ULTRACARE DISPOSABLE PEN NEEDLES, MODELS 31 GAUGE X3/16, 29 GAUGE X 1/2

K050464 · Ultimed, Inc. · FMI · May 11, 2005 · General Hospital

Device Facts

• Record ID: K050464
• Device Name: ULTRACARE DISPOSABLE PEN NEEDLES, MODELS 31 GAUGE X3/16, 29 GAUGE X 1/2
• Applicant: Ultimed, Inc.
• Product Code: FMI · General Hospital
• Decision Date: May 11, 2005
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 880.5570
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The UltiCare disposable pen needles are used with insulin pen injector devices for the subcutaneous injection of insulin in the treatment of diabetes.

Device Story

UltiCare Disposable Pen Needles are sterile, single-use, hypodermic single lumen needles; designed for use with insulin pen injector devices. Device consists of double-ended cannula, needle hub, needle shield, and primary container. Available in sizes 29G to 31G and lengths 3/16" to 1/2". Used by patients or clinicians for subcutaneous insulin delivery. Non-toxic and nonpyrogenic. Mechanical device; no electronic or software components.

Clinical Evidence

No clinical data. Bench testing only, demonstrating compliance with ISO 11608-2, ISO 9626, and ISO 7864 standards.

Technological Characteristics

Stainless steel needle tubing; double-ended cannula design. Sizes: 29G-31G, 3/16"-1/2" lengths. Standards: ISO 11608-2 (pen-injector needles), ISO 9626 (stainless steel tubing), ISO 7864 (sterile hypodermic needles). Sterile, single-use, non-toxic, nonpyrogenic.

Indications for Use

Indicated for patients with diabetes requiring subcutaneous insulin injection via pen injector 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

• Becton Dickinson B-D Ultra-Fine III Pen Needle (K002938)
• Becton Dickinson B-D Ultra-Fine Original Pen Needle (K031200)

Submission Summary (Full Text)

{0}------------------------------------------------

K050464

Confidential

Date Prepared

21 February 2004

## MAY 1 1 2005

## 510(k) Summary

#### Submitter

Ulti Med Inc. 287 East Sixth Street St. Paul, Minnesota Contact Person: Thomas E. Erickson

Telephone: [phone] Fax: [phone]

#### Name of Device

| Common Name: | Pen Needles |
|----------------------|-----------------------------------------------------------------------------------------------|
| Proprietary Name: | UltiCare™ Disposable Pen Needles (sizes varying between 31 Gauge x 3/16" and 29 Gauge x 1/2") |
| Classification Name: | Hypodermic single lumen needles |
| Regulation: | 880.5570 |
| Class: | Class II |
| Product Code: | FMI |

### Predicate Devices

The UltiCare Disposable Pen Needles are substantially equivalent in intended use, function and basic composition to the currently marketed Becton Dickinson B-D Ultra-Fine III Pen Needle; Model 31 gauge x 3/16", K002938, and to the Becton Dickinson B-D Ultra-Fine Original Pen Needle (29 gauge x 1/2"), K031200.

#### Device Description

The UltiCare Disposable Pen Needles are sterile, single-use, type A, hypodermic single lumen needles designed for use with insulin pen injector devices. The UltiCare Disposable Pen Needles consist of a double-ended cannula, a needle hub, a needle shield and the needle primary container. The UltiCare Disposable Pen Needles are non-toxic and nonpyrogenic, and are available in a variety of needle sizes (29 gauge to 31 gauge) and lengths (3/16" to 1/2").

#### Intended Use

The UltiCare disposable pen needles are used with insulin pen injector devices for the subcutaneous injection of insulin in the treatment of diabetes.

#### Technological Characteristics

The UltiCare Disposable Pen Needles have similar technological characteristics to the currently marketed predicate devices listed above. The UltiCare Disposable Pen Needles meet the following standards:

ISO 11608-2, Pen-injectors for Medical Use - Part 2: Needles - Requirements and Test Methods

ISO 9626, Stainless Steel Needle Tubing for Manufacture of Medical Devices ISO 7864, Sterile Hypodermic Needles for Single Use

{1}------------------------------------------------

Image /page/1/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a stylized caduceus symbol, which features a staff with a snake winding around it, and the text "DEPARTMENT OF HEALTH AND HUMAN SERVICES . USA" arranged in a circular pattern around the symbol. The text is in all caps and is smaller than the caduceus symbol.

#### Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

# MAY 1 1 2005

Ulti Med, Incorporated C/O Ms. Carole Stamp Principal Regulatory and Quality Advisor Regulatory and Clinical Research Institute, Incorporated 5353 Wayzata Boulevard, Suite 505 Minneapolis, Minnesota 55416-1334

Re: K050464

Trade/Device Name: UltiCare Disposable Pen Needles Regulation Number: 880.5570 Regulation Name: Hypodermic Single Lumen Needle Regulatory Class: II Product Code: FMI Dated: February 21, 2005 Received: February 25, 2005

Dear Ms. Stamp:

We have reviewed your Section 510(k) premarket notification of intent to market the device we nave roviewed your 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 mersule comments, or to devices that have been reclassified in accordance with the provisions of Amendinens, or to act , sod Cosmetic Act (Act) that do not require approval of a premarket the rederal I vou, Drag, and Osou may, therefore, market the device, subject to the general approvisions of the Act. The general controls provisions of the Act include controls providents or a registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.

If your device is classified (see above) into either class II (Special Controls) or class III II your device is classified (best additional controls. Existing major regulations affecting (1 MA), it may of subject to tack adata f Federal Regulations, Title 21, Parts 800 to 898. In your device can be found in the evas nouncements concerning your device in the Federal Register.

{2}------------------------------------------------

#### Page 2 - Ms. Stamp

Please be advised that FDA's issuance of a substantial equivalence determination does not I lease to advisod that 12 a determination that your device complies with other requirements mean that I DA nas made statutes and regulations administered by other Federal agencies. of the Fler of ally I ouchar backs requirements, including, but not limited to: registration I ou intest compry with a 807); labeling (21 CFR Part 801); good manufacturing practice allu listing (21 CF Rev or )) - systems (QS) regulation (21 CFR Part 820); and if requirements as set form in are quadiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

This letter will allow you to begin marketing your device as described in your Section 510(k) rms fet notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), If you don't the Office of Compliance at [phone]. Also, please note the regulation entitled "Misbranding by reference to premarket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the may obtain of Small Manufacturers, International and Consumer Assistance at its toll-free number [phone] or [phone] or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely yours,

Sautte y. Mchian O.M.S.

Chiu Lin, Ph.D. Director Division of Anesthesiology, General Hospital, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

{3}------------------------------------------------

Indications for Use

510(k) Number (if known):

K 050464

Device Name: UltiCare™ Disposable Pen Needles

Indications for Use:

The UltiCare disposable pen needles are used with insulin pen injector devices for the subcutaneous injection of insulin in the treatment of diabetes.

ﭘﮭ

Prescription Use V (21 CFR 801 Subpart C) (Part 21 CFR 801 Subpart D)

AND/OR Over-The-Counter Use

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Ats on

Traditional 510(k) Ulti Med Inc.

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

240(K) Mumber: ---------------------------------------------------------------------------------------------------------------------------------------------------------------