ULTICARE DISPOSABLE SYRINGES AND NEEDLES

K062702 · Ultimed, Inc. · FMF · Nov 29, 2006 · General Hospital

Device Facts

• Record ID: K062702
• Device Name: ULTICARE DISPOSABLE SYRINGES AND NEEDLES
• Applicant: Ultimed, Inc.
• Product Code: FMF · General Hospital
• Decision Date: Nov 29, 2006
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 880.5860
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The UltiCare disposable syringes and needles are used to draw a quantity of pharmaceutical from its container and allow administration of the pharmaceutical directly to the patient. As an alternative use the product will allow administration of the pharmaceutical to the patient via an intravenous port, heparin lock, or saline lock. The Insulin Syringes are intended for subcutancous injection of U-100 insulin.

Device Story

UltiCare disposable syringes and needles are sterile, single-use, piston-type devices consisting of a barrel, plunger rod, and permanently attached (unibody) hypodermic needle. Available in various combinations of syringe sizes (0.3–3.0 cc) and needle gauges (22–31G). Used by clinicians or patients to draw pharmaceuticals from containers and administer them via subcutaneous injection or through intravenous/heparin/saline ports. Devices are non-toxic and non-pyrogenic. No electronic or software components.

Clinical Evidence

No clinical data. Bench testing only.

Technological Characteristics

Standard piston-type syringe with permanently attached (unibody) hypodermic single lumen needle. Materials: non-toxic, non-pyrogenic. Sizes: 0.3 to 3.0 cc. Needle gauges: 22 to 31G. Lengths: 5/16" to 1.5". Sterile, single-use, disposable.

Indications for Use

Indicated for patients requiring subcutaneous injection of U-100 insulin (0.3 to 1.0 cc syringes) or administration of pharmaceuticals via direct injection, intravenous port, heparin lock, or saline lock (0.3 to 3.0 cc syringes).

Regulatory Classification

Identification

A piston syringe is a device intended for medical purposes that consists of a calibrated hollow barrel and a movable plunger. At one end of the barrel there is a male connector (nozzle) for fitting the female connector (hub) of a hypodermic single lumen needle. The device is used to inject fluids into, or withdraw fluids from, the body.

Predicate Devices

• UltiCare Low Dead Space Disposable Syringe (1 ml/cc x 22 G x 1.5") (K994230)
• UltiCare Disposable Syringe (3 ml/cc, 22 G x 1.5") (K033794)
• Becton Dickinson BD Insulin Syringes – Ultra-Fine™ and Ultra-Fine™ II (K024112)

Submission Summary (Full Text)

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Ulti Med UltiCare™ Disposable Syringes and Needles Traditional 510(k)

K062702

### 510(k) Summary

NOV 3 U 2006

#### Submitter

Date Prepared October 10, 2006

Ulti Med Inc. 287 East Sixth Street St. Paul, Minnesota Contact Person: Thomas E. Erickson Telephone: [phone] Fax: [phone]

### Name of Device

| Common Name: | Disposable syringes and needles, insulin syringes |
|----------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Proprietary Name: | UltiCare™ Disposable Syringes and Needles and Insulin Syringes<br>(numerous sizes and combinations varying between the smallest 0.3cc<br>x 31G x 5/16" and the largest 3.0cc x 22G x 1.5") |
| Classification Name: | Piston Syringe, Hypodermic single lumen needles |
| Regulation: | 880.5860, 880.5570 |
| Class: | Class II |
| Product Code: | FMF/FMI |

### Predicate Devices

The UltiCare Disposable Syringes and Needles are substantially equivalent in intended use, function and basic composition to the currently marketed UltiCare Low Dead Space Disposable Syringe (1 ml/cc x 22 G x 1.5"), K994230, and to the UltiCare Disposable Syringe (3 ml/cc, 22 G x 1.5"), K033794.

The Insulin Syringes are substantially equivalent in intended use, function and basic composition to the currently marketed Becton Dickinson BD Insulin Syringes – Ultra-Fine™ and Ultra-Fine™ II, K024112.

### Device Description

The UltiCare Disposable Syringes and Needles and Insulin Syringes are standard piston type syringes with permanently attached (unibody) needles. They are sterile, single-use, disposable piston syringes consisting of a syringe barrel, a plunger rod, and a hypodermic single lumen needle. The UltiCare Disposable Syringes and Insulin Syringes are non-toxic and non-pyrogenic, and are available in a variety of combinations of syringe sizes (0.3 to 3.0 cc (ml)), needle sizes (31 to 22 gauge), and needle lengths (5/16" to 1.5").

### Intended Use

The UltiCare disposable syringes and needles are used to draw a quantity of pharmaceutical from its container and allow administration of the pharmaceutical directly to the patient. As an alternative use the product will allow administration of the pharmaceutical to the patient via an intravenous port, heparin lock, or saline lock.

The Insulin Syringes are intended for subcutancous injection of U-100 insulin.

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/1/Picture/1 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo features a stylized image of an eagle or bird with outstretched wings. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the bird.

JUN 2 1 2007

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

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

Re: K062702

Trade/Device Name: Insulin Syringes, UltiCare™ Disposable Syringes and Needles Regulation Number: 21 CFR 880.5860 Regulation Name: Piston Syringe Regulatory Class: II Product Code: FMF, FMF, FMI Dated: September 8, 2006 Received: September 11, 2006

Dear Ms. Stamp

This letter corrects our substantially equivalent letter of November 29, 2006.

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 (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.

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.

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

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Page 2 - Ms. Stamp

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); 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.

This letter will allow you to continue marketing your device as described in your Section 510(k) premarket 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), please contact the Office of Compliance at [phone] http://www.fda.gov/cdrb/organiz.html#OC for OC organization structure). 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 Division of Small Manufacturers, International and Consumer Assistance at its tollfree number [phone] or [phone] or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html

Sincerely yours,

Chiu-Lin, Ph.D.

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

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Ulti Med UltiCare™ Disposable Syringes and Needles Traditional 510(k)

01

## Indications for Use

510(k) Number: K062702

Device Name: Insulin Syringes

Indications For Use:

The Insulin Syringes (0.3 to 1.0 cc) are intended for subcutaneous injection of U-100 insulin.

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

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

PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PACE IF NEEDED) Concurrence of CDRH, Office of Device Evaluation (ODE)

Surg Quane

euthesiology, General Hospits " onlivi, Dental Device

Ka2702

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Ulti Med UltiCare™ Disposable Syringes and Needles Traditional 510(k)

K067702

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# Indications for Use

510(k) Number: K062702

Device Name: UltiCare™ Disposable Syringes and Necdles

Indications For Use:

The UltiCare disposable syringes and needles (0.3 to 3.0 cc) are used to draw a quantity of pharmaceutical from its container and allow administration of the pharmaceur icul directly to the patient. As an alternative use the product will allow administration of the pharmacenty to to the patient via an intravenous port, heparin lock, or saline lock.

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

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)

Ald C. Chyn for mw 11/28/2006