(99 days)
Not Found
No
The summary describes a standard endoscopic video camera system and does not mention any AI or ML capabilities, image processing beyond basic visualization, or performance studies related to algorithmic analysis.
No
The device is an endoscopic video camera system used for visualization during surgery, not for treatment or therapy.
No
The device is described as an endoscopic video camera used for visualization during surgical procedures. Its purpose is to provide images for the surgeon, not to diagnose a condition.
No
The device description explicitly states that the system consists of a camera head with light source and a Camera Control Unit (CCU), which are hardware components.
Based on the provided information, the Arthrex Synergy UHD4 System is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states it's an "endoscopic video camera" used for visualization during surgical procedures. IVDs are used to examine specimens (like blood, urine, tissue) outside the body to diagnose diseases or conditions.
- Device Description: The description confirms it's a camera system used with an endoscope for visualization during surgery.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples, detecting analytes, or providing diagnostic information based on laboratory testing.
The device is a surgical imaging system, not a diagnostic test performed on biological samples.
N/A
Intended Use / Indications for 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.
Product codes (comma separated list FDA assigned to the subject device)
GCJ
Device Description
The Arthrex SynergyUHD4 System consists of a camera head with light source and a Camera Control Unit (CCU). The system is used in conjunction with an endoscope to allow for visualization onto a monitor during minimally invasive surgical procedures.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Endoscopic video
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Bench testing was performed to demonstrate equivalence to the predicate regarding environmental conditions, power requirements, image capture, and video output and resolution. Sterilization and electrical safety validations were performed on the system components and comply with ISO 17665-1 and IEC 60601-1:2012 3rd Edition.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 876.1500 Endoscope and accessories.
(a)
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.(b)
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.
0
Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is a stylized image of three human profiles facing to the right, stacked on top of each other. The profiles are black and have a flowing, abstract design.
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.
1
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 (800) 638-2041 or (301) 796-7100 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 (800) 638-2041 or (301) 796-7100 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
2
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) |
|---|
| ☑ Prescription Use (Part 21 CFR 801 Subpart D) |
| ☐ Over-The-Counter Use (21 CFR 801 Subpart C) |
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3
| Date Summary Prepared | October 22, 2015 |
|---|---|
| Manufacturer/ | |
| Distributor/ | |
| Sponsor | Arthrex, Inc. |
| 1370 Creekside Boulevard | |
| Naples, FL 34108-1945 USA | |
| 510(k) Contact | David L Rogers |
| Regulatory Affairs Specialist | |
| Arthrex, Inc. | |
| 1370 Creekside Boulevard | |
| Naples, FL 34108-1945 USA | |
| Telephone: 239/643.5553, ext. 71924 | |
| Fax: 239/598.5508 | |
| Email: david.rogers@Arthrex.com | |
| Trade Name | Arthrex SynergyUHD4 System |
| Common Name | Endoscopic Video Camera System |
| Product Code, | |
| 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 |
| the Endohub-1.0 Endoscopic Video Camera with Video Capture cleared under | |
| predicate K071756. | |
| Device Description | The Arthrex SynergyUHD4 System consists of a camera head with light source and a |
| Camera Control Unit (CCU). The system is used in conjunction with an endoscope | |
| to allow for visualization onto a monitor during minimally invasive surgical | |
| procedures. | |
| Indications for Use | The Arthrex SynergyUHD4 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, urologic, sinuscopic, and plastic surgical procedures. The | |
| device is also intended to be used as an accessory for microscopic surgery. | |
| Substantial | |
| Equivalence Summary | The Arthrex SynergyUHD4 System is substantially equivalent to the predicate |
| device in which the basic design features and intended uses are the same. Any | |
| differences between the Arthrex SynergyUHD4 System and the predicates are | |
| considered minor and do not raise questions concerning safety and effectiveness. | |
| There are no significant differences between the new device and predicate that | |
| raise issues of safety or effectiveness. Bench testing was performed to | |
| demonstrate equivalence to the predicate regarding environmental conditions, | |
| power requirements, image capture, and video output and resolution. | |
| Sterilization and electrical safety validations were performed on the system | |
| components and comply with ISO 17665-1 and IEC 60601-1:2012 3rd Edition. | |
| Accordingly, Arthrex believes that the Arthrex SynergyUHD4 System is substantially | |
| equivalent to the Endohub-1.0 Video Camera System cleared under K071756. | |
| Based on the indications for use, technological characteristics, and the summary | |
| 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: 239/643.5553, extension 71924 Fax: 239/598.5508 Email: David.Rogers@Arthrex.com