FEEL-FINE INSULIN PEN NEEDLE by FEEL TECH

Feel Fine Insulin Pen Needle consists of a sterile cap, needle cap needle hub, which can be fixed with needle and blister paper. The sterile cap functions to maintain the sterility of the needle because sterile cap covers the needle hub and needle cap with blister paper sealed on the opening hole of sterile cap. The needle hub can be connected with pen. The necdle cap covers intended to provide physical protection to the needle tube. They are supplied with a sterile fluid path, (EO), nontoxic, and non pyrogenic, for single use only, disposable. The devices operate on the principles of common piston syringes.

AI/ML Overview

This response is based on the provided text only and does not include external information.

The document describes the Feel Fine Insulin Pen Needle and its substantial equivalence to a predicate device, the B.Braun "one.clickTM needle" (K033575). It does not provide detailed acceptance criteria with specific numerical performance metrics or a comprehensive study report with quantitative results for the Feel Fine Insulin Pen Needle. Instead, it indicates that the device's safety and effectiveness were demonstrated through bench tests.

Here's an analysis of the information available against your requested criteria:

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

Acceptance Criteria	Reported Device Performance
Biocompatibility	Demonstrated in bench tests, indicating the device is as safe, as effective, and performs in a substantially equivalent manner to the predicate device.
Mechanical Testing	Demonstrated in bench tests, indicating the device is as safe, as effective, and performs in a substantially equivalent manner to the predicate device.
Sterility Testing (including EO residues)	Demonstrated in bench tests, indicating the device is as safe, as effective, and performs in a substantially equivalent manner to the predicate device. The device is EO sterilized.
Technological Characteristics	Identical to the predicate device.
Performance (general)	Performs the same way as common piston syringes.

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

The document does not specify the sample size used for any of the bench tests (biocompatibility, mechanical, sterility). It also does not explicitly state the data provenance (e.g., country of origin, retrospective or prospective) for these tests.

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

This information is not provided. The document refers to "bench tests" for performance evaluation, not clinical studies involving expert assessment of outcomes or images for establishing ground truth in the context of diagnostic devices.

4. Adjudication method for the test set

This information is not provided. As the tests are described as "bench tests" for engineering and material properties, an adjudication method in the context of clinical interpretation would likely not be applicable.

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

An MRMC comparative effectiveness study was not conducted. This device is an insulin pen needle, a physical medical device for injection, not an AI-assisted diagnostic or interpretative tool. Therefore, the concept of human readers improving with AI assistance is not applicable.

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

This information is not applicable. The Feel Fine Insulin Pen Needle is a physical medical device, not an algorithm.

7. The type of ground truth used

The ground truth for the "performance" of the pen needle was established through "bench tests" for properties like biocompatibility, mechanical integrity, and sterility. These are typically assessed against pre-defined engineering and material standards, rather than expert consensus, pathology, or outcomes data in a clinical trial setting. The "ground truth" here refers to compliance with these standards and equivalence to the predicate device's established performance.

8. The sample size for the training set

This information is not applicable. The device is a physical medical device, not a machine learning algorithm, and therefore does not have a "training set" in the AI context.

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

This information is not applicable for the reasons stated in point 8.

Summary

{0}------------------------------------------------

page 1 of 1

JUN - 4 2008

510(K) Summary for K080904 Feel Tech # 92-4 Haengjung-ri, Gwangdcok-myeon, Cheonan-si, Choong-nam Korea Tel. : 82-41-522-2446-8 Fax .: 82-41-522-2449 Contact person: Boo Sool Kim Date prepared: June 2, 2008

Trade Name: Feel Fine Insulin Pen Ncedle 1.

Common Name: Pen needle 2.
Classification Name: Syringe, piston, product code FMI, Regulation: 880.5570 3.
1. Class of device: Class II.
The legally marketed device to which we are claiming equivalence [807.92(a)(3)) : 5. B.Braun "one.clickTM needle", K033575.
Description of device: Feel Fine Insulin Pen Needle consists of a sterile cap, needle cap 6. needle hub, which can be fixed with needle and blister paper. The sterile cap functions to maintain the sterility of the needle because sterile cap covers the needle hub and needle cap with blister paper sealed on the opening hole of sterile cap. The needle hub can be connected with pen. The necdle cap covers intended to provide physical protection to the needle tube. They are supplied with a sterile fluid path, (EO), nontoxic, and non pyrogenic, for single use only, disposable. The devices operate on the principles of common piston syringes.
Intended use: These disposable sterilc insulin pen needles are intended for 7. subcutaneous injection of insulin in the treatment of diabetes.
Technological characteristics: Feel Fine Insulin Pen Needles and the predicate devices 8. have identical technological characteristics and perform the same way as common piston syringes. These needles are EO sterilized.
Performance: Bench tests were performed. Bench testing included biocompatibility, 9. mechanical testing, sterility testing including EO residues. The tests demonstrated that the device is as safe, as effective, and performs in a substantially equivalent manner to the predicate device.

{1}------------------------------------------------

Image /page/1/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle with its wings spread, and the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circle around the eagle. The eagle is black, and the text is also black.

Food and Drug Administration 9200 Corporate Bouievard Rockville MD 20850

JUN - 4 2008

Feel Tech C/O Mr. Daniel Kamm Principal Consultant Kamm & Associates P.O. Box 7007 Deerfield, Illinois 60015

Re: K080904

Trade/Device Name: Feel Fine Insulin Pen Needle Regulation Number: 21 CFR 880.5570 Regulation Name: Hypodermic Single Lumen Needle Regulatory Class: II Product Code: FMI Dated: March 28, 2008 Received: April 1, 2008

Dear Mr. Kamm:

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,

{2}------------------------------------------------

Page 2 - Mr. Kamm

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); 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.

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), please contact the Office of Compliance 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 Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely yours,

Clare

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

{3}------------------------------------------------

K080904

Indications for Use

510(k) Number (if known): K080904

Feel Fine Insulin Pen Needle Device Name:

Indications For Use:

These disposable sterile insulin pen needles are intended for subcutaneous injection of insulin in the treatment of diabetes.

V Prescription Us (Part 21 CFR 801 Subpart D) AND/OR

Over-The-Counter Use (21 CFR 807 Subpart C)

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Anthony O. Natan

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

Page 1 of 1

510(k) Number: K4849994

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).