Pen Needle

K230635 · Jiangsu Caina Medical Co.,Ltd · FMI · Jun 2, 2023 · General Hospital

Device Facts

• Record ID: K230635
• Device Name: Pen Needle
• Applicant: Jiangsu Caina Medical Co.,Ltd
• Product Code: FMI · General Hospital
• Decision Date: Jun 2, 2023
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 880.5570
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

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

Device Story

Pen Needle is a sterile, single-use, manual hypodermic needle designed for attachment to pen injector devices via screw threads. It facilitates the subcutaneous delivery of drugs. The device comprises a needle tube (medical grade stainless steel), needle hub, needle container, and needle shield (plastic resins), with medical-grade silicone lubricant. It is intended for use in clinical or home settings by patients or healthcare providers. The user attaches the needle to a pen injector, performs the injection, and disposes of the device. The device ensures drug delivery through the subcutaneous route, benefiting patients requiring regular injections by providing a compatible interface for pen-based medication administration.

Clinical Evidence

No clinical data. Bench testing only. Performance verified against ISO 9626:2016 and ISO 11608-2:2022. Biocompatibility evaluated per ISO 10993-1 for externally communicating, blood path indirect, prolonged contact devices, including cytotoxicity, irritation, sensitization, systemic toxicity, pyrogenicity, and hemolysis. Packaging integrity validated via ASTM F1929-15, F88/F88M-21, F1886/F1886M-16, and F1140/F1140M-13. Sterilization residuals confirmed compliant with ISO 10993-7:2008 AMD.1:2019.

Technological Characteristics

Materials: Medical grade stainless steel (needle tube), plastic resins (hub, container, shield), medical grade silicone (lubricant). Principle: Manual, screw-thread attachment to pen injectors. Sterilization: Ethylene Oxide (EO) to SAL 10^-6. Standards: ISO 9626:2016, ISO 11608-2:2022, ISO 10993-1, ISO 10993-7, USP <788>, USP <85>, USP <151>, ASTM F1929-15, ASTM F88/F88M-21, ASTM F1886/F1886M-16, ASTM F1140/F1140M-13, ISTA 3A:2018.

Indications for Use

Indicated for use with pen injector devices for the subcutaneous injection of drugs in patients requiring such therapy.

Regulatory Classification

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.

Predicate Devices

• Droplet® Pen Needle (K171982)

Submission Summary (Full Text)

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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

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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 ([e-mail]) or phone [phone] 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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#### K230635 510(k) Summary

- Date of Preparation: May 05, 2023 1.
- 2. 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: [phone] Fax: [phone] 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: [e-mail] Tel: [phone]-8027 Fax: [phone]-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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- 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.

- 6. Identification of Predicate Device
Predicate Device 510(k) Number: K171982 Product Name: Droplet® Pen Needle

- 7. Clinical Test Conclusion
Not applicable.

- 8. Substantially Equivalent (SE) Comparison

| ITEM | Proposed Device | Predicate Device<br>K171982 | Comment |
|--------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------|
| Product code | FMI | FMI | Same |
| Regulation<br>No. | 21 CFR 880.5570 | 21 CFR 880.5570 | Same |
| Classification<br>Name | Hypodermic Single Lumen<br>Needle | Hypodermic Single Lumen Needle | Same |
| Regulation<br>Class | II | II | Same |
| Indications<br>for use | Pen Needle is intended for<br>use with pen injector devices<br>for the subcutaneous<br>injection of drugs | Droplet® Pen Needles<br>are intended for use<br>with pen injector<br>devices for the<br>subcutaneous injection<br>of drugs. | Same |
| Prescription/<br>OTC | OTC | OTC | Same |
| Supplied | Yes | Yes | Same |
| sterile | | | |
| Single use | Yes | Yes | Same |
| Principle of<br>operation | Manual | Manual | Same |
| Method of<br>attachment to<br>pen injector | Screw threads | Screw threads | Same |
| Model | 0.18mm(34G) x 4mm TW | 4mm x 32G | Different<br>Comment 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 TW<br>0.25mm(31G) x 8mm ETW<br>0.30mm(30G) x 5mm TW<br>0.30mm(30G) x 5mm ETW<br>0.30mm(30G) x 6mm TW<br>0.30mm(30G) x 6mm ETW<br>0.30mm(30G) x 8mm TW<br>0.30mm(30G) x 8mm ETW<br>0.30mm(30G) x 10mm TW<br>0.30mm(30G) x 10mm ETW<br>0.33mm(29G) x 8mm TW<br>0.33mm(29G) x 8mm TW<br>0.33mm(29G) x 10mm TW<br>0.33mm(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 | Different<br>Comment 2 |
| Shelf Life | 5 year | 5 year | Same |
| Unit<br>Packaging | Polypropylene<br>container with seal<br>made of medical<br>grade paper | Polypropylene<br>container with seal<br>made of medical<br>grade paper | Same |
| Material | Needle Tube:<br>Medical Grade<br>Stainless Steel<br>Needle Hub, Needle<br>Container, Needle Shield:<br>Plastic resins<br>Lubricant: Medical grade<br>silicone | Needle Tube:<br>Medical Grade<br>Stainless Steel<br>Needle Hub, Needle<br>Container, Needle Shield:<br>Plastic resins<br>Lubricant: Medical grade<br>silicone | Same |
| Configuration | Needle Tube<br>Needle Hub<br>Needle Container<br>Needle Shield | Needle Tube<br>Needle Hub<br>Needle Container<br>Needle Shield | Same |
| Performance<br>Testing | Complied with:<br>ISO 11608-2<br>ISO 9626 | Complied with:<br>ISO 11608-2<br>ISO 9626<br>ISO 7864 | Different<br>Comment 3 |

### Table 1 Comparison of Technology Characteristics

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#### 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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#### > 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.