ULTICARE DISPOSABLE PEN NEEDLES

K100812 · Ultimed, Inc. · FMI · Jun 3, 2010 · General Hospital

Device Facts

• Record ID: K100812
• Device Name: ULTICARE DISPOSABLE PEN NEEDLES
• Applicant: Ultimed, Inc.
• Product Code: FMI · General Hospital
• Decision Date: Jun 3, 2010
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 880.5570
• Device Class: Class 2
• Attributes: Therapeutic, 3rd-Party Reviewed

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, Type A, hypodermic single lumen needles; designed for use with insulin pen injector devices for subcutaneous insulin delivery. Device components include a double-ended hollow steel cannula, needle hub, needle shield, and primary container. Operation involves screwing the needle hub onto an insulin pen injector; the proximal end of the cannula penetrates the insulin cartridge seal. After removing the shield, the user performs the injection. Used in clinical or home settings by patients or healthcare providers. Benefits include reliable insulin delivery for diabetes management.

Clinical Evidence

No clinical data. Bench testing only. Performance testing included compliance with ISO 7864, ISO 9626, and ISO 11608-2. Biocompatibility testing performed per ISO 10993-1 for limited exposure devices. Sterilization validated per ISO 11135 with residues meeting ISO 10993-7 limits.

Technological Characteristics

Materials: Steel cannula, plastic hub/shield. Dimensions: 29-32 gauge, 3/16"-1/2" lengths. Principle: Hypodermic single lumen needle for subcutaneous injection. Sterilization: Ethylene oxide (ISO 11135). Standards: ISO 7864, ISO 9626, ISO 11608-2, ISO 10993-1, ISO 10993-7.

Indications for Use

Indicated for patients requiring subcutaneous insulin injection for the treatment of diabetes. Compatible with insulin 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 Needles (K031200)
• Daejin Tech Medical Manufacturing Co., Ltd Top Fine® Insulin Pen Needles (K063466)

Submission Summary (Full Text)

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UltiMed UltiCare Disposable Pen Needles Traditional 510(k) Premarket Notification

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#### TRADITIONAL 510(K) SUMMARY 5.0

| Submitted by: | JUN - 3 2010<br>UltiMed Inc.<br>287 East Sixth Street<br>St. Paul, MN 55101 |
|-----------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Contact Person: | Mary Beth Henderson, Ph.D.<br>Principal Advisor<br>Regulatory & Clinical Research Institute, Inc.<br>5353 Wayzata Boulevard, Suite 505<br>Minneapolis, Minnesota 55416<br>952-227-3380<br>[e-mail] |
| Date of Summary: | May 7, 2010 |
| Device Trade Name: | UltiMed UltiCare™ Disposable Pen Needles |
| Common or Usual Name: | Pen Needles |
| Classification Name: | Hypodermic single lumen needles (§880.5570) |
| Product Code: | FMI |
| Predicate Device(s): | K002938: Becton Dickinson B-D Ultra-Fine™ III Pen Needle; Model 31<br>gauge x 3/16"<br>K031200: Becton Dickinson B-D Ultra-Fine™ Original Pen Needles (29<br>gauge x 1/2")<br>K063466: Daejin Tech Medical Manufacturing Co., Ltd Top Fine®<br>Insulin Pen Needles (29 - 32 gauge; 1/4" - 1/2") |
| Device Description: | The UltiCare Disposable Pen Needles are sterile, single-use, Type A,<br>hypodermic single lumen needles designed for use with insulin pen<br>injector devices. The UltiCare Disposable Pen Needles consist of a<br>double-ended cannula, a needle hub, a needle shield and the needle<br>primary container. The UltiCare Disposable Pen Needles are non-toxic<br>and non-pyrogenic, and are available in a variety of needle sizes (29<br>gauge to 32 gauge) and lengths (3/16" to 1/2"). |
| Intended Use: | The UltiCare Disposable Pen needles are used with insulin pen injector<br>devices for the subcutaneous injection of insulin in the treatment of<br>diabetes. |

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Technological Characteristics: The UltiCare Disposable Pen Needles are substantially equivalent in The UltiCare Disposable Fen Necdles and oals device desomptible predicate devices.

composition to the predicate devices consist of a double-ended The subject device and the predicate devices condios ormany container.
cannula, a needle hub, a needle shield and a needle primary container. cannula, a needle hub, a needle shield and a now from the upper (proximal)
The hollow steel cannula is ground at both ends. The upper (proximal) The hollow steel cannula is ground at both these who specific needle
part of the cannula is surrounded by a plastic screw thread. After part of the cannula is suffounded by a plaus one intention inside. After hub, so that the upper cannula end is totally madel in oroximal thread is
opening the sterile, primary container pockaging, the proximal thread is
the sterile, primary contai opening the sterile, primary continues positions the seal of the screwed onto the pen injector thereby ponotrainly container is then cartridge inside the injector. The needing the needle removed. After activating the per-micelor and rother any shield from the lower (distan) part cubcutaneous injection.

devices are ready for use to: Jae 10. January and be in a range of The UltiCare Disposable Pen Needles will be Grandian in the University
needle gauges and lengths encompassed by the predicate devices.

The UltiCare Disposable Pen Needles have been designed and tested
The UltiCare Disposable Pen Needers and EDA quidance The UltiCare Disposable Pen Needes nave adon and FDA guidance
to meet the requirements of voluntary standards and FDA guidance to meet the requirements of voluntaly stancelicate devices. Results of
documents applicable to the studies and predicate devices of substantial documents applicable to the subject the conclusion of substantial the non-clinical testing supports the considerior of Subdevices.

### Performance Testing:

The UltiCare Disposable Pen Needles have been designed and The UltiCare Disposable Pen Needles have been results outlined in ISO
successfully tested to meet the applicable requirements outlined in ISO
ne and and 11000 a 7864, ISO 9626 and ISO 11608-2.

7864, ISO 9020 and 100 thernal standards include: paper Additional performance testing to internal standardo include the testing.

### Biocompatibility Testing:

The materials of the UltiCare Disposable Pen Needles have The materials of the Ulting as outlined in ISO 10993-1 for devices
successfully passed testing as outlined in ISO 10993-1 for devices successfully passed testing as outlined in 100 1000 - 1000 - 1000 - 100 - 100 - 100 - 100 - 100 -Limited Exposure.

# Sterilization and Shelf-life Testing:

Stemlization and of the UltiCare Disposable Pen Needles has been validated
Sterilization of the UltiCare Disposable ISO 11135. The maximum Sterilization of the UltiCare Disposable Pen Necedits T. The maximum
using the half-cycle method as outlined in ISO 11135 . The maximum
will not using the half-cycle method as outined in 100 - 1100 - 1100 - 1100 - 1100 - 1100 - 100 - 100 - 100 - 100 - 100 - 100 - 100 - 100 - 100 - 100 - 100 - 100 - 100 - 100 - 100 - 1 levels of residues of elimits presented in ISO 10993-7.

exceed the limits presented in 100 m 100 m read after sterilization.

### Clinical Data:

No prospective clinical trials were conducted in support of this Traditional 510(k).

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K/008/2 Page 3 of 3

## Substantial Equivalence:

ារ ប ista . 1774 The UltiCare Disposable Pen Needles are substantially equivalent to The UltiCare Disposable Fen Necdes are ration, and basic composition
the intended use, function, principle of operation, and basic composition the intended use, function, principic of operation to voluntary standards
of the predicate devices. The non-clinical testing to voluntary standards of the predicate devices: "nees provide evidence the UltiCare and applicable FDA guidantees provident to the predicate Disposable Fen Necules are oubotanian), and performance.

devices in corner of each the UltiCare Disposable Pen Needles i he minor differences between the Oldoule Blopounsedle length, and the predicate devices of and the predicate devices; including novals group of safety or effectiveness.

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

JUN - 3 2010

UltiMed. Incorporated C/O Mr. Mark Job Responsible Third Party Official Regulatory Technology Services, LLC 1394 25th Street, NW Buffalo, Minnesota 55313

Re: K100812

Trade/Device Name: UltiMed UltiCare™ Disposable Pen Needles Regulation Number: 21 CFR 880.5570 Regulation Name: Hypodermic Single Lumen Needle Regulatory Class: II Product Code: FMI Dated: May 21, 2010 Received: May 24, 2010

Dear Mr. Job:

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. Mark Job

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,

Susan Bunner

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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UltiMed UltiCare Disposable Pen Needles Traditional 510(k) Premarket Notification

Page 4-1 of 1

### INDICATIONS FOR USE STATEMENT 4.0

510(k) Number:

To be determined.

Device Name:

UltiMed UltiCare™ Disposable Pen Needles

Intended Use:

The UltiCare Disposable Pen Needles are used with insulin pen injector devices for the subcutaneous injection of insulin per
treatment of diabetes treatment of diabetes.

Prescription Use: YES

AND/OR

Over-the-Counter Use: NO

(21 CFR 801 Subpart C)

(Part 21 CFR 801 Subpart D)

(Please do NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE

(ODE)

Jivision Sign-Off) Juvision of Anesthesiology, General Hospital nfection Control, Dental Devices

510(k) Number: K100817