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 svringes. This premarket notification is for additional needle gauges and lengths as compared to our previous submission, K091472.

AI/ML Overview

The provided text describes the 510(k) summary for the Easy-Touch Insulin Syringe (K102178). This document is a premarket notification to the FDA for a medical device and is not a study proving device performance against specific acceptance criteria in the context of AI/ML or diagnostic imaging.

Therefore, many of the requested categories in your prompt are not applicable to the provided text. The device in question is a simple medical tool (insulin syringe), and the "study" referred to in the document is a series of bench tests to demonstrate substantial equivalence to predicate devices, not a clinical trial with human subjects or complex performance metrics.

Here's an attempt to answer the applicable parts of your request based on the provided information, with notes where information is not available or not relevant:

Acceptance Criteria and Device Performance for Easy-Touch Insulin Syringe (K102178)

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria Category	Reported Device Performance (from K102178)
Biocompatibility	Bench tests demonstrated that the device is "as safe" as the predicate device.
Mechanical Testing	Bench tests demonstrated that the device "performs in a substantially equivalent manner" to the predicate device.
Sterility Testing	Bench tests demonstrated that the device is "as safe" as the predicate device (including EO residues).
Performance	Bench tests demonstrated that the device is "as effective" as the predicate device.
Intended Use	For the injection of U100 insulin. The device and predicate have "identical technological characteristics and perform the same way as common piston syringes."

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

Sample Size: Not specified. The document only mentions "Bench tests were performed."
Data Provenance: Not specified, but given it's a bench test (laboratory testing), it's not applicable in the same way as clinical data (e.g., country of origin, retrospective/prospective).

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

Not Applicable. For a simple physical device like an insulin syringe, "ground truth" established by human experts in the context of diagnostics or AI is not relevant. The "truth" of its performance (e.g., sterility, mechanical function) is determined by standardized laboratory tests and measurements.

4. Adjudication method for the test set

Not Applicable. Adjudication methods like 2+1 or 3+1 are used for human expert consensus in diagnostic evaluations. This device relies on objective physical and chemical testing.

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 AI/ML device or a diagnostic device where human readers would be involved.

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

Not Applicable. This is not an AI/ML device.

7. The type of ground truth used

Objective lab measurements and adherence to standards. The "ground truth" for a mechanical device like this is based on whether it meets predefined physical, chemical, and biological specifications (e.g., proper dimensions, lack of particulate matter, absence of microbial growth, proper dose delivery, biocompatibility).

8. The sample size for the training set

Not Applicable. This is a physical medical device, not an AI/ML model that requires a training set.

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

Not Applicable. See point 8.

Summary

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K10217.8

2 2010 SEP

510(K) Summary, K10

MHC Medical Products 100 Commerce Blvd Loveland, OH 54140 Ph: 513 354-2694 Fax: 800.861.1906 Contact person: John Edmiston Date prepared: July 16, 2010

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 and Easy.Touch Insulin Syringe, K091474, MHC Medical Products.
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 svringes. This premarket notification is for additional needle gauges and lengths as compared to our previous submission, K091472.
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. merhanical 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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Exhibit 6. Truthful and Accuracy Statement as required per 21CFR807.87(k).

I certify that, in my capacity as Vice-president of MHC Medical Products, I believe, to the best of my knowledge, that all data and information submitted in this premarket notification are truthful and accurate, and that no material fact has been omitted.

Jutland

John Edmiston July 16, 2010

. .

ਾ

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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 & 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 symbol that resembles three overlapping human figures or abstract shapes.

Public Health Service

Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002

MHC Medical Products C/O Mr. Daniel Kamm Kamm & Associates 8870 Ravello Court Naples, Florida 34114

2 2010 SEP

Re: K102178

Trade/Device Name: Easy-Touch Insulin Syringe Regulation Number: 21 CFR 880.5860 Regulation Name: Piston Syringe Regulatory Class: II Product Code: FMF Dated: July 19, 2010 Received: August 13, 2010

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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

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/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/Resourcesfor You/Industry/default.htm.

Sincerely vours.

Nh for

Anthony D. Watson, B.S., M.S., M.B.A. 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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K102178

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)

Rih C. Chaym 9/1/10
(Division Sign Off)

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

510(k) Number: __ 10211

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).