(107 days)
No
The device description focuses on mechanical safety features and standard material properties, with no mention of AI or ML.
Yes
Explanation: The device is intended for the subcutaneous injection of insulin in the treatment of diabetes, which is a therapeutic purpose.
No
Explanation: The device is a pen needle intended for subcutaneous injection of insulin, which is a treatment delivery function, not a diagnostic one. It is used to administer medication, not to identify a disease or condition.
No
The device description clearly outlines physical components (needle tube, trigger shield, spring, fixer, needle hub, etc.) and describes mechanical functions (shield retraction and extension, locking mechanism). It also details bench testing related to physical properties and performance, not software validation.
Based on the provided information, the Promisemed Covered Safety Pen Needle is not an IVD (In Vitro Diagnostic) device.
Here's why:
- Intended Use: The intended use is "for subcutaneous injection of insulin in the treatment of diabetes." This describes a device used for administering a substance into the body, not for testing samples taken from the body.
- Device Description: The description details a mechanical device for delivering medication, consisting of a needle, safety features, and components for attachment to a pen injector. It does not mention any components or processes related to analyzing biological samples.
- Performance Studies: The performance studies focus on the physical and functional characteristics of the needle and its safety mechanism (needle material, dimensions, flow rate, bond strength, safety mechanism activation, etc.). These are typical tests for a drug delivery device, not for an IVD which would involve analytical performance studies (sensitivity, specificity, etc.).
- Lack of IVD Characteristics: There is no mention of analyzing samples (blood, urine, tissue, etc.), reagents, or any diagnostic purpose.
IVD devices are used to examine specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes. The Promisemed Covered Safety Pen Needle is a drug delivery device.
N/A
Intended Use / Indications for Use
Promisemed Covered Safety Pen Needle is intended for subcutaneous injection of insulin in the treatment of diabetes.
Product codes
FMI
Device Description
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 again 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 distinguished by needle gauge and length.
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)
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, East 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, 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.
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 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
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,
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
2
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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3
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
4
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.
5
| 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 Covered
Safety Pen Needle | Verifine Safety Type
Insulin Pen Needle | Comments |
| Manufacturer | Promisemed Hangzhou
Meditech Co., Ltd | Promisemed Hangzhou
Meditech 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 Covered
Safety Pen Needle is
intended for
subcutaneous injection
of insulin in the
treatment of diabetes. | The Safety Type Insulin
Pen Needle is intended
for use with pen
injector device for
subcutaneous injection
of insulin. | Same |
| Operating Principle | The needle tube is
covered by trigger
shield and is not
exposed before usage.
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 again
and lock in place. Once
the Promisemed
Covered Safety Pen
Needle is in the locked
mode, it can no longer
be used. | Additionally, after
withdrawal of the
Safety Type Insulin Pen
Needle from the body,
the attached needle
safety shield
automatically covers
the needle to minimize
the risk of accidental
needlestick.
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 and
lock in place. Once the
Safety Type Insulin Pen
Needle is in the locked
mode, it can no longer
be used. | Same |
| Gauge | G29, G30, G31 | G29, G30, G31 | Same |
| Needle Length | 4mm,5mm,6mm,8mm | 4mm,5mm,6mm,8mm | Same |
| Sharps Injury
Prevention Features | Trigger shield | Trigger shield | Same |
| | Image: Needle with purple trigger shield | Image: Needle with blue trigger shield | Different
The needle tube
is not exposed in
subject device.
While in the
predicate it is
exposed before
usage. The
modification is
verified per ISO
7864:2016, ISO
23908:2011 and
ISO 11608-2:2012. |
| Configuration and
Material | Needle Tube: X5CrNi18-
10
Needle Hub:
Polyformaldehyde
(POM)
Fixer:
Polyformaldehyde
(POM) | Needle Tube: X5CrNi18-
10
Needle Hub:
Polyformaldehyde
(POM)
Fixer:
Polyformaldehyde
(POM) | Same |
| | Spring: 0Cr18Mn8Ni5N | Spring: 0Cr18Mn8Ni5N | Same |
| | Needle container:
Polypropylene (PP) | Needle container:
Polypropylene (PP) | Same |
| | Trigger shield:
Acrylonitrile Butadiene
Styrene (ABS) | Trigger shield:
Acrylonitrile Butadiene
Styrene (ABS) | Material is the
same. |
| | *Location slot is lower | *Location slot is higher | The location slot
in subject device
is moved
downward. This
change makes the
baseline position
of trigger shield
move upward in
finished subject
device which
allowing the
needle tube be
covered
completely
before use. The
modification is
verified per ISO
7864:2016, ISO
23908:2011and
ISO 11608-2:2012. |
| Performance | Complied with ISO 7864,
ISO 9626, ISO 11608-2
and ISO 23908 | Complied with ISO 7864,
ISO 9626, ISO 11608-2
and ISO 23908 | Same |
| | EO Sterilization | Gamma Sterilization | Different
Both are
sterilized to SAL
10-6 level. The
sterilization of
subject devie is
validated per
ISO11135:2014. |
| Sterilization | SAL:10-6 | SAL: 10-6 | Same |
| Shelf Life | 5 years | 5 years | Same |
| Single use | Yes | Yes | Same |
| Biocompatibility | Complied with
ISO10993 series
standards, and the
following tests are
performed
- Cytotoxicity: No
cytotoxicity - Skin Irritation: No
evidence of skin
irritation - Skin Sensitization: No
evidence of
sensitization | Complied with
ISO10993 series
standards, and the
following tests are
performed - Cytotoxicity: No
cytotoxicity - Skin Irritation: No
evidence of skin
irritation - Skin Sensitization: No
evidence of
sensitization | Same |
6
7
8
| -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,
9
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.