(351 days)
Not Found
No
The device description and performance studies focus on the mechanical and material properties of a simple disposable needle, with no mention of computational analysis, algorithms, or data processing that would indicate AI/ML.
No.
A therapeutic device is one that treats or mitigates a disease or condition. This device, an "Injection Pen Needle," is used for the "subcutaneous injection of drugs," which means it delivers medication but is not the therapeutic agent itself.
No
This device, an Injection Pen Needle, is used for subcutaneous injection of drugs, which is a therapeutic function, not a diagnostic one.
No
The device description clearly outlines physical components (seal, needle hub, needle tube, etc.) and describes a physical mechanism for drug delivery, indicating it is a hardware device.
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 drugs" using a pen injector. This describes a device used for administering medication directly into the body, not for testing samples taken from the body to diagnose or monitor a condition.
- Device Description: The description details a needle designed to connect to a pen injector and deliver a drug. It focuses on the physical mechanism of injection and the components involved in that process.
- Lack of IVD Characteristics: There is no mention of analyzing samples (blood, urine, tissue, etc.), detecting analytes, or providing diagnostic information.
IVD devices are specifically designed to perform tests on samples from the human body to provide information for diagnosis, monitoring, or screening. This device's function is purely for drug delivery.
N/A
Intended Use / Indications for Use
The Injection Pen Needle is intended for use with pen injector devices for the subcutaneous injection of drugs.
Product codes
FMI
Device Description
The Injection Pen Needle is designed for use with pen injectors for subcutaneous injection of a desired dose of drugs approved for delivery using a pen needle. It consists of a seal, needle hub, needle tube, needle sheath and primary container. The Injection Pen Needle is offered in the following sizes: Model(s): 0.30x6mm/30G, 0.30x8mm/30G, 0.25x6mm/31G, 0.25x8mm/31G, 0.23x4mm/32G
It is a single-use disposable device that is provided sterile and has a shelf life of 3 years. The needle hub is connects to the pen injector and the needle tube punctures the sealed medicine container. The medicine solution is pushed out through the needle tube by the injection mechanism of the pen injector.
The needle tube is a stainless steel needle tube with lubricant coating on the surface and a beveled tip. The seal (medical glue-coated dialysis paper) and the primary container (medical polypropylene) constitute the sterile barrier system of the product.
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
Not Found
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 Injection Pen Needle met all design specifications and is Substantially Equivalent (SE) to the predicate device. Testing was conducted in accordance with recognized standards and FDA Guidance.
Performance:
The Injection Pen Needle was tested for device performance with the following recognized standards. Results of the testing demonstrated that the acceptance criteria were met for all gauges and lengths of needles and would support a shelf life of 3 years.
- ISO 7864:2016 Sterile hypodermic needles for single use Requirements and test methods.
- ISO 9626:2016 Stainless steel needle tubing for the manufacture of medical devices -Requirements and test methods.
- ISO 11608-2:2012 Needle-based injection systems for medical use Requirements and test methods -● Part 2: Needles.
Compatibly was demonstrated to the following FDA cleared/approved injectors via ISO 11608-2: 2012 clauses 4.4 and 4.9: PEN INJECTOR - HumaPen Luxura (K142518); PEN INJECTOR - NovoPen Echo (K182387); PEN INJECTOR - NOVOLOG MIX 70/30 (BLA 021172); PEN INJECTOR - LANTUS SOLOSTAR (BLA 021081).
Biocompatibility:
The Injection Pen Needle was evaluated for biocompatibility endpoints associated with a limited contact (≤ 24 hrs) external communicating, circulating blood contacting device per FDA Guidance: "Use of International Standard ISO 10993-1. Biological Evaluation of Medical Devices Part 1: Evaluation and Testing within a risk management process, June 2016'' and the list of recognized standards below. The endpoints evaluated include: Cyotoxicity, Sensitization, Irritation, Acute Systemic Toxicity, Hemocompatibility, Pyrogenicity. Results of the testing demonstrated that the acceptance criteria were met.
- ISO 10993-5:2009, Biological Evaluation of Medical Device, Part 5-Tests for Vitro cytotoxicity.
- ISO 10993-10:2010 Standard, Biological Evaluation of Medical Device, Part 10-Test for irritation and delay-type hypersensitivity.
- ISO 10993-11:2017 Biological evaluation of medical devices - Part 11: Tests for systemic toxicity.
- ISO 10993-4:2017 Biological evaluation of medical devices--Part 4: Selection of tests for interactions. with blood.
- ASTM F756, Standard Practice for Assessment of Hemolytic Properties of Materials
- USP41 Bacterial Endotoxins Test.
Sterility:
The Injection Pen Needle is supplied sterile in sterile packaging for single use and is sterilized by Ethylene Oxide to achieve a SAL of 10-6. Sterilization was validated and tested to ensure that sterility is maintained during the shelf life of 3 years in accordance with the following recognized standards. Results of the testing demonstrated that the acceptance criteria were met.
- ISO 11135:2014 Sterilization of health-care products Ethylene oxide Requirements for the. development, validation and routine control of a sterilization process for medical devices
- ISO 10993-7:2008 Biological evaluation of medical devices - Part 7: Ethylene oxide sterilization residuals
- ASTM F1980-16 Standard Guide for Accelerated Aging of Sterile Barrier Systems for Medical Devices
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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).
0
Image /page/0/Picture/0 description: The image contains 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 consists of the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG" in blue, with the word "ADMINISTRATION" underneath. The logo is simple and professional, and it is easily recognizable.
August 25, 2020
Gangan Medical Technology Jiangsu Co., Ltd. % Ray Wang General Manager Beijing Believe-Med Technology Service Co., Ltd. R912, Building #15, XiYueHui, No.5, YiHe North Rd., FangShan District BeiJing. China 102401
Re: K192464
Trade/Device Name: Injection Pen Needle Regulation Number: 21 CFR 880.5570 Regulation Name: Hypodermic Single Lumen Needle Regulatory Class: Class II Product Code: FMI Dated: July 21, 2020 Received: July 23, 2020
Dear Ray Wang:
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,
For CAPT Alan 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
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3
K192464 510(k) Summary
This 510(k) Summary of 510(k) safety and effectiveness information is being submitted in accordance with requirements of Title 21, CFR Section 807.92.
1. Date of Preparation: August 12, 2020
2. Sponsor Identification/Contact Information:
Submitter Name: Gangan Medical Technology Jiangsu Co., Ltd. Addresss: 1st-4th floor, Building G130, fifth phase of standard workshop, China Medical City, 225300 Taizhou City, China
Contact Person: Wu Shuhui Position: Quality Manager Telephone number: +86-010-56965029 Fax Number:: +86-523-80108778 Email: ShuHui.Wu@ganlee.com
3. Identification of Subject Device
510(k) Number: K192464 Trade Name: Injection Pen Needle Common Name: Hypodermic single lumen needle Classification Name: Needle, hypodermic, single lumen Regulatory Classification: 2 Product Code: FMI Regulation Number: 21 CFR 880.5570 Review Panel: General Hospital;
Identification of Predicate Device(s) 4.
510(k) Number: K171982 Product Name: Droplet Pen Needles Common Name: Hypodermic single lumen needle Classification Name: Needle, hypodermic, single lumen Regulatory Classification: 2 Product Code: FMI Regulation Number: 880.5570 Review Panel: General Hospital
5. Indications for Use Statement:
The Injection Pen Needle is intended for use with pen injector devices for the subcutaneous injection of drugs.
Device Description 6.
The Injection Pen Needle is designed for use with pen injectors for subcutaneous injection of a desired dose
4
of drugs approved for delivery using a pen needle. It consists of a seal, needle hub, needle tube, needle sheath and primary container. The Injection Pen Needle is offered in the following sizes: Model(s): 0.30x6mm/30G, 0.30x8mm/30G, 0.25x6mm/31G, 0.25x8mm/31G, 0.23x4mm/32G
It is a single-use disposable device that is provided sterile and has a shelf life of 3 years. The needle hub is connects to the pen injector and the needle tube punctures the sealed medicine container. The medicine solution is pushed out through the needle tube by the injection mechanism of the pen injector.
The needle tube is a stainless steel needle tube with lubricant coating on the surface and a beveled tip. The seal (medical glue-coated dialysis paper) and the primary container (medical polypropylene) constitute the sterile barrier system of the product.
7. Comparison of Technology to Predicate Device
A technological comparison table is provided below that compares the subject device and predicate device:
| Item | Proposed Device(s) | Predicate Device(K171982) | Remark |
|---|---|---|---|
| Device name | Injection Pen Needle | Droplet Pen Needle | N/A |
| Classification Name | Needle, hypodermic, single lumen | Needle, hypodermic, single lumen | SAME |
| Product Code | FMI | FMI | SAME |
| Regulation Number | 21 CFR 880.5570 | 21 CFR 880.5570 | SAME |
| Intended Use | The Injection Pen Needle is intended for use with a pen injector device for the subcutaneous injection of drugs. | The Droplet® Pen Needle is intended for use with a pen injector device for the subcutaneous injection of drugs. | SAME |
| Prescription/OTC | Prescription Use | Prescription Use | SAME |
| Components | Primary Container, Needle Sheath, Needle Tube and Hub | Primary Container, Needle Shield, Needle Tube and Hub | SAME |
| Supplied Sterile | Yes | Yes | SAME |
| Single use | Yes | Yes | SAME |
| Principle of operation | Manual | Manual | SAME |
| Compatibility | Pen Injector Device | Pen Injector Device | SAME |
| Method of attachment to pen injector | Screw threads | Screw threads | SAME |
| Length | 4mm, 6mm, 8mm | 4mm, 5mm, 6mm, 8mm, 10mm, 12mm | SAME |
| Gage | 30G, 31G, 32G | 29G, 31G, 32G | Different |
| Sterilization Method | EO | Gamma irradiation | Different |
| Sterility | SAL=10-6 | SAL=10-6 | SAME |
| Shelf Life | 3 years | 5 years | Different |
| Unit Packaging | Polypropylene container with seal made of medical grade | Polypropylene container with seal made of medical grade | SAME |
Table 1 Comparison Table
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| paper | paper | |||
|---|---|---|---|---|
| Materials | Needle Tube | 304 austenitic stainless steel | Medical Grade Stainless Steel | Similar |
| Hub, Primary | ||||
| Container, | ||||
| Needle Sheath | Polypropylene | Polypropylene | Similar | |
| Lubricant | Medical grade silicone | Medical grade silicone | Similar | |
| Adhesive | UV Cured Adhesive | Not Available | Different | |
| Performance | ISO 11608-2, ISO 9626, ISO | ISO 11608-2, ISO 9626, ISO | SAME | |
| Compliance | 7864 | 7864 | SAME | |
| Biocompatibility | Biocompatibility evaluation per | |||
| ISO 10993-1 | Biocompatibility evaluation per | |||
| ISO 10993-1 | SAME |
The indications for use and intended use of the subject device is equivalent to that of the predicate device. The differences that exist between the subject device and predicate device are the following:
- . Gauge size
- Shelf life
- . Sterilization method
- Materials of composition
Based on the aforementioned modifications to the subject device, the subject device does not raise different types of safety and effectiveness questions when compared to the predicate device. Differences between the devices were verified or validated through non-clinical testing.
Non-Clinical Test Summary 8.
Non clinical tests were conducted to verify that the Injection Pen Needle met all design specifications and is Substantially Equivalent (SE) to the predicate device. Testing was conducted in accordance with recognized standards and FDA Guidance.
Performance:
The Injection Pen Needle was tested for device performance with the following recognized standards. Results of the testing demonstrated that the acceptance criteria were met for all gauges and lengths of needles and would support a shelf life of 3 years.
- ISO 7864:2016 Sterile hypodermic needles for single use Requirements and test methods. .
- . ISO 9626:2016 Stainless steel needle tubing for the manufacture of medical devices -Requirements and test methods.
- ISO 11608-2:2012 Needle-based injection systems for medical use Requirements and test methods -● Part 2: Needles.
Compatibly was demonstrated to the following FDA cleared/approved injectors via ISO 11608-2: 2012 clauses 4.4 and 4.9: PEN INJECTOR - HumaPen Luxura (K142518); PEN INJECTOR - NovoPen Echo (K182387); PEN INJECTOR - NOVOLOG MIX 70/30 (BLA 021172); PEN INJECTOR - LANTUS SOLOSTAR (BLA 021081).
Biocompatibility:
6
The Injection Pen Needle was evaluated for biocompatibility endpoints associated with a limited contact (≤ 24 hrs) external communicating, circulating blood contacting device per FDA Guidance: "Use of International Standard ISO 10993-1. Biological Evaluation of Medical Devices Part 1: Evaluation and Testing within a risk management process, June 2016'' and the list of recognized standards below. The endpoints evaluated include: Cyotoxicity, Sensitization, Irritation, Acute Systemic Toxicity, Hemocompatibility, Pyrogenicity. Results of the testing demonstrated that the acceptance criteria were met.
- . ISO 10993-5:2009, Biological Evaluation of Medical Device, Part 5-Tests for Vitro cytotoxicity.
- . ISO 10993-10:2010 Standard, Biological Evaluation of Medical Device, Part 10-Test for irritation and delay-type hypersensitivity.
- . ISO 10993-11:2017 Biological evaluation of medical devices - Part 11: Tests for systemic toxicity.
- ISO 10993-4:2017 Biological evaluation of medical devices--Part 4: Selection of tests for interactions . with blood.
- . ASTM F756, Standard Practice for Assessment of Hemolytic Properties of Materials
- USP41 Bacterial Endotoxins Test.
Sterility
The Injection Pen Needle is supplied sterile in sterile packaging for single use and is sterilized by Ethylene Oxide to achieve a SAL of 10-6 . Sterilization was validated and tested to ensure that sterility is maintained during the shelf life of 3 years in accordance with the following recognized standards. Results of the testing demonstrated that the acceptance criteria were met.
- ISO 11135:2014 Sterilization of health-care products Ethylene oxide Requirements for the . development, validation and routine control of a sterilization process for medical devices
- ISO 10993-7:2008 Biological evaluation of medical devices - Part 7: Ethylene oxide sterilization residuals
- . ASTM F1980-16 Standard Guide for Accelerated Aging of Sterile Barrier Systems for Medical Devices
9. Substantially Equivalent Conclusion
Differences between the technological characteristics of the subject device as compared to the predicate do not raise different questions of safety and effectiveness. The differences between the device are supported by non-clinical testing. The Injection Pen needle is Substantially Equivalent (SE) to the Droplet Pen Needles, cleared under K171982.