A general purpose hand-held mechanical device intended for the subcutaneous injection of Insulin and other approved drugs. The device is designed for use with disposable 1ml non-fixed needle syringe and to accommodate self use in the home by the patient in order to aid and support compliance with the recommended treatment regime.

Device Description

A hand-held general purpose mechanical injection device for the sub-cutaneous injection of Insulin and other approved medicines.

AI/ML Overview

The provided text describes a 510(k) submission for the "Autoject®2 Non-Fixed Needle type" syringe introducer. This type of submission is for demonstrating substantial equivalence to a legally marketed predicate device, rather than proving that a device meets specific acceptance criteria through a comprehensive study with defined performance metrics and ground truth.

Therefore, many of the requested details about acceptance criteria, study design, expert involvement, and ground truth establishment are not applicable in the context of this 510(k) summary. The submission focuses on demonstrating equivalence to an existing device, the Autoject® 2 (Fixed Needle type), by highlighting similarities in design, intended use, and general performance.

Here's a breakdown of the information as it relates to the provided text:

Acceptance Criteria and Device Performance

Since this is a 510(k) submission for substantial equivalence, formal "acceptance criteria" as would be set for a novel device proving its efficacy and safety are not explicitly stated within the provided text. The primary acceptance criterion for the FDA in this context is the demonstration of substantial equivalence to a predicate device.

The document states: "The Autoject® 2 (Non-fixed Needle type) is visually identical to and has the same area of intended use i.e. for the sub-cutaneous injection of medicament, as the current 510(K) approved Autoject® 2 (Fixed Needle type) device to which substantial equivalence is claimed."

The specific performance aspect mentioned is "dose accuracy."

Acceptance Criteria	Reported Device Performance
Substantial Equivalence to Autoject® 2 (Fixed Needle type)	Claimed to be substantially equivalent in principle, design concepts, applications, and performance.
Dose Accuracy (implicit)	"Due to a small amount of residual drug being left in the space between the syringe and the needle hub the dose accuracy results show a slightly lower level of performance. However, if this residue is taken into account the performance of both types of devices are extremely close."

Study Details

The document mentions "NON-CLINICAL TRIAL DATA" and references "the study carried out in Australia." However, the details of this study are very limited in the provided text.

Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Sample Size: Not specified in the provided text.
- Data Provenance: A study was "carried out in Australia." It's not specified if it was retrospective or prospective.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
- Not Applicable. The provided text does not describe a study involving expert-established ground truth for a test set in the way you might find for a diagnostic or AI device. The study mentioned is for a mechanical injection device.
Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not Applicable. No information on adjudication methods for a test set is provided as this is not a diagnostic device or a study requiring such an approach.
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
- No. This is a mechanical injection device. MRMC studies and AI assistance for human readers are entirely irrelevant to this device and its 510(k) submission.
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- No. This is a mechanical injection device. The concept of an "algorithm only" or "human-in-the-loop" performance study does not apply.
The type of ground truth used (expert concensus, pathology, outcomes data, etc)
- Not Applicable. The "ground truth" for a mechanical device like this would likely relate to objective physical measurements (e.g., dose delivered, injection depth, force required) rather than expert consensus on diagnostic interpretations, pathology, or outcomes data in the typical sense. The text mentions "dose accuracy results," implying quantitative measurements.
The sample size for the training set
- Not Applicable. This is a mechanical device, not a machine learning algorithm requiring a training set.
How the ground truth for the training set was established
- Not Applicable. As above, no training set for an algorithm is involved.

Summary

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NOV 1 0 1999

AUTOJECT ®2 NON-FIXED NEED Is

10. 510K) SUMMARY

Submitted by:

Robert Shaw Director/ Vice President Owen Mumford Incorporated 849 Pickens Industrial Drive Suite 14 Marietta GA 30062

Tel: 770 425 5138

Device Name: Substantial Equivalence: Classification Name:

Autoject .2 (Non-Fixed Needle type) Autoject ®2 (Fixed Needle type) Syringe Needle Introducer

Owen Mumford have successfully been marketing the Autoject® 2 device throughout the world for several years. The Autoject ®2 (Non-Fixed Needle type) is simply a member of the same family of devices. The product has been widely accepted as an excellent medium for the administration of drugs via automatic injection throughout the EEC, Israel, Canada and Australia

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510(K) SUBMISSION AUTOJECT® 2 NON-FIXED NEEDLE

10. 510(K) SUMMARY

DESCRIPTION

A hand-held general purpose mechanical injection device for the sub-cutaneous injection of Insulin and other approved medicines.

The Autoject® 2 (Non-fixed Needle type) is visually identical to and has the same area of intended use i.e. for the sub-cutaneous injection of medicament, as the current 510(K) approved Autoject® 2 (Fixed Needle type) device to which substantial equivalence is claimed. The firing mechanisms of both devices are identical, the only difference being the design changes necessary for the syringe housing to accommodate and make safe the use of Non-Fixed needle type syringe,

INTENDED USE

Both the Autoject 62 (Non-Fixed Needle type) and the Autoject® 2 (Fixed Needle type) devices are intended for the sub-cutaneous injection of drug treatments.

OPERATIONAL

The principle, design concepts and applications of the Autoject 62 (Non-Fixed Needle type) and the Autoject 02 (Fixed Needle type) devices are substantially equivalent.

PERFORMANCE

Performance of both devices is substantially equivalent, the difference in ability to empty the contents of the syringe is due to the limitations of the type of syringe, i.e. Fixed or Non-fixed needle syringes. Due to a small amount of residual drug being left in the space between the syringe and the needle hub the dose accuracy results show a slightly lower level of performance. However, if this residue is taken into account the performance of both types of devices are extremely close,

NON-CLINICAL TRIAL DATA.

The correspondence included in section 9 of this submission, referencing the study carried out in Australia, clearly indicates the success of the device when used in the application of the medicament

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Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of the department's name arranged in a circular fashion around a symbol. The symbol is a stylized representation of three human profiles facing to the right, stacked on top of each other. The profiles are rendered in black, and the text is also in black.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

NOV 1 0 1999

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

Re: K993385

Autojet®2 (Non-Fixed Needle type) Syringe Trade Name: Needle Introducer II Requlatory Class: Product Code: KZH September 24, 1999 Dated: Received: October 8, 1999

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, Druq, 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 aqainst 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 Regulations, Title 21, Parts 800 to 895. A substantially equivalent determination assumes compliance with the Good Manufacturing Practice for Medical Devices: General (GMP) requlation (21 CFR Part 820) and that, through periodic GMP inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP requlation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in

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Page 2 - Mr. Shaw

the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.

This letter will allow you to begin marketinq 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 diaqnostic 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" (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 (800) 638-2041 or (301) 443-6597 or at its internet address "http://www.fda.qov/cdrh/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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510(k) Number (if known): K993385

Device Name: Autoject 2, Non-fixed Needle

Indications For Use:

A general purpose hand-held mechanical device intended for the subcutaneous injection of Insulin and other approved drugs. The device is designed for use with disposable Iml non-fixed needle syringe and to accommodate self use in the home by the patient in order to aid and support compliance with the recommended treatment regime,

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

Concurrence of the CDRH,Office of Device Evaluation (ODE)

Prescription Use (per 21 CFR 801.109)

Patraux OR Vincenti 0

Division Sinn-Off n of Dental, Infection Control, al Hospits 510(k) Numbe

Over-The-Counter Use

(Optional Formal 1-2-96)

Regulation Number and Section

§ 880.6920 Syringe needle introducer.

(a)
Identification. A syringe needle introducer is a device that uses a spring-loaded mechanism to drive a hypodermic needle into a patient to a predetermined depth below the skin surface.(b)
Classification. Class II (performance standards).