FEEL-JECT INSULIN SYRINGE by FEEL TECH

The Feel-ject insulin syringe consists of a calibrated hollow barrel which can contain the medication and the distal end of barrel is fixed with needle. The needle cannot be exchanged after assembling because needle is fixed in the barrel nozzle lumen. The plunger and gasket are the same shape as the conventional insulin syringes. The needle cap cover is intended to provide physical protection to the needle tube. The cap is color coded orange, same as equivalent insulin syringes. The syringes are available in 0.5 ml/cc and 1 ml/cc sizes. They are supplied with a sterile fluid path, (EO), non-toxic, and non pyrogenic, for single use only, disposable. The devices operate on the principles of common piston syringes.

AI/ML Overview

The provided text describes a 510(k) premarket notification for the Feel-ject Insulin Syringe. This type of regulatory submission establishes substantial equivalence to a predicate device, rather than focusing on novel device performance metrics or studies in the way an AI/ML medical device might. Therefore, many of the requested categories are not directly applicable or reported in this document.

Here's an analysis based on the available information:

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria Category	Acceptance Criteria (Target/Threshold)	Reported Device Performance
Biocompatibility	Suitable for patient contact	Bench tests demonstrated "as safe, as effective"
Mechanical Testing	Functionally equivalent to predicate	Bench tests demonstrated "performs in a substantially equivalent manner"
Sterility	Sterile, non-pyrogenic	"Sterility testing including EO residues" demonstrated "as safe, as effective"
EO Residues	Acceptable levels	"Sterility testing including EO residues" demonstrated "as safe, as effective"
Non-toxic	Non-toxic	"non-toxic" (stated in description)
Non-pyrogenic	Non-pyrogenic	"non pyrogenic" (stated in description)

Missing Information: Specific quantitative acceptance criteria (e.g., specific thresholds for biocompatibility tests, deflection limits for mechanical tests, sterility assurance levels) are not provided in this summary. The assessment is qualitative, relying on "as safe, as effective, and performs in a substantially equivalent manner" to the predicate device.

2. Sample Size Used for the Test Set and Data Provenance

This information is not provided in the document. The text mentions "Bench tests were performed" but does not detail the sample sizes for these tests or the data provenance. These are physical product tests, not analyses of data sets in the context of AI/ML.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts

This information is not applicable/provided. For a physical medical device like an insulin syringe, "ground truth" is typically established through adherence to pre-defined engineering and quality standards, not expert labels on a dataset. The document refers to "bench tests" to demonstrate equivalence to a predicate device.

4. Adjudication Method for the Test Set

This information is not applicable/provided. Adjudication methods (like 2+1, 3+1) are typically used for establishing ground truth in AI/ML performance studies where expert consensus is needed. For bench testing of a physical device, the results are typically objectively measured against predefined specifications.

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

This information is not applicable. An insulin syringe is a physical device, not an AI/ML algorithm that assists human readers. Therefore, an MRMC study related to AI assistance is not relevant to this product.

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

This information is not applicable. This is a physical, non-AI medical device. There is no algorithm.

7. The Type of Ground Truth Used

The "ground truth" for this device's performance is established by conformance to established engineering standards, biocompatibility requirements, and sterility standards, demonstrating equivalence to a legally marketed predicate device (UltiCare™ Disposable Syringes and Needles K062702). This is verified through objective "bench tests" rather than expert consensus on medical images or pathology.

8. The Sample Size for the Training Set

This information is not applicable/provided. This device does not involve a "training set" in the context of AI/ML.

9. How the Ground Truth for the Training Set was Established

This information is not applicable/provided. As above, there is no "training set" for this physical device.

In summary, the provided document for the Feel-ject Insulin Syringe is a 510(k) summary focused on demonstrating substantial equivalence to a predicate device through bench testing of physical characteristics and compliance with manufacturing standards, rather than the type of performance study for an AI/ML medical device many of the questions are geared towards.

Summary

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K070917
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510(K) Summary Feel Tech # 92-4 Haengjung-ri, Gwangdeok-myeon, Cheonan-si, Choong-nam Korea JUN 2 0 2007 Tel. : 82-41-522-2446-8 Fax .: 82-41-522-2449 Contact person: Boo Sool Kim Date prepared: March 22, 2007

1. Trade Name: Feel-ject Insulin Syringe Common Name: Insulin syringe Classification Name: Syringe, piston, product code FMF, Regulation: 880.5860 Class of device: Class II.
The legally marketed device to which we are claiming equivalence {807.92(a){3}] : 2. UltiCare™ Disposable Syringes and Needles K062702 manufactured by Ulti Med Inc.
1. Description of device: The Feel-ject insulin syringe consists of a calibrated hollow barrel which can contain the medication and the distal end of barrel is fixed with needle . The needle cannot be exchanged after assembling because needle is fixed in the barrel nozzle lumen. The plunger and gasket are the same shape as the conventional insulin syringes. The needle cap cover is intended to provide physical protection to the needle tube. The cap is color coded orange, same as equivalent insulin syringes. The syringes are available in 0.5 ml/cc and 1 ml/cc sizes. They are supplied with a sterile fluid path, (EO), non-toxic, and non pyrogenic, for single use only, disposable. The devices operate on the principles of common piston syringes.
1. Intended use: For the injection of U100 insulin.
ട. Technological characteristics: The Feel-ject Insulin Syringes and the predicate devices have identical technological characteristics and perform the same way as common piston syringes. These syringes are EO sterilized.
1. Performance: Bench tests were performed. Bench testing included biocompatibility, 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.

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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 circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is a stylized emblem featuring a symbol that resembles an abstract eagle or bird-like figure.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

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

JUN 2 0 2007

Re: K070917

Trade/Device Name: Feel-Ject Insulin Syringe Regulation Number: 880.5860 Regulation Name: Piston Syringe Regulatory Class: II Product Code: FMF Dated: March 22, 2007 Received: April 3, 2007

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.

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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 (OS) 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 vour 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.

Chis. L. Diaz

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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K070917

Indications for Use

510(k) Number (if known):

Device Name: Feel-ject Insulin Syringe

Indications For Use:

The Feel-tech disposable sterile insulin syringes are intended for injection of U100 insulin only.

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

Over-The-Counter Use __X (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)

Sohail Erwaster Arwim 6/5/09

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

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510(k) Number: K072917

Regulation Number and Section

§ 880.5860 Piston syringe.

(a)
Identification. A piston syringe is a device intended for medical purposes that consists of a calibrated hollow barrel and a movable plunger. At one end of the barrel there is a male connector (nozzle) for fitting the female connector (hub) of a hypodermic single lumen needle. The device is used to inject fluids into, or withdraw fluids from, the body.(b)
Classification. Class II (performance standards).