Terumo Pen Injector Needle 34

K140516 · Kofu Factory of Terumo Corp. · FMI · Aug 5, 2014 · General Hospital

Device Facts

• Record ID: K140516
• Device Name: Terumo Pen Injector Needle 34
• Applicant: Kofu Factory of Terumo Corp.
• Product Code: FMI · General Hospital
• Decision Date: Aug 5, 2014
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 880.5570
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Terumo® Pen Injector Needle 34 is intended for use with a pen injector device for the subcutaneous injection of drugs, including insulin.

Device Story

Terumo® Pen Injector Needle 34 is a manual, single-use, disposable hypodermic needle; designed for subcutaneous drug delivery via pen injector. Device features double-tapered stainless steel cannula; 29G at cartridge interface tapering to 34G at patient interface; 4 mm insertion length. Patient interface end utilizes 3-bevel asymmetrical tip. Device includes plastic hub, inner protector cap, and outer case. Operated manually by patient or clinician; user attaches needle to pen injector, removes caps, performs injection, and uses outer case for safe removal/disposal. Device facilitates drug administration; provides patient benefit through fine-gauge needle design for subcutaneous access.

Clinical Evidence

No clinical data. Substantial equivalence supported by bench testing, including ISO 11608-2 performance standards (surface finish, dimensions, stiffness, flow rate, bond strength, needle points), biocompatibility (ISO 10993), and sterilization validation (ISO 11137-1).

Technological Characteristics

Cannula: Stainless steel; Lubricant: Silicone oil; Adhesive: Polyacrylate; Hub/Outer Case: Polypropylene; Protector Cap: Polyethylene. Double-tapered design (29G to 34G). Manual operation. Sterilization: Electron beam (SAL 10^-6). Complies with ISO 11608-2:2012, ISO 9626, ISO 10993-1, and ISO 11137-1.

Indications for Use

Indicated for subcutaneous injection of drugs, including insulin, using a pen injector device. Suitable for general use.

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

• BD 31G and 32G Extra Thin Wall (XTW) Pen Needles with PentaPoint™ (K123300)
• Terumo® Micro Tapered Pen Needle (K052561)

Submission Summary (Full Text)

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Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an abstract image of a human figure in profile, with three faces overlapping each other.

Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

August 5, 2014

Mr. Phillip Michael Lester Regulatory Affairs Specialist Terumo Medical Corporation 950 Elkton Boulevard ELKTON MD 21921

Re: K140516

Trade/Device Name: Terumo® Pen Injector Needle 34 Regulation Number: 21 CFR 880.5570 Regulation Name: Needle, Hypodermic, Single Lumen Regulatory Class: II Product Code: FMI Dated: July 8, 2014 Received: July 9, 2014

Dear Mr. Lester:

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. 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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Page 2 - Mr. Lester

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 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); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Small Manufacturers, International and Consumer Assistance at its tollfree number [phone] or [phone] or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm. Also, please note the regulation entitled. "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number [phone] or [phone] or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely yours,

Mary S. Runner -S

Erin I. Keith, M.S. Director Division of Anesthesiology, General Hospital, Respiratory, Infection Control and Dental Devices Office of Device Evaluation 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) K140516

Device Name The Terumo® Pen Injector Needle 34

Indications for Use (Describe)

The Terumo® Pen Injector Needle 34 is intended for use with a pen injector device for the subcutaneous injection of drugs, including insulin.

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

X Prescription Use (Part 21 CFR 801 Subpart D)

× Over-The-Counter Use (21 CFR 801 Subpart C)

Digitally signed by Richard C.

Date: 2014.08.01 14:09:47 -04'00'

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#### FOR FDA USE ONLY

Concurrence of Center for Devices and Radiological Health (CDRH) (Signature)

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Chapman -S

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#### SECTION 5 - 510(k) SUMMARY

A summary of 510(k) safety and effectiveness information in accordance with the requirements of 21 CFR 807.92.

# Summary of Safety and Effectiveness

| A. Submitter Information. | 39 |
|----------------------------------|----|
| B. Device Name. | 40 |
| C. Predicate Device. | 40 |
| D. Reason for 510(k) Submission. | 40 |
| E. Device Description. | 40 |
| F. Intended Use. | 41 |
| G. Substantial Equivalence. | 41 |
| H. Nonclinical Tests. | 45 |
| I. Clinical Tests. | 47 |
| J. Conclusion. | 47 |

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TERUMO CORPORATION Terumo® Pen Injector Needle 34 Section 5. 510(k) Summary

#### 510(k) SUMMARY

## A. SUBMITTER INFORMATION (807.92(a)(1))

| Prepared by: | Phillip Michael Lester |
|--------------|-------------------------------|
| | Regulatory Affairs Specialist |
| | Terumo Medical Corporation |
| | Tel. [phone] |
| | Fax [phone] |

| Prepared for: | Owner/Operator<br>Terumo Corporation<br>44-1, 2-Chome, Hatagaya<br>Shibuya-Ku, Tokyo, Japan 151-0072<br>Registration Number: 8010026 |
|-----------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| | Manufacturer and Sterilization Facility (Applicant)<br>Kofu Factory of Terumo Corporation<br>1727-1, Tsuijiarai, Showa-Cho<br>Nakakoma-Gun, Yamanashi, Japan 409-3853<br>Registration Number: 9681835 |
| Contact Person: | Phillip Michael Lester<br>Regulatory Affairs Specialist<br>Terumo Medical Corporation<br>950 Elkton Boulevard<br>Elkton, MD 21921<br>Tel. [phone]<br>Fax [phone]<br>E-mail: [e-mail] |

Date prepared: April 4, 2014

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## B. DEVICE NAME (807.92(a)(2))

| Proprietary Name: | Terumo® Pen Injector Needle 34 (or similar) |
|-----------------------|---------------------------------------------|
| Common Name: | Hypodermic single lumen needle |
| Classification Name: | Needle, Hypodermic, Single Lumen |
| Classification Panel: | General Hospital |
| Regulation: | 21 CFR 880.5570 |
| Product Code: | FMI |
| Classification: | Class II |

## C. PREDICATE DEVICE (807.92(a)(3))

The legally marketed device(s) to which substantial equivalence is claimed is/are:

- 1. K123300 BD 31G and 32G Extra Thin Wall (XTW) Pen Needles with PentaPoint™, manufactured by Becton, Dickinson and Company, New Jersey.
- 2. K052561 Terumo® Micro Tapered Pen Needle, manufactured by Kofu Factory of Terumo Corporation, Japan.

# D. REASON FOR 510(K) SUBMISSION

This 510(k) is being submitted due to design modifications to the previously cleared device (K052561) that would prompt a new submission: 1) new needle gauge size, 34G (0.18 mm); 2) new needle insertion length of 4 mm (from previous 5 mm, cleared under K052561); 3) change in sterilization method (from gamma to electron beam); and 4) a change in the indications for use from the previously cleared device. Therefore, this Traditional 510(k) is being submitted for modifications to the current device (K052561) that do not qualify for Special 510(k).

# E. DEVICE DESCRIPTION (807.92(a)(4))

The Terumo® Pen Injector Needle 34 is comprised of a double-tapered stainless steel needle cannula that is pointed at both the cartridge interface end, to puncture the cartridge for drug delivery, and the patient interface end, for injection into the patient's body tissue. The patient interface end features a 3-bevel, asymmetrical needle edge.

The cannula tapers from a 29G (0.33 mm) outer diameter at the cartridge interface

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end to a 34G (0.18 mm) outer diameter at the needle tip (patient interface end). It is normal-walled (min. 0.089 mm inner diameter) at the needle tip, and the internal diameter tapers like the outer diameter (wall thickness is uniform throughout the needle length). The double-pointed needle is attached to a plastic hub which screws on to a compatible pen injector (not supplied with this device).

The needle insertion length (from the glue mount on the hub to the tip of the patient interface end) is 4 mm (5/32"). The length of the needle cartridge side is 6.5 mm (1/4"). The patient interface end (needle tip) is covered by a white plastic needle protector cap (inner needle cap) which is then covered by a clear plastic outer case (outer needle case). The cartridge interface end is then covered with a sealing film.

Just prior to use, the outer needle case is removed and retained for recapping once the injection is completed. The inner needle cap is then removed to expose the needle and the injection administered. After the injection, the user inserts the used needle into the open end of the outer needle case so it can be safely removed from the pen injector and disposed of immediately.

This pen needle device is individually packaged and sterilized by electron beam. It is a manually operated, disposable device intended for single use only.

#### F. INTENDED USE (807.92(a)(5))

The Terumo® Pen Injector Needle 34 is intended for use with a pen injector device for the subcutaneous injection of drugs, including insulin.

## G. SUBSTANTIAL EQUIVALENCE COMPARISON (807.92(a)(6))

The Terumo® Pen Injector Needle 34, subject of this Traditional 510(k), is substantially equivalent in its intended use, technology/principal of operation, materials, and performance to:

- 1. K123300 BD 31G and 32G Extra Thin Wall (XTW) Pen Needles with PentaPoint™, manufactured by Becton, Dickinson and Company, New Jersey.
- 2. K052561 Terumo® Micro Tapered Pen Needle, manufactured by Kofu Factory of Terumo Corporation, Japan.

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A comparison of the intended use/indications for use and technological characteristics is summarized in the table on the following page. The minor differences of indications for use and the technological differences do not impact the safety and effectiveness of the device.

Note: A statement of substantial equivalence to another product is required by 21CFR807.87, and relates only to whether the present product can be marketed without prior reclassification or clinical approval. The present submission is, therefore, not related to the coverage of any patent, and is not to be interpreted as an admission or used as evidence in a patent infringement lawsuit. As the Commissioner of the FDA has stated, " ...a determination of substantial equivalence under the federal Food, Drug, and Cosmetic Act relates to the fact that the product can lawfully be marketed without pre-market approval or reclassification. This determination is not intended to have any bearing whatever on the resolution of patent infringement suits" 42 Fed. Reg. 42,520, et seq. (1977)

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| Device<br>Characteristic | New Device: Terumo® Pen Injector<br>Needle 34 | Predicate: TERUMO® Micro<br>Tapered Pen Needle (K052561) | Predicate: BD 31G and 32G Extra<br>Thin Wall (XTW) Pen Needles with<br>PentaPoint™ (K123300) | |
|--------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------|
| Manufacturer | Kofu Factory of Terumo Corporation | Kofu Factory of Terumo Corporation | Becton, Dickinson and Company | |
| Intended Use | The Terumo® Pen Injector Needle<br>34 is intended for use with a pen<br>injector device for the subcutaneous<br>injection of drugs, including insulin. | The TERUMO® Micro tapered<br>pen needle is intended for use with<br>a pen injector device for the<br>subcutaneous injection of insulin.<br>It is indicated for general use and<br>for pediatric patients. | BD Pen Needle is intended for use<br>with pen injector device for<br>subcutaneous injection of drugs,<br>including insulin and exenatide. | |
| Operation<br>Principle | Manual | Manual | Manual | |
| Design /<br>Construction | • Needle assembly (cannula, needle<br>hub, protector cap)<br>• Designed to fit specified pen<br>injectors (new ISO 11608-2:2012<br>compatibility requirements) | • Needle assembly (cannula, needle<br>hub, protector cap)<br>• Designed to fit Type A pen<br>injectors (ISO 11608-2:2000) | • Needle assembly (cannula, needle<br>hub, protector cap)<br>• Designed to fit Type A pen<br>injectors | |
| Materials | • Cannula – Stainless Steel<br>• Lubricant - Silicone Oil<br>• Adhesive – Polyacrylate<br>• Needle Hub – Polypropylene<br>• Protector Cap – Polyethylene<br>• Outer Case – Polypropylene<br>• Sealing Film – Kraft Paper | • Cannula – Stainless Steel<br>• Lubricant - Silicone Oil<br>• Adhesive – Polyacrylate<br>• Needle Hub – Polypropylene<br>• Protector Cap – Polyethylene<br>• Outer Case – Polypropylene<br>• Sealing Film – Kraft Paper | • Cannula – Stainless Steel<br>• Lubricant - Silicone Based<br>Note: this is the information publicly<br>available for the device. | |
| Package | • Plastic outer case<br>• Sealing Film<br>• Shelf box | • Plastic outer case<br>• Sealing Film<br>• Shelf box | • Plastic outer case<br>• Sealing Film<br>• Shelf box | |
| Device<br>Characteristic | | New Device: TerumoⓇ Pen Injector<br>Needle 34 | Predicate: TERUMO® Micro<br>Tapered Pen Needle (K052561) | Predicate: BD 31G and 32G Extra<br>Thin Wall (XTW) Pen Needles with<br>PentaPoint™ (K123300) |
| Specifications | Taper | Double Tapered Design; 29G (0.33 mm) O.D. > 34G (0.18 mm) O.D. | Double Tapered Design; 28G (0.35 mm) O.D. > 33G (0.20 mm) O.D. | None; remains straight throughout |
| | Needle<br>Length | 4 mm (5/32") – Patient Interface<br>6.5 mm (1/4") – Cartridge Interface | 5 mm (3/16") – Patient Interface<br>5.5 mm (7/32") – Cartridge Interface | 4mm for 32G; 5mm and 8mm for<br>31G – Patient Interface |
| | Effective<br>Gauge | 34G | 33G | 31 and 32G |
| | Tip Configuration | Patient-side: Asymmetrical 3-bevel<br>Cartridge-side: Bent (Eccentric) | Patient-side: Asymmetrical 3-bevel<br>Cartridge-side: Bent (Eccentric) | Patient-side: 5-bevel |
| | Wall Type | Normal Wall (min. 0.089 mm) at<br>distal tip (patient interface end)* | Normal Wall (min. 0.089 mm) at<br>distal tip (patient interface end) | Extra Thin Wall |
| | Sterilization | E-beam radiation (validated in<br>accordance with ISO 11137-1 to<br>achieve SAL 10⁻⁶) | Gamma radiation (validated in<br>accordance with ISO 11137-1 to<br>achieve SAL 10⁻⁶) | Gamma radiation |

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*The I.D. tapers like the O.D. of the device. The I.D. is the distal portion of the needle. The wall thickness of the cannula remains uniform throughout.

The proposed device and the predicate devices are classified under 21 CFR 880.5570, which states: "A hypodermic single lumen needle is a device intended to inject fluids into, or withdraw fluids from, parts of the surface of the skin."

The proposed device and the predicate devices use statements similar to the excerpt from the regulation. The intended use of the devices are identical (the injection of fluids subcutaneously), and the indications only differ slightly between the proposed device and the predicates. The proposed device only differs from K 123300 in that exenatide is not included. However, the Terumo device is otherwise identical in indications for use to the BD Pen Needle (K123300).

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# H. NON CLINICAL TESTS (807.92(b)(1))

## Performance

Performance testing was conducted to ensure the safety and effectiveness of the Terumo® Pen Injector Needle 34 throughout the shelf life, verify conformity to the applicable parts of ISO standards, and demonstrate substantial equivalence to the predicate device. No new issues of safety and effectiveness were raised with the testing performed. The following performance tests were performed:

| Test | Standard | Result |
|----------------------------------------------------------------------------------|-----------------------------------------------|--------------------|
| Surface finish | ISO 11608-2: 2012,<br>ISO 9626: 1991, A1 2001 | Meets<br>standard. |
| Cleanliness | | |
| Limits for acidity and alkalinity | | |
| Dimensions | | |
| Stiffness | | |
| Resistance to breakage | | |
| Resistance to corrosion | | |
| Dimensions for needles | ISO 11608-2: 2012 | Meets<br>standard. |
| Determination of flow rate through the<br>needle | | |
| Bond between hub and needle tube | | |
| Needle points | | |
| Freedom from defects | | |
| Lubrication | | |
| Dislocation of measuring point at patient<br>end | | |
| Determination of functional compatibility<br>with needle-based injection systems | | |
| Ease of assembly and disassembly | | |
| Sterility | ISO 11608-2: 2012,<br>ISO 11137-1: 2006 | Meets<br>standard. |

No deviations from recognized consensus ISO standards were identified in the testing to standards, except where the design of the needle resulted in a modified method or acceptance criterion.

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Additionally, performance testing other than to the above ISO Standards was performed on the device. The device complies with the acceptance criteria established based on the predicates:

| Performance Test | Results |
|----------------------------|---------------------------|
| Penetration resistance | Meets acceptance criteria |
| Seal film fitting strength | Meets acceptance criteria |
| Cap-hub fitting strength | Meets acceptance criteria |

Performance testing demonstrates that the Terumo® Pen Injector Needle 34 conforms to the recognized consensus ISO standards, is substantially equivalent to the predicate devices, and is acceptable for clinical use throughout the shelf life.

## Biocompatibility

In accordance with ISO 10993-1, the Terumo® Pen Injector Needle 34 is classified as: Externally Communicating Device, Blood Path Indirect, Short Term (<24 hours) Use, as the cannula is immediately withdrawn after injection into the body. The finished device's blood/body contacting parts were tested in accordance with the tests recommended in the FDA General Program Memorandum #G95-1 (5/1/95): Use of International Standard ISO 10993-1, "Biological Evaluation of Medical Devices Part 1: Evaluation and Testing" and Draft Guidance for Industry and Food and Drug Administration Staff - Use of International Standard ISO-10993, "Biological Evaluation of Medical Devices Part 1: Evaluation and Testing." Screening tests were performed on accelerated aged devices to show that the biocompatibility is maintained throughout the shelf life of the product. Results of the testing demonstrate that the device is biocompatible throughout the shelf life of the product.

| Non-aged, sterile, whole device | |
|----------------------------------------------|--|
| Cytotoxicity | |
| Sensitization | |
| Intracutaneous reactivity (acute) | |
| Systemic toxicity (acute) | |
| Pyrogenicity | |
| Hemolysis | |
| Physicochemical Profile (USP <661> and FTIR) | |

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| Accelerated-aged (5 years), sterile, whole device |
|---------------------------------------------------|
| Cytotoxicity |
| Hemolysis |
| Physicochemical Profile (USP <661> and FTIR) |

## Sterilization

The sterility of the device is assured using a sterilization method validated in accordance with ANSI/AAMI/ISO 11137 - Medical Devices - Validation and Routine Control of Radiation Sterilization. Though the sterilization method has changed from gamma irradiation to electron beam irradiation for the modified device, the Terumo® Pen Injector Needle 34 is sterilized to provide a Sterility Assurance Level (SAL) of 10 . Performance testing demonstrated that the device functionality is substantially equivalent, and biocompatibility testing confirmed that the device is still biocompatible.

## Risk Analysis

A Product Risk Analysis was conducted in accordance with ISO 14971, taking into account the modifications to the previous device, and it was determined that any new risks were adequately captured and mitigated.

## I. CLINICAL TESTS (807.92(b)(2))

This 510(k) does not include data from clinical tests.

## J. CONCLUSION (807.92(b)(3))

In summary, the Terumo® Pen Injector Needle 34, subject of this 510(k), is substantially equivalent in its intended use, technology/principal of operation, materials, and performance to:

- 1. K123300 BD 31G and 32G Extra Thin Wall (XTW) Pen Needles with PentaPoint™, manufactured by Becton, Dickinson and Company, New Jersey.
- 2. K052561 Terumo® Micro Tapered Pen Needle, manufactured by Kofu Factory of Terumo Corporation, Japan.

There is no significant difference that raises any new issues of safety and effectiveness.