The Advocate Insulin Pen Needle consists of a polypropylene 'outer cap' enclosure. This polypropylene cap contains an opening at one end to allow the needle or cannula to exit. The other end of the outer cap is the 'hub' that can be connected to various pens. Contained within the outer cap is the cannula assembly made up of the stainless steel cannula that is contained within an 'inner cap' polypropylene shell that is located on top of the hub. Medical grade blister paper covers and seals the hub. The Advocate Insulin Pen Needles when sealed with the blister paper are EO sterilized and provide a sterile fluid path during use. The Advocate Insulin Pen Needles when connected to the pen injector, is intended for subcutaneous injection of insulin.

AI/ML Overview

The requested information regarding acceptance criteria and study details for the Advocate Insulin Pen Needles, based on the provided FDA 510(k) summary, is presented below.

Please note: The provided document is a 510(k) summary, which focuses on demonstrating substantial equivalence to a predicate device rather than presenting detailed clinical study results with human readers or AI performance metrics. Therefore, several sections of your request related to AI, human reader improvement, and training set details are not applicable or cannot be extracted from this document.

1. Table of Acceptance Criteria and Reported Device Performance

Performance Test	Normative References/Description	Acceptance Criteria (Implied by "All pre-determined acceptance criteria were met")	Reported Device Performance
Accelerated Shelf Life	ASTM F 1980-07, ISO 11607-1, ISO 11608-2, ASTM F 1929, ASTM F88	Meet requirements of the referenced standards (e.g., maintain sterility, package integrity, and functional performance over simulated shelf life).	All pre-determined acceptance criteria were met.
EO Sterilization Validation	Validation process used a standard half-cycle method to demonstrate the efficacy of the EO sterilization process.	Efficacy of EO sterilization process demonstrated.	All pre-determined acceptance criteria were met.
EO Residual	Sterilant residual limit for limited exposure met of EO <4mg and ECH <9mg.	EO residual <4mg and ECH <9mg.	All pre-determined acceptance criteria were met.
Biocompatibility Testing	Cytotoxicity - ISO 10993-5, Sensitization - ISO 10993-10, Intracutaneous reactivity - ISO 10993-10, Systemic Toxicity - ISO 10993-11, Haemocompatibility - ISO 10993-4	Meet the requirements of the referenced ISO 10993 standards (e.g., non-cytotoxic, non-sensitizing, non-irritating, non-systemically toxic, haemocompatible).	All pre-determined acceptance criteria were met.
Performance Testing (Mechanical & Functional Compatibility)	ISO 11608 – 2 Includes mechanical testing and determination of functional compatibility with specific pen injector devices (NIS).	Meet the requirements of ISO 11608-2 (e.g., satisfactory mechanical strength, functional compatibility with NIS pen injectors).	All pre-determined acceptance criteria were met.

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

The provided document does not specify the exact sample sizes for each performance test. The tests are non-clinical, evaluating the physical and biological characteristics of the device itself (e.g., sterility, material properties, mechanical function) rather than performance on patient data.

Sample Size: Not explicitly stated for individual tests.
Data Provenance: Not applicable in the context of clinical data provenance (country, retrospective/prospective) as these are non-clinical device performance tests. The tests were conducted internally by the manufacturer or contract labs.

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

Not applicable. These are non-clinical (engineering and laboratory) tests. "Ground truth" in this context refers to established scientific and engineering standards and validated test methodologies, not expert interpretation of clinical images or data.

4. Adjudication Method for the Test Set

Not applicable. This concept applies to the resolution of disagreements among human expert evaluators, which is not relevant for objective non-clinical performance tests.

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. The document describes a medical device (insulin pen needles), not an AI diagnostic or assistive technology. No MRMC study was performed.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done

Not applicable. The device is a physical medical instrument, not an algorithm.

7. The Type of Ground Truth Used

The "ground truth" for these performance tests is defined by established international and national standards (e.g., ISO, ASTM), validated laboratory methods, and manufacturing specifications. For example:

Sterility: Absence of viable microorganisms, confirmed by validated methods.
Biocompatibility: Absence of adverse biological reactions, confirmed by meeting ISO 10993 standards.
Mechanical Performance: Meeting specified force, torque, and dimensional requirements according to ISO 11608-2.
EO Residuals: Chemical analysis confirming levels below specified thresholds.

8. The Sample Size for the Training Set

Not applicable. As this is not an AI/algorithm-based device, there is no "training set."

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

Not applicable. (See #8).

Summary

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

October 19, 2016

Diabetic Supply of Suncoast, Inc. c/o Matt Hedlund 510k Consultant 3924 NE 157th Place Lake Forest Park, Washington 98155

Re: K160199

Trade/Device Name: Advocate Insulin Pen Needles Regulation Number: 21 CFR 880.5570 Regulation Name: Hypodermic Single Lumen Needle Regulatory Class: II Product Code: FMI Dated: September 21, 2016 Received: September 22, 2016

Dear Matt Hedlund:

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 (reporting of medical devicerelated 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 yours,

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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)

K160199

Device Name Advocate Insulin Pen Needles

Indications for Use (Describe)

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

Type of Use (Select one or both, as applicable)

Prescription Use (Part 21 CFR 801 Subpart D)

Z Over-The-Counter Use (21 CFR 801 Subpart C)

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510(k) Summary for K160199

Diabetic Supply of Suncoast, Inc. PO Box 2102 Vega Alta, PR 00692 1-866-373-2824 Contact: Victoria Thuss Date Prepared: October 11, 2016

1. Subject Device Trade Name: Advocate Insulin Pen Needles Common Name: Pen Needle Regulation Number: 21 CFR 880.5570 Regulation Name: Hypodermic single lumen needle Requlatory Class: Class II Product Code: FMI
1. Predicate Device Trade Name: Comfort EZ Pen Needle 510(k) Number: K121632 Common Name: Pen Needle Regulation Number: 21 CFR 880.5570 Regulation Name: Hypodermic single lumen needle Requlatory Class: Class II Product Code: FMI
1. Description of Device: The Advocate Insulin Pen Needle consists of a polypropylene 'outer cap' enclosure. This polypropylene cap contains an opening at one end to allow the needle or cannula to exit. The other end of the outer cap is the 'hub' that can be connected to various pens. Contained within the outer cap is the cannula assembly made up of the stainless steel cannula that is contained within an 'inner cap' polypropylene shell that is located on top of the hub. Medical grade blister paper covers and seals the hub. The Advocate Insulin Pen Needles when sealed with the blister paper are EO sterilized and provide a sterile fluid path during use. The Advocate Insulin Pen Needles when connected to the pen injector, is intended for subcutaneous injection of insulin.
1. Indications for Use: These disposable sterile insulin pen needles are intended for subcutaneous injection of insulin in the treatment of diabetes. This is the same indication for use statement as the statement for the predicate device, K121632.

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1. Technological characteristics: The following is a comparison of the technological characteristics of the subject device with the predicate device:

TechnologicalCharacteristic	Subject DeviceAdvocate Insulin Pen Needle	Predicate DeviceComfort EZ Pen Needle -K121632
Size	31G 5 mm; 31G 6 mm;31G 8 mm; 32G 4 mm;33 G 4 mm; 29G 12mm	31 G 5 mm; 31 G 6 mm;31 G 8 mm; 32 G 4 mm;32 G 5 mm; 32 G 6 mm
Design	Outer Cap; Inner Cap; Cannula;Hub; Paper Seal	Outer Cap; Inner Cap;Cannula; Hub; Paper Seal
Material	Polypropylene; Stainless Steel;Dialyzing Paper; Glue; SiliconeOil	Polypropylene; StainlessSteel; Dialyzing Paper; Glue;Silicone Oil
Sterilization	EO Sterilization	EO Sterilization
	SAL of 10-6	SAL of 10-6
Labeling	Primary Packaging Label-Size; EO Sterile; Use By Date;Lot; Single Use; ManufacturerInformation;Warnings; Enclosed PackageInsert.	Primary Packaging Label-Size; EO Sterile; Use By Date;Lot; Single Use; ManufacturerInformation;Warnings.
Performance Testing	BiocompatibilityPen Injector (NIS) CompatibilityMechanical TestingSterility ValidationEO ResidueShelf Life Testing	BiocompatibilityPen Injector (NIS) CompatibilityMechanical TestingSterility ValidationEO ResidueShelf Life Testing

Conclusion: The technological characteristics of the Advocate Insulin Pen Needles are the same as the Predicate Device. The differences of certain pen sizes (33 G 4 mm; 29G 12mm) with the Predicate Device do not raise new questions of safety and/or effectiveness as these two pen sizes have the same intended use, material, design, sterilization, labeling, and performance testing as the Predicate Device.

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1. Performance testing: The following table defines the nonclinical performance testing submitted. All pre-determined acceptance criteria were met:

Performance Test	Normative References/ Description
Accelerated Shelf Life	ASTM F 1980-07ISO 11607-1ISO 11608-2ASTM F 1929ASTM F88
EO Sterilization Validation	The validation process used a standard halfcycle method to demonstrate the efficacy ofthe EO sterilization process.
EO Residual	Sterilant residual limit for limited exposuremet of EO<4mg and ECH <9mg.
Biocompatibility Testing	Cytotoxicity - ISO 10993-5Sensitization - ISO 10993-10Intracutaneous reactivity - ISO 10993-10Systemic Toxicity - ISO 10993-11Haemocompatibiltiy - ISO 10993-4
Performance Testing	ISO 11608 – 2 Includes mechanical testingand determination of functional compatibilitywith specific pen injector devices (NIS).

Conclusion: The performance testing demonstrates that the Advocate Insulin Pen Needles submitted under this 510(k) are substantially equivalent to the Predicate Device.

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).