Insulin Pen Needle (Ordinary Type), Insulin Pen Needle (Safety Type)

• K Number: K202319
• Device Name: Insulin Pen Needle (Ordinary Type), Insulin Pen Needle (Safety Type)
• Manufacturer: Tianjin Huahong Technology Co., Ltd.
• Date Cleared: 2021-11-12 ( 452 days)
• Product Code: FMI
• Regulation Number: 880.5570

Intended Use

The Insulin Pen Needle (Ordinary Type) is intended for use with pen injector devices for the subcutaneous injection of insulin. The Insulin Pen Needle (Safety Type) is sterile, single-use safety needle intended for use with pen injector devices for the subcutaneous injection of insulin.

Device Description

The proposed devices, Insulin Pen Needle (Ordinary Type) and Insulin Pen Needle (Safety Type) are single use device, which is designed for used with a pen injector for the subcutaneous injection of insulin. For the safety type, it is designed with a sharp injury prevention feature to minimize the risk from accidental needles sticks. The proposed device is available in 29G, 30G, 31G, 32G and 33G five different specifications with the needle length available in 4mm, 8mm, 10mm and 12mm for Insulin Pen Needle (Ordinary Type) and 4mm, 5mm, and 8mm for Insulin Pen Needle (Safety Type). The product is for single use and provided sterile (Irradiation). The shelf-life of the product is five-years.

Predicate Devices

K181069, K170988

Reference Devices

Not Found

AI/ML (Artificial Intelligence / Machine Learning)

No
The device description and performance studies focus on the mechanical and material properties of a pen needle, with no mention of AI or ML.

Therapeutic

No.
The device is an insulin pen needle, which is used for the subcutaneous injection of insulin. It is a delivery mechanism for a therapeutic substance (insulin), but it does not inherently provide therapy itself.

Diagnostic

No.

The device is an insulin pen needle used for the subcutaneous injection of insulin, which is a delivery device, not a diagnostic one.

SaMD (Software as a Medical Device)

No

The device description clearly states it is a physical, single-use needle designed for subcutaneous injection of insulin, with a safety feature on one type. It is a hardware device.

IVD (In Vitro Diagnostic)

Based on the provided information, this device is not an IVD (In Vitro Diagnostic).

Here's why:

• Intended Use: The intended use is for the subcutaneous injection of insulin. This is a direct administration of a substance into the body, not a test performed in vitro (outside the body) on a sample from the body.
• Device Description: The description details a needle designed for injection, with features related to size, length, and safety mechanisms for preventing needle sticks. This aligns with an injection device, not a diagnostic test.
• Lack of Diagnostic Elements: There is no mention of analyzing biological samples (blood, urine, tissue, etc.), detecting markers, or providing diagnostic information.
• Performance Studies: The performance studies focus on the physical characteristics of the needle, safety mechanisms, and compliance with standards related to injection devices. There are no studies related to diagnostic accuracy, sensitivity, specificity, etc.

IVD devices are used to examine specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes. This device's function is to deliver insulin, which is a therapeutic action, not a diagnostic one.

PCCP (Predetermined Change Control Plan) Authorized

N/A

Overview

Intended Use / Indications for Use

The Insulin Pen Needle (Ordinary Type) is intended for use with pen injector devices for the subcutaneous injection of insulin.

The Insulin Pen Needle (Safety Type) is sterile, single-use safety needle intended for use with pen injector devices for the subcutaneous injection of insulin.

Product codes (comma separated list FDA assigned to the subject device)

FMI

Device Description

The proposed devices, Insulin Pen Needle (Ordinary Type) and Insulin Pen Needle (Safety Type) are single use device, which is designed for used with a pen injector for the subcutaneous injection of insulin. For the safety type, it is designed with a sharp injury prevention feature to minimize the risk from accidental needles sticks. The proposed device is available in 29G, 30G, 31G, 32G and 33G five different specifications with the needle length available in 4mm, 8mm, 10mm and 12mm for Insulin Pen Needle (Ordinary Type) and 4mm, 5mm, and 8mm for Insulin Pen Needle (Safety Type). The product is for single use and provided sterile (Irradiation). The shelf-life of the product is five-years.

Mentions image processing

Not Found

Mentions AI, DNN, or ML

Not Found

Input Imaging Modality

Not Found

Anatomical Site

Not Found

Indicated Patient Age Range

Not Found

Intended User / Care Setting

In hospital or in the home environment.

Description of the training set, sample size, data source, and annotation protocol

Not Found

Description of the test set, sample size, data source, and annotation protocol

Not Found

Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)

Non clinical tests were conducted to verify that the proposed device met all design specifications and that the subject device is Substantially Equivalent (SE) to the predicate device. The test results demonstrated that the proposed device complies with the following standards:

Performance Testing:

• ISO 7864: 2016 Sterile hypodemic needles for single use
• ISO 9626: 2016 Stainless steel needle tubing for the manufacture of medical devices A
• ISO 11608-2: 2012 Needle-based injection systems for medical use- Requirements and test methods- Part 2: Needles
• ISO 23908 :2011 Sharps injury protection - Requirements and test methods - Sharps protection features for single-use hypodermic needles, introducers for catheters and needles used for blood sampling

Biocompatibility Testing:
In accordance with ISO 10993-1, the Insulin Pen Needles are classified as: Externally communicating, indirect blood path with prolonged contact duration (>24 h to 30 d). The following testing was conducted:

• Cytotoxicity
• Sensitization
• Irritation
• Acute Systemic Toxicity
• Material-Mediated Pyrogenicity
• Subacute Toxicity
• Hemocompatibility

Particulate matter testing was conducted in accordance with USP Particulate Matter in Injections and met the USP acceptance criteria.

Sterility, Shipping and Shelf-Life:
The Insulin Pen Needles were sterilized by irradiation to achieve a SAL of 10-6. The radiation source was CO60, and the radiation dose was 25kGy, which was established according to VDmax method per ISO11137-2, Sterilization of healthcare products. Radiation. Establishing the sterilization dose. The sterilization was validated according to ISO 11137-2. The Insulin Pen Needles were evaluated for bacterial endotoxin utilizing the USP Limulus Amebocyte Lysate (LAL) method.

• Package integrity testing, after environmental conditioning and simulated transportation was conducted on the final, packaged, and sterile devices. All packaging deemed acceptable for protection of product and sterility maintenance.
• Sterile Barrier Packaging Testing performed on the proposed device:
  • Seal strength ASTM F88/F88-15
  • Dye penetration ASTM F1929-15
• Shelf life of 5 years is validated using the FDA recognized standard ASTM F1980-16 Standard Guide for Accelerated Aging of Sterile Barrier Systems for Medical Devices

Simulated clinical use testing:
A simulated clinical use study was performed on 600 device samples for the Insulin Pen Needle (Safety Type) according to FDA Guidance (Guidance for Industry and FDA Staff: Medical Device with Sharps Injury Prevention Feature) and ISO 23908:2011 to evaluate the safety mechanism of the proposed device. The results demonstrated that the proposed device met the pre-established criteria.

Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)

Not Found

Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.

K181069, K170988

Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.

Not Found

Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).

Not Found

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).

Summary

0

Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.

November 12, 2021

Tianjin Huahong Technology Co., Ltd. Yan Li Regulatory Affair A01, Plant B, No. 278, Hangkong Road, Tianiin Pilot Free Trade Zone Tianjin, 300308 China

Re: K202319

Trade/Device Name: Insulin Pen Needle (Ordinary Type), Insulin Pen Needle (Safety Type) Regulation Number: 21 CFR 880.5570 Regulation Name: Hypodermic Single Lumen Needle Regulatory Class: Class II Product Code: FMI Dated: September 30, 2021 Received: October 12, 2021

Dear Yan Li:

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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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.

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

1

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) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

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 https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.

For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email ([e-mail]) or phone [phone] or 301-796-7100).

Sincerely,

CAPT Alan M. Stevens Assistant Director DHT3C: Division of Drug Delivery and General Hospital Devices, and Human Factors OHT3: Office of GastroRenal, ObGyn, General Hospital and Urology Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health

Enclosure

2

Indications for Use

510(k) Number (if known) K202319

Device Name

Insulin Pen Needle (Ordinary Type), Insulin Pen Needle (Safety Type)

Indications for Use (Describe)

The Insulin Pen Needle (Ordinary Type) is intended for use with pen injector devices for the subcutaneous injection of insulin.

The Insulin Pen Needle (Safety Type) is sterile, single-use safety needle intended for use with pen injector devices for the subcutaneous injection of insulin.

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

| | Prescription Use (Part 21 CFR 801 Subpart D)

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

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510(k) Summary

This 510(k) Summary is being submitted in accordance with requirements of Title 21, CFR Section 807.92.

The assigned 510(k) Number: K202319

1. Applicant information

Tianjin Huahong Technology Co., Ltd.

A01, Plant B, No. 278, Hangkong Road, Tianjin Pilot Free Trade Zone (Air Port Industrial Park) 300308 Tianjin China Contact Person: Yan Li Position: Regulatory Affair Tel: [phone] Fax: [phone] Email: [e-mail]

• 2. Date of Preparation: November 10, 2021
• Identification of Proposed Device 3.

Trade Name: Insulin Pen Needle (Ordinary Type), Insulin Pen Needle (Safety Type)

Common Name: Insulin Pen Needle

Regulatory Information

Classification Name: Needle, Hypodermic, Single Lumen;

Classification: II;

Product Code: FMI;

Regulation Number: 21 CFR 880.5570;

Review Panel: General Hospital;

• Identification of Predicate Device 4.
  Predicate Device 1 510(k) Number: K181069 Trade Name: Disposable Insulin Pen Needle Predicate Device 2 510(k) Number: K170988

4

Trade Name: DropSafe Safety Pen Needle

న్. Device Description

The proposed devices, Insulin Pen Needle (Ordinary Type) and Insulin Pen Needle (Safety Type) are single use device, which is designed for used with a pen injector for the subcutaneous injection of insulin. For the safety type, it is designed with a sharp injury prevention feature to minimize the risk from accidental needles sticks. The proposed device is available in 29G, 30G, 31G, 32G and 33G five different specifications with the needle length available in 4mm, 8mm, 10mm and 12mm for Insulin Pen Needle (Ordinary Type) and 4mm, 5mm, and 8mm for Insulin Pen Needle (Safety Type). The product is for single use and provided sterile (Irradiation). The shelf-life of the product is five-years.

6. Indications for Use

The Insulin Pen Needle (Ordinary Type) is intended for use with pen injector devices for the subcutaneous injection of insulin.

The Insulin Pen Needle (Safety Type) is sterile, single-use safety needle intended for use with pen injector devices for the injection of insulin.

• 7. Comparison of Technological Characteristics

ITEM	Proposed Device	Predicate Device 1
	K202319	K181069
Proprietary/ trade name	Insulin Pen Needle (Ordinary Type)	Disposable Insulin Pen Needle
Regulation No.	880.5570	880.5570
Product Code	FMI	FMI
Class	II	II
Intended Use	The Insulin Pen Needle (Ordinary Type) is intended for use with pen injector devices for the subcutaneous injection of insulin.	The Disposable Insulin Pen Needle is intended for use with pen injector devices for the subcutaneous injection of insulin.
Environment of use	In hospital or in the home environment.	In hospital or in the home environment.
Type-of-use	Disposable	Disposable
Configuration and materials of	Needle Tube Stainless Steel	Needle Tube Stainless Steel
	Needle Hub Polypropylene	Hub Polypropylene

Table 1 General Comparison for Insulin Pen Needle (Ordinary Type)

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| construction for all

components	Outer Sheath	Polypropylene	Cup	Polyethylene
	Inner Sheath	Polypropylene	Inner Sheath	Polypropylene
	Sealed Paper	Paper	Sealed Paper	Paper
Operation Mode	For Manual Use Only		For Manual Use Only
Method of
attachment to pen
injector	Through threaded connection		Through threaded connection

Table 2 Safety and Performance Comparison for Insulin Pen Needle (Ordinary Type)

| ITEM | Proposed Device
K202319 | Predicate Device 1
K181069 |
|--------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------|
| Needle Gauge | 29G, 30G, 31G, 32G, 33G | 28G, 29G, 30G,
31G, 32G, 33G |
| Needle Length | 4mm, 5mm, 6mm, 8mm, 10mm, 12mm | 4mm, 6mm, 8mm,
12mm |
| Patient-contact materials | | |
| Needle Tube | Stainless Steel (SUS304) | Stainless Steel |
| Lubricant | MDX4-4159 | Unknown |
| adhesive | UV glue | Unknown |
| Bond between hub and needle tube | Clause 4.4 of ISO 11608-2:2012;
Clause 4.12 of ISO 7864:2016 | Clause 4.4 of ISO
11608-2:2012;
Clause 4.12 of ISO
7864:2016 |
| Design specification of the inner
sheath (dimensions, color,
materials and strength) | 14.35.85.8mm;
Transparent color; Polypropylene;
Tensile stress at yield>20MPa; Flexural
modulus: >800MPa; Charpy Notched Impact
Strength (23°C) >2.8kJ/m². | Unknown |
| Design specification of the outer
sheath (dimensions, color,
materials and strength) | 30.313.413.4mm;
Transparent color; Polypropylene;
Tensile stress at yield>20MPa; Flexural
modulus: >800MPa; Charpy Notched Impact
Strength (23°C) >2.8kJ/m². | Unknown |
| Needle tip configuration | Conform with ISO 7864 standards | Conform with ISO
7864 standards |
| Cytotoxicity | No Cytoxicity | |
| Intracutaneous reactivity | No Irritation to Skin | |
| Skin Sensitization | No skin sensitization | Conform with ISO
10993 standards |
| Acute Systemic Toxicity | No Systemic Toxicity | |
| Pyrogen | No pyrogen | |

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Hemolysis	No hemolysis
Subacute Systemic Toxicity	No Subacute Systemic Toxicity	Unknown
Method	Irradiation Sterilized	EO Sterilized
SAL	10-6	10-6
Endotoxin Limit	20 EU per device	20 EU per device
Shelf life	5 years	Unknown
Label/ Labeling	Complied with 21 CFR part 801	Complied with 21 CFR part 801

ITEM	Proposed Device	Predicate Device 2
	K202319	K170988
Regulation No.	880.5570	880.5570
Product Code	FMI	FMI
Class	II	II
Intended Use	The Insulin Pen Needle (Safety Type) is sterile, single-use safety needle intended for use with pen injector devices for the injection of insulin.	The DropSafe Safety Pen Needles are sterile, single-use safety needles intended for use with pen injector devices for the injection of drugs.
Environment of use	In hospital or in the home environment.	In hospital or in the home environment.
Proprietary/ trade name	Insulin Pen Needle (Safety Type)	DropSafe Safety Pen Needles
Type-of-use	Disposable	Disposable
Configuration and materials of construction for all components	Needle Tube Stainless Steel (SUS304)
Needle Hub Polypropylene
Outer Sheath Polypropylene
Inner Sheath Polypropylene
Sealed Paper Paper
Spring Stainless Steel (SUS304)
Upper Cover Polypropylene	Cannula Medical grade stainless steel
Hub Plastic resin
Primary container Plastic resin
Slider Unknown
Seal Unknown
Spring-operated Stainless steel wire
Needle shield Plastic resin
Operation Mode	For Manual Use Only	For Manual Use Only
Method of attachment to pen	Threaded connection method.	Threaded connection method.

Table 3 General Comparison for Insulin Pen Needle (Safety Type)

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injector
Safety Feature	Prevent from needlestick	Prevent from needlestick
Method of
activation	Trigger shield	Trigger shield

Table 4 Safety and Performance Comparison for Insulin Pen Needle (Safety Type)

	Proposed Device	Predicate Device 2
ITEM	K202319	K170988
Needle Gauge	29G, 30G, 31G, 32G, 33G	31G
Needle Length	4mm, 5mm, 6mm, 8mm	6mm and 8mm
Patient-contact material
Needle Tube	Stainless Steel (SUS304)	Medical grade stainless steel
Lubricant	MDX4-4159	Unknown
adhesive	UV glue	Unknown
Bond between hub and needle tube	Drawing force ≥ 22N (29G);
Drawing force ≥ 11N (30G-33G);Clause 4.4 of ISO 11608-2:2012;
Clause 4.12 of ISO 7864:2016	Clause 4.4 of ISO 11608-2:2012;
Clause 4.12 of ISO 7864:2016
Design specification of the inner
sheath (dimensions, color,
materials and strength)	21.510.79.8mm;
Transparent color; Polypropylene.
Tensile stress at yield>20MPa;
Flexural modulus: >800MPa;
Charpy Notched Impact Strength
(23 °C) >2.8kJ/m².	Unknown
Design specification of the outer
sheath (dimensions, color,
materials and strength)	43.818.618.6mm; Transparent
color; Polypropylene.
Tensile stress at yield>20MPa;
Flexural modulus: >800MPa;
Charpy Notched Impact Strength
(23 °C) >2.8kJ/m².	Unknown
Design specification of the upper
cover (dimensions, color,
materials and strength)	30.214.614.6mm;
White;
Polypropylene.
Tensile stress at yield>20MPa;
Flexural modulus: >800MPa;
Charpy Notched Impact Strength
(23 °C) >2.8kJ/m².	Unknown
Needle tip configuration	Conform with ISO 7864
standards	Conform with ISO 7864
standards
Biocompatibility
Cytotoxicity	No Cytoxicity
Intracutaneous reactivity	No Irritation to Skin
Skin Sensitization	No skin sensitization	Conform with ISO 10993
standards
Acute Systemic Toxicity	No Systemic Toxicity
Pyrogen	No pyrogen
Hemolysis	No hemolysis
Subacute Systemic Toxicity	No Subacute Systemic Toxicity	Unknown
Sterilization
Method	Irradiation Sterilized	Irradiation Sterilized
SAL	10-6	10-6
Endotoxin Limit	20 EU per device	20 EU per device
Shelf life	5 years	Unknown
Label/ Labeling	Complied with 21 CFR part 801	Complied with 21 CFR part 801

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8. Compatible injectors

The Insulin Pen Needle was tested for use with the following pen injectors:

Autopen® K983974 Owen Mumford, Inc.

Novopen Echo® K162602 Novo Nordisk Inc.

Humapen and Humapen Ergo K982842 Eli Lilly and Company

Humapen Luxura K142518 Eli Lilly and Company

Humapen Memoir K053563 Eli Lilly and Company

9. Summary of Non-clinical Performance Testing

Non clinical tests were conducted to verify that the proposed device met all design specifications and that the subject device is Substantially Equivalent (SE) to the predicate device. The test results demonstrated that the proposed device complies with the following standards:

Performance Testing:

• ISO 7864: 2016 Sterile hypodemic needles for single use

• ISO 9626: 2016 Stainless steel needle tubing for the manufacture of medical devices A

• ISO 11608-2: 2012 Needle-based injection systems for medical use- Requirements and test methods- Part 2: Needles

• ISO 23908 :2011 Sharps injury protection - Requirements and test methods - Sharps protection features for single-use hypodermic needles, introducers for catheters and needles used for blood sampling

Biocompatibility Testing:

In accordance with ISO 10993-1, the Insulin Pen Needles are classified as: Externally communicating, indirect blood path with prolonged contact duration (>24 h to 30 d). The following testing was

9

conducted:

• Cytotoxicity ●
• . Sensitization
• Irritation
• Acute Systemic Toxicity
• . Material-Mediated Pyrogenicity
• . Subacute Toxicity
• . Hemocompatibility

Particulate matter testing was conducted in accordance with USP Particulate Matter in Injections and met the USP acceptance criteria.

Sterility, Shipping and Shelf-Life:

The Insulin Pen Needles were sterilized by irradiation to achieve a SAL of 10th. The radiation source was CO60, and the radiation dose was 25kGy, which was established according to VDmax method per ISO11137-2, Sterilization of healthcare products. Radiation. Establishing the sterilization dose. The sterilization was validated according to ISO 11137-2. The Insulin Pen Needles were evaluated for bacterial endotoxin utilizing the USP Limulus Amebocyte Lysate (LAL) method.

• · Package integrity testing, after environmental conditioning and simulated transportation was conducted on the final, packaged, and sterile devices. All packaging deemed acceptable for protection of product and sterility maintenance.
• · Sterile Barrier Packaging Testing performed on the proposed device:
  • 0 Seal strength ASTM F88/F88-15
  • o Dye penetration ASTM F1929-15
• · Shelf life of 5 years is validated using the FDA recognized standard ASTM F1980-16 Standard Guide for Accelerated Aging of Sterile Barrier Systems for Medical Devices

10. Simulated clinical use testing

A simulated clinical use study was performed on 600 device samples for the Insulin Pen Needle (Safety Type) according to FDA Guidance (Guidance for Industry and FDA Staff: Medical Device with Sharps Injury Prevention Feature) and ISO 23908:2011 to evaluate the safety mechanism of the proposed device. The results demonstrated that the proposed device met the pre-established criteria.

• 11. Conclusion
      The clinical and non-clinical tests demonstrate that the subject device is substantially equivalent to the predicate device.