(191 days)
No
The device description and performance studies focus on the physical characteristics and mechanical performance of a simple medical device (insulin pen needle) and do not mention any computational or data-driven capabilities.
No
A therapeutic device is one that treats a disease or condition. This device, an insulin pen needle, is used for the administration of insulin, which is a therapeutic agent, but the needle itself does not have a therapeutic effect; it is a delivery mechanism.
No
The device is an insulin pen needle, which is used for the subcutaneous injection of insulin. It is an accessory to an insulin pen injector and does not perform any diagnostic function.
No
The device description clearly outlines physical components (needle container, needle shield, needle tube, needle hub, UV glue, silicone oil) and manufacturing processes, indicating it is a physical medical device, not software-only.
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 insulin using a pen injector device. This is a direct administration of a substance into the body, not a test performed on a sample taken from the body.
- Device Description: The device is a needle designed to facilitate the delivery of insulin. It does not perform any diagnostic testing or analysis of biological samples.
- Lack of IVD Characteristics: The description does not mention any components or functions related to analyzing blood, urine, tissue, or any other biological sample for diagnostic purposes.
IVD devices are used to examine specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes. This device's function is purely for drug delivery.
N/A
Intended Use / Indications for Use
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.
Product codes
FMI
Device Description
Promisemed Insulin 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 Insulin Pen Needle consists of needle container, needle shield, needle tube, needle hub, 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 Insulin Pen Needle is the modification of the Verifine Common Type Insulin Pen Needle cleared in K161950 in extension of the range of gauge and needle length as well as change in material of needle shield. Promisemed Insulin Pen Needle is sterility Assurance Level (SAL) of 10 %, 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
all age groups including neonate, infant, children and adult
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 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: Stainless steel needle tubing for the manufacture of medical devices -Requirements and test methods
- ISO11608-2: Needle-based injection systems for medical use Requirements and test methods — Part 2: Needles
- ISO 7864: Sterile hypodermic needles for single use Requirements and test methods
- Biocompatibility
- a. ISO 10993-1:2009 Biological Evaluation of Medical Devices -- Part 1: Evaluation and testing within a risk management process
- b. ISO 10993-5:2009 Biological Evaluation of Medical Devices -- Part 5: Tests for in Vitro Cytotoxicity
- c. ISO 10993-10:2010 Biological Evaluation of Medical Devices -- Part 10: Tests for Irritation and Skin Sensitization
- d. ISO 10993-11:2006, Biological evaluation of medical devices Part 11: Tests for systemic toxicity-Acute systemic toxicity and pyrogen test
- f. ASTM F756-13 Standard Practice for Assessment of Hemolytic Properties of Materials.
- g. Particulate matter testing was conducted in accordance with USP Particulate Matter in Injections and met the USP acceptance criteria.
- h. Package integrity testing, after environmental conditioning and simulated transportation in accordance with ISTA 3A, was conducted on the final, packaged, and sterile devices. All packaging deemed acceptable for protection of product and sterility maintenance.
- i. Sterile Barrier Packaging Testing performed on the proposed device: Seal strength ASTM F88/F88-15, Dye penetration ASTM F1929-15
- i. Shelf life of 5 years is validated using the FDA recognized standard 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
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July 21, 2021 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 China
Re: K210059
Trade/Device Name: Promisemed Insulin Pen Needle Regulation Number: 21 CFR 880.5570 Regulation Name: Hypodermic Single Lumen Needle Regulatory Class: Class II Product Code: FMI Received: June 21, 2021
Dear Wei-Shan 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 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
2
Indications for Use
510(k) Number (if known) K210059
Device Name Promisemed Insulin Pen Needle
Indications for Use (Describe)
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.
| 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
510(k) Summary
1 Date Prepared
July 21, 2021
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, Regulatory Affairs Manager
Telephone No.:
+86 571 88772985
Fax No.:
+86 571 88772985
Email Address:
ന Trade Name, Common Name, Classification
Trade/Product Name: Promisemed Insulin Pen Needle Common Name: Insulin Pen Needle Classification name: Needle, Hypodermic, Single Lumen Regulation Number: 21 CFR 880.5570 Device Class: Class II Product Code: FMI
- 4 Identification of Predicate Device(s) K161950: Verifine Common Type Insulin Pen Needle
4
ഹ Description of the Device
Promisemed Insulin 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 Insulin Pen Needle consists of needle container, needle shield, needle tube, needle hub, 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 Insulin Pen Needle is the modification of the Verifine Common Type Insulin Pen Needle cleared in K161950 in extension of the range of gauge and needle length as well as change in material of needle shield. Promisemed Insulin Pen Needle is sterility Assurance Level (SAL) of 10 %, non-pyrogenic and single-use devices. It is supplied with several models. Different models are distinguished by needle gauge and length.
-
6 Indications for Use
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. -
Similarities and Differences of the Proposed Device to the Predicate 7 Device
Promisemed Insulin Pen Needle is substantially equivalent in its technologies and functions to the Verifine Common Type Insulin Pen Needle which cleared under premarket notification number K161950.
Three design changes were made to the subject device, introducion of new gauge specification (34G), new needle length specification(3.5mm and 10mm) and Needle Shield material change. The following are comparisons between subject device and the predicate device.
A detailed comparison to the predicate is provided in Table 1.
| Subject Device | Predicate Device (K161950) | ||||||
|---|---|---|---|---|---|---|---|
| Trade Name | Promisemed | ||||||
| Needle | Insulin | Pen | Verifine | ||||
| Insulin Pen Needle | Common | Type | Comments |
5
| Manufacturer | Promisemed
Meditech Co., Ltd
Hangzhou | Promisemed
Meditech Co., Ltd
Hangzhou | | | Needle shield: Polyethylene
(PE) | Needle shield:
Polypropylene (PP) | Different
Both PE and PP belong
are commonly used
thermoplastic material.
This difference does not
affect the substantially
equivalence on the safety
and effectiveness. |
|-----------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Device Class | Class II | Class II | Same | | Joint medium: UV glue | Joint medium: UV glue | Same |
| Product Code | FMI | FMI | Same | | Lubricant: Silicon oil | Lubricant: Silicon oil | Same |
| Regulation
number | 880.5570 | 880.5570 | Same | Performance | Seal: Dialyzer paper
Complied with ISO 7864, ISO
9626, ISO 11608-2 | Seal: Dialyzer paper
Complied with ISO 7864,
ISO 9626, ISO 11608-2 | Same |
| Regulation
Name | Needle, Hypodermic, Single
Lumen | Needle, Hypodermic, Single
Lumen | Same | Sterilization | EO Sterilization | EO Sterilization | Same |
| Intended Use/
Indications for
Use | 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. | The Common Type Insulin
Pen Needle is intended for
use with pen injector
device for subcutaneous
injection of insulin. | Different
The indications for Use is
similar except that the
subject device
specifically identifies
intended population,
sterile and single use,
and for home or
healthcare/health care
centers | | SAL:10-6 | SAL:10-6 | Same |
| Operating
Principle | 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 | Shelf Life | 5 years | 5 years | Same |
| Gauge | 29G, 30G, 31G, 32G,33G,
34G | 29G, 30G, 31G, 32G,33G | Different
New gauge specification
(34G) is introduced. This
difference does not
affect the substantially
equivalence on the safety
and effectiveness | Single use | Yes | Yes | Same |
| Needle Length | 3.5mm±0.4mm,
(4mm, 5mm, 6mm, 8mm,
10mm, 12mm) ±1.2mm | (4mm,5mm,6mm,8mm,
12mm) ±1.2mm | Different
Needle length of 3.5 mm
and 10mm were newly
introduced specifications.
This difference does not
affect the substantially
equivalence on the safety
and effectiveness. | 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
-Acute Systemic Toxicity:No
systemic toxicity
-Hemolysis: No evidence of
hemolysis
-Pyrogen: Non-pyrogenic | 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
-Acute Systemic
Toxicity:No systemic
toxicity
-Hemolysis: No evidence of
hemolysis
-Pyrogen: Non- pyrogenic | Same |
| Material | Needle Tube: X5CrNi18-10 | Needle Tube: X5CrNi18-10 | Same | | | | |
| | Needle Hub: Polypropylene
(PP) | Needle Hub: Polypropylene
(PP) | Same | | | | |
| | Needle container:
Polypropylene (PP) | Needle container:
Polypropylene (PP) | Same | | | | |
6
Discussion:
The Promisemed Insulin Pen Needle has the same intended use and technological characteristics as the predicate device. The basic technological and operating principles are the same for both devices. Both the subject and predicate devices are disposable, sterile, single patient use devices.
The difference in gauge size and material of needle shield does not affect the substantially equivalence on the safety and effectiveness. The Needle length of 3.5mm with tightened tolerance limits (±0.4mm), is within the same needle length range as the predicate 4mm (±1.20 mm), both meet the requirement of ISO 11608-2 to a 95%/95% C/R and substantially equivalent. The subject device has raised no different questions of safety and effectiveness.
7
8 Performance Testing Summary
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: Stainless steel needle tubing for the manufacture of medical devices -Requirements and test methods
- · ISO11608-2: Needle-based injection systems for medical use Requirements and test methods — Part 2: Needles
- ISO 7864: Sterile hypodermic needles for single use Requirements and test methods
- · Biocompatibility
- a. ISO 10993-1:2009 Biological Evaluation of Medical Devices -- Part 1: Evaluation and testing within a risk management process
- b. ISO 10993-5:2009 Biological Evaluation of Medical Devices -- Part 5: Tests for in Vitro Cytotoxicity
- c. ISO 10993-10:2010 Biological Evaluation of Medical Devices -- Part 10: Tests for Irritation and Skin Sensitization
- d. ISO 10993-11:2006, Biological evaluation of medical devices Part 11: Tests for systemic toxicity-Acute systemic toxicity and pyrogen test
- f. ASTM F756-13 Standard Practice for Assessment of Hemolytic Properties of Materials.
- g. Particulate matter testing was conducted in accordance with USP Particulate Matter in Injections and met the USP acceptance criteria.
- h. Package integrity testing, after environmental conditioning and simulated transportation in accordance with ISTA 3A, was conducted on the final, packaged, and sterile devices. All packaging deemed acceptable for protection of product and sterility maintenance.
- i. Sterile Barrier Packaging Testing performed on the proposed device: Seal strength ASTM F88/F88-15, Dye penetration ASTM F1929-15
- i. Shelf life of 5 years is validated using the FDA recognized standard ASTM F1980-16 Standard Guide for Accelerated Aging of Sterile Barrier Systems for Medical Devices
8
Conclusion 9
The differences between the predicate and the subject device do not raise any new or different questions of safety or effectiveness. The Promisemed Insulin Pen Needle is substancially equivalent to the Verifine Common Type Insulin Pen Needle with respect to the Indications for Use, target populations, treatment method, and technological characteristics.