The proposed device, Pen Needle, is designed for use with pen injectors for subcutaneous injection of a desired dose of drugs approved for delivery using a pen needle. It is provided sterile, single use. The proposed device consists of four components, which are 1) Needle Container 2) Needle Shield 3) Needle Tube and 4) Needle Hub. Needle Container, together with Sealed Paper can forming the unit packaging of Pen Needle, that maintains the sterility of Pen Needle Hub can be connected screwed onto the pen injectors.

AI/ML Overview

The provided document is a 510(k) premarket notification for a medical device (Pen Needle) and focuses on demonstrating substantial equivalence to a predicate device. It is not an AI/ML medical device submission. Therefore, the document does not contain information typically found in an AI/ML medical device acceptance criteria and study section, such as:

A table of acceptance criteria and reported device performance for an AI/ML algorithm.
Sample sizes used for a test set or data provenance for an AI/ML algorithm.
Number of experts or qualifications of experts used for AI ground truth.
Adjudication methods for AI test sets.
Multi-Reader Multi-Case (MRMC) comparative effectiveness studies.
Standalone AI performance.
Type of ground truth used for AI/ML.
Sample size or ground truth establishment for an AI/ML training set.

The document discusses non-clinical tests performed to verify the Pen Needle met design specifications and complied with ISO standards, focusing on manufacturing quality, sterility, and biocompatibility rather than an AI algorithm's performance.

Therefore, I cannot extract the requested information as it is not present in the provided text.

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.

June 2, 2023

Jiangsu Caina Medical Co., Ltd. Camel Zhou Management Representative No.23, Huanxi Road, Zhutang Town Jiangyin, Jiangsu 214415 China

Re: K230635

Trade/Device Name: Pen Needle Regulation Number: 21 CFR 880.5570 Regulation Name: Hypodermic Single Lumen Needle Regulatory Class: Class II Product Code: FMI Dated: December 22, 2022 Received: March 7, 2023

Dear Camel Zhou:

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.

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Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA

Page 2

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 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.

Image /page/1/Picture/6 description: The image shows a digital signature. The signature is by Courtney Evans -S. The date of the signature is 2023.06.02. The time of the signature is 13:52:41 -04'00'.

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

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DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration

Indications for Use

510(k) Number (if known)

K230635

Device Name Pen Needle

Indications for Use (Describe)

Pen Needle is intended for use with pen injector devices for the subcutaneous injection of drugs.

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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Image /page/3/Picture/1 description: The image shows the logo for CAINA. The logo is blue and green, and it includes the text "CAINA" in large, bold letters. Below the company name is the website address, www.cainamed.com. The logo is simple and modern, and it is likely used to represent the company's brand.

K230635 510(k) Summary

Date of Preparation: May 05, 2023 1.
1. Sponsor Identification

Jiangsu Caina Medical Co., Ltd.

No.23, Huanxi Road, Zhutang Town, Jiangyin, Jiangsu, 214415, China

Establishment Registration Number: 3005670221

Contact Person: Jun Lu Position: General Manager Tel: +86-510-86205183 Fax: +86-510-86215183 Email: jun.lu(@cainamed.com

3. Designated Submission Correspondent

Ms. Tracy Gong (Primary Contact Person) Email: tracy.gong(@cainamed.com Mr. Camel Zhou (Alternative Contact Person) Email: camel.zhou@cainamed.com Tel: +86-510-86866666-8027 Fax: +86-510-86866666-8009

4. Identification of Proposed Device

Trade Name: Pen Needle

Regulatory Information

Regulation Name: Hypodermic Single Lumen Needle Device Class: II Product Code: FMI Regulation Number: 21 CFR 880.5570 Review Panel: General Hospital

Indications for Use Statement: Pen Needle is intended for use with pen injector devices for the subcutaneous injection of drugs.

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Image /page/4/Picture/1 description: The image shows the logo for CAINA. The logo is blue and green, with the word "CAINA" in large, bold letters. Below the logo is the website address "www.cainamed.com" in a smaller font. The logo is simple and modern, and the colors are eye-catching.

Device Description ર.
The proposed device, Pen Needle, is designed for use with pen injectors for subcutaneous injection of a desired dose of drugs approved for delivery using a pen needle. It is provided sterile, single use.

The proposed device consists of four components, which are 1) Needle Container 2) Needle Shield 3) Needle Tube and 4) Needle Hub. Needle Container, together with Sealed Paper can forming the unit packaging of Pen Needle, that maintains the sterility of Pen Needle Hub can be connected screwed onto the pen injectors.

1. Identification of Predicate Device
  Predicate Device 510(k) Number: K171982 Product Name: Droplet® Pen Needle
1. Clinical Test Conclusion
  Not applicable.
1. Substantially Equivalent (SE) Comparison

ITEM	Proposed Device	Predicate DeviceK171982	Comment
Product code	FMI	FMI	Same
RegulationNo.	21 CFR 880.5570	21 CFR 880.5570	Same
ClassificationName	Hypodermic Single LumenNeedle	Hypodermic Single Lumen Needle	Same
RegulationClass	II	II	Same
Indicationsfor use	Pen Needle is intended foruse with pen injector devicesfor the subcutaneousinjection of drugs	Droplet® Pen Needlesare intended for usewith pen injectordevices for thesubcutaneous injectionof drugs.	Same
Prescription/OTC	OTC	OTC	Same
Supplied	Yes	Yes	Same
sterile
Single use	Yes	Yes	Same
Principle ofoperation	Manual	Manual	Same
Method ofattachment topen injector	Screw threads	Screw threads	Same
Model	0.18mm(34G) x 4mm TW	4mm x 32G	DifferentComment 1
	0.18mm(34G) x 4mm ETW	5mm x 32G
	0.20mm(33G) x 4mm TW	6mm x 32G
	0.20mm(33G) x 4mm ETW	8mm x 32G
	0.20mm(33G) x 5mm TW	5mm x 31G
	0.20mm(33G) x 5mm ETW	6mm x 31G
	0.20mm(33G) x 6mm TW	8mm x 31G
	0.20mm(33G) x 6mm ETW	10mm x 29G
	0.23mm(32G) x 4mm TW	12mm x 29G
	0.23mm(32G) x 4mm ETW
	0.23mm(32G) x 5mm TW
	0.23mm(32G) x 5mm ETW
	0.23mm(32G) x 6mm TW
	0.23mm(32G) x 6mm ETW
	0.25mm(31G) x 4mm TW
	0.25mm(31G) x 4mm ETW
	0.25mm(31G) x 5mm TW
	0.25mm(31G) x 5mm ETW
	0.25mm(31G) x 6mm TW
	0.25mm(31G) x 6mm ETW
	0.25mm(31G) x 8mm TW0.25mm(31G) x 8mm ETW0.30mm(30G) x 5mm TW0.30mm(30G) x 5mm ETW0.30mm(30G) x 6mm TW0.30mm(30G) x 6mm ETW0.30mm(30G) x 8mm TW0.30mm(30G) x 8mm ETW0.30mm(30G) x 10mm TW0.30mm(30G) x 10mm ETW0.33mm(29G) x 8mm TW0.33mm(29G) x 8mm TW0.33mm(29G) x 10mm TW0.33mm(29G) x 10mm TW
	0.33mm(29G) x 12mm TW
Biocompatibility	Conform with ISO 10993 standards	Conform with ISO 10993 standards	Same
Sterility	SAL=10-6	SAL=10-6	Same
Sterilization method	EO sterilized	Gamma irradiation	DifferentComment 2
Shelf Life	5 year	5 year	Same
UnitPackaging	Polypropylenecontainer with sealmade of medicalgrade paper	Polypropylenecontainer with sealmade of medicalgrade paper	Same
Material	Needle Tube:Medical GradeStainless SteelNeedle Hub, NeedleContainer, Needle Shield:Plastic resinsLubricant: Medical gradesilicone	Needle Tube:Medical GradeStainless SteelNeedle Hub, NeedleContainer, Needle Shield:Plastic resinsLubricant: Medical gradesilicone	Same
Configuration	Needle TubeNeedle HubNeedle ContainerNeedle Shield	Needle TubeNeedle HubNeedle ContainerNeedle Shield	Same
PerformanceTesting	Complied with:ISO 11608-2ISO 9626	Complied with:ISO 11608-2ISO 9626ISO 7864	DifferentComment 3

Table 1 Comparison of Technology Characteristics

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Image /page/6/Picture/1 description: The image shows the logo for CAINA. The logo is in blue and green. The text "CAINA" is in large, bold, blue letters, with a green triangle in the middle of the A's. Below the text is the website address "www.cainamed.com" in a smaller, blue font.

Comment 1

The models for proposed device are different from the predicate device. However, this difference is just in dimension. Different gauge, length and wall of needle tube will be selected by users. This difference does not affect intended use and not affect substantially equivalence on safety and effectiveness.

Comment 2

The sterilization method of proposed device is Eto, the sterilization method of predicate device is gamma irradiation. Both of them achieve a Sterility Assurance Level (SAL) of 106. Examination of the Ethylene Oxide (EO) and Ethylene Chlorohydrin (ECH) residuals have met with prolonged exposure devices allowable limits of ISO 10993-7AMD1:2019, this sterilization method difference does not affect substantially equivalence on safety and effectiveness.

Comment 3

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Predicate Device have been performed testing according to the requirements of clause 4.6 Freedom from defects (The needle tube shall fulfil the requirements of ISO 7864:1993, 11.3.) of ISO 11608-2:2012, the subject device performed the same testing according to the requirements of clause 5.2.5 Freedom from defects of the updated ISO 11608-2:2022. Although the reference ISO standards are different, but the same tests have been performed. The difference on reference ISO standards does not affect substantially equivalence on safety and effectiveness.

9. Non-Clinical Test

Non-clinical tests were conducted to verify that the proposed device met all design specifications as was Substantially Equivalent (SE) to the predicate device. The test results demonstrated that the proposed device complies with the following standards:

A ISO 9626:2016 Stainless steel needle tubing for the manufacture of medical devices - Requirements and test methods
ISO 11608-2:2022 Needle-based injection systems for medical use - Requirements and test methods -Part 2: Double-ended pen needles

Biocompatibilitv

In accordance with ISO 10993-1, the needle is classified as: Externally Communicating Device, Blood path indirect, Prolonged contact (> 24 hours to 30 days). The following endpoints were evaluated:

A Cytotoxicity
Irritation
Sensitization >
Acute Systemic Toxicity A
Subchronic Systemic Toxicity
Material-Mediated Pyrogenicity
Hemolysis
Particulate testing per USP <788> Light obscuration method

Sterilization, Shipping and Shelf-Life

The subject device has a 5-year shelf life

USP-NF <151> Pyrogen Test
A ASTM F1929-15 Standard test method for detecting seal leaks in porous medical packaging by dye penetration.
ASTM F88/F88M-21 standard method for seal strength of flexible barrier materials >
ASTM F1886/F1886M-16 Standard Test Method for Determining Integrity of Seals for Flexible Packaging by Visual Inspection
A ASTM F1140/F1140M-13 Standard Test Methods for Internal Pressurization Failure Resistance of Unrestrained Packages
A USP-NF <85> Bacterial Endotoxins Test
ISO 10993-7:2008 AMD.1:2019 Biological evaluation of medical devices- Part 7: Ethylene Oxide Sterilization Residuals

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Image /page/8/Picture/1 description: The image shows the logo for CAINA. The logo consists of the word "CAINA" in blue, with a green triangle in the middle of the "A" in the word. Below the word "CAINA" is the website address "www.cainamed.com" in a smaller font size.

> ISTA 3A:2018 Simulated Distribution

10. Substantially Equivalent (SE) Conclusion

The differences between the predicate and the subject device do not raise any new or different questions of safety or effectiveness. The Pen Needle is substantially equivalent to the Droplet® Pen Needle with respect to the indications for use, target population, 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).