The AMSure® Pre-filled Syringe for Balloon Inflation with Sterile Water is a 3cc, 5cc, 10cc and 30cc syringe pre-filled with USP purified water and gamma irradiated. The syringe is produced using polypropylene for the device barrel and plunger and pharmaceutical grade latex free rubber for both the plunger gasket and syringe tip cover. The shelf life of AMSure® Pre-filled Syringe for Balloon Inflation with Sterile Water is 3 years.

AI/ML Overview

The provided document describes the AMSure® Pre-filled Syringe for Balloon Inflation with Sterile Water, which is a pre-filled syringe intended for inflating foley catheter balloons. The document is a 510(k) Premarket Notification, which aims to demonstrate substantial equivalence to a predicate device, not necessarily to prove absolute safety and effectiveness through extensive clinical trials.

Therefore, the information regarding acceptance criteria and study details is presented in the context of demonstrating substantial equivalence rather than a detailed clinical effectiveness study of a novel AI device.

Here's the information as requested, based on the provided text:

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

The document states that the AMSure® Pre-filled Syringe for Balloon Inflation with Sterile Water underwent performance testing to establish substantial equivalence. It does not provide specific quantitative acceptance criteria or detailed performance metrics in the way a clinical study report for an AI device might. Instead, it refers to conformity with established standards.

Acceptance Criteria (General Description from Text)	Reported Device Performance (General Description from Text)
Functional Criteria	Meets acceptance criterion for all functional criteria.
Sterility Criteria	Meets acceptance criterion for all sterility criteria.
Biocompatibility Criteria	Meets acceptance criterion for all biocompatibility criteria.
Other Performance Criteria	Meets acceptance criterion for all other performance criteria.
Conformity with ISO7886-1, ISO 80369-7, USP 40	Conforms with these standards.
Conformity with ISO 10993-5, ISO 10993-10 requirements	Conforms with these standards.

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 the sample size used for the performance tests, nor does it provide details on the data provenance (country of origin, retrospective/prospective). The tests mentioned are laboratory/bench tests, not typically clinical studies involving patient data.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

This type of information is not applicable to this 510(k) submission. The "ground truth" for this device's evaluation is based on established engineering specifications, material science, and regulatory standards for medical devices, not expert human interpretation of medical data.

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

Not applicable. The evaluation relies on standardized test methods and conformity to norms, not on expert adjudication of medical findings.

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

Not applicable. This device is a pre-filled syringe, not an AI or diagnostic imaging device that would typically undergo an MRMC study.

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

Not applicable. This is a physical medical device, not a software algorithm.

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

The "ground truth" for evaluating this device's performance is based on established engineering specifications, material standards, and regulatory requirements (e.g., ISO, USP standards) for syringe functionality, sterility, and biocompatibility.

8. The sample size for the training set

Not applicable. This device is not an AI algorithm that requires a training set.

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

Not applicable. This device is not an AI algorithm.

Summary

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September 4, 2018

Amsino International, Inc. Cathy Hong Senior RA Specialist 708 Corporate Center Drive Pomona, CA 91768

Re: K181814

Trade/Device Name: AMSure® Pre-filled Syringe for Balloon Inflation with Sterile Water Regulation Number: 21 CFR§ 876.5130 Regulation Name: Urological Catheter and Accessories Regulatory Class: II Product Code: EZL Dated: July 6, 2018 Received: July 9, 2018

Dear Cathy Hong:

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 mav, 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 avare 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/CombinationProducts/GuidanceRegulatoryInformation/ucm597488.html; 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 http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm.

For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). 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 (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).

Sincerely,

Image /page/1/Picture/6 description: The image shows the name "Glenn B. Bell -S" in a large, bold font. The text is black and is set against a light background. The letters are clearly legible and evenly spaced.

for Benjamin R. Fisher, Ph.D. Director Division of Reproductive, Gastro-Renal, and Urological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known)

K181814

Device Name

AMSure® Pre-filled Syringe for Balloon Inflation with Sterile Water

Indications for Use (Describe)

Pre-filled Syringe for Balloon Inflation with Sterile Water is intended to be used in inflating foley catheter balloon,

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.

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FORM FDA 3881 (7/17)

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Image /page/3/Picture/0 description: The image shows the logo for AMSINO. The logo is in blue and white. The word "AMSINO" is written in large, bold letters. There are two horizontal lines under the word "AMSINO".

Worldwide AMSure® Pre-filled Syringe for Balloon Inflation with Sterile Water

Traditional 510(k) Premarket Notification

Section 5: 510(k) Summary

Submitter Information .

Submitter: Amsino International Inc. 708 Corporate Center Drive, Pomona CA 91768, USA
Contact Person: Cathy Hong

Senior RA Specialist

Phone: +86(21)-69117118

Fax: +86(21)-59148142

E-mail: Cathy Hong@amsino.com

Date Prepared: July 06, 2018

. Device Information

Common or Usual Name: Pre-filled Syringe for Balloon Inflation with Sterile Water

Trade or Proprietary Name: AMSure® Pre-filled Syringe for Balloon Inflation with Sterile Water

Product Item: CIS1003, CIS1005, CIS1010, CIS3530

Regulation Number: 876.5130 Classification Name: Urological Catheter and Accessories Device Class: Class II Review Panel: Gastroenterology/Urology Product Code: EZL

. Predicate Device Information

Device Name: Primary Care Solution Pre-Filled 10cc and Pre-Filled 30cc Inflation Syringe with Sterile Water

510(k) Number: K030813

. Device Description:

The AMSure® Pre-filled Syringe for Balloon Inflation with Sterile Water is a 3cc, 5cc, 10cc and 30cc syringe pre-filled with USP purified water and gamma irradiated. The syringe is produced using polypropylene for the device barrel and plunger and
Amsino International, Inc.

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Image /page/4/Picture/0 description: The image contains the word "AMSINO" in large, bold, white letters against a blue background. There are two horizontal white lines underneath the word. The font is a serif typeface, and the overall design is simple and clean. The logo appears to be for a company or organization named Amsino.

Worldwide® AMSure® Pre-filled Syringe for Balloon Inflation with Sterile Water

Traditional 510(k) Premarket Notification

pharmaceutical grade latex free rubber for both the plunger gasket and syringe tip cover. The shelf life of AMSure® Pre-filled Syringe for Balloon Inflation with Sterile Water is 3 years.

There is no prior submission for the AMSure® Pre-filled Syringe for Balloon Inflation with Sterile Water.

● Indications for Use

Pre-filled Syringe for Balloon Inflation with Sterile Water is intended to be used in inflating foley catheter balloon.

. Product Comparison Summary

The proposed AMSure® Pre-filled Syringe for Balloon Inflation with Sterile Water is equivalent to the Primary Care Solution, Inc.'s Primary Care Solution Pre-Filled 10cc and Pre-Filled 30cc Inflation Syringe with Sterile Water. The proposed device has the same indications for use, same operation principle, and the same general characteristics with the predicate device.

The design and materials of the proposed devices are identical to the predicate device (K030813).

No.	DeviceCharacteristic	Predicate Device	Proposed Device	ComparisonResults
1	Product Code	EZL	EZL	Same
2	Indications forUse	A sterile water pre-filled syringe for use in inflating foley catheter balloon.	A sterile water pre-filled syringe for use in inflating foley catheter balloon.	Same
3	RegulationNumber	876.5130	876.5130	Same
4	DesignConfiguration	Image: syringes	Image: syringes	Similar
5	PrincipleofOperation	Normal	Normal	Same
6	Materials of main components
	Barrel	Polypropylene	Polypropylene	Same
	Plunger	Polypropylene	Polypropylene	Same
	Plunger Gasket	Black pharmaceutical grade,synthetic rubber (Latex free)	Black pharmaceutical grade,synthetic rubber (Latex free)	Same
	Tip Cover	Same as gasket	Same as gasket	Same
	Solution	Purified water, USP	Purified water, USP	Same
7	TechnicalPerformance	Conform with ISO7886-1,ISO 80369-7 and USP 31	Conform with ISO7886-1,ISO 80369-7 and USP 40.	Similar
8	Biologicalevaluation	Conform with ISO 10993-5,ISO 10993-10 requirements	Conform with ISO 10993-5,ISO 10993-10 requirements	Same
9	Sterile method	Gamma Irradiation	Gamma Irradiation	Same
10 SingleUse/Reusable	Single Use	Single Use	Same

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Image /page/5/Picture/0 description: The image shows the word "AMSINO" in a stylized font. The letters are white and are set against a blue background. The font appears to be a serif font, and the letters are bolded.

Advancing Healtheare Worldwide "AMSure® Pre-filled Syringe for Balloon Inflation with Sterile Water

Traditional 510(k) Premarket Notification

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Image /page/6/Picture/0 description: The image shows the word "AMSINO" in a stylized font. The letters are white and have a blue background. There is a blue line above and below the word.

re Worldwide AMSure® Pre-filled Syringe for Balloon Inflation with Sterile Water

Traditional 510(k) Premarket Notification

The AMSure® Pre-filled Syringe for Balloon Inflation with Sterile Water has the same indications for use and function as the predicate device. The syringe used for the predicate device and proposed device is the same made by Amsino Medical (Kunshan) Co., Ltd. The standards used for the performance test of the proposed device are the latest ones, and the test results meet its requirements.

. Performance Data

The AMSure® Pre-filled Syringe for Balloon Inflation with Sterile Water meet the acceptance criterion for all functional, sterility, biocompatibility and other performance criteria which verify it to be substantially equivalent to the predicate devices. Results of the testing demonstrate that there are no new issues of safety and efficacy that are raised with the AMSure® Pre-filled Syringe for Balloon Inflation with Sterile Water.

Conclusions .

The information provided within this pre-market notification demonstrates that the AMSure® Pre-filled Syringe for Balloon Inflation with Sterile Water is substantially equivalent to the predicate device.

End of Summary

Regulation Number and Section

§ 876.5130 Urological catheter and accessories.

(a)
Identification. A urological catheter and accessories is a flexible tubular device that is inserted through the urethra and used to pass fluids to or from the urinary tract. This generic type of device includes radiopaque urological catheters, ureteral catheters, urethral catheters, coudé catheters, balloon retention type catheters, straight catheters, upper urinary tract catheters, double lumen female urethrographic catheters, disposable ureteral catheters, male urethrographic catheters, and urological catheter accessories including ureteral catheter stylets, ureteral catheter adapters, ureteral catheter holders, ureteral catheter stylets, ureteral catheterization trays, and the gastro-urological irrigation tray (for urological use).(b)
Classification. (1) Class II (performance standards).(2) Class I for the ureteral stylet (guidewire), stylet for gastrourological catheter, ureteral catheter adapter, ureteral catheter connector, and ureteral catheter holder. The devices subject to this paragraph (b)(2) are exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 876.9.