The Stat Medical Pen Needle is intended for use with a pen injector device for the subcutaneous injection of insulin. This is the same intended use as previously cleared for the Stat Medical Pen Needle, K042917.

Device Description

The Stat Medical Pen needle consists of 4 parts, the needle hub, the needle protector and the outer cover. The cannula is manufactured from 304 stainless steel. The cannula is produced into three sizes for the device (the 29g 12.7 mm (1/2 in), 31g 5mm (3/16 in) and the 31g 8mm (5/16 in). The cannula length and inner diameter are a constant for these three sizes, which differ in the outer diameter of the cannula.

The hub is molded from medical grade polypropylene, and medical grade silicon. The needle is glued into place in the hub and is coated with a medical grade silicon/lube. The silicone oil/lube is non-toxic, pyrogen free, and free from contamination. After assembly, the hub and needle assembly are tested, packaged, and sterilized.

The Stat Pen Needle is provided sterile via EO sterilization and is for Single Use only.

The modification to the original filing is the correction of where the silicon coating is applied to the device, and a change in the product labeling to include the identification of the silicon coating. Product labeling may be found in section 9 of this submission.

AI/ML Overview

This document is a 510(k) summary for a medical device (Stat Medical Pen Needle), not a study analyzing device performance against acceptance criteria in the context of AI/ML or comparative effectiveness. Therefore, most of the requested information regarding acceptance criteria, study design, expert involvement, and AI performance metrics is not applicable.

Here's a breakdown of what can be extracted and what cannot:

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

This document does not specify quantitative acceptance criteria or provide performance data from a study for the device. It focuses on demonstrating substantial equivalence to a predicate device.

Acceptance Criteria	Reported Device Performance
Not specified	Not specified

2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective):

Not applicable. This is a 510(k) submission document for a physical medical device, not an AI/ML-driven study. There is no "test set" in the context of evaluating algorithm performance.

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. There is no "ground truth" to establish in this context as it's not an AI/ML study. The determination of device characteristics and substantial equivalence is based on engineering specifications and comparison to a predicate device, not expert consensus on data.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:

Not applicable. There is no test set for adjudication.

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 is not an MRMC comparative effectiveness study involving human readers and AI.

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

Not applicable. This is not a study of an algorithm; it's a submission for a physical medical device.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):

Not applicable. There is no ground truth in the context of an AI/ML study mentioned here. The "truth" for this device revolves around its physical properties, manufacturing processes, and adherence to safety and performance standards equivalent to a predicate device.

8. The sample size for the training set:

Not applicable. There is no training set mentioned, as this is not an AI/ML study.

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

Not applicable. There is no training set and therefore no ground truth establishment for a training set.

Summary of Device and 510(k) Filing Information (from the document):

Name of Device: Stat Medical Pen Needle / Super-Fine Pen Needle
Common Name: Sterile disposable hypodermic needle
Intended Use: For use with a pen injector device for the subcutaneous injection of insulin.
Description: Consists of a needle hub, needle protector, outer cover, and a cannula made of 304 stainless steel. Available in 29g 12.7mm, 31g 5mm, and 31g 8mm. The hub is molded from medical grade polypropylene and silicon. The needle is silicon coated, glued, tested, packaged, and sterilized by EO.
Modification: Correction of where the silicon coating is applied and a change in product labeling to include identification of the silicon coating.
Substantial Equivalence Claim: Based on same indication for use, same operating principle, incorporation of same materials, same sterilization and packaging, and same basic design as a predicate device (K042917).
Regulatory Status: Cleared via 510(k) (K092016) on October 2, 2009. Classified as Class II, product code FMI (Hypodermic single lumen needle).

Summary

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OCT - 2 2009

6.0 510(k) Summary

Date of Submission: June 12, 2009

Submitted by:

Mary L. Jean Director QARA Tel: 305-949-7828 Fax: 305-949-7370

Stat Medical Devices, Inc. 2056 NE 153rd Street North Miami Beach, Florida 33162

Name of Device:	Stat Medical Pen Needle
Common or Usual Name:	Sterile disposable hypodermic needle
Proprietary Name:	Super-Fine Pen Needle
Classification Name:	Hypodermic single lumen needle
Classification Product Code:	FMI
Class:	II

Intended use:

Description of Device:

The Stat Pen Needle is provided sterile via EO sterilization and is for Single Use only.

Substantial Equivalence:

The modified Stat Medical Pen Needles have the same following similarities to devices that previously received 510(k) clearance:

same indication for use t
. same operating principle

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. incorporation of same materials
◆ same sterilization and packaging materials and processes
. same basic design

In summary, the Stat Medical Super Fine Pen Needle described in this submission are, in our opinion, substantially equivalent to the predicate device.

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo features a stylized caduceus, a symbol often associated with healthcare, alongside the department's name in a circular arrangement. The text reads "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA". The logo is black and white.

Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-0609 Silver Spring, MD 20993-0002

Ms. Mary L. Jean Director of Quality Assurance/Regulatory Affairs Stat Medical Devices, Incorporated 2056 North East 153td Street North Miami Beach, Florida 33162

OCT - 2 2009

Re: K092016

Trade/Device Name: Super-Fine Pen Needles Regulation Number: 21 CFR 880.5570 Regulation Name: Hypodermic Single Lumen Needle Regulatory Class: II Product Code: FMI Dated: September 3, 2009 Received: September 4, 2009

Dear Ms. Jean:

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 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.

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Page 2- Ms. Jean

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. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH /CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to a http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely vours.

Susan Burns

Susan Runner, D.D.S., M.A. Acting Division Director Division of Anesthesiology, General Hospital, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health

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Indications for Use

510(k) Number (if known):

Device Name:

K092016 Super-Fine Pen Needles

Indications for Use:

The Stat Medical Super-Fine Pen Needle is intended for use with pen injector devices for the subcutaneous injection of insulin.

Prescription Use X . . (Part 21 CFR 801 Subpart D)

AND/OR

Over-The-Counter Use _ (21 CFR 801 Subpart C)

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Cintham V. Anm

(Division Sign-Off) Division of Anesthesiology, General Hospital Infection Control, Dental Devices

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510(k) Number: 大ゆりコタ/ 6

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).