AUTO-INJECTOR, SURE-INJECT 2000 by MIGHTY MO, CORP.

This letter is a decision letter for a 510(k) submission, not a study report. Therefore, it does not contain the detailed information about acceptance criteria and study designs that would typically be found in a clinical study report or a premarket approval (PMA) submission.

The letter states that the device, the "Auto-Injector, Sure-Inject 2000™" (later referred to as "Auto Injector Pro-Ject 2000" in the Indications for Use), has been found "substantially equivalent" to legally marketed predicate devices. This substantial equivalence determination is the primary "acceptance criterion" for 510(k) submissions.

Here's what can be inferred or stated based on the provided document:

1. A table of acceptance criteria and the reported device performance:

Acceptance Criteria: For a 510(k) submission, the primary "acceptance criterion" is demonstrating substantial equivalence to a legally marketed predicate device. This typically involves showing that the new device has the same intended use and the same technological characteristics as the predicate, or if there are different technological characteristics, that they do not raise different questions of safety and effectiveness.
Reported Device Performance: The letter states, "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...". This implies that the data submitted by Mighty Mo, Corporation met the FDA's requirements for demonstrating substantial equivalence.
Specific performance metrics (like accuracy, precision, etc.) are NOT detailed in this letter. These would have been part of the technical documentation submitted by the manufacturer.

2. Sample size used for the test set and the data provenance:

NOT APPLICABLE / NOT PROVIDED: The letter does not describe a specific "test set" or data provenance as it's a regulatory decision letter, not a study report. Any testing performed would have been part of the manufacturer's submission to demonstrate substantial equivalence, but the details are not disclosed here.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

NOT APPLICABLE / NOT PROVIDED: This information pertains to establishing ground truth for a clinical study, which is not detailed in this regulatory letter.

4. Adjudication method for the test set:

NOT APPLICABLE / NOT PROVIDED: Similar to point 3, this is for clinical study design and not present in this document.

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 an auto-injector for insulin, not an imaging or diagnostic device that would typically involve "human readers" or AI assistance in interpretation. The letter does not mention any AI components.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:

NOT APPLICABLE: As mentioned above, this device is an auto-injector, not an algorithm-based diagnostic or assistive system.

7. The type of ground truth used:

NOT APPLICABLE / NOT PROVIDED: The concept of "ground truth" as used in relation to study data (e.g., pathology, outcomes data) is not detailed in this regulatory letter. The "truth" for this submission is based on the predicate device's established safety and effectiveness.

8. The sample size for the training set:

NOT APPLICABLE / NOT PROVIDED: If any training was performed for the device's development (e.g., in engineering tests), those details are not in this letter. This term is also more commonly associated with machine learning models.

9. How the ground truth for the training set was established:

NOT APPLICABLE / NOT PROVIDED: Similar to point 8.

In summary:

This document is an FDA 510(k) clearance letter. It confirms that the "Auto-Injector, Sure-Inject 2000™" (also referred to as "Pro-Ject 2000") for self-injection of insulin was found substantially equivalent to a predicate device. The letter itself does not contain the detailed study information regarding acceptance criteria, sample sizes, expert qualifications, or ground truth establishment that would be part of the manufacturer's 510(k) submission. These details would be found in the technical report or summary of data submitted by the company to the FDA.

Summary

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Image /page/0/Picture/1 description: The image shows the seal of the Department of Health & Human Services (HHS) of the United States. The seal features a stylized eagle with its wings spread, symbolizing protection and service. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" are arranged in a circular pattern around the eagle.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

JUL 1 1998

Mr. John D'Angelo ·Chariman Mighty Mo, Corporation 150 2nd Avenue North, Suite 920 St. Petersburg, Florida 33701

Re : K981266 Trade Name: Auto-Injector, Sure-Inject 2000™ Regulatory Class: II Product Code: KZH Dated: May 8, 1998 Received: May 20, 1998

Dear Mr. D'Angelo:

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 qeneral 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 Requlations, Title 21, Parts 800 to 895. ਰੋ 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 action. In addition, FDA may publish further announcements concerning your device in the Federal Register. 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. D'Angelo

through 542 of the Act for devices under the Electronic enrough 312 or chotrol 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/dsmamajn.html".

Sincerely yours,

Timothy A. Ulatowski

Timothy A. Ulatowski Diredtor 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 _________________________________________________________________________________________________________________________________________________________________________ of __

)510(k) Number (if known): K 981266

Device Name: Auto Injector Pro-Ject 2000

Indications For Use:

510 K # :K 981266

"Indications For Use"

The Pro-Ject 2000 is indicted for self-injection of Insulin

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Patua Crescente
(Division Sign-Off)

Division of Dental, Infection Control, and General Hospital Devices

510(k) Number K981266

Prescription Use (Per 21 CFR 801.109) OR

Over-The-Counter Use

(Optional Format 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).