(209 days)
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.
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 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.
Here's a breakdown of the requested information based on the provided FDA 510(k) summary for the Hantech Medical Device Co., Ltd. Disposable Insulin Pen Needle (K222739).
It's important to note that this document is a 510(k) premarket notification, which demonstrates substantial equivalence to a predicate device, rather than a full study proving a device meets novel acceptance criteria. Therefore, many of the typical AI/ML study components (like expert consensus, adjudication, MRMC studies, training set details) are not applicable here. This submission focuses on demonstrating that the new device performs similarly to an already approved device through established engineering and biocompatibility testing.
1. Table of Acceptance Criteria and Reported Device Performance
For this type of device, "acceptance criteria" are generally derived from recognized international and national standards, and "reported device performance" indicates conformity to these standards.
| Acceptance Criteria Category | Specific Criteria (from referenced standards) | Reported Device Performance |
|---|---|---|
| Biocompatibility | Absence of cytotoxicity (ISO 10993-5:2009) | No cytotoxicity |
| Absence of skin sensitization (ISO 10993-10:2010) | No evidence of sensitization | |
| Absence of hemolysis (ISO 10993-4:2017) | No evidence of hemolysis | |
| Acceptable intradermal reactivity (ISO 10993-10:2010) | Not explicitly detailed as "acceptable" but implied by conformity. "No evidence of skin irritation" is noted. | |
| Absence of acute systemic toxicity (ISO 10993-11:2017) | No systemic toxicity | |
| Non-pyrogenic (ISO 10993-11:2017) | Non-pyrogenic | |
| Absence of subacute systemic toxicity (ISO 10993-11:2017) | No Subacute Systemic Toxicity | |
| Acceptable particulate levels (USP 788) | Implied by conformity, no specific value given. | |
| Sterilization | Sterility Assurance Level (SAL) of $10^{-6}$ (ISO 11135:2014) | Sterilized by ethylene oxide gas SAL = $10^{-6}$ |
| Compliance with ethylene oxide sterilization residuals (ISO 10993-7:2008) | Implied by conformity to ISO 10993-7. | |
| Packaging integrity and sterile barrier system requirements (ISO 11607-1:2019, ISO 11607-2:2019) | Implied by conformity to these standards. | |
| Shelf life stability (based on stability study and accelerated aging - ASTM F1980-16) | 5 years shelf life | |
| Performance | Requirements for hypodermic needles (ISO 7864:2016) | Complied with ISO 7864 |
| Requirements for stainless steel needle tubing (ISO 9626:2016) | Complied with ISO 9626 | |
| Requirements for needle-based injection systems (ISO 11608-2:2012) | Complied with ISO 11608-2 | |
| Labeling | Compliance with 21 CFR Part 801 | Meet the requirements of 21 CFR Part 801 |
2. Sample Size Used for the Test Set and the Data Provenance
The document does not specify a "test set" in the context of clinical data or AI model evaluation. Instead, testing refers to product compliance with international standards for medical devices. The sample sizes for these specific engineering and biocompatibility tests are not detailed in this summary, but would typically be defined by the relevant ISO standards (e.g., a certain number of units for sterility testing or mechanical strength tests).
- Data Provenance: The tests were conducted by the manufacturer, Hantech Medical Device Co., Ltd., which is located in Ningbo, Zhejiang, China. The testing would be prospective in the sense that physical devices were manufactured and then tested to demonstrate compliance.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and the Qualifications of Those Experts
Not applicable. For this type of medical device 510(k) submission, "ground truth" is not established by human experts interpreting clinical data. Instead, it's established by objective measurements against predefined engineering standards and biocompatibility requirements. The "experts" involved would be qualified laboratory technicians, engineers, and biocompatibility specialists carrying out the specified tests following established protocols.
4. Adjudication Method for the Test Set
Not applicable. There is no qualitative assessment by human readers that would require an adjudication method. Test results are quantitative measurements or assessments against scientific criteria.
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 device is a physical medical product (insulin pen needle), not an AI/ML diagnostic or assistive technology. Therefore, no MRMC study or AI assistance evaluation was performed.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
Not applicable. As noted above, this is a physical medical device, not an algorithm or software.
7. The Type of Ground Truth Used (expert consensus, pathology, outcomes data, etc.)
The "ground truth" for this substantially equivalent device is the demonstrated compliance with recognized international and national standards for mechanical performance, sterility, and biocompatibility, as well as comparison to the characteristics of a legally marketed predicate device. This is based on objective laboratory and quality control testing, not clinical outcomes data, pathology, or expert consensus on interpretations.
8. The Sample Size for the Training Set
Not applicable. This is not an AI/ML device that requires a training set.
9. How the Ground Truth for the Training Set Was Established
Not applicable. This is not an AI/ML device, so no training set or its associated ground truth establishment is relevant.
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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
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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
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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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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
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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.
| Devicefeature | Subject Device | Predicate Device K210059 | Comments |
|---|---|---|---|
| Indicationsfor use | The Disposable Insulin PenNeedle is intended for usewith pen injector device forsubcutaneous injection ofinsulin. It is sterile and forsingle use only. It can beused by the patient at homeor healthcare professionalsat medical/health carecenters. | Promisemed Insulin PenNeedle is intended for usewith pen injector device forsubcutaneous injection ofinsulin. It is sterile and forsingle use only. It is suitablefor all age groups includingneonate, infant, children andadult, and can be used by thepatient at home or healthcareprofessionals at medical/health care centers. | Same |
| Productcode | FMI | FMI | Same |
| Regulation | 21 CFR 880.5570 | 21 CFR 880.5570 | Same |
| Devicefeature | 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 withinserting the needle into theskin manually. The patientend and the cartridge end ofthe tube are lubricated usinga silicone based lubricant forease of injection and rubberseptum penetration. | The user proceeds withinserting the needle into theskin manually. The patientend and the cartridge end ofthe tube are lubricated usinga silicone based lubricant forease of injection and rubberseptum penetration. | Same |
| Specific drug use | Insulin | Insulin | Same |
| Needlegauge | 29G, 30G, 31G, 32G, 33G,34G | 29G, 30G, 31G, 32G, 33G,34G | |
| NeedleLength | 4mm, 5mm, 6mm, 8mm,12mm | $3.5mm \pm 0.4mm$(4mm, 5mm, 6mm, 8mm,12mm) $\pm 1.2mm$ | Substantially equivalentComment 1 |
| Lubricant | Silicon oil | Silicon oil | Same |
| Single Use | Yes | Yes | Same |
| Materials | Needle tube Stainless Steel(SUS304) | Needle tube X5CrNi18-10 | Substantially equivalentComment 2 |
| Needle Hub Polypropylene | Needle Hub Polypropylene | ||
| Needle containerPolypropylene | Needle containerPolypropylene | ||
| Needle ShieldPolypropylene | Needle ShieldPolyethylene | ||
| Joint mediumUV glue | Joint mediumUV glue | ||
| SealDialyzer paper | SealDialyzer paper | ||
| Sterilization | Sterilized by ethylene oxidegas SAL = 10-6 | Sterilized by ethylene oxidegas SAL = 10-6 | Same |
| Shelf Life | 5 years | 5 years | Same |
| Performance | Complied with ISO 7864, ISO9626, ISO 11608-2 | Complied with ISO 7864, ISO9626, ISO 11608-2 | Same |
| Biocompatibility | Complied with ISO10993series standards, and thefollowing tests areperformedCytotoxicity: No cytotoxicity | Complied with ISO10993series standards, and thefollowing tests areperformedCytotoxicity: No cytotoxicity | Same |
| Devicefeature | Subject Device | Predicate Device K210059 | Comments |
| - Skin Irritation: No evidenceof skin irritation- Skin Sensitization: Noevidence of sensitization-Acute Systemic Toxicity:Nosystemic toxicity-Hemolysis: No evidence ofhemolysis-Pyrogen: Non-pyrogenic-Subacute Systemic Toxicity:No Subacute SystemicToxicity | - Skin Irritation: No evidenceof skin irritation- Skin Sensitization: Noevidence of sensitization-Acute Systemic Toxicity:Nosystemic toxicity-Hemolysis: No evidence ofhemolysis-Pyrogen: Non-pyrogenic | ||
| Labeling | Meet the requirements of 21CFR Part 801 | Meet the requirements of 21CFR Part 801 | Same |
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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
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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
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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.
§ 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).