Promisemed Covered Safety Pen Needle

K202681 · Promisemed Hangzhou Meditech Co., Ltd. · FMI · Dec 31, 2020 · General Hospital

Device Facts

• Record ID: K202681
• Device Name: Promisemed Covered Safety Pen Needle
• Applicant: Promisemed Hangzhou Meditech Co., Ltd.
• Product Code: FMI · General Hospital
• Decision Date: Dec 31, 2020
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 880.5570
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

Promisemed Covered Safety Pen Needle is intended for subcutaneous injection of insulin in the treatment of diabetes.

Device Story

The Promisemed Covered Safety Pen Needle is a single-use, sterile, hypodermic needle designed for use with pen injectors for subcutaneous insulin delivery. It features a trigger shield mechanism that covers the needle before use, retracts during skin insertion, and automatically extends and locks after withdrawal to prevent accidental needlesticks. The device is operated manually by the patient or clinician. It consists of a needle tube, trigger shield, spring, fixer, needle hub, and container. The device is supplied in various gauges (29G, 30G, 31G) and lengths (4mm, 5mm, 6mm, 8mm). It is sterilized via ethylene oxide (EO) to a sterility assurance level of 10^-6.

Clinical Evidence

No clinical data. Substantial equivalence is supported by bench testing, including biocompatibility (ISO 10993 series), sterility validation (ISO 11135), and mechanical performance testing (ISO 7864, ISO 9626, ISO 11608-2, ISO 23908).

Technological Characteristics

Materials: Needle tube (X5CrNi18-10), Hub/Fixer (Polyformaldehyde/POM), Spring (0Cr18Mn8Ni5N), Container (Polypropylene/PP), Trigger shield (ABS). Sterilization: EO (ISO 11135). Standards: ISO 7864 (pierce force), ISO 9626 (needle material), ISO 11608-2 (dimensions/flow), ISO 23908 (safety mechanism).

Indications for Use

Indicated for subcutaneous insulin injection in patients with diabetes.

Regulatory Classification

Identification

A hypodermic single lumen needle is a device intended to inject fluids into, or withdraw fluids from, parts of the body below the surface of the skin. The device consists of a metal tube that is sharpened at one end and at the other end joined to a female connector (hub) designed to mate with a male connector (nozzle) of a piston syringe or an intravascular administration set.

Predicate Devices

• Verifine® Safety Type Insulin Pen Needle (K161950)

Submission Summary (Full Text)

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December 31, 2020

Promisemed Hangzhou Meditech Co., Ltd. % Wei-Shan Hsu Regulatory manager Vee Care (Asia) Limited 17th Chung Pont Commercial Building, 300 Hennessy Road Hong Kong, Hong Kong 0000 China

Re: K202681

Trade/Device Name: Promisemed Covered Safety Pen Needle Regulation Number: 21 CFR 880.5570 Regulation Name: Hypodermic Single Lumen Needle Regulatory Class: Class II Product Code: FMI Dated: December 7, 2020 Received: December 7, 2020

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,

Rumi Young Acting 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) K202681

# Device Name

Promisemed Covered Safety Pen Needle

# Indications for Use (Describe)

Promisemed Covered Safety Pen Needle is intended for subcutaneous injection of insulin in the treatment of diabetes.

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

Prescription Use (Part 21 CFR 801 Subpart D)

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

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# K202681 - 510(k) Summary

## Date Prepared 1

Dec 30th, 2020

### 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 Covered Safety Pen Needle Common Name: Needle, Hypodermic, Single Lumen Classification name: Needle, Hypodermic, Single Lumen Regulation Number: 21 CFR 880.5570 Device Class: Class II Product Code: FMI Review Panel: General Hospital

### Predicate Device 4

K161950: Verifine® Safety Type Insulin Pen Needle Classification name: Needle, Hypodermic, Single Lumen Regulation Number: 21 CFR 880.5570

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Device Class: Class II Product Code: FMI

#### Description of the Device 5

Promisemed Covered Safety Pen Needle is manufactured by Promisemed Hangzhou Meditech Co., Ltd, which is designed for use with a pen injector for the subcutaneous injection of insulin. The user proceeds with inserting the needle into the skin manually.

The Promisemed Covered Safety Pen Needle consists of needle tube, trigger shield, spring, fixer, needle hub, needle container, UV glue and silicone oil. UV glue is used to glue needle tube and needle hub and the silicone oil is used to needle tube lubrication.

Promisemed Covered Safety Pen Needle is the modification of Verifine Safety Type Insulin Pen Needle cleared in K161950. The baseline location of trigger shield is adjusted to allow the needle tube be covered by trigger shield thoroughly before use. This modification prevents accidental needle sticks before inserting the needle into the skin while the needle container is removed. As the user proceeds with inserting the needle into the skin the shield will retract. After the injection is completed and needle is removed from the skin, the shield will automatically extend to cover the needle aqain and lock in place. Once the Covered Safety Insulin Pen Needle is in the locked mode, it can no longer be used.

Promisemed Covered Safety Pen Needle is sterility Assurance Level (SAL) of 10-6, non-pyrogenic and single-use devices. It is supplied with several models. Different models are distinquished by needle gauge and length.

| Model | Needle Outer Diameter | Needle length | Color |
|----------|-----------------------|---------------|--------|
| CPN-29-4 | 0.33 mm (29G) | 4 mm | Green |
| CPN-29-5 | | 5 mm | Violet |
| CPN-29-6 | | 6 mm | Orange |

The dimension for Promisemed Covered Safety Pen Needle is shown as below.

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| CPN-29-8 | 0.30 mm (30G) | 8 mm | Blue |
|----------|---------------|------|--------|
| CPN-30-4 | | 4 mm | Green |
| CPN-30-5 | | 5 mm | Violet |
| CPN-30-6 | | 6 mm | Orange |
| CPN-30-8 | | 8 mm | Blue |
| CPN-31-4 | 0.25mm (31G) | 4 mm | Green |
| CPN-31-5 | | 5 mm | Violet |
| CPN-31-6 | | 6 mm | Orange |
| CPN-31-8 | | 8 mm | Blue |

#### 6 Intended Use

Promisemed Covered Safety Pen Needle is intended for subcutaneous injection of insulin in the treatment of diabetes.

#### Substantial Equivalence Discussion 7

The Promisemed Covered Safety Pen Needle is substantially equivalent to the predicate device, the Verifine Safety Type Insulin Pen Needle (K161950) in that these devices have similar designs, methods of construction and operation, and indications for use. The differences from the predicate include change of assembled position of trigger shield, and change of sterilization method.

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

| | Subject Device | Predicate Device<br>(K161950) | |
|--------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Trade Name | Promisemed Covered<br>Safety Pen Needle | Verifine Safety Type<br>Insulin Pen Needle | Comments |
| Manufacturer | Promisemed Hangzhou<br>Meditech Co., Ltd | Promisemed Hangzhou<br>Meditech Co., Ltd | |
| Device Class | Class II | Class II | Same |
| Product Code | FMI | FMI | Same |
| Regulation number | 880.5570 | 880.5570 | Same |
| Regulation Name | Needle, Hypodermic,<br>Single Lumen | Needle, Hypodermic,<br>Single Lumen | Same |
| Intended Use/<br>Indications for Use | Promisemed Covered<br>Safety Pen Needle is<br>intended for<br>subcutaneous injection<br>of insulin in the<br>treatment of diabetes. | The Safety Type Insulin<br>Pen Needle is intended<br>for use with pen<br>injector device for<br>subcutaneous injection<br>of insulin. | Same |
| Operating Principle | The needle tube is<br>covered by trigger<br>shield and is not<br>exposed before usage.<br>As the user proceeds<br>with inserting the<br>needle into the skin the<br>shield will retract.<br>After the injection is<br>completed and needle<br>is removed from the<br>skin, the shield will<br>automatically extend to<br>cover the needle again<br>and lock in place. Once<br>the Promisemed<br>Covered Safety Pen<br>Needle is in the locked<br>mode, it can no longer<br>be used. | Additionally, after<br>withdrawal of the<br>Safety Type Insulin Pen<br>Needle from the body,<br>the attached needle<br>safety shield<br>automatically covers<br>the needle to minimize<br>the risk of accidental<br>needlestick.<br>As the user proceeds<br>with inserting the<br>needle into the skin the<br>shield will retract.<br>After the injection is<br>completed and needle<br>is removed from the<br>skin, the shield will<br>automatically extend to<br>cover the needle and<br>lock in place. Once the<br>Safety Type Insulin Pen<br>Needle is in the locked<br>mode, it can no longer<br>be used. | Same |
| Gauge | G29, G30, G31 | G29, G30, G31 | Same |
| Needle Length | 4mm,5mm,6mm,8mm | 4mm,5mm,6mm,8mm | Same |
| Sharps Injury<br>Prevention Features | Trigger shield | Trigger shield | Same |
| | Image: Needle with purple trigger shield | Image: Needle with blue trigger shield | Different<br>The needle tube<br>is not exposed in<br>subject device.<br>While in the<br>predicate it is<br>exposed before<br>usage. The<br>modification is<br>verified per ISO<br>7864:2016, ISO<br>23908:2011 and<br>ISO 11608-2:2012. |
| Configuration and<br>Material | Needle Tube: X5CrNi18-<br>10<br>Needle Hub:<br>Polyformaldehyde<br>(POM)<br>Fixer:<br>Polyformaldehyde<br>(POM) | Needle Tube: X5CrNi18-<br>10<br>Needle Hub:<br>Polyformaldehyde<br>(POM)<br>Fixer:<br>Polyformaldehyde<br>(POM) | Same |
| | Spring: 0Cr18Mn8Ni5N | Spring: 0Cr18Mn8Ni5N | Same |
| | Needle container:<br>Polypropylene (PP) | Needle container:<br>Polypropylene (PP) | Same |
| | Trigger shield:<br>Acrylonitrile Butadiene<br>Styrene (ABS) | Trigger shield:<br>Acrylonitrile Butadiene<br>Styrene (ABS) | Material is the<br>same. |
| | *Location slot is lower | *Location slot is higher | The location slot<br>in subject device<br>is moved<br>downward. This<br>change makes the<br>baseline position<br>of trigger shield<br>move upward in<br>finished subject<br>device which<br>allowing the<br>needle tube be<br>covered<br>completely<br>before use. The<br>modification is<br>verified per ISO<br>7864:2016, ISO<br>23908:2011and<br>ISO 11608-2:2012. |
| Performance | Complied with ISO 7864,<br>ISO 9626, ISO 11608-2<br>and ISO 23908 | Complied with ISO 7864,<br>ISO 9626, ISO 11608-2<br>and ISO 23908 | Same |
| | EO Sterilization | Gamma Sterilization | Different<br>Both are<br>sterilized to SAL<br>10-6 level. The<br>sterilization of<br>subject devie is<br>validated per<br>ISO11135:2014. |
| Sterilization | SAL:10-6 | SAL: 10-6 | Same |
| Shelf Life | 5 years | 5 years | Same |
| Single use | Yes | Yes | Same |
| Biocompatibility | Complied with<br>ISO10993 series<br>standards, and the<br>following tests are<br>performed<br>- Cytotoxicity: No<br>cytotoxicity<br>- Skin Irritation: No<br>evidence of skin<br>irritation<br>- Skin Sensitization: No<br>evidence of<br>sensitization | Complied with<br>ISO10993 series<br>standards, and the<br>following tests are<br>performed<br>- Cytotoxicity: No<br>cytotoxicity<br>- Skin Irritation: No<br>evidence of skin<br>irritation<br>- Skin Sensitization: No<br>evidence of<br>sensitization | Same |

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| -Acute Systemic | -Acute Systemic |
|------------------------|------------------------|
| Toxicity: No systemic | Toxicity: No systemic |
| toxicity | toxicity |
| -Hemolysis: No | -Hemolysis: No |
| evidence of hemolysis | evidence of hemolysis |
| -Pyrogen: No pyrogenic | -Pyrogen: No pyrogenic |

# Discussion:

The differences from the predicate is the change of assembled position of trigger shield, and Sterilization method, the Safety and performance of which were verified and validated through ISO 7864, ISO23908, and ISO 11608-2 testing (See Section 8). The sterilization was validated in accordance with ISO 11135:2014.

The differences between the predicate and the subject device do not raise any new or different questions of safety or effectiveness.

#### 8 Non-Clinical Testing

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

- ISO 9626:2016 Needle material
- ISO11608-2:2012 Needle Dimensions, Flow rate, Bond between hub and needle tube, Needle points, Freedown from defects, Lubrication, Dislocation of measuring point patient end, Functional compatibility with needle-based injected systems, Easy of assemble and disassembly
- ISO 7864:2016 Pierce Force
- ISO 23908:2011 Accidental access to a sharp once in safe mode, Safety mechanism activation,Safety overriding and unlocking force after activation
- Biocompatibility

The subject device was evaluated for the following endpoints per ISO 10993-1:2018, ISO 10993-5: 2009, ISO 10993-10: 2013, ISO 10993-11:2006, ISO 10993-11:2017 and ASTM F756-13 - Cytotoxicity, Sensitization,

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Irritation, Acute Systemic Toxicity, Material Mediated Pyrogenicity, Subacute/Subchronic Toxicity, and Hemocompatibility.

- Sterilization
The subject device complies with ISO 11135:2014, ISO 11737-1:2018, ISO 11737-2:2009 and ISO 10993-7:2008 for EO sterilization.

- Clinical Testing: 9 Not Applicable
- 10 Conclusion

The modifications to the design and sterilization of the subject device met the requirements of the standards. The proposed Promisemed Covered Safety Pen Needle is substantially equivalent to the Safety Type Insulin Pen Needle cleared under K161950 with respect to the indications for use, target populations, treatment method, use enviroment, and technological characteristics.