(280 days)
Not Found
No
The description focuses on the mechanical and control aspects of a peristaltic pump, with no mention of AI or ML capabilities. The "Mentions AI, DNN, or ML" section explicitly states "Not Found".
No
The device aids in visualization, diagnosis, and treatment by supplying fluid for irrigation, but it does not directly treat a disease or condition itself. It is an accessory for other therapeutic procedures.
No
The device is a pump intended to supply fluid for irrigation, aiding in visualization for diagnosis and treatment, but it does not perform the diagnosis itself. Its function is supportive to diagnostic procedures.
No
The device description explicitly lists hardware components such as a host machine (including drive system, peristaltic pump head, housing), operating components (rotatable knob, footswitch), and optional hanger assembly and irrigation tube. This indicates it is a physical medical device with hardware, not software-only.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is to supply fluid for irrigation during endoscopic procedures to aid in visualization, diagnosis, and treatment. This is a therapeutic or procedural support function, not a diagnostic test performed on samples taken from the body.
- Device Description: The device is a pump that transfers water. It does not analyze biological samples or provide diagnostic information based on in vitro testing.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue, etc.), reagents, or providing diagnostic results based on such analysis.
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 falls outside of that definition.
N/A
Intended Use / Indications for Use
The Endoscopic Water Pump is a peristaltic pump intended to supply fluid to compatible endoscopes or endotherapy devices for irrigation of the gastric and colonic mucosa during endoscopic or endotherapeutic procedures, allowing to aid in visualisation, diagnosis and treatment.
Product codes
OCX
Device Description
AGS's Endoscopic Water Pump comprises:
- A host machine (including drive system, peristaltic pump head, housing, etc.); -
- Operating component (Rotatable Knob and Footswitch); -
- -Hanger assembly(optional);
- -An irrigation tube (optional)
The Endoscopic Water Pump is a motorized pump designed to transfer water from a bottle, via a tube, to an endoscope or EndoTherapy devices, and the pump is operated by a footswitch. It uses a peristaltic pump head to move the water through the tube. The speed of the rotation of the pump head is adjustable by the user, using flow control knob on the front of the pump.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
gastric and colonic mucosa
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 (study type, sample size, AUC, MRMC, standalone performance, key results)
The Endoscopic Water Pump meets all design specifications and medical device standards for electrical safety and EMC (IEC 60601), and the Irrigation tube meet the standard for sterility (ISO 11135). The non-clinical performance meets the design specification and shows substantial equivalence to the predicated device.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
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.
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Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: a symbol on the left and the text "FDA U.S. FOOD & DRUG ADMINISTRATION" on the right. The symbol on the left is a stylized depiction of a human figure, while the text on the right is written in a clear, sans-serif font. The word "FDA" is in a blue box.
March 20, 2025
Hangzhou AGS MedTech Co., Ltd. Yanping Fu RA Manager Building 2, 5 and 7, No. 389, Xingzhong Road Linping District, Hangzhou, Zhejiang 311103 China
Re: K241704
Trade/Device Name: Endoscopic Water Pump Regulation Number: 21 CFR 876.1500 Regulation Name: Endoscope And Accessories Regulatory Class: Class II Product Code: OCX Dated: February 17, 2025 Received: February 18, 2025
Dear Yanping Fu:
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.
All medical devices, including Class I and unclassified devices and combination product device constituent parts are required to be in compliance with the final Unique Device Identification System rule ("UDI Rue"). The UDI Rule requires, among other things, that a device bear a unique device identifier (UDI) on its label and package (21 CFR 801.20(a)) unless an exception or alternative applies (21 CFR 801.20(b)) and that the dates on the device label be formatted in accordance with 21 CFR 801.18. The UDI Rule (21 CFR 830.300(a) and 830.320(b)) also requires that certain information be submitted to the Global Unique Device Identification Database (GUDID) (21 CFR Part 830 Subpart E). For additional information on these requirements, please see the UDI System webpage at https://www.fda.gov/medical-devices/device-advicecomprehensive-regulatory-assistance/unique-device-identification-system-udi-system.
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
3
Indications for Use
Submission Number (if known)
Device Name
Endoscopic Water Pump
Indications for Use (Describe)
The Endoscopic Water Pump is a peristaltic pump intended to supply fluid to compatible endoscopes or endotherapy devices for irrigation of the gastric and colonic mucosa during endoscopic or endotherapeutic procedures, allowing to aid in visualisation, diagnosis and treatment.
Type of Use (Select one or both, as applicable)
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 shows the logo for AGS. The logo consists of a blue and green circular design on the left, followed by the letters "AGS" in bold, black font on the right. The circular design appears to be three curved shapes intertwined, with the top shape being blue, the middle shape being green, and the bottom shape being blue.
CH2.03 510(k) Summary
Endoscopic Water Pump
CH2.03 510(k) Summary
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Image /page/5/Picture/0 description: The image shows the logo for AGS. The logo consists of a blue circular design with a green triangle in the center, followed by the letters "AGS" in bold, black font. The logo is simple and modern, and the colors are eye-catching.
510(k) Summary
We submit this 510(k) Summary as per 21 CFR 807.92, it meets the content and format regulatory requirements.
CH2.03.1 Submitter
| Submitted by/Owner: | Hangzhou AGS MedTech Co., Ltd.
Building 2, 5 and 7, No.389, Xingzhong Road, Linping
District, 311103 Hangzhou, Zhejiang, PEOPLE'S
REPUBLIC OF CHINA |
|---------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Establishment
Registration Number: | 3010288205 |
| Registration Status: | Active |
| Contact Person: | Yanping Fu
Phone: 0086-15958493282
Fax: 0086-0571-87671230
Email: fuyp@bioags.com |
| Date Prepared: | June 11, 2024 |
CH2.03.2 Proposed Device
| Trade Name: | / |
|---|---|
| Device Name: | Endoscopic Water Pump |
| Common Name: | Endoscopic Water Pump |
| Regulation class: | Class II |
| Regulation Number: | 876.1500 |
| Regulation Description: | Endoscope and accessories |
| Review Panel: | Gastroenterology/Urology |
| Product Code: | OCX |
| Product Code Name: | Endoscopic Irrigation/Suction System |
CH2.03.3 Predicate Device
| Trade Name: | / |
|---|---|
| Device Name: | Olympus Endoscopic Flushing Pump(OFP-2) |
| Common Name: | Endoscopic Flushing or Lavage Pump |
| 510(K) Number: | K100899 |
| Regulation class: | Class II |
| Regulation Number: | 876.1500 |
| Regulation Description: | Endoscope and accessories |
| Review Panel: | Gastroenterology/Urology |
| Product Code: | FEQ |
| Product Code Name: | Pump, Air, Non-manual, For endoscope |
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Image /page/6/Picture/0 description: The image contains the logo for AGS. The logo consists of a circular symbol on the left and the letters "AGS" on the right. The circular symbol is made up of three curved shapes in blue and green, arranged in a triangular pattern. The letters "AGS" are in a bold, sans-serif font and are black in color.
CH2.03.4 Device Description
AGS's Endoscopic Water Pump comprises:
- A host machine (including drive system, peristaltic pump head, housing, etc.); -
- Operating component (Rotatable Knob and Footswitch); -
- -Hanger assembly(optional);
- -An irrigation tube (optional)
The Endoscopic Water Pump is a motorized pump designed to transfer water from a bottle, via a tube, to an endoscope or EndoTherapy devices, and the pump is operated by a footswitch. It uses a peristaltic pump head to move the water through the tube. The speed of the rotation of the pump head is adjustable by the user, using flow control knob on the front of the pump.
CH2.03.5 Indication for use statement
The Endoscopic Water Pump is a peristaltic pump intended to supply fluid to compatible endoscopes or endotherapy devices for irrigation of the gastric and colonic mucosa during endoscopic or endotherapeutic procedures, allowing to aid in visualization, diagnosis and treatment.
CH2.03.6 Comparison of Technology Characteristics
Our proposed device Endoscopic Water Pump is substantially equivalent to the predicate devices. The differences between Endoscopic Water Pump and the predicate devices do not raise any questions regarding its safety and effectiveness. The differences are listed in the table below:
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| Item | | Proposed device
Hangzhou AGS MedTech Co., Ltd. | Predicate device (K100899)
OLYMPUS AMERICA INC | Comparison |
|-----------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Technical | Configuration | AGS's Endoscopic Water Pump comprises:
- A host machine (including drive system, peristaltic pump head, housing, etc.);
- Operating component (Rotatable Knob and Footswitch);
- Hanger assembly(optional)
- An irrigation tube (optional) | Olympus Flushing Pump comprises:
- Flushing Pump OFP-2 host machine;
- Power cord;
- Footswitch;
- Water container (optional);
- Water tube (optional); | Similar.
AGS' Endoscopic Water Pump don't contain optional water container, while Olympus Flushing Pump contain optional water container, the difference don't raise question about safety and effectiveness. |
| | Performance | Maximum output flow | Water feed: controlled by footswitch.
Flow rate: variable, controlled from front panel.
Flow rate delivery from the pump will depend on the length and type of endoscopes or EndoTherapy Accessory attached.
The operator must therefore assess the condition of the patient and use clinical judgement to set the flow rate from the pump to avoid causing patient trauma.
For endoscopes incorporating an auxiliary water channel and using irrigation tube AG-5247-3.2:
The flow rate when using the GIF-HQ290 should be approx. 240~248ml/min when the pump head is new and its flow setting is 10 (maximum). The | Variable, controlled from front panel.
1.For endoscopes incorporating an auxiliary water channel and using auxiliary water channel tube MAJ-1608/MAJ-1651:
The flow rate when using the CF-Q180AL should be approx. 230ml/min when the pump head is new and its flow setting is 9 (maximum). The flow rate will reduce as the pump head deteriorates.
We recommend flow settings of 1 - 6 for auxiliary water channel use.
- For instrument channel flushing (1):
The flow rate when using the CF-Q260AL/DL (3.2mm diameter channel) without an instrument inserted should be approx. 785ml/min when the pump head is new and |
| Item | Proposed device
Hangzhou AGS MedTech Co., Ltd. | Predicate device (K100899)
OLYMPUS AMERICA INC | Comparison | |
| | flow rate will reduce as the pump head deteriorates.
We recommend flow settings of 1-10 for auxiliary water channel use.
For instrument channel flushing (1): The flow rate when using the GIF-Q260 (2.8mm diameter channel) without an instrument inserted should be approx. 240~258ml/min when the pump head is new and its flow setting is 10 (maximum). The flow rate will reduce as the pump head deteriorates.
We recommend flow settings of 1 - 10 for instrument channel use. | its flow setting is 9 (maximum). The flow rate will reduce as the pump head deteriorates.
We recommend flow settings of 5 - 9 for instrument channel use. - For instrument channel flushing (2):
The flow rate when using the GIF-Q260 (2.8mm diameter channel) with a 2.5mm diameter ultrasound probe inserted should be approx. 100ml/min when the pump head is new and its flow setting is 9 (maximum). The flow rate will reduce as the pump head deteriorates.
We recommend flow settings of 5 - 9 for instrument channel use. | proposed device is big than predicate device, we confirmed that the proposed device can meet the clinical requirements through simulate the clinical use of proposed device.
Above all, the simulation test in Section 12 which demonstrates the substantial equivalence of the Endoscopic Water Pump. | |
| Shelf life | 5 years for host machine | / | Different, the shelf life of predicate device is unknown, but we conducted the shelf life validation in Section 14 which can prove that the difference of shelf life doesn't raise different questions regarding its safety and effectiveness. | |
| Irrigation tube | Sterile Supplied | Yes. | MAJ-1608, MAJ-1651 is single day use item,
MAJ-1607, MAJ-1681, MAJ-1682 is single use, | Different.
Our Irrigation tubes are sterile |
| | Item | Proposed device
Hangzhou AGS MedTech Co., Ltd. | Predicate device (K100899)
OLYMPUS AMERICA INC | Comparison |
| | Shelf Life | 3 years | unknown | Different.
Shelf life of Predicate device is
unknown, but we conducted the shelf
life validation in Section 14 which
can prove that the difference of shelf
life doesn't raise different questions
regarding its safety and effectiveness. |
| | Single Use | Yes | MAJ-1608, MAJ-1651 is single day use item | Different.
Our Irrigation tubes are single
use, substantially equivalent. |
| Biological | Materials
contacting with
human
body | ABS, PVC, PC | unknown | Different
The biological information of
predicate device is unknown. And the |
| | Biocompatibility | ISO 10993-5:2009, ISO 10993-10:2021,
ISO 10993-23:2021 | unknown | biological risks are acceptable, please
refer to Section 15. |
| | | | MAJ-1651, MAJ-1681 and MAJ-1682 supplied
sterile | supplied, substantially equivalent. |
Table CH2.03.6 Comparison of technical characteristics
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Image /page/8/Picture/0 description: The image contains the logo for AGS. The logo consists of a circular design with three curved shapes in blue and green, resembling a stylized atom or a three-way intersection. To the right of the circular design, the letters 'AGS' are written in bold, black font.
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Image /page/9/Figure/0 description: The image contains the logo for AGS. The logo consists of a circular symbol with three curved shapes in blue and green, resembling a stylized recycling symbol. To the right of the symbol, the letters "AGS" are written in a bold, sans-serif font.
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Image /page/10/Picture/0 description: The image contains the logo for AGS. The logo consists of a circular graphic on the left and the letters "AGS" on the right. The circular graphic is blue and green and appears to be three curved shapes that are intertwined. The letters "AGS" are in a bold, sans-serif font and are black.
CH1.01 Cover Letter Endoscopic Water Pump
CH2.03.7 Applicable Guidance Document
NA
CH2.03.8 Performance Data
The Endoscopic Water Pump meets all design specifications and medical device standards for electrical safety and EMC (IEC 60601), and the Irrigation tube meet the standard for sterility (ISO 11135). The non-clinical performance meets the design specification and shows substantial equivalence to the predicated device.
CH2.03.9 Clinical Test
No Clinical test is included in this submission.
CH2.03.10 Conclusion
In accordance with the Federal Food, Drug and Cosmetic Act, 21 CFR Part 807, Based on the information provided in this premarket notification, Hangzhou AGS MedTech Co., Ltd has demonstrated that proposed device Endoscopic Water Pump is substantially equivalent to the predicate devices.