mi-eye 2, mi-eye 2 monitor

K162475 · Trice Medical · HRX · Sep 16, 2016 · Orthopedic

Device Facts

• Record ID: K162475
• Device Name: mi-eye 2, mi-eye 2 monitor
• Applicant: Trice Medical
• Product Code: HRX · Orthopedic
• Decision Date: Sep 16, 2016
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 888.1100
• Device Class: Class 2

Intended Use

The mi-eye 2 is indicated for use in diagnostic and operative arthroscopic procedures to provide illumination and visualization of an interior cavity of the body through either a natural or surgical opening.

Device Story

Portable, battery-operated arthroscopic visualization system; consists of sterile, single-use probe with integrated camera, LED light source, and rigid shaft; connects via cable to 10.8" LCD monitor. Probe features retractable needle and flushing port for field-of-view cleaning. Physician operates device during diagnostic/operative procedures to visualize interior body cavities. Real-time video displayed on monitor; assists clinician in direct visualization of surgical site. Benefits include portability and integrated imaging/illumination for minimally invasive access.

Clinical Evidence

Bench testing only. Device underwent biocompatibility, software, electrical, and mechanical testing per ISO 10993-1, ANSI/AAMI/EN-60601-1-2, ISO-11135-1, ISO-9626, and ISO-7864 standards.

Technological Characteristics

Rigid shaft probe (50mm, 95mm, 160mm lengths) with integrated camera, LED illumination, and imaging optics. Stainless steel needle tubing (ISO-9626). Battery-operated; 10.8" LCD monitor. Sterilization via Ethylene Oxide (ISO-11135-1).

Indications for Use

Indicated for patients undergoing diagnostic and operative arthroscopic and endoscopic procedures requiring illumination and visualization of interior body cavities via natural or surgical openings.

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.

Predicate Devices

• mi-eye Camera Enabled Probe (K141119)

Submission Summary (Full Text)

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

September 16, 2016

Trice Medical, Inc. Ms. Tiffini Diage Consulting Director, Regulatory Affairs 1000 Continental Dr. Suite 240 King Of Prussia, Pennsylvania 19406

Re: K162475

Trade/Device Name: mi-eye 2, mi-eye 2 Monitor Regulation Number: 21 CFR 888.1100 Regulation Name: Arthroscope Regulatory Class: Class II Product Code: HRX Dated: August 30, 2016 Received: September 7, 2016

Dear Ms. Diage:

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 devicerelated adverse events) (21 CFR Part 803); good manufacturing practice requirements as set forth

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in the quality systems (OS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 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" (21 CFR 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/ResourcesforYou/Industry/default.htm.

Sincerely.

Christopher J. Ronk -S

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

Enclosure

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## Indications for Use

510(k) Number (if known) K162475

Device Name mi-eye 2, mi-eye 2 monitor

Indications for Use (Describe)

The mi-eye 2 is indicated for use in diagnostic and operative arthroscopic procedures to provide illumination and visualization of an interior cavity of the body through either a natural or surgical opening.

| Type of Use (Select one or both, as applicable) | |
|-------------------------------------------------|--|
|-------------------------------------------------|--|

X Prescription Use (Part 21 CFR 801 Subpart D)

| Over-The-Counter Use (21 CFR 801 Subpart C)

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510(k) Summary

| Submitter: | Trice Medical, Inc.<br>1000 Continental Drive, Suite 240<br>King of Prussia, PA 19406 |
|-----------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Contact Person: | Tiffini Diage<br>Consulting Director Regulatory Affairs<br>Phone: [phone]<br>E-mail: [e-mail] |
| Trade Name: | mi-eye 2, mi-eye 2 Monitor |
| Common Name: | Arthroscope |
| Classification: | Class II |
| Product Code: | HRX, 888.1100 |
| 510(k) Number | K162475 |
| Predicate Device(s): | The subject device is equivalent to the following devices:<br>• K141119 – mi-eye Camera Enabled Probe |
| Device Description: | The Camera Enabled Probe is a battery operated, portable,<br>visualization device that uses a probe with integrated camera<br>and separate LCD monitor attached via cable. The sterile,<br>single-use probe includes the camera and image capture features<br>with LED light source. The LCD Monitor displays real-time<br>video from the probe and is attached via cable to provide power<br>to the probe. The probe scope extends from the handle as a rigid<br>shaft with retractable needle and flushing port for cleaning the<br>field of view. The distal tip of the probe contains the camera,<br>illumination, and imaging optics.<br>The mi-eye 2 devices are identical in design and function and<br>available in three lengths: 50mm, 95mm, and 160mm. The<br>monitor has a 10.8" (diagonal) screen. The entire unit weight is<br>less than 300 grams. |
| Indication for Use: | The mi-eye 2 device is indicated for use in diagnostic and<br>operative arthroscopic and endoscopic procedures to provide<br>illumination and visualization of an interior cavity of the body<br>through either a natural or surgical opening. |
| Functional and<br>Safety Testing: | To verify that device design meets its functional and<br>performance requirements, representative samples of the device<br>underwent biocompatibility, software, electrical, and mechanical<br>testing in accordance with the following industry standards.<br><br>ISO 10993-1:2009 Biological evaluation of medical devices -<br>Part 1: Evaluation and testing within a risk management process<br>ANSI / AAMI / EN-60601-1-2 Medical Electrical Equipment --<br>Part 1-2: General Requirements for Basic Safety and Essential<br>Performance<br><br>ISO-11135-1 > Sterilization of Health Care Products. Ethylene<br>Oxide. Requirements for Development, Validation and Routine<br>Control of a Sterilization Process for Medical Devices<br>ISO-9626 > Stainless Steel Needle Tubing for the Manufacture<br>of Medical Devices<br>ISO-7864 > Sterile Hypodermic Needles for Single Use |
| Conclusion: | The changes made to the previously cleared mi-eye Camera<br>Enabled Probe (now called mi-eye 2) device do not affect the<br>established safety and efficacy of the device. Mi-eye 2 is<br>equivalent to the predicate device. This conclusion is based<br>upon the devices' identical indications for use, principles of<br>operation, technology, and performance specifications. The<br>changes made were tested using the same acceptance criteria as<br>the predicate device and provide objective evidence that there are<br>no new risks and the device is substantially equivalent. |

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