The Easy.Touch 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 0.3 ml/cc, 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

This 510(k) submission (K091474) for the Easy.Touch Insulin Syringe describes a device seeking substantial equivalence to a predicate device. The information provided focuses on the device's technical characteristics and bench testing, rather than a clinical study evaluating diagnostic performance. Therefore, many of the requested categories related to diagnostic study design or AI performance are not applicable.

Here's an analysis of the provided information:

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria Category	Acceptance Criteria	Reported Device Performance
Intended Use	For the injection of U100 insulin.	The device is intended for the injection of U100 insulin.
Biocompatibility	(Implicit: Must be safe for human contact and not cause adverse biological reactions)	Bench tests demonstrated biocompatibility.
Mechanical Testing	(Implicit: Syringe must function reliably, dispense accurately, and withstand expected forces)	Bench tests demonstrated appropriate mechanical performance.
Sterility	Must be sterile (sterile fluid path, EO sterilized), non-toxic, non-pyrogenic.	Supplied with a sterile fluid path, (EO), non-toxic, and non pyrogenic.
Substantial Equivalence	Device is as safe, as effective, and performs in a substantially equivalent manner to the predicate device (Feel-ject Insulin Syringe K070917).	Bench tests demonstrated the device is as safe, as effective, and performs in a substantially equivalent manner to the predicate device.
Device Characteristics	Calibrated hollow barrel, fixed needle, standard plunger/gasket, color-coded needle cap, available in 0.3ml/cc, 0.5ml/cc, 1ml/cc sizes.	The Easy.Touch insulin syringe consists of a calibrated hollow barrel, fixed needle, plunger and gasket of the same shape as conventional insulin syringes, color-coded orange cap, and available in 0.3 ml/cc, 0.5 ml/cc and 1 ml/cc sizes. These are identical to the predicate device's technological characteristics.

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

This information is not provided in the submission. The submission references "bench tests," which typically do not involve human subjects or a "test set" in the context of diagnostic performance. These tests relate to the physical and biological properties of the device.

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

This information is not provided and is not applicable for this type of device and testing. Ground truth determination by experts is relevant for diagnostic accuracy studies.

4. Adjudication Method for the Test Set

This information is not provided and is not applicable. Adjudication methods are used in studies involving human interpretation or expert consensus for ground truth.

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 provided and is not applicable. This device is an insulin syringe, not an AI-assisted diagnostic tool.

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

This information is not provided and is not applicable. This device is not an algorithm or AI system.

7. The Type of Ground Truth Used (expert consensus, pathology, outcomes data, etc.)

For the bench tests, the "ground truth" would be established by measurement standards and compliance with recognized industry standards and regulatory requirements for medical devices (e.g., ISO standards for sterility, biocompatibility, mechanical integrity). It's not based on expert consensus, pathology, or outcomes data in the typical sense of a diagnostic or therapeutic clinical study.

8. The Sample Size for the Training Set

This information is not provided and is not applicable. The device does not involve a "training set" as it's not a machine learning or AI algorithm.

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

This information is not provided and is not applicable.

Summary of the Study and Evidence:

The provided 510(k) summary for the Easy.Touch Insulin Syringe describes bench testing as the primary study performed to demonstrate substantial equivalence to a predicate device (Feel-ject Insulin Syringe K070917).

The study did not involve human subjects or clinical performance data in the typical sense of a diagnostic study. Instead, it focused on:

Biocompatibility: Ensuring the materials are safe for human contact.
Mechanical Testing: Verifying the syringe's functional integrity, such as plunger force, barrel integrity, and needle attachment.
Sterility Testing: Confirming the device is sterile, non-toxic, and non-pyrogenic.
EO Residues Testing: Ensuring no harmful ethylene oxide residues remain after sterilization.

The acceptance criteria for these tests would be defined by relevant national and international standards (e.g., ISO standards for medical devices) and FDA guidance for piston syringes. The reported performance is that these "tests demonstrated that the device is as safe, as effective, and performs in a substantially equivalent manner to the predicate device."

Therefore, the "study" that proves the device meets acceptance criteria is a series of bench tests evaluating the physical, chemical, and biological properties of the syringe against predetermined standards and in comparison to a legally marketed predicate device. The document implies compliance with these standards and equivalence based on the successful completion of these tests.

Summary

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K091474

510(K) Summary, K09

JUL - 9 2009

Masters Healthcare, LLC 11930 Kemper Springs Drive, Cincinnati, Ohio 45240, U.S.A. Ph: 513 619-8030 Fax: 513 354-2687 Contact person: John Edmiston Date prepared: May 14, 2009

Trade Name: Easy.Touch Insulin Syringe 1. 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. Feel-ject Insulin Syringe made by Feel Tech (Korea) K070917
Description of device: The Easy.Touch insulin syringe consists of a calibrated hollow 3. 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 0.3 ml/cc, 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.
Intended use: For the injection of U100 insulin. 4.
Technological characteristics: The Easy•Touch Insulin Syringes and the predicate 5. devices have identical technological characteristics and perform the same way as common piston syringes. These syringes are EO sterilized.
Performance: Bench tests were performed. Bench testing included biocompatibility, 6. 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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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/1/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized eagle with three stripes representing the department's mission. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES. USA" is arranged in a circular pattern around the eagle.

Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Masters Healthcare, LLC C/O Mr. Daniel Kamm Principal Consultant Kamm & Associates 333 Milford Road Deerfield, Illinois 60015

JUL - 9 2009

Re: K091474

Trade/Device Name: Easy Touch Insulin Syringe Regulation Number: 21 CFR 880.5860 Regulation Name: Piston Syringe Regulatory Class: II Product Code: FMF Dated: May 15, 2009 Received: May 29, 2009

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 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); 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 http://www.fda.gov/cdrh/mdz/ 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 (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely yours,

Anthony D, mat
Susan Runner, D.D.S., M.A.

Acting 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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Indications for Use

510(k) Number (if known):

Easy.Touch Insulin Syringe Device Name:

Indications For Use:

The Easy•Touch disposable sterile insulin syringes are intended for injection of U100 insulin only.

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

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)

(Division Sign-Off)

Division of Anesthesiology, General Hospital Infection Control, Dental Devices

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510(k) Number: K091474

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).