(107 days)
Promisemed Covered Safety Pen Needle is intended for subcutaneous injection of insulin in the treatment of diabetes.
Promisemed Covered Safety Pen Needle is manufactured by Promisemed Hangzhou Meditech Co., Ltd, which is designed for use with a pen injector for the subcutaneous injection of insulin. The user proceeds with inserting the needle into the skin manually.
The Promisemed Covered Safety Pen Needle consists of needle tube, trigger shield, spring, fixer, needle hub, needle container, UV glue and silicone oil. UV glue is used to glue needle tube and needle hub and the silicone oil is used to needle tube lubrication.
Promisemed Covered Safety Pen Needle is the modification of Verifine Safety Type Insulin Pen Needle cleared in K161950. The baseline location of trigger shield is adjusted to allow the needle tube be covered by trigger shield thoroughly before use. This modification prevents accidental needle sticks before inserting the needle into the skin while the needle container is removed. As the user proceeds with inserting the needle into the skin the shield will retract. After the injection is completed and needle is removed from the skin, the shield will automatically extend to cover the needle aqain and lock in place. Once the Covered Safety Insulin Pen Needle is in the locked mode, it can no longer be used.
Promisemed Covered Safety Pen Needle is sterility Assurance Level (SAL) of 10-6, non-pyrogenic and single-use devices. It is supplied with several models. Different models are distinquished by needle gauge and length.
This document is a 510(k) Pre-market Notification for a medical device called "Promisemed Covered Safety Pen Needle". It focuses on establishing substantial equivalence to a predicate device, not on presenting a standalone study of the device's performance against specific acceptance criteria in a clinical or AI context. Therefore, much of the requested information regarding AI/clinical studies, expert ground truth, sample sizes for test/training sets, and MRMC studies is not applicable or not provided in this regulatory document.
However, based on the provided text, I can extract information related to non-clinical testing and the acceptance criteria established by adherence to recognized international standards.
1. Table of Acceptance Criteria and Reported Device Performance
The device performance is demonstrated by compliance with international standards. The acceptance criteria are implicit in the requirements of these standards.
| Acceptance Criteria (Defined by Standard) | Reported Device Performance |
|---|---|
| ISO 9626:2016 (Needle material) | Complied |
| ISO 11608-2:2012 | Complied |
| Needle Dimensions | Complied |
| Flow rate | Complied |
| Bond between hub and needle tube | Complied |
| Needle points | Complied |
| Freedom from defects | Complied |
| Lubrication | Complied |
| Dislocation of measuring point patient end | Complied |
| Functional compatibility with needle-based injected systems | Complied |
| Ease of assembly and disassembly | Complied |
| ISO 7864:2016 (Pierce Force) | Complied |
| ISO 23908:2011 | Complied |
| Accidental access to a sharp once in safe mode | Complied |
| Safety mechanism activation | Complied |
| Safety overriding and unlocking force after activation | Complied |
| ISO 10993-1:2018, ISO 10993-5:2009, ISO 10993-10:2013, ISO 10993-11:2006, ISO 10993-11:2017 & ASTM F756-13 (Biocompatibility) | Complied |
| Cytotoxicity | No cytotoxicity |
| Sensitization | No evidence of sensitization |
| Irritation | No evidence of skin irritation |
| Acute Systemic Toxicity | No systemic toxicity |
| Material Mediated Pyrogenicity | No pyrogenic |
| Hemocompatibility | No evidence of hemolysis |
| ISO 11135:2014, ISO 11737-1:2018, ISO 11737-2:2009 & ISO 10993-7:2008 (Sterilization) | Complied |
| Sterility Assurance Level (SAL) | 10^-6 |
2. Sample size used for the test set and the data provenance
The document does not specify exact sample sizes for each non-clinical test. The testing was conducted to verify compliance with various ISO standards, which typically involve specific sample size requirements for each test. The data provenance is presumed to be from tests performed by the manufacturer, Promisemed Hangzhou Meditech Co., Ltd., in China, as they are the submitter. The tests are non-clinical (bench testing), not derived from patient data.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
Not applicable. This is a non-clinical device safety and performance evaluation based on adherence to engineering and biological safety standards, not a study requiring expert ground truth for diagnostic purposes.
4. Adjudication method for the test set
Not applicable. The tests are based on objective measurements and compliance with standard specifications, not subjective expert judgment or adjudication.
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 pen needle for insulin injection; it does not involve human readers, AI, or diagnostic interpretation.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This device is a mechanical medical device, not an algorithm or AI system.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
The "ground truth" for the non-clinical tests is defined by the objective metrics and specifications outlined in the referenced ISO and ASTM standards (e.g., specific dimensions, force thresholds, biological response, sterility levels).
8. The sample size for the training set
Not applicable. This is a medical device approval based on non-clinical testing against standards, not an AI model requiring a training set.
9. How the ground truth for the training set was established
Not applicable. See point 8.
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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.
December 31, 2020
Promisemed Hangzhou Meditech Co., Ltd. % Wei-Shan Hsu Regulatory manager Vee Care (Asia) Limited 17th Chung Pont Commercial Building, 300 Hennessy Road Hong Kong, Hong Kong 0000 China
Re: K202681
Trade/Device Name: Promisemed Covered Safety Pen Needle Regulation Number: 21 CFR 880.5570 Regulation Name: Hypodermic Single Lumen Needle Regulatory Class: Class II Product Code: FMI Dated: December 7, 2020 Received: December 7, 2020
Dear Wei Hsu:
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,
Rumi Young Acting 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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Indications for Use
510(k) Number (if known) K202681
Device Name
Promisemed Covered Safety Pen Needle
Indications for Use (Describe)
Promisemed Covered Safety Pen Needle is intended for subcutaneous injection of insulin in the treatment of diabetes.
| 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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K202681 - 510(k) Summary
Date Prepared 1
Dec 30th, 2020
Submitter's Information 2
Name of Sponsor:
Promisemed Hangzhou Meditech Co., Ltd.
Address:
No. 1388 Cangxing Street, Cangqian Community, Yuhang District, Hangzhou
City, 311121 Zhejiang, China
Contact Name:
Zearou Yang
Telephone No.:
+86 571 88772985
Fax No.:
+86 571 88772985
Email Address:
Trade Name, Common Name, Classification ന
Trade/Product Name: Promisemed Covered Safety Pen Needle Common Name: Needle, Hypodermic, Single Lumen Classification name: Needle, Hypodermic, Single Lumen Regulation Number: 21 CFR 880.5570 Device Class: Class II Product Code: FMI Review Panel: General Hospital
Predicate Device 4
K161950: Verifine® Safety Type Insulin Pen Needle Classification name: Needle, Hypodermic, Single Lumen Regulation Number: 21 CFR 880.5570
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Device Class: Class II Product Code: FMI
Description of the Device 5
Promisemed Covered Safety Pen Needle is manufactured by Promisemed Hangzhou Meditech Co., Ltd, which is designed for use with a pen injector for the subcutaneous injection of insulin. The user proceeds with inserting the needle into the skin manually.
The Promisemed Covered Safety Pen Needle consists of needle tube, trigger shield, spring, fixer, needle hub, needle container, UV glue and silicone oil. UV glue is used to glue needle tube and needle hub and the silicone oil is used to needle tube lubrication.
Promisemed Covered Safety Pen Needle is the modification of Verifine Safety Type Insulin Pen Needle cleared in K161950. The baseline location of trigger shield is adjusted to allow the needle tube be covered by trigger shield thoroughly before use. This modification prevents accidental needle sticks before inserting the needle into the skin while the needle container is removed. As the user proceeds with inserting the needle into the skin the shield will retract. After the injection is completed and needle is removed from the skin, the shield will automatically extend to cover the needle aqain and lock in place. Once the Covered Safety Insulin Pen Needle is in the locked mode, it can no longer be used.
Promisemed Covered Safety Pen Needle is sterility Assurance Level (SAL) of 10-6, non-pyrogenic and single-use devices. It is supplied with several models. Different models are distinquished by needle gauge and length.
| Model | Needle Outer Diameter | Needle length | Color |
|---|---|---|---|
| CPN-29-4 | 0.33 mm (29G) | 4 mm | Green |
| CPN-29-5 | 5 mm | Violet | |
| CPN-29-6 | 6 mm | Orange |
The dimension for Promisemed Covered Safety Pen Needle is shown as below.
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| CPN-29-8 | 0.30 mm (30G) | 8 mm | Blue |
|---|---|---|---|
| CPN-30-4 | 4 mm | Green | |
| CPN-30-5 | 5 mm | Violet | |
| CPN-30-6 | 6 mm | Orange | |
| CPN-30-8 | 8 mm | Blue | |
| CPN-31-4 | 0.25mm (31G) | 4 mm | Green |
| CPN-31-5 | 5 mm | Violet | |
| CPN-31-6 | 6 mm | Orange | |
| CPN-31-8 | 8 mm | Blue |
6 Intended Use
Promisemed Covered Safety Pen Needle is intended for subcutaneous injection of insulin in the treatment of diabetes.
Substantial Equivalence Discussion 7
The Promisemed Covered Safety Pen Needle is substantially equivalent to the predicate device, the Verifine Safety Type Insulin Pen Needle (K161950) in that these devices have similar designs, methods of construction and operation, and indications for use. The differences from the predicate include change of assembled position of trigger shield, and change of sterilization method.
A detailed comparison to the predicate is provided in Table 1.
| Subject Device | Predicate Device(K161950) | ||
|---|---|---|---|
| Trade Name | Promisemed CoveredSafety Pen Needle | Verifine Safety TypeInsulin Pen Needle | Comments |
| Manufacturer | Promisemed HangzhouMeditech Co., Ltd | Promisemed HangzhouMeditech Co., Ltd | |
| Device Class | Class II | Class II | Same |
| Product Code | FMI | FMI | Same |
| Regulation number | 880.5570 | 880.5570 | Same |
| Regulation Name | Needle, Hypodermic,Single Lumen | Needle, Hypodermic,Single Lumen | Same |
| Intended Use/Indications for Use | Promisemed CoveredSafety Pen Needle isintended forsubcutaneous injectionof insulin in thetreatment of diabetes. | The Safety Type InsulinPen Needle is intendedfor use with peninjector device forsubcutaneous injectionof insulin. | Same |
| Operating Principle | The needle tube iscovered by triggershield and is notexposed before usage.As the user proceedswith inserting theneedle into the skin theshield will retract.After the injection iscompleted and needleis removed from theskin, the shield willautomatically extend tocover the needle againand lock in place. Oncethe PromisemedCovered Safety PenNeedle is in the lockedmode, it can no longerbe used. | Additionally, afterwithdrawal of theSafety Type Insulin PenNeedle from the body,the attached needlesafety shieldautomatically coversthe needle to minimizethe risk of accidentalneedlestick.As the user proceedswith inserting theneedle into the skin theshield will retract.After the injection iscompleted and needleis removed from theskin, the shield willautomatically extend tocover the needle andlock in place. Once theSafety Type Insulin PenNeedle is in the lockedmode, it can no longerbe used. | Same |
| Gauge | G29, G30, G31 | G29, G30, G31 | Same |
| Needle Length | 4mm,5mm,6mm,8mm | 4mm,5mm,6mm,8mm | Same |
| Sharps InjuryPrevention Features | Trigger shield | Trigger shield | Same |
| Image: Needle with purple trigger shield | Image: Needle with blue trigger shield | DifferentThe needle tubeis not exposed insubject device.While in thepredicate it isexposed beforeusage. Themodification isverified per ISO7864:2016, ISO23908:2011 andISO 11608-2:2012. | |
| Configuration andMaterial | Needle Tube: X5CrNi18-10Needle Hub:Polyformaldehyde(POM)Fixer:Polyformaldehyde(POM) | Needle Tube: X5CrNi18-10Needle Hub:Polyformaldehyde(POM)Fixer:Polyformaldehyde(POM) | Same |
| Spring: 0Cr18Mn8Ni5N | Spring: 0Cr18Mn8Ni5N | Same | |
| Needle container:Polypropylene (PP) | Needle container:Polypropylene (PP) | Same | |
| Trigger shield:Acrylonitrile ButadieneStyrene (ABS) | Trigger shield:Acrylonitrile ButadieneStyrene (ABS) | Material is thesame. | |
| *Location slot is lower | *Location slot is higher | The location slotin subject deviceis moveddownward. Thischange makes thebaseline positionof trigger shieldmove upward infinished subjectdevice whichallowing theneedle tube becoveredcompletelybefore use. Themodification isverified per ISO7864:2016, ISO23908:2011andISO 11608-2:2012. | |
| Performance | Complied with ISO 7864,ISO 9626, ISO 11608-2and ISO 23908 | Complied with ISO 7864,ISO 9626, ISO 11608-2and ISO 23908 | Same |
| EO Sterilization | Gamma Sterilization | DifferentBoth aresterilized to SAL10-6 level. Thesterilization ofsubject devie isvalidated perISO11135:2014. | |
| Sterilization | SAL:10-6 | SAL: 10-6 | Same |
| Shelf Life | 5 years | 5 years | Same |
| Single use | Yes | Yes | Same |
| Biocompatibility | Complied withISO10993 seriesstandards, and thefollowing tests areperformed- Cytotoxicity: Nocytotoxicity- Skin Irritation: Noevidence of skinirritation- Skin Sensitization: Noevidence ofsensitization | Complied withISO10993 seriesstandards, and thefollowing tests areperformed- Cytotoxicity: Nocytotoxicity- Skin Irritation: Noevidence of skinirritation- Skin Sensitization: Noevidence ofsensitization | Same |
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| -Acute Systemic | -Acute Systemic |
|---|---|
| Toxicity: No systemic | Toxicity: No systemic |
| toxicity | toxicity |
| -Hemolysis: No | -Hemolysis: No |
| evidence of hemolysis | evidence of hemolysis |
| -Pyrogen: No pyrogenic | -Pyrogen: No pyrogenic |
Discussion:
The differences from the predicate is the change of assembled position of trigger shield, and Sterilization method, the Safety and performance of which were verified and validated through ISO 7864, ISO23908, and ISO 11608-2 testing (See Section 8). The sterilization was validated in accordance with ISO 11135:2014.
The differences between the predicate and the subject device do not raise any new or different questions of safety or effectiveness.
8 Non-Clinical Testing
The bench testing performed verifies that the performance of the subject devices is substantially equivalent in terms of critical performance characteristics to the predicate device. These tests include:
- ISO 9626:2016 Needle material
- ISO11608-2:2012 Needle Dimensions, Flow rate, Bond between hub and needle tube, Needle points, Freedown from defects, Lubrication, Dislocation of measuring point patient end, Functional compatibility with needle-based injected systems, Easy of assemble and disassembly
- ISO 7864:2016 Pierce Force
- ISO 23908:2011 Accidental access to a sharp once in safe mode, Safety mechanism activation,Safety overriding and unlocking force after activation
- Biocompatibility
The subject device was evaluated for the following endpoints per ISO 10993-1:2018, ISO 10993-5: 2009, ISO 10993-10: 2013, ISO 10993-11:2006, ISO 10993-11:2017 and ASTM F756-13 - Cytotoxicity, Sensitization,
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Irritation, Acute Systemic Toxicity, Material Mediated Pyrogenicity, Subacute/Subchronic Toxicity, and Hemocompatibility.
-
Sterilization
The subject device complies with ISO 11135:2014, ISO 11737-1:2018, ISO 11737-2:2009 and ISO 10993-7:2008 for EO sterilization. -
Clinical Testing: 9 Not Applicable
-
10 Conclusion
The modifications to the design and sterilization of the subject device met the requirements of the standards. The proposed Promisemed Covered Safety Pen Needle is substantially equivalent to the Safety Type Insulin Pen Needle cleared under K161950 with respect to the indications for use, target populations, treatment method, use enviroment, and technological characteristics.
§ 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).