OWEN MUMFORD 3ML AUTOPEN

K983974 · Owen Mumford USA, Inc. · FMF · Dec 21, 1998 · General Hospital

Device Facts

• Record ID: K983974
• Device Name: OWEN MUMFORD 3ML AUTOPEN
• Applicant: Owen Mumford USA, Inc.
• Product Code: FMF · General Hospital
• Decision Date: Dec 21, 1998
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 880.5860
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The delivery of insulin products using a variable dose pen for insulin dependent diabetics. The Owen Mumford Autopen® 3ml is a non-sterile, automatic, subcutaneous injection device which uses a replaceable 3ml insulin cartridge (supplied by others) held within the body of the device. Maximum delivery is 42 units in 2 unit increments. An automatic drive system is used to displace the insulin from the cartridge through sterile disposable pen needles.

Device Story

Autopen 3ml is a cylindrical, non-sterile, automatic subcutaneous injection device (165mm x 15mm). It holds a user-supplied 3ml insulin cartridge. Operation involves manual dose selection (up to 42 units in 2-unit increments) and an automatic mechanical drive system to displace insulin through a sterile disposable pen needle. Used by patients for self-administration of insulin. Device design is mechanically identical to the predicate Autopen 1.5ml, scaled to accommodate the larger 3ml cartridge. Improvements over the predicate include a one-piece cap, a more durable one-piece cartridge housing, and enhanced visibility of dose selector printing.

Clinical Evidence

Bench testing only. The device was tested to draft ISO/TC 84/WG3 standard "pen injectors of medical use" to confirm safety and effectiveness.

Technological Characteristics

Cylindrical form factor (165mm x 15mm). Mechanical, non-sterile, automatic subcutaneous injection device. Uses a replaceable 3ml insulin cartridge and sterile disposable pen needles. Mechanical drive system for insulin displacement. No software or electronic components.

Indications for Use

Indicated for insulin-dependent diabetics requiring subcutaneous insulin delivery via a variable dose pen injector.

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

• Autopen® 1.5ml (K895890)

Submission Summary (Full Text)

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## Owen Mumford, Inc.

849 Pickens Industrial Drive Suite 14 Marietta, Georgia 30062-3165

Tel: [phone] Fax: [phone]

# 510(K) SUBMISSION

《983974

# AUTOPEN 3ml

## SUMMARY

Submitted By:

Robert E. Shaw Owen Mumford, Inc. 849 Pickens Industrial Dr. Suite 14 Marietta, GA 30062-3165

Device Name: Substantial Equivalence: Classification Name:

Autopen® 3ml Autopen® 1.5ml K895890 Introducer, Syringe Piston

### DESCRIPTION:

Autopen® is cylindrical in shape, approximately 165mm x 15mm including cover. The Owen Mumford 3ml Autopen® is based upon a proven design marketed in both Europe since 1988 and the United Sates since 1989 when 510(k) approval was granted for the Owen Mumford 1.5ml Autopen® K895890. There has been no change at all to the design concept since then, and only minor design improvements otherwise in response to customer feedback and continuous improvement as required of a company with ISO 9001, FDA GMP and EN 46001 status. These changes are essentially cosmetic such as:

A) A one piece cap instead of a three piece cap to facilitate assembly.

- The cartridge housing was modified to a one piece rather than a two piece B) to piece to improve durability.
- C) The cartridge housing can now accommodate a 3.0ml cartridge as opposed to the 1.5ml and is made of one piece rather than 2 separate components in the Owen Mumford 1.5ml Autopen® K895890.
- D) The printing on the dose selector was changed to improve visibility.

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K983974

Page 2 510(k) Submission Autopen 3ml Summary

#### INTENDED USE:

The delivery of insulin products using a variable dose pen for insulin dependent diabetics. The Owen Mumford Autopen® 3ml is a non-sterile, automatic, subcutaneous injection device which uses a replaceable 3ml insulin cartridge (supplied by others) held within the body of the device. Maximum delivery is 42 units in 2 unit increments. An automatic drive system is used to displace the insulin from the cartridge through sterile disposable pen needles.

### OPERATIONAL:

The internal and operational mechanisms of the Autopen® 3ml are mechanically identical to it substantially equivalent Autopen® 1.5ml. The only difference is one of scale to operate the larger diameter 3.0ml cartridge.

#### PROFORMANCE:

The Autopen® 3ml has been tested to draft ISO/TC 84/WG3 standard "pen injectors of medical use". As confirmed by ISO test results, Autopen® is safe and effective when used as intended.

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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

DEC 2 1 1998

Mr. Robert E. Shaw Owen Mumford, Incorporated 849 Pickens Industrial Drive Suite 14 30062-3165 Marletta, Georgia

Re: K983974 Owen Mumford 3ml Autopen® Trade Name: Requlatory Class: II Product Code: FMF Dated: November 6, 1998 November 9, 1998 Received:

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 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). 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 (Premarket Approval), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 895. A substantially equivalent determination assumes compliance with the Current Good Manufacturing Practice requirements, as set forth in the Quality System Regulation (QS) for Medical General regulation (21 CFR Part 820) and that, Devices: through periodic QS inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to 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" (21CFR 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/dsma/dsmamain.html".

Sincerely yours,

Timothy A. Ulatowski

Director Division of Dental, Infection Control, and General Hospital Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Page 1 of 1

510(k) Number (if known):

Autopen 3ml Device Name:

Indications For Use:

The delivery of insulin products using a variable dose pen for insulin dependent diabetics. The Owen Mumford 3ml Autopen is a non-sterile automatic subcutaneous injection device which uses a replaceable 3ml insulin cartridge Suboutineous injoction in automatic drive system is used to displace the insulin from the cartridge through a sterile disposable needle.

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Concurrence of CDRH, Office of Device Evaluation (ODE) . : . . . . : - -Over-The-Counter Use_ OR Prescription Use (Per 21 CFR 801.109) (Optional Format 1-2-96)

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510(k) Number