STAT MEDICAL PEN NEEDLE by EMERGO GROUP, INC.

This document is a 510(k) summary, which typically focuses on demonstrating substantial equivalence to a predicate device rather than providing detailed study results and acceptance criteria in the way a clinical study report would. Therefore, much of the requested information regarding detailed acceptance criteria and study particulars will not be found directly in this document.

However, I can extract the information that is present and indicate where the document is silent on certain points.

Acceptance Criteria and Device Performance Table:

Feature/Metric	Acceptance Criteria	Reported Device Performance
Intended Use	For subcutaneous injection of insulin with a pen injector device (single-use).	"The Stat Medical Pen Needle is a single use device intended for use with a pen injector device for the subcutaneous injection of insulin." (This is its stated intended use, implying it meets this foundational criteria for equivalence).
Material	Not specified in this document.	Not specified in this document.
Dimensions (Gauge, Length)	Not specified in this document.	Not specified in this document.
Sterility	Must be sterile.	As a hypodermic single lumen needle, sterility is a fundamental requirement and implied by the classification (21 CFR 880.5570) and general GMP principles. Specific acceptance criteria (e.g., SAL) are not detailed here.
Biocompatibility	Must be biocompatible (no adverse reactions).	Implied by the device type and FDA regulations, but specific criteria and performance are not detailed here.
Needle Tip Sharpness/Penetration Force	Not specified in this document.	Not specified in this document.
Compatibility with Pen Injectors	Compatible with "a pen injector device."	Stated as "intended for use with a pen injector device." Specific compatibility tests or quantitative results are not in this summary.
Performance in Use (e.g., ease of attachment, fluid flow)	Not specified in this document.	Not specified in this document.

Additional Information based on the provided document:

Sample Size Used for the Test Set and Data Provenance:
- Test Set Sample Size: Not specified in this document. 510(k) summaries for Class II devices demonstrating substantial equivalence often rely on comparison to a predicate and adherence to recognized standards, rather than new, extensive clinical trials with specified sample sizes for "test sets" in the context of AI.
- Data Provenance: Not applicable. This document is related to a medical device (a pen needle), not an AI device or a study involving data.
Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications:
- Not applicable. This device is a physical medical instrument, not an AI or diagnostic tool requiring expert ground truth for a test set.
Adjudication Method for the Test Set:
- Not applicable.
Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:
- Not applicable. This is not an AI-assisted diagnostic device.
Standalone (Algorithm Only) Performance:
- Not applicable. This is not an algorithm.
Type of Ground Truth Used:
- Not applicable. The "ground truth" for a pen needle would be its physical and functional specifications meeting standards and equivalence to a predicate.
Sample Size for the Training Set:
- Not applicable. This device does not use a "training set" in the context of AI or machine learning.
How the Ground Truth for the Training Set was Established:
- Not applicable.

Summary of the Document's Purpose:

This document is an FDA 510(k) clearance letter for the "Stat Medical Pen Needle." Its primary purpose is to inform the manufacturer (Emergo Group, Inc. c/o BSI, Inc.) that the FDA has determined the device is "substantially equivalent" to legally marketed predicate devices. This determination allows the manufacturer to market the device.

The letter explicitly states that the review determined the device is substantially equivalent to predicate devices marketed prior to May 28, 1976 (or devices that do not require PMA approval), based on the "indications for use stated in the enclosure" (which is page {2} in your input).

The 510(k) process for devices like a pen needle typically relies on demonstrating that the new device has the same intended use, similar technological characteristics, and raises no new questions of safety and effectiveness as a legally marketed predicate device. The "study" in this context would be the information provided in the 510(k) submission, which would include engineering drawings, material specifications, performance testing data (e.g., sterilization validation, biocompatibility, force testing, flow rates, dimensions), and a comparison to the predicate device. These details are not typically summarized in the final FDA clearance letter provided here.

Summary

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Image /page/0/Picture/1 description: The image is a black and white seal for the Department of Health & Human Services - USA. The seal is circular with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. In the center of the seal is a stylized image of a bird.

APR 2 2 2005

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Emergo Group, Incorporated C/O Mr. Paul Brooks Responsible Third Party Official BSI, Incorporated 12110 Sunset Hills Road, Suite 200 Reston, Virginia 20190

Re: K042917

Trade/Device Name: Stat Medical Pen Needle Regulation Number: 21 CFR 880.5570 Regulation Name: Hypodermic Single Lumen Needle Regulatory Class: II Product Code: FMI Dated: April 7, 2005 Received: April 8, 2005

Dear Mr. Brooks:

We have reviewed your Section 510(k) premarket notification of intent to market the device we nave reviewed your becalent be oces) the device is substantially equivalent (for the referenced above and nave determined to legally marketed predicate devices marketed in indications for use stated in the encreases in the enactment date of the Medical Device interstate comments, or to thay 20, 1978, as secured in accordance with the provisions of Amendinents, of to devrees mat news Act (Act) that do not require approval of a premarket the Federal Food, Drug, and Cosmetic Pool , Love, Lore, subject to the general approval application (1 Mr.). I The general controls provisions of the Act include controls provisions of the rec. "The genting of devices, good manufacturing practice, requirements for and prohibitions against misbranding and adulteration.

If your device is classified (see above) into either class II (Special Controls) or class III If your device is classified (see above) into crontrols. Existing major regulations affecting (PMA), it may oe subject to suer additions, Title 21, Parts 800 to 898. In the Colors your device can be found in the South no announcements concerning your device in the Federal Register.

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Page 2 - Mr. Brooks

Please be advised that FDA's issuance of a substantial equivalence determination does not Please be advisod that I DA b issuance on that your device complies with other requirements mean that ITDA nas made a decommanent and regulations administered by other Federal agencies. of the Act of ally rederal statutes and regarments, including, but not limited to: registration You must comply with an all also hot s rog 21 CFR Part 801); good manufacturing practice and listing (21 CFR Pat 607), laceling (QS) regulation (21 CFR Pat 820); and if requirents as set forth in the quality by start of Steans (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) This letter will anow you to began manisting of substantial equivalence of your device to a premiarket notification. This Printers 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 at 150 for your we at (240) 276-0115. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the illay obtain other general micromational and Consumer Assistance at its toll-free Dribber (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely yours,

Jenite y. M. Mchane O md.

Chiu Lin, Ph.D. Director Division of Anesthesiology, General Hospital, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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510(k) Number (if known): ____________________________________________________________________________________________________________________________________________________

Device Name: Stat Medical Pen Needle

Indications for Use:

The Stat Medical Pen Needle is a single use device intended for use with a pen injector device for the subcutaneous injection of insulin.

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X Prescription Use only

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

(Optional Format 3-10-98)

(Posted July 1, 1998)

Chir Vm

vision Sign-Off , General Hospital, vision of Anesthesiology Intection Control, Den

510(k) Number:

K972911

Regulation Number and Section

§ 880.5570 Hypodermic single lumen needle.

(a)
Identification. A hypodermic single lumen needle is a device intended to inject fluids into, or withdraw fluids from, parts of the body below the surface of the skin. The device consists of a metal tube that is sharpened at one end and at the other end joined to a female connector (hub) designed to mate with a male connector (nozzle) of a piston syringe or an intravascular administration set.(b)
Classification. Class II (performance standards).