MEDOJECT fine Pen Needles

K220614 · Chirana T. Injecta · FMI · Jun 15, 2022 · General Hospital

Device Facts

• Record ID: K220614
• Device Name: MEDOJECT fine Pen Needles
• Applicant: Chirana T. Injecta
• Product Code: FMI · General Hospital
• Decision Date: Jun 15, 2022
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 880.5570
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

MEDOJECT™ fine Pen Needles for single use are intended for subcutaneous delivery of insulin in conjunction with injection pens.

Device Story

MEDOJECT™ fine Pen Needles are sterile, single-use, hypodermic needles designed for subcutaneous insulin delivery. The device consists of a stainless steel cannula, polypropylene hub, protective caps, and a paper seal. It is intended for use by patients or clinicians in home or clinical settings. The user attaches the needle to a compatible injection pen (ISO 11608-1 compliant) and manually inserts the needle tip into the skin to deliver the insulin dose. The device facilitates drug administration by providing a sterile, sharp, and compatible interface between the pen injector and the patient's subcutaneous tissue. The needle caps ensure sterility and protection until the point of use. The device is available in various gauges (29G-32G) and lengths (4mm-12.7mm) to accommodate different patient needs.

Clinical Evidence

No clinical data. Substantial equivalence is supported by bench testing, including conformance to ISO 7864 (sterile needles), ISO 11608-2 (needle-based injection systems), and ISO 9626 (stainless steel tubing). Biocompatibility testing was performed per ISO 10993-1, including cytotoxicity, sensitization, irritation, systemic toxicity, material-mediated pyrogenicity, and hemocompatibility. Sterility, shipping, and shelf-life were validated per ISO 11135, ASTM D4169, and ASTM F1980.

Technological Characteristics

Cannula: 304 stainless steel; Hub/Outer Cap: polypropylene; Inner Cap: polyethylene; Joint: medical grade glue; Lubricant: medical grade silicone; Seal: medical paper. Sterilization: Ethylene Oxide (SAL 10⁻⁶). Connectivity: Mechanical screw-thread attachment per ISO 11608-1. Dimensions: 29G-32G gauges; 4mm-12.7mm lengths.

Indications for Use

Indicated for subcutaneous delivery of insulin in patients requiring insulin therapy using injection pens.

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

• UltiCare Disposable Pen Needles (K213407)

Submission Summary (Full Text)

{0}

FDA U.S. FOOD & DRUG ADMINISTRATION

Chirana T. Injecta
% Nathan Wright
Engineer and Regulatory Specialist
Empirical Testing Corp.
4628 Northpark Drive
Colorado Springs, Colorado 80918

Re: K220614
Trade/Device Name: MEDOJECT fine Pen Needles
Regulation Number: 21 CFR 880.5570
Regulation Name: Hypodermic Single Lumen Needle
Regulatory Class: Class II
Product Code: FMI
Dated: May 11, 2022
Received: May 13, 2022

Dear Nathan Wright:

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

U.S. Food & Drug Administration
10903 New Hampshire Avenue
Silver Spring, MD 20993
www.fda.gov

{1}

K220614 - Nathan Wright
Page 2

requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting (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-reporting-combination-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-devices/medical-device-safety/medical-device-reporting-mdr-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/medical-devices/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-devices/device-advice-comprehensive-regulatory-assistance/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,

Courtney Evans -S
Digitally signed by Courtney Evans -S
Date: 2022.06.15 15:32:31 -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

{2}

FORM FDA 3881 (6/20)
Page 1 of 1
PSC Publishing Services [phone] EF

| DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration Indications for Use | Form Approved: OMB No. 0910-0120 Expiration Date: 06/30/2023 See PRA Statement below. |
| --- | --- |
| 510(k) Number (if known) K220614 | |
| Device Name MEDOJECT™ fine Pen Needles | |
| Indications for Use (Describe) MEDOJECT™ fine Pen Needles for single use are intended for subcutaneous delivery of insulin in conjunction with injection pens. | |
| Type of Use (Select one or both, as applicable) ☐ Prescription Use (Part 21 CFR 801 Subpart D) ☑ 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 [e-mail] | |
| "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}

K220614 - 510(K) SUMMARY

| Preparation Date: | March 2, 2022 |
| --- | --- |
| Submitter’s Name: | CHIRANA T. Injecta, a.s. |
| Submitter’s Address: | Nám. Dr. Schweitzera 194
Stará Turá 916 01
Slovak Republic |
| Submitter’s Telephone: | 421-32-770-9972 |
| Contact Person: | Nathan Wright MS
Empirical Testing Corp.
1-719-351-0248
[e-mail] |
| Trade or Proprietary Name: | MEDOJECT™ fine Pen Needles |
| Classification Name: | Hypodermic single lumen needles |
| Classification: | Class II per 21 CFR §880.5570 |
| Product Code: | FMI |
| Classification Panel: | Drug Delivery and General Hospital Devices, and Human Factors (DHT3C) |

Predicate Device: K213407, UltiCare Disposable Pen Needles, UltiMed Incorporated

## DESCRIPTION OF THE DEVICE SUBJECT TO PREMARKET NOTIFICATION:

The MEDOJECT™ fine Pen Needles consist of a cap, needle cap, needle, hub, and paper. The cap and paper function to maintain the sterility of the needle. The device is single use and supplied sterile (ethylene oxide sterilized). The hub is connected to the injection pen for manual subcutaneous injection of appropriate does to the user. The needle cap protects the needle. The available size options are shown below.

| Needle Size | Color Code | | Item Code |
| --- | --- | --- | --- |
| 29G x 10mm | | Yellow | CHPN2910 |
| 29G x 12.7mm | | Pink | CHPN29127 |
| 30G x 6mm | | Dark Blue | CHPN3006 |
| 30G x 8mm | | Light Blue | CHPN3008 |
| 31G x 4mm | | Green | CHPN3104 |
| 31G x 5mm | | Dark Violet | CHPN3105 |
| Needle Size | Color Code | | Item Code |
| --- | --- | --- | --- |
| 31G x 6mm | | Dark Blue | CHPN3106 |
| 31G x 8mm | | Light Blue | CHPN3108 |
| 32G x 4mm | | Green | CHPN3204 |
| 32G x 5mm | | Dark Violet | CHPN3205 |
| 32G x 6mm | | Dark Blue | CHPN3206 |
| 32G x 8mm | | Light Blue | CHPN3208 |

## INDICATIONS FOR USE

The MEDOJECT™ fine Pen Needles are single use and are intended for subcutaneous delivery of insulin in conjunction with injection pens.

| Characteristic | Subject Device
MEDOJECT™ fine Pen Needles | Predicate Device
UltiCare Disposable Pen Needles, UltiMed Incorporated (K213407) |
| --- | --- | --- |
| Indications for Use | MEDOJECT™ fine Pen Needles for single use are intended for subcutaneous delivery of insulin in conjunction with injection pens. | The UltiCare™ Disposable Pen Needles are used with pen injector devices for the subcutaneous injection of drugs. |
| Rx or OTC | Over the Counter | Over the Counter |

## Discussion of differences in Indications for Use:

There are editorial differences to the indications for use statement between the subject and predicate device which do not change the indications. The predicate generically indicates the pen needles for drug delivery while the subject limits the delivery to only insulin, which is within the predicate indication.

CHIRANA T. Injecta MEDOJECT™ fine Pen Needles

{4}

K220614 - 510(k) Summary

# TECHNOLOGICAL CHARACTERISTICS

The table below includes a comparison of the technological characteristics between the subject and the predicate devices:

| | MEDOJECT™ fine Pen Needles | UltiCare Disposable Pen Needles | Comparison |
| --- | --- | --- | --- |
| 510(k) Number | Subject | K213407 | |
| Manufacturer | CHIRANA T. Injecta, a.s. | UltiMed Incorporated | |
| Regulation Number | 21 CFR § 880.5570 | 21 CFR § 880.5570 | Same |
| Classification Name | Hypodermic Single Lumen Needle | Hypodermic Single Lumen Needle | Same |
| Regulatory Class | Class II | Class II | Same |
| Product Code | FMI | FMI | Same |
| Operating Principle | The user manually inserts the needle tip into the skin to deliver insulin to the patient through a pen injector to which the pen needle is attached. | The user manually inserts the needle tip into the skin to deliver drug to the patient through a pen injector to which the pen needle is attached. | Same |
| Needle Gauge | 29G, 30G, 31G, 32G | 29G, 30G, 31G, 32G | Same |
| Needle Length¹ | 4mm, 5mm, 6mm, 8mm, 10mm, 12.7mm | 4mm, 5mm, 6mm, 8mm, 12.7mm | Similar |
| Material² | Cannula: 304 stainless steel
Needle hub: polypropylene
Needle Outer Cap: polypropylene
Needle Inner Cap: polyethylene
Joint medium: Medical grade glue
Lubricant: medical grade silicone
Seal: medical paper | Cannula: 304 stainless steel
Needle hub: polyethylene
Needle Outer Cap: Unknown
Needle Inner Cap: Unknown
Joint medium: Unknown
Lubricant: Unknown
Seal: Unknown | See Note |
| Needle Connector Type | Compatible with pen injectors which comply to ISO 11608-1 with screw threading attachment. | Compatible with pen injectors which comply to ISO 11608-1 with screw threading attachment. | Same |
| Design³ | Outer Cap; Inner Cap; Cannula;
Hub; Paper Seal | Protective Outer Container; Shield; Cannula; Hub | Similar |
| Biocompatibility | Per ISO 10993 | Per ISO 10993 | Same |
| Sterility | Ethylene Oxide to SAL of 10⁻⁶ | Ethylene Oxide to SAL of 10⁻⁶ | Same |
| Shelf Life⁴ | 5 years | Unknown | See Note |

¹The subject offers an additional needle length (10mm) not offered by the predicate to accommodate a wider range of patient needs. This difference does not affect the safety and effectiveness of the subject because all subject needle lengths are according to the size specifications in ISO 11608-2.
²Subject and predicate materials are similar but not identical. Differences in hub materials or in joint medium, lubricant, and seal do not introduce concerns for safety and efficacy of the subject device. Biocompatibility testing and performance testing confirmed that all materials of subject are safe and effective for use.
³The subject and predicate have the same needle, hub, and outer and inner cap design. The use of a paper seal and its material in the predicate is unknown. Differences in paper seal do not affect safety and effectiveness of the subject device. Performance testing confirmed that the subject design was safe and effective for use.
⁴Differences in shelf life would have no effect on the safety and effectiveness of the subject device. The shelf life of the sterile subject device was established through shelf life testing.

# PERFORMANCE DATA

The MEDOJECT™ fine Pen Needles described in this summary were tested and demonstrated to be in conformance with the following FDA recognized standards:

- ISO 7864 4th Ed-2016, Sterile hypodermic needles for single use – Requirements and test methods
- Limits for extractable metals

CHIRANA T. Injecta MEDOJECT™ fine Pen Needles

{5}

K220614 - 510(k) Summary

- ISO 11608-2 2nd Ed-2012, Needle-based injection systems for medical use – Requirements and test methods – Part 2: Needles
- Flow rate through rate
- Bond between hub and needle tube
- Functional compatibility with insulin injectors
- Ease of assembly and disassembly
- ISO 9626 2nd Ed-2016, Stainless steel needle tubing for the manufacture of medical devices – Requirements and test methods
- Needle sharpness – penetration force
- Limits of acidity and alkalinity
- Stiffness
- Resistance to breakage
- Resistance to corrosion

## Biocompatibility

In accordance with ISO 10993-1, the pen needle is classified as Externally Communicating Device, Blood Contact Indirect, Prolonged Contact (24 hours to 30 days). The following testing was conducted:

- Cytotoxicity (ISO 10993-5)
- Sensitization (ISO 10993-10)
- Irritation/Intracutaneous reactivity (SIO 10993-10)
- Subacute/Sub-chronic Toxicity (ISO 10993-11)
- Acute Systemic Toxicity (ISO 10993-11)
- Material-Mediated Pyrogenicity (ISO 10993-11/USP <151>)
- Hemocompatibility (ASTM F756)

## Sterility, Shipping, and Shelf-Life

- EO sterilization validation (ISO 11135)
- Simulated Packaging (ASTM D4169)
- Accelerated aging for shelf-life (ASTM F1980)

## CONCLUSION

The differences between the predicate and the subject device do not raise any new or different questions of safety or effectiveness. The MEDOJECT™ fine Pen Needles are substantially equivalent to the UltiCare Disposable Pen Needle (K213407) with respect to the indications for use, target populations, treatment method, and technological characteristics.

CHIRANA T. Injecta MEDOJECT™ fine Pen Needles