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.

Device 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. B) The cartridge housing was modified to a one piece rather than a two 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. 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.

AI/ML Overview

Here's a breakdown of the acceptance criteria and study information based on the provided text for the Owen Mumford Autopen 3ml:

Context: The provided text is a 510(k) submission summary for the Owen Mumford Autopen 3ml, which is a device for insulin delivery. The core of the document focuses on demonstrating substantial equivalence to a previously approved device (Autopen 1.5ml K895890).

Acceptance Criteria and Reported Device Performance

The document doesn't explicitly list "acceptance criteria" in a numerical table format for a specific "study." Instead, it states that the device was tested to draft ISO/TC 84/WG3 standard "pen injectors of medical use" and that "As confirmed by ISO test results, Autopen® is safe and effective when used as intended."

This implies that the acceptance criteria are the requirements set forth in the mentioned ISO draft standard, and the device's performance met these criteria. However, no specific performance metrics or thresholds are provided in the text.

Table of Acceptance Criteria and Reported Device Performance (Inferred):

Acceptance Criteria (Inferred from ISO Draft Standard)	Reported Device Performance
Conformance to draft ISO/TC 84/WG3 standard "pen injectors of medical use" (e.g., accuracy of dose delivery, mechanical integrity, usability)	"Autopen® is safe and effective when used as intended." (Implies compliance with the standard's requirements for safety and efficacy.)

Study Details

Given the nature of the 510(k) submission, the "study" referred to is primarily a performance verification against a recognized standard rather than an independent clinical trial.

Sample size used for the test set and the data provenance:
- Sample Size: Not specified. The document only mentions "ISO test results" without detailing the number of devices tested.
- Data Provenance: Not explicitly stated, but the testing would have been conducted by or for Owen Mumford. The location of the testing laboratory is not provided. It's an internal test to demonstrate compliance with a standard.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not applicable as this was a performance test against an engineering standard, not a clinical study requiring expert ground truth for diagnostic purposes. The "ground truth" would be the objectively measured performance against the specifications defined by the ISO standard.
Adjudication method for the test set:
- Not applicable. Performance testing against an engineering standard typically involves objective measurements and comparisons against established parameters, not adjudication in the clinical sense.
If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:
- Not applicable. This device is a mechanical injection pen, not an AI-assisted diagnostic or therapeutic tool. Therefore, MRMC studies and AI-related effectiveness are irrelevant here.
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Not applicable. This is a mechanical device, not an algorithm.
The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- The "ground truth" for this performance test would be objective engineering measurements (e.g., dose accuracy, force required for injection, mechanical reliability) as defined and specified by the draft ISO/TC 84/WG3 standard "pen injectors of medical use."
The sample size for the training set:
- Not applicable. There is no AI component or machine learning "training set" involved with this mechanical device.
How the ground truth for the training set was established:
- Not applicable for the same reason as above.

Summary

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Owen Mumford, Inc.

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

Tel: 770-425-5138 Fax: 770-426-5365

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:

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.

a Canto Masma Caracter P

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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 (301) 594-4692. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. 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 (800) 638-2041 or (301) 443-6597 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:

부산관리 관련 무료를

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

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)

(Division Sign-Off) Division of Dental, Infection Control, and General Hospital Devices

510(k) Number

Regulation Number and Section

§ 880.5860 Piston syringe.

(a)
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.(b)
Classification. Class II (performance standards).