The Vacutore® Air/Water Bottle Tubing (Model GAR025, GAR076) is to connect an air/CO2 source, a sterile water source (water bottle), and an endoscope to supply air/CO2 and water during gastrointestinal endoscopic procedures. It is a 24-hour multi-patient use device.

Device Description

The Vacutore® Air/Water Bottle Tubing is intended for 24-hour multi-patient use. Air/water bottle tubing is supplied in sterile. The Vacutore® Air/Water Bottle Tubing is manufactured for use in conjunction with sterile water bottle, and together with Olympus 160 and Pentax 90 series endoscopes. The air/water bottle tubing is individually packed in sealed package, sold as a sterile device. The air/water bottle tubing is designed to be attached to the air/water port of the endoscopes to provide irrigation through the air/water channel to the distal end of endoscope.

AI/ML Overview

The provided document is a 510(k) Premarket Notification for a medical device called "Vacutore® Air/Water Bottle Tubing." This type of submission focuses on demonstrating substantial equivalence to a predicate device, rather than proving novel effectiveness through a comprehensive study with specific acceptance criteria related to a diagnostic output or algorithm performance.

Therefore, the typical metrics for acceptance criteria and study descriptions (like sensitivity, specificity, types of ground truth, number of experts, MRMC studies, effect sizes, and separate test/training sets with explicit ground truth establishment) are generally not applicable in the context of this device and submission type.

Instead, the acceptance criteria here relate to the performance, safety, and functional equivalence of the tubing device compared to an existing predicate.

Here's an analysis based on the information provided, addressing the questions as much as possible for this type of device:

1. A table of acceptance criteria and the reported device performance

The document does not explicitly state numerical "acceptance criteria" and "reported device performance" in the way one would for an AI diagnostic device (e.g., "sensitivity > 90%"). Instead, it lists tests performed and states that these tests support substantial equivalence. The "performance" is implicitly "met all tests successfully" to be considered substantially equivalent.

Acceptance Criterion (Implicit)	Reported Device Performance (Implicit)
Assembling Integrity	Passed
Endoscope Compatibility	Passed
Compatibility with Bottle	Passed
Two-Way Valve Integrity	Passed
Flow Clamp Test	Passed
Water Flow Test	Passed
Back Flow Performance Test	Passed
Sterility (SAL of 10⁻⁶)	Passed (Validated EO sterilization)
EO residuals (ANSI/AAMI/ISO 10993-7)	Below maximum levels
Shelf Life (3 years)	Passed (Verified by accelerated aging, seal strength, dye penetration, microbial barrier, vacuum leak, sterility tests)
Biocompatibility (ISO 10993-1)	Passed (Acute Systemic Toxicity, In Vitro Cytotoxicity, Skin sensitization, Irritation tests showed biocompatibility)
Barrier Integrity & Simulated Use Testing (24-hour multi-patient use)	Passed (Verified back-flow prevention and 24-hour multi-patient use)

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

The document does not specify a "sample size" in terms of number of patients or images, as this is a tubing device. The testing was performed on "Smartdata samples from initial production lots." The provenance of these samples would be the manufacturer, Smartdata Suzhou Co., Ltd., in China. These would be considered prospective in the sense they are new production samples being tested.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

This is not applicable. The device is a piece of medical tubing, not a diagnostic or AI-driven decision support system that requires expert interpretation for ground truth. The "ground truth" here is physical performance (e.g., does it leak? does it flow water correctly? is it sterile?).

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

This is not applicable. Adjudication methods are used to establish ground truth in studies involving human interpretation or clinical outcomes. For bench testing of a physical device, the results are typically objectively measured and do not require expert adjudication in this manner.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

No. An MRMC study is relevant for diagnostic or AI-assisted interpretation, where human readers evaluate cases with and without AI assistance. This device is a piece of tubing used in endoscopic procedures, not an AI diagnostic tool.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

No. This refers to the performance of an algorithm without human input, which is not relevant for this device. The testing described is "standalone" in the sense that the tubing itself was tested for its physical and functional properties.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

The "ground truth" for this device's performance is based on objective measurement of physical properties and adherence to established standards. Examples include:

Physical integrity (no leaks, secure connections)
Flow rates (water flow test)
Sterility (Sterility Assurance Level, EO residuals)
Material compatibility (biocompatibility tests)
Durability (shelf life accelerated aging)
Functional performance (back-flow prevention, compatibility with endoscopes/bottles).

8. The sample size for the training set

Not applicable. This device does not involve a "training set" in the context of machine learning or AI models.

9. How the ground truth for the training set was established

Not applicable, as there is no training set.

Summary

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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: the Department of Health & Human Services logo on the left and the FDA logo on the right. The FDA logo includes the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue text.

September 6, 2019

Smartdata Suzhou Co., Ltd % Anna Reifschneider Responsible Third-Party Official Accelerated Device Approval Services, LLC 6800 S.W. 40th Street, Ste. 444 Ludlum, FL 33155-3708

Re: K191366

Trade/Device Name: Vacutore Air/Water Bottle Tubing Regulation Number: 21 CFR 876.1500 Regulation Name: Endoscope and accessories Regulatory Class: II Product Code: OCX Dated: August 23, 2019 Received: August 26, 2019

Dear Anna Reifschneider:

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.

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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 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.

for

Martha W. Betz, Ph.D. Acting 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

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Indications for Use

510(k) Number (if known) K191366

Device Name

Vacutore® Air/Water Bottle Tubing

Indications for Use (Describe)

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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K191336 Page 1 of 5

510(k) Premarket Notification: Traditional Air/Water Bottle Tubing Smartdata Suzhou Co., Ltd. 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.

Cindy Ye

General Manager +86 512 6598 3722

+852 6393 5184

1. Submission Sponsor

Submitter's Name:	Smartdata Suzhou Co., Ltd
Submitter's Address:	4f, Block 7, 198#, Jinshan RdNew DistrictSuzhou, Jiangsu 215011CHINA
Establishment Registration No.:	3008058134

2. Sponsor Contact

Contact Person:
-----------------	--

Telephone:

Email:

3. Date Prepared

15th Mar 2019

4. Device Identification

Trade Device Name: Common Device Name: Classification Name: Regulation Number: Classification

Vacutore® Air/Water Bottle Tubing Air/Water Tubing for Endoscope OCX - Endoscopic Irrigation/Suction System 876.1500 2

cindy.ye@smartdatamedical.com

5. Predicate Device Identification

Predicate Device 510(k) No .: Predicate Device Trade Name: Predicate Device Product Code: K093665 Endo SmartCap™ FAJ

6. Device Description:

The Vacutore® Air/Water Bottle Tubing is intended for 24-hour multi-patient use. Air/water bottle tubing is supplied in sterile. Table 1 shows the components included in the application.

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Table 1 – Components included in the application
Components	Qty	Classification Name	RegulationNumber	Classification
Vacutore® Air/Water BottleTubing(GAR025)	1	OCX - EndoscopicIrrigation/SuctionSystem	876.1500	2
Vacutore® Air/Water BottleTubing(GAR072)	1	OCX - EndoscopicIrrigation/SuctionSystem	876.1500	2
Vacutore® Air/Water BottleTubing(GAR076)	1	OCX - EndoscopicIrrigation/SuctionSystem	876.1500	2

The Vacutore® Air/Water Bottle Tubing is manufactured for use in conjunction with sterile water bottle, and together with Olympus 160 and Pentax 90 series endoscopes. The air/water bottle tubing is individually packed in sealed package, sold as a sterile device. The air/water bottle tubing is designed to be attached to the air/water port of the endoscopes to provide irrigation through the air/water channel to the distal end of endoscope.

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 are conducted for verification.

There were no prior submissions for the Vacutore® Air/Water Bottle Tubing.

7. Intended Use:

The Vacutore® Air/Water Bottle Tubing (Model GAR025, GAR072 & GAR076) is to connect an air/CO2 source, a sterile water source (water bottle), and an endoscope to supply air/CO2 and water during gastrointestinal endoscopic procedures. It is a 24-hour multi-patient use device.

8. Technological Characteristics

Table 2 summaries the Vacutore® Air/Water Bottle Tubing technological characteristics as compared to the predicate device from Endo SmartCap™.

Table 2 Summary of design, features and principles of operation between the Vacutore® Air/Water Bottle Tubing (GAR025, GAR076) technological characteristics as compared to the predicate devices.

Specification	Predicate Device	Proposed Device	SubstantialEquivalence
Device name	Endo SmartCap™	Vacutore® Air/Water BottleTubing	N/A
K number	K093665	---	N/A
Manufacturer	Medivators, Inc.	Smartdata Suzhou Co., Ltd	N/A
Product code	FAJ	OCX	N/A

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Classification	2	2	Identical
Regulation No	876.1500	876.1500	Identical
RegulationName	Endoscope and accessories	Endoscope and accessories	Identical
Supplied Sterile	Yes	Yes	Identical
Compatibility	Pentax GI Endoscope	GAR025: Olympus 160 seriesendoscopeGAR072 & GAR076: Pentax 90series endoscope	SubstantialEquivalent
Indicationsfor Use	ENDO SMARTCAP™ Tubing isintended to be used with an airor CO2 source and/ or pumpalong with a sterile water sourceto supply air or CO2 and sterilewater to an gastrointestinalendoscope during endoscopicprocedures	The Vacutore® Air/Water BottleTubing (Model GAR025, GAR072& GAR076) is to connect anair/CO2 source, a sterile watersource (water bottle), and anendoscope to supply air/CO2 andwater during gastrointestinalendoscopic procedures. It is a24-hour multi-patient use device.	SubstantialEquivalent
Environment ofUse	Hospital and or clinics	Hospital and or clinics	Identical
Material	Methyl methacrylateacrylonitrile-butadiene-styrenecopolymer, Polycarbonate,Polyethylene, PolyvinylChloride, ThermoplasticElastomer, Nitrile ButadieneRubber	Thermoplastic polyurethanes,Polyvinyl Chloride, Silicone,Polyoxymethylene,Polycarbonate, stainless steel304, Acrylonitrile ButadieneStyrene	SubstantialEquivalent
Packaging	Each model packed separatelyin a seal pouched	Each model packed separately ina seal pouched	Identical
Manufacturingmethod	Injection moulding	Injection moulding	SubstantialEquivalent
Sterilization	EO gas	EO gas	Identical
Shelf Life	Three years	Three years	Identical

9. Non-Clinical Performance Data

Smartdata performed bench testing to support substantial equivalence. The following testing were performed on Smartdata samples from initial production lots, including sterilization.

9.1 Performance Test

9.1.1 Vacutore® Air/Water Bottle Tubing (GAR025, GAR072 and GAR076)

Assembling Integrity 9.1.1.1
9.1.1.2 Endoscope Compatibility
9.1.1.3 Compatibility with Bottle
9.1.1.4 Two-Way Valve Integrity
9.1.1.5 Flow Clamp Test
9.1.1.6 Water Flow Test
9.1.1.7 Back Flow Performance Test

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510(k) Premarket Notification: Traditional Air/Water Bottle Tubing Smartdata Suzhou Co., Ltd. CONFIDENTIAL

9.2 Sterilization

Vacutore® Air/Water Bottle Tubing is sold in sterile package, like the Medivators predicate devices. The subject device has been sterilized in a validated EO sterilization cycle. The EO sterilization cycle has a Sterility Assurance Level (SAL) of 106 EO residuals on the components are below the maximum levels defined in ANSI/AAMI/ISO 10993-7:2008 Biological Evaluation of Medical Devices - Part 7: Ethylene Oxide sterilization residuals. The Vacutore® Air/Water Bottle Tubing, and the predicate devices, are not labeled as pyrogen-free because they do not have any blood or cerebrospinal fluid contact.

9.3 Shelf Life

The Vacutore® Air/Water Bottle Tubing has a three (3) year expiration date, based on the design and material equivalence to the predicate devices and existing sterile barrier data from Smartdata existing packaging. The Vacutore® Air/Water Bottle Tubing is packaged in a paper/film pouch respectively like other sterile products Smartdata currently manufactures. These pouches have been tested by Sanitation Environment Technology Institute, Soochow University .which is an CNAS accredited laboratory. The tests conducted including accelerated aging, seal strength, dye penetration, microbial barrier properties, vacuum leak test and the sterility test. Smartdata conducted the performance test after the accelerated aging process. The test result can imply that the air/water bottle tubing can provide and maintain a sterile barrier and its intended performance for at least three (3) years.

9.4 Biocompatibilitv

The biocompatibility of the Vacutore® Air/Water Bottle Tubing 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"". It included the following tests.

Acute Systemic Toxicity Test -
In Vitro Cytotoxicity -
। Skin sensitization
Irritation -

The air/water bottle tubing is classified as surface device with mucosal membrane contact for a limited duration (not more than 24 hours). The test result shows that the air/water bottle tubing is biocompatible.

0.5 Barrier Integrity and Simulated Use Testing

The barrier integrity and simulated use testing of Vacutore® Air/Water Bottle Tubing was conducted. The test result can imply that the air/water valve in the endoscope provide sufficient back-backflow prevention to the Vacutore® Air/Water Bottle Tubing and verified 24-hour multi-patient use

10. 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.

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11. Conclusion

Vacutore® Air/Water Bottle Tubing has the same intended use as the predicate devices.

Based on the technological characteristics and overall performance of the devices in bench testing, Smartdata believes that no significant differences exist between the proposed air/water bottle tubing and the predicate devices.

The Vacutore® Air/Water Bottle Tubing does not raise any new issues of safety and effectiveness.

From a clinical perspective and comparing design specifications, the Vacutore® Air/Water Bottle Tubing, and the predicate device are substantially equivalent.

Regulation Number and Section

§ 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.