(206 days)
Not Found
No
The document describes a standard 4K camera system for endoscopic surgery and does not mention any AI or ML capabilities, image processing beyond basic signal conversion, or data sets for training or testing algorithms.
No
The device is a 4K UHD Camera System used for providing imaging in endoscopic surgery for diagnosis, treatment, and observation. It is an imaging tool, not a device that directly performs therapy.
Yes
The "Intended Use / Indications for Use" section explicitly states that the device is "for endoscopic diagnosis, treatment, and observation." The mention of "diagnosis" indicates its role in identifying or characterizing medical conditions, which aligns with the definition of a diagnostic device.
No
The device description explicitly lists hardware components such as the camera head, objective lens, power cable, video cables, and camera control unit. While it mentions software validation, the core of the device is hardware-based for image acquisition and processing.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is to "provide imaging of the operative area in endoscopic surgery" for "endoscopic diagnosis, treatment, and observation." This describes a device used during a medical procedure to visualize internal structures, not a device used to examine specimens outside the body to diagnose a condition.
- Device Description: The description focuses on the camera system components (camera head, control unit, cables) and their function in capturing images during surgery. There is no mention of analyzing biological samples or performing tests on specimens.
- Lack of IVD Characteristics: The document does not mention any of the typical characteristics of an IVD, such as:
- Analysis of biological samples (blood, urine, tissue, etc.)
- Reagents or assays
- Measurement of analytes
- Diagnosis based on laboratory test results
The device is clearly intended for direct visualization within the body during endoscopic procedures.
N/A
Intended Use / Indications for Use
4K UHD Camera System is used to provide imaging of the operative area in endoscopic surgery.
4K Camera Control Unit
The 4K camera control unit has been designed to be used with endoscopes, 4K camera head, light source, monitors, and other ancillary equipment for endoscopic diagnosis, treatment, and observation. The 4K camera head is compatible with the 4K camera control unit only.
4K Camera Head
The 4K camera head has been designed to be used with endoscopes, 4K camera control unit, and other ancillary equipment for endoscopic diagnosis, treatment, and observation.
Product codes (comma separated list FDA assigned to the subject device)
HET, EOB, FGB, GCJ, NWB, FET, HRX
Device Description
The proposed system, 4K UHD Camera System, comprises the 4K camera head, objective lens and power cable and video cables. The proposed system is reusable device, and provided non-sterile. The proposed camera head and should be cleaned and disinfected after each use.
The video cables include an SDI video cable and an HDMI video cable. The 4K camera control unit has two models (ES-CS4K100 and ES-CS4K200) with the only difference on signal output terminals, the detail difference refers to Table 3 of this document; the 4K camera head only has one model (ES-CS4K100C). Therefore, the 4K UHD Camera System is available in two models in combination of the 4K camera control unit and 4K camera head. The system model and primary components of the proposed system are provided in Table 1.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Optical
Anatomical Site
Operative area in endoscopic surgery (general)
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Used in hospitals, clinics and doctor's office by doctors and trained healthcare professionals.
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)
Non-clinical tests were conducted to verify that the proposed device met all design specifications. The tests included:
- A Depth of Field Test
- A Resolution Test
- A Direction of View and Field of View Test
- Color Reproduction and Signal Noise Ratio Test
- Geometric Distortion Test
- Image Frame Frequency and System Delay
- Image Intensity Uniformity
The key results demonstrated that the proposed device complies with the following standards:
- IEC 60601-1:2005+AMD1:2012
- IEC 60601-1-2:2014
- IEC 60601-2-18:2009
- ASTM D4169-16
- AAMI TIR 30:2016
- AAMI TIR 12:2010
The software of the proposed device was validated as Moderate level of concern (LoC) in accordance with the Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices.
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
§ 884.1720 Gynecologic laparoscope and accessories.
(a)
Identification. A gynecologic laparoscope is a device used to permit direct viewing of the organs within the peritoneum by a telescopic system introduced through the abdominal wall. It is used to perform diagnostic and surgical procedures on the female genital organs. This generic type of device may include: Trocar and cannula, instruments used through an operating channel, scope preheater, light source and cables, and component parts.(b)
Classification. (1) Class II (performance standards).(2) Class I for gynecologic laparoscope accessories that are not part of a specialized instrument or device delivery system, do not have adapters, connector channels, or do not have portals for electrosurgical, lasers, or other power sources. Such gynecologic laparosope accessory instruments include: the lens cleaning brush, biopsy brush, clip applier (without clips), applicator, cannula (without trocar or valves), ligature carrier/needle holder, clamp/hemostat/grasper, curette, instrument guide, ligature passing and knotting instrument, suture needle (without suture), retractor, mechanical (noninflatable), snare, stylet, forceps, dissector, mechanical (noninflatable), scissors, and suction/irrigation probe. The devices subject to this paragraph (b)(2) are exempt from the premarket notification procedures in subpart E of part 807 of this chapter, subject to the limitations in § 884.9.
0
Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health & Human Services logo on the left and the FDA text logo on the right. The text logo has the FDA acronym in a blue square, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue.
August 21, 2020
Scivita Medical Technology Co., Ltd. % Diana Hong General Manager Mid-Link Consulting Co, Ltd P.O. Box 120-119 Shanghai. 200120 CHINA
Re: K200216
Trade/Device Name: 4K UHD Camera System Regulation Number: 21 CFR 884.1720 Regulation Name: Gynecologic Laparoscope and Accessories Regulatory Class: II Product Code: HET, EOB, FGB, GCJ, NWB, FET, HRX Dated: July 9, 2020 Received: July 22, 2020
Dear Diana Hong:
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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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
1
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 device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
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 https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
Jason R. Roberts, Ph.D. Acting Assistant Director DHT3B: Division of Reproductive, Gynecology and Urology Devices OHT3: Office of GastroRenal, ObGyn, General Hospital and Urology Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known) K200216
Device Name 4K UHD Camera System
Indications for Use (Describe)
4K UHD Camera System is used to provide imaging of the operative area in endoscopic surgery.
4K Camera Control Unit
The 4K camera control unit has been designed to be used with endoscopes, 4K camera head, light source, monitors, and other ancillary equipment for endoscopic diagnosis, treatment, and observation. The 4K camera head is compatible with the 4K camera control unit only.
4K Camera Head
The 4K camera head has been designed to be used with endoscopes, 4K camera control unit, and other ancillary equipment for endoscopic diagnosis, treatment, and observation.
| Type of Use (Select one or both, as applicable) | |
|---|---|
| ------------------------------------------------- | -- |
|X Prescription Use (Part 21 CFR 801 Subpart D)
Over-The-Counter Use (21 CFR 801 Subpart C)
CONTINUE ON A SEPARATE PAGE IF NEEDED.
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Form Approved: OMB No. 0910-0120
3
510(k) Summary
This 510(k) Summary is being submitted in accordance with requirements per 21 CFR 807.92.
- Sponsor Identification
Sponsor Identification: Scivita Medical Technology Co., Ltd. No.8, Zhong Tian Xiang, Suzhou Industrial Park, Suzhou, Jiangsu, 215000, China.
Establishment Registration Number: Not yet registered
Contact Person: Ruqin Wu Position: Quality Manager Tel: +86-512-81877788 Fax: +86-512-85187285 Email: wuruqin@scivitamedical.com
Designated Submission Correspondent:
Ms. Diana Hong (Primary Contact Person) Ms. Jing Cheng (Alternative Contact Person)
Mid-Link Consulting Co., Ltd P.O. Box 120-119, Shanghai, 200120, China
Tel: +86-21-22815850, Fax: 360-925-3199 Email: info@mid-link.net
Date of Preparation: August 20, 2020
4
2. Device Information
Trade Name: 4K UHD Camera System Common Name: Endoscopic Video Imaging System Model: ES-CS4K100/100C ES-CS4K200/100C Regulation Number: 21 CFR 884.1720 Regulation Name: Gynecologic Laparoscope And Accessories Regulatory Class: II Product Code: HET, EOB, FGB, GCJ, NWB, FET, HRX
3. Identification of Predicate Device
510(k) Number: K151011 Product Name: Olympus Medical Systems Corp. The predicate device has not been subject to a design-related recall.
4. Device Description
The proposed system, 4K UHD Camera System, comprises the 4K camera head, objective lens and power cable and video cables. The proposed system is reusable device, and provided non-sterile. The proposed camera head and should be cleaned and disinfected after each use.
The video cables include an SDI video cable and an HDMI video cable. The 4K camera control unit has two models (ES-CS4K100 and ES-CS4K200) with the only difference on signal output terminals, the detail difference refers to Table 3 of this document; the 4K camera head only has one model (ES-CS4K100C). Therefore, the 4K UHD Camera System is available in two models in combination of the 4K camera control unit and 4K camera head. The system model and primary components of the proposed system are provided in Table 1.
| 4K UHD Camera System | System model | Primary component |
|---|---|---|
| ES-CS4K100/100C | 4K camera control unit (ES-CS4K100) | |
| 4K camera head (ES-CS4K100C) | ||
| ES-CS4K200/100C | 4K camera control unit (ES-CS4K200) | |
| 4K camera head (ES-CS4K100C) |
Table 1 System model and primary component
Working Principle and/or Mechanism of Action:
The 4K UHD Camera System can provide 4K images via different signal output terminals. The 4K camera head incorporates a complementary metal oxide semiconductor (CMOS) image sensor to convert optical images into electronical signals. The objective lens on end of the 4K camera head is used to connect the camera head with the endoscope.
5
The 4K UHD Camera System is designed to be used with endoscopes, a light source (ES-LS110D), monitors, light guide cables and other ancillary equipment for endoscopic diagnosis, treatment and observation.
Conditions of Use:
4K UHD Camera System is intended to be used in hospitals, clinics and doctor's office by doctors and trained healthcare professionals. Compatible equipment of the proposed system is provided in the Table 2.
| Equipment | Manufacturer | Model | K Number |
|---|---|---|---|
| 4K UHD Camera System | SCIVITA | ES-CS4K 100/100C | This application |
| HSV LAPAROSCOPY SET | |||
| (optional select one from all endoscope | |||
| when connecting with the proposed | |||
| device to test) | WOLF | Laparoscope | |
| (0°, 30°,45°) | K941541 | ||
| HENKE SASS WOLF OF AMERICA | |||
| ARTHROSCOPE | WOLF | Arthroscope | |
| (0°,30°,70°) | K080560 | ||
| SINUSCOPE AND ACCESSORIES | WOLF | Sinuscope | |
| (0°,30°,70°) | K981751 | ||
| LED LIGHT SOURCE | SCIVITA | ES-LS110D | |
| Monitor | SONY | LMD-X2705MD/ | |
| LMD-X550MD/ | |||
| LMD-X310MD/ | |||
| LMD-X310MT | K150377 |
Table 2 Recommended compatible equipment of the proposed system
The key performance specifications of the proposed system are provided in the Table 3.
Table 3 General specifications
| Weight | 5Kg | |
|---|---|---|
| Dimension(W×H×D) | 370 (W) ×95 (H)×425.5(D) mm | |
| Camera Head | 1/3" Three Chip CMOS | |
| Signal output (resolution) | 4096×2160, 1920×1080 | |
| Signal | ||
| output | ||
| (interface type) | ES-CS4K100/100C | There are HDMI×2, SDI-1 BNC terminal×4, SDI-2 BNC |
| terminal×1 seven interfaces in total. This model can output | ||
| the following three types: 4K SDI × 1, 2K SDI × 1, 4K | ||
| HDMI × 2 | ||
| ES-CS4K200/100C | There are HDMI×2, SDI-1 BNC terminal×4, SDI-2 BNC | |
| terminal×1 seven interfaces in total. This model can |
6
| | output the following four types: 4K SDI × 1, 2K SDI × 1,
4K HDMI × 1, 2K HDMI × 1 |
|---------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Video output format | HDMI output: 2160/59.94p, 2160/50p, 1080/59.94p,
1080/59.94i, 1080/50p, 1080/50i
SDI output: 2160/59.94p, 2160/50p, 1080/59.94p,
1080/59.94i, 1080/50p, 1080/50i |
| Image recording | The data is stored in real time to the external access USB
interface device by photographing or recording functions. |
| Operation mode | Continuous operation |
| White balance | Automatic white balance |
The level of concern of the software contained in the subject device is determined to be Moderate Level of Concern.
5. Indications for use:
4K UHD Camera System is used to provide imaging of the operative area in endoscopic surgery.
4K Camera Control Unit
The 4K camera control unit has been designed to be used with endoscopes, 4K camera head, light source, monitors, and other ancillary equipment for endoscopic diagnosis, treatment, and observation. The 4K camera head is compatible with the 4K camera control unit only.
4K Camera Head
The 4K camera head has been designed to be used with endoscopes, 4K camera control unit, and other ancillary equipment for endoscopic diagnosis, treatment, and observation
The indications for use statement of the subject device is similar to that of the video processor component of the predicate device. The main difference in the indication for use is the subject device doesn't include indications for the light source because a light source is not included in this subject device submissions for use of the camera control unit and camera head of the subject device and predicate device are the differences in the indications do not represent a new intended use.
7
- Comparison of Technological Characteristics
| ITEM | Subject Device K200216 | Predicate Device K151011 |
|---|---|---|
| Name | 4K UHD Camera System | VISERA 4K UHD SYSTEM |
| Product Code | HET, EOB, FGB, GCJ, NWB, FET, | |
| HRX | HET, GCJ, EOB, EOQ, FGB, NWB | |
| Regulation Number | 21 CFR 884.1720 | 21 CFR 884.1720, |
| Class | II | II |
| Indications for Use | 4K UHD Camera System is used to | |
| provide imaging of the operative area in | ||
| endoscopic surgery. |
4K Camera Control Unit
The 4K camera control unit has been
designed to be used with endoscopes, 4K
camera head, light source, monitors, and
other ancillary equipment for endoscopic
diagnosis, treatment, and observation.
The 4K camera head is compatible with
the 4K camera control unit only.
4K Camera Head
The 4K camera head has been designed
to be used with endoscopes, 4K camera
control unit, and other ancillary
equipment for endoscopic diagnosis,
treatment, and observation | VISERA 4K UHD CAMERA CONTROL
UNIT OLYMPUS OTV-S400
The camera control unit has been designed
to be used with Olympus endoscopes,
camera heads, light source, monitors, and
other ancillary equipment for endoscopic
diagnosis, treatment, and observation.
VISERA 4K UHD XENON LIGHT
SOURCE OLYMPUS CLV-S400
The light source has been designed to be
used with Olympus endoscopes, camera
control unit, light guide cables, and other
ancillary equipment for endoscopic
diagnosis, treatment, and observation.
4K CAMERA HEAD OLYMPUS
CH-S400-XZ-EB
The camera head has been designed to be
used with Olympus endoscopes, camera
control unit, and other ancillary equipment
for endoscopic diagnosis, treatment, and
observation. |
| Single use / Reusable | Reusable | Reusable |
| Sterile | No | No |
| Configuration
(primary components) | 4K Camera Control Unit
4K Camera Head | light source
4K Camera Control Unit
4K Camera Head |
| ITEM | Subject Device K200216 | Predicate device |
| Model | ES-CS4K100
ES-CS4K200 | K151011
VISERA 4K UHD CAMERA CONTROL
UNIT OLYMPUS OTV-S400 |
| Power supply | 100-240V AC, 50/60Hz | 100-240V~ ±10%,
50/60Hz±1Hz |
| Dimension | 370(W) ×95(H)×425.5(D) mm | 390(W) × 160(H) × 506(D) mm |
| Weight | 5Kg | 13.5Kg |
| Input power | 150VA | 350VA |
| Resolution | 4096×2160pxl,
1920×1080pxl | 4096×2160,
3840×2160,
1920×1080 |
| Image
signal
output | ES-CS4K100 | Total seven signal output terminals
HDMI (4K HMDI) ×2,
SDI (4K SDI) terminal×4,
SDI (3G/HD-SDI) terminal×1;
The seven signal output terminals can
output three types of signal output: 4K
SDI , 2K SDI , 4K HDMI |
| | ES-CS4K200 | Total seven signal output terminals:
HDMI (4K HMDI) ×1,
HDMI (HMDI)×1,
SDI (4K) terminal×4,
SDI (3G/HD-SDI) terminal×1;
The seven signal output terminals can
output four types of signal output: 4K SDI, 2K SDI , 4K HDMI, 2K HDMI |
| Standard Color Chart
Output | Color bar image | Color bar image |
| Observation light imaging | White light imaging(WLI)
Six imaging function | White light imaging (WLI)
Narrow band imaging (NBI) |
Table 4 General Comparison
Table 5 Comparison of ES-CS4K100/200 Camera Control Unit
8
| Table 6 Comparison of Camera Head | |
|---|---|
| ITEM | Subject Device K200216 | Predicate Device K151011 |
|---|---|---|
| Model | ES-CS4K100C | 4K CAMERA HEAD OLYMPUS |
| CH-S400-XZ-EB | ||
| Camera Head dimension | W48 mm × H64 mm × L168 mm | W43.6 mm × H49.5 mm × L122.5 mm |
| Cable dimension | φ5mm× 2.9m | 5.1 mm x 3 m |
9
| Wight(excluding cable) | 231.4g (excluding cable) | 280 g (excluding cable) |
|---|---|---|
| Reprocessing | End user reprocess | End user sterilized |
| Disinfection by using glutaraldehyde | ||
| solution | EOG/ STERRAD |
The differences in technological characteristics do not raise different questions of safety and effectiveness.
-
- Summary of Non-Clinical Performance Testing
Non clinical tests were conducted to verify that the proposed device met all design specifications as is Substantially Equivalent (SE) to the predicate device. The test results demonstrated that the proposed device complies with the following standards:
- Summary of Non-Clinical Performance Testing
-
IEC 60601-1:2005+AMD1:2012 Medical Electrical Equipment- Part 1: General requirements for basic safety and essential performance.
-
IEC 60601-1-2:2014, Medical electrical equipment- Part 1-2: General requirements for basic safety and essential performance- Collateral standard: Electromagnetic compatibility- Requirements and tests.
-
IEC 60601-2-18:2009 Medical electrical equipment Part 2-18: Particular requirements for the basic safety and > essential performance of endoscopic equipment
-
ASTM D4169-16 Standard Practice for Performance Testing of Shipping Containers and Systems.
-
AAMI TIR 30:2016 A compendium of processes, materials, and acceptance criteria for cleaning reusable medical devices
-
AAMI TIR 12:2010 Designing, testing, and labeling reusable medical devices for reprocessing in health care facilities: A guide for medical device manufacturers
The software of the proposed device was validated as Moderate level of concern (LoC) in accordance with the following guidance documents: Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices -Guidance for Industry and FDA Staff
The following performance testing were also conducted on the subject device and the subject device met all predefined acceptance criteria:
- A Depth of Field Test
- A Resolution Test
- A Direction of View and Field of View Test
- Color Reproduction and Signal Noise Ratio Test >
-
Geometric Distortion Test
-
Image Frame Frequency and System Delay
-
Image Intensity Uniformity
10
8. Conclusion
The performance testing summarized above support a substantial equivalence determination. The performance testing demonstrate that the subject device is as safe and as effective as the legally marketed predicate device.