Promisemed Sterile Hypodermic Syringes, Verifine Sterile Hypodermic Syringes

K211242 · Promisemed Hangzhou Meditech Co., Ltd. · FMF · Sep 9, 2021 · General Hospital

Device Facts

• Record ID: K211242
• Device Name: Promisemed Sterile Hypodermic Syringes, Verifine Sterile Hypodermic Syringes
• Applicant: Promisemed Hangzhou Meditech Co., Ltd.
• Product Code: FMF · General Hospital
• Decision Date: Sep 9, 2021
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 880.5860
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

It is intended to be used for medical purposes to inject fluids into or withdraw fluids from the body.

Device Story

Sterile, single-use, manually operated hypodermic syringe; consists of calibrated barrel, plunger, and fixed stainless steel needle. Needle lubricated with silicone. Used by healthcare personnel (doctors, nurses) in clinical settings for fluid injection or withdrawal. Device functions via manual plunger operation to fill or discharge fluids. Benefits include sterile, single-use delivery of medication or fluid management. No automated processing or software components.

Clinical Evidence

Bench testing only. Performance verified per ISO 7886-1:2017, ISO 9626:2016, and ISO 7864:2016. Biocompatibility validated per ISO 10993 series (cytotoxicity, irritation, sensitization, systemic toxicity, hemolysis, pyrogenicity). Sterility validated per ISO 11135:2014 (SAL 10^-6). Packaging integrity validated per ASTM D4169, ASTM F88/F88-15, and ASTM F1929-15. Shelf life validated per ASTM F1980-16.

Technological Characteristics

Materials: Stainless steel (X5CrNi18-10) needle, polypropylene barrel/plunger, polyethylene/polypropylene needle cap, polyisoprene rubber piston. Manual operation. EO sterilization (ISO 11135:2014). Complies with ISO 7886-1, ISO 9626, ISO 7864. Single-use. No software or electronic components.

Indications for Use

Indicated for use by healthcare personnel for the injection of fluids into or withdrawal of fluids from the body. No specific patient population, age, or disease state restrictions are noted.

Regulatory Classification

Identification

A piston syringe is a device intended for medical purposes that consists of a calibrated hollow barrel and a movable plunger. At one end of the barrel there is a male connector (nozzle) for fitting the female connector (hub) of a hypodermic single lumen needle. The device is used to inject fluids into, or withdraw fluids from, the body.

Predicate Devices

• Sol-M TB Syringe (K153537)

Submission Summary (Full Text)

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Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.

September 9, 2021

Promisemed Hangzhou Meditech Co., Ltd. % Wei Hsu Regulatory Manager Vee Care (Asia) Limited 17th Chung Pont Commercial Building, 300 Hennessy Road Hong Kong, Hong Kong China

Re: K211242

Trade/Device Name: Promisemed Sterile Hypodermic Syringes, Verifine Sterile Hypodermic Syringes Regulation Number: 21 CFR 880.5860 Regulation Name: Piston Syringe Regulatory Class: Class II Product Code: FMF Dated: August 9, 2021 Received: August 9, 2021

Dear Wei Hsu:

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

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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 ([e-mail]) or phone [phone] or 301-796-7100).

Sincerely,

For CAPT Alan Stevens Assistant Director DHT3C: Division of Drug Delivery and General Hospital Devices, and Human Factors 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) K211242

#### Device Name

Promisemed Sterile Hypodermic Syringes Verifine Sterile Hypodermic Syringes

Indications for Use (Describe)

It is intended to be used for medical purposes to inject fluids into or withdraw fluids from the body.

Type of Use (Select one or both, as applicable)

X Prescription Use (Part 21 CFR 801 Subpart D)

| Over-The-Counter Use (21 CFR 801 Subpart C)

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# K211242 510(k) Summary

#### 1 Date Prepared

Sep 9th, 2021

#### Submitter's Information 2

### Name of Sponsor:

Promisemed Hangzhou Meditech Co., Ltd.

### Address:

No. 1388 Cangxing Street, Cangqian Community, Yuhang District, Hangzhou

City, 311121 Zhejiang, China

### Contact Name:

Zearou Yang

### Telephone No.:

[phone]

Fax No.:

[phone]

# Email Address:

[e-mail]

#### Trade Name, Common Name, Classification ന

Trade/Product Name: Promisemed Sterile Hypodermic Syringes

Verifine Sterile Hypodermic Syringes

Common Name: Sterile Hypodermic Syringes

Classification name: Syringe, Piston

Regulation Number: 21 CFR 880.5860

Device Class: Class II

Product Code: FMF

- ldentification of Predicate Device ব K153537: Sol-M TB Syringe

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#### Description of the Device ഗ

A sterile device consisting of a calibrated barrel with plunger and a fixed needle at the distal end intended to be used for injection/withdrawal of fluids/gas (e.g., medication) to/from a medical device or the body (i.e., capable of both). It is made of stainless steel needle, plastic and silicone materials, and is manually operated. It is intended for various medical applications and is not dedicated to medication administration.

It is intended be used by health-care personnel (doctors, nurses, etc.). The needle is lubricated with silicone. Product is sterile and sterilization process is validated according to ISO 11135:2014.

| Capacity | Gauge | Length |
|----------|-------|------------------------------------------------|
| 0.5ml | 28G | |
| | 27G | |
| | 26G | |
| | 24G | 10mm, 12mm, 16mm, 20mm, 25mm, 32mm, 38mm, 50mm |
| | 23G | |
| | 22G | |
| | 21G | |
| 1.0 ml | 28G | |
| | 27G | |
| | 26G | |
| | 24G | 10mm, 12mm, 16mm, 20mm, 25mm, 32mm, 38mm, 50mm |
| | 23G | |
| | 22G | |
| | 21G | |

This is a single-use device without any accessory.

#### Indications for use statement 6

lt is intended to be used for medical purposes to inject fluids into or withdraw fluids from the body.

- 7 Similarities and Differences of the Proposed Devices to the Predicate Devices

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The Sterile Hypodermic Syringes is substantially equivalent to the predicate device, the Sol-M TB Syringe (K153537) in that these devices have same intended use and technological characteristics. The basic technological and operating principles are the same for both devices. Both the subject and predicate devices are disposable, sterile, single patient use devices. The differences between the subject device and predicate device do not affect the basic design principle and usage.

| | Subject Device | Predicate Device<br>(K153537) | |
|--------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Trade Name | Promisemed Sterile<br>Hypodermic Syringes<br>Verifine Sterile<br>Hypodermic Syringes | Sol-M TB Syringe | Comments |
| Manufacturer | Promisemed Hangzhou<br>Meditech Co., Ltd | Sol-Millennium Medical,<br>Inc. | |
| Device Class | Class II | Class II | Same |
| Product Code | FMF | FMF | Same |
| Regulation number | 880.5860 | 880.5860 | Same |
| Regulation Name | Piston syringe | Piston syringe | Same |
| Intended Use/<br>Indications for Use | It is intended to be used<br>for medical purposes to<br>inject fluids into or<br>withdraw fluids from the<br>body. | It is intended to be used<br>for medical purposes to<br>inject fluids into or<br>withdraw fluids from the<br>body. | Same |
| Operating<br>Principle | Plunger is used to fill<br>syringe as well as<br>discharge the fluid. | Plunger is used to fill<br>syringe as well as<br>discharge the fluid. | Same |
| Volume | 0.5ml,1.0ml | 0.5ml,1.0ml | Same |
| Tip type | Fixed Needle | Fixed Needle | Same |
| Gauge | 28G, 27G, 26G, 25G,<br>24G, 23G, 22G, 21G | 23G, 26G, 27G | Different<br>Subject device<br>has wider gauge<br>size than<br>predicate device.<br>Differences are<br>addressed through<br>testing per ISO<br>9626:2016 and ISO<br>7864:2016. |
| Needle Length | 10mm, 12mm, 16mm,<br>20mm, 25mm, 32mm,<br>38mm, 50mm | 1/2" (12.5mm), 3/8"<br>(9.6 mm) | Different<br>Subject device<br>has wider needle<br>length than<br>predicate device.<br>Differences are<br>addressed through |
| | | | testing per ISO<br>9626:2016 and ISO<br>7864:2016. |
| Gradations<br>legibility | Bold markings | Bold markings | Same |
| Lubricant | Silicone | Silicone | Same |
| Barrel<br>transparency | Transparent | Transparent | Same |
| Reuse durability | Single Use | Single Use | Same |
| Biocompatibility | Complied with ISO10993<br>series standards, and the<br>following tests are<br>performed<br>- Cytotoxicity: No<br>cytotoxicity<br>- Skin Irritation: No<br>evidence of skin irritation<br>- Skin Sensitization: No<br>evidence of sensitization<br>- Acute Systemic Toxicity:<br>No systemic toxicity<br>- Hemolysis: No evidence<br>of hemolysis<br>- Pyrogen: Non pyrogenic<br>- USP <788> Particulate<br>matter | Per ISO 10993-1 | Same |
| Materials | Needle: Stainless Steel<br>(X5CrNi18-10)<br>Barrel: Polypropylene<br>Plunger: Polypropylene/<br>Acrylonitrile Butadiene<br>Styrene<br>Needle cap:<br>Polyethylene/<br>Polypropylene<br>Piston: Polyisoprene<br>rubber | Needle: Stainless Steel<br>Barrel: Polypropylene<br>Plunger: Polypropylene<br>Needle cap:<br>Polypropylene<br>Gasket: Santoprene | The needle of<br>both devices is<br>made of stainless<br>steel.<br>The syringe bodies<br>of subject device<br>and predicate<br>device have<br>material<br>differences.<br>Differences are<br>addressed through<br>biocompatibility<br>testing per ISO<br>10993. |
| Performance | Complied with<br>ISO 7886-1, ISO 9626, ISO<br>7864 | Complied with<br>ISO 7886-1, ISO 9626, ISO<br>7864 | Same |
| Sterilization<br>method | EO Sterilization | EO Sterilization | Same |

A detailed comparison to the predicate is provided in Table 1.

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### Discussions of differences in technological characteristics

· The subject device has wider gauge size and needle length than predicate device. Differences are addressed through testing per ISO 9626:2016 and ISO 7864:2016. The difference in gauge size and needle length does not affect the effectiveness and safety of the device.

· The syringe bodies of subject device and predicate device have material differences. The biocompatibility tests conducted demonstrate the safety of subject device. Difference do not affect the effectiveness and safety of the device.

#### 8 Performance Testing Summary

The bench testing performed verifies that the performance of the subject device is substantially equivalent in terms of critical performance characteristics to the predicate device. These tests include:

- · ISO 7886-1:2017, Sterile hypodermic syringes for single use. Part 1: Syringes for manual use
- · ISO 9626:2016, Stainless steel needle tubing for the manufacture of medical devices — Requirements and test methods
- · ISO 7864:2016, Sterile hypodermic needles for single use Requirements and test methods
- USP<85> Bacterial Endotoxin Test

# Sterility, Shipping and Shelf-Life

The sterilization of the product is achieved using ethylene oxide sterilization. Sterilization condition is validated per ISO 11135: 2014 overkill half-cycle approach. The sterility assurance level (SAL) is 10-6. The amount of ethylene oxide and chlorohydrin residual levels are within the limit and in compliance with ISO 10993-7: 2008 requirement.

The device is non-pyrogenic. Endotoxin is tested per USP<85> and is conducted on every batch. Endotoxin limit for the subject device is less than 20 EU/Device.

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- . Package integrity testing, after environmental conditioning and simulated transportation in accordance with ASTM D4169, was conducted on the final, packaged, and sterile devices. All packaging deemed acceptable for protection of product and sterility maintenance.
- Sterile Barrier Packaging Testing performed on the subject device: . Seal strength ASTM F88/F88-15 Dye penetration ASTM F1929-15
- . Shelf life of 5 years is validated using the FDA recognized standard ASTM F1980-16 Standard Guide for Accelerated Aging of Sterile Barrier Systems for Medical Devices
- · Biocompatibility

In accordance with ISO 10993-1 the device is classified as External communicating device, Blood path, indirect, with limited contact duration (≤ 24h). The biosafety tests that required consideration were validated:

- a. ISO 10993-5:2009 Biological Evaluation of Medical Devices -- Part 5: Tests for in Vitro Cytotoxicity
- b. ISO 10993-10:2010 Biological Evaluation of Medical Devices -- Part 10: Tests for Irritation and Skin Sensitization
- c. ISO 10993-11:2006, Biological evaluation of medical devices Part 11: Tests for systemic toxicity-Acute systemic toxicity and pyrogen test
- d. USP42-NF37<151> Pyrogen Test
- e. USP<788> Particulate matter in injections
- f. ISO 10993-4:2017, Biological evaluation of medical devices Part 4: Selection of tests for interactions with blood
- g. ISO 10993-7:2008, Biological evaluation of medical devices Part 7: Ethylene oxide sterilization residuals

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#### Conclusion 9

Based on the information provided within this 510(k) submission, the proposed subject device is substantially equivalent to the predicate device and is as safe and as effective as the legally marketed predicate device.