(112 days)
No
The description focuses on the optical and mechanical aspects of a rigid endoscope and does not mention any AI or ML capabilities. The "Mentions AI, DNN, or ML" section explicitly states "Not Found".
No
The device is a laparoscopic tool used for visualization during surgery, not for treatment or therapy.
No.
The device is described as an endoscopic surgical tool for visualization during procedures, not for making a diagnosis.
No
The device description explicitly states it is a "rigid endoscope" consisting of a "lighting system and optical imaging system," which are hardware components.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states that the device is used for "endoscopic surgery within the thoracic and peritoneal cavities including the female reproductive organs" and "transanal and transvaginal applications." This describes a surgical instrument used for direct visualization and manipulation within the body.
- Device Description: The description details a "rigid endoscope" with a "lighting system and optical imaging system." This is consistent with a surgical endoscope, not a device used to examine samples in vitro (outside the body).
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue, etc.) or providing diagnostic information based on such analysis. IVDs are typically used to detect, measure, or identify substances or characteristics in these samples to aid in diagnosis, monitoring, or screening.
Therefore, the 4K UHD Laparoscope is a surgical device, not an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
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.
Product codes
GCJ, NMH, HET
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 4K UHD Laparoscope is a reusable device that is cleaned and steam sterilized before first use and each subsequent use.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Optical imaging
Anatomical Site
thoracic and peritoneal cavities including the female reproductive organs; transanal and transvaginal
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
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:
- 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 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.
No clinical study is included in this submission.
Key Metrics
Not Found
Predicate Device(s)
Reference Device(s)
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 876.1500 Endoscope and accessories.
(a)
Identification. An endoscope and accessories is a device used to provide access, illumination, and allow observation or manipulation of body cavities, hollow organs, and canals. The device consists of various rigid or flexible instruments that are inserted into body spaces and may include an optical system for conveying an image to the user's eye and their accessories may assist in gaining access or increase the versatility and augment the capabilities of the devices. Examples of devices that are within this generic type of device include cleaning accessories for endoscopes, photographic accessories for endoscopes, nonpowered anoscopes, binolcular attachments for endoscopes, pocket battery boxes, flexible or rigid choledochoscopes, colonoscopes, diagnostic cystoscopes, cystourethroscopes, enteroscopes, esophagogastroduodenoscopes, rigid esophagoscopes, fiberoptic illuminators for endoscopes, incandescent endoscope lamps, biliary pancreatoscopes, proctoscopes, resectoscopes, nephroscopes, sigmoidoscopes, ureteroscopes, urethroscopes, endomagnetic retrievers, cytology brushes for endoscopes, and lubricating jelly for transurethral surgical instruments. This section does not apply to endoscopes that have specialized uses in other medical specialty areas and that are covered by classification regulations in other parts of the device classification regulations.(b)
Classification —(1)Class II (special controls). The device, when it is an endoscope disinfectant basin, which consists solely of a container that holds disinfectant and endoscopes and accessories; an endoscopic magnetic retriever intended for single use; sterile scissors for cystoscope intended for single use; a disposable, non-powered endoscopic grasping/cutting instrument intended for single use; a diagnostic incandescent light source; a fiberoptic photographic light source; a routine fiberoptic light source; an endoscopic sponge carrier; a xenon arc endoscope light source; an endoscope transformer; an LED light source; or a gastroenterology-urology endoscopic guidewire, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 876.9.(2) Class I for the photographic accessories for endoscope, miscellaneous bulb adapter for endoscope, binocular attachment for endoscope, eyepiece attachment for prescription lens, teaching attachment, inflation bulb, measuring device for panendoscope, photographic equipment for physiologic function monitor, special lens instrument for endoscope, smoke removal tube, rechargeable battery box, pocket battery box, bite block for endoscope, and cleaning brush for endoscope. The devices subject to this paragraph (b)(2) are exempt from the premarket notification procedures in subpart E of part 807of this chapter, subject to the limitations in § 876.9.
0
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
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 (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
2
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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3
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
4
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, |
5
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
6
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 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. | These endoscopes are 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. | Same | ||
| Single use / | |||
| Reusable | Reusable | Reusable | Same |
| Feature | Rigid endoscope | Rigid endoscope | Same |
| Mechanism | Viewing Optics | Viewing Optics | Same |
| Principle of | |||
| operation | During operation, the external light | ||
| source is transmitted to the front end of | |||
| the laparoscope through the lighting | |||
| system of the laparoscope to illuminate | |||
| the area to be observed. The object is | |||
| imaged on the imaging system through | |||
| the objective lens, and then transmitted | During operation, the external | ||
| light source is transmitted to the | |||
| front end of the laparoscope | |||
| through the lighting system of | |||
| the laparoscope to illuminate the | |||
| area to be observed. The object | |||
| is imaged on the imaging system | Same | ||
| to the eyepiece for direct observation | |||
| by the human eye, or magnified by an | |||
| external camera system and observed | |||
| on the monitor. | through the objective lens, and | ||
| then transmitted to the eyepiece | |||
| for direct observation by the | |||
| human eye, or magnified by an | |||
| external camera system and | |||
| observed on the monitor. | |||
| Outer | |||
| Diameter | 5.5 mm and 10 mm | 5.4 mm and 10 mm | Different |
| Working | |||
| Length | 4K5500, 4K5530, 4K5545: 300mm | ||
| 4K5500R, 4K5530R, 4K5545R: 290mm | |||
| 4K1000, 4K1030, 4K1045: 330mm | |||
| 4K1000R, 4K1030R, 4K1045R: 320mm | WA4KL500: 315.3±0.5mm | ||
| WA4KL530: 315.5±1.5mm | |||
| WA4KL545: 315.5±1.5mm | |||
| WA4KL100: 315.9±0.5mm | |||
| WA4KL130: 317.1±1.5mm | |||
| WA4KL145: 317.7±1.5mm | Different | ||
| Direction of | |||
| View | 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 | |||
| Objective | |||
| glass cover | Sapphire | Sapphire | |
| Optical fiber | |||
| emission | |||
| surface | Light Guide fibre | Light Guide fibre | Same |
| Metal filler | AISI 304 Medical stainless steel | Medical stainless steel | |
| Adhesives | Epoxy resin fiber optic adhesive (Epotek | ||
| 353ND) | Epoxy resin fiber optic adhesive | ||
| Main part | AISI 304 Medical stainless steel | Medical stainless steel | |
| Thermal | |||
| Safety | 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 |
| Intracutaneous | |||
| Reactivity | Comply with ISO 10993-10 | Unknown | Different |
| Sterilization | |||
| Method | Steam sterilization / Low-temperature | ||
| plasma sterilization | Autoclaved sterilization | Different | |
| Labeling | Complied with 21 CFR Part 801 | Complied with 21 CFR Part 801 | Same |
Table 2 General Comparison
7
8
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
9
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