The Comfort EZ™ 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 28 through 31 gauge needle sizes, in 0.3 ml/cc and 1 ml/cc capacities. 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 document is a 510(k) summary for the Comfort EZ™ Insulin Syringe, which is a medical device for the injection of U100 insulin. The submission aims to demonstrate substantial equivalence to a predicate device, the Feel-ject 2. Insulin Syringe.

Here's an analysis of the acceptance criteria and the study that proves the device meets them, based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria are implicitly defined by the characteristics of the predicate device (Feel-ject Insulin Syringe) and relevant international standards. The Comfort EZ™ Insulin Syringe aims to be "identical" in these aspects to achieve substantial equivalence.

Acceptance Criteria Category	Specific Criteria (based on Predicate/Standards)	Reported Device Performance (Comfort EZ™)
Intended Use	For the injection of U100 insulin.	Identical
Method of Use	Standard procedure for syringe use (removing caps, measuring dosage, single use, sharps disposal).	Identical
Type	Type 8 of ISO8537:1991(E); syringe with fixed needle tube and fitted with protective end cap.	Identical
Barrel Marking Scale	Conforms to ISO 8537:1991(E).	Identical
Lubricant	Polydimethysiloxane.	Identical
Lubricant amount	0.25 mg/cm2 max.	Identical
Barrel transparency	Haze 25% max. (2mm sheet).	Identical
Reuse	For only use (single use).	Identical
Biocompatibility	Conforms to ISO 10993-1.	Identical (Conforms to ISO 10993-1 through testing)
Materials	1) Plastic parts: polypropylene; 2) Gasket: natural rubber; 3) Packing film: Polyethylene film.	Identical (Same materials as predicate)
Sterility	Sterilized by ethylene oxide gas SAL = 10-6.	Identical (Sterilized by EO SAL = 10-6)
Packaging (Primary)	Each syringe individually packaged in a Tyvek peel pouch.	(Implied identical for individual)
Packaging (Secondary)	10 syringes in a poly bag; 10 poly bags in a cardboard box.	10 syringes in a poly bag; 10 poly bags in a cardboard box (i.e., 100 syringes).
Mechanical Testing	Hub/needle bond strength (ISO 7894:1993).	Demonstrated conformance
Sterility Testing	ISO 11607 and ISO 11135, including EO residues (ISO 10997-7).	Demonstrated conformance
Standards Compliance	ISO 8537 Sterile, Single-Use Syringes, with or without Needle, for Insulin.	Conforms to ISO8537:1991(E)

The overall performance criterion is "substantially equivalent" to the predicate device due to identical technological characteristics, materials, manufacturing methods, and conformance to relevant standards.

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

The document states that "Bench and standards compliance testing was performed." However, it does not specify the sample size for any of these tests.

Regarding data provenance:

Biocompatibility: Conforms to ISO 10993-1. The list of tests (Cytotoxicity, Maximization, Intracutaneous Toxicity, Hemolysis, Systemic toxicity, Pyrogen Testing) implies lab testing.
Mechanical testing: Hub/needle bond strength (ISO 7894:1993).
Sterility testing: ISO 11607 and ISO 11135, including EO residues testing (ISO 10997-7).
Standards Compliance: ISO 8537:1991(E).

The document is a US FDA 510(k) submission, and the predicate device is from Korea (Feel Tech). The location where the "bench and standards compliance testing" for the Comfort EZ™ syringe was performed is not explicitly stated, but it would typically be conducted by the manufacturer (Simple Diagnostics, based in Florida, USA) or a contracted lab. The data is retrospective in the sense that the tests were performed to demonstrate equivalence for the 510(k) submission.

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

This question is not applicable to this type of device and submission. The "ground truth" for a mechanical device like an insulin syringe is based on objective measurements against established international consensus standards (like ISO standards) and material science, not expert interpretation of subjective data like images. Therefore, clinical experts or radiologists are not involved in establishing ground truth for performance testing.

4. Adjudication method for the test set

This question is not applicable. Adjudication methods (like 2+1 or 3+1) are typically used in clinical studies or studies involving human readers/interpreters to resolve discrepancies in subjective assessments, which is not the nature of the bench and standards compliance testing performed for this device.

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 question is not applicable. This submission is for a physical medical device (insulin syringe), not an AI algorithm or a diagnostic tool that involves human readers or image interpretation. Therefore, no MRMC study was conducted or is relevant.

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

This question is not applicable as it pertains to AI algorithms, not physical medical devices like syringes.

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

The "ground truth" for the test set in this context is based on:

International Standards: e.g., ISO 8537 for syringes, ISO 10993 for biocompatibility, ISO 7894 for mechanical testing, ISO 11607 and ISO 11135 for sterility.
Predicate Device Specifications: The characteristics, materials, and performance of the legally marketed Feel-ject 2. Insulin Syringe (K070917) form a primary basis for equivalence, implying its validated performance constitutes a "ground truth" for comparison.
Objective Bench Test Results: Direct physical, chemical, and biological measurements demonstrating compliance with the above standards and equivalence to the predicate.

8. The sample size for the training set

This question is not applicable. There is no "training set" in the context of demonstrating substantial equivalence for a physical medical device like an insulin syringe. Training sets are relevant for machine learning algorithms.

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

This question is not applicable as there is no training set.

Summary

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510(K) Summary, K122787

Simple Diagnostics®

6 2012 DEC

11555 Heron Bay Blvd., Suite 200 Coral Springs, Florida 33076 (877) 342-2385 な Contact person: Muhammad Arif Date prepared: October 17, 2012

Trade Name: Comfort EZTM 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)] : Feel-ject 2. Insulin Syringe made by Feel Tech (Korea) K070917
Description of device: The Comfort EZ™ 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 28 through 31 gauge needle sizes, in 0.3 ml/cc and 1 ml/cc capacities. 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 Comfort EZTM Insulin Syringes and the predicate 5. devices have identical technological characteristics and perform the same way as common piston svringes. The materials utilized remain the same as the predicate, mainly stainless steel for the needles and polypropylene for the barrel components. These syringes are EO sterilized and are for single use only.

Device Name	Feel-ject Insulin Syringe made by Feel Tech(Korea) K070917	Comfort EZTM insulinsyringe
Intended Use	For the injection of U100 insulin.	Identical
Method of Use	1. To expose plunger, remove large white cap.2. To expose needle, pull small orange cap straightoff, being careful not to bend needle.3. To measure correct dosage, align top edge ofplunger tip with your dosage mark on the syringescale.4. Use syringe only once. To prevent misuse afterinjection, use sharps container	Identical

Comparison Table.

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Device Name	Feel-ject Insulin Syringe made by Feel Tech(Korea) K070917	Comfort EZTM insulinsyringe
Type	Type 8 of ISO8537:1991(E); syringe with fixed needletube and fitted with protective end cap.	Identical
Barrel Marking	Scale: conforms to ISO 8537:1991(E)	Identical
Lubricant	Polydimethysiloxane	Identical
Lubricant amount(mg/cm2)	0.25 max	Identical
Barrel transparency	Haze 25% max. (2mm sheet)	Identical
Reuse	For only use	Identical
Biocompatibility	Conforms to ISO 10993-1	Identical
Materials	1) Plastic parts: polypropylene	Identical
	2) Gasket : natural rubber	Identical
	3) Packing film : Polyethylene film	Identical
Sterility	Sterilized by ethylene oxide gas SAL = 10-6	Identical
Packaging	Each syringe is individually packaged in a Tyvek peelpouch. There are 10 syringes packaged in a poly bag.There are 10 poly bags packaged in a cardboard box.	Ten syringes are packaged in apoly bag. There are 10 polybags packaged in a cardboardbox. (i.e. 100 syringes)

Performance: Bench and standards compliance testing was performed. 6. Bench testing included: Biocompatibility: (ref ISO 10993) Cytotoxicity, Maximization, Intracutaneous Toxicity, Hemolysis, Systemetic toxicity, and Pyrogen Testing, Mechanical testing: Hub/needle bond strength. ISO 7894:1993 Sterility testing (ISO 11607 and ISO 11135) including EO residues testing (ISO 10997-7.) Standards compliance: ISO 8537 Sterile, Single-Use Syringes, with or without Needle, for Insulin Scale: conforms to ISO8537:1991(E) The tests demonstrated that the device is as safe, as effective, and performs in a

substantially equivalent manner to the predicate device.

1. Clinical testing: Not required to establish equivalence.
Conclusion: The Comfort EZ™ insulin syringe complies with applicable standards for 8. insulin svringes, uses identical materials and manufacturing methods to the predicate, and has been tested for biocompatibility and performance characteristics. The syringe has the identical intended use to the predicate. We therefore conclude that the Comfort EZ™ syringe is substantially equivalent to the predicate device.

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Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a stylized eagle with its wings spread, and three wavy lines below it. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES-USA" is arranged in a circular fashion around the eagle.

Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-002

December 6, 2012

Simple Diagnostics, Incorporated C/O.Mr. Daniel Kamm, P.E. Kamm & Associates 8870 Ravello Court Naples, Florida 34114

Re: K122787

Trade/Device Name: Comfort EZTM Insulin Syringe Regulation Number: 21 CFR 880.5860 Regulation Name: Piston Syringe Regulatory Class: II Product Code: FMF Dated: September 8, 2012 Received: September 11, 2012

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 yours,

Anthony Ls. m.

ﺍﻟﻤﺴﺘﻘﻠﺔ ﺍﻟﻤﺴﺘﻘﻠﺔ ﺍﻟﻤﺴﺘﻘﻠﺔ ﺍﻟﻤﺴﺘﻘﻠﺔ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺴﺘﻘﻠﺔ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺴﺘﻘﻠﺔ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺴﺘﻘﻠﺔ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺴﺘﻘﻠﺔ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺴﺘﻘﻠﺔ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺴﺘﻘﻠﺔ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤ

Anthony D. Watson, B.S., M.S., M.B.A. Director Director of Anesthesiology, General Hospital, Respiratory, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Indications for Use

K122787 510(k) Number (if known):

Comfort EZ™ Insulin Syringe Device Name:

Indications For Use:

The Comfort EZ™ 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)

Digitally signed by Richard C. Chapman Date: 2012.12.12:06 08:30:06 -05'00'

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

K122787 510(k) Number:

Page 1 of 1

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Indications for Use

K122787 510(k) Number (if known):

Comfort EZ™ Insulin Syringe Device Name:

Indications For Use:

The Comfort EZ™ disposable sterlle 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)

Gail G. Gantt
Digitally signed by Gail G. Gantt
DN: c=US, o=U.S. Government, ou=HHS,
ou=FDA, ou=People, cn=Gail G. Gantt,
0.9.2342.19200300.100.1.1=1300087388
Date: 2012.12.06 15:10:58 -05'00'

Page 1 of 1

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

K122787 510(k) Number:

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).