(42 days)
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.
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.
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.
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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.
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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.
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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.
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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.
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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.
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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."
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The sample size for the training set:
- Not applicable. There is no AI component or machine learning "training set" involved with this mechanical device.
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How the ground truth for the training set was established:
- Not applicable for the same reason as above.
§ 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).