X-Safety Pen Needle is a single-use, double-ended, sterile needles for needlebased injection systems (NISs) that fulfil the specifications of ISO 11608-1. This device is constructed as a double-ended, stainless steel needle of various sizes that is with a threaded plastic hub. The device includes needle shielding safety features (at both patient-end and cartridge-end or at patient-end only) to reduce the risk of needle stick injury and its container can be provided as short or long type. It is packaged in a sealed sterility barrier, and the needle is lubricated. This is a single-use device and delivered sterilization process is validated according to EN ISO 11135. Sterilization process undergoes routine control.

AI/ML Overview

The Promisemed X-Safety Pen Needle is a single-use, double-ended, sterile needle intended for use with needle-based injection systems for drug injection. The device performance was assessed through various bench tests compliant with ISO, ASTM, and USP standards.

The acceptance criteria and reported device performance are summarized in the table below:

Table_1: Acceptance Criteria and Reported Device Performance

Test Category	Acceptance Criteria	Reported Device Performance
Material Standards	Compliant with ISO 9626 (Stainless steel needle tubing)	Complied with ISO 9626
Needle Performance	Compliant with ISO 11608-2 (Needle-based injection systems - Needles)	Complied with ISO 11608-2
	Compliant with ISO 7864 (Sterile hypodermic needles for single use)	Complied with ISO 7864
Safety Features	Compliant with ISO 23908 (Sharps injury protection)	Complied with ISO 23908 (specifically for sharps protection features at the cartridge end, which is an additional feature compared to the predicate)
Biocompatibility	Compliant with ISO 10993 series standards, including: Cytotoxicity, Skin Irritation, Skin Sensitization, Acute and Subacute Systemic Toxicity, Hemolysis, Pyrogen	No cytotoxicity, No evidence of skin irritation, No evidence of sensitization, No systemic toxicity, No evidence of hemolysis, Non-pyrogenic. Testing compliant with ISO 10993-1, ISO 10993-5, ISO 10993-10, ISO 10993-11.
Hemolytic Properties	Compliant with ASTM F756 (Assessment of Hemolytic Properties of Materials)	Complied with ASTM F756
Pyrogenicity	Compliant with USP42-NF37 <151> Pyrogen test	Complied with USP42-NF37 <151>
Endotoxins	Compliant with USP39 NF34 <85> Endotoxin test (LAL)	Complied with USP39 NF34 <85>
Particulate Matter	Compliant with USP <788> Particulate Matter in Injections	Met the USP acceptance criteria
Sterilization	Compliant with ISO 11135 (Ethylene oxide sterilization), SAL: 10-6	Complied with ISO 11135, SAL: 10-6
Package Integrity	Package integrity testing after environmental conditioning and simulated transportation (ISTA-3A 2008). Seal strength (ASTM F88/F88-15), Dye penetration (ASTM F1929-15)	All packaging deemed acceptable for protection of product and sterility maintenance. Complied with ASTM F88/F88-15 and ASTM F1929-15.
Sterility	Sterility test (USP38-NF33_C71)	Complied with USP38-NF33_C71
Shelf-Life	Validated using ASTM F1980-07 (Accelerated Aging of Sterile Barrier Systems for Medical Devices) to achieve a 5-year shelf-life.	5 years life is validated

Study Details:

Sample Size and Data Provenance: The document does not specify exact sample sizes for each test. However, it indicates that testing was conducted on the "final, packaged, and sterile devices," implying a representative sample. The data provenance is from Promisemed Hangzhou Meditech Co., Ltd. in China, as they are the manufacturer and submitter of the 510(k). The studies appear to be prospective bench studies performed by the manufacturer or their designated testing facilities to demonstrate compliance with international and national standards.
Number of Experts and Qualifications for Ground Truth: Not applicable. These are bench performance tests evaluating physical, chemical, and biological properties according to standardized protocols, not human-interpreted diagnostic results. Thus, no medical experts were involved in establishing ground truth for these types of tests. The "ground truth" is defined by the objective pass/fail criteria of the scientific standards themselves.
Adjudication Method for Test Set: Not applicable. As these are objective bench tests with predefined pass/fail criteria from international standards, there is no need for expert adjudication.
Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study: No, an MRMC comparative effectiveness study was not performed. This type of study is relevant for diagnostic devices that involve human interpretation of results, not for the performance of a hypodermic needle.
Standalone Performance: Yes, the described studies represent the standalone performance of the device (Promisemed X-Safety Pen Needle) against established technical and safety standards. There is no human-in-the-loop performance component in these specific evaluations.
Type of Ground Truth Used: The ground truth for these tests is based on objective, standardized criteria established by international and national organizations (e.g., ISO, ASTM, USP). For instance, for material composition, the ground truth is the chemical specification of 304 Stainless steel; for cytotoxicity, it's the absence of cytotoxic effects as defined by ISO 10993-5; for sterility, it's achieving a Sterility Assurance Level (SAL) of 10^-6.
Sample Size for Training Set: Not applicable. This device is a medical instrument (pen needle), not an AI algorithm. Therefore, there is no "training set" in the context of machine learning.
How Ground Truth for Training Set Was Established: Not applicable, as there is no training set for this device.

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 & 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.

September 19, 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: K220129

Trade/Device Name: Promisemed X-Safety Pen Needle Regulation Number: 21 CFR 880.5570 Regulation Name: Hypodermic Single Lumen Needle Regulatory Class: Class II Product Code: FMI Dated: August 24, 2022 Received: August 24, 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

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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,

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

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Indications for Use

510(k) Number (if known) K220129

Device Name Promisemed X-Safety Pen Needle

Indications for Use (Describe)

Promisemed X-safety pen needle is intended for use with needle based injector for the injection of drugs.

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

X 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 1

September 19, 2022

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.:

+86 571 88772985

Fax No.:

+86 571 88772985

Email Address:

zearou.yang@promisemed.ca

ന Trade Name, Common Name, Classification

Trade/Product Name: X-Safety Pen Needle Common Name: Hypodermic single lumen needle Classification name: Needle, Hypodermic, Single Lumen Regulation Number: 21 CFR 880.5570 Device Class: Class II Product Code: FMI

Identification of Predicate Device(s) ব K163578: EasyTouch Safety Pen Needle

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Description of the Device ഗ

X-Safety Pen Needle is a single-use, double-ended, sterile needles for needlebased injection systems (NISs) that fulfil the specifications of ISO 11608-1.

This device is constructed as a double-ended, stainless steel needle of various sizes that is with a threaded plastic hub.

The device includes needle shielding safety features (at both patient-end and cartridge-end or at patient-end only) to reduce the risk of needle stick injury and its container can be provided as short or long type.

It is packaged in a sealed sterility barrier, and the needle is lubricated.

This is a single-use device and delivered sterilization process is validated according to EN ISO 11135. Sterilization process undergoes routine control.

6 Intended Use

Promisemed X-safety pen needle is intended for use with needle based injector for the injection of drugs.

7 Similarities and Differences of the Proposed Device to the Predicate Device

Promisemed X-Safety Pen Needle is substantially equivalent in its technologies and functions to the EasyTouch Safety Pen Needle which cleared under premarket notification number K163578. 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(K163578)
Trade Name	Promisemed X-Safety PenNeedle	EasyTouch Safety PenNeedle	Comments
Manufacturer	Promisemed HangzhouMeditech Co., Ltd	MHC Medical Products,LLC.
Device Class	Class II	Class II	Same
Product Code	FMI	FMI	Same
Regulationnumber	880.5570	880.5570	Same
Regulation Name	Needle, Hypodermic,Single Lumen	Needle, Hypodermic,Single Lumen	Same
Intended Use/Indications forUse	Promisemed X-Safety PenNeedle	The EasyTouch ™ SafetyPen Needle	Same
	Needle is intended for usewith needle basedinjector for the injectionof drugs.	is intendedfor use with peninjector devices for theinjection of drugs,including insulin andexenatide.Additionally, theattached safety shieldautomatically locks inplace and reduces theoccurrence ofaccidental needle sticksfrom the patient end ofthe needle. The shieldalso serves to hide theneedle before and afterinjection.	The subject deviceinclude needleshielding safetyfeatures (at bothpatient end andcartridge end or atpatient end only)to reduce the riskof needle stickinjury.
OperatingPrinciple	Serves as a single use penneedle. The device isremoved from itspackaging and screwedinto a pen injectordevice. The patient theninjects the medicine byfirst setting the dose onthe pen, and theninserting the needle intothe skin and then pressingthe button on the pen.After the injection theneedle automaticallyretracts into a shieldedhousing, thus preventingan accidental needlestick.For safety features atboth patient end andcartridge end: A secondshield covers the needletail when the needle isremoved from theinjector.Once the sharps injuryprevention feature isactivated, it locks inplace and the product canno longer be used again.	Serves as a single usepen needle. The deviceis removed from itspackaging and screwedinto a pen injectordevice. The patientthen injects themedicine by firstsetting the dose on thepen, and then insertingthe needle into the skinand then pressing thebutton on the pen.After the injection theneedle automaticallyretracts into a shieldedhousing, thuspreventing anaccidental needle stick.	DifferentAn additionalprotective design isintroduced insubject device (forsafety features atboth patient endand cartridge end)which preventaccidental needlesticks at thecartridge end uponremoval of theneedle from theinjector.
Gauge	29G, 30G, 31G, 32G	29G, 30G, 31G	DifferentSubject device hasadditional gaugesize (32G) thanpredicate device.
Needle Length	4mm, 5mm, 6mm, 8mm	5mm, 6mm, 12.7mm	Different
			Subject device has shorter needle length than predicate device.
Material (Needle, Hub, Hub protector, Safety feature)	Needle Tube: 304Stainless steel X5CrNi18-10	Needle Tube: 304Stainless steel needle	Same
	Needle Hub:Polypropylene (PP)	Needle Hub:Polypropylene (PP)	Same
	Container: Polypropylene (PP)	Hub protector:Polypropylene (PP)	Same
	Trigger spring/Posterior spring: Stainless steel	Safety Feature:Stainless steel spring	Same
	Lubricant: Silicon oil	Lubricant: Silicon oil	Same
Performance	Complied with ISO 9626, ISO 7864, ISO11608-1, ISO 11608-2	Complied with ISO 9626, ISO 7864, ISO11608-1, ISO 11608-2	Same
Sterilization	EO Sterilization	EO Sterilization	Same
	SAL:10-6	SAL:10-6	Same
Shelf Life	5 years	5 years	Same
Single use	Yes	Yes	Same
Biocompatibility	Complied with ISO10993 series standards, and the following tests are performed- Cytotoxicity: No cytotoxicity- Skin Irritation: No evidence of skin irritation- Skin Sensitization: No evidence of sensitization-Acute and Subacute Systemic Toxicity: No systemic toxicity-Hemolysis: No evidence of hemolysis-Pyrogen: Non-pyrogenic	Complied with ISO10993 series standards, and the following tests are performed and passed- Cytotoxicity: No cytotoxicity- Skin Irritation: No evidence of skin irritation- Skin Sensitization: No evidence of sensitization-Acute Systemic Toxicity: No systemic toxicity- Hemolysis: No evidence of hemolysis- Pyrogen: Non-pyrogenic	Same

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The Promisemed X-Safety 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 subject device has additional safety feature at the cartridge end which has been validated through ISO 23908. The subject device has wider gauge size and

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shorter needle length than predicate device. The specification of needle length and gauze size fulfil the requirement of ISO 9626:2016 and ISO 7864:2016. The differences between the subject device and its predicate do not alter the intended use and do not raise new questions of safety and effectiveness.

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
· 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

ISO 10993-1:2018 Biological Evaluation of Medical Devices -- Part 1: Evaluation and testing within a risk management process
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
· ISO 10993-11:2006, Biological evaluation of medical devices Part 11: Tests for systemic toxicity-Acute systemic toxicity
· ISO 10993-11:2017, Biological evaluation of medical devices Part 11: Tests for systemic toxicity-Subacute systemic toxicity

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ASTM F756-13 Standard Practice for Assessment of Hemolytic Properties of Materials
USP42-NF37<151> pyrogen test
USP39 NF34<85> Endotoxin test (LAL)
· Particulate matter testing was conducted in accordance with USP <788> Particulate Matter in Injections and met the USP acceptance criteria.
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 ISTA-3A 2008, 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 ASTM F1980-07 Standard Guide for Accelerated Aging of Sterile Barrier Systems for Medical Devices
Conclusion g

Based on the information provided within this 510(k) submission, the proposed subject device is substantially equivalent to the predicate device 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).