(76 days)
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.
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.
This document describes the regulatory submission for the HD-Camera HDC1000, a medical device intended for diagnostic and operative endoscopic procedures to provide illumination, visualization, image recording, and documentation. The submission focuses on demonstrating substantial equivalence to a predicate device, the OVS1 Video System.
1. Table of Acceptance Criteria and Reported Device Performance
The document does not explicitly state "acceptance criteria" for the device's technical specifications in a table format. Instead, it describes performance testing conducted to demonstrate conformance to standards and substantial equivalence to a predicate device. The performance data section refers to various standards that the device conforms to, which implicitly represent the acceptance criteria for those specific aspects.
Based on the information provided, here's a summary of the performance claims and an attempt to infer "acceptance criteria" from the comparative bench testing with the predicate device, where the implied criterion is comparability.
| Feature/Test | Acceptance Criteria (Implied / Conformance to Standards) | Reported Device Performance |
|---|---|---|
| Electrical Safety | Conformance to IEC 60601-1:2005 | Test results demonstrate that the proposed device conforms toIEC 60601-1:2005. |
| Electromagnetic Compatibility (EMC) | Conformance to IEC 60601-1-2:2007 | Test results demonstrate that the proposed device conforms to IEC 60601-1-2:2007. |
| Endoscopic Equipment Safety & Performance | Conformance to IEC 60601-2-18:2009 | Test results demonstrate that the proposed device conforms to IEC 60601-2-18:2009. |
| Software Development | Conformance to FDA guidance "Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices" and IEC 62304:2006 | Software was developed, tested, and verified in accordance with the FDA guidance document and IEC 62304:2006. |
| Cleaning Instructions Validation | Instructions validated for camera head and cable reprocessing. | Cleaning instructions provided in the labeling for the camera head and cable were validated. |
| Sterilization Validation | Conformance to AAMI/ANSI/ISO 14937:2009 and AAMI TIR12:2010. | Sterilization validation testing was performed in accordance with AAMI/ANSI/ISO 14937:2009 and AAMI TIR12:2010. |
| Overall Performance (Design Verification) | Device performs as intended, no new safety/effectiveness questions. | Design verification testing demonstrates that the device performs as intended and that the performance does not raise new questions of safety and effectiveness. |
| Comparative Bench Testing | Performance substantially equivalent to the predicate device (OVS1 Video System) across key metrics. | Comparative bench testing was performed to demonstrate substantial equivalence, including "signal to noise ratio (SNR), resolution, latency, shading correction accuracy, white balance accuracy and maximum light source intensity." Specific numerical performance for these metrics is not provided in this excerpt. |
2. Sample Size Used for the Test Set and Data Provenance
The document states that "comparative bench testing was performed." However, it does not specify any sample size for this test set (e.g., number of devices tested, number of images/videos analyzed).
The data provenance is not explicitly mentioned but can be inferred as arising from bench testing conducted by independent laboratories. There is no indication of patient data or clinical studies; it is likely an engineering/technical evaluation.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
This information is not provided in the document. The comparative bench testing described here appears to be a technical comparison against a predicate device and industry standards, rather than an evaluation requiring expert clinical interpretation to establish a ground truth.
4. Adjudication Method for the Test Set
This information is not provided and is not applicable given the nature of the described testing (bench testing against technical standards and a predicate device). No human-based adjudication for ground truth is mentioned.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance?
No, a multi-reader multi-case (MRMC) comparative effectiveness study was not done. This device is a camera system for endoscopic visualization, not an AI diagnostic tool. The document focuses on the camera's technical performance and equivalence to a predicate device.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done?
This question is not applicable as the device is an HD-Camera, a hardware system for image and video capture, not an algorithm or AI system for standalone performance evaluation.
7. The Type of Ground Truth Used
For the safety, EMC, software, cleaning, sterilization, and general design verification tests, the "ground truth" implicitly refers to the requirements specified in the respective international standards (e.g., IEC 60601-1, IEC 60601-1-2, IEC 60601-2-18, IEC 62304, AAMI/ANSI/ISO 14937, AAMI TIR12) and conformity to FDA guidance documents.
For the comparative bench testing (SNR, resolution, latency, shading correction accuracy, white balance accuracy, maximum light source intensity), the "ground truth" is likely derived from measured technical specifications of both the proposed device and the predicate device, with the aim to demonstrate substantial equivalence. It refers to objective, measurable physical properties rather than subjective clinical diagnoses or pathology.
8. The Sample Size for the Training Set
This information is not applicable. The HD-Camera HDC1000 is a hardware device for image acquisition, not a machine learning or AI model that requires a training set.
9. How the Ground Truth for the Training Set Was Established
This information is not applicable for the same reason as above; there is no training set for this type of device.
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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
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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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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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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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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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- 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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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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proposed device and the predicate device do not raise new questions of safety and effectiveness.
§ 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.