabilization at the medial talus site
KNEE:
	1.	Medial collateral ligament repair
	2.	Lateral collateral ligament repair
	3.	Join capsule closure to anterior proximal tibia
	4.	Posterior oblique ligament or joint capsule to tibia repair
	5.	Extra capsular reconstruction/ITB tenodesis
	6.	Patellar ligament and tendon avulsion repairs
	Continued on next page

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SUMMARY OF SAFETY AND EFFECTIVENESS, Continued

Indication Statement (continued) ARTHROSCOPIC PROCEDURES

SHOULDER:

Bankart repair 1.
1. SLAP lesion repair
1. Rotator cuff repair
Capsule shift repair (glenoid rim) 4.

vitro and in viyo strength and failure modes.

Technological Characteristics

The modified device has the same technological characteristics as the predicate device. There are no changes in chemistry, material or composition. When compared to the predicate device, it only differs in that the ETHICON Absorbable poly (Llactide/glycolide) Surgical Suture, Undyed is being attached to its anchor system.

Performance Data

Conclusions

Based on the 510(k) summaries and 510(k) statements (21 CFR 807) and the information provided herein, we conclude that the modified device is substantially equivalent to the predicate device under the Federal Food. Drug. and Cosmetic Act.

Nonclinical laboratory testing was performed to assess the in

Gregory Jones Director, Regulatory Affairs ETHICON, Inc. Rt. #22, West Somerville, NJ 08876-0151

Date

Contact

March 10, 1997

Modified PANALOK Wedge Absorbable Suture Anchor System ETHICON, Inc.

(

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Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized eagle with three stripes representing the agency's mission. The eagle is encircled by the words "DEPARTMENT OF HEALTH & HUMAN SERVICES · USA" in a circular arrangement. The logo is simple and monochromatic.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

JUN - 9 1997

Mr. Gregory Jones Director, Requlatory Affairs ------Ethicon, Inc. P.O. Box 151 Somerville, New Jersey 08876-0151

参

Re : K970896 Trade Name: Mitek 3.5mm Panalok Wedqe Absorbable Suture Anchor System Regulatory Class: II Product Code: MAI Dated: March 10, 1997 Received: March 11, 1997

Dear Mr. Jones:

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 qeneral 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 Good Manufacturing Practice for Medical Devices: General (GMP) regulation (21 CFR Part 820) and that, through periodic

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GMP inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in requlatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your w 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 Gontrol provisions, or other Federal laws or regulations.

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 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 and additionally 809.10 for in vitro diagnostic devices), 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" (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
Radiological Health

Enclosure

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510(k) Number (if known): Device Name:

Indications for Use:

学

Modified Mitek 3.5mm PANALOK Wedge Absorbable Suture Anchor System

The Modified Mitek 3.5mm PANALOK Wedge Absorbable Suture Anchor System is indicated for use in soft tissue to bone fixation in association with adequate post operative ------------------------------------------------------------------------------------------------------------------------immobilization as follows:

Open Procedures

Arthroscopic Procedures

Shoulder:

Bankart repair 2. Slap lesion repair
Rotator cuff repair
Capsule shift repair

(glenoid rim)

Shoulder:

1. Bankart repair
1. Slap lesion repair
1. Rotator cuff repair
1. a. Capsule shift/capsulolabral reconstruction, at the anterior glenoid rim site

INDICATION FOR USE

b. Capsule shift/capsulolabral reconstruction at the lesser tuberosity of the humerus
1. Biceps tenodesis
1. Acromio-clavicular separation

Elbow:

1. Bicep tendon reattachment

Ankle:

1. Achilles tendon repair/reconstruction
1. Lateral stabilization
1. Medial stabilization at the talus site

Knee:

1. Media! collateral ligament repair
1. Lateral collateral ligament repair
1. Joint capsule closure to the anterior proximal tibia
1. Posterior oblique ligament or joint capsule to tibia repair
1. Extra capsular reconstruction/ITB tenodesis
1. Patellar ligament and tendon avulsion repairs

ﺮ ﺗﺒﺎﺭ ﭘﻪ ﺩﺭ ﺩﺭ ﺩﺭ ﺩﺭ ﺩﺭ ﺩﺭ ﺩﺭ ﺩﺭ ﺩﺭ ﺩﺭ ﺩﺭ ﺩﺭ ﺩﺭ ﺩﺭ ﺩﺭ ﺩﺭ ﺩﺭ ﺩﺭ ﺩﺭ ﺩﺭ ﺩﺭ ﺩﺭ ﺩﺭ ﺩﺭ ﺩﺭ ﺩﺭ ﺩﺭ ﺩﺭ ﺩﺭ ﺩﺭ ﺩﺭ ﺩﺭ ﺩﺭ ﺩﺭ ﺩﺭ ﺩﺭ ﺩﺭ ﺩﺭ ﺩﺭ ﺩﺭ ﺩﺭ ﺩﺭ ﺩﺭ ﺩﺭ ﺩﺭ ﺩﺭ ﺩﺭ ﺩﺭ ﺩﺭ ﺩﺭ ﺩﺭ ﺩﺭ ﺩﺭ ﺩﺭ ﺩ

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K970896

イン

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Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use	X	OR	Over-The Counter Use	X
(Per 21 CFR 801.109)
(Division Sign-Off)		(Optional Format 1-2-9G)
Division of General Restorative Devices
510(k) Number		K970891

Modified PANALOK Wedge Absorbable Suture Anchor System ETHICON, Inc.

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.