MITEK ARTHROSCOPES

K133941 · Medos International SARL · HRX · Apr 18, 2014 · Orthopedic

Device Facts

• Record ID: K133941
• Device Name: MITEK ARTHROSCOPES
• Applicant: Medos International SARL
• Product Code: HRX · Orthopedic
• Decision Date: Apr 18, 2014
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 888.1100
• Device Class: Class 2

Intended 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.

Device Story

SwingScope is a multi-angle, rigid 4.3 mm arthroscope; enables surgeons to vary direction of view from 10° to 90° via a dial; reduces need for multiple fixed-angle scopes. Device provides 55° field of view; 5mm to 40mm depth of field. Shaft rotates via light post. Proximal eyepiece connects to standard camera coupler; light post compatible with ACMI light sources. Used in OR by surgeons for joint visualization. Reusable; requires cleaning and sterilization between uses. Benefits include optimized field of view from single port.

Clinical Evidence

No clinical data. Bench testing only. Verification tests included performance (field of view, resolution, illumination, direction of view range/torque, rotation), cleaning validation, and biocompatibility. All tests passed.

Technological Characteristics

Rigid 4.3 mm arthroscope; stainless steel construction; 10°-90° variable direction of view; 55° field of view; 5-40mm depth of field. Compatible with ACMI light sources and standard camera couplers. Reusable; sterilized via moist heat (ISO 17665-1) or ethylene oxide (ISO 11135-01). Complies with EN 60601-18, IEC 60601-1-2, and DIN ISO 8600-3:2004.

Indications for Use

Indicated for patients undergoing arthroscopic procedures in joints including knee, shoulder, hip, ankle, and elbow to provide visualization during surgery.

Regulatory Classification

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.

Submission Summary (Full Text)

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## 510(k) SUMMARY

K133941 Page 1 of 4 APR 1 8 2014

### Mitek Arthroscope

.

| Recognized Manufacturer: | Medos International SarL<br>Puits Godet 20<br>CH 2000 Neuchâtel<br>Switzerland | |
|--------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------|
| Submitter: | DePuy Mitek, Inc.<br>a Johnson & Johnson company<br>325 Paramount Drive<br>Raynham, MA 02767 | |
| Contact Person | Susan Kagan<br>Project Manager,<br>Regulatory Affairs<br>DePuy Mitek, Inc.<br>a Johnson & Johnson company<br>325 Paramount Drive<br>Raynham, MA 02767, USA | Telephone: [phone]<br>Facsimile: 508-977-6911<br>e-mail: [e-mail] |
| Name of Medical Device | Proprietary Name: SwingScope<br>Classification Name: Arthroscope<br>Common Name: Arthroscope | |
| Substantial Equivalence | Mitek Arthroscopes are substantially equivalent to the predicate devices listed in Table1.<br>Table 1: Predicate Devices | |

Premarket Notification: Traditional 510(k) Mitek Arthroscopes

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| Device<br>Classification | 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

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

| Safety and<br>Performance | Standard/<br>Guidance | Description |
|---------------------------|--------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| | EN 60601-18 | Medical electrical equipment -- Part 18: Particular Requirements<br>for Basic Safety and Essential performance of endoscopic<br>equipment |
| | ANSI/AAMI/ISO<br>17665-1 | Sterilization of Healthcare Products-Moist Heat-Part 1:<br>Requirements For The Development, Validation And Routine<br>Control Of A Sterilization Process For Medical Devices |
| | ISO 11135-01 | Sterilization of health care products - Ethylene oxide - Part 1:<br>Requirements for development, validation and routine control of<br>a sterilization process for medical devices |
| | ISO 10993-1 | Biological evaluation of medical devices - Part 1: Evaluation and<br>testing |
| | ISO 17664 | Sterilization of medical devices. Information to be provided by the<br>manufacturer for the processing of re sterilizable medical device |
| | IEC 60601-1-2 | Medical electrical equipment - Part 1-2: General requirements for<br>basic safety and essential performance - Collateral standard:<br>Electromagnetic compatibility - Requirements and tests |
| | DIN ISO 8600-<br>3:2004 | Optics and optical instruments -- Medical endoscopes and<br>endoscopic accessories -- Part 3: Determination of field of view<br>and 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

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| Free from aberrations | Passed |
|----------------------------------------------------------------------------------------------------------------|--------|
| Results of performance testing have demonstrated that the proposed<br>device 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 [phone] or [phone] 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 [phone] or [phone] 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

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