(20 days)
No
The 510(k) summary describes a standard endoscopic camera system for visualization and does not mention any features or components related to AI or ML.
No
The device is described as a camera system for visualization during surgical procedures, not for treatment or therapy.
No
The device is described as a camera system for visualization during surgical procedures, providing high definition views. It does not mention analyzing or interpreting images to make a diagnosis.
No
The device description explicitly states it consists of a "camera control unit and a camera head," which are hardware components.
Based on the provided information, the ConMed Linvatec HD Digital Camera System is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states it's for endoscopic surgical procedures to provide visualization during surgery. IVDs are used to examine specimens (like blood, tissue, or urine) outside the body to diagnose diseases or conditions.
- Device Description: The description focuses on providing high-definition visualization during minimally invasive surgical procedures using an endoscope. This is a tool for in vivo (within the living body) procedures, not in vitro (in glass/outside the body) testing.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples, reagents, or any other components typically associated with IVD devices.
Therefore, the ConMed Linvatec HD Digital Camera System is a surgical imaging device, not an IVD.
N/A
Intended Use / Indications for Use
The ConMed Linvatec HD Digital Camera System is intended for endoscopic camera use in a variety of endoscopic surgical procedures including orthopedic, laparoscopic, urologic, sinuscopic, plastic and as an accessory for microscopic surgery. Sterilization of the camera head and cable is required before use. The ConMed Linvatec HD Digital Camera System will be capable of interfacing with a remote controlled operating system, Linvatec Light Source (K031994) with no impact on normal camera system operation.
Product codes
GCJ
Device Description
The ConMed Linvatec HD Digital Camera System consists of a camera control unit and a camera head that is used in conjunction with an endoscope to allow for high definition visualization during minimally invasive surgical procedures. Like the unmodified device, sterilization of the camera head and cable is required before use. Additionally, the camera heads may be sterilized using steam sterilization like the unmodified device.
The ConMed Linvatec HD Digital Camera System will be capable of interfacing with the ConMed I.S. Operating Room Control System with no impact on normal camera system operation.
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 (study type, sample size, AUC, MRMC, standalone performance, key results)
Not Found
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
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.
0
November 9, 2006
DEC - 5 2005
510k Summary
In accordance with the requirements of the Safe Medical Device Act of 1990 and 21 CFR 807.92, ConMed Linvatec Corporation is hereby submitting the 510(k) Summary of Safety and Effectiveness for the HD Digital Camera System 510(k) Number Kos343 7 5
Submitter A.
ConMed Linvatec Corporation 11311 Concept Boulevard Largo, Florida 33773-4908
B. Company Contact
Elizabeth Paul Manager, Regulatory Affairs (727) 399-5234 Telephone (727) 399-5264 FAX
். Device Name
| Trade Name: | TrueHD (1080P) Digital Camera System |
|---|---|
| Common Name: | HD Digital Camera System |
| Classification Name: | Laparoscope, General & Plastic Surgery |
| Endoscope and Accessories | |
| Proposed Class: | Class II |
| Device Product Code: | GCJ |
1
510k Summary HD Digital Camera System 510(k) # Ko63459 November 9, 2006
D. Predicate/Legally Marketed Device Linvatec Corporation 3-CCD Digital Camera System 510(k) K031098
ய் Device Description
The device description of the modified device is identical to the legally marketed, unmodified device (510(k) K031098) with the exception that the modified device enables high definition visualization.
Modified Device
The ConMed Linvatec HD Digital Camera System consists of a camera control unit and a camera head that is used in conjunction with an endoscope to allow for high definition visualization during minimally invasive surgical procedures. Like the unmodified device, sterilization of the camera head and cable is required before use. Additionally, the camera heads may be sterilized using steam sterilization like the unmodified device.
The ConMed Linvatec HD Digital Camera System will be capable of interfacing with the ConMed I.S. Operating Room Control System with no impact on normal camera system operation.
Unmodified Device (reference)
The ConMed Linvatec Digital Camera System consists of a camera control unit and a camera head that is used in conjunction with an endoscope to allow for visualization during minimally invasive surgical procedures. Sterilization of the camera head and cable is required before use. The camera heads may be sterilized using steam sterilization.
The ConMed Linvatec 3-CCD HD Digital Camera System will be capable of interfacing with the ConMed I.S. Operating Room Control System with no impact on normal camera system operation.
Page 4.1
2
F. Intended Use
Note: The device description of the modified device is identical to the legally marketed, unmodified device (510(k) K031098).
The ConMed Linvatec HD Digital Camera System is intended for endoscopic camera use in a variety of endoscopic surgical procedures including orthopedic, laparoscopic, urologic, sinuscopic, plastic and as an accessory for microscopic surgery. Sterilization of the camera head and cable is required before use. The ConMed Linvatec HD Digital Camera System will be capable of interfacing with a remote controlled operating system, Linvatec Light Source (K031994) with no impact on normal camera system operation.
Substantial Equivalence G.
The modifications to the legally marketed device in the HD Digital Camera System do not affect the intended use nor alter the fundamental scientific technology of the device. In addition, the modified device is substantially equivalent in materials, design and sterilization requirements to the unmodified device. The device modifications do not introduce any new issues of safety or efficacy.
3
Public Health Service
Image /page/3/Picture/2 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. In the center of the circle is an abstract image of an eagle.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
ConMed Linvatec Corporation % Ms. Elizabeth Paul Manager, Regulatory Affairs 11311 Concept Boulevard Largo, Florida 33773-4908
DEC - 5 2006
Re: K063457
Trade/Device Name: HD Digital Camera System Regulation Number: 21 CFR 876.1500 Regulation Name: Endoscope and accessories Regulatory Class: II Product Code: GCJ Dated: November 9, 2006 Received: November 16, 2006
Dear Ms. Paul:
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.
If your device is classified (see above) into cither class II (Special Controls) or class III (PMA), it may be subject to such 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); 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.
4
Page 2 - Ms. Elizabeth Paul
This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Office of Compliance at (240) 276-0115. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely vours,
Barbara Buckner
Mark N. Melkerson Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
5
Indications for Use
November 9, 2006
510(k) Number (if known): Koo 3457
Device Name: HD Digital Camera System
Indications For Use:
The ConMed Linvatec HD Digital 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.
Note: The indications for use of the modified device is identical to the legally marketed, unmodified device (510(k) K031098).
Prescription Use
(Part 21 CFR 801 Subpart D)
AND/OR
Over-The-Counter Use (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Raubare Buchur
(Division Sign-Off) Division of General, Restorative, and Neurological Devices
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510(k) Number K063457