The EasyTouch™ Safety Pen Needle is intended for use with pen injection of drugs, including insulin and exenatide. Additionally, the attached safety shield automatically locks in place and reduces the occurrence of accidental needle sticks from the patient end of the shield also serves to hide the needle before and after injection.

Device Description

EasyTouch™ Safety Pen Needle is designed to be used with pen injectors for subcutaneous injections of a desired dose of drugs approved for delivery using a pen needle. The EasyTouch™ Safety Pen Needle is sterile (Ethylene Oxide sterilization procedure), and non-pyrogenic. It is a disposable, single use device. Additionally, the EasyTouch™ Safety Pen Needle is designed to reduce the occurrence of accidental needle sticks by providing a sheath that locks of the needle after use. Prior to injection, the end user will attach the EasyTouch™ Safety Pen Needle to an injector pen. The protective sheath will hide the needle from the user prior to use. Upon application of the needle to the sheath will retract to allow for the needle to enter the body. After the injection is complete, and the needle is removed from the skin, the protective sheath will automatically extend over the needle and lock into place. The EasyTouch™ Safety Pen Needle should be removed from the pen and discarded properly.

AI/ML Overview

The provided text describes the 510(k) premarket notification for the EasyTouch™ Safety Pen Needle (K163578). This document primarily establishes substantial equivalence to a predicate device (BD Autoshield™ Pen Needle, K060007) based on technical characteristics and non-clinical testing. It does not contain information about acceptance criteria and a study proving the device meets those criteria in the context of a typical AI/ML medical device submission.

However, I can extract the information related to the device's performance based on the non-clinical testing performed, which serves as evidence for its safety and effectiveness, and thus acts as a form of "acceptance criteria" for the 510(k) submission.

Here's the breakdown of the information requested, based on the provided text:

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

The document doesn't explicitly state "acceptance criteria" in a quantitative, pass/fail table for a specific performance metric like sensitivity or specificity. Instead, the "acceptance criteria" are implied by the requirements of the standards and regulations the device needs to comply with. The "reported device performance" is that the device "passed" these tests or "complies" with the standards.

Acceptance Criteria (Implied by Test/Standard)	Reported Device Performance
Biocompatibility: No cytotoxicity (ISO 10993-5)	No cytotoxicity
Biocompatibility: No skin irritation (ISO 10993-10)	No evidence of skin irritation
Biocompatibility: No skin sensitization (ISO 10993-10)	No evidence of sensitization
Biocompatibility: No acute systemic toxicity (ISO 10993-11)	No systemic toxicity
Biocompatibility: No pyrogenicity (ISO 10993-11)	All tests passed
Biocompatibility: No hemolysis (ISO 10993)	No evidence of hemolysis
Mechanical Testing: Proper functioning of safety feature (FDA Guidance: Medical Devices with Sharps Injury Prevention Features)	Safety feature function evaluated and passed
Pen Injector Compatibility: Proper function with multiple pen injectors (ISO 11608-1 and ISO 11608-2)	Pen needle works properly with multiple brands of pen injectors
Sterility: Sterility Assurance Level (SAL) of 10⁻⁶	SAL: 10⁻⁶ (Ethylene Oxide sterilization)
Packaging Integrity, Permeability, Compression Resistance, Resistance to Bacteria for 5-year shelf life	Accelerated packaging testing assured a 5-year shelf life
Compliance with ISO 7864 (Sterile hypodermic needles for single use)	Testing performed to assure compliance
Compliance with ISO 9626 (Stainless steel needle tubing for medical devices)	Testing performed to assure compliance

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

The document details non-clinical bench testing. It does not specify "sample sizes" for individual tests in the way an AI/ML study would for a test set of images. For mechanical testing of the safety feature, it states "utilizing both professional health care workers and non-clinician pen users using gloved hands." The exact number of users or devices tested is not provided.

Test Set Sample Size: Not explicitly stated for specific tests (e.g., number of devices for mechanical testing, number of runs for sterility).
Data Provenance: Not applicable in the context of clinical patient data. The tests are bench tests performed in a lab setting, likely at the manufacturer's facility or a contract testing lab.

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

This is not applicable as the study described is a non-clinical device performance and safety study, not a study involving expert annotation or ground truth establishment for AI/ML algorithms. The "ground truth" for the tests is defined by the objective pass/fail criteria of the specified international standards (ISO) and FDA guidance documents.

4. Adjudication method for the test set

Not applicable. The performance is determined by objective measurement against established standards, not by expert adjudication of classifications.

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 a 510(k) submission for a physical medical device (safety pen needle), not an AI/ML software device. Therefore, MRMC studies and AI-assisted human reader performance are not relevant or discussed.

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

No. This is a physical medical device. The concept of "standalone algorithm performance" is not applicable.

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

The "ground truth" for the non-clinical tests is based on objective, measurable criteria defined by international standards (ISO) and FDA guidance documents for device performance, safety, and biocompatibility. For instance, a sterility test's ground truth is a quantified sterility assurance level, and biocompatibility tests have established biological endpoints.

8. The sample size for the training set

Not applicable. This is not an AI/ML algorithm.

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

Not applicable. This is not an AI/ML algorithm.

Summary

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August 3, 2018

MHC Medical Products, LLC. % Daniel Kamm Kamm & Associates 8870 Ravello Ct. Naples, Florida 34114

Re: K163578

Trade/Device Name: EasyTouch™ Safety Pen Needle Regulation Number: 21 CFR 880.5570 Regulation Name: Hypodermic Single Lumen Needle Regulatory Class: Class II Product Code: FMI Dated: July 3, 2018 Received: July 6, 2018

Dear Daniel 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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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 of medical device-related adverse events) (21 CFR 803); 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.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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 Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely.

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Tina Kiang, Ph.D. Acting Director Division 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

510(k) Number (if known) K163578

Device Name EasyTouch™ Safety Pen Needle

Indications for Use (Describe)

Type of Use (Select one or both, as applicable)
Prescription Use (Part 21 CFR 801 Subpart D)	Over-The-Counter Use (21 CFR 801 Subpart C)

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510(k) Summary K163578 MHC Medical Products 8695 Seward Rd. Fairfield, OH 45011 Tel: 877-358-4342 Contact Person: Sean O'Keefe Date Prepared: August 1, 2018

1. Identification of the Proposed Device:

Trade Name: EasyTouch™ Safety Pen Needle Regulation Number: 21 CFR 880.5570 Regulation Name: Hypodermic Single Lumen Needle Regulatory Class: Class II Product Code: FMI

1. Identification of the Predicate Device: BD Autoshield™ Pen Needle, K060007. Regulation Number: 21 CFR 880.5570 Regulation Name: Hypodermic Single Lumen Needle Regulatory Class: Class II Product Code: FMI
1. Description of Device: EasyTouch™ Safety Pen Needle is designed to be used with pen injectors for subcutaneous injections of a desired dose of drugs approved for delivery using a pen needle. The EasyTouch™ Safety Pen Needle is sterile (Ethylene Oxide sterilization procedure), and non-pyrogenic. It is a disposable, single use device. Additionally, the EasyTouch™ Safety Pen Needle is designed to reduce the occurrence of accidental needle sticks by providing a sheath that locks of the needle after use. Prior to injection, the end user will attach the EasyTouch™ Safety Pen Needle to an injector pen. The protective sheath will hide the needle from the user prior to use. Upon application of the needle to the sheath will retract to allow for the needle to enter the body. After the injection is complete, and the needle is removed from the skin, the protective sheath will automatically extend over the needle and lock into place. The EasyTouch™ Safety Pen Needle should be removed from the pen and discarded properly.
1. Intended Use/Indications for Use: The EasyTouch™ Safety Pen Needle is intended for use with pen injector devices for the injection of drugs, including insulin and exenatide. Additionally, the attached safety shield automatically locks in place and reduces the occurrence of accidental needle sticks from the patient end of the needle. The shield also serves to hide the needle before and after injection.
1. Technical Characteristics: EasyTouch™ Safety Pen Needles and the predicate devices have identical technological characteristics and perform the same way as common pen needles. The EasyTouch™ Safety Pen Needle and the predicate device both include safety features that are identical in function and performance. A detailed comparison table follows:

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Comparison Table

	BD Autoshield™ Pen Needle, K060007	EasyTouch™ Safety Pen Needle
Indications for Use	The BD AutoShield™ Pen Needle isintended for use with pen injector devicesfor the injection of drugs, including insulinand exenatide. Additionally, the attachedsafety shield automatically locks in placeand reduces the occurrence of accidentalneedle sticks from the patient end of theneedle. The shield also serves to hide theneedle before and after injection.	The EasyTouch™ Safety Pen Needle isintended for use with pen injector devicesfor the injection of drugs, including insulinand exenatide. Additionally, the attachedsafety shield automatically locks in place andreduces the occurrence of accidental needlesticks from the patient end of the needle. Theshield also serves to hide the needle beforeand after injection. SAME.
USE	OTC	SAME
Principle ofoperation	Serves as a single use pen needle. Thedevice is removed from its packaging andscrewed into a pen injector device. Thepatient then injects the medicine by firstsetting the dose on the pen, and theninserting the needle into the skin and thenpressing the button on the pen. After theinjection the needle automatically retractsinto a shielded housing, thus preventingan accidental needle stick.	SAME
Interface with peninjector (e.g. luertaper or others),	Employs standardized dimensions and luertaper per ISO 11608, Needle-basedinjection systems for medical use –Requirements and test methods —Thedimensions of the attachment part of theneedle shall be such that the needle fitsand functions with pen injectors which arein accordance with ISO 11608-1.Unscrewing torque of the needle:0.06~0.08 N.m. The standard 6% luertaper is employed to help ensure a leakfree connection to the syringe or penassembly.	SAME
Materialinformation: Hub,Hub protector,Safety featureNeedle	Hub: PolypropyleneHub Protector: PolypropyleneSafety Feature: Stainless steel springNeedle: 304 Stainless steel needle withsilicone lubricant	Hub: PolypropyleneHub Protector: PolypropyleneSafety Feature: Stainless steel springNeedle: 304 Stainless steel needle withsilicone lubricantSAME
Sizes/Lengths	29G, 30G, and 31G5 mm, 8 mm, 12.7 mm lengths	29G: 3/16" (5mm) and 5/16" (8mm)(29G only). This is a subset of the predicate.
Sterilization	SAL: 10⁻⁶Gamma Sterilized	SAL: 10⁻⁶ SAMEEthylene Oxide EQUIVALENTSee discussion below.
Shelf life	5 Years	5 Years SAME
Single use	YES	YES SAME
Biocompatibility	Complies with ISO10993	Complies with ISO10993
	BD Autoshield™ Pen Needle, K060007	EasyTouch™ Safety Pen Needle
	series standards, (presumed, not stated in510(k) summary)	series standards, and the following tests areperformed,● Cytotoxicity: No cytotoxicity● Skin Irritation: No evidence of skinirritation● Skin Sensitization: No evidence ofsensitization● Acute Systemic Toxicity: No systemictoxicity● Hemolysis: No evidence of hemolysisSAME
Photo	Image: BD Autoshield Pen Needle	Image: EasyTouch Safety Pen NeedleSIMILARITY IS OBVIOUS

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6. Non-clinical testing: Bench Tests were performed. Bench Testing included:

a. Performance of a Risk Analysis to guide the bench testing regimens.
b. Biocompatibility per the ISO10993 series of biocompatibility tests: In- Vitro Cytotoxicity report, ISO 10993-5 Skin Sensitization test report ISO-10993-10 Intracutaneous study , ISO-10993-10 Systemic Toxicity test report, ISO-10993-11 Pyrogen test report , ISO-10993-11 All tests passed.
ﻥ Mechanical testing: To establish proper functioning of the safety feature, testing was performed to evaluate the function of the safety feature in a simulated clinical environment utilizing both professional health care workers and non-clinician pen users using gloved hands. Reference: FDA Guidance Document: Guidance for Industry and FDA Staff, Medical Devices with Sharps Injury Prevention Features Document Issued on: August 9, 2005
ರ. Pen injector compatibility testing was performed to show that the pen needle works properly with multiple brands of pen injectors. Validation basis ISO11608-1 and ISO11608-2
e. Sterility testing including EO residues. A sterility assurance level of 10* has been demonstrated. We use Ethylene oxide sterilization whereas the predicate device uses gamma sterilization. The SAL levels for both methods are the same.
f. Packaging and shelf life testing: Accelerated packaging testing was performed to assure a 5 year shelf life: Packaging integrity, packaging permeability, compression resistance, resistance to bacteria.
Testing was performed to assure compliance with ISO 7864, Sterile hypodermic needles for single oo use -- Requirements and test methods.

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h. Testing was performed to assure compliance with ISO 9626, Stainless steel needle tubing for the manufacture of medical devices -- Requirements and test methods
1. Clinical testing: Clinical testing was not required (per FDA guidance) to establish substantial equivalence. However SIMULATED CLINICAL TESTING was performed to meet the requirements of the FDA Guidance on Sharps Injury Prevention (2005) (see above)
1. Conclusion: Based on device comparison information and non-clinical bench testing, the proposed device is substantially equivalent to legally marketed predicate device BD Autoshield™ Pen Needle, K06007.

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).