DISPOSABLE HYPODERMIC NEEDLE

K092831 · Feel Tech · FMI · Jan 14, 2010 · General Hospital

Device Facts

• Record ID: K092831
• Device Name: DISPOSABLE HYPODERMIC NEEDLE
• Applicant: Feel Tech
• Product Code: FMI · General Hospital
• Decision Date: Jan 14, 2010
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 880.5570
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

FEELject NEEDLES is intended for use with syringes and injection devices for general purpose fluid injection/aspiration.

Device Story

FEELject NEEDLES are disposable, single-lumen hypodermic needles consisting of a sharpened metal tube attached to a female connector (hub) and a protective cap. Used in clinical settings for fluid injection or aspiration via syringes or injection devices. Device is non-toxic, non-pyrogenic, and intended for single use.

Clinical Evidence

Bench testing only. Testing included biocompatibility and sterility verification to demonstrate substantial equivalence to the predicate device.

Technological Characteristics

Single-lumen hypodermic needle; metal tube with female connector hub; various gauge sizes and lengths; sterilized by EtO gas; non-toxic; non-pyrogenic; disposable; single-use.

Indications for Use

Indicated for general purpose fluid injection or aspiration when used with syringes and injection devices.

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 Hypoint Needle (K070440)

Submission Summary (Full Text)

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#### 510(k) Summary 5.

## See 510(k) Summary, below.

### 1. Trade Name: FEELject NEEDLES

JAN 1 4 2010

- 2. Common Name: Disposable Hypodermic Needle. Classification Name: Single Lumen Hypodermic Needle. Product Code: FMI Regulation: 880.5570 Class of device : ClassII.
- 3. The legally marketed device to which we are claiming equivalence: BD Hypoint Needle (K070440)
- 4. Description of device:

FEELject NEEDLES is intended for use with syringes and injection devices for general purpose fluid injection/aspiration.

. The device consists of a metal tube that is sharpened at one end and at the other end joined to a female connector (hub)

The needle cap covers intended to provide physical protection to the needle tube.

- 5. Intended Use: FEELject NEEDLES is intended for use with syringes and injection devices for general purpose fluid injection/aspiration.
- 6. Technological Characteristics: FEELject NEEDLES and the predicate device have identical technological characteristics and perform the same way as common hypodermic Needle. FEELject NEEDLES are offered in various gauge sizes and needle lengths They are sterilized by EtO gas FEEL ject NEEDLES are Non-toxic, Non-Pyrogenic disposable and intended for single use
- 7. Performance: Bench tests were performed.

Bench testing included biocompatibility, sterility testing.

The tests demonstrated that the device is as safe , as effective and performs in a substantially equivalent manner to the predicate device.

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Food and Drug Administration 10903 New Hampshire Avenue Document Control Room W-066-0609 Silver Spring, MD 20993-0002

Feel Tech Corporation C/O Mr. Peter Chun President 300 Atwood Pittsburgh, Pennsylvania 15213

JAN 1 4 2010

Re: K092831

Trade/Device Name: FEELject NEEDLES Regulation Number: 21CFR 880.5570 Regulation Name: Hypodermic Single Lumen Needle Regulatory Class: II Product Code: FMI Dated: August 18, 2009 Received: September 14, 2009

Dear Mr. Chun:

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. Chun

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/Resourcesfor You/Industry/default.htm.

Sincerely yours.

Cathorn Q. water

nthony D. Watson, BS, MS, MBA 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): K09 .

Device Name: FEELject NEEDLES

Indications For Use: FEEL ject NEEDLES is intended for use with syringes and injection devices for general purpose fluid injection/aspiration.

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

Over-The-Counter Use (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)

Clawki

(Division Sign-Off) Division of Anesthesiology, General Hospital Infection Control, Dental Devices

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510(k) Number: K092831