(76 days)
Not Found
No
The summary describes a standard video-management system for endoscopy and does not mention any AI or ML capabilities, image processing beyond basic capture and storage, or data sets for training/testing.
No.
The device is listed as a system used during diagnostic and operative endoscopic procedures to provide illumination and visualization of body cavities, hollow organs and to allow for image recording and documentation. It aids the user in performing the procedure but is not directly therapeutic.
Yes
The device is intended to be used during "diagnostic and operative endoscopic procedures" to provide "illumination and visualization of body cavities, hollow organs" and to allow for "image recording and documentation." This clearly indicates its role in supporting diagnostic activities.
No
The device description explicitly states it consists of hardware components including a camera, integrated light source, capture module, camera control unit (CCU), coupler, and camera head. It also mentions sterilization and electrical safety testing, which are relevant to hardware.
Based on the provided information, the HD-Camera HDC1000 is not an In Vitro Diagnostic (IVD) device.
Here's why:
- IVD devices are used to examine specimens derived from the human body. The intended use of the HD-Camera HDC1000 is to provide illumination and visualization directly within body cavities, hollow organs, and canals during endoscopic procedures. It is used to view the surgical site in real-time, not to analyze samples taken from the body.
- The device description focuses on optical imaging and visualization. It describes how the camera captures images from within the body using an endoscope. There is no mention of analyzing biological samples or performing tests on them.
- The performance studies described are related to electrical safety, software validation, cleaning/sterilization, and comparative bench testing of image quality. These are typical tests for endoscopic imaging systems, not for IVD devices which would involve performance metrics related to the accuracy and reliability of diagnostic tests on specimens.
In summary, the HD-Camera HDC1000 is a medical device used for direct visualization during endoscopic procedures, not for the in vitro examination of biological specimens.
N/A
Intended Use / Indications for Use
The HD-Camera HDC1000 is intended to be used during diagnostic and operative endoscopic procedures to provide illumination and visualization of body cavities, hollow organs and to allow for image recording and documentation. The HD-Camera HDC1000 is indicated for use with compatible rigid or flexible endoscopes and other video equipment and endoscopic accessories.
Product codes
FET, NTN
Device Description
The HD-Camera HDC1000 is a video-management system that consists of a camera, an integrated light source and a capture module for storing and compressing video and still images. It is used in conjunction with an endoscope or microscope, a light cable and other endoscopic accessories to illuminate surgical sites and to view the surgical sites on video monitors during diagnostic and operative endoscopic procedures. The camera of the proposed device consists of a camera control unit (CCU), a coupler, and a camera head with an integral cable that connects to the camera control unit (CCU). The optical image is transferred from the surgical site to the camera head by compatible rigid and flexible endoscopes that are attached to the camera head using an optical coupler. The camera head including camera cable and the coupler are reusable devices and must be sterilized using the STERRAD ® advanced sterilization process or may be used with a sterile cover or sleeve. The camera control unit (CCU) is not intended to enter the sterile field, and cannot be sterilized.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Optical
Anatomical Site
Body cavities, hollow organs, and canals
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
Electrical safety and electromagnetic compatibility testing was performed by independent laboratories in accordance with the following standards: IEC 60601-1:2005, IEC60601-1-2:2007, IEC60601-2-18:2009. Test results demonstrate that the proposed device conforms to the above standards.
The software was developed, tested, and verified in accordance with the FDA guidance document, "Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices" and in accordance with IEC62304:2006.
The cleaning instructions provided in the labeling for the camera head and cable were validated. Sterilization validation testing was performed in accordance with AAMI/ANSI/ISO 14937:2009 and AAMI TIR12:2010.
Design verification testing of the HD-Camera HDC1000 demonstrates that the device performs as intended and that the performance does not raise new questions of safety and effectiveness.
Finally, comparative bench testing was performed to demonstrate that the performance of the HD-Camera HDC1000 is substantially equivalent to that of the predicate device OVS1 Video System. The comparative bench test included signal to noise ratio (SNR), resolution, latency, shading correction accuracy, white balance accuracy and maximum light source intensity.
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 & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized image of three human profiles facing to the right, with flowing lines beneath them.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
October 13, 2015
W.O.M. World Of Medicine GmbH % Susanne Raab Regulatory Consultant Susan Raab 1480 Cambridge Street Cambridge, MA 02139
Re: K152109
Trade/Device Name: HD-Camera HDC1000 Regulation Number: 21 CFR 876.1500 Regulation Name: Endoscope and accessories Regulatory Class: II Product Code: FET, NTN Dated: July 24, 2015 Received: July 29, 2015
Dear Susanne Raab,
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 (reporting of medical device
1
related 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.
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,
Herbert P. Lerner -S
for Benjamin R. Fisher, Ph.D. Director Division of Reproductive, Gastro-Renal, and Urological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known) K152109
Device Name HD-Camera HDC1000
Indications for Use (Describe)
The HD-Camera HDC1000 is intended to be used during diagnostic and operative endoscopic procedures to provide illumination and visualization of body cavities, hollow organs and to allow for image recording and documentation. The HD-Camera HDC1000 is indicated for use with compatible rigid or flexible endoscopes and other video equipment and endoscopic accessories.
| Type of Use (Select one or both, as applicable) |
|---|
| ------------------------------------------------- |
| New construction/Modification | Emergency/Standby Use |
|---|---|
| --------------------------------------------- | ------------------------------------- |
X Prescription Use (Part 21 CFR 801 Subpart D)
| | Over-The-Counter Use (21 CFR 801 SubpartC)
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Image /page/3/Picture/0 description: The image shows the logo for WOM, which is a stylized circle with a red triangle at the bottom. Below the logo is the text "WOM" in a sans-serif font. Below that is the text "HD-Camera HDC1000" and "510(k) Premarket Notification". The text is in a smaller font than the logo.
510(k) SUMMARY OF SAFETY & EFFECTIVENESS
1) General Information:
| Submitter: | W.O.M. WORLD OF MEDICINE GmbH |
|---|---|
| Salzufer 8 | |
| 10587 Berlin | |
| Germany | |
| Phone: +49 30 39981 594 | |
| Fax: +49 30 39981 593 | |
| FDA Registration Number: | 3001556604 |
| Contact Person: | Susanne Raab |
| Regulatory Consultant | |
| 1480 Cambridge Street | |
| Cambridge, MA 02139 | |
| Phone: (617) 547-0628 | |
| Fax: | |
| (617) 520-2401 | |
| e-mail: sbraab@comcast.net | |
| Date Prepared: | July 24, 2015 |
| 2) Proposed Device: | |
| Trade Name: | HD-Camera HDC1000 |
| Common Name: | Endoscopic Video Imaging |
| System/Component, Gastroenterology- | |
| Urology | |
| Classification Name: | Endoscope and accessories |
| Regulation Number: | 21 C.F.R. 876.1500 |
| Regulatory Class: | II |
| Product Code: | FET. NTN |
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Image /page/4/Picture/0 description: The image shows the WOM logo, which is a stylized symbol above the letters "WOM". Below the logo is the text "HD-Camera HDC1000" followed by "510(k) Premarket Notification". The logo consists of a circle with a design inside, and a small triangle at the bottom of the design.
3) Predicate Devices:
| Trade Name: | OVS1 Video System |
|---|---|
| 510(k) Number: | K024291 |
| Classification Name: | Laparoscope, General and Plastic Surgery |
| Regulation Number: | 21 C.F.R. 888.1100 |
| Regulatory Class: | II |
| Product Code: | GCJ, FCW |
4) Device Description:
The HD-Camera HDC1000 is a video-management system that consists of a camera, an integrated light source and a capture module for storing and compressing video and still images. It is used in conjunction with an endoscope or microscope, a light cable and other endoscopic accessories to illuminate surgical sites and to view the surgical sites on video monitors during diagnostic and operative endoscopic procedures. The camera of the proposed device consists of a camera control unit (CCU), a coupler, and a camera head with an integral cable that connects to the camera control unit (CCU). The optical image is transferred from the surgical site to the camera head by compatible rigid and flexible endoscopes that are attached to the camera head using an optical coupler. The camera head including camera cable and the coupler are reusable devices and must be sterilized using the STERRAD ® advanced sterilization process or may be used with a sterile cover or sleeve. The camera control unit (CCU) is not intended to enter the sterile field, and cannot be sterilized.
5) Intended Use:
The HD-Camera HDC1000 is intended to be used during diagnostic and operative endoscopic procedures to provide illumination and visualization of
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Image /page/5/Picture/0 description: The image shows the logo for WOM, which is a circle with a stylized figure inside and a red triangle at the bottom. Below the logo is the text "WOM" in a larger font. Below that is the text "HD-Camera HDC100" and "510(k) Premarket Notification".
body cavities, hollow organs and canals and to allow for image recording and documentation. The HD-Camera HDC1000 is indicated for use with compatible rigid i flexible endoscopes and other video equipment and endoscopic accessories.
6) Comparison of Technological Characteristics:
The proposed device HD-Camera HDC1000 and the predicate device OVS1 Video System incorporate the same basic design. Specifically, both the HD-Camera HDC1000 and the predicate device are 1-Chip cameras that consist of three main components: a camera head, various optical couplers, and a camera control unit (CCU). In addition, the HD-Camera HDC 1000 and the predicate device are designed with an integrated LED light source.
Both the HD-Camera HDC1000 and the predicate device receive optical images from a variety of scopes that are attached to the camera head via a coupler or direct attachment and use a CCD image sensor to convert the optical image into an electronic signal. The camera head of the HD-Camera HDC1000 and the predicate device incorporate a button keypad to control the system itself and any other connected video equipment.
The camera control unit (CCU) of the proposed device and the predicate device are software controlled and are equipped with a graphical user interface (GUI). The GUI of both the HD-Camera HDC1000 and the predicate device is designed with a menu key that allows the user to select and change various preprogrammed settings and to make changes in the assignment of the buttons on the keypad of the camera head.
The differences in the technological characteristics of both the proposed device HDC1000 and Predicate Device are minor and do not raise new questions of
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Image /page/6/Picture/0 description: The image shows the logo for WOM, which is a circle with a stylized figure inside and a red triangle at the bottom. Below the logo is the text "WOM" in a larger font. Below that is the text "HD-Camera HDC100" and "510(k) Premarket Notification".
safety and effectiveness. The differences between the HDC1000 and the Predicate Device are the following:
- Unlike the camera head unit of the Predicate Device, the camera head unit . of the proposed device can be sterilized.
- The button keypad of the camera head of the Predicate Device is designed . with three buttons. The proposed device HDC1000 is designed with two camera head buttons.
- . The camera head of the Predicate device incorporates a digital zoom feature whereas the proposed device HDC1000 is to be used with a zoom lens.
- The chip pixels of the camera head of the devices differ slightly. The . camera head of the proposed device incorporates a chip with 1280 x 720 pixels versus 1920 x 1080 pixels of the predicate device.
- The proposed device HDC1000 has a frame rate of 30fps and the ● Predicate Device of 60fps.
- . The CCU of the Predicate Device contains a touchscreen with a graphical interface including display. The HDC1000 is designed with a plastic foil keypad with a graphical interface and adjustments are only displayed on the monitor.
- The CCU of the Predicate Device offers fiberscope and ENT in addition . to the above mentioned pre-programmed procedure profiles.
- . The CCU of the proposed device incorporates two HDMI signal outputs and the Predicate device one DVI (HDMI), one 3G-SDI, one USB 2.0 and one Ethernet signal output.
- The resolution of the video output of the CCU of the HDC1000 is 1280 x . 720 pixels versus 1920 x 1080 pixels of the Predicate device.
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Image /page/7/Picture/0 description: The image shows the logo for WOM, which is a circle with a design inside and a small triangle at the bottom. Below the logo, the text "WOM" is written in a bold font. The text "HD-Camera HDC1000 510(k) Premarket Notification" is written below the logo in a smaller font.
- The CCU of the HDC1000 is designed to be used with a SDHC card as a ● storage media and that of the Predicate Device with a USB flash thumb.
7) Performance Data:
Electrical safety and electromagnetic compatibility testing was performed by independent laboratories in accordance with the following standards:
- · IEC 60601-1:2005 Medical Electrical Equipment Part 1: General Requirements for Basic Safety and Essential Performance;
• IEC60601-1-2:2007 - Medical Electrical Equipment – Part 1-2: General Requirements for Basic Safety and Essential Performance – Collateral Standard: Electromagnetic Compatibility - Requirements and Tests;
· IEC60601-2-18:2009 - Medical Electrical Equipment - Part 2-18: Particular Requirements for the Basic Safety and Essential Performance of Endoscopic Equipment.
Test results demonstrate that the proposed device conforms to the above standards.
The software was developed, tested, and verified in accordance with the FDA guidance document, "Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices" and in accordance with the following standard:
· IEC62304:2006 - Medical Device Software - Software Life Cycle Processes.
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Image /page/8/Picture/0 description: The image shows the logo for WOM, which is a circle with a design inside and a triangle at the bottom. Below the logo is the text "WOM" in a larger font. Below that is the text "HD-Camera HDC1000" and "510(k) Premarket Notification".
The cleaning instructions provided in the labeling for the camera head and cable were validated. Sterilization validation testing was performed in accordance with the below standard:
· AAMI/ANSI/ISO 14937:2009 - Sterilization of Health Care Products -General Requirements for Characterization of a Sterilizing Agent and the Development, Validation and Routine Control of a Sterilization Process for Medical Devices;
· AAMI TIR12:2010 - Designing, Testing and Labeling reusable medical devices for reprocessing in health care facilities: A Guide for Medical Device Manufacturers.
Design verification testing of the HD-Camera HDC1000 demonstrates that the device performs as intended and that the performance does not raise new questions of safety and effectiveness.
Finally, comparative bench testing was performed to demonstrate that the performance of the HD-Camera HDC1000 is substantially equivalent to that of the predicate device OVS1 Video System. The comparative bench test included signal to noise ratio (SNR), resolution, latency, shading correction accuracy, white balance accuracy and maximum light source intensity.
8) Conclusions:
Based on the same intended use, the same basic technological characteristics and performance testing, the HD-Camera HDC1000 is substantially equivalent to the predicate device OVS1 Video System. The differences between the
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Image /page/9/Picture/0 description: The image shows the logo for WOM, which is a circle with a stylized figure inside and a small triangle at the bottom. Below the logo is the text "WOM" in a larger font. Below that is the text "HD-Camera HDC1000" and "510(k) Premarket Notification".
proposed device and the predicate device do not raise new questions of safety and effectiveness.