(209 days)
No
The device description and performance studies focus on the physical components, sterilization, and basic performance of a disposable insulin pen needle, with no mention of AI or ML technologies.
No.
This device is a needle for subcutaneous injection of insulin, not a therapeutic device itself. It facilitates the delivery of medication (insulin) but does not directly provide therapy.
No
The device is a needle used for injecting insulin, not for diagnosing a condition. Its purpose is to deliver medication, not to identify or monitor a disease.
No
The device description clearly outlines physical components like a needle tube, needle hub, needle container, needle shield, and seal, indicating it is a hardware medical device.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostic devices are used to examine specimens taken from the human body (like blood, urine, tissue) to provide information about a person's health. This information is used for diagnosis, monitoring, or screening.
- Device Function: The Disposable Insulin Pen Needle is a device used to deliver a substance (insulin) into the body. It is a delivery mechanism, not a tool for analyzing biological samples.
- Intended Use: The intended use clearly states it's for "subcutaneous injection of insulin." This is a therapeutic action, not a diagnostic one.
The device description and performance studies also focus on the physical characteristics, sterility, and performance of the needle for injection, not on any diagnostic capabilities.
N/A
Intended Use / Indications for Use
The Disposable Insulin Pen Needle is intended for use with pen injector device for subcutaneous injection of insulin. It is sterile and for single use only. It can be used by the patient at home or healthcare professionals at medical/health care centers.
Product codes
FMI
Device Description
The Disposable Insulin Pen Needle consists of a needle tube, a needle hub, a needle container, a needle shield and a seal. The needle tube is a double-ended needle that can be assembled into the needle hub using UV glue. The needle hub has the means of needle assembly attachment to allow it to be screwed onto the pen-injector device. This allows the Non-Patient (NP) end of the needle to penetrate through the rubber septum of the pen injector cartridge. The Patient and NP ends of the needle are lubricated using silicon oil for ease of injection and rubber septum penetration. The needle shield is assembled over the Patient end of the needle to protect the point from damage and accidental needle sticks. This needle assembly is inserted into a needle container and sealed with a peel-away label to provide a sterile barrier and tamper evidence. The peel-away label is pre-printed with information, which includes the lot number and needle gauge / length. It is supplied with several models. Different models are distinguished by needle gauge and length. The Disposable Insulin Pen Needle is a single-use disposable device and is provided sterile (EO sterilization). It is non-toxic and nonpyrogenic.
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
patient at home or healthcare professionals at medical/health care centers.
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)
The following performance data were provided in support of the substantial equivalence determination.
Biocompatibility testing: Biocompatibility of the Disposable Insulin Pen Needle was evaluated in accordance with ISO 10993-1:2018 for the body contact category of "External communication device - Blood path indirect" with a contact duration of "Prolonged (24 hours-30days )". The performed tests were: Cytotoxicity (ISO 10993-5: 2009), Skin sensitization (ISO 10993-10: 2010), Hemolysis (ISO 10993-4: 2017), Intradermal reactivity (ISO 10993-10: 2010), Acute systemic toxicity (ISO 10993-11: 2017), Pyrogenicity (ISO 10993-11: 2017), Subacute Systemic Toxicity (ISO 10993-11: 2017), and Particulates (USP 788).
Sterilization and shelf life testing: The sterilization method has been validated to ISO11135. The shelf life of the Disposable Insulin Pen Needle is determined based on stability study which includes ageing test. Testing performed according to ISO 11135:2014, ISO 10993-7:2008, ISO 11607-1: 2019, ISO 11607-2: 2019, and ASTM F1980-16.
Performance testing: Testing performed according to ISO 7864:2016, ISO 9626:2016, and ISO 11608-2:2012.
Key results: The non-clinical testing demonstrates that the device is as safe, as effective and performs as well as the legally marketed device.
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 shows the logo for the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health & Human Services logo on the left and the FDA logo on the right. The FDA logo is in blue and includes the letters "FDA" in a square and the words "U.S. FOOD & DRUG ADMINISTRATION".
April 6, 2023
Hantech Medical Device Co., Ltd. Rachel Jin Official Correspondent No 288, Sanheng Road Changhe Industridal Park, Cixi Ningbo, Zhejiang 315326 China
Re: K222739
Trade/Device Name: Disposable Insulin Pen Needle Regulation Number: 21 CFR 880.5570 Regulation Name: Hypodermic Single Lumen Needle Regulatory Class: Class II Product Code: FMI Dated: March 7, 2023 Received: March 7, 2023
Dear Rachel Jin:
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
1
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) 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 (QS) 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 medical devices and radiation-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,
Alan Sth
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 Ouality Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known) K222739
Device Name Disposable Insulin Pen Needle
Indications for Use (Describe)
The Disposable Insulin Pen Needle is intended for use with pen injector device for subcutaneous injection of insulin. It is sterile and for single use only. It can be used by the patient at home or healthcare professionals at medical/health care centers.
| 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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3
K22Z739 510(k) summary
I Submitter
Device submitter: Hantech Medical Device Co., Ltd. No 288, Sanheng Road Changhe Industridal Park, Cixi 315326, Ningbo PEOPLE'S REPUBLIC OF CHINA
Contact person: Name: Arnold Yang Title: Regulatory Affairs Manager Phone: +86 18917368988 Fax: +86 574 5899 5557 E-mail: rachel@hantechmedical.com
Date: 03/07/2023
II Device
Trade Name of Device: Disposable Insulin Pen Needle Common Name: Disposable Insulin Pen Needle Regulation Number: 21 CFR 880.5570 Classification: II Classification Name: Needle, Hypodermic, Single Lumen Product code: FMI Review Panel: General Hospital
III Predicate Devices
| Trade name: | Promisemed Insulin Pen Needle |
|---|---|
| Common name: | Insulin Pen Needle |
| Classification: | Class II, 21 CFR 880.5570 |
| Product Code: | FMI |
| Premarket Notification: | K210059 |
| Manufacturer: | Promisemed Hangzhou Meditech Co., Ltd. |
IV Device description
The Disposable Insulin Pen Needle consists of a needle tube, a needle hub, a needle container, a needle shield and a seal. The needle tube is a double-ended needle that can be assembled into the needle hub using UV glue. The needle hub has the means of needle assembly attachment to allow it to be screwed onto the pen-injector device. This allows the Non-Patient (NP) end of the needle to penetrate through the rubber septum of the pen injector
4
cartridge. The Patient and NP ends of the needle are lubricated using silicon oil for ease of injection and rubber septum penetration. The needle shield is assembled over the Patient end of the needle to protect the point from damage and accidental needle sticks. This needle assembly is inserted into a needle container and sealed with a peel-away label to provide a sterile barrier and tamper evidence. The peelaway label is pre-printed with information, which includes the lot number and needle gauge / length. It is supplied with several models. Different models are distinguished by needle gauge and length. The Disposable Insulin Pen Needle is a single-use disposable device and is provided sterile (EO sterilization). It is non-toxic and nonpyrogenic.
| Device | Needle length | Needle gauge |
|---|---|---|
| Disposable Insulin Pen Needle | 4mm, 5mm, 6mm, 8mm, 12mm, | 34G, 33G, 32G, 31G, 30G, 29G, |
V Indications for use
The Disposable Insulin Pen Needle is intended for use with pen injector device for subcutaneous injection of insulin. It is sterile and for single use only. It can be used by the patient at home or healthcare professionals at medical/health care centers.
VI Comparison of technological characteristics with the predicate devices
The Disposable Insulin Pen Needle has the same intended use, technology, and design as the predicate device and performance specifications are either identical or substantially equivalent to existing legally marketed predicate device. The differences between the Disposable Insulin Pen Needle and predicate device do not alter suitability of the proposed device for its intended use.
| Device
| feature | Subject Device | Predicate Device K210059 | Comments |
|---|---|---|---|
| Indications | |||
| for use | The Disposable Insulin Pen | ||
| Needle is intended for use | |||
| with pen injector device for | |||
| subcutaneous injection of | |||
| insulin. It is sterile and for | |||
| single use only. It can be | |||
| used by the patient at home | |||
| or healthcare professionals | |||
| at medical/health care | |||
| centers. | Promisemed Insulin Pen | ||
| Needle is intended for use | |||
| with pen injector device for | |||
| subcutaneous injection of | |||
| insulin. It is sterile and for | |||
| single use only. It is suitable | |||
| for all age groups including | |||
| neonate, infant, children and | |||
| adult, and can be used by the | |||
| patient at home or healthcare | |||
| professionals at medical | |||
| /health care centers. | Same | ||
| Product | |||
| code | FMI | FMI | Same |
| Regulation | 21 CFR 880.5570 | 21 CFR 880.5570 | Same |
| Device | |||
| feature | Subject Device | Predicate Device K210059 | Comments |
| number | |||
| Class | CLASS II | CLASS II | Same |
| Type of Use | Over-The-Counter Use | Over-The-Counter Use | Same |
| Classification Name | Needle, Hypodermic, Single Lumen | Needle, Hypodermic, Single Lumen | Same |
| Principle of operation | The user proceeds with | ||
| inserting the needle into the | |||
| skin manually. The patient | |||
| end and the cartridge end of | |||
| the tube are lubricated using | |||
| a silicone based lubricant for | |||
| ease of injection and rubber | |||
| septum penetration. | The user proceeds with | ||
| inserting the needle into the | |||
| skin manually. The patient | |||
| end and the cartridge end of | |||
| the tube are lubricated using | |||
| a silicone based lubricant for | |||
| ease of injection and rubber | |||
| septum penetration. | Same | ||
| Specific drug use | Insulin | Insulin | Same |
| Needle | |||
| gauge | 29G, 30G, 31G, 32G, 33G, | ||
| 34G | 29G, 30G, 31G, 32G, 33G, | ||
| 34G | |||
| Needle | |||
| Length | 4mm, 5mm, 6mm, 8mm, | ||
| 12mm | $3.5mm \pm 0.4mm$ | ||
| (4mm, 5mm, 6mm, 8mm, | |||
| 12mm) $\pm 1.2mm$ | Substantially equivalent | ||
| Comment 1 | |||
| Lubricant | Silicon oil | Silicon oil | Same |
| Single Use | Yes | Yes | Same |
| Materials | Needle tube Stainless Steel | ||
| (SUS304) | Needle tube X5CrNi18-10 | Substantially equivalent | |
| Comment 2 | |||
| Needle Hub Polypropylene | Needle Hub Polypropylene | ||
| Needle container | |||
| Polypropylene | Needle container | ||
| Polypropylene | |||
| Needle Shield | |||
| Polypropylene | Needle Shield | ||
| Polyethylene | |||
| Joint medium | |||
| UV glue | Joint medium | ||
| UV glue | |||
| Seal | |||
| Dialyzer paper | Seal | ||
| Dialyzer paper | |||
| Sterilization | Sterilized by ethylene oxide | ||
| gas SAL = 10-6 | Sterilized by ethylene oxide | ||
| gas SAL = 10-6 | Same | ||
| Shelf Life | 5 years | 5 years | Same |
| Performance | Complied with ISO 7864, ISO | ||
| 9626, ISO 11608-2 | Complied with ISO 7864, ISO | ||
| 9626, ISO 11608-2 | Same | ||
| Biocompatibility | Complied with ISO10993 | ||
| series standards, and the | |||
| following tests are | |||
| performed | |||
| Cytotoxicity: No cytotoxicity | Complied with ISO10993 | ||
| series standards, and the | |||
| following tests are | |||
| performed | |||
| Cytotoxicity: No cytotoxicity | Same | ||
| Device | |||
| feature | Subject Device | Predicate Device K210059 | Comments |
| - Skin Irritation: No evidence | |||
| of skin irritation |
- Skin Sensitization: No
evidence of sensitization
-Acute Systemic Toxicity:No
systemic toxicity
-Hemolysis: No evidence of
hemolysis
-Pyrogen: Non-pyrogenic
-Subacute Systemic Toxicity:
No Subacute Systemic
Toxicity | - Skin Irritation: No evidence
of skin irritation - Skin Sensitization: No
evidence of sensitization
-Acute Systemic Toxicity:No
systemic toxicity
-Hemolysis: No evidence of
hemolysis
-Pyrogen: Non-pyrogenic | |
| Labeling | Meet the requirements of 21
CFR Part 801 | Meet the requirements of 21
CFR Part 801 | Same |
5
6
Discussion:
Comment 1
The subject device's needle length is covered by the range of lengths in the predicate device.
Comment 2
The materials of needle tube is different between the subject device and predicate device. The biocompatibility test of the subject device was conducted to demonstrate that the subject device met the biocompatibility requirements. So this difference does not raise any safety and effectiveness problems.
VII Performance data
The following performance data were provided in support of the substantial equivalence determination.
Biocompatibility testing
7
Biocompatibility of the Disposable Insulin Pen Needle was evaluated in accordance with ISO 10993-1:2018 for the body contact category of "External communication device - Blood path indirect" with a contact duration of "Prolonged (24 hours-30days )". The following tests were performed, as recommended:
| Cytotoxicity | ISO 10993-5: 2009 |
|---|---|
| Skin sensitization | ISO 10993-10: 2010 |
| Hemolysis | ISO 10993-4: 2017 |
| Intradermal reactivity | ISO 10993-10: 2010 |
| Acute systemic toxicity | ISO 10993-11: 2017 |
| Pyrogenicity | ISO 10993-11: 2017 |
| Subacute Systemic Toxicity | ISO 10993-11: 2017 |
| Particulates | USP 788 |
Sterilization and shelf life testing
The sterilization method has been validated to ISO11135, which has thereby determined the routine control and monitoring parameters. The shelf life of the Disposable Insulin Pen Needle is determined based on stability study which includes ageing test.
The testing is performed according to the following standards:
- ISO 11135:2014 Sterilization of health-care products Ethylene oxide A 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 A sterilization residuals
-
ISO 11607-1: 2019 Packaging for terminally sterilized medical devices - Part 1: Requirements for materials, sterile barrier systems and packaging systems
-
ISO 11607-2: 2019 Packaging for terminally sterilized medical devices - Part 2: Validation requirements for forming, sealing and assembly processes
-
ASTM F1980-16 Standard Guide for Accelerated Aging of Sterile Barrier Systems for Medical Devices
Performance testing
Performance testing is performed according to the following standards:
-
ISO 7864:2016 Disposable Medical Safety Hypodermic Needles — Requirements and test methods
-
ISO 9626:2016, Stainless Steel Needle Tubing For The Manufacture of Medical Devices
-
ISO ISO 11608-2:2012, Needle-based injection systems for medical use -Requirements and test methods - Part 2: Needles
VIII Conclusion
8
The Disposable Insulin Pen Needle is substantially equivalent to its predicate device (Promisemed Insulin Pen Needle). The non-clinical testing demonstrates that the device is as safe, as effective and performs as well as the legally marketed device.