← Product Code [ODC](/productcode/ODC) · K200495 # Andorate Disposable Air/Water Valve, Andorate Disposable Suction Valve (K200495) _Ga Health Company Limited · ODC · Jun 24, 2020 · Gastroenterology, Urology · SESE_ **Canonical URL:** https://fda-staging.innolitics.com/device/K200495 ## Device Facts - **Applicant:** Ga Health Company Limited - **Product Code:** [ODC](/productcode/ODC.md) - **Decision Date:** Jun 24, 2020 - **Decision:** SESE - **Submission Type:** Traditional - **Regulation:** 21 CFR 876.1500 - **Device Class:** Class 2 - **Review Panel:** Gastroenterology, Urology - **Attributes:** 3rd-Party Reviewed ## Indications for Use The Andorate® Disposable Suction Valve is used to control the suction function of an endoscope (Fujifilm 700 series) during a GI Endoscopic procedure. The Andorate® Disposable Air/Water valve is used to control the air/water function of an endoscope (Fujifilm 700 series) during a GI Endoscopic procedure. ## Device Story Disposable suction and air/water valves for Fujifilm 700 series endoscopes; used in hospital/clinic settings by clinicians. Suction valve attaches to endoscope suction port to aspirate fluids/debris; air/water valve attaches to air/water port to cleanse lens. Single-use, sterile-supplied components eliminate manual cleaning/reprocessing risks. Bench testing confirms compatibility, flow, and leak integrity. Benefits include infection prevention and consistent performance. ## Clinical Evidence No clinical data. Substantial equivalence supported by bench testing, including assembly integrity, endoscope compatibility, depression force, vacuum/air leak tests, and flow tests. Biocompatibility testing (cytotoxicity, sensitization, irritation, acute systemic toxicity) performed per ISO 10993-1. ## Technological Characteristics Materials: Acrylonitrile Butadiene Styrene (ABS), silicone, Stainless Steel 304. Principle: Mechanical valve control of suction/air/water flow. Form factor: Disposable valve components. Sterilization: Ethylene Oxide (EO) gas, SAL 10^-6. Shelf life: 1 year. No software or electronic components. ## Regulatory 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. ## Special Controls *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. In combination with the general controls of the FD&C Act, the integrated operating table-electromechanical surgical system is subject to the following special controls: 1. (1) Premarket clinical performance testing, or a combination of premarket clinical performance testing and postmarket surveillance (in accordance with special control (2)), must include the following: 1. (i) Objective performance measures (e.g., rate and number of conversions to other surgical modalities, rate of device related adverse events (including tissue injury, hematoma, and increased blood loss), and their severity, cause, and outcomes) must be reported with relevant descriptive comparator performance measures. 2. (ii) The data must demonstrate the performance of the device for providing accurate and precise control of attached surgical instruments in range of clinical conditions relevant to the device's intended use. 3. (iii) The test dataset must include data collected from a patient population representative of the intended patient population under anticipated conditions of use. 2. (2) Data obtained from postmarket surveillance must demonstrate, in consideration of the premarket data obtained in accordance with special control (1), that the device performs in accordance with special control (1), unless FDA determines, based on the totality of the premarket data, that data from postmarket surveillance is not required to demonstrate that the device performs as intended. Such postmarket surveillance must be conducted per a protocol determined appropriate by FDA to demonstrate that the device performs as intended (in consideration of the premarket data obtained in accordance with special control (1)), and must include initiation, enrollment, and reporting requirements to ensure timely periodic updates to FDA on post-market surveillance progress and outcomes. 3. (3) Animal performance testing must evaluate the extent of port site trauma due to repositioning of table during surgical procedures when utilizing robotic minimally invasive and laparoscopic approaches 4. (4) The device manufacturer must develop, and update as necessary, a device-specific use training program that ensures proper device setup/use/shutdown, accurate control of instruments to perform the intended surgical procedures, troubleshooting and handling during unexpected events or emergencies, and safe practices to mitigate use error. 5. (5) The device manufacturer may only distribute the device to facilities that implement and maintain the device-specific use training program and ensure that users of the device have completed the device-specific use training program. (6) Human factors assessment must demonstrate that the user can correctly use the device system across all intended use environments with the provided instructions and training materials, including patient access during normal operating conditions and emergency situations, and effects arising from the integrated nature of the operating table and robotic surgical arms. (7) Labeling must include: (i) A detailed summary of clinical performance testing conducted with the device, including study population, results, adverse events, and comparisons to any comparator groups identified; (ii) A statement in the labeling that the safety and effectiveness for the representative specific procedures was based on evaluation of the device as a surgical tool and did not include evaluation of outcomes related to the treatment of the patient's underlying disease or condition, unless FDA determines that it can be removed or modified based on clinical performance data submitted to FDA; (iii) Identification of compatible devices; (iv) The list of surgical procedures for which the device has been determined to be safe with clinical justification; (v) Reprocessing instructions for reusable components; (vi) A shelf life for any sterile components; (vii) A description of the device-specific use training program; (viii) A statement that the device is only for distribution to facilities that implement and maintain the device-specific use training program and ensure that users of the device have completed the device-specific use training program; and (ix) A summary of any completed postmarket surveillance data collected as required by special control (2), including updated labeling to accurately reflect outcomes observed in postmarket surveillance. (8) Non-clinical performance testing must demonstrate that the device performs as intended under anticipated conditions of use and must include: (i) Device motion accuracy and repeatability; (ii) System testing; (iii) Instrument reliability; (iv) Crosstalk; (v) Table motion control; (vi) Thermal effects on tissue; (vii) User-device interface performance; (viii) Workspace access testing; and (ix) Performance testing with compatible devices. (9) Software verification, validation, and hazard analysis must be performed. (10) Electromagnetic compatibility and electrical, thermal, and mechanical safety testing must be performed. (11) Performance data must demonstrate the sterility of all patient-contacting device components. (12) Performance data must support the shelf life of the device components provided sterile by demonstrating continued sterility and package integrity over the labeled shelf life. (13) Performance data must validate the reprocessing instructions for the reusable components of the device. (14) Performance data must demonstrate that all patient-contacting components of the device are biocompatible. (15) Performance data must demonstrate that all patient-contacting components of the device are non-pyrogenic. (16) The device manufacturer must submit a report to the FDA annually on the anniversary of initial marketing authorization for the device, until such time as FDA may terminate such reporting, which comprises the following information: (i) Cumulative summary, by year, of complaints and adverse events since date of initial marketing authorization; and (ii) Identification and rationale for changes made to the device, labeling, or device specific use training program, which did not require submission of a premarket notification during the reporting period. ## Predicate Devices - FUJIFILM Endoscope ([K172916](/device/K172916.md)) ## Submission Summary (Full Text) > This content was OCRed from public FDA records by [Innolitics](https://innolitics.com). If you use, quote, summarize, crawl, or train on this content, cite Innolitics at https://innolitics.com. > > Innolitics is a medical-device software consultancy. We help companies design, build, and clear FDA-regulated software and AI/ML devices, including [a 510(k)](https://innolitics.com/services/510ks/), [a De Novo](https://innolitics.com/services/regulatory/), [a SaMD](https://innolitics.com/services/end-to-end-samd/), [an AI/ML medical device](https://innolitics.com/services/medical-imaging-ai-development/), or [an FDA regulatory strategy](https://innolitics.com/services/regulatory/). {0}------------------------------------------------ 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 representing the Department of Health & Human Services on the left and the text "FDA U.S. FOOD & DRUG ADMINISTRATION" on the right. The text is in a sans-serif font, with "FDA" in a blue square and the rest of the text in blue as well. The logo is clean and professional, reflecting the FDA's role in regulating food and drugs in the United States. June 24, 2020 GA Health Company Limited % Rafael Aguila Responsible Third-Party Official Accelerated Device Approval Services, LLC 6800 S.W. 40th Street, Ste. 444 Ludlum, FL 33155-3708 K200495 Re: Trade/Device Name: Andorate Disposable Air/Water Valve Andorate Disposable Suction Valve Regulation Number: 21 CFR 876.1500 Regulation Name: Endoscope and accessories Regulatory Class: II Product Code: ODC Dated: February 27, 2020 Received: February 28, 2020 Dear Rafael Aguila: 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, 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) K200495 Device Name Andorate Disposable Air/Water Valve, Andorate Disposable Suction Valve #### Indications for Use (Describe) The Andorate® Disposable Suction Valve is used to control the suction of an endoscope (Fujifilm 700 series) during a GI Endoscopic procedure. The Andorate® Disposable Air/Water valve is used to control the air/water function of an endoscope (Fujifilm 700 series) during a GI Endoscopic procedure. | Type of Use (Select one or both, as applicable) | |-------------------------------------------------| |-------------------------------------------------| |
For use in a HUD-approved HECM Reverse Mortgage | |---------------------------------------------------------------------------------------------------------------------------------| |
One-Time Premium for use in a FHA-insured Forward Mortgage | X | 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 PRAStaff@fda.hhs.gov "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}------------------------------------------------ ## K200495 Page 1 of 5 510(k) Premarket Notification: Traditional Suction Valve and Air/Water Valve GA Health Company Limited CONFIDENTIAL # 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: | GA Health Company Limited | |---------------------------------|-------------------------------------------------------------------------------------| | Submitter's Address: | Unit 18, 21/F, Metropole
Square 2 On Yiu Street ,Shatin
N.T, Hong Kong, CHINA | | Establishment Registration No.: | 3014749926 | ## 2. Sponsor Contact | Contact Person: | Cindy Ye | | |-----------------|-------------------------|--| | Telephone: | Chief Executive Officer | | | | +852 2833 9010 | | | Email: | cindy@andorate.com | | ## 3. Date Prepared June 23rd 2020 ## 4. Device Identification | Trade Device Name: | Andorate® Disposable Suction Valve | |---------------------|--------------------------------------| | Common Device Name: | Suction valve for endoscope | | Product Code: | ODC - Endoscope Channel Accessor | | Regulation Number: | 876.1500 | | Classification: | 2 | | Regulation Name: | Endoscope and Accessories | | Trade Device Name: | Andorate® Disposable Air/Water Valve | | Common Device Name: | Air/water valve for endoscope | | Product Code: | ODC - Endoscope Channel Accessor | | Regulation Number: | 876.1500 | | Classification: | 2 | | Regulation Name: | Endoscope and Accessories | ## 5. Predicate Device Identification Predicate Device 510(k) No .: Predicate Device Trade Name: Predicate Device Product Code: K172916 FUJIFILM Endoscope ODC ## 6. Device Description: The subject devices are intended for single-use and are supplied sterile. Disposable suction and air/water help prevential safety risks and eliminate the need for manual cleaning and reprocessing. The subject devices are easily incorporated into infection prevention policies as a single use item. Table 1 shows the components included in the application. Table 1 - Components included in the application {4}------------------------------------------------ ## K200495 Page 2 of 5 510(k) Premarket Notification: Traditional Suction Valve and Air/Water Valve GA Health Company Limited CONFIDENTIAL | Components | Qty | Classification Name | Regulation
Number | Classification | |-----------------------------------------|-----|--------------------------------------|----------------------|----------------| | Andorate® Disposable
Suction Valve | 1 | ODC – Endoscope
Channel Accessory | 876.1500 | 2 | | Andorate® Disposable
Air/Water Valve | 1 | ODC – Endoscope
Channel Accessory | 876.1500 | 2 | The suction valve is designed to be attached to the suction port of the endoscope and the air/water valve is designed to be attached to the air/water port of the endoscope. The activation of the suction valve allows the user to aspirate excess fluids or other debris obscuring the endoscopic image. while the activation of the air/water valve allows the user to control air and water flow to assist in cleansing the lens during procedures. The suction and air/water are housed together with biopsy valve and auxiliary water connector in a single tray and packaged in sealed packed. The subject devices are supplied as sterile The subject devices in this submission have the same operation and method of action with the predicate device. According to the Medical Device Recalls database in FDA website, no product recall was found for the predicate device. According to the FDA MAUDE database, safety issues on fluid leakage and backflow were identified. In the performance test, the leakage test and backflow test were conducted for verification. There were no prior submissions for the subject devices. 7. Intended Use: The Andorate® Disposable Suction Valve is used to control the suction function of an endoscope (Fujifilm 700 series) during a GI Endoscopic procedure. 8. Intended Use: The Andorate® Disposable Air/Water valve is used to control the air/ water function of an endoscope (Fujifilm 700 series) during a GI Endoscopic procedure. ## 9. Technological Characteristics The following table (Table 2) is summaries of the Andorate® Disposable Suction Valve and Andorate® Disposable Air/Water Valve technological characteristics as compared to the predicate device. 2 Summary of design. features and principles of operation and Table technological characteristics between the subject and predicate devices (suction and air/water valves). | Specification | Predicate Device | Subject Devices | Substantial
Equivalence | |---------------|-----------------------------------------------------|-----------------------------------------------------------------------------------|----------------------------| | Device name | FUJIFILM Endoscope (Suction
and air/water valve) | Andorate® Disposable Suction
Valve and Andorate®
Disposable Air/Water Valve | N/A | | K number | K172916 | K200495 | N/A | | Manufacturer | FUJIFILM Corporation | GA Health Company Limited | N/A | {5}------------------------------------------------ ## K200495 Page 3 of 5 510(k) Premarket Notification: Traditional Suction Valve and Air/Water Valve GA Health Company Limited CONFIDENTIAL | Product code | FDF, FDS | ODC | N/A | |---------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------| | Classification | 2 | 2 | Identical | | Regulation No | 876.1500 | 876.1500 | Identical | | Regulation
Name | Endoscope and accessories | Endoscope and accessories | Identical | | Supplied Sterile | No* | Yes | Substantial
Equivalent | | Compatibility | FUJIFILM 700 series endoscope | FUJIFILM 700 series endoscope | Identical | | Intended Use | The suction valve is a medical
device that is attached to a
FUJIFILM
gastrointestinal
endoscope in order to suck
mucus or air in the body cavity.

The air/water valve is a medical
device that is attached to a
FUJIFILM
gastrointestinal
endoscope in order to jet air or
water. | The Andorate® Disposable
Suction Valve is used to control
the suction function of an
endoscope (Fujifilm 700 series)
during a GI Endoscopic
procedure.

The Andorate® Disposable
Air/Water Valve is used to
control the air/water function
of an endoscope (Fujifilm 700
series) during a GI
Endoscopic procedure. | Substantial
Equivalent | | Environment of
Use | Hospital and or clinics | Hospital and or clinics | Identical | | Single Use,
Disposable | Yes | Yes | Identical | | Material | Polycarbonate, stainless steel
304, thermoplastic elastomer | Acrylonitrile Butadiene Styrene,
silicone, Stainless Steel 304 | Substantial
Equivalent | | Packaging | Each model packed in a PE bag
with a carton box | Suction, air/water, biopsy valves
and auxiliary water connector are
housed in a single tray and
packaged in a sealed pouched | Substantial
Equivalent | | Manufacturing
method | Injection moulding and over-
moulding. | Injection moulding | Substantial
Equivalent | | Sterilization | Supplied non-sterile
Sterilized after each use | EO gas | Identical | | Shelf Life | 1 year | 1 year | N/A | *Remark: The predicate device is supplied as non-sterile and the end-user should be sterilized prior using, while the subject device is sold as sterile in which no sterilization is needed by the end-user prior to using. ## 10. Non-Clinical Performance Data The bench testing was performed to support substantial equivalence. The following testing were performed on subject devices from initial production lots, including sterilization. {6}------------------------------------------------ ## K200495 Page 4 of 5 510(k) Premarket Notification: Traditional Suction Valve and Air/Water Valve GA Health Company Limited CONFIDENTIAL ## 10.1 Performance Test ## 10.1.1Andorate® Disposable Suction Valve - 10.1.1.1 Assembling Integrity - 10.1.1.2 Endoscope Compatibility - 10.1.1.3 Depression Force - 10.1.1.4 Vacuum Leak Test - 10.1.1.5 Suction Flow Test ## 10.1.2Andorate® Disposable Air/Water Valve - 10.1.2.1 Endoscope Compatibility Testing - 10.1.2.2 Air Leakage Testing - 10.1.2.3 Assembling Integrity Verification - 10.1.2.4 Air Flow Test - 10.1.2.5 Depression Force Testing - 10.1.2.6 Water Flow Test ## 10.2 Sterilization All the subject devices are sold in sterile packaging. Also, 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 below the maximum levels defined in ANSI/AAMI/ISO 10993-7:2008 are Biological Evaluation of Medical Devices - Part 7: Ethylene Oxide sterilization residuals. The subject and the predicate devices, are not labeled as pyrogen-free because they do not have any blood or cerebrospinal fluid contact. #### 10.3 Shelf Life The Andorate® Disposable Suction and Air/Water have a one (1) year expiration date. The subject devices are packaged in a paper/film pouch respectively. These pouches have been tested by Sanitation Environment Technology Institute, Soochow University. The tests conducted including accelerated aging, seal strength, dye penetration, microbial barrier properties, vacuum leak test and the sterility test. The performance test was conducted for the subject devices after the accelerated aging process. The test result can imply that the subject devices can provide and maintain a sterile barrier and its intended performance before the expiration date. #### 10.4 Biocompatibility The biocompatibility of the subject devices were conducted in accordance with the FDA guideline "Use of International Standard ISO 10993-1, "Biological evaluation of medical devices – Part 1: Evaluation and testing within a risk management process"". It included the following tests. - Acute Systemic Toxicity Test - - In Vitro Cytotoxicity - - -Skin sensitization - -Irritation The subject 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 subject devices are biocompatible. {7}------------------------------------------------ ## K200495 Page 5 of 5 510(k) Premarket Notification: Traditional Suction Valve and Air/Water Valve GA Health Company Limited CONFIDENTIAL # 11. Clinical Testing Similar devices have been on the market for many years with proven safety and efficacy for the use of the device. These devices have no direct patient contact. Based on this history and the use of the device, clinical testing was not necessary to support substantial equivalence data. The non-clinical testing performed supports safety and efficacy of the devices and provides data to show substantial equivalence to the predicate device. ## 12. Conclusion The subject devices have the same intended use as the predicate device. Based on the technological characteristics and overall performance of the devices in bench testing, there are no significant differences exist between the subject devices and the predicate devices. The subject devices do not raise any new issues of safety and effectiveness. From a clinical perspective and comparing design specifications, the subject devices and the predicate device are substantially equivalent. --- **Source:** [https://fda-staging.innolitics.com/device/K200495](https://fda-staging.innolitics.com/device/K200495) **Published by [Innolitics](https://innolitics.com)** — a medical-device software consultancy. We help companies design, build, and clear FDA-regulated software and AI/ML devices. If you're preparing [a 510(k)](https://innolitics.com/services/510ks/), [a De Novo](https://innolitics.com/services/regulatory/), [a SaMD](https://innolitics.com/services/end-to-end-samd/), [an AI/ML medical device](https://innolitics.com/services/medical-imaging-ai-development/), or [an FDA regulatory strategy](https://innolitics.com/services/regulatory/), [get in touch](https://innolitics.com/contact). **Cite:** Innolitics at https://innolitics.com