(34 days)
The Autoject 2 is a hand held mechanical device intended for a self-administered automated subcutaneous injection of FDA approved drugs. The device is designed for use with a 1ml glass fixed needle syringe, for use in the home by the patient or care-giver to aid and support a recommended treatment regime.
The Autoject 2 O.T.C is a hand held non-sterile semi-automatic device using pre-filled 1ml glass syringes capable of a subcutaneous injection of FDA approved drugs. The devices are designed for re-usable use to aid and support patient/ care-giver use in the home with a treatment regime.
The provided text describes a medical device, the Autoject 2, and indicates that a 510(k) premarket notification was submitted and found substantially equivalent to a predicate device. However, the document does not contain details about specific acceptance criteria, comprehensive study designs, or detailed performance metrics that would typically be found in a robust study report proving a device meets acceptance criteria.
The information primarily focuses on the device's description, intended use, and a list of tests performed. It mentions "User Trials" but provides no specifics on their methodology or results beyond a general statement of "success."
Therefore, I cannot populate all the requested sections with specific, quantitative data. I will extract what is available and clearly state what information is not present in the provided text.
Here's an attempt to answer based solely on the provided text, highlighting the absence of detailed information:
1. A table of acceptance criteria and the reported device performance
| Acceptance Criteria (Inferred from tests performed) | Reported Device Performance (as stated in document) |
|---|---|
| Performance during 1 Meter Drop Test | Correct action (pass, no quantitative data available) |
| Force to Load | Correct action (pass, no quantitative data available) |
| Force to Fire | Correct action (pass, no quantitative data available) |
| Force to Remove RNS | Correct action (pass, no quantitative data available) |
| Force to Adjust Depth Adjuster | Correct action (pass, no quantitative data available) |
| Load and Fire Test | Correct action (pass, no quantitative data available) |
| Dry Firing | Correct action (pass, no quantitative data available) |
| Environmental Test | Correct action (pass, no quantitative data available) |
| Dose Efficiency Testing | Correct action (pass, no quantitative data available) |
| Handling a variety of drugs | Capable (pass, details under section 6, not provided) |
| User/Caregiver preference (User Trials) | Clearly indicates success (pass, no quantitative data available, user demographics or study details not provided) |
Note: The document only lists tests and states "proving the correct action" or "clearly indicates the success." It does not provide specific acceptance criterion values (e.g., "Force to Fire < 10N") or quantitative results for these tests.
2. Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective)
- Sample Size (Test Set): Not specified. The document mentions "User Trials" and "a number of tests" but does not quantify the number of devices or subjects used in these tests.
- Data Provenance: Not specified. The country of origin of the data is not mentioned, nor is it explicitly stated whether the data is retrospective or prospective. It is implied to be prospective testing for this 510(k) submission.
3. 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/Not specified. For a mechanical device like Autoject 2, "ground truth" would typically refer to objective measurements of force, function, and drop test outcomes, and user feedback. The document does not describe the involvement of "experts" in establishing ground truth for these performance tests or user trials.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set
Not applicable/Not specified. The document does not describe any adjudication methods, as this is typically relevant for subjective assessments, particularly in image interpretation or complex diagnostic scenarios, which are not detailed here.
5. 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 syringe needle introducer, not an AI diagnostic assistant. Therefore, an MRMC study comparing human readers with and without AI assistance is not relevant or described.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
Not applicable. This device is a mechanical medical device, not an algorithm. Performance tests would inherently involve the device acting "standalone" in its mechanical functions, but this terminology typically applies to AI algorithms.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
The "ground truth" for the performance tests would be objective physical measurements (e.g., force, direct observation of function, adherence to environmental conditions) and for the user trials, it would be patient/caregiver preference data (likely survey responses or qualitative feedback). The document provides no details on how this "ground truth" was rigorously established or quantified.
8. The sample size for the training set
Not applicable. This is a mechanical device, not a machine learning model, so there is no "training set" in the context of AI.
9. How the ground truth for the training set was established
Not applicable. As there is no training set for a mechanical device.
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NOV 1 3 2001
SUMMARY
Mr Robert Shaw. Submitted by: Vice President. Owen Mumford Incorporated. 1755 - A West Oak Commons Court. Marietta. Georgia 30062. USA.
770 977-2226. Tel: 770-977-2866 Fax:
| Device Name: | Autoject 2. |
|---|---|
| Classification Name: | Syringe Needle Introducers |
| Predicate Device: | Autoject 2 (K945660) |
Owen Mumford Limited has been successfully marketing syringe needle introducers throughout the world since 1986.
These products provide a safe and simple way to aid the patient in the home with a recommended treatment regime via a user administered semi-automatic injection.
Device Description.
The Autoject 2 O.T.C is a hand held non-sterile semi-automatic device using pre-filled 1ml glass syringes capable of a subcutaneous injection of FDA approved drugs.
The devices are designed for re-usable use to aid and support patient/ care-giver use in the home with a treatment regime.
The device contains a number of features, which adds to its safety and effectiveness as described under section 1 of this O.T.C application.
Intended Use.
The device is intended for a user administered semi-automatic injection of FDA approved drugs for use in the home by the patient or care-giver.
Operational.
The design concepts of the Autoject 2 submitted in this O.T.C application are such that it makes the principle safe and effective and user friendly in its function and is simply a later model of the current approved Autoject 2 (K945567).
510(K) Submission. Autoject 2. September 2001
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Performance.
A number of tests have been performed proving the correct action of a wide range of functions for this O.T.C application, they are as follows :-
- 1 Meter Drop Test. �
- Force to Load. �
- � Force to Fire.
- Force to Remove RNS. �
- Force to Adjust Depth Adjuster. �
- Load and Fire Test. �
- � Dry Firing.
- Environmental Test. �
- � Dose Efficiency Testing.
Additional tests have been performed in support of this O.T.C application to show that the Autoject 2 is capable of handling a variety of drugs. This is detailed under section 6 of this OTC application.
User Trials.
The correspondence included under section 9 of this over-the-counter submission clearly indicates the success of the device for patient/ care-giver preference as part of a recommended treatment regime.
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Image /page/2/Picture/1 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo features the department's symbol, which consists of three stylized human profiles facing to the right. The symbol is enclosed within a circular border, and the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is written around the upper portion of the circle.
Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
NOV 1 3 2001
Mr. Robert Shaw Vice President Owen Mumford USA, Incorporated 1755-A West Oak Commons Court Marietta, Georgia 30062
Re: K013362
Trade/Device Name: Autoject 2 Regulation Number: 880.6920 Regulation Name: Syringe Needle Introducer Regulatory Class: II Product Code: KZH Dated: August 31, 2001 Received: October 10,2001
Dear Mr. Shaw:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and 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) that do not require approval of a premarket approval application (PMA). 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 (PMA), 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 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies.
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Page 2 - Mr. Shaw
You must comply with all the Act's requirements, including, but not limited to: registration 1 ou inust comply with and 807); labeling (21 CFR Part 801); good manufacturing practice and insting (21 es result in the quality systems (QS) regulation (21 CFR Part 820); and if requirements tas set form in are quardiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
This letter will allow you to begin marketing your device as described in your Section 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 regulation (21 CFR Part 801 If you desire specific as not 10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4618. 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 Part 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers, International and aller receiner 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,
Timoth 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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INTENDED USE.
NOV 1 3 2001
Unknown.
510(k) Number:................................................................................................................................................................
Autoject 2 for O.T.C. Device Name : ................................................................................................................................................................
Indications for Use.
The Autoject 2 is a hand held mechanical device intended for a self-administered automated subcutaneous injection of FDA approved drugs.
The device is designed for use with a 1ml glass fixed needle syringe, for use in the home by the patient or care-giver to aid and support a recommended treatment regime.
Please do not write below this line - Continue on another page if necessary.
Concurrence of the CDRH, Office of Evaluation (ODE).
Prescription Use:............................................................................................................................................................. (per 21 CFR 801.109)
510(K) Submission. Autoject 2. September 2001
Over-the -Counter Use: .......................................................................................................................................................
Petrici Cucereh
(Division Sign-Off) Division of Dental, Infection Control, and General Hospital Devices 510(k) Number _ 10133
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§ 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).