COMFORT EZ by SIMPLE DIAGNOSTICS, INC.

The Pen Needle consists of a sterile cap, needle cap needle hub, which can be fixed with needle and protected by 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 to the pen. The needle cap cover is 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 document describes a 510(k) submission for the Comfort EZ Pen Needle, a Class II medical device. The submission primarily focuses on demonstrating substantial equivalence to predicate devices, rather than presenting a study of AI-based diagnostic performance. Therefore, many of the requested elements for describing a study proving a device meets acceptance criteria related to AI or diagnostic accuracy are not applicable.

Based on the provided text, the device in question is a Comfort EZ Pen Needle, which is a medical device for drug delivery (insulin) and not a diagnostic AI system. Therefore, the typical acceptance criteria and study designs relevant to AI/diagnostic performance (such as sensitivity, specificity, MRMC studies, ground truth establishment by experts, etc.) are not applicable to this document.

The "study" described in this 510(k) summary is a set of bench tests and demonstrations of substantial equivalence to existing predicate devices, as is standard for many medical devices, particularly those for which equivalence can be shown based on design and performance characteristics rather than complex diagnostic interpretation.

Here's an attempt to address the points based on the provided text, noting where the requested information is not relevant to a pen needle:

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

Since this is a non-AI, non-diagnostic device, the acceptance criteria are based on physical and functional properties, and the performance is reported against these.

Acceptance Criteria	Reported Device Performance
Biocompatibility	Met (implied by "device is as safe, as effective, and performs in a substantially equivalent manner to the previous predicate devices")
Compatibility with ISO "Type A" pens	Met ("They are compatible with ISO "Type A" standard pens.")
Mechanical testing	Met (implied by "Bench tests were performed... The tests demonstrated that the device is as safe, as effective, and performs in a substantially equivalent manner...")
Sterility testing (including EO residues)	Met ("These syringes are EO sterilized. The sterility assurance level is 10^-6.")
Non-toxic and non-pyrogenic	Met ("supplied with a sterile fluid path, (EO), nontoxic, and non pyrogenic")
Single-use only	Designed accordingly ("for single use only, disposable")
Substantial Equivalence to Predicate Devices	Demonstrated and accepted by FDA (K121632 approved based on equivalence to Feel Fine (K080904), K100005, and K051899 BD Pen Needles)
Labeling Comparability	Evaluated and found comparable to predicate (BD) labeling.

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

Sample Size: Not explicitly stated for each bench test. Bench tests typically involve a specific number of units to ensure statistical significance for the particular test being conducted (e.g., a certain number of needles for mechanical force testing, or samples for sterility testing). The document does not provide these specifics.
Data Provenance: Not explicitly stated (e.g., country of origin, retrospective/prospective). This is standard for internal product development and testing of a device rather than a clinical study with patient data. The tests would be performed in a controlled laboratory environment.

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

Not Applicable. This device does not involve diagnostic interpretation or "ground truth" established by human experts in the way an AI diagnostic device would. Bench tests follow established laboratory protocols and standards (e.g., ISO standards for pen compatibility, AAMI standards for sterility). Compliance with these standards serves as the "ground truth" for device performance.

4. Adjudication method for the test set:

Not Applicable. There's no human interpretation or subjective assessment that would require adjudication.

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:

No. This is not an AI or diagnostic device, so an MRMC study is not relevant.

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

Not Applicable. This is not an algorithm or AI device. The "performance" described is the physical and functional performance of the pen needle itself.

7. The type of ground truth used:

The "ground truth" for this device's performance is established by international standards (e.g., ISO "Type A" for pen compatibility), manufacturing specifications, and industry best practices for medical device safety and efficacy (e.g., biocompatibility standards, sterility assurance levels). It's not based on expert consensus, pathology, or outcomes data in the way a diagnostic device's ground truth would be.

8. The sample size for the training set:

Not Applicable. This device does not involve machine learning or a "training set."

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

Not Applicable. There is no training set for this type of device.

Summary

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510(K) Summary, K12 V 32

Image /page/0/Picture/2 description: The image shows the logo for Simple Diagnostics. The logo consists of a stylized letter "S" on the left, followed by the words "Simple Diagnostics" in a simple font. A registered trademark symbol is located to the upper right of the word "Diagnostics".

11555 Heron Bay Blvd., Suite 200 Coral Springs, Florida 33076 (877) 342-2385 हूं Contact person: Muhammad Arif Date prepared: May 22, 2012

Trade Name: Comfort EZ Pen Needle 1. Common Name: Pen Needle Classification Name: Syringe, piston, product code FM1, Regulation: 880.5570 Class of device: Class II.
The legally marketed device to which we are claiming equivalence [807.92(a)(3)] : 2. Feel Fine insulin pen needle K080904 (Comfort EZ is a relabeled version of this product) as well as K100005 and K051899 Becton Dickenson Pen Needles.
Description of device: The Pen Needle consists of a sterile cap, needle cap needle hub, 3. which can be fixed with needle and protected by 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 to the pen. The needle cap cover is 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 sterile insulin pen needles are intended for 4. subcutaneous injection of insulin in the treatment of diabetes.
Technological characteristics: The Comfort EZ Pen Needles and the predicate న. devices have identical technological characteristics and perform the same way as common piston syringes. These syringes are EO sterilized. The sterility assurance level is 10th They are compatible with ISO "Type A" standard pens.
Performance: Bench tests were performed. Bench testing included biocompatibility, 6. compatibility with ISO Type A pens, 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 previous predicate devices. The Comfort EZ devices are relabeled versions of the Feel Fine (K080904) product. Predicate labeling (BD) was evaluated and found to be comparable to our current labeling.

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Truthful and Accuracy Statement as required per 21CFR807.87(k). Exhibit 6.

I certify that, in my capacity as President of Simple Diagnostics, Inc. 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.

Signature

Muhammad Arif March 1, 2012

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Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is circular and contains the department's name around the perimeter. In the center is an abstract symbol that resembles an eagle or a stylized human figure with outstretched arms. The logo is printed in black and white.

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

AUG 1 0 2012

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

Re: K121632

Trade/Device Name: Comfort EZ Pen Needle Regulation Number: 21 CFR 880.5570 Regulation Name: Hypodermic Single Lumen Needle Regulatory Class: II Product Code: FMI Dated: May 25, 2012 Received: June 12, 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), nlease 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,

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

Enclosure

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Indications for Use

510(k) Number (if known): K12

Device Name: Comfort EZ Pen Needle

Indications For Use:

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

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)

Rill Caye 8/1/12

(Division Sign-Off) Jivision Olgh Olyn Officesiology, General Hospital fection Control, Dental Devices

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510(k) Number: K121632

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).