Arthrex Synergy UHD4 System

K153218 · Arthrex, Inc. · GCJ · Feb 12, 2016 · Gastroenterology, Urology

Device Facts

• Record ID: K153218
• Device Name: Arthrex Synergy UHD4 System
• Applicant: Arthrex, Inc.
• Product Code: GCJ · Gastroenterology, Urology
• Decision Date: Feb 12, 2016
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 876.1500
• Device Class: Class 2

Intended Use

The Arthrex Synergy UHD4 System is intended to be used as an endoscopic video camera in a variety of endoscopic surgical procedures, including but not limited to: orthopedic, laparoscopic, and plastic surgical procedures. The device is also intended to be used as an accessory for microscopic surgery.

Device Story

Arthrex Synergy UHD4 System is an endoscopic video camera system comprising a camera head with integrated light source and a Camera Control Unit (CCU). Used in conjunction with an endoscope to provide visualization on a monitor during minimally invasive surgical procedures. Operated by surgeons in clinical settings (OR). The system captures optical signals via the endoscope, processes them through the CCU, and outputs high-definition video for real-time surgical guidance. Enables visualization of internal anatomy to assist surgeons in performing procedures; improves surgical accuracy and patient outcomes through enhanced imaging.

Clinical Evidence

Bench testing only. Validations performed for environmental conditions, power requirements, image capture, and video output/resolution. Electrical safety and sterilization validations conducted per IEC 60601-1:2012 3rd Edition and ISO 17665-1.

Technological Characteristics

System includes camera head with light source and CCU. Connectivity for video output. Electrical safety per IEC 60601-1:2012 3rd Edition. Sterilization per ISO 17665-1.

Indications for Use

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

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

• Endohub-1.0 Endoscopic Video Camera with Video Capture (K071756)

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

February 12, 2016

Arthrex Incorporated Mr. David Rogers Regulatory Affairs Specialist 1370 Creekside Boulevard Naples, Ohio 34108

Re: K153218

Trade/Device Name: Arthrex Synergy UHD4 System Regulation Number: 21 CFR 876.1500 Regulation Name: Endoscope and accessories Regulatory Class: Class II Product Code: GCJ Dated: January 14, 2016 Received: January 15, 2016

Dear Mr. Rogers:

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 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.

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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 -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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# Indications for Use

510(k) Number (if known)

## K153218

Device Name Arthrex Synergy UHD4 System

#### Indications for Use (Describe)

The Arthrex Synergy UHD4 System is intended to be used as an endoscopic video camera in a variety of endoscopic surgical procedures, including but not limited to: orthopedic, laparoscopic, and plastic surgical procedures. The device is also intended to be used as an accessory for microscopic surgery.

| Type of Use (Select one or both, as applicable) |
|----------------------------------------------------------------------------------------------------------------------------------------------------------------|
| <span style="font-family: Arial, sans-serif; font-size: 10pt;"> <span style="font-size: 11pt;">☑</span> Prescription Use (Part 21 CFR 801 Subpart D) </span> |
| <span style="font-family: Arial, sans-serif; font-size: 10pt;"> ☐ Over-The-Counter Use (21 CFR 801 Subpart C) </span> |

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| Date Summary Prepared | October 22, 2015 |
|-------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Manufacturer/<br>Distributor/<br>Sponsor | Arthrex, Inc.<br>1370 Creekside Boulevard<br>Naples, FL 34108-1945 USA |
| 510(k) Contact | David L Rogers<br>Regulatory Affairs Specialist<br>Arthrex, Inc.<br>1370 Creekside Boulevard<br>Naples, FL 34108-1945 USA<br>Telephone: [phone], ext. 71924<br>Fax: [phone]<br>Email: [e-mail] |
| Trade Name | Arthrex SynergyUHD4 System |
| Common Name | Endoscopic Video Camera System |
| Product Code,<br>Classification Name, CFR | GCJ |
| | 21 CFR 876.1500: Endoscope and accessories |
| Predicate Device | K071756: Endohub-1.0 Endoscopic Video Camera with Video Capture |
| Purpose of Submission | This Special 510(k) premarket notification is intended to address modifications to<br>the Endohub-1.0 Endoscopic Video Camera with Video Capture cleared under<br>predicate K071756. |
| Device Description | The Arthrex SynergyUHD4 System consists of a camera head with light source and a<br>Camera Control Unit (CCU). The system is used in conjunction with an endoscope<br>to allow for visualization onto a monitor during minimally invasive surgical<br>procedures. |
| Indications for Use | The Arthrex SynergyUHD4 System is intended to be used as an endoscopic video<br>camera in a variety of endoscopic surgical procedures, including but not limited to:<br>orthopedic, laparoscopic, urologic, sinuscopic, and plastic surgical procedures. The<br>device is also intended to be used as an accessory for microscopic surgery. |
| Substantial<br>Equivalence Summary | The Arthrex SynergyUHD4 System is substantially equivalent to the predicate<br>device in which the basic design features and intended uses are the same. Any<br>differences between the Arthrex SynergyUHD4 System and the predicates are<br>considered minor and do not raise questions concerning safety and effectiveness.<br>There are no significant differences between the new device and predicate that<br>raise issues of safety or effectiveness. Bench testing was performed to<br>demonstrate equivalence to the predicate regarding environmental conditions,<br>power requirements, image capture, and video output and resolution.<br>Sterilization and electrical safety validations were performed on the system<br>components and comply with ISO 17665-1 and IEC 60601-1:2012 3rd Edition.<br>Accordingly, Arthrex believes that the Arthrex SynergyUHD4 System is substantially<br>equivalent to the Endohub-1.0 Video Camera System cleared under K071756.<br>Based on the indications for use, technological characteristics, and the summary<br>of data submitted, Arthrex, Inc. has determined that the Arthrex SynergyUHD4 |

# 510K SUMMARY OF SAFETY AND EFFECTIVENESS

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## MANUFACTURER / SPONSOR / CONTACT

#### 1.1.1.1.1MANUFACTURER / SPONSOR

Arthrex, Inc. 1370 Creekside Boulevard Naples, Florida 34108-1945 USA Establishment Registration Number: 1220246

# 1.1.1.2 CONTACT

David L Rogers Regulatory Affairs Specialist Arthrex, Inc. 1370 Creekside Boulevard Naples, Florida 34108-1945 USA Telephone: [phone], extension 71924 Fax: [phone] Email: [e-mail]