EasyTouch Safety Pen Needle

K163578 · Mhc Medical Products, LLC · FMI · Aug 3, 2018 · General Hospital

Device Facts

• Record ID: K163578
• Device Name: EasyTouch Safety Pen Needle
• Applicant: Mhc Medical Products, LLC
• Product Code: FMI · General Hospital
• Decision Date: Aug 3, 2018
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 880.5570
• Device Class: Class 2
• Attributes: Therapeutic

Indications for Use

The EasyTouch™ Safety Pen Needle is intended for use with pen injector devices for the injection of drugs, including insulin and exenatide. Additionally, the attached safety shield automatically locks in place and reduces the occurrence of accidental needle sticks from the patient end of the needle. The shield also serves to hide the needle before and after injection.

Device Story

EasyTouch™ Safety Pen Needle is a sterile, single-use, disposable hypodermic needle for subcutaneous drug delivery via pen injectors. Device attaches to standard injector pens; protective sheath hides needle before use. During injection, sheath retracts; upon removal from skin, sheath automatically extends and locks over needle to prevent accidental sticks. Used by patients or healthcare providers in home or clinical settings. Benefits include reduced risk of sharps injury. Device is mechanical; no electronic or software components.

Clinical Evidence

No clinical trials performed. Substantial equivalence supported by bench testing and simulated clinical environment testing. Simulated use study evaluated safety feature functionality with both professional healthcare workers and non-clinician users. Additional testing included biocompatibility (cytotoxicity, skin irritation/sensitization, systemic toxicity, hemolysis), pen injector compatibility (ISO 11608-1/2), sterility (EO residue), and shelf-life/packaging integrity.

Technological Characteristics

Hub/Protector: Polypropylene. Needle: 304 Stainless steel with silicone lubricant. Safety feature: Stainless steel spring. Dimensions: 29G (5mm, 8mm). Connectivity: None. Sterilization: Ethylene Oxide (SAL 10⁻⁶). Standards: ISO 11608 (pen interface), ISO 10993 (biocompatibility), ISO 7864 (sterile needles), ISO 9626 (tubing).

Indications for Use

Indicated for patients requiring subcutaneous drug injections (e.g., insulin, exenatide) via pen injector devices. No specific age or gender contraindications provided.

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 Autoshield™ Pen Needle (K060007)

Submission Summary (Full Text)

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August 3, 2018

MHC Medical Products, LLC. % Daniel Kamm Kamm & Associates 8870 Ravello Ct. Naples, Florida 34114

Re: K163578

Trade/Device Name: EasyTouch™ Safety Pen Needle Regulation Number: 21 CFR 880.5570 Regulation Name: Hypodermic Single Lumen Needle Regulatory Class: Class II Product Code: FMI Dated: July 3, 2018 Received: July 6, 2018

## Dear Daniel Kamm:

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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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 of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (OS) 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 Industry and Consumer Education at its toll-free number [phone] or [phone] or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. 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 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 Industry and Consumer Education at its toll-free number [phone] or [phone] or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely.

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Tina Kiang, Ph.D. Acting 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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# Indications for Use

510(k) Number (if known) K163578

Device Name EasyTouch™ Safety Pen Needle

#### Indications for Use (Describe)

The EasyTouch™ Safety Pen Needle is intended for use with pen injection of drugs, including insulin and exenatide. Additionally, the attached safety shield automatically locks in place and reduces the occurrence of accidental needle sticks from the patient end of the shield also serves to hide the needle before and after injection.

| Type of Use (Select one or both, as applicable) | |
|-----------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------|
| <span style="white-space: nowrap;"><input type="checkbox"/> Prescription Use (Part 21 CFR 801 Subpart D)</span> | <span style="white-space: nowrap;"><input checked="" type="checkbox"/> Over-The-Counter Use (21 CFR 801 Subpart C)</span> |

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510(k) Summary K163578 MHC Medical Products 8695 Seward Rd. Fairfield, OH 45011 Tel: [phone] Contact Person: Sean O'Keefe Date Prepared: August 1, 2018

### 1. Identification of the Proposed Device:

Trade Name: EasyTouch™ Safety Pen Needle Regulation Number: 21 CFR 880.5570 Regulation Name: Hypodermic Single Lumen Needle Regulatory Class: Class II Product Code: FMI

- 2. Identification of the Predicate Device: BD Autoshield™ Pen Needle, K060007. Regulation Number: 21 CFR 880.5570 Regulation Name: Hypodermic Single Lumen Needle Regulatory Class: Class II Product Code: FMI
- 3. Description of Device: EasyTouch™ Safety Pen Needle is designed to be used with pen injectors for subcutaneous injections of a desired dose of drugs approved for delivery using a pen needle. The EasyTouch™ Safety Pen Needle is sterile (Ethylene Oxide sterilization procedure), and non-pyrogenic. It is a disposable, single use device. Additionally, the EasyTouch™ Safety Pen Needle is designed to reduce the occurrence of accidental needle sticks by providing a sheath that locks of the needle after use. Prior to injection, the end user will attach the EasyTouch™ Safety Pen Needle to an injector pen. The protective sheath will hide the needle from the user prior to use. Upon application of the needle to the sheath will retract to allow for the needle to enter the body. After the injection is complete, and the needle is removed from the skin, the protective sheath will automatically extend over the needle and lock into place. The EasyTouch™ Safety Pen Needle should be removed from the pen and discarded properly.
- 4. Intended Use/Indications for Use: The EasyTouch™ Safety Pen Needle is intended for use with pen injector devices for the injection of drugs, including insulin and exenatide. Additionally, the attached safety shield automatically locks in place and reduces the occurrence of accidental needle sticks from the patient end of the needle. The shield also serves to hide the needle before and after injection.
- 5. Technical Characteristics: EasyTouch™ Safety Pen Needles and the predicate devices have identical technological characteristics and perform the same way as common pen needles. The EasyTouch™ Safety Pen Needle and the predicate device both include safety features that are identical in function and performance. A detailed comparison table follows:

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## Comparison Table

| | BD Autoshield™ Pen Needle, K060007 | EasyTouch™ Safety Pen Needle |
|-----------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Indications for Use | The BD AutoShield™ Pen Needle is<br>intended for use with pen injector devices<br>for the injection of drugs, including insulin<br>and exenatide. Additionally, the attached<br>safety shield automatically locks in place<br>and reduces the occurrence of accidental<br>needle sticks from the patient end of the<br>needle. The shield also serves to hide the<br>needle before and after injection. | The EasyTouch™ Safety Pen Needle is<br>intended for use with pen injector devices<br>for the injection of drugs, including insulin<br>and exenatide. Additionally, the attached<br>safety shield automatically locks in place and<br>reduces the occurrence of accidental needle<br>sticks from the patient end of the needle. The<br>shield also serves to hide the needle before<br>and after injection. SAME. |
| USE | OTC | SAME |
| Principle of<br>operation | Serves as a single use pen needle. The<br>device is removed from its packaging and<br>screwed into a pen injector device. The<br>patient then injects the medicine by first<br>setting the dose on the pen, and then<br>inserting the needle into the skin and then<br>pressing the button on the pen. After the<br>injection the needle automatically retracts<br>into a shielded housing, thus preventing<br>an accidental needle stick. | SAME |
| Interface with pen<br>injector (e.g. luer<br>taper or others), | Employs standardized dimensions and luer<br>taper per ISO 11608, Needle-based<br>injection systems for medical use –<br>Requirements and test methods —The<br>dimensions of the attachment part of the<br>needle shall be such that the needle fits<br>and functions with pen injectors which are<br>in accordance with ISO 11608-1.<br>Unscrewing torque of the needle:<br>0.06~0.08 N.m. The standard 6% luer<br>taper is employed to help ensure a leak<br>free connection to the syringe or pen<br>assembly. | SAME |
| Material<br>information: Hub,<br>Hub protector,<br>Safety feature<br>Needle | Hub: Polypropylene<br>Hub Protector: Polypropylene<br>Safety Feature: Stainless steel spring<br>Needle: 304 Stainless steel needle with<br>silicone lubricant | Hub: Polypropylene<br>Hub Protector: Polypropylene<br>Safety Feature: Stainless steel spring<br>Needle: 304 Stainless steel needle with<br>silicone lubricant<br>SAME |
| Sizes/Lengths | 29G, 30G, and 31G<br>5 mm, 8 mm, 12.7 mm lengths | 29G: 3/16" (5mm) and 5/16" (8mm)<br>(29G only). This is a subset of the predicate. |
| Sterilization | SAL: 10⁻⁶<br>Gamma Sterilized | SAL: 10⁻⁶ SAME<br>Ethylene Oxide EQUIVALENT<br>See discussion below. |
| Shelf life | 5 Years | 5 Years SAME |
| Single use | YES | YES SAME |
| Biocompatibility | Complies with ISO10993 | Complies with ISO10993 |
| | BD Autoshield™ Pen Needle, K060007 | EasyTouch™ Safety Pen Needle |
| | series standards, (presumed, not stated in<br>510(k) summary) | series standards, and the following tests are<br>performed,<br>● Cytotoxicity: No cytotoxicity<br>● Skin Irritation: No evidence of skin<br>irritation<br>● Skin Sensitization: No evidence of<br>sensitization<br>● Acute Systemic Toxicity: No systemic<br>toxicity<br>● Hemolysis: No evidence of hemolysis<br>SAME |
| Photo | Image: BD Autoshield Pen Needle | Image: EasyTouch Safety Pen Needle<br>SIMILARITY IS OBVIOUS |

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### 6. Non-clinical testing: Bench Tests were performed. Bench Testing included:

- a. Performance of a Risk Analysis to guide the bench testing regimens.
- b. Biocompatibility per the ISO10993 series of biocompatibility tests: In- Vitro Cytotoxicity report, ISO 10993-5 Skin Sensitization test report ISO-10993-10 Intracutaneous study , ISO-10993-10 Systemic Toxicity test report, ISO-10993-11 Pyrogen test report , ISO-10993-11 All tests passed.
- ﻥ Mechanical testing: To establish proper functioning of the safety feature, testing was performed to evaluate the function of the safety feature in a simulated clinical environment utilizing both professional health care workers and non-clinician pen users using gloved hands. Reference: FDA Guidance Document: Guidance for Industry and FDA Staff, Medical Devices with Sharps Injury Prevention Features Document Issued on: August 9, 2005
- ರ. Pen injector compatibility testing was performed to show that the pen needle works properly with multiple brands of pen injectors. Validation basis ISO11608-1 and ISO11608-2
- e. Sterility testing including EO residues. A sterility assurance level of 10* has been demonstrated. We use Ethylene oxide sterilization whereas the predicate device uses gamma sterilization. The SAL levels for both methods are the same.
- f. Packaging and shelf life testing: Accelerated packaging testing was performed to assure a 5 year shelf life: Packaging integrity, packaging permeability, compression resistance, resistance to bacteria.
- Testing was performed to assure compliance with ISO 7864, Sterile hypodermic needles for single oo use -- Requirements and test methods.

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- h. Testing was performed to assure compliance with ISO 9626, Stainless steel needle tubing for the manufacture of medical devices -- Requirements and test methods
- 7. Clinical testing: Clinical testing was not required (per FDA guidance) to establish substantial equivalence. However SIMULATED CLINICAL TESTING was performed to meet the requirements of the FDA Guidance on Sharps Injury Prevention (2005) (see above)
- 8. Conclusion: Based on device comparison information and non-clinical bench testing, the proposed device is substantially equivalent to legally marketed predicate device BD Autoshield™ Pen Needle, K06007.