The Dual Safety Pen Needle is intended for use with pen injector devices for subcutaneous injection of insulin. The product has two safety shields which lock in place after use (patient-end) and upon removal of the needle from the pen (pen connector-end). The lock shields help reduce the occurrence of needle sticks from both ends of the needle.

Device Description

The device is a pen needle with shields at both the patient end and the pen connector end which are intended to reduce risk of needle stick before and after injections. The patient end mechanism shields the needle before and after an injection, and a second mechanism passively covers the pen connector needle following removal from the patient end shield indicates the needle has fully penetrated the skin. A second shield covers the pen connector needle when it is removed from the pen.

AI/ML Overview

This looks like a 510(k) summary for a medical device called "Dual Safety Pen Needle" (K191853). It describes the device, its intended use, a comparison to a predicate device, and summaries of non-clinical and clinical tests.

Here's an analysis of the acceptance criteria and study information, organized as requested:

1. Table of Acceptance Criteria and Reported Device Performance

2. Sample Size Used for the Test Set and Data Provenance

Sample Size for Clinical Simulated Use Test Set: A total of 500 samples were tested.
Data Provenance: The document does not explicitly state the country of origin for the clinical study data. It implies an internal study ("internal protocol and test results") but no specific geographic location for the conduct of the test is mentioned. The study appears to be prospective as it involves the evaluation of the device by participants.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts

Number of Experts: 8 participants were selected to evaluate the subject device.
Qualifications of Experts: These participants included endocrine doctors and nurses who provide training to patients in the use of pen needles for insulin injection. No specific years of experience are mentioned.

4. Adjudication Method for the Test Set

The document describes a usability/simulated use study where participants evaluated the device. The "ground truth" here is the effectiveness of the safety mechanism as observed during use. The study reported "zero failures." This suggests a direct observation and categorical outcome (success/failure) rather than an adjudication process requiring multiple expert opinions on a subjective measure. Therefore, no formal adjudication method (like 2+1, 3+1) is described, as the outcome appears to be objectively observed during the simulated use.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

No, a MRMC comparative effectiveness study was not done. The document describes a usability/simulated use test for the safety mechanism and various bench tests for physical and biological properties. It does not mention a comparative effectiveness study involving human readers (or users) comparing performance with and without AI assistance, as AI is not a component of this device.

6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study

Not applicable. This device is a physical medical instrument (pen needle), not an AI algorithm. Therefore, a standalone algorithm performance study is not relevant.

7. Type of Ground Truth Used

For the Clinical Simulated Use testing, the ground truth appears to be observed effectiveness/failure of the safety mechanism during actual handling by trained users. The outcome was "zero failures" across 500 samples, indicating the mechanism worked as intended.
For the Non-Clinical tests (e.g., sterilization, biocompatibility, product functionality, sharps injury protection, packaging), the ground truth is established by compliance with recognized international standards (ISO, ASTM, USP) and manufacturer's internal protocols, which are based on objective measurements and test methods defined by these standards.

8. Sample Size for the Training Set

Not applicable. This device is a physical medical instrument, not a machine learning model, so there is no "training set."

9. How the Ground Truth for the Training Set Was Established

Not applicable. As there is no training set for a machine learning model, this question is not relevant.

Summary

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Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health and Human Services logo. To the right of that 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 5, 2019

Promisemed Hangzhou Meditech Co., Ltd. % John Beasley Senior Consultant MedTech Review, LLC 257 Garnet Garden Street Henderson, Nevada 98015

Re: K191853

Trade/Device Name: Dual Safety Pen Needle Regulation Number: 21 CFR 880.5570 Regulation Name: Hypodermic Single Lumen Needle Regulatory Class: Class II Product Code: FMI Dated: July 10, 2019 Received: July 10, 2019

Dear John Beasley:

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,

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) K191853

Device Name Dual Safety 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)

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510(k) Summary

Preparation Date: 09/05/2019

Contact Details		21 CFR 807.92(a)(1)
Applicant Name	Promisemed Hangzhou Meditech Co., Ltd.
Applicant Address	Bldg. 1, No. 12, Longtan Road, Cangqian Street, Yuhang District, Hangzhou City, Zhejiang, 311121, CH
Applicant Telephone Number	865-718-8772985
Applicant Contact	Mr. Zearou Yang
Applicant Contact Email	zearou.yang@promisemed.ca
Correspondent Name	MedTech Review, LLC
Correspondent Address	257 Garnet Garden Street, Henderson, NV, 89015, US
Correspondent Telephone Number	1-612-889-5168
Correspondent Contact	Mr. John Beasley, RAC (US)
Correspondent Contact Email	john@medtechreview.com
Device Name		21 CFR 807.92(a)(2)
Device Trade Name	Dual Safety Pen Needle
Common Name	HYPODERMIC SINGLE LUMEN NEEDLE.
Classification Name	NEEDLE, HYPODERMIC, SINGLE LUMEN
Regulation Number	880.5570
Product Code	FMI
Legally Marketed Predicate Devices		21 CFR 807.92(a)(3)
Predicate [510(k)] #	Predicate Trade Name	Product Code
K161950	Verifine ® Safety Type Insulin Pen Needle	FMI
Device Description Summary		21 CFR 807.92(a)(4)
Item	Subject DeviceK191853	Predicate DeviceK161950	Similarities/Differences
Product Code	FMI	FMI	No difference in FDA product code.
Intended Use	The Dual Safety PenNeedle is intended foruse with pen injectordevices forsubcutaneous injectionof insulin. The producthas two safety shieldswhich lock in place afteruse (patient-end) andupon removal of theneedle from the pen(pen connector-end).The lock shields helpreduce the occurrenceof needle sticks fromboth ends of theneedle.	The Safety Type InsulinPen Needle is intendedfor use with pen injectordevices forsubcutaneous injectionof insulin. Additionally,after withdrawal of theSafety Type Insulin PenNeedle from the body,the attached needlesafety shieldautomatically coversthe needle to minimizethe risk of accidentalneedlestick.	The safety pen needle products (subjectdevice and predicate device) help protectagainst accidental needle sticks and aresubstantially equivalent in their intended use.
OperatingPrinciple	As the user proceedswith inserting theneedle into the skin theshield will retract.After the injection iscompleted and needleis removed from theskin, the shield willautomatically extend tocover the needle andlock in place.A click of the patientend shield indicates theneedle has fullypenetrated the skin. Asecond shield coversthe pen connectorneedle when the needleis removed from thepen.Once the Dual SafetyPen Needle is in thelocked mode, it can nolonger be used.	As the user proceedswith inserting theneedle into the skin theshield will retract.After the injection iscompleted and needleis removed from theskin, the shield willautomatically extend tocover the needle andlock in place.This product featuresan audible cue (a click)when the injection iscomplete.Once the Safety TypeInsulin Pen Needle is inthe locked mode, it canno longer be used.	The safety pen needle products (subjectdevice and predicate device) use the sameoperating principles: the use of lock shieldsthat help reduce the occurrence of needlesticks.
Length	4 ± 0.5 mm5 ± 0.5 mm6 ± 0.5 mm8 ± 1.2 mm	4 ± 0.5 mm5 ± 0.5 mm6 ± 0.5 mm8 ± 1.2 mm	The needle tube lengths of the subject deviceare the same as the predicate device.
Item	Subject DeviceK191853	Predicate DeviceK161950	Similarities/Differences
Gauge	29G6mm29G8mm	29G6mm29G8mm	The available needle lengths per gauge of thesubject device are the same as in thepredicate device.
	30G4mm30G5mm30G6mm30G8mm31G4mm31G5mm31G*6mm	30G4mm30G5mm30G6mm30G8mm31G4mm31G5mm31G*6mm
	31G*8mm	31G*8mm
Sharps InjuryPreventionFeatures	The patient end of thedevice has amechanism that allowsthe needle to beshielded and lockedafter use.The non-patient (penconnection) end of thecannula is visible priorto attachment to thepen injector. Followingremoval of the devicefrom the pen injector,the needle is shieldedwith a mechanism thatis designed to reducethe occurrence ofaccidental needle stickinjuries.	The patient end of thedevice has amechanism that allowsthe needle to beshielded and lockedafter use.	The sharps injury prevention features of thesubject device includes both ends of theneedle as compared to only the patient end ofthe needle in the predicate device.
Device Materials	Fixer, inside fixer:POMHub: POMNeedle hub:X5CrNi18-10Springs:0Cr18Mn8Ni5NShield: ABContainer: PP	Fixer: POMHub: POMNeedle tube:X5CrNi18-10Spring:0Cr18Mn8Ni5NShield: ABSContainer: PP	The subject device contains an additionalposterior trigger spring in comparison to thepredicate device. Device materials and boththe nature of body contact and the duration ofbody with the patient/user are the same.
Performance	Complies withISO 7864,ISO 9626,ISO 11608-2, andISO 23908	Complies withISO 7864,ISO 9626,ISO 11608-2, andISO 23908	The performance characteristics of the subjectdevice are the same as the predicate device.
Force to ActivateSharps InjuryPreventionFeature	Complies with ISO23908. The force toactivate the sharpsinjury preventionfeature is 1N to 5N forboth ends of the DualSafety Pen Needle.	Complies with ISO23908. The force toactivate the sharpsinjury preventionfeature is 1N to 5N forthe Safety Type InsulinPen Needle.	The forces for activate the patient-end sharpsinjury prevention feature of the subject deviceare the same as the predicate device. Thepredicate device does not have a pen-endsharps prevention feature.
Item	Subject DeviceK191853	Predicate DeviceK161950	Similarities/Differences
Force toOverride SharpsInjury PreventionFeature	Complies with ISO23908. The forcerequired to override thesharps injury preventionfeature greater than20N for both ends ofthe Dual Safety PenNeedle.	Complies with ISO23908. The forcerequired to override thesharps injury preventionfeature is greater than20N for the Safety TypeInsulin Pen Needle.	The forces for overriding the patient-endsharps injury prevention feature of the subjectdevice are the same as the predicate device.The predicate device does not have a pen-end sharps prevention feature.
Sterilization	SAL: 10-6Ethylene OxideSterilization	SAL: 10-6Gamma RadiationSterilization	The sterilization methods of the subject andpredicate devices are different; however, bothare traditional methods of processing medicaldevices so as to provide sterility assurancelevels of 10-6.
Shelf Life	5 years	5 years	Device stability and expiry date of the subjectdevice are the same as the predicate device.
Single Use	Yes	Yes	The safety pen needle products (subjectdevice and predicate device) are single usedevices.
Biocompatibility	Complies with ISO10993 SeriesStandards for• Cytotoxicity• Skin Irritation• Skin Sensitization• Acute Systemic• Toxicity• Hemolysis• Non pyrogenic(material mediatedpyrogenicity)	Complies with ISO10993 SeriesStandards for• Cytotoxicity• Skin Irritation• Skin Sensitization• Acute Systemic• Toxicity• Hemolysis• Non pyrogenic(material mediatedpyrogenicity)	The biological safety of the subject device isidentical to the predicate device.
	Non Clinical and/or Clinical Tests Summary & Conclusions		21 CFR 807.92(b)

Intended Use/Indications for Use

Indications for Use Comparison

Promisemed adds an additional safety shield to the predicate device such that the subject device's two safety shields lock in place (i) after use (patient-end) and (ii) upon removal of the needle from the pen (pen connector-end). The lock shields help reduce the occurrence of needle sticks from both ends of the needle. This additional protection does not constitute a new intended use. However, the Indications For Use' has been revised to reflect the additional safety shield. Both safety pen needle products (the predicate device and the subject device) help protect against accidental needle sticks.

21 CFR 807.92(a)(5)

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Technological Comparison

21 CFR 807.92(a)(6)

For both the subject and predicate devices, the non-patient (pen connector) ends of the cannula are visible prior to attachment to the pen injector. However, the predicate device is modified such that following removal of the subject device from the pen injector, its needle is shielded with a mechanism designed to reduce the occurrence of accidental needle stick injuries.

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Non-Clinical Summary:

Product functionality: After sterilization, the device meets criteria specified in ISO 11608-2.

Shelf life: Sterile devices meet criteria specified in ISO 11608-2 after accelerated aging. The product is labeled with an expiry date of 5 years.

Biocompatibility: Device meets cytotoxicity requirements of ISO 10093-5 Biological evaluation of medical devices -Part 5: Tests for in vitro cytotoxicity

Biocompatibility: Device meets sensitization requirements of ISO 10993-10 Biological evaluation of medical devices -Part 10:Tests for irritation and skin sensitization.

Biocompatibility: Device meets intracutaneous reactivity requirements of ISO 10993-10 Biological evaluation of medical devices - Part 10:Tests for irritation and skin sensitization.

Biocompatibility: Device meets hemocompatibility requirements of both ISO 10993-4 Biological evaluation of medical devices Part 4: Selection of tests for interactions with blood and ASTM F756 Standard Practice for Assessment of Hemolytic Properties of Materials

Biocompatibility: Device meets system toxicity requirements of ISO 10993-11:2006(R)2010, Biological evaluation of medical devices - Part 11: Tests for systemic toxicity.

Sharps injury protection: Device meets safety mechanism activation requirements as per ISO 23908.internal protocol and test results

Sharps injury protection: Device meets safety overriding/unlocking force after activation requirements as per ISO 23908, internal protocol and test results

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Clinical Simulated Use testing evaluated whether the posterior safety protective mechanism of the Dual Safety Pen Needle is effective. A total of 8 participants were selected to evaluate the subject device, and included endocrine doctors and nurses who provide training to patients in the use of pen needles for insulin injection. A total of 500 samples were tested and the evaluations resulted in zero failures of each of the Dual Safety Pen Needle.

Sterilization: A Sterility Assurance Level (SAL) of 10° has been validated in accordance with the requirements of ISO 11135:2014 for Ethylene Oxide.

LAL Pyrogen Testing: Device meets endotoxin requirements of USP39_NF34<85> Bacterial Endotoxins Test.

Packaging: Shipping package meets requirements of ISTA 3A. Unit package functionality meets acceptance criteria specified in ASTM F1929-98 (2004) for dye penetration and peel strength after EO sterilization. The unit package also provides a seal having a microbial barrier that meets log reduction value (LRV) requirements of ASTM F1608-16.

Conclusion:

Based on device comparison information and functional performance bench testing, the proposed device is substantially equivalent to the legally marketed predicate device (K161950).

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).

Acceptance Criteria Category	Specific Criteria/Standard	Reported Device Performance
Product Functionality	Meets criteria specified in ISO 11608-2 (Pen-injectors - Part 2: Needles)	Device meets criteria specified in ISO 11608-2 after sterilization.
Shelf Life	Sterile devices meet criteria specified in ISO 11608-2 after accelerated aging.	Product is labeled with an expiry date of 5 years.
Biocompatibility: Cytotoxicity	Meets cytotoxicity requirements of ISO 10993-5 (Biological evaluation of medical devices - Part 5: Tests for in vitro cytotoxicity)	Device meets cytotoxicity requirements of ISO 10993-5.
Biocompatibility: Sensitization	Meets sensitization requirements of ISO 10993-10 (Biological evaluation of medical devices - Part 10: Tests for irritation and skin sensitization)	Device meets sensitization requirements of ISO 10993-10.
Biocompatibility: Intracutaneous Reactivity	Meets intracutaneous reactivity requirements of ISO 10993-10 (Biological evaluation of medical devices - Part 10: Tests for irritation and skin sensitization)	Device meets intracutaneous reactivity requirements of ISO 10993-10.
Biocompatibility: Hemocompatibility	Meets hemocompatibility requirements of both ISO 10993-4 (Biological evaluation of medical devices Part 4: Selection of tests for interactions with blood) and ASTM F756 (Standard Practice for Assessment of Hemolytic Properties of Materials)	Device meets hemocompatibility requirements of both ISO 10993-4 and ASTM F756.
Biocompatibility: Systemic Toxicity	Meets systemic toxicity requirements of ISO 10993-11:2006(R)2010 (Biological evaluation of medical devices - Part 11: Tests for systemic toxicity)	Device meets system toxicity requirements of ISO 10993-11:2006(R)2010.
Sharps Injury Protection: Activation Force	Meets safety mechanism activation requirements as per ISO 23908 and internal protocol. Force to activate the sharps injury prevention feature is 1N to 5N for both ends.	Device meets safety mechanism activation requirements as per ISO 23908. Force to activate the sharps injury prevention feature is 1N to 5N for both ends of the Dual Safety Pen Needle.
Sharps Injury Protection: Override/Unlocking Force	Meets safety overriding/unlocking force after activation requirements as per ISO 23908 and internal protocol. Force required to override the sharps injury prevention feature greater than 20N for both ends.	Device meets safety overriding/unlocking force after activation requirements as per ISO 23908. Force required to override the sharps injury prevention feature greater than 20N for both ends of the Dual Safety Pen Needle.
Sterilization	Sterility Assurance Level (SAL) of 10^-6 validated in accordance with ISO 11135:2014 for Ethylene Oxide.	SAL of 10^-6 has been validated in accordance with the requirements of ISO 11135:2014 for Ethylene Oxide.
LAL Pyrogen Testing	Meets endotoxin requirements of USP39_NF34<85> Bacterial Endotoxins Test.	Device meets endotoxin requirements of USP39_NF34<85> Bacterial Endotoxins Test.
Packaging: Shipping	Meets requirements of ISTA 3A.	Shipping package meets requirements of ISTA 3A.
Packaging: Unit Functionality	Meets acceptance criteria specified in ASTM F1929-98 (2004) for dye penetration and peel strength after EO sterilization.	Unit package functionality meets acceptance criteria specified in ASTM F1929-98 (2004) for dye penetration and peel strength after EO sterilization.
Packaging: Microbial Barrier	Provides a seal having a microbial barrier that meets log reduction value (LRV) requirements of ASTM F1608-16.	Unit package provides a seal having a microbial barrier that meets LRV requirements of ASTM F1608-16.
Clinical Simulated Use Effectiveness	Posterior safety protective mechanism of the Dual Safety Pen Needle is effective (zero failures).	Evaluations resulted in zero failures of each of the Dual Safety Pen Needle.