(30 days)
Not Found
No
The summary describes a simple irrigation tubing system and does not mention any AI or ML components or functionalities.
No.
The device is irrigation tubing used during gastrointestinal endoscopic procedures; it facilitates the procedure but does not directly treat a disease or condition.
No
The device provides irrigation during gastrointestinal endoscopic procedures and does not perform any diagnostic function such as detecting, diagnosing, or monitoring a disease or condition.
No
The device description explicitly states it is "tubing and accessories" and is a physical, sterile device intended for use with irrigation pumps and endoscopes. It is a hardware component.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is to provide irrigation during gastrointestinal endoscopic procedures. This is a procedural aid, not a diagnostic test performed on samples taken from the body.
- Device Description: The description focuses on the physical components and how they facilitate irrigation during a procedure. It doesn't mention analyzing biological samples or providing diagnostic information.
- Lack of IVD Characteristics: There is no mention of analyzing blood, urine, tissue, or any other biological sample. The device's function is purely mechanical (delivering fluid).
IVD devices are specifically designed to examine specimens derived from the human body to provide information for diagnostic, monitoring, or screening purposes. This device does not fit that description.
N/A
Intended Use / Indications for Use
The 24 hour use AquaPulse® Irrigation Tubing (tubing and accessories to accommodate various GI endoscopes and irrigation pumps) is intended to provide irrigation via a sterile water bottle during gastrontestinal endoscopic procedures when used in conjunction with an irrigation pump.
Product codes (comma separated list FDA assigned to the subject device)
OCX
Device Description
The AquaPulse® Irrigation Tubing is intended for 24-hour use and then discarded. The irrigation tubing is manufactured for use in conjunction with sterile water bottle, and together with irrigation pumps. The irrigation tubing is individually packed in sealed package, sold as a sterile device. The irrigation tubing is designed to the auxiliary water connector or biopsy irrigation accessory and to be inserted into pump head of the irrigation pump to provide irrigation through the auxiliary water channel to the distal end of endoscope.
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 and or 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 bench testing was performed to support substantial equivalence such as verification tests on flow performances of modified devices. The performance data demonstrated that the subject devices met established specifications and it demonstrated substantial equivalence to the previously cleared predicate devices.
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
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November 10, 2022
GA Health Company Limited Lam Yu Assistant Regulatory Affairs Manager Unit 18, 21/F, Metropole Square, 2 On Yiu Street, Shatin Hong Kong, CHINA
Re: K223171
Trade/Device Name: AquaPulse® Irrigation Tubing Regulation Number: 21 CFR 876.1500 Regulation Name: Endoscope And Accessories Regulatory Class: Class II Product Code: OCX Dated: October 7, 2022 Received: October 11, 2022
Dear Lam Yu:
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 statutes and regulations administered by other Federal agencies. You must comply with all the Act's
1
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 (OS) 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 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).
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
2
Indications for Use
510(k) Number (if known) K223171
Device Name AquaPulse® Irrigation Tubing
Indications for Use (Describe)
The 24 hour use AquaPulse® Irrigation Tubing (tubing and accessories to accommodate various GI endoscopes and irrigation pumps) is intended to provide irrigation via a sterile water bottle during gastrontestinal endoscopic procedures when used in conjunction with an irrigation pump.
| 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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K223171 Page 1 of 4
510(k) Summary
The 510(k) summary of safety and effectiveness information is being submitted in accordance with the requirements of the Safe Medical Devices Act of 1990 and 21 CFR 807.92.
1. Submission Sponsor
Submitter's Name: Submitter's Address:
Establishment Registration No.:
- Sponsor Contact
Cindy Ye Chief Executive Officer Telephone: +852 2833 9010 Email: cindy.ye@gahealth.com
GA Health Company Limited Unit 18, 21/F, Metropole Square
2 On Yiu Street, Shatin, N.T,
Hong Kong. CHINA
3014749926
Lam Wing Yu Senior Requlatory Affairs Specialist Telephone: +852 2833 9010 Email: rainy.lam@gahealth.com
3. Date Prepared
30 September 2022
4. Device Identification
- Device Name: Common Name: Classification Number: Classification Name: Product Code: Product Code Name: Regulatory Class: Device Panel:
AquaPulse® Irrigation Tubing Irrigation tubing for endoscope 21 CFR 876.1500 Endoscope and accessories ОСХ Endoscopic Irrigation/Suction System 2 Gastroenterology/Urology
5. Predicate Device Identification
Predicate Device 510(k) No.: Predicate Device Trade Name: Predicate Device Product Code: K202560 AquaPulse® Irrigation Tubing ОСХ
6. Device Description:
The AquaPulse® Irrigation Tubing is intended for 24-hour use and then discarded. The irrigation tubing is manufactured for use in conjunction with sterile water bottle, and together with irrigation pumps. The irrigation tubing is individually packed in sealed package, sold as a sterile device. The irrigation tubing is designed to the auxiliary water connector or biopsy irrigation accessory and to be inserted into pump head of the irrigation pump to provide irrigation through the auxiliary water channel to the distal end of endoscope.
4
7. Indications for Use:
The 24 hour use AquaPulse® Irrigation Tubing (tubing and accessories to accommodate various GI endoscopes and irrigation pumps) is intended to provide irrigation via a sterile water bottle during gastrointestinal endoscopic procedures when used in conjunction with an irrigation pump.
8. Technological Characteristics
Table 2 summarizes a comparison of the device features, indications for use, and other information necessary to demonstrate that the modified device is substantially equivalent to the predicate device. The difference does not affect the substantial equivalence of the device.
The predicate and subject devices are both irrigation tubing with same indications for use. There are some minor differences in the technological characteristics. These differences are material for tubing and shelf-life.
Table 2 Summary of design, features and principles of operation and technological characteristics between the subject device and predicate devices
| Specification | Predicate Device | Subject Device | Substantial
Equivalence |
|------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------|
| Product code | OCX | OCX | Identical |
| Regulatory
Classification | 2 | 2 | Identical |
| Regulation No | 21 CFR 876.1500 | 21 CFR 876.1500 | Identical |
| Regulation
Description | Endoscope and accessories | Endoscope and accessories | Identical |
| Compatibility | Olympus® OFP, Endo Status™
EGA-500 and Endogator® EGP-
100 Irrigation Pump | Olympus® OFP, Endo Status™
EGA-500 and Endogator® EGP-
100 Irrigation Pump | Identical |
| Intended Use | The 24 hour use AquaPulse®
Irrigation Tubing (tubing and
accessories to accommodate
various GI endoscopes and
irrigation pumps) is intended to
provide irrigation via a sterile
water
bottle
during
gastrointestinal
endoscopic
procedures when used in
conjunction
with an irrigation
pump. | The 24 hour use AquaPulse®
Irrigation Tubing (tubing and
accessories to accommodate
various GI endoscopes and
irrigation pumps) is intended to
provide irrigation via a sterile
water
bottle
during
gastrointestinal
endoscopic
procedures when used in
conjunction
with an irrigation
pump. | Identical |
| Environment
of Use | Hospital and or clinics | Hospital and or clinics | Identical |
| Single Use,
Disposable | 24-hour use then discard | 24-hour use then discard | Identical |
| Material | Polycarbonate and Polyvinyl
Chloride | Polycarbonate and Polyvinyl
Chloride (Material not Made with
DEHP) | Substantial
Equivalent |
5
| Specification | Predicate Device | Subject Device | Substantial
Equivalence |
|----------------------------------|--------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------|----------------------------|
| Packaging | Irrigation tubing is packaged in a
sealed pouch | Irrigation tubing is packaged in a
sealed pouch | Identical |
| Manufacturing
method | Injection molding and extrusion | Injection molding and extrusion | Identical |
| Backflow
Prevention
Design | Diaphragm in the connector
allow pressurized water passing
through in one-way but not the
other way | Diaphragm in the connector
allow pressurized water passing
through in one-way but not the
other way | Identical |
| Sterilization | EO gas | EO gas | Identical |
| Shelf Life | 1 year | 3 years | Substantial
Equivalent |
9. Performance Test
The bench testing was performed to support substantial equivalence such as verification tests on flow performances of modified devices. The performance data demonstrated that the subject devices met established specifications and it demonstrated substantial equivalence to the previously cleared predicate devices.
10. Sterilization
All the subject devices are sold in a sterile package. The subject devices have been sterilized in a validated EO sterilization cycle. The EO sterilization cycle has a Sterility Assurance Level (SAL) of 10°. EO residuals on the components are below the maximum levels defined in ANSI/AAMI/ISO 10993-7 Biological Evaluation of Medical Devices - Part 7: Ethylene Oxide sterilization residuals.
11. Shelf Life
The modified devices have a three (3) year shelf life, based on the design and existing sterile barrier data from the existing packaging integrity test and performance test were conducted after accelerated aging test. The test result can imply that the modified device can provide and maintain a sterile barrier and its intended performance for at least the claimed shelf life.
12. Biocompatibility
The biocompatibility of the modified devices was conducted in accordance with the FDA quideline "Use of International Standard ISO 10993-1, "Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process". The modified devices are classified as surface devices with mucosal membrane contact for a limited duration (not more than 24 hours). The test result shows that the modified devices are biocompatible.
13. Clinical Testing
No clinical data is being submitted to support this Special 510(k).
14. Conclusion
The subject devices have the same intended use as the predicate devices. Based on the technological characteristics and overall performance of the devices in bench testing and
6
biocompatibility test, there are no significant differences exist between the subject devices and the predicate devices. The subject device is as safe and as effective as the predicate device. From a clinical perspective and comparing design specifications, the subject devices and the predicate device are substantially equivalent.