Prefilled Syringe

K202698 · Hangzhou Primecare Medical Co., Ltd. · EZL · Dec 15, 2020 · Gastroenterology, Urology

Device Facts

• Record ID: K202698
• Device Name: Prefilled Syringe
• Applicant: Hangzhou Primecare Medical Co., Ltd.
• Product Code: EZL · Gastroenterology, Urology
• Decision Date: Dec 15, 2020
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 876.5130
• Device Class: Class 2

Indications for Use

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

Device Story

Single-use 10cc and 30cc syringes pre-filled with USP purified water; gamma irradiated. Used in clinical settings to inflate urinary catheter balloons. Operator manually pushes plunger to inject water into catheter balloon. Indirect body contact < 24 hours. Benefits include sterile, ready-to-use delivery of inflation fluid, simplifying catheter maintenance.

Clinical Evidence

Bench testing only. Biocompatibility testing (cytotoxicity, sensitization, irritation per ISO 10993) and performance testing (ISO 7886-1, ISO 11040-4/6/8, ISO 80369-1/7/20, USP 40) were conducted. All parameters met predefined acceptance criteria.

Technological Characteristics

Materials: Polypropylene (barrel/plunger), pharmaceutical grade latex-free rubber (stopper/cap). Contents: USP purified water. Manual operation. Sterile (gamma irradiation). Conforms to ISO 7886-1, ISO 11040-4/6/8, and ISO 80369-7.

Indications for Use

Indicated for foley catheter balloon inflation in patients requiring urinary catheterization.

Regulatory Classification

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).

Predicate Devices

• Primary Care Solutions Prefilled 10cc and Prefilled 30cc Inflation Syringes with Sterile Water (K030813)

Submission Summary (Full Text)

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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 ([e-mail]) or phone [phone] 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: [phone] Fax: [phone]

| Primary Contact | Olivia Meng |
|--------------------|----------------------------------------------------|
| Person: | Regulatory Affairs Manager |
| | Guangzhou Osmunda Medical Device Technical Service |
| | Co., Ltd. |
| | Tel: [phone] |
| | Fax: [phone] |
| Secondary Contact | Xueqing Yan |
| Person: | Quality Supervisor |
| | Hangzhou Primecare Medical Co., Ltd. |
| | Phone: [phone] |
| | Fax: [phone] |
| 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 |

3. 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.

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.

# 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 of<br>Differences | |
|------------------------|----------------------------------------------------------------------------------------------------------|---------------------------------------------|------------------------------|------|
| Device name | Primary Care Solutions<br>Prefilled 10cc and Prefilled<br>30cc Inflation Syringes<br>with 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 7886.1<br>and ISO 80369-7 | Conforms with ISO 7886.1<br>and ISO 80369-7 | Same | |
| Disposable? | Disposable for single use | Disposable for single use | Same | |
| Materials<br>Of | Barrel | Polypropylene | Polypropylene | Same |

#### COMPARISON OF TECHNOLOGICAL CHARACTERISTICS WITH THE PREDICATE DEVICE 6.

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| Main<br>Components | Plunger | Polypropylene | Polypropylene | |
|--------------------|----------------|-------------------------------------------|-------------------------------------------|------|
| | Stopper | Pharmaceutical Grade<br>Latex Free Rubber | Pharmaceutical Grade Latex<br>Free Rubber | |
| | Protective Cap | Pharmaceutical Grade<br>Latex Free Rubber | Pharmaceutical Grade Latex<br>Free 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
- 2. ISO 11040-8: 2016 Prefilled Syringes Requirements and test methods for finished prefilled syringes
- 3. ISO 11040-4: 2015 Prefilled Syringes Glass barrels for injectables and sterilized subassembled syringes ready for filling

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- 4. ISO 11040-6: 2019 Prefilled Syringes Plastic barrels for injectables and sterilized subassembled syringes ready for filling
- 5. ISO 80369-1: 2018 Small-bore connectors for liquids and gases in healthcare applications - Part 1: General requirements
- 6. ISO 80369-7: 2016 Small-bore connectors for liquids and gases in healthcare applications - Part 7: Connectors for intravascular or hypodermic applications
- 7. ISO 80369-20: 2015 Small-bore connectors for liquids and gases in healthcare applications - Part 20: Common test methods
- 8. 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.