(112 days)
The 4K UHD Laparoscope is intended to be used for endoscopic surgery within the thoracic and peritoneal cavities including the female reproductive organs. The device is also indication of transanal and transvaginal applications.
The 4K UHD Laparoscope is a rigid endoscope, which consists of lighting system and optical imaging system. The 4K UHD Laparoscope has 12 models which are available in two insertion portion widths (5.5 mm and 10 mm), four working lengths (290mm, 300mm, 320mm) and three different directions of view (0°, 30°, 45°). The 12 models are all connected with adaptor 2 for different brand source light. The 4K UHD Laparoscope can be connected to Scivita 4K UHD Camera System, Scivita LED Light Source or Wolf light source and SONY Monitor. The 4K UHD Laparoscope is a reusable device that is cleaned and steam sterilized before first use and each subsequent use.
The provided text describes the acceptance criteria and the study that proves the device meets them, specifically for the "4K UHD Laparoscope" (K203255).
Here's a breakdown of the requested information:
1. A table of acceptance criteria and the reported device performance
The document doesn't explicitly present a table of acceptance criteria with reported device performance in the typical sense of numerical thresholds and corresponding results for each. Instead, it describes adherence to recognized standards and qualitative comparisons to a predicate device. The performance is implied by the successful completion of these tests and the determination of substantial equivalence.
However, based on the non-clinical tests mentioned, we can infer some performance aspects and how "acceptance" was framed:
| Acceptance Criteria (Inferred from standards and comparisons) | Reported Device Performance |
|---|---|
| Biocompatibility | |
| ISO 10993-5:2009 (Tests for in vitro cytotoxicity) | Complies with ISO 10993-5 |
| ISO 10993-10:2010 (Tests for irritation and skin sensitization) | Complies with ISO 10993-10 for Sensitization |
| ISO 10993-10:2010 (Tests for intracutaneous reactivity) | Complies with ISO 10993-10 for Intracutaneous Reactivity |
| Electrical Safety & Essential Performance | |
| IEC 60601-2-18:2009 (Basic safety and essential performance of endoscopic equipment) | Complies with IEC 60601-2-18 |
| Endoscope Standards | |
| ISO 8600-1:2015 (General requirements for medical endoscopes) | Complies with ISO 8600-1; Field of view meets requirements within 15% deviation. |
| ISO 8600-5:2005 (Determination of optical resolution) | Complies with ISO 8600-5 |
| Image Quality Performance | |
| Depth of Field | Range of 3-200 mm (Proposed device has a wider range than predicate device (6-200 mm), which "gives physicians more options." This is presented as an advantage meeting clinical needs.) |
| Geometric Distortion | Tests conducted (results not numerically detailed, but implies acceptable performance for SE) |
| Color Reproduction | Tests conducted (results not numerically detailed, but implies acceptable performance for SE) |
| SNR (Signal-to-Noise Ratio) | Tests conducted (results not numerically detailed, but implies acceptable performance for SE) |
| Intensity Uniformity | Tests conducted (results not numerically detailed, but implies acceptable performance for SE) |
| Image Frame Frequency | Tests conducted (results not numerically detailed, but implies acceptable performance for SE) |
| System Delay | Tests conducted (results not numerically detailed, but implies acceptable performance for SE) |
| Sterilization Efficacy | |
| Steam sterilization / Low-temperature plasma sterilization | Sterility Assurance Level (SAL) reached 10^-6 after steam sterilization and low-temperature plasma sterilization. |
| Labeling | |
| 21 CFR Part 801 | Complied with 21 CFR Part 801 |
The study described is a non-clinical test program designed to compare the proposed device's performance against recognized standards and a legally marketed predicate device ("ULTRA" Telescopes, K150633, from Olympus Winter & Ibe GmbH). The goal was to establish Substantial Equivalence (SE).
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Sample Size for Test Set: Not specified in the document. The non-clinical tests typically involve a sample of the manufactured device models.
- Data Provenance: The tests were conducted by Scivita Medical Technology Co., Ltd. (based in China, as per the sponsor identification) as part of their 510(k) submission. The data is prospective from these internal tests.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
Not applicable. This device is a hardware laparoscope, and the performance assessment is based on physical and optical measurements against engineering standards and comparison with a predicate device, not on expert interpretation of output data like medical imaging analysis. Therefore, there's no "ground truth" derived from medical experts in the context of diagnostic performance.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable. Since the "test set" refers to physical and optical performance characteristics of the device itself (e.g., cytotoxicity, electrical safety, optical resolution, depth of field), expert adjudication methods typically used for interpreting diagnostic outputs (like imaging) are not relevant here. The evaluation involves compliance with established standards and direct measurement/comparison.
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. This document pertains to the clearance of a 4K UHD Laparoscope, which is a physical endoscopic device, not an AI-powered diagnostic tool. Therefore, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study focusing on human reader improvement with AI assistance is not relevant and was not performed.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
No. This device is a hardware laparoscope. There is no algorithm to be tested in a standalone fashion.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
For the non-clinical tests:
- Biocompatibility: Ground truth is defined by the absence of toxicity, irritation, or sensitization as per the criteria outlined in ISO 10993 standards.
- Electrical Safety & Performance: Ground truth is compliance with the requirements of IEC 60601-2-18.
- Endoscope Standards: Ground truth is compliance with the requirements of ISO 8600-1 and ISO 8600-5.
- Image Quality Performance: Ground truth is established by quantitative measurements (e.g., depth of field, geometric distortion) and comparison to the predicate device's performance, ensuring similar or improved characteristics that meet clinical needs.
- Sterilization Efficacy: Ground truth is achieving a Sterility Assurance Level (SAL) of 10^-6.
The overall "ground truth" for the submission is the determination of Substantial Equivalence to the predicate device based on these engineering and performance standards.
8. The sample size for the training set
Not applicable. This is not an AI/machine learning device; therefore, there is no "training set."
9. How the ground truth for the training set was established
Not applicable, as there is no training set.
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Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
February 24, 2021
Scivita Medical Technology Co., Ltd. % Diana Hong General Manager Mid-Link Consulting Co.,Ltd P.O.Box 120-119 Shanghai, 200120 China
Re: K203255
Trade/Device Name: 4K UHD Laparoscope Regulation Number: 21 CFR 876.1500 Regulation Name: Endoscope and Accessories Regulatory Class: Class II Product Code: GCJ Dated: December 25, 2020 Received: December 30, 2020
Dear Diana Hong:
We have reviewed vour 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/cfpmp/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
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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 (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,
Long Chen. Ph.D. Assistant Director DHT4A: Division of General Surgery Devices OHT4: Office of Surgical and Infection Control Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known) K203255
Device Name 4K UHD Laparoscope
Indications for Use (Describe)
The 4K UHD Laparoscope is intended to be used for endoscopic surgery within the thoracic and peritoneal cavities including the female reproductive organs. The device is also indication of transanal and transvaginal applications.
| ☑ Prescription Use (Part 21 CFR 801 Subpart D) | ☐ Over-The-Counter Use (21 CFR 801 Subpart C) |
|---|---|
| ----------------------------------------------------------------------------------------------------------------- | ------------------------------------------------------------ |
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Tab #6 510(k) Summary
This 510(k) Summary is being submitted in accordance with requirements of Title 21, CFR Section 807.92.
The assigned 510(k) Number: _K203255
-
- Date of Preparation: 12/24/2020
-
- Sponsor Identification
Scivita Medical Technology Co., Ltd.
No. 8, Zhong Tian Xiang, Suzhou Industrial Park, Suzhou, Jiangsu Prov., 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)
- Designated Submission Correspondent
Mid-Link Consulting Co., Ltd.
P.O. Box 120-119, Shanghai, 200120, China
Tel: +86-21-22815850, Fax: +1-360-925-3199 Email: info@mid-link.net
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4. Identification of Proposed Device
Trade Name: 4K UHD Laparoscope Common Name: Laparoscopes Model: 4K5500, 4K5500R, 4K5530, 4K5530R, 4K5545, 4K5545R, 4K1000, 4K1000R, 4K1030, 4K1030R, 4K1045 and 4K1045R
Regulatory Information Classification Name: Laparoscope, General & Plastic Surgery Classification: II; Product Code: GCJ / NMH / HET; Regulation Number: 21 CFR 876.1500 & 21 CFR 884.1720 Review Panel: General & Plastic Surgery
Indication for use:
The 4K UHD Laparoscope is intended to be used for endoscopy and endoscopic surgery within the thoracic and peritoneal cavities including the female reproductive organs. The device is also indicated for visualization of transanal and transvaginal applications.
Device Description:
The 4K UHD Laparoscope is a rigid endoscope, which consists of lighting system and optical imaging system.
The 4K UHD Laparoscope has 12 models which are available in two insertion portion widths (5.5 mm and 10 mm), four working lengths (290mm, 300mm, 320mm) and three different directions of view (0°, 30°, 45°). The 12 models are all connected with adaptor 2 for different brand source light. The specifications of the proposed device are listed in Table 1.
The 4K UHD Laparoscope can be connected to Scivita 4K UHD Camera System, Scivita LED Light Source or Wolf light source and SONY Monitor. The associated compatible device information is as follows:
| Endoscope camera system | 4K UHD Camera System, Model: ES-CS4K100/100C and ES-CS4K200/100C (K200216) |
|---|---|
| Scivita light source | Led Light Source manufactured by Scivita, Model: ES-LS110D (510K Exempt, product code: NTN) |
| Wolf light source | Visera 4k UHD Xenon Light Source manufactured by Richard Wolf Medical Instruments Corp., Model: 5123 |
| Monitor | Monitor manufactured by SONY, Model: LMD-X2705MD, |
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LMD-X550MD, LMD-X310MD and LMD-X310MT (K150377)
The 4K UHD Laparoscope is a reusable device that is cleaned and steam sterilized before first use and each subsequent use.
| No. | Model | Diameter | Working Length | Directions of View |
|---|---|---|---|---|
| 1 | 4K5500 | 5.5 mm | 300 mm | 0° |
| 2 | 4K5500R | 5.5 mm | 290 mm | 0° |
| 3 | 4K5530 | 5.5 mm | 300 mm | 30° |
| 4 | 4K5530R | 5.5 mm | 290 mm | 30° |
| 5 | 4K5545 | 5.5 mm | 300 mm | 45° |
| 6 | 4K5545R | 5.5 mm | 290 mm | 45° |
| 7 | 4K1000 | 10 mm | 330 mm | 0° |
| 8 | 4K1000R | 10 mm | 320 mm | 0° |
| 9 | 4K1030 | 10 mm | 330 mm | 30° |
| 10 | 4K1030R | 10 mm | 320 mm | 30° |
| 11 | 4K1045 | 10 mm | 330 mm | 45° |
| 12 | 4K1045R | 10 mm | 320 mm | 45° |
Table 1 Specifications
-
- Identification of Predicate Devices
Predicate Device 510(k) Number: K150633 Product Name: "ULTRA" Telescopes Manufacturer: Olympus Winter & Ibe GmbH Models: WA4KL100, WA4KL130, WA4KL145, WA4KL500, WA4KL530 and WA4KL545
- Identification of Predicate Devices
-
- Non-Clinical Test Conclusion
Non clinical tests were conducted to verify that the proposed device met all design specifications as was Substantially Equivalent (SE) to the predicate device. The test results demonstrated that the proposed device complies with the following standards:
- Non-Clinical Test Conclusion
-
ISO 10993-5:2009 Biological evaluation of medical devices - Part 5: Tests for in vitro cytotoxicity;
-
ISO 10993-10:2010 Biological evaluation of medical devices - Part 10: Tests for irritation and skin sensitization;
-
IEC 60601-2-18:2009 Medical electrical equipment - Part 2-18: Particular requirements for the basic safety and essential performance of endoscopic equipment
-
ISO 8600-1:2015 Endoscopes - Medical endoscopes and endotherapy devices -- Part 1: General
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requirements
-
ISO 8600-5:2005 Optics and photonics - Medical endoscopes and endotherapy devices - Part 5: Determination of optical resolution of rigid endoscopes with optics
In addition, the image quality performance tests were conducted to quantitatively compare the proposed device and predicate device in terms of depth of field, geometric distortion, color reproduction and SNR, intensity uniformity, image frame frequency and system delay. -
- Clinical Test Conclusion
No clinical study is included in this submission.
- Clinical Test Conclusion
-
- Substantially Equivalent (SE) Comparison
| ITEM | Proposed Device | Predicate Device K150633 | Remark |
|---|---|---|---|
| Product Code | GCJ / NMH / HET | GCJ / NMH / HET | Same |
| Regulation | 21 CFR 876.1500 | 21 CFR 876.1500 | Same |
| No. | 21 CFR 884.1720 | 21 CFR 884.1720 | Same |
| Class | II | II | Same |
| Indication forUse | The 4K UHD Laparoscope is intended tobe used for endoscopy and endoscopicsurgery within the thoracic andperitoneal cavities including the femalereproductive organs. The device is alsoindicated for visualization of transanaland transvaginal applications. | These endoscopes are intended tobe used for endoscopy andendoscopic surgery within thethoracic and peritoneal cavitiesincluding the female reproductiveorgans. The device is alsoindicated for visualization oftransanal and transvaginalapplications. | Same |
| Single use /Reusable | Reusable | Reusable | Same |
| Feature | Rigid endoscope | Rigid endoscope | Same |
| Mechanism | Viewing Optics | Viewing Optics | Same |
| Principle ofoperation | During operation, the external lightsource is transmitted to the front end ofthe laparoscope through the lightingsystem of the laparoscope to illuminatethe area to be observed. The object isimaged on the imaging system throughthe objective lens, and then transmitted | During operation, the externallight source is transmitted to thefront end of the laparoscopethrough the lighting system ofthe laparoscope to illuminate thearea to be observed. The objectis imaged on the imaging system | Same |
| to the eyepiece for direct observationby the human eye, or magnified by anexternal camera system and observedon the monitor. | through the objective lens, andthen transmitted to the eyepiecefor direct observation by thehuman eye, or magnified by anexternal camera system andobserved on the monitor. | ||
| OuterDiameter | 5.5 mm and 10 mm | 5.4 mm and 10 mm | Different |
| WorkingLength | 4K5500, 4K5530, 4K5545: 300mm4K5500R, 4K5530R, 4K5545R: 290mm4K1000, 4K1030, 4K1045: 330mm4K1000R, 4K1030R, 4K1045R: 320mm | WA4KL500: 315.3±0.5mmWA4KL530: 315.5±1.5mmWA4KL545: 315.5±1.5mmWA4KL100: 315.9±0.5mmWA4KL130: 317.1±1.5mmWA4KL145: 317.7±1.5mm | Different |
| Direction ofView | 0°, 30°, 45° | 0°, 30°, 45° | Same |
| Field of View | 75° | 88° | Different |
| Depth of Field | 3-200 mm | 6-200 mm | Different |
| Patient Contact Material | |||
| Objectiveglass cover | Sapphire | Sapphire | |
| Optical fiberemissionsurface | Light Guide fibre | Light Guide fibre | Same |
| Metal filler | AISI 304 Medical stainless steel | Medical stainless steel | |
| Adhesives | Epoxy resin fiber optic adhesive (Epotek353ND) | Epoxy resin fiber optic adhesive | |
| Main part | AISI 304 Medical stainless steel | Medical stainless steel | |
| ThermalSafety | IEC 60601-2-18 | IEC 60601-2-18 | Same |
| Biocompatibility | |||
| Cytotoxicity | Comply with ISO 10993-5 | Comply with ISO 10993-5 | Same |
| Sensitization | Comply with ISO 10993-10 | Unknown | Different |
| IntracutaneousReactivity | Comply with ISO 10993-10 | Unknown | Different |
| Sterilization | |||
| Method | Steam sterilization / Low-temperatureplasma sterilization | Autoclaved sterilization | Different |
| Labeling | Complied with 21 CFR Part 801 | Complied with 21 CFR Part 801 | Same |
Table 2 General Comparison
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Different - Outer Diameter
Both the proposed device and the predicate device provide two options for outer diameter. Although the declared size of the outer diameter of the proposed device is not exactly the same as that of the predicate device, the difference is too slight to cause safety and performance issues. Thus, this difference does not affect substantially equivalence between the proposed device and predicate device.
Different - Working Length
Although the working length of the proposed device is not the same as that of the predicate device, the proposed device offers a wider range of options, allowing physicians to make choices based on the patient's condition. Thus, this difference does not affect substantially equivalence between the proposed device and predicate device.
Different - Field of View
Field of view, namely the view of an endoscope with optics, refers to the maximum range that the endoscope can observe at the same time, that is, the cone angle with the vertex at the end of the endoscope head. Although the field of view of the proposed device is different from that of predicate device, it can meet the needs of clinical diagnosis and treatment. In addition, the field of view of the proposed device meets the requirements of ISO 8600-1 with a deviation of not greater than 15%. Thus, this difference does not affect substantially equivalence between the proposed device and predicate device.
Different - Depth of Field
The proposed device has a wider range of depth of field than the predicate device to give physicians more options for diagnosis and treatment based on the patient's condition. Thus, this difference does not affect substantially equivalence between the proposed device and predicate device.
Different - Sensitization and Intracutaneous Reactivity
Although the results of sensitization and intracutaneous reactivity of the predicate device are unknown, the proposed device did both biocompatibility tests. The results showed that the proposed device posed no risk to humans. Thus, this difference does not affect substantially equivalence between the proposed device and predicate device.
Different - Sterilization
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Although the sterilization method of the proposed device is different from that of the predicate device, the sterilization verification is performed for the proposed device. The results showed that the Sterility Assurance Level (SAL) reached 10 after steam sterilization and low-temperature plasma sterilization. Thus, this difference does not affect substantially equivalence between the proposed device and predicate device.
-
- Substantially Equivalent (SE) Conclusion
Based on the comparison and analysis above, the proposed device is determined to be Substantially Equivalent (SE) to the predicate device.
- Substantially Equivalent (SE) Conclusion
§ 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.