CAMERA ENABLED PROBE

K141119 · Trice Medical, Inc. · HRX · Jul 29, 2014 · Orthopedic

Device Facts

• Record ID: K141119
• Device Name: CAMERA ENABLED PROBE
• Applicant: Trice Medical, Inc.
• Product Code: HRX · Orthopedic
• Decision Date: Jul 29, 2014
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 888.1100
• Device Class: Class 2

Intended Use

The Camera Enabled Probe is indicated for use in diagnostic and operative arthroscopic and endoscopic procedures to provide illumination and visualization of an interior cavity of the body through either a natural or surgical opening.

Device Story

Camera Enabled Probe is a portable, battery-operated visualization system for arthroscopic and endoscopic procedures. System consists of a sterile, single-use probe with an integrated camera and LED light source, connected via cable to a handheld LCD monitor. Probe features a rigid shaft with a retractable needle and flushing port for field-of-view cleaning. Device is used by clinicians in clinical settings to provide real-time video of interior body cavities. Output is displayed on the LCD monitor, allowing the physician to visualize the surgical site during diagnostic or operative procedures. Benefits include portability and integrated visualization for minimally invasive access.

Clinical Evidence

No clinical data provided. Substantial equivalence is supported by bench testing, including biocompatibility (ISO 10993-1), electrical safety (IEC 60601-1), electromagnetic compatibility (EN 60601-1-2), and sterilization validation (ISO 11135-1).

Technological Characteristics

Portable, battery-operated arthroscope. Materials include stainless steel (ISO 9626). Features integrated LED illumination and CMOS imaging optics. Available in 50mm, 95mm, and 160mm lengths. System includes a 220mm x 135mm x 39mm LCD monitor. Total weight <300g. Sterilization via Ethylene Oxide (ISO 11135-1).

Indications for Use

Indicated for patients undergoing diagnostic or 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

• C-MOR Visualization System (K093717)

Submission Summary (Full Text)

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JUL 2 9 2014

# 2.0 510(k) Summary

| Table 1: 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] |
| Date Prepared: · | 4/29/14 |
| Trade Name: | Camera Enabled Probe |
| Common Name: | Arthroscope |
| Classification: | Class II |
| Product Code: | HRX, 888.1100 |
| Predicate Device(s): | The subject device is equivalent to the following devices:<br>• K093717 - C-MOR Visualization System |
| 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<br>features with LED light source. The LCD Monitor displays real-<br>time video from the probe and is attached via cable to provide<br>power to the probe. The probe scope extends from the handle<br>as a rigid shaft with retractable needle and flushing port for<br>cleaning the field of view. The distal tip of the probe contains<br>the illumination and imaging optics.<br>The Camera Enabled Probes are identical in design and function<br>and available in three lengths: 50mm, 95mm, and 160mm. The<br>monitor is 220mm X 135mm X 39mm. The entire unit weight is<br>less than 300 grams. |
| Indication for Use: | The Camera Enabled Probe 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. |

Trice Medical, Inc.

Premarket Notification for the Camera Enabled Probe

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| Functional and<br>Safety Testing: | To verify that device design meets its functional and<br>performance requirements, representative samples of the<br>device underwent biocompatibility, software, electrical, and<br>mechanical testing in accordance with the following industry<br>standards. |
|-----------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| | ISO 10993-1:2009 Biological evaluation of medical devices - Part<br>1: Evaluation and testing within a risk management process |
| | IEC-60601-1 > Medical Electrical Equipment - Part 1: General<br>Requirements for Basic Safety and Essential Performance |
| | EN-60601-1-2 > Medical Electrical Equipment. General<br>Requirements for Basic Safety and Essential Performance.<br>Collateral Standard. Electromagnetic Compatibility.<br>Requirements and Tests |
| | 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 |
| | ISO-9626 > Stainless Steel Needle Tubing for the Manufacture of<br>Medical Devices |
| | ISO-7864 > Sterile Hypodermic Needles for Single Use |
| Conclusion: | Trice considers the Camera Enabled Probe device to be<br>equivalent to the predicate device listed above. This conclusion<br>is based upon the devices' similarities in indications for use,<br>principles of operation, technology, and materials. |

Trice Medical, Inc.

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Premarket Notification for the Camera Enabled Probe

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Public Health Service

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

July 29, 2014

Trice Medical Incorporated Ms. Tiffini Diage Consulting Director Regulatory Affairs 1000 Continental Drive, Suite 240 King of Prussia, Pennsylvania 19406

Re: K141119

Trade/Device Name: Camera Enabled Probe Regulation Number: 21 CFR 888.1100 Regulation Name: Arthroscope Regulatory Class; Class II Product Code: HRX Dated: July 17, 2014 Received: July 18, 2014

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 device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set

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Page 2 - Ms. Tiffini Diage

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/Resourcesfor You/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/ReportalProblem/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/MedicalDeviccs/ResourcesforYou/Industry/default.htm.

Sincerely yours.

# David Krause -S

for 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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DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration

## Indications for Use

510(k) Number (if known)

KI4119

Device Name Camera Enabled Probe

Indications for Use (Describe)

The Camera Enabled Probe is indicated for use in diagnostic and operative arthroscopic and endoscopic procedures to provide illumination and visualization of an interior cavity of the a natural or surgical opening.

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

2 Prescription Use (Part 21 CFR 801 Subpart D)

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

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