(233 days)
Not Found
No
The description focuses on mechanical operation and flow rate control, with no mention of AI/ML terms or functionalities.
Yes
The device is used for endoscopic irrigation, which is a medical procedure, and similar to the predicate devices which are also irrigation pumps used in a medical context.
No
The device is described as a pump used for endoscopic irrigation, which involves moving liquid through a tube set into an endoscopic system for washing purposes. Its function is to facilitate the cleaning of endoscopes and anatomical sites during procedures, not to diagnose medical conditions.
No
The device description explicitly states it is a "peristaltic roller pump head" which is a hardware component. The summary also describes the physical mechanism of operation involving moving liquid through a tube set.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for "endoscopic irrigation for use with washing catheters, integral endoscope water jet channels and endoscope working channels." This describes a device used during an endoscopic procedure to physically irrigate or wash an area within the body.
- Device Description: The description details a peristaltic pump that moves liquid through a tube set. This is a mechanical function for delivering fluid.
- Lack of IVD Characteristics: There is no mention of the device being used to examine specimens in vitro (outside the body) to provide information about a physiological state, health, or disease. IVDs typically involve analyzing biological samples like blood, urine, tissue, etc.
This device is clearly intended for use in vivo (within the body) during an endoscopic procedure, not for in vitro diagnostic testing.
N/A
Intended Use / Indications for Use
The Endoscopic Irrigation Pump Series is indicated for endoscopic irrigation for use with washing catheters, integral endoscope water jet channels and endoscope working channels.
Product codes (comma separated list FDA assigned to the subject device)
OCX
Device Description
The Endoscope Irrigation Pump Series (Beamer AVEOTM Pump "AVEOPUMP" and ENDOLINQ Endoscopic Irigation Pump "JSFP-2") is the second-generation pump developed by Chougging Jinshan. Both models can provide an adjustable flow-rate from 0-1000 mL/min, and the pump flow can be adjusted in 100 mL/min increments, total 10 configurations available. The series works by turning a penstaltic roller pump head to move liquid through a tube set and into an endoscopic system. The pump head will not operate if the pump head is open, and will cease to operate if the pump head is opened while the motor is activated.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
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)
To demonstrate safety and effectiveness of Endoscopic Irrigation Pump Series and to show substantial equivalence to the predicate device, Jinshan completed the following non-clinical tests. Results confirm that the design inputs and performance specifications for the device are met. The Endoscopic Irrigation Pump Series passed the testing in accordance with internal requirements, and international standards shown below, supporting its safety and effectiveness, and its substantial equivalence to the predicate device:
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.
0
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.
October 20, 2021
Chongqing Jinshan Science & Technology Co., Ltd. Qing Xu, RA Yubei District No.18 Ningshang Avenue Jinshan International Industrial City Chongqing, Chongqing 400000 CHINA
Re: K210618
Trade/Device Name: Beamer Aveo Irrigation Pump, Endoling Endoscopic Irrigation Pump, Endoscopic Irrigation Pump Series Regulation Number: 21 CFR 876.1500 Regulation Name: Endoscope and accessories Regulatory Class: Class II Product Code: OCX Dated: February 26, 2021 Received: March 1, 2021
Dear Oing Xu:
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 (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/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.
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 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).
Sincerely,
Shanil 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
2
DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration
Indications for Use
Form Approved: OMB No. 0910-0120 Expiration Date: 06/30/2023 See PRA Statement below.
510 (k) Number (if known)
K210618
Device Name
Endoscopic Irrigation Pump Series
Indications for Use (Describe)
The Endoscopic Irrigation Pump Series is indicated for endoscopic irrigation for use with washing catheters, integral endoscope water jet channels and endoscope working channels.
| 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) |
CONTINUE ON A SEPARATE PAGE IF NEEDED.
This section applies only to requirements of the Paperwork Reduction Act of 1995.
DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.
The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:
Department of Health and Human Services
Food and Drug Administration
Office of Chief Information Officer
Paperwork Reduction Act (PRA) Staff
"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."
3
5. 510(k) Summary
The following information is provided in accordance with 21 CFR 807.92 for the Premarket 510(k) Summary:
5.1 Submitter Information
| Company: | Qing Xu
RA
Chongqing Jinshan Science & Technology Co., Ltd.
No.18, Nishang Road, LiangLu Industrial City, 401120
Yubei District
Chongqing, Chongqing China
Telephone: (0086)023-86098111
Fax: (0086)023-86098777
xuq@jinshangroup.net |
|------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Contact: | Qing Xu
RA
Chongqing Jinshan Science & Technology Co., Ltd.
No.18, Nishang Road, LiangLu Industrial City, 401120
Yubei District
Chongqing, Chongqing China
Telephone: (0086)023-86098111
Fax: (0086)023-86098777
xuq@jinshangroup.net |
| Date Summary Prepared: | February 26, 2021 |
| 5.2 Name of the Device | |
| Trade Name: | Endoscopic Irrigation Pump Series |
| Common Name: | Endoscopic Irrigation/Suction System |
| Classification Name: | Gastroenterology/Urology |
| Review Panel: | Gastroenterology & Urology (GU) |
| Regulation: | 876.1500 |
| Class: | Class II |
| Product Code: | OCX |
5.3 Equivalence Claimed to Predicate Device
The Endoscopic Irrigation Pump Series is equivalent to the Endogator Advantage Irrigation Pump, Model EPA-500 (K113119), manufactured by BYRNE MEDICAL, INC .. Endogator Endoscopy Irrigation Pump, Model
4
EGP-100 (K060962) is provided as a secondary predicate device.
5.4 Indication for Use Statement
The Endoscopic Irrigation Pump Series is indicated for endoscopic imigation for use with washing catheters, integral endoscope water jet channels and endoscope working channels.
5.5 Device Description
The Endoscope Irrigation Pump Series (Beamer AVEOTM Pump "AVEOPUMP" and ENDOLINQ Endoscopic Irigation Pump "JSFP-2") is the second-generation pump developed by Chougging Jinshan. Both models can provide an adjustable flow-rate from 0-1000 mL/min, and the pump flow can be adjusted in 100 mL/min increments, total 10 configurations available. The series works by turning a penstaltic roller pump head to move liquid through a tube set and into an endoscopic system. The pump head will not operate if the pump head is open, and will cease to operate if the pump head is opened while the motor is activated.
5.6 Substantial Equivalence Discussion
The following table compares the Endoscopic Irrigation Pump Series to the predicate device with respect to indications for use, principles of operation, technological characteristics, and performance, and forms the basis for the determination of substantial equivalence. The subject device does not rase any new questions of safety or effectiveness as compared to the predicate device.
5.7 Non-Clinical Performance Data
To demonstrate safety and effectiveness of Endoscopic Irrigation Pump Series and to show substantial equivalence to the predicate device, Jinshan completed the following non-clinical tests. Results confirm that the design inputs and performance specifications for the device are met. The Endoscopic Irrigation Pump Series passed the testing in accordance with internal requirements, and international standards shown below, supporting its safety and effectiveness, and its substantial equivalence to the predicate device:
5.8 Clinical Performance Data
N/A
5.9 Statement of Substantial Equivalence
The Endoscopic Irrigation Pump Senes has the same intended use as the predicate devices, and the same or similar technological characteristics. The differences in technological characteristics do not raise new or different questions of safety and effectiveness. Performance testing has demonstrated the Endoscopic Inigation Pump Series is as safe and effective as the predicate device. Therefore, the Endoscopic Imgation Pump Series is substantially equivalent to the predicate device.