Promisemed Insulin Pen Needle is intended for use with pen injector device for subcutaneous injection of insulin. It is sterile and for single use only. It is suitable for all age groups including neonate, infant, children and adult, and can be used by the patient at home or healthcare professionals at medical/health care centers.

Device Description

Promisemed 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 user proceeds with inserting the needle into the skin manually.

The Promisemed Insulin Pen Needle consists of needle container, needle shield, needle tube, needle hub, 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 Insulin Pen Needle is the modification of the Verifine Common Type Insulin Pen Needle cleared in K161950 in extension of the range of gauge and needle length as well as change in material of needle shield. Promisemed Insulin 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 distinguished by needle gauge and length.

AI/ML Overview

This is a 510(k) premarket notification for a medical device, the Promisemed Insulin Pen Needle. These documents typically focus on demonstrating substantial equivalence to a predicate device rather than providing detailed acceptance criteria and study reports for novel AI algorithms.

Therefore, the requested information for an AI/ML powered device, such as acceptance criteria in the form of performance metrics (sensitivity, specificity), descriptions of test sets (sample size, provenance), expert ground truth, adjudication methods, MRMC studies, standalone performance, and training set details, is not applicable to this submission.

This submission focuses on engineering and biocompatibility testing to demonstrate that the Promisemed Insulin Pen Needle performs as safely and effectively as a previously cleared insulin pen needle (K161950), despite minor changes in gauge range, needle length, and material of the needle shield.

Here's a summary of what is available in the document regarding performance and testing:

1. Table of Acceptance Criteria and Reported Device Performance:

The document doesn't present a table of acceptance criteria with specific performance metrics like sensitivity, specificity, accuracy, etc., as these are not relevant for a mechanical device like an insulin pen needle. Instead, it refers to compliance with established international standards for such devices.

Acceptance Criteria (Standard Compliance)	Reported Device Performance (Compliance Statement)
ISO 9626	"Complied with ISO 7864, ISO 9626, ISO 11608-2" (implied for both subject and predicate device, indicating the subject device also complies)
ISO 11608-2	"Complied with ISO 7864, ISO 9626, ISO 11608-2" (implied for both subject and predicate device, indicating the subject device also complies). Specifically mentioned that 3.5mm needle length meets the "requirement of ISO 11608-2 to a 95%/95% C/R" (Confidence/Reliability, a statistical measure often used for medical device performance validation).
ISO 7864	"Complied with ISO 7864, ISO 9626, ISO 11608-2" (implied for both subject and predicate device, indicating the subject device also complies)
Biocompatibility (ISO 10993 series)	Complied with ISO10993 series standards. Tests performed:
- Cytotoxicity	No cytotoxicity
- Skin Irritation	No evidence of skin irritation
- Skin Sensitization	No evidence of sensitization
- Acute Systemic Toxicity	No systemic toxicity
- Hemolysis (ASTM F756-13)	No evidence of hemolysis
- Pyrogenicity (ISO 10993-11)	Non-pyrogenic
Particulate Matter (USP <788>)	Met the USP acceptance criteria.
Package Integrity (ISTA 3A, ASTM F88, ASTM F1929)	All packaging deemed acceptable for protection of product and sterility maintenance.
Shelf Life (ASTM F1980-16)	5 years validated.
Sterility Assurance Level (SAL)	10⁻⁶ (Same as predicate)

2. Sample size used for the test set and the data provenance:
Not applicable for this type of device submission. Performance is assessed through compliance with engineering standards and biocompatibility testing on material samples and device prototypes. The data provenance would be from laboratory testing conducted in China (Promisemed Hangzhou Meditech Co., Ltd. is based in China). The document indicates the testing was "bench testing."

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
Not applicable. Ground truth for a mechanical device is established by compliance with engineering specifications and recognized consensus standards, not by expert consensus on clinical output.

4. Adjudication method for the test set:
Not applicable.

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 not an AI-powered diagnostic or assistive tool.

6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:
Not applicable.

7. The type of ground truth used:
For the engineering performance tests (e.g., needle strength, flow rate), the ground truth is defined by the acceptance limits specified within the referenced international standards (ISO 9626, ISO 11608-2, ISO 7864). For biocompatibility, the ground truth is the absence of adverse biological reactions as per ISO 10993 series. For sterility, it's achieving an SAL of 10⁻⁶.

8. The sample size for the training set:
Not applicable as this is not an AI/ML device requiring a training set.

9. How the ground truth for the training set was established:
Not applicable.

Summary

{0}------------------------------------------------

Image /page/0/Picture/0 description: The image shows the logo for the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health & Human Services seal on the left and the FDA acronym followed by the full name of the agency on the right. The FDA part of the logo is in blue, with the acronym in a square and the agency name in a sans-serif font.

July 21, 2021 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 China

Re: K210059

Trade/Device Name: Promisemed Insulin Pen Needle Regulation Number: 21 CFR 880.5570 Regulation Name: Hypodermic Single Lumen Needle Regulatory Class: Class II Product Code: FMI Received: June 21, 2021

Dear Wei-Shan 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

{1}------------------------------------------------

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 (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 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 (DICE@fda.hhs.gov) or phone (1-800-638-2041 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

{2}------------------------------------------------

Indications for Use

510(k) Number (if known) K210059

Device Name Promisemed Insulin Pen Needle

Indications for Use (Describe)

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)

CONTINUE ON A SEPARATE PAGE IF NEEDED.

This section applies only to requirements of the Paperwork Reduction Act of 1995.

DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.

The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:

Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov

"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."

{3}------------------------------------------------

510(k) Summary

1 Date Prepared

July 21, 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, Regulatory Affairs Manager

Telephone No.:

+86 571 88772985

Fax No.:

+86 571 88772985

Email Address:

zearou.yang@promisemed.ca

ന Trade Name, Common Name, Classification

Trade/Product Name: Promisemed 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 Common Type Insulin Pen Needle

{4}------------------------------------------------

ഹ Description of the Device

The Promisemed Insulin Pen Needle consists of needle container, needle shield, needle tube, needle hub, 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 Insulin Pen Needle is the modification of the Verifine Common Type Insulin Pen Needle cleared in K161950 in extension of the range of gauge and needle length as well as change in material of needle shield. Promisemed Insulin Pen Needle is sterility Assurance Level (SAL) of 10 %, non-pyrogenic and single-use devices. It is supplied with several models. Different models are distinguished by needle gauge and length.

6 Indications for Use
Promisemed Insulin Pen Needle is intended for use with pen injector device for subcutaneous injection of insulin. It is sterile and for single use only. It is suitable for all age groups including neonate, infant, children and adult, and can be used by the patient at home or healthcare professionals at medical/health care centers.
Similarities and Differences of the Proposed Device to the Predicate 7 Device
Promisemed Insulin Pen Needle is substantially equivalent in its technologies and functions to the Verifine Common Type Insulin Pen Needle which cleared under premarket notification number K161950.

Three design changes were made to the subject device, introducion of new gauge specification (34G), new needle length specification(3.5mm and 10mm) and Needle Shield material change. The following are comparisons between subject device and the predicate device.

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

	Subject Device			Predicate Device (K161950)
Trade Name	PromisemedNeedle	Insulin	Pen	VerifineInsulin Pen Needle	Common	Type	Comments

{5}------------------------------------------------

Manufacturer	PromisemedMeditech Co., LtdHangzhou	PromisemedMeditech Co., LtdHangzhou			Needle shield: Polyethylene(PE)	Needle shield:Polypropylene (PP)	DifferentBoth PE and PP belongare commonly usedthermoplastic material.This difference does notaffect the substantiallyequivalence on the safetyand effectiveness.
Device Class	Class II	Class II	Same		Joint medium: UV glue	Joint medium: UV glue	Same
Product Code	FMI	FMI	Same		Lubricant: Silicon oil	Lubricant: Silicon oil	Same
Regulationnumber	880.5570	880.5570	Same	Performance	Seal: Dialyzer paperComplied with ISO 7864, ISO9626, ISO 11608-2	Seal: Dialyzer paperComplied with ISO 7864,ISO 9626, ISO 11608-2	Same
RegulationName	Needle, Hypodermic, SingleLumen	Needle, Hypodermic, SingleLumen	Same	Sterilization	EO Sterilization	EO Sterilization	Same
Intended Use/Indications forUse	Promisemed Insulin PenNeedle is intended for usewith pen injector device forsubcutaneous injection ofinsulin.It is sterile and for single useonly. It is suitable for all agegroups including neonate,infant, children and adult,and can be used by thepatient at home orhealthcare professionals atmedical/health care centers.	The Common Type InsulinPen Needle is intended foruse with pen injectordevice for subcutaneousinjection of insulin.	DifferentThe indications for Use issimilar except that thesubject devicespecifically identifiesintended population,sterile and single use,and for home orhealthcare/health carecenters		SAL:10-6	SAL:10-6	Same
OperatingPrinciple	The user proceeds withinserting the needle into theskin manually. The patientend and the cartridge end ofthe tube are lubricated usinga silicone based lubricant forease of injection and rubberseptum penetration.	The user proceeds withinserting the needle intothe skin manually. Thepatient end and thecartridge end of the tubeare lubricated using asilicone based lubricant forease of injection andrubber septumpenetration.	Same	Shelf Life	5 years	5 years	Same
Gauge	29G, 30G, 31G, 32G,33G,34G	29G, 30G, 31G, 32G,33G	DifferentNew gauge specification(34G) is introduced. Thisdifference does notaffect the substantiallyequivalence on the safetyand effectiveness	Single use	Yes	Yes	Same
Needle Length	3.5mm±0.4mm,(4mm, 5mm, 6mm, 8mm,10mm, 12mm) ±1.2mm	(4mm,5mm,6mm,8mm,12mm) ±1.2mm	DifferentNeedle length of 3.5 mmand 10mm were newlyintroduced specifications.This difference does notaffect the substantiallyequivalence on the safetyand effectiveness.	Biocompatibility	Complied with ISO10993series standards, and thefollowing tests areperformed- Cytotoxicity: Nocytotoxicity- Skin Irritation: No evidenceof skin irritation- Skin Sensitization: Noevidence of sensitization-Acute Systemic Toxicity:Nosystemic toxicity-Hemolysis: No evidence ofhemolysis-Pyrogen: Non-pyrogenic	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 evidence ofhemolysis-Pyrogen: Non- pyrogenic	Same
Material	Needle Tube: X5CrNi18-10	Needle Tube: X5CrNi18-10	Same
	Needle Hub: Polypropylene(PP)	Needle Hub: Polypropylene(PP)	Same
	Needle container:Polypropylene (PP)	Needle container:Polypropylene (PP)	Same

{6}------------------------------------------------

Discussion:

The Promisemed Insulin Pen Needle has the same intended use and technological characteristics as the predicate device. 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 difference in gauge size and material of needle shield does not affect the substantially equivalence on the safety and effectiveness. The Needle length of 3.5mm with tightened tolerance limits (±0.4mm), is within the same needle length range as the predicate 4mm (±1.20 mm), both meet the requirement of ISO 11608-2 to a 95%/95% C/R and substantially equivalent. The subject device has raised no different questions of safety and effectiveness.

{7}------------------------------------------------

8 Performance Testing Summary

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: Stainless steel needle tubing for the manufacture of medical devices -Requirements and test methods
· 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
· 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.
- g. Particulate matter testing was conducted in accordance with USP <788> Particulate Matter in Injections and met the USP acceptance criteria.
- h. Package integrity testing, after environmental conditioning and simulated transportation in accordance with ISTA 3A, was conducted on the final, packaged, and sterile devices. All packaging deemed acceptable for protection of product and sterility maintenance.
- i. Sterile Barrier Packaging Testing performed on the proposed device: Seal strength ASTM F88/F88-15, Dye penetration ASTM F1929-15
- i. 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

{8}------------------------------------------------

Conclusion 9

The differences between the predicate and the subject device do not raise any new or different questions of safety or effectiveness. The Promisemed Insulin Pen Needle is substancially equivalent to the Verifine Common Type Insulin Pen Needle with respect to the Indications for Use, target populations, treatment method, and technological characteristics.

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).