Verifine Safety Syringe with Fixed Needle

K213560 · Promisemed Hangzhou Meditech Co., Ltd. · FMF · Apr 5, 2022 · General Hospital

Device Facts

• Record ID: K213560
• Device Name: Verifine Safety Syringe with Fixed Needle
• Applicant: Promisemed Hangzhou Meditech Co., Ltd.
• Product Code: FMF · General Hospital
• Decision Date: Apr 5, 2022
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 880.5860
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

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

Device Story

Verifine Safety Syringe with Fixed Needle is a sterile, single-use piston syringe for manual fluid injection or withdrawal. Device comprises a calibrated barrel, plunger, and fixed stainless steel needle. Features an integrated safety shield mechanism; after injection, user pushes shield axially until audible click, permanently locking shield over needle to prevent sharps injury and render device unusable. Used by healthcare personnel in clinical settings. Benefits include reduced risk of accidental needle sticks during disposal. Device is manually operated; no electronic or automated components.

Clinical Evidence

Bench testing only. Performance verified against ISO 7886-1 (syringes), ISO 9626 (needle tubing), ISO 7864 (needles), and ISO 23908 (sharps protection). Biocompatibility testing conducted per ISO 10993-1 (cytotoxicity, irritation, sensitization, systemic toxicity, hemolysis, pyrogenicity). Sterility and shelf-life validated per ISO 11135 and ASTM F1980. Package integrity confirmed via ASTM D4169, ASTM F88, and ASTM F1929.

Technological Characteristics

Materials: Stainless steel (X5CrNi18-10) needle; Polypropylene barrel, push-button, sliding sleeve, cover; Polyethylene needle cap; Polyisoprene rubber piston; ABS plunger stopper/tight ring. Manual operation. EO sterilization (SAL 10^-6). 5-year shelf life. Complies with ISO 7886-1, ISO 9626, ISO 7864, ISO 23908.

Indications for Use

Indicated for injection of fluids into or withdrawal of fluids from the body for medical purposes in patients requiring such procedures.

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

• Sterile Hypodermic Syringes (K211242)

Submission Summary (Full Text)

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April 5, 2022

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: K213560

Trade/Device Name: Verifine Safety Syringe with Fixed Needle Regulation Number: 21 CFR 880.5860 Regulation Name: Piston Syringe Regulatory Class: Class II Product Code: FMF, MEG Dated: March 17, 2022 Received: March 17, 2022

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 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

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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 mediation-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,

CAPT Alan M. 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) K213560

Device Name Verifine Safety Syringe with Fixed Needle

Indications for Use (Describe)

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

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

| <span style="font-family:Wingdings;"> </span> Prescription Use (Part 21 CFR 801 Subpart D) |
|--------------------------------------------------------------------------------------------|
| Over-The-Counter Use (21 CFR 801 Subpart C) |

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

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# 510(k) Summary

#### 1 Date Prepared

April 3rd, 2022

#### 2 Submitter's Information

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]

#### 3 Trade Name, Common Name, Classification

Trade/Product Name: Verifine Safety Syringe with Fixed Needle Common Name: Piston Syringe Classification name: Piston Syringe Regulation Number: 21 CFR 880.5860 Device Class: Class II Product Code: FMF, MEG

- 4 ldentification of Predicate Device K211242; Sterile Hypodermic Syringes

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#### 5 Description of the Device

Verifine Safety Syringe with Fixed Needle is a sterile device consisting of a calibrated barrel with plunger and a fixed needle at the distal end.

It is made of plastic and silicone materials.

It includes an attached needle with a safety mechanism. The protective shield covers the needle. After injection, the shield is permanently locked in place by pushing axially until a click is heard, reducing risk of needle sticks and rendering the device unusable.

It can be used by health care personnel.

This is a single-use device.

| Capacity | Gauge | Needle Length | Packaging Configuration |
|----------|-------|------------------------------|---------------------------------------------------------------------------------------|
| 0.5 ml | 28G | 12mm, 16mm, 25mm, 32mm, 38mm | Polypropylene/<br>Polyethylene<br>composite<br>membrane (XPP-B)<br>and Dialyzer paper |
| | 27G | 12mm, 16mm, 25mm, 32mm, 38mm | |
| | 26G | 12mm, 16mm, 25mm, 32mm, 38mm | |
| | 25G | 12mm, 16mm, 25mm, 32mm, 38mm | |
| | 24G | 12mm, 16mm, 25mm, 32mm, 38mm | |
| | 23G | 12mm, 16mm, 25mm, 32mm, 38mm | |
| | 22G | 12mm, 16mm, 25mm, 32mm, 38mm | |
| | 21G | 12mm, 16mm, 25mm, 32mm, 38mm | |
| 1.0 ml | 28G | 12mm, 16mm, 25mm, 32mm, 38mm | Polypropylene/<br>Polyethylene<br>composite<br>membrane (XPP-B)<br>and Dialyzer paper |
| | 27G | 12mm, 16mm, 25mm, 32mm, 38mm | |
| | 26G | 12mm, 16mm, 25mm, 32mm, 38mm | |
| | 25G | 12mm, 16mm, 25mm, 32mm, 38mm | |
| | 24G | 12mm, 16mm, 25mm, 32mm, 38mm | |
| | 23G | 12mm, 16mm, 25mm, 32mm, 38mm | |
| | 22G | 12mm, 16mm, 25mm, 32mm, 38mm | |
| | 21G | 12mm, 16mm, 25mm, 32mm, 38mm | |

#### 6 Indication

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

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- 7 Similarities and Differences of the Proposed Devices to the Predicate Devices
The Verifine Safety Syringe with fixed Needle is substantially equivalent to the predicate device, the Sterile Hypodermic Syringes (K211242) 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 intended use or raise new questions of safety and effectiveness.

| | Subject Device | Predicate Device (K211242) | |
|-----------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Trade Name | Verifine Safety Syringe with Fixed Needle | Sterile Hypodermic Syringes | |
| Manufacturer | Promisemed Hangzhou Meditech Co., Ltd | Promisemed Hangzhou Meditech Co., Ltd | |
| Device Class | Class II | Class II | Same |
| Product Code | FMF, MEG | FMF | Similar |
| Regulation number | 880.5860 | 880.5860 | Same |
| Regulation Name | Piston syringe | Piston syringe | Same |
| Intended Use/ Indications for Use | It is intended to inject fluids into or withdraw fluids from the body for medical purposes. | It is intended to be used for medical purposes to inject fluids into or withdraw fluids from the body. | Same |
| Operating Principle | Plunger is used to fill syringe as well as discharge the fluid. The protective shield will permanently be locked in place by pulling forward till click, providing protection against needle sticks. | Plunger is used to fill syringe as well as discharge the fluid. | Different<br>The subject device has additional safety shield to prevent sharp injury. |
| Volume | 0.5ml,1.0ml | 0.5ml,1.0ml | Same |
| Tip type | Fixed Needle | Fixed Needle | Same |
| Gauge | 28G, 27G, 26G, 25G, 24G, 23G, 22G, 21G | 28G, 27G, 26G, 25G, 24G, 23G, 22G, 21G | Same |
| Needle Length | 12mm, 16mm, 25 mm, 32mm, 38mm | 10mm, 12mm, 16mm, 20mm, 25mm, 32mm, 38mm, 50mm | Different<br>The needle length range of subject device is within that of predicate device. |
| Gradations | Legible | Legible | Same |
| legibility | | | |
| Lubricant | Silicone oil | Silicone oil | 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 | 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 | Same |
| Configuration<br>and<br>Materials | Needle: Stainless Steel<br>(X5CrNi18-10)<br>Barrel/push-button:<br>Polypropylene<br>Plunger: Polypropylene<br>Needle cap: Polyethylene<br>Piston: Polyisoprene<br>rubber<br>Sliding Sleeve, Cover:<br>Polypropylene<br>Plunger stopper, Tight<br>ring: Acrylonitrile<br>Butadiene Styrene | Needle: Stainless Steel<br>(X5CrNi18-10)<br>Barrel/push-button:<br>Polypropylene<br>Plunger: Polypropylene/<br>Acrylonitrile Butadiene<br>Styrene<br>Needle cap:<br>Polyethylene/<br>Polypropylene<br>Piston: Polyisoprene<br>rubber | The needle of both devices<br>is made of stainless steel.<br>The syringe bodies of<br>subject device and predicate<br>device have material<br>differences. Differences are<br>addressed through<br>biocompatility testing per<br>ISO 10993. |
| Performance | Complied with ISO 7886-1,<br>ISO 9626, ISO 7864, ISO<br>23908 | Complied with ISO 7886-<br>1, ISO 9626, ISO 7864 | Different<br>The subject device has<br>additional safety shield to<br>prevent sharp injury. The<br>difference is addressed<br>through testing per<br>ISO23908. |
| Sterilization<br>method and SAL | EO Sterilization<br>$SAL = 10^{-6}$ | EO Sterilization<br>$SAL = 10^{-6}$ | Same |

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

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# Discussions of differences in technological characteristics

-The needle length of subject device is within the range of predicate device. The difference needle length does not affect the effectiveness and safety of the device.

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- The syringe bodies of subject device and predicate device have material differences. This difference does not affect the effectiveness and safety of the device. The biocompatibility tests conducted demonstrate the safety of subject device.

- The operating procedure is the same as predicate device. The subject device has additional safety shield to protect against sharps injury. The sharps protection feature is addressed through testing per ISO23908. This difference does not impact the safety and effectiveness 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
- •ISO 23908:2011, Sharps injury protection Requirements and test methods Sharps protection features for single-use hypodermic needles, introducers for catheters and needles used for blood sampling
- •USP<85> Bacterial Endotoxin Test

Biocompatibility

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

- ISO 10993-5:2009 Biological Evaluation of Medical Devices -- Part 5:Tests for in Vitro Cytotoxicity
- ISO 10993-10:2010 Biological Evaluation of Medical Devices -- Part 10: Tests for Irritation and Skin Sensitization

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- ISO 10993-11:2006, Biological evaluation of medical devices Part 11: Tests for systemic toxicity-Acute systemic toxicity
- ISO 10993-4:2017, Biological evaluation of medical devices Part 4: Selection of tests for interactions with blood
- ISO 10993-7:2008, Biological evaluation of medical devices Part 7: Ethylene oxide sterilization residuals
- USP42-NF37<151> Pyrogen Test
- · USP<788> Particulate matter in injections

## Sterility, Shipping, and Shelf-Life

- ISO 11135:2014, Sterilization of health-care products Ethylene oxide Requirements for the development, validation and routine control of a sterilization process for medical devices
- Package integrity testing, after environmental conditioning and simulated transportation in accordance with ASTM D4169-16, 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 proposed device:
- Seal strength ASTM F88/F88-15
- Dye penetration ASTM F1929-15
- Sterility test USP38-NF33 C71
- 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

#### の Conclusion

Based on the information provided within this 510(k) submission, the differences between the predicate and the subject device do not raise any new or different questions of safety or effectiveness. The proposed subject device is substantially equivalent to the predicate device and is as safe and as effective as the legally marketed predicate device.