True HD 3MOS Camera System

K161017 · Conmed Corporation · GCJ · May 9, 2016 · Gastroenterology, Urology

Device Facts

• Record ID: K161017
• Device Name: True HD 3MOS Camera System
• Applicant: Conmed Corporation
• Product Code: GCJ · Gastroenterology, Urology
• Decision Date: May 9, 2016
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 876.1500
• Device Class: Class 2

Intended Use

The ConMed True HD 3MOS Camera System is intended for use in a variety of endoscopic surgical procedures including but not limited to orthopedic, laparoscopic, urologic, sinuscopic, plastic and as an accessory for microscopic surgery.

Device Story

System consists of camera control unit (CCU) and camera head; used with endoscopes, light sources, and monitors for high-definition visualization during minimally invasive surgery. Input: optical images captured by CMOS sensor in camera head. Transformation: CCU processes optical signals into 1920x1080 video output. Used in OR/clinic by surgeons/physicians. Output displayed on monitors to assist visualization during procedures; enables real-time surgical guidance. Benefits: high-definition imaging for improved surgical accuracy.

Clinical Evidence

Bench testing only. Verification and validation included functional testing, video image quality assessment, and software validation. Standards compliance: IEC 60601-1 (Electrical Safety), IEC 60601-1-2 (EMC), IEC 60601-2-18 (Endoscopic equipment), and AAMI TIR12 (Reprocessing). Risk analysis performed per ISO 14971:2007.

Technological Characteristics

Camera head with CMOS image sensor; CCU with full metal chassis. Outputs 1920x1080 video. Sterilization: steam sterilization for camera heads/cables. Software: leverages Panasonic (SOUP) components. Standards: IEC 60601-1, IEC 60601-1-2, IEC 60601-2-18, ISO 14971:2007, IEC 62304.

Indications for Use

Indicated for patients undergoing endoscopic surgical procedures, including orthopedic, laparoscopic, urologic, sinuscopic, plastic, and microscopic surgeries.

Regulatory Classification

Identification

An endoscope and accessories is a device used to provide access, illumination, and allow observation or manipulation of body cavities, hollow organs, and canals. The device consists of various rigid or flexible instruments that are inserted into body spaces and may include an optical system for conveying an image to the user's eye and their accessories may assist in gaining access or increase the versatility and augment the capabilities of the devices. Examples of devices that are within this generic type of device include cleaning accessories for endoscopes, photographic accessories for endoscopes, nonpowered anoscopes, binolcular attachments for endoscopes, pocket battery boxes, flexible or rigid choledochoscopes, colonoscopes, diagnostic cystoscopes, cystourethroscopes, enteroscopes, esophagogastroduodenoscopes, rigid esophagoscopes, fiberoptic illuminators for endoscopes, incandescent endoscope lamps, biliary pancreatoscopes, proctoscopes, resectoscopes, nephroscopes, sigmoidoscopes, ureteroscopes, urethroscopes, endomagnetic retrievers, cytology brushes for endoscopes, and lubricating jelly for transurethral surgical instruments. This section does not apply to endoscopes that have specialized uses in other medical specialty areas and that are covered by classification regulations in other parts of the device classification regulations.

Special Controls

*Classification* —(1)*Class II (special controls).* The device, when it is an endoscope disinfectant basin, which consists solely of a container that holds disinfectant and endoscopes and accessories; an endoscopic magnetic retriever intended for single use; sterile scissors for cystoscope intended for single use; a disposable, non-powered endoscopic grasping/cutting instrument intended for single use; a diagnostic incandescent light source; a fiberoptic photographic light source; a routine fiberoptic light source; an endoscopic sponge carrier; a xenon arc endoscope light source; an endoscope transformer; an LED light source; or a gastroenterology-urology endoscopic guidewire, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 876.9.(2) Class I for the photographic accessories for endoscope, miscellaneous bulb adapter for endoscope, binocular attachment for endoscope, eyepiece attachment for prescription lens, teaching attachment, inflation bulb, measuring device for panendoscope, photographic equipment for physiologic function monitor, special lens instrument for endoscope, smoke removal tube, rechargeable battery box, pocket battery box, bite block for endoscope, and cleaning brush for endoscope. The devices subject to this paragraph (b)(2) are exempt from the premarket notification procedures in subpart E of part 807of this chapter, subject to the limitations in § 876.9.

Predicate Devices

• ConMed 3-CCD High Definition Digital Camera System (K063457)

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

May 9, 2016

ConMed Corporation Diair Cantisani Regulatory Affairs Specialist 525 French Road Utica, New York 13502

Re: K161017

Trade/Device Name: True HD 3MOS Camera System Regulation Number: 21 CFR 876.1500 Regulation Name: Endoscope and Accessories Regulatory Class: Class II Product Code: GCJ Dated: April 8, 2016 Received: April 12, 2016

Dear Diair Cantisani:

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

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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" (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 yours,

Jennifer R. Stevenson -A

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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# Indications for Use

510(k) Number (if known)

K161017

### Device Name

ConMed True HD 3MOS Camera System

Indications for Use (Describe)

The ConMed True HD 3MOS Camera System is intended for use in a variety of endoscopic surgical procedures including but not limited to orthopedic, laparoscopic, urologic, sinuscopic, plastic and as an accessory for microscopic surgery.

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

| <span></span> <span></span> Prescription Use (Part 21 CFR 801 Subpart D) |
|--------------------------------------------------------------------------|
| <span></span> <span></span> Over-The-Counter Use (21 CFR 801 Subpart C) |

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Image /page/3/Picture/0 description: The image shows the logo for Conmed Corporation. The logo features a stylized blue swoosh on the left, followed by the word "CONMED" in bold, black letters. Below the company name is the word "CORPORATION" in smaller, blue letters.

# 510(k) SUMMARY OF SAFETY AND EFFECTIVENESS True HD 3MOS Camera System

In accordance with the requirements of the Safe Medical Device Act of 1990 and 21CFR 807.92, ConMed Corporation is hereby submitting the 510(k) Summary of Safety and Effectiveness for 510(k) number ______________________________________________________________________________________________________________________________________________

#### I. SUBMITTER

ConMed Corporation 525 French Road Utica, NY 13502

Establishment Registration: 1320894

#### II. COMPANY CONTACT

Diair Cantisani, Regulatory Affairs Specialist Phone: [phone] Fax: [phone] Date Prepared: February 29, 2016

#### III. DEVICE

| Device Trade Name: | True HD 3MOS Camera System |
|----------------------|----------------------------------------|
| Common Name: | HD 3MOS Camera System |
| Classification Name: | Laparoscope, General & Plastic Surgery |
| Regulatory Class: | Class II, per 21 CFR 876.1500 |
| Review Panel: | General and Plastic Surgery |
| Product Codes: | GCJ |

#### IV. PREDICATE DEVICE

| Device Name: | ConMed 3-CCD High Definition Digital Camera System |
|---------------|----------------------------------------------------|
| Company Name: | ConMed Corporation |
| 510(k) #: | K063457 |

#### V. DEVICE DESCRIPTION

## Modified Device

The ConMed True HD 3MOS Camera System consists of a camera control unit (CCU) and a camera head that is used in conjunction with endoscopes, light source, light guide cables, monitors and other ancillary equipment to allow for high definition visualization during minimally invasive surgical procedures.

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Image /page/4/Picture/0 description: The image shows the logo for CONMED Corporation. The logo features a blue square with a white, curved shape inside, followed by the word "CONMED" in black, sans-serif font. Below the word "CONMED" is the word "CORPORATION" in a smaller, sans-serif font, underlined by a thin blue line.

Like the predicate device, sterilization of the camera head and cable is required before use. The camera heads must be sterilized using steam sterilization.

# Unmodified Device

The ConMed HD Digital Camera System consists of a camera control unit (CCU) and a camera head that is used in conjunction with an endoscope to allow for high definition visualization during minimally invasive surgical procedures. Sterilization of the camera head and cable is required before use. The camera heads must be sterilized using steam sterilization.

#### VI. INTENDED USE / INDICATIONS FOR USE

The True HD 3MOS Camera System is intended for use in a variety of endoscopic surgical procedures including but not limited to orthopedic, laparoscopic, urologic, sinuscopic, plastic and as an accessory for microscopic surgery.

#### VII. SUMMARY OF THE TECHNOLOGICAL CHARACTERISTICS

The ConMed True HD 3MOS Camera System has the same technological characteristics and design as the predicate device except for the following features:

- . The camera head incorporates a CMOS image sensor in oppose to the CCD image sensor featured in the predicate device.
- The proposed device software system leverages key components from a camera base component procured from Panasonic (SOUP) versus the in-house developed software system utilized in the predicate device.
- . Unlike the predicate device that outputs 1280 x 720 pixels and 1920 x 1080 pixels video resolution the proposed device True HD 3MOS Camera System outputs 1920 x 1080 pixels only.
- The camera control unit introduces a full metal chassis in oppose to the metal and plastic bezel chassis in the predicate device.

#### VIII. PERFORMANCE TESTING

Testing has been completed to demonstrate that the device performs as intended given the modification, and is substantially equivalent to the predicate device.

Completed test data includes the following:

- . Performance testing were conducted to demonstrate that the True HD 3MOS Camera System performs according to specifications and functions as intended.

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Image /page/5/Picture/0 description: The image shows the logo for CONMED Corporation. The logo features a blue abstract shape resembling a stylized "C" on the left. To the right of the shape is the word "CONMED" in bold, black letters. Below "CONMED" is the word "CORPORATION" in smaller, black letters.

The tests results demonstrated the safety and effectiveness of the devices in accordance with design specifications and applicable standards.

- System Testing ●
- o Verification
- Functional testing
- Video Image ■
- Software
- o Validation
- Functional testing
- Video Image
- Software
- Standards evaluation
- Electromagnetic compatibility, IEC60601-1-2 о
- Electrical Safety, IEC60601-1 O
- Particular Standard, safety and essential performance of endoscopic O equipment, IEC60601-2-18
- o Reprocessing, AAMI TIR12
- . Risk analysis was carried out in accordance with established in-house acceptance criteria based on ISO 14971:2007. The design verification tests and their acceptance criteria were identified and performed as a result of this risk analysis assessment.
- The software validation activities were performed in accordance with the . IEC62304.
- The instructions for reprocessing of the camera heads of the subject devices include Cleaning and Sterilization. All cleaning and sterilization methods have been validated.

#### SUBSTANCIAL EQUIVALENCE IX.

The differences between the predicate devices and the proposed device do not raise any new risks of safety or efficacy. Supporting information in this submission confirms that the ConMed True HD 3MOS Camera System is safe and effective for its intended use and is substantially equivalent in design, intended use, principals of operation, and technical characteristics to the ConMed 3-CCD High Definition Digital Camera System (K063457).

#### X. CONCLUSION

Based upon the testing and analysis performed, the ConMed True HD 3MOS Camera System is as safe, as effective, and performs as well as the ConMed 3-CCD High Definition Digital Camera System (K063457) for image visualization and user interaction.