Additionally, after withdrawal of the Verifine Safety Type Insulin Pen Needle from the body, the attached needle safety shield automatically covers the needle to minimize the risk of accidental needlestick.

Device Description

Verifine Safety Type Insulin 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 Verifine Safety Type Insulin 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.

The user proceeds with inserting the needle into the skin manually. Verifine Safety Type Insulin Pen Needle is designed to reduce occurrence of accidental needle sticks from patient end of the needle by providing a shield that covers and locks the needle after use. 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 and lock in place. Once the Safety Type Insulin Pen Needle is in the locked mode, it can no longer be used.

Verifine Safety Type Insulin Pen Needle is sterile with a Sterility Assurance Level (SAL) of 10-6, non-pyrogenic and single-use devices. It is supplied with several models. Different models are distinguished by needle gauge and length.

AI/ML Overview

This document is a 510(k) premarket notification for the Verifine Safety Type Insulin Pen Needle. It focuses on demonstrating substantial equivalence to a predicate device rather than presenting new clinical study data with acceptance criteria for device performance.

Therefore, the requested information regarding acceptance criteria and the study that proves the device meets the acceptance criteria, especially points 2-9, cannot be fully provided from the given document as it does not detail a study designed to establish such performance metrics with specific acceptance criteria in the manner requested for a novel device.

The document primarily focuses on bench testing against international standards and biocompatibility testing to demonstrate that the proposed device performs comparably to the predicate and is safe.

Here's an attempt to extract the relevant information where available, with explicit notes on what is not provided by the document:

1. Table of Acceptance Criteria and Reported Device Performance

The document defines acceptance criteria by compliance with recognized international standards for medical needles and sharps injury protection. It states that the device "Complied with" these standards, indicating their requirements serve as the acceptance criteria.

Acceptance Criteria (Standard Compliance)	Reported Device Performance
ISO 9626	Complied with (Stainless steel needle tubing requirements)
ISO 11608-2	Complied with (Needle-based injection systems requirements)
ISO 7864	Complied with (Sterile hypodermic needles requirements)
ISO 23908	Complied with (Sharps injury protection requirements)
ISO 10993-1, -5, -10, -11	Complied with (Biocompatibility: No cytotoxicity, no skin irritation, no sensitization, no acute systemic toxicity, no pyrogenic, no systemic toxicity from repeated exposure)
ASTM F756-13	Complied with (No evidence of hemolysis)
Sterility Assurance Level	10^-6
Shelf Life	5 years

2. Sample size used for the test set and the data provenance

Sample Size for Test Set: Not explicitly stated for each test. The document refers to "bench testing" and "biocompatibility testing" but does not detail the number of units tested.
Data Provenance: Not explicitly stated, but it would be from the manufacturer's internal testing facilities as implied by the "Performance Testing Summary" and "Biocompatibility" sections. It is not described as involving external clinical data or specific geographic regions. It is a retrospective summary of testing performed by the manufacturer.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

Not Applicable / Not Provided. This type of information is typically relevant for studies involving subjective expert review (e.g., image interpretation). For bench testing against engineering standards and biocompatibility, the "ground truth" is established by the specifications of the standards themselves and objective measurements, not by expert consensus in the typical sense of a human-in-the-loop study.

4. Adjudication method for the test set

Not Applicable / Not Provided. Adjudication methods (like 2+1, 3+1) are used for studies where multiple experts independently assess data and discrepancies need to be resolved. This document describes objective engineering and biological tests against established standards, not a subjective assessment requiring adjudication.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

Not Applicable. This device is an insulin pen needle, not an AI-assisted diagnostic tool. Therefore, MRMC studies and AI assistance metrics are not relevant to this submission.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

Not Applicable. Again, this is a physical medical device, not an algorithm. Standalone performance as described (algorithm only) is not relevant. The "standalone" performance here would refer to the device's ability to meet the specified performance standards on its own.

7. The type of ground truth used

Standard Specifications and Laboratory Measurements. The "ground truth" for the performance testing is defined by the requirements and test methods outlined in the cited ISO and ASTM standards (e.g., ISO 9626 for needle tubing, ISO 11608-2 for injection systems, ISO 23908 for sharps protection, ISO 10993 series for biocompatibility). The device performance is measured against these objective, verifiable specifications in a laboratory setting.

8. The sample size for the training set

Not Applicable / Not Provided. This refers to a "training set" in the context of machine learning or AI. This device is a physical product and does not involve AI development or training sets.

9. How the ground truth for the training set was established

Not Applicable / Not Provided. (See point 8).

Summary

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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.

April 22, 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: K210065

Trade/Device Name: Verifine Safety Type Insulin Pen Needle Regulation Number: 21 CFR 880.5570 Regulation Name: Hypodermic Single Lumen Needle Regulatory Class: Class II Product Code: FMI Dated: March 23, 2021 Received: March 23, 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 (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).

Sincerely,

For 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) K210065

Device Name Verifine Safety Type Insulin Pen Needle

Indications for Use (Describe)

Verifine Safety Type Insulin Pen Needle is intended for use with pen injector device for subcutaneous injection of insulin.

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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510(k) Summary

Date Prepared ー

April 22nd, 2021

Submitter's Information 2

Submission Sponsor:

Name: Promisemed Hangzhou Meditech Co., Ltd.

Address:No. 1388 Cangxing Street, Canggian Community, Yuhang District,

Hangzhou City, 311121 Zhejiang, China

Contact Name: Zearou Yang

Telephone No.: +86 571 88772985

Fax No.: +86 571 88772985

Email Address: zearou.yang@promisemed.ca

Submission Correspondent:

Name: Vee Care (Asia) Limited

Address: 17F Chung Pont Commercial Building, 300 Hennessy Road, Hong Kong,

China

Contact Name: Wei-Shan Hsu

E-mail: ws@vee.com.hk

Trade Name, Common Name, Classification 3

Trade/Product Name: Verifine Safety Type Insulin Pen Needle

Common Name: Insulin Pen Needle

Classification name: Needle, Hypodermic, Single Lumen

Regulation Number: 21 CFR 880.5570

Device Class: Class II

Product Code: FMI

4 Identification of Predicate Device(s)

K161950: Verifine Safety Type Insulin Pen Needle

5 Description of the Device

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Verifine Safety Type Insulin 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.

6 Indications for Use

Verifine Safety Type Insulin Pen Needle is intended for use with pen injector device for subcutaneous injection of insulin.

7 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 9626: Stainless steel needle tubing for the manufacture of medical devices - Requirements and test methods

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· ISO11608-2: Needle-based injection systems for medical use Requirements and test methods - Part 2: Needles · ISO 7864: Sterile hypodermic needles for single use - Requirements and test methods
· ISO 23908: Sharps injury protection Requirements and test methods Sharps protection features for single-use hypodermic needles, introducers for catheters and needles used for blood sampling
· Biocompatibility
- a. ISO 10993-1:2009 Biological Evaluation of Medical Devices -- Part 1: Evaluation and testing within a risk management process
- b. ISO 10993-5:2009 Biological Evaluation of Medical Devices -- Part 5: Tests for in Vitro Cytotoxicity
- c. ISO 10993-10:2010 Biological Evaluation of Medical Devices -- Part 10: Tests for Irritation and Skin Sensitization
- d. ISO 10993-11:2006, Biological evaluation of medical devices Part 11: Tests for systemic toxicity-Acute systemic toxicity and pyrogen test
- f. ASTM F756-13 Standard Practice for Assessment of Hemolytic Properties of Materials

Similarities and Differences of the Proposed Devices to the 8 Predicate Devices

The Verifine Safety Type Insulin Pen Needle is substantially equivalent to the predicate device, the Verifine Safety Type Insulin Pen Needle (K161950) in that these devices have identical designs, methods of construction and operation, and indications for use. The differences from the predicate is the sterilization method. The differences above between the subject device and predicate device do not affect the basic design principle, usage of the subject device.

	Subject Device	Predicate Device (K161950)
Trade Name	Verifine Safety TypeInsulin Pen Needle	Verifine Safety Type Insulin Pen Needle	Comments
Manufacturer	Promisemed HangzhouMeditech Co., Ltd	Promisemed HangzhouMeditech Co., Ltd
Device Class	Class II	Class II
			Same

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

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Product Code	FMI	FMI	Same
Regulation number	880.5570	880.5570	Same
Regulation Name	Needle,Hypodermic,Single Lumen	Needle,Hypodermic,SingleLumen	Same
IntendedUse/Indications for Use	The Safety Type InsulinPen Needle is intendedfor use with pen injectordevice for subcutaneousinjection of insulin.Additionally, afterwithdrawal of the SafetyType Insulin Pen Needlefrom the body, theattached needle safetyshield automaticallycovers the needle tominimize the risk ofaccidental needlestick.	The Safety Type Insulin PenNeedle is intended for use withpen injector device forsubcutaneous injection ofinsulin.Additionally, after withdrawalof the Safety Type Insulin PenNeedle from the body, theattached needle safety shieldautomatically covers theneedle to minimize the risk ofaccidental needlestick.	Same
Operating Principle	As the user proceeds withinserting the needle intothe skin the shield willretract. After theinjection is completedand needle is removedfrom the skin, the shieldwill automatically extendto cover the needle andlock in place. Once theSafety Type Insulin PenNeedle is in the lockedmode, it can no longer beused.	As the user proceeds withinserting the needle into theskin the shield will retract.After the injection iscompleted and needle isremoved from the skin, theshield will automaticallyextend to cover the needle andlock in place. Once the SafetyType Insulin Pen Needle is inthe locked mode, it can nolonger be used.	Same
Gauge	G29, G30, G31	G29, G30, G31	Same
Needle Length	4mm,5mm,6mm,8mm	4mm,5mm,6mm,8mm	Same
SharpsInjuryPreventionFeatures	Trigger shield	Trigger shield	Same
ConfigurationandMaterial	Needle Tube: X5CrNi18-10	Needle Tube: X5CrNi18-10	Same
	Needle Hub:Polyformaldehyde (POM)	Needle Hub: Polyformaldehyde(POM)	Same
	Fixer: Polyformaldehyde(POM)	Fixer: Polyformaldehyde (POM)	Same
	Spring: 0Cr18Mn8Ni5N	Spring: 0Cr18Mn8Ni5N	Same
	Needle container:	Needle container:	Same
	Polypropylene (PP)	Polypropylene (PP)	Same
	Trigger shield:Acrylonitrile ButadieneStyrene (ABS)	Trigger shield: AcrylonitrileButadiene Styrene (ABS)	Same
Performance	Complied with ISO 7864,ISO 9626, ISO 11608-2 andISO 23908	Complied with ISO 7864, ISO9626, ISO 11608-2 and ISO 23908	Same
Sterilization	EO Sterilization	Gamma Sterilization	Different¹
			been performed(Appendix 16A).A 5 years shelf-life has beenvalidatedsupported byacceleratedaging testingusing EOsterilizedproduct(Appendix 16B).
	SAL:10-6	SAL:10-6	Same
Shelf Life	5 years	5 years	Same
Single use	Yes	Yes	Same
Biocompatibility	Complied with ISO10993series standards, and thefollowing tests areperformed- Cytotoxicity: Nocytotoxicity- Skin Irritation: Noevidence of skin irritation- Skin Sensitization: Noevidence of sensitization- Acute SystemicToxicity:No systemictoxicity- Hemolysis: No evidenceof hemolysis- Pyrogen: No pyrogenic- Repeated exposuresystemic toxicity: Nosystemic toxicity	Complied with ISO10993 seriesstandards, and the followingtests are performed- Cytotoxicity: No cytotoxicity- Skin Irritation: No evidence ofskin irritation- Skin Sensitization: Noevidence of sensitization- Acute Systemic Toxicity:Nosystemic toxicity- Hemolysis: No evidence ofhemolysis- Pyrogen: No pyrogenic	Different2

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Justification for the differences: の

1) Different Sterilization

The proposed sterilization method for the subect device is Ethylene Oxide sterilization as opposed to the predicate device which is sterilized by Gamma Irradiation. This difference in sterilization does not raise any additional concerns of safety or effectiveness because the proposed device met the necessary biocompatibility and sterility testing requirements per ISO 10993.

1. Different Biocompatibility
  In addition to the Biocompatibility testing of the predicate device, the subject device was tested for Repeated Exposure Systemic Toxicity due to the nature

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of the device and the possibility of inadvertant reuse. This additional testing does not raise any additional concerns of safety or effectiveness.

10 Conclusion

Based on the information provided within this 510(k) submission, proposed Verifine Safety Type Insulin Pen Needle is substantially equivalent to the predicate device (K161950) and is as safe, as effective and performs as well as the legally marketed predicate device.

Regulation Number and Section

§ 880.5570 Hypodermic single lumen needle.

(a)
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.(b)
Classification. Class II (performance standards).