(27 days)
Not Found
No
The summary does not mention AI, ML, or any related concepts like deep learning, neural networks, or specific algorithms typically associated with AI/ML in medical imaging. The performance studies focus on standard functional and safety testing, not AI/ML model validation.
No
This device is for visualization during surgical procedures, not for treatment or therapy. It acts as an accessory for existing endoscopic surgeries.
No
The device is a camera system used for visualization during surgical procedures, not for making diagnoses. Its intended use is to provide high definition visualization during minimally invasive surgical procedures, not to perform diagnostic interpretations or analyses.
No
The device description explicitly states it consists of a camera control unit (CCU) and a camera head, which are hardware components. The summary also mentions hardware-related testing like electrical safety and electromagnetic compatibility.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states the device is for "visualization during minimally invasive surgical procedures." This involves directly viewing internal structures of the body during surgery.
- Device Description: The description confirms it's a camera system used with endoscopes to provide visual feedback during surgery.
- Lack of IVD Characteristics: IVD devices are used to examine specimens (like blood, urine, tissue) outside the body to provide information for diagnosis, monitoring, or screening. This device does not perform any such analysis of specimens.
The device is a surgical imaging system, not an in vitro diagnostic device.
N/A
Intended Use / Indications for 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.
Product codes
GCJ
Device Description
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.
Like the predicate device, sterilization of the camera head and cable is required before use. The camera heads must be sterilized using steam sterilization.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
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
Performance testing were conducted to demonstrate that the True HD 3MOS Camera System performs according to specifications and functions as intended. The tests results demonstrated the safety and effectiveness of the devices in accordance with design specifications and applicable standards.
(study type, sample size, AUC, MRMC, standalone performance, key results)
System Testing
o Verification
Functional testing
Video Image
Software
o Validation
Functional testing
Video Image
Software
Standards evaluation
Electromagnetic compatibility, IEC60601-1-2
Electrical Safety, IEC60601-1
Particular Standard, safety and essential performance of endoscopic equipment, IEC60601-2-18
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.
Key Metrics
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
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.
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Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a stylized human figure with three heads in profile, representing the department's focus on people. The figure is positioned to the right of the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA", which is arranged in a circular pattern around the figure.
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
1
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 (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 -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
2
Indications for Use
510(k) Number (if known)
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)
| Prescription Use (Part 21 CFR 801 Subpart D) |
|---|
| 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: 508-948-2084 Fax: 508-366-8858 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
- o Verification
- 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.