(461 days)
Not Found
No
The device description and intended use focus on mechanical components for controlling endoscope functions, with no mention of AI/ML, image processing, or data analysis.
No
The device is described as an accessory kit for endoscopes, controlling functions like water/gas injection and suction. It does not exert a therapeutic effect on the patient itself.
No
The device is described as controlling functions (water/gas injection and suction) during endoscopic operation, and performance studies focus on physical properties, not diagnostic capabilities. There is no mention of outputting information for medical decision-making.
No
The device description explicitly lists physical components (Water/gas button, Attraction button, Biopsy cap, Water injection adapter) that are connected to an endoscope operating handle. This indicates a hardware device, not a software-only one.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is to control functions of a gastrointestinal endoscope (water/gas injection and suction) during an endoscopic operation. This is a direct interaction with the patient's body for a diagnostic or therapeutic procedure, not an analysis of a sample taken from the body.
- Device Description: The device is a kit of valves and adapters that connect to the endoscope's operating handle. These are mechanical components used to manipulate the endoscope's functions.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue, etc.), reagents, or any process that would involve testing a sample in vitro (outside the body).
IVD devices are specifically designed to examine specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes. This device's function is entirely focused on the operation of the endoscope itself within the body.
N/A
Intended Use / Indications for Use
The values are used in conventional gastrointestinal endoscope to control the functions of water/gas injection and suction during the endoscopic operation.
Product codes (comma separated list FDA assigned to the subject device)
ODC
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
gastrointestinal
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Hospital/clinics
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)
The following bench tests were performed on Disposable Endoscopy Adapter Set: Appearance, Physical properties. The results of all testing were passing.
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
§ 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.
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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"
1
(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).
2
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
3
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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4
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
5
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, Minhang | |
| District, Shanghai, China | |
| Contact | |
| Person: | Yihua Ma |
| RA Supervisor | |
| Shanghai SeeGen Photoelectric Technology Co., Ltd | |
| Address: 3 Floor, Building No.1, 4299 JinDu Road, Minhang | |
| District, Shanghai, China | |
| Phone: 0086-18616909737 | |
| Email: mayihua@seegen.com.cn | |
| Date | |
| Prepared: | 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 |
6
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 Endoscope
Valves Kit (Proposed
Device) | Disposable Endoscopy
Adapter Set, K220210 | Discussion | |
|-----------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------|------------------|
| 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. | The Disposable Endoscopy
Adapter Set is a collection of
several sterile units. It is
intended to be fitted to
multiple endoscope working
channels/ports to control the
flow of fluids, gases and other
materials.
- Disposable Air/Water Valve:
This unit is intended to be
fitted to an endoscope
air/water channel to control
the inflow of medical gases
and water, whilst preventing
back-flow. - Disposable Suction Valve:
This unit is intended to be
fitted to an endoscope suction
channel to control the
operations of suction, whilst
preventing inflow of air. - Disposable Biopsy Valve:
This unit is intended to be
fitted to an endoscope biopsy
port to prevent leakage of
gases and body fluids during
an endoscopic procedure. - Disposable Water Jet
Adapter: This unit is intended | Substantially
equivalent | |
| SEEEGEN 视介光电
vision borderless | | | | Section 5 510(k) |
| Item | Disposable Endoscope
Valves Kit (Proposed
Device) | Disposable Endoscopy
Adapter Set, K220210 | Discussion | |
| | | to provide irrigation via sterile
water supply during GI
endoscopic procedures when
used in conjunction with an
irrigation pump. | | |
| Product
Code | ODC | ODC | Same | |
| Regulation
Number | 21 CFR 876.1500 | 21 CFR 876.1500 | Same | |
| Classificatio
n | II | II | Same | |
| Water/gas button | | Air/Water Valve | | |
| Compatible
Endoscopes | OLYMPUS 100/200 series
upper and lower
gastrointestinal electronic
endoscopes
FUJIFILM 600/700 series
upper and lower
gastrointestinal electronic
endoscopes
PENTAX i10/90K series
upper and lower
gastrointestinal electronic
endoscopes
PENTAX NP1 series
upper and lower
gastrointestinal electronic
endoscopes
PENTAX NP2 series
upper and lower
gastrointestinal electronic
endoscopes | Olympus
140/160/180/190/240/260/2
90 series endoscopes;
PENTAX GI Video
Endoscope 90K/90i Series,
K10/i10 Series;
Fujifilm® 500/600/ 700 series
endoscopes | Substantially
equivalent
supported by
bench testing. | |
| Sterile | EO Sterilization | EO Sterilization | Same | |
| Material | Polycarbonate, Silicone
rubber, Stainless Steel | Silicone Rubber,
ABS, SUS304 | Substantially
equivalent
supported by
biocompatibility
testing. | |
| Environment
Use | Hospital/clinics | Hospital/clinics | Same | |
| Suction button | | Suction Valve | | |
| Compatible
Endoscopes | OLYMPUS 100/200 series
upper and lower
gastrointestinal electronic
endoscopes
FUJIFILM 600/700 series
upper and lower | Olympus
140/160/180/190/240/260/2
90 series endoscopes;
PENTAX GI Video
Endoscope 90K/90i Series,
K10/i10 Series; | Substantially
equivalent
supported by
bench testing. | |
| Item | Disposable Endoscope
Valves Kit (Proposed
Device) | Disposable Endoscopy
Adapter Set, K220210 | Discussion | |
| | gastrointestinal electronic
endoscopes
PENTAX i10/90K series
upper and lower
gastrointestinal electronic
endoscopes
PENTAX NP1 series
upper and lower
gastrointestinal electronic
endoscopes
PENTAX NP2 series
upper and lower
gastrointestinal electronic
endoscopes | Fujifilm® 500/600/ 700 series
endoscopes | | |
| Sterile | EO Sterilization | EO Sterilization | Same | |
| Material | Polycarbonate, Silicone
rubber, Stainless Steel | ABS, Silicone, Rubber,
SUS304 | Substantially
equivalent
supported by
biocompatibility
testing. | |
| Environment
Use | Hospital/clinics | Hospital/clinics | Same | |
| Biopsy cap | | Biopsy Valve | | |
| Compatible
Endoscopes | OLYMPUS 100/200 series
upper and lower
gastrointestinal electronic
endoscopes
FUJIFILM 600/700 series
upper and lower
gastrointestinal electronic
endoscopes
PENTAX i10/90K series
upper and lower
gastrointestinal electronic
endoscopes
PENTAX NP1 series
upper and lower
gastrointestinal electronic
endoscopes
PENTAX NP2 series
upper and lower
gastrointestinal electronic
endoscopes | Olympus
140/160/180/190/240/260/2
90 series endoscopes;
PENTAX GI Video
Endoscope 90K/90i Series,
K10/i10 Series;
Fujifilm® 500/600/ 700 series
endoscopes | Substantially
equivalent
supported by
bench testing. | |
| Item | Disposable Endoscope
Valves Kit (Proposed
Device) | Disposable Endoscopy
Adapter Set, K220210 | Discussion | |
| Environment
Use | Hospital/clinics | Hospital/clinics | Same | |
| Water injection adapter | | Water Jet Adapter | | |
| Compatible
Endoscopes | OLYMPUS 100/200 series
upper and lower
gastrointestinal electronic
endoscopes
FUJIFILM 600/700 series
upper and lower
gastrointestinal electronic
endoscopes
PENTAX i10/90K series
upper and lower
gastrointestinal electronic
endoscopes
PENTAX NP1 series
upper and lower
gastrointestinal electronic
endoscopes
PENTAX NP2 series
upper and lower
gastrointestinal electronic
endoscopes | Olympus
140/160/180/190/240/260/2
90 series endoscopes;
PENTAX GI Video
Endoscope 90K/90i Series,
K10/i10 Series;
Fujifilm® 500/600/ 700 series
endoscopes | Substantially
equivalent
supported by
bench testing. | |
| Sterile | EO Sterilization | EO Sterilization | Same | |
| Material | Polycarbonate, Silicone
rubber | Metal Type: PC, SUS303,
Silicone Rubber,
Plastic Type: PC, Silicone
Rubber | Same as Plastic
Type | |
| Environment
Use | 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.
8
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.
9
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.
10
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.