The device is a single-use 10cc and 30cc syringe pre-filled with USP purified water and gamma irradiated. The device has two models, PCAA01 and PCAA03. They are only different in volume; PCAA01 is 10cc, and PCAA03 is 30cc. The syringe is produced using polypropylene for the device barrel and plunger and pharmaceutical grade latex free rubber for both the plunger gasket and protect cap. The device contacts indirectly with the human body. The duration of contact is less than 24 hours. The product is used in conjunction with the urinary catheter to push the plunger of the syringe to inject the sterilized pre-filled purified water into the balloon of the urinary catheter to inflate the balloon.

AI/ML Overview

Here's a breakdown of the acceptance criteria and study information for the Prefilled Syringe, based on the provided text:

Device: Prefilled Syringe (10cc and 30cc for Foley catheter balloon inflation)

1. Table of Acceptance Criteria and Reported Device Performance

The provided document describes compliance with recognized standards rather than specific numerical acceptance criteria and reported performance values. The summary states: "All of the tested parameters met the predefined acceptance criteria."

Acceptance Criteria Category	Relevant Standard(s)	Reported Device Performance
Biocompatibility	ISO 10993-1:2018 (Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process)	The prefilled syringe was evaluated according to ISO 10993-1:2018. Specific tests performed included: - Cytotoxicity (ISO 10993-5: 2009) - Sensitization (ISO 10993-10:2010) - Irritation (ISO 10993-10:2010)All tested parameters met predefined acceptance criteria.
Performance Testing	ISO 7886-1: 2017 (Sterile hypodermic syringes for single use Part 1: Syringes for manual use)ISO 11040-8: 2016 (Prefilled Syringes Requirements and test methods for finished prefilled syringes)ISO 11040-4: 2015 (Prefilled Syringes Glass barrels for injectables and sterilized subassembled syringes ready for filling)ISO 11040-6: 2019 (Prefilled Syringes Plastic barrels for injectables and sterilized subassembled syringes ready for filling)ISO 80369-1: 2018 (Small-bore connectors for liquids and gases in healthcare applications - Part 1: General requirements)ISO 80369-7: 2016 (Small-bore connectors for liquids and gases in healthcare applications - Part 7: Connectors for intravascular or hypodermic applications)ISO 80369-20: 2015 (Small-bore connectors for liquids and gases in healthcare applications - Part 20: Common test methods)USP 40 Purified Water <6719>	Performance testing was conducted according to the listed ISO and USP standards. All tested parameters met predefined acceptance criteria.
Material Equivalence	N/A (Comparison to predicate device)	Proposed Device: Polypropylene (barrel, plunger), Pharmaceutical Grade Latex Free Rubber (stopper, protective cap), Purified Water USP (solution).Predicate Device: Identical materials.The devices have similar technological characteristics and materials.
Sterilization Equivalence	N/A (Comparison to predicate device)	Proposed Device: Sterile (gamma irradiation).Predicate Device: Sterile (gamma irradiation).Both devices use the same sterilization method.

2. Sample Size Used for the Test Set and Data Provenance

The document does not explicitly state the sample sizes for the "test set" in terms of how many syringes were tested for biocompatibility or performance. It only mentions that "Performance testing was conducted on the Prefilled Syringe according to the following standards." The provenance of the data is not specified; however, the manufacturer is based in China, suggesting the testing was likely conducted by or for the manufacturer. No indication of retrospective or prospective study is provided.

3. Number of Experts Used to Establish Ground Truth and Qualifications

This information is not applicable as the device is a prefilled syringe for foley catheter balloon inflation, not a diagnostic or AI-driven device that requires expert ground truth for interpretation. The "ground truth" here would be the physical properties and functional performance of the device against established engineering and biological standards.

4. Adjudication Method for the Test Set

This information is not applicable for this type of medical device testing. Adjudication methods like "2+1" or "3+1" are typically used for establishing ground truth in image analysis or clinical endpoint assessment, which is not relevant to the performance and biocompatibility testing of a prefilled syringe.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

This information is not applicable. An MRMC study assesses the performance of human readers, often with and without AI assistance, for diagnostic tasks. The Prefilled Syringe is a physical medical device (syringe with purified water) and its performance is evaluated against engineering and biological standards, not by human interpretation or diagnostic accuracy.

6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study

This information is not applicable. The device is a physical medical device, not an algorithm or AI system. Therefore, there is no "standalone" algorithm performance to assess.

7. Type of Ground Truth Used

The ground truth for the Prefilled Syringe is based on:

Established Industry Standards: Primarily ISO standards (e.g., ISO 7886-1, ISO 11040 series, ISO 80369 series, ISO 10993 series) and USP (United States Pharmacopeia) for purified water. These standards define the acceptable physical, chemical, mechanical, and biological properties and performance requirements for such devices.
Predicate Device Equivalence: The comparison to the predicate device (K030813) serves as a benchmark, establishing that the proposed device is "as safe and as effective" based on similar technological characteristics and performance.

8. Sample Size for the Training Set

This information is not applicable. As a physical medical device (syringe), it does not involve machine learning or AI, and therefore, there is no "training set."

9. How the Ground Truth for the Training Set Was Established

This information is not applicable as there is no training set for this device.

Summary

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December 15, 2020

Hangzhou Primecare Medical Co., Ltd. % Olivia Meng Regulatory Affairs Manager Guangzhou Osmunda Medical Device Technical Service Co., Ltd. 8-9th Floor, R&D Building, No.26 Qinglan Street, Panyu District Guangzhou, Guangdong 510006 China

Re: K202698

Trade/Device Name: Prefilled Syringe Regulation Number: 21 CFR§ 876.5130 Regulation Name: Urological Catheter and Accessories Regulatory Class: II Product Code: EZL Dated: September 11, 2020 Received: September 16, 2020

Dear Olivia Meng:

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-regulatoryinformation/postmarketing-safety-reporting-combination-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 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,

Sharon M. Andrews Director DHT3B: Division of Reproductive, Gynecology and Urology Devices OHT3: Office of GastroRenal, ObGyn, General Hospital and Urology Devices Office of Product Evaluation and Ouality Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known) K202698

Device Name Prefilled Syringe

Indications for Use (Describe)

The 10cc and 30cc pre-filled syringes are intended to be used for foley catheter balloon inflation.

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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510(k) Summary – K202698

In accordance with 21 CFR 807.92 the following summary of information is provided:

1. SUBMITTER

Hangzhou Primecare Medical Co., Ltd. Room 408-409, Zancheng Center West, Shangcheng District, 310008 Hangzhou, Zhejiang Province, PEOPLE'S REPUBLIC OF CHINA Phone: +86-13357148752 Fax: +86-0571-81958625

Primary Contact	Olivia Meng
Person:	Regulatory Affairs Manager
	Guangzhou Osmunda Medical Device Technical Service
	Co., Ltd.
	Tel: (+86)-20-6231 6262
	Fax: (+86)-20-8633 0253
Secondary Contact	Xueqing Yan
Person:	Quality Supervisor
	Hangzhou Primecare Medical Co., Ltd.
	Phone: +86-13357148752
	Fax: +86-0571-81958625
Date prepared	December 15, 2020
2. DEVICE
Device Name:	Prefilled Syringe
Common name:	Prefilled Syringe
Model:	PCAA01, PCAA03
Regulation Number	21 CFR 876.5130
Regulation Name	Urological catheter and accessories
Regulatory Class:	2
Product Code:	EZL
Product Code Name:	Catheter, Retention Type, Balloon

PREDICATE DEVICE

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K030813, Primary Care Solutions Prefilled 10cc and Prefilled 30cc Inflation Syringes with Sterile Water; Catalog numbers 1010 and 1030 respectively This predicate has not been subject to a design-related recall.

DEVICE DESCRIPTION 4.

5. INDICATIONS FOR USE

The 10cc and 30cc pre-filled syringes are intended to be used for foley catheter balloon inflation.

The intended use of the device is the same as the intended use of the predicate device.

	Predicate Device	Proposed Device	Discussion ofDifferences
Device name	Primary Care SolutionsPrefilled 10cc and Prefilled30cc Inflation Syringeswith Sterile Water;	Prefilled Syringe
K number	K030813	K202698
Size	10cc and 30cc	10cc and 30cc	Same
Principle of operation	Manual	Manual	Same
Design	Conforms with ISO 7886.1and ISO 80369-7	Conforms with ISO 7886.1and ISO 80369-7	Same
Disposable?	Disposable for single use	Disposable for single use	Same
MaterialsOf	Barrel	Polypropylene	Polypropylene	Same

COMPARISON OF TECHNOLOGICAL CHARACTERISTICS WITH THE PREDICATE DEVICE 6.

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MainComponents	Plunger	Polypropylene	Polypropylene
	Stopper	Pharmaceutical GradeLatex Free Rubber	Pharmaceutical Grade LatexFree Rubber
	Protective Cap	Pharmaceutical GradeLatex Free Rubber	Pharmaceutical Grade LatexFree Rubber
	Solution	Purified Water, USP	Purified Water, USP
Sterile?		Sterile (gamma irradiation)	Sterile (gamma irradiation)	Same

As evidenced by the table above, the subject and predicate device have similar technological characteristics.

7. PERFORMANCE DATA

The following performance data were provided in support of the substantial equivalence determination.

Biocompatibility testing

The biocompatibility evaluation for the Prefilled Syringe was conducted in accordance with the International Standard ISO 10993-1:2018, "Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process" as recognized by FDA. The biocompatible testing included the following tests:

Cytotoxicity - (ISO 10993-5: 2009)
Sensitization - (ISO 10993-10:2010)
Irritation - (ISO 10993-10:2010)

Performance testing

Performance testing was conducted on the Prefilled Syringe according to the following standards:

1. ISO 7886-1: 2017 Sterile hypodermic syringes for single use Part 1: Syringes for manual use
1. ISO 11040-8: 2016 Prefilled Syringes Requirements and test methods for finished prefilled syringes
1. ISO 11040-4: 2015 Prefilled Syringes Glass barrels for injectables and sterilized subassembled syringes ready for filling

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1. ISO 11040-6: 2019 Prefilled Syringes Plastic barrels for injectables and sterilized subassembled syringes ready for filling
1. ISO 80369-1: 2018 Small-bore connectors for liquids and gases in healthcare applications - Part 1: General requirements
1. ISO 80369-7: 2016 Small-bore connectors for liquids and gases in healthcare applications - Part 7: Connectors for intravascular or hypodermic applications
1. ISO 80369-20: 2015 Small-bore connectors for liquids and gases in healthcare applications - Part 20: Common test methods
1. USP 40 Purified Water <6719>

All of the tested parameters met the predefined acceptance criteria.

CONCLUSION 8.

From the results of non-clinical data including the performance testing described, it is concluded that the Prefilled Syringe is as safe and as effective as the predicate device. The information provided within this pre-market notification demonstrates that the device is substantially equivalent to the predicate device.

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.