(461 days)
The values are used in conventional gastrointestinal endoscope to control the functions of water/gas injection and suction during the endoscopic operation.
Disposable Endoscope Valves Kit consists of Water/gas button, Attraction button, Biopsy cap and Water injection adapter. Disposable Endoscope Valves Kit connect the endoscope operating handle matched with the model, and install the water gas button into the water gas port of the operating handle; Align the positioning boss of the suction button with the card slot of the operating handle and install it into the suction port; Install the biopsy cap into the clamp opening of the operating handle.
The provided text describes the acceptance criteria and a study demonstrating the substantial equivalence of the "Disposable Endoscope Valves Kit" to a predicate device. However, it does not include information typically found in studies proving an AI/ML device meets acceptance criteria, such as specific performance metrics like sensitivity, specificity, or AUC, detailed sample sizes for test sets, expert qualifications, or adjudication methods for ground truth.
This document is a 510(k) summary for a medical device that does not appear to be an AI/ML device. It seems to be a physical medical accessory. Therefore, the questions related to AI/ML specific criteria (such as effect size of human readers with AI vs without AI, standalone algorithm performance, training set details) are not applicable to this submission.
The study described is a non-clinical performance data study, not a clinical study involving AI/ML.
Here's an attempt to answer the relevant questions based on the provided text, while noting the limitations due to the nature of the device:
1. A table of acceptance criteria and the reported device performance
The document frames "acceptance criteria" as meeting regulatory standards and demonstrating substantial equivalence to a predicate device through non-clinical testing. It doesn't list quantitative performance metrics for the proposed device in the way one would for an AI/ML diagnostic tool (e.g., sensitivity, specificity).
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| Biological Evaluation | Meets ISO 10993 requirements |
| Sterilization | Meets ISO 11135-1 and ISO 10993-7 requirements (EO Sterilization) |
| Appearance | Passing |
| Physical Properties | Passing |
| Substantial Equivalence | Established through comparison to predicate device K220210 |
2. Sample size used for the test set and the data provenance
The document mentions "bench tests" were performed. For these non-clinical performance tests (Appearance, Physical properties), the specific sample size is not explicitly stated, nor is the data provenance. These would typically involve testing a certain number of manufactured units.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
This question is not applicable as the device is a physical accessory and the evaluation is based on engineering and material standards, not diagnostic interpretation requiring expert ground truth in the AI/ML context.
4. Adjudication method for the test set
This question is not applicable for the same reasons as above. The evaluation of appearance and physical properties would follow established testing protocols and standards, not a clinical adjudication process.
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 such study was conducted or reported. This type of study is relevant for AI/ML diagnostic devices, which this device is not. The document explicitly states: "No Clinical Study is included in this submission."
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
This question is not applicable. The device is a physical endoscope accessory, not an algorithm.
7. The type of ground truth used
For the non-clinical tests (biological evaluation, sterilization, appearance, physical properties), the "ground truth" would be compliance with established international standards (ISO series) and predefined specifications for the physical characteristics of the device. This is not "expert consensus, pathology, or outcomes data" in the typical sense of AI/ML diagnostic validation.
8. The sample size for the training set
This question is not applicable as this is not an AI/ML device and therefore does not have a "training set."
9. How the ground truth for the training set was established
This question is not applicable for the same reason as above.
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Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food & 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.
November 22, 2023
Shanghai SeeGen Photoelectric Technology Co., Ltd. Yihua Ma RA Supervisor 3 Floor, Building No.1, 4299 JinDu Road, Minhang District Shanghai, Shanghai 201108 China
Re: K222499
Trade/Device Name: Disposable Endoscope Valves Kit Regulation Number: 21 CFR 876.1500 Regulation Name: Endoscope And Accessories Regulatory Class: Class II Product Code: ODC Dated: November 3, 2023 Received: November 3, 2023
Dear Yihua Ma:
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 (the 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 available 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.
Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device"
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(https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download).
Your device is also subject to, among other requirements, the Quality System (QS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30. Design controls; 21 CFR 820.90. Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review. the OS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181).
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 of medical device-related adverse events) (21 CFR Part 803) for devices or postmarketing safety reporting (21 CFR Part 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 Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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 mediation-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).
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Sincerely,
Shanil P. Haugen -S
Shanil P. Haugen, Ph.D. Assistant Director DHT3A: Division of Renal, Gastrointestinal, Obesity and Transplant Devices OHT3: Office of Gastrorenal, ObGyn, General Hospital, and Urology 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) K222499
Device Name Disposable Endoscope Valves Kit
Indications for Use (Describe)
The values are used in conventional gastrointestinal endoscope to control the functions of water/gas injection and suction during the endoscopic operation.
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)
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Image /page/4/Picture/0 description: The image contains the logo for SEEGEN, a company specializing in vision technology. The logo features the company name in a stylized font, with the tagline "vision borderless" underneath. The text "机分光电" is also present, possibly indicating the company's focus on optical or photoelectric technology. The overall design suggests a modern and innovative approach to vision-related solutions.
Section 5 510(k) Summary
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510(k) Summary
This summary of 510(k) safety and effectiveness information is being submitted in accordance with requirements of 21 CFR Part 807.92.
5.1 Submitter
| Submitted by: | Shanghai SeeGen Photoelectric Technology Co., Ltd. |
|---|---|
| Address: 3 Floor, Building No.1, 4299 JinDu Road, MinhangDistrict, Shanghai, China | |
| ContactPerson: | Yihua MaRA Supervisor |
| Shanghai SeeGen Photoelectric Technology Co., LtdAddress: 3 Floor, Building No.1, 4299 JinDu Road, MinhangDistrict, Shanghai, ChinaPhone: 0086-18616909737Email: mayihua@seegen.com.cn | |
| DatePrepared: | July 15, 2022 |
5.2 Device
| Device Name: | Disposable Endoscope Valves Kit |
|---|---|
| Common Name: | Endoscope Channel Accessory |
| Regulatory Class: | Class II |
| Regulation Number: | 21 CFR 876.1500 |
| Regulation Name: | Endoscope and Accessories |
| Product Code: | ODC |
5.3 Predicate Device
| Device Name: | Disposable Endoscopy Adapter Set, K220210 |
|---|---|
| Common Name: | Endoscope Channel Accessory |
| Regulatory Class: | Class II |
| Regulation Number: | 21 CFR 876.1500 |
| Regulation Name: | Endoscope and Accessories |
| Product Code: | ODC |
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5.4 Device Description
Disposable Endoscope Valves Kit consists of Water/gas button, Attraction button, Biopsy cap and Water injection adapter. Disposable Endoscope Valves Kit connect the endoscope operating handle matched with the model, and install the water gas button into the water gas port of the operating handle; Align the positioning boss of the suction button with the card slot of the operating handle and install it into the suction port; Install the biopsy cap into the clamp opening of the operating handle.
5.5 Indication for Use:
The values are used in conjunction with conventional gastrointestinal endoscope to control the functions of water/gas injection and suction during the endoscopic operation.
| Item | Disposable EndoscopeValves Kit (ProposedDevice) | Disposable EndoscopyAdapter Set, K220210 | Discussion | |
|---|---|---|---|---|
| Indicationfor Use | The values are used inconjunction withconventionalgastrointestinal endoscopeto control the functions ofwater/gas injection andsuction during theendoscopic operation. | The Disposable EndoscopyAdapter Set is a collection ofseveral sterile units. It isintended to be fitted tomultiple endoscope workingchannels/ports to control theflow of fluids, gases and othermaterials.- Disposable Air/Water Valve:This unit is intended to befitted to an endoscopeair/water channel to controlthe inflow of medical gasesand water, whilst preventingback-flow.- Disposable Suction Valve:This unit is intended to befitted to an endoscope suctionchannel to control theoperations of suction, whilstpreventing inflow of air.- Disposable Biopsy Valve:This unit is intended to befitted to an endoscope biopsyport to prevent leakage ofgases and body fluids duringan endoscopic procedure.- Disposable Water JetAdapter: This unit is intended | Substantiallyequivalent | |
| SEEEGEN 视介光电vision borderless | Section 5 510(k) | |||
| Item | Disposable EndoscopeValves Kit (ProposedDevice) | Disposable EndoscopyAdapter Set, K220210 | Discussion | |
| to provide irrigation via sterilewater supply during GIendoscopic procedures whenused in conjunction with anirrigation pump. | ||||
| ProductCode | ODC | ODC | Same | |
| RegulationNumber | 21 CFR 876.1500 | 21 CFR 876.1500 | Same | |
| Classification | II | II | Same | |
| Water/gas button | Air/Water Valve | |||
| CompatibleEndoscopes | OLYMPUS 100/200 seriesupper and lowergastrointestinal electronicendoscopesFUJIFILM 600/700 seriesupper and lowergastrointestinal electronicendoscopesPENTAX i10/90K seriesupper and lowergastrointestinal electronicendoscopesPENTAX NP1 seriesupper and lowergastrointestinal electronicendoscopesPENTAX NP2 seriesupper and lowergastrointestinal electronicendoscopes | Olympus140/160/180/190/240/260/290 series endoscopes;PENTAX GI VideoEndoscope 90K/90i Series,K10/i10 Series;Fujifilm® 500/600/ 700 seriesendoscopes | Substantiallyequivalentsupported bybench testing. | |
| Sterile | EO Sterilization | EO Sterilization | Same | |
| Material | Polycarbonate, Siliconerubber, Stainless Steel | Silicone Rubber,ABS, SUS304 | Substantiallyequivalentsupported bybiocompatibilitytesting. | |
| EnvironmentUse | Hospital/clinics | Hospital/clinics | Same | |
| Suction button | Suction Valve | |||
| CompatibleEndoscopes | OLYMPUS 100/200 seriesupper and lowergastrointestinal electronicendoscopesFUJIFILM 600/700 seriesupper and lower | Olympus140/160/180/190/240/260/290 series endoscopes;PENTAX GI VideoEndoscope 90K/90i Series,K10/i10 Series; | Substantiallyequivalentsupported bybench testing. | |
| Item | Disposable EndoscopeValves Kit (ProposedDevice) | Disposable EndoscopyAdapter Set, K220210 | Discussion | |
| gastrointestinal electronicendoscopesPENTAX i10/90K seriesupper and lowergastrointestinal electronicendoscopesPENTAX NP1 seriesupper and lowergastrointestinal electronicendoscopesPENTAX NP2 seriesupper and lowergastrointestinal electronicendoscopes | Fujifilm® 500/600/ 700 seriesendoscopes | |||
| Sterile | EO Sterilization | EO Sterilization | Same | |
| Material | Polycarbonate, Siliconerubber, Stainless Steel | ABS, Silicone, Rubber,SUS304 | Substantiallyequivalentsupported bybiocompatibilitytesting. | |
| EnvironmentUse | Hospital/clinics | Hospital/clinics | Same | |
| Biopsy cap | Biopsy Valve | |||
| CompatibleEndoscopes | OLYMPUS 100/200 seriesupper and lowergastrointestinal electronicendoscopesFUJIFILM 600/700 seriesupper and lowergastrointestinal electronicendoscopesPENTAX i10/90K seriesupper and lowergastrointestinal electronicendoscopesPENTAX NP1 seriesupper and lowergastrointestinal electronicendoscopesPENTAX NP2 seriesupper and lowergastrointestinal electronicendoscopes | Olympus140/160/180/190/240/260/290 series endoscopes;PENTAX GI VideoEndoscope 90K/90i Series,K10/i10 Series;Fujifilm® 500/600/ 700 seriesendoscopes | Substantiallyequivalentsupported bybench testing. | |
| Item | Disposable EndoscopeValves Kit (ProposedDevice) | Disposable EndoscopyAdapter Set, K220210 | Discussion | |
| EnvironmentUse | Hospital/clinics | Hospital/clinics | Same | |
| Water injection adapter | Water Jet Adapter | |||
| CompatibleEndoscopes | OLYMPUS 100/200 seriesupper and lowergastrointestinal electronicendoscopesFUJIFILM 600/700 seriesupper and lowergastrointestinal electronicendoscopesPENTAX i10/90K seriesupper and lowergastrointestinal electronicendoscopesPENTAX NP1 seriesupper and lowergastrointestinal electronicendoscopesPENTAX NP2 seriesupper and lowergastrointestinal electronicendoscopes | Olympus140/160/180/190/240/260/290 series endoscopes;PENTAX GI VideoEndoscope 90K/90i Series,K10/i10 Series;Fujifilm® 500/600/ 700 seriesendoscopes | Substantiallyequivalentsupported bybench testing. | |
| Sterile | EO Sterilization | EO Sterilization | Same | |
| Material | Polycarbonate, Siliconerubber | Metal Type: PC, SUS303,Silicone Rubber,Plastic Type: PC, SiliconeRubber | Same as PlasticType | |
| EnvironmentUse | Hospital/clinics | Hospital/clinics | Same |
5.6 Substantial Equivalence and Technological Characteristics
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Image /page/7/Picture/0 description: The image shows the logo for SEEGEN, which is written in red, along with the Chinese characters "顺介光电". Below the Chinese characters, the words "vision borderless" are written in a smaller font. The logo is simple and modern, and the colors are eye-catching.
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Image /page/8/Picture/0 description: The image contains the logo for SEEGEN, with the number 7 stylized to look like a lightning bolt. To the right of the logo are Chinese characters, and below the logo is the text "vision borderless". The logo is in red, while the Chinese characters and the text "vision borderless" are in gray.
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Image /page/9/Picture/0 description: The image shows the logo for SEEGEN, a vision borderless company. The logo is in red and white. The text "SEEGEN" is in red, and the text "vision borderless" is in white.
5.7 Substantial Equivalence
Disposable Endoscopy Adapter Set, K220210 are used as predicate device compared to proposed device Disposable Endoscope Valves Kit manufactured by Shanghai SeeGen Photoelectric Technology Co., Ltd.
5.8 Non-clinical Performance Data
The proposed device meets the requirements of ISO 10993 "Biological Evaluation of Medical Devices – Part 1: Evaluation and Testing", ISO 11135-1 "Sterilization of Health Care products Ethylene Oxide - Part 1: Requirements for Development, Validation, and Routine Control of Sterilization processes for Medical Devices", and ISO 10993-7 "Biological evaluation of medical devices - Part 7: ethylene oxide sterilization residuals".
The following bench tests were performed on Disposable Endoscopy Adapter Set: Appearance, Physical properties. The results of all testing were passing.
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5.9 Clinical Test Data
No Clinical Study is included in this submission.
5.10 Conclusion
In accordance with the Federal Food, Drug and Cosmetic Act, 21 CFR Part 807, Based on the information provided in this premarket notification, Shanghai SeeGen Photoelectric Technology Co., Ltd. has demonstrated that proposed device Disposable Endoscope Valves Kit is substantially equivalent to Yangzhou Fartley Medical Instrument Technology Co., Ltd.'s currently marketed Disposable Endoscopy Adapter Set, K220210.
§ 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.