UNIFINE PENTIPS

K973899 · Owen Mumford USA, Inc. · FMI · Dec 4, 1997 · General Hospital

Device Facts

• Record ID: K973899
• Device Name: UNIFINE PENTIPS
• Applicant: Owen Mumford USA, Inc.
• Product Code: FMI · General Hospital
• Decision Date: Dec 4, 1997
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 880.5570
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Unifine Pentip are intended for the subcutaneous injection of drugs from prefilled cartridges used in conjunction with variable dose delivery systems such as Pen Injectors. Its intended use is substantially equivalent to that of the BD Microfine.

Device Story

Unifine Pentip is a single-use, disposable, hypodermic single-lumen needle; designed for attachment to variable dose pen injectors containing prefilled drug cartridges. Operation involves removing protective paper, screwing the needle onto the injector cartridge housing, dialing the dose, and performing subcutaneous injection. Primarily used for insulin delivery. Device is intended for patient self-use or clinician administration. Design and principle of operation are mechanically equivalent to existing hypodermic needles.

Clinical Evidence

No clinical data provided. Substantial equivalence is based on design, mechanical similarity, and performance comparison to the predicate device. Marketing history in Europe for over 12 months without adverse reports is noted.

Technological Characteristics

Single-lumen hypodermic needle; disposable; single-use. Mechanical design and form factor are equivalent to the predicate Becton Dickinson Microfine. No electronic components, software, or energy sources.

Indications for Use

Indicated for subcutaneous drug delivery from prefilled cartridges using multidose pen injectors; intended for single-use, disposable application.

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 Microfine

Reference Devices

• Braun Omnican

Submission Summary (Full Text)

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K973899

DEC - 4 1997

## 510k SUBMISSION

# UNIFINE PENTIPS

## SUMMARY

Submitted by:

Robert E. Shaw Owen Mumford, Inc. 849 Pickens Industrial Dr. Suite 14 Marietta, GA 30062

Unifine Pentip Device Name: Becton Dickinson Microfine Substantial Equivalence: Hypodermic Single Lumen Needle Classification Name:

Owen Mumford has been marketing the Unifine Pentip throughout Europe for over 12 months without any adverse customer reports. The product has also been sold throughout Europe by the original manufacture under the name "Braun Omnican."

#### DESCRIPTION

The Owen Mumford Unifine Pentip is visually and mechanically extremely similar to the BD Microfine Pentip to which substantial equivalence is claimed.

#### INTENDED USE

The Unifine Pentip are intended for the subcutaneous injection of drugs from prefilled cartridges used in conjunction with variable dose delivery systems such as Pen Injectors. Its intended use is substantially equivalent to that of the BD Microfine.

#### OPERATIONAL

The principle operation and design concepts of the Unifine Pentip are substantially equivalent to that of the BD Microfine Pentip.

### PERFORMANCE

Performance of the Unifine Pentip, when compared to the BD Microfine, is substantially equivalent.

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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Mr. Robert E. Shaw ·Vice President Owen Mumford, Incorporated 849 Pickens Industrial Drive, Suite 14 Marietta, Georgia 30062

DEC - 4 1997

K973899 Re : Unifine Pentips Trade Name: Requlatory Class: II Product Code: FMI Dated: October 14, 1997 Received: October 14, 1997

Dear Mr. Shaw:

We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to 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). You may, therefore, market the device, subject to the general controls provisions The general controls provisions of the Act 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 (Premarket Approval), it may be subject to such additional controls. Existing major requlations affecting your device can be found in the Code of Federal Requlations, Title 21, Parts 800 to 895. ਸੋ substantially equivalent determination assumes compliance with the current Good Manufacturing Practice requirement, as set forth in the Quality System Regulation (QS) for Medical General requlation (21 CFR Part 820) and that, Devices: through periodic (QS) inspections, the Food and Drug Failure to Administration (FDA) will verify such assumptions. comply with the GMP regulation may result in regulatory In addition, FDA may publish further announcements action. concerning your device in the Federal Reqister. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531

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Page 2 - Mr. Shaw

through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or requlations.

This letter will allow you to begin marketing your device as described in your 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 requlation (21 CFR Part 801 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at [phone]. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number [phone] or [phone] or at its internet address "http://www.fda.gov/cdrh/dsmamain.html".

Sincerely yours,

Timoth A Ulatowski Director Division of Dental, Infection Control and General Hospital Devices Office of Device Evaluation Center for Devices and Radioloqical Health

.Enclosure

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510(k) Number (if known): Not known

UNIFINE PENTIPS Device Name:

Indications for use:

The Unifine Pentip is single use, disposable hypodermic single lumen needle designed for use with multidose injection devices that use prefilled cartridges.

The protective paper is removed from the Pentip which is then screwed onto the device cartridge housing and then used in the prescribed manner.

One of the main uses of the Pentip is for use with pen Injectors for the delivery of insulin which is supplied in the form of prefilled cartridges. The patient places a fresh Pentip needle onto the Pen Injector, dials a dose, inserts the Pentip into the skin and delivers the dose.

| Concurrence of CDRH, Office of Device Evaluation (ODE). | |
|---------------------------------------------------------|------------------|
| (Division Sign-Off) | Patricia Cucente |
| Division of Dental, Infection Control, | |
| and General Hospital Devices | |
| F 0(k) Number | 8973899 |
| Prescription Use | X |
| OR Over-the-Counter Use | |

(Per 21CFR 801.109)

(Optional Format 1-2-96)