EASY TOUCH

K112789 · Mhc Medical Products, LLC · FMI · Dec 23, 2011 · General Hospital

Device Facts

• Record ID: K112789
• Device Name: EASY TOUCH
• Applicant: Mhc Medical Products, LLC
• Product Code: FMI · General Hospital
• Decision Date: Dec 23, 2011
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 880.5570
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

These disposable sterile insulin pen needles are intended for subcutaneous injection of insulin in the treatment of diabetes

Device Story

Easy.Touch Pen Needle is a sterile, single-use, disposable hypodermic needle designed for subcutaneous insulin delivery. The device consists of a needle hub, needle, needle cap, and sterile cap. It attaches to standard insulin pens to facilitate medication administration. The device operates on the principle of common piston syringes. It is intended for use by patients or healthcare providers in clinical or home settings. The device provides a sterile fluid path and is supplied EO sterilized. It serves as a relabeled version of the Feel Fine pen needle.

Clinical Evidence

Bench testing only. Testing included biocompatibility, compatibility with ISO Type A pens, mechanical testing, and sterility testing (including EO residues). No clinical data was required or provided.

Technological Characteristics

Single-use, sterile, disposable hypodermic needle. Compatible with ISO Type A standard pens. Sterilization method: Ethylene Oxide (EO) to a sterility assurance level of 10^-6. Materials are non-toxic and non-pyrogenic.

Indications for Use

Indicated for subcutaneous insulin injection in patients with diabetes. For use with insulin 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

• Feel Fine insulin pen needle (K080904)
• Becton Dickenson Pen Needles (K100005)
• Becton Dickenson Pen Needles (K051899)

Submission Summary (Full Text)

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K112789

## 510(K) Summary, K11

DEC 2 3 2011

MHC Medical Products 11930 Kemper Springs Drive, Cincinnati, Ohio 45240, U.S.A. Ph: 513 619-8030 Fax: [phone] Contact person: John Edmiston Date prepared: September 19, 2011

- 1. Trade Name: Easy. Touch Pen Needle Common Name: Pen Needle Classification Name: Syringe, piston, product code FMI, Regulation: 880.5570 Class of device: Class II.
- 2. The legally marketed device to which we arc claiming equivalence [807.92(a)(3) : Feel Fine insulin pen needle K080904 (Easy.Touch is a relabeled version of this product) as well as K100005 and K051899 Becton Dickenson Pen Needles.
- 3. Description of device: The Pen Needle consists of a sterile cap, needle cap needle hub, which can be fixed with needle and protected by blister paper. The sterile cap functions to maintain the sterility of the needle because sterile cap covers the needle hub and needle cap with blister paper sealed on the opening hole of sterile cap. The needle hub can be connected to the pen. The needle cap cover is intended to provide physical protection to the needle tube. They are supplied with a sterile fluid path, (EO), nontoxic, and non pyrogenic, for single use only, disposable. The devices operate on the principles of common piston syringes.
- 4. Intended use: These disposable sterile insulin pen needles are intended for subcutaneous injection of insulin in the treatment of diabetes.
- 5. Technological characteristics: The Easy Touch Pen Needles and the predicate devices have identical technological characteristics and perform the same wav as common piston syringes. These syringes are EO sterilized. The sterility assurance level is 10° They are compatible with ISO "Type A" standard pens.
- Performance: Bench tests were performed. Bench testing included biocompatibility, 6. compatibility with ISO Type A pens, mechanical testing, sterility testing including EO residues. The tests demonstrated that the device is as effective, and performs in a substantially equivalent manner to the previous predicate devices. The Easy. Touch devices are relabeled versions of the Feel Fine (K080904) product. Predicate labeling (BD) was evaluated and found to be comparable to our current labeling.

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## Truthful and Accuracy Statement as required per 21CFR807.87(k). Exhibit 6.

I certify that, in my capacity as Vice President of MHC Medical Products, I believe, to the best of my knowledge, that all data and information submitted in this premarket notification are truthful and accurate, and that no material fact has been omitted.

JOHN EDMISTON

September 19, 2011

ジール | アイフリ

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Image /page/2/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 text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is an abstract symbol resembling an eagle or bird in flight, composed of three curved lines.

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

MHC Medical Products C/O Mr. Daniel Kamm Principal Consultant Kamm & Associates 8870 Ravello Court Naples, Florida 34114

DEC 2 3 2011

Re: K112789

Trade/Device Name: Easy-Touch Pen Needle Regulation Number: 21 CFR 880.5570 Regulation Name: Hypodermic Single Lumen Needle Regulatory Class: II Product Code: FMI Dated: November 17, 2011 Received: November 22, 2011

Dear Mr. 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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## Page 2 - Mr. Kamm

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 go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices /ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. 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,

Anthony D. Aain

Anthony D. Watson, B.S., M.S., M.B.A. Director Division of Anesthesiology, General Hospital, 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): K11 2789 .

Device Name: Easy.Touch Pen Needle

Indications For Use:

These disposable sterile insulin pen needles are intended for subcutaneous injection of insulin in the treatment of diabetes

Prescription Use (Part 21 CFR 801 Subpart D) AND/OR

Over-The-Counter Use _ X (21 CFR 807 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Rill C. Chope 12/21/11
(Division Sign-Off)

Division of Anesthesiology, General Hospital Infection Control, Dental Devices

510(k) Number: k112789

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