Mitek Sports Medicine Arthroscopes are indicated for use in arthroscopic procedures (such as the knee, shoulder, hip, ankle, elbow) to provide visualization during surgery.

Device Description

The Mitek Arthroscope is a multi-angle, rigid 4.3 mm arthroscope that has the capability of varying direction of view from 10° to 90° which enables surgeons to maximize and optimize their field of view inside the joint from any given port. This reduces the need for multiple fixed-angle arthroscopes. The direction of view is altered by the direction of view dial; the direction of view is indicated by markings on the scope body. The Mitek Arthroscope provides a 55° field of view and a depth of field from 5mm to 40mm. The device shaft can also rotate by rotating the device (typically by the light post). A standard eyepiece located on the proximal end of the device is compatible with a standard camera coupler. The light post on the subject device is compatible with an ACMI light source. There are two light post stainless steel adaptors that accompany the Mitek Arthroscope. Two adapters are provided to facilitate connection with medical light source cables with a diameter of 5.0mm and smaller. The Mitek Arthroscope is a reusable device and must be cleaned and sterilized according to the user manual prior to every use.

AI/ML Overview

This document describes the premarket notification (510(k)) for the Mitek Arthroscope, a medical device.

Here's the breakdown of the requested information:

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria are implicitly defined by the successful adherence to recognized standards and the passing of all specific tests.

Acceptance Criteria (Implied by Standards & Tests)	Reported Device Performance
Performance:
Field of View meets specifications	Passed
Fixed Focus meets specifications	Passed
Direction of View Range meets specifications	Passed
Direction of View Torque meets specifications	Passed
Rotation of View meets specifications	Passed
Illumination meets specifications	Passed
Scope Resolution meets specifications	Passed
Visual Inspection meets specifications	Passed
Hermetic sealing meets specifications	Passed
Free from aberrations	Passed
Cleaning & Sterilization:
Cleaning validation (conforms to ISO 17664)	Performed & Conforms
Sterilization (Moist Heat, EO) Validation (conforms to ANSI/AAMI/ISO 17665-1, ISO 11135-01)	Performed & Conforms
Biocompatibility:
Evaluation and testing (conforms to ISO 10993-1)	Performed & Conforms
Electrical Safety:
Basic Safety & Essential performance (conforms to EN 60601-18)	Performed & Conforms
Electromagnetic compatibility (conforms to IEC 60601-1-2)	Performed & Conforms

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

The document does not explicitly state the sample size for the individual performance tests (Field of View, Fixed Focus, etc.). It mentions that "Verification tests of the Mitek Arthroscope included performance, cleaning validation and biocompatibility." The data provenance is not specified, but these are likely internal laboratory tests performed by the manufacturer. It is a prospective study in the sense that the tests were performed on the newly developed device to demonstrate its performance.

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

This device is an arthroscope, a medical instrument, not an AI or diagnostic device. Therefore, the concept of "ground truth established by experts" in the context of interpretation of medical images or data is not applicable here. The "ground truth" for the performance tests would be the established engineering specifications and measurement standards.

4. Adjudication Method for the Test Set

The document does not describe an adjudication method in the context of multiple observers or interpretations, as this is a device performance test, not a diagnostic study. The "adjudication" is implied by the "Passed" results against established criteria.

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

No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done. This type of study is typically performed for diagnostic devices or AI systems to assess their impact on human reader performance. The Mitek Arthroscope is a surgical visualization device.

6. Standalone Performance Study

Yes, a standalone performance study was done. The "Summary of Testing" table (Table 3) directly presents the results of various performance tests of the Mitek Arthroscope itself (e.g., Field of View, Fixed Focus, Scope Resolution). The entire "Non-Clinical Testing" section describes these standalone performance assessments.

7. Type of Ground Truth Used

The ground truth used for the performance tests was based on engineering specifications and recognized national and international standards. For example, DIN ISO 8600-3:2004 (Optics and optical instruments -- Medical endoscopes and endoscopic accessories -- Part 3: Determination of field of view and direction of view of endoscopes with optics) explicitly defines how certain optical parameters should be measured and what constitutes acceptable performance. Similarly, other standards like EN 60601-18 and ISO 10993-1 provide the "ground truth" for electrical safety and biocompatibility, respectively.

8. Sample Size for the Training Set

This document describes the clearance of a physical medical device (an arthroscope), not an AI or machine learning algorithm. Therefore, there is no "training set" in the context of machine learning. The device is manufactured based on design specifications.

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

As there is no training set for an AI algorithm in this context, this question is not applicable.

Summary

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510(k) SUMMARY

K133941 Page 1 of 4 APR 1 8 2014

Mitek Arthroscope

Recognized Manufacturer:	Medos International SarLPuits Godet 20CH 2000 NeuchâtelSwitzerland
Submitter:	DePuy Mitek, Inc.a Johnson & Johnson company325 Paramount DriveRaynham, MA 02767
Contact Person	Susan KaganProject Manager,Regulatory AffairsDePuy Mitek, Inc.a Johnson & Johnson company325 Paramount DriveRaynham, MA 02767, USA	Telephone: 508-880-8097Facsimile: 508-977-6911e-mail: SKagan@its.jnj.com
Name of Medical Device	Proprietary Name: SwingScopeClassification Name: ArthroscopeCommon Name: Arthroscope
Substantial Equivalence	Mitek Arthroscopes are substantially equivalent to the predicate devices listed in Table1.Table 1: Predicate Devices

Premarket Notification: Traditional 510(k) Mitek Arthroscopes

Page 1

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DeviceClassification	Classification:	Class II
	FDA Product Code:	HRX Arthroscope
	Regulation:	21 CFR 888.1100

Device The Mitek Arthroscope is a multi-angle, rigid 4.3 mm arthroscope that Description has the capability of varying direction of view from 10° to 90° which enables surgeons to maximize and optimize their field of view inside the joint from any given port. This reduces the need for multiple fixed-angle arthroscopes.

The direction of view is altered by the direction of view dial; the direction of view is indicated by markings on the scope body. The Mitek Arthroscope provides a 55° field of view and a depth of field from 5mm to 40mm. The device shaft can also rotate by rotating the device (typically by the light post). A standard eyepiece located on the proximal end of the device is compatible with a standard camera coupler. The light post on the subject device is compatible with an ACMI light source.

There are two light post stainless steel adaptors that accompany the Mitek Arthroscope. Two adapters are provided to facilitate connection with medical light source cables with a diameter of 5.0mm and smaller.

The Mitek Arthroscope is a reusable device and must be cleaned and sterilized according to the user manual prior to every use.

Indications Mitek Sports Medicine Arthroscopes are indicated for use in arthroscopic for Use procedures (such as the knee, shoulder, hip, ankle, elbow) to provide visualization during surgery.

Non-Clinical No clinical studies are required to demonstrate safety and efficacy of the Testing device in support of an application for premarket clearance. The Mitek Arthroscope does not differ from the predicate device in fundamental scientific technology or intended use.

Verification tests of the Mitek Arthroscope included performance, cleaning validation and biocompatibility to show that the device meets its product specifications over a range of operating conditions.

Premarket Notification: Traditional 510(k) Mitek Arthroscopes

Page 2

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Verification testing conforms to the following Standards and Guidance documents listed in Table 2.

Safety andPerformance	Standard/Guidance	Description
	EN 60601-18	Medical electrical equipment -- Part 18: Particular Requirementsfor Basic Safety and Essential performance of endoscopicequipment
	ANSI/AAMI/ISO17665-1	Sterilization of Healthcare Products-Moist Heat-Part 1:Requirements For The Development, Validation And RoutineControl Of A Sterilization Process For Medical Devices
	ISO 11135-01	Sterilization of health care products - Ethylene oxide - Part 1:Requirements for development, validation and routine control ofa sterilization process for medical devices
	ISO 10993-1	Biological evaluation of medical devices - Part 1: Evaluation andtesting
	ISO 17664	Sterilization of medical devices. Information to be provided by themanufacturer for the processing of re sterilizable medical device
	IEC 60601-1-2	Medical electrical equipment - Part 1-2: General requirements forbasic safety and essential performance - Collateral standard:Electromagnetic compatibility - Requirements and tests
	DIN ISO 8600-3:2004	Optics and optical instruments -- Medical endoscopes andendoscopic accessories -- Part 3: Determination of field of viewand direction of view of endoscopes with optics

Table 3 provides a summary of testing parameters and results.

Table 3. Summary of Testing
Test	Results
Field of View	Passed
Fixed Focus	Passed
Direction of View Range	Passed
Direction of View Torque	Passed
Rotation of View	Passed
Illumination	Passed
Scope Resolution	Passed
Visual Inspection
Hermetic sealing	Passed

Table 3. Summary of Testing

Premarket Notification: Traditional 510(k) Mitek Arthroscopes

Page 3

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Free from aberrations	Passed
Results of performance testing have demonstrated that the proposeddevice is suitable for its intended use.

Based on the indications for use, technological characteristics, and comparison to the predicate devices, the proposed The Mitek Arthroscope has shown to be substantially equivalent to the predicate devices under the Federal Food, Drug and Cosmetic Act.

Premarket Notification: Traditional 510(k) Mitek Arthroscopes

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Image /page/4/Picture/0 description: The image shows the logo for the Department of Health & Human Services USA. The logo is a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" written around the perimeter. Inside the circle is an image of an abstract eagle.

DEPARTMENT OF HEALTH & HUMAN SERVICES

Public Health Service

Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

April 18, 2014

Medos International SARL - DePuy Mitek Incorporated Ms. Susan Kagan Project Manager Regulatory Affairs 325 Paramount Drive Ravnham, Massachusetts 02767

Re: K133941

Trade/Device Name: Arthroscopes (SwingScope) Regulation Number: 21 CFR 888.1100 Regulation Name: Arthroscope Regulatory Class: Class II Product Code: HR X Dated: March 4, 2014 Received: March 10, 2014

Dear Ms. Kagan:

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. 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 801); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set

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Page 2 - Ms. Susan Kagan

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.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR 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 the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.

Sincerely yours,

David Krause -S

for

Binita S. Ashar, M.D., M.B.A., F.A.C.S. Acting Director Division of Surgical Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Indications for Use

K133941 510(k) Number (if known):

Device Name: Mitek Arthroscopes

Indications for Use:

Mitek Sports Medicine Arthroscopes are indicated for use in arthroscopic procedures (such as the knee, shoulder, hip, ankle, elbow) to provide visualization during surgery.

Prescription Use _____________________________________________________________________________________________________________________________________________________________ (Part 21 CFR 801 Subpart D) AND/OR

Over-The-Counter Use _ (21 CFR 807 Subpart C)

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Joshua C. Nipper -S

Page 1 of 1

Regulation Number and Section

§ 888.1100 Arthroscope.

(a)
Identification. An arthroscope is an electrically powered endoscope intended to make visible the interior of a joint. The arthroscope and accessories also is intended to perform surgery within a joint.(b)
Classification. (1) Class II (performance standards).(2) Class I for the following manual arthroscopic instruments: cannulas, currettes, drill guides, forceps, gouges, graspers, knives, obturators, osteotomes, probes, punches, rasps, retractors, rongeurs, suture passers, suture knotpushers, suture punches, switching rods, and trocars. The devices subject to this paragraph (b)(2) are exempt from the premarket notification procedures in subpart E of part 807 of this chapter, subject to the limitations in § 888.9.