(452 days)
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.
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.
This document describes the Insulin Pen Needle (Ordinary Type) and Insulin Pen Needle (Safety Type) by Tianjin Huahong Technology Co., Ltd. being substantially equivalent to predicate devices. The information provided heavily focuses on comparisons to predicate devices and adherence to various ISO standards and FDA guidelines, rather than presenting a standalone study with acceptance criteria and device performance in a typical clinical measurement context.
Here's an attempt to extract and synthesize the requested information, acknowledging that some details, especially concerning statistical performance measures for clinical efficacy, are not explicitly provided in this type of 510(k) summary. The document emphasizes adherence to technical standards and biocompatibility, which are critical for medical devices but different from performance metrics for diagnostic or therapeutic accuracy.
1. Table of Acceptance Criteria and Reported Device Performance
The acceptance criteria are primarily defined by adherence to international standards and predicate device characteristics. Since this is a 510(k) submission for pen needles, the "performance" is generally about meeting physical, chemical, and biological safety requirements, rather than a diagnostic accuracy or treatment effectiveness metric as might be seen for other types of devices.
| Acceptance Criteria (Based on ISO Standards & Predicate Comparison) | Reported Device Performance (Summary of Test Results) |
|---|---|
| Physical & Mechanical: | |
| Needles conform to ISO 7864:2016 (Sterile hypodermic needles) | Conform with ISO 7864 standards |
| Needle tubing conforms to ISO 9626:2016 (Stainless steel tubing) | Complies with ISO 9626:2016 |
| Needles conform to ISO 11608-2:2012 (Needle-based injection systems, Part 2: Needles) | Complies with ISO 11608-2:2012. Bond between hub and needle tube: Clause 4.4 of ISO 11608-2:2012; Clause 4.12 of ISO 7864:2016. (For safety type, additional drawing force requirements: ≥ 22N (29G); ≥ 11N (30G-33G)) |
| Sharps injury protection features conform to ISO 23908:2011 (for Safety Type) | The results demonstrated that the proposed device met the pre-established criteria. (A simulated clinical use study was performed) |
| Biocompatibility (ISO 10993-1): | |
| Cytotoxicity | No Cytotoxicity |
| Sensitization | No skin sensitization |
| Irritation | No Irritation to Skin |
| Acute Systemic Toxicity | No Systemic Toxicity |
| Material-Mediated Pyrogenicity | No pyrogen |
| Subacute Toxicity | No Subacute Systemic Toxicity |
| Hemocompatibility (Hemolysis) | No hemolysis |
| Sterility & Shelf-Life: | |
| Sterility Assurance Level (SAL) | 10^-6 (Irradiation sterilized, dose 25kGy, validated per ISO 11137-2) |
| Endotoxin Limit | 20 EU per device (Utilizing USP <85> LAL method) |
| Particulate Matter (USP <788>) | Met USP acceptance criteria |
| Shelf Life | 5 years (Validated using ASTM F1980-16) |
| Packaging Integrity | All packaging deemed acceptable for protection of product and sterility maintenance (tested via ASTM F88/F88-15 seal strength, ASTM F1929-15 dye penetration) |
| Material Composition: | |
| Needle Tube Material | Stainless Steel (SUS304) |
| Hub Material | Polypropylene |
| Lubricant | MDX4-4159 |
| Adhesive | UV glue |
| Compatibility with Pen Injectors | Tested with specified pen injectors (Autopen®, Novopen Echo®, Humapen and Humapen Ergo, Humapen Luxura, Humapen Memoir) |
2. Sample size used for the test set and the data provenance
-
Simulated Clinical Use Study (for Safety Type):
- Sample Size: 600 device samples.
- Data Provenance: Not explicitly stated (e.g., country of origin, retrospective/prospective), but it was a "simulated clinical use study," implying prospective testing under controlled conditions.
-
Other Non-clinical Tests (e.g., physical, mechanical, biocompatibility, sterility):
- Specific sample sizes for each test are not provided in this summary. These tests are typically conducted on representative batches of the manufactured device.
- Data Provenance: These are laboratory-based, non-clinical tests, not involving human subjects or patient data. The manufacturer (Tianjin Huahong Technology Co., Ltd. in China) conducted or commissioned these tests.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
This type of information (number and qualifications of experts for ground truth) is relevant for studies involving subjective assessment or interpretation (e.g., imaging devices, diagnostic algorithms). For physical medical devices like insulin pen needles, "ground truth" is typically established by objective measurements against established engineering standards and biological safety tests. Therefore, this information is not applicable and not provided in the document. The "ground truth" is the objective standard itself (e.g., SAL of 10^-6, absence of cytotoxicity).
4. Adjudication method for the test set
Not applicable. Adjudication methods (like 2+1 or 3+1 for resolving discrepancies in expert opinions) are used in studies where subjective evaluations are made. For pen needles, performance is assessed against objective, measurable criteria and standards.
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. This is a medical device (insulin pen needle), not an AI-powered diagnostic or assistive technology that involves "human readers" or AI assistance.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This is a physical medical device, not an algorithm.
7. The type of ground truth used
The "ground truth" for the performance claims of these insulin pen needles is based on:
- International Standards: Adherence to established ISO standards (e.g., ISO 7864, ISO 9626, ISO 11608-2, ISO 23908) for physical, mechanical, and safety properties.
- Biocompatibility Standards: Adherence to ISO 10993 series for biological evaluation of medical devices.
- Pharmacopoeia Standards: Adherence to USP <788> for particulate matter and USP <85> for endotoxin limits.
- Engineering Specifications: Device specifications (e.g., material composition, dimensions, bond strength) measured against defined tolerances.
- Predicate Device Comparison: Establishing substantial equivalence by demonstrating that the proposed device performs comparably to legally marketed predicate devices regarding safety and effectiveness.
8. The sample size for the training set
Not applicable. "Training set" refers to data used to train machine learning models. This is a physical medical device submission, not an AI/ML device.
9. How the ground truth for the training set was established
Not applicable. As explained above, this is not an AI/ML device.
{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 (DICE@fda.hhs.gov) or phone (1-800-638-2041 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)
CONTINUE ON A SEPARATE PAGE IF NEEDED.
This section applies only to requirements of the Paperwork Reduction Act of 1995.
DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.
The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:
Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov
"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."
{3}------------------------------------------------
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: +86-22-58775333 Fax: +86-22-58775353 Email: yan.li@hh-technology.com
-
- 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.
-
- 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)
{5}------------------------------------------------
| construction for allcomponents | 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 ofattachment to peninjector | Through threaded connection | Through threaded connection |
Table 2 Safety and Performance Comparison for Insulin Pen Needle (Ordinary Type)
| ITEM | Proposed DeviceK202319 | Predicate Device 1K181069 |
|---|---|---|
| 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 ISO11608-2:2012;Clause 4.12 of ISO7864:2016 |
| Design specification of the innersheath (dimensions, color,materials and strength) | 14.35.85.8mm;Transparent color; Polypropylene;Tensile stress at yield>20MPa; Flexuralmodulus: >800MPa; Charpy Notched ImpactStrength (23°C) >2.8kJ/m². | Unknown |
| Design specification of the outersheath (dimensions, color,materials and strength) | 30.313.413.4mm;Transparent color; Polypropylene;Tensile stress at yield>20MPa; Flexuralmodulus: >800MPa; Charpy Notched ImpactStrength (23°C) >2.8kJ/m². | Unknown |
| Needle tip configuration | Conform with ISO 7864 standards | Conform with ISO7864 standards |
| Cytotoxicity | No Cytoxicity | |
| Intracutaneous reactivity | No Irritation to Skin | |
| Skin Sensitization | No skin sensitization | Conform with ISO10993 standards |
| Acute Systemic Toxicity | No Systemic Toxicity | |
| Pyrogen | No pyrogen |
{6}------------------------------------------------
| 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 PolypropyleneOuter Sheath PolypropyleneInner Sheath PolypropyleneSealed Paper PaperSpring Stainless Steel (SUS304)Upper Cover Polypropylene | Cannula Medical grade stainless steelHub Plastic resinPrimary container Plastic resinSlider UnknownSeal UnknownSpring-operated Stainless steel wireNeedle 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)
{7}------------------------------------------------
| injector | ||
|---|---|---|
| Safety Feature | Prevent from needlestick | Prevent from needlestick |
| Method ofactivation | 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 innersheath (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 outersheath (dimensions, color,materials and strength) | 43.818.618.6mm; Transparentcolor; Polypropylene.Tensile stress at yield>20MPa;Flexural modulus: >800MPa;Charpy Notched Impact Strength(23 °C) >2.8kJ/m². | Unknown |
| Design specification of the uppercover (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 7864standards | Conform with ISO 7864standards |
| Biocompatibility | ||
| Cytotoxicity | No Cytoxicity | |
| Intracutaneous reactivity | No Irritation to Skin | |
| Skin Sensitization | No skin sensitization | Conform with ISO 10993standards |
| 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 |
{8}------------------------------------------------
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 <788> 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 <85> 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.
-
- Conclusion
The clinical and non-clinical tests demonstrate that the subject device is substantially equivalent to the predicate device.
- Conclusion
§ 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).