(300 days)
Not Found
No
The device description and performance studies focus on mechanical and material properties of a physical needle and safety shield mechanism. There is no mention of software, data processing, or algorithms that would indicate AI/ML.
No.
The device is an insulin pen needle, which is used for the subcutaneous injection of insulin but does not itself provide a therapeutic effect. It is an accessory to a pen injector device.
No
The device is an insulin pen needle, which is used for the subcutaneous injection of insulin. It is an administering or therapeutic device, not a diagnostic one.
No
The device description clearly outlines physical components like needles, shields, hubs, and materials like UV glue and silicone oil. It also describes mechanical actions like shield retraction and extension. There is no mention of software as a component or function of the device.
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 therapeutic delivery of a substance into the body, not a test performed on a sample taken from the body to diagnose a condition.
- Device Description: The description details the physical components of a needle designed for injection. It does not mention any components or processes related to analyzing biological samples.
- Function: The device's function is to facilitate the delivery of insulin into the subcutaneous tissue. The safety feature on the Safety Type is also related to preventing injury during the injection process, not to diagnostic testing.
- Lack of IVD Characteristics: There is no mention of analyzing blood, urine, tissue, or any other biological sample. There is no mention of reagents, assays, or any other elements typically associated with in vitro diagnostics.
In summary, the device is a medical device used for drug delivery (insulin injection), which falls under a different regulatory category than In Vitro Diagnostics.
N/A
Intended Use / Indications for Use
The Common Type Insulin Pen Needle is intended for use with pen injector device for subcutaneous injection of insulin.
The Safety Type Insulin Pen Needle is intended for use with pen injector device for subcutaneous injection of insulin. 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.
Product codes (comma separated list FDA assigned to the subject device)
FMI
Device Description
The proposed product, 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 products have two types, common type and safety type. Both of the two types are sterile with a Sterility Assurance Level (SAL) of 104, non-pyrogenic and single-use devices. Each type has several models. Different models are distinguished by needle gauge and length.
The Common Type Insulin Pen Needle consists of needle shield, 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.
The Safety Type Insulin Pen Needle consists of needle shield, spring, housing, 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.
The user proceeds with inserting the needle into the skin manually. Safety Type Insulin Pen Needle is designed to reduce occurrence of accidental needle sticks from patient end of the needle by providing a shield that covers and locks the needle after use. 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.
Both the Common Type Insulin Pen Needle and the Safety Type Pen Needle are for OTC use, and they are external communication, blood indirect devices. The contact duration for both subjected devices is within 24h, and they belong to limited contact device according ISO 10993-1.
The dimension for both Common Type Insulin Pen Needle and the Safety Type Pen Needle are shown as below.
| Type | Model | Needle OD | Needle available length |
|---|---|---|---|
| Common Type | IPN-29-12 | 0.33mm | 12mm |
| IPN-30-8 | 0.30mm | 8mm | |
| IPN-31-4 | 0.25mm | 4mm | |
| IPN-31-5 | 0.25mm | 5mm | |
| IPN-31-6 | 0.25mm | 6mm | |
| IPN-31-8 | 0.25mm | 8mm | |
| IPN-32-4 | 0.23mm | 4mm | |
| IPN-32-5 | 0.23mm | 5mm | |
| IPN-32-8 | 0.23mm | 8mm | |
| IPN-33-4 | 0.20mm | 4mm | |
| Safety Type | SPN-29-6 | 0.33mm | 6mm |
| SPN-29-8 | 0.33mm | 8mm | |
| SPN-30-4 | 0.30mm | 4mm | |
| SPN-30-5 | 0.30mm | 5mm | |
| SPN-30-6 | 0.30mm | 6mm | |
| SPN-30-8 | 0.30mm | 8mm | |
| SPN-31-4 | 0.25mm | 4mm | |
| SPN-31-5 | 0.25mm | 5mm | |
| SPN-31-6 | 0.25mm | 6mm | |
| SPN-31-8 | 0.25mm | 8mm |
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
Over-The-Counter Use
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)
Nonclinical testing was performed to demonstrate substantial equivalence to predicate devices.
Simulated Clinical Use Testing: For the Safety Type Insulin Pen Needle, a simulated clinical use testing was conducted with 600 subject devices. No needlestick injuries occurred and there was zero failure of the protective feature.
Clinical Testing: Substantial equivalence does not depend on clinical test data.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
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/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is a stylized image of three human profiles facing to the right, stacked on top of each other.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
May 11, 2017
Promisemed Hangzhou Meditech Co., Ltd. % Field Fu Consultant Shenzhen Joyantech Consulting Co., Ltd No. 55 Shizhou Middle Road, Nanshan District Shenzhen, GD755 Guangdong CHINA
Re: K161950
Trade/Device Name: Verifine® Common Type Insulin Pen Needle and Verifine® Safety Type Insulin Pen Needle Regulation Number: 21 CFR 880.5570 Regulation Name: Hypodermic Single Lumen Needle Regulatory Class: Class II Product Code: FMI Dated: April 5, 2017 Received: April 10, 2017
Dear Field Fu:
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. 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.
1
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 requirements, including, but not limited to: registration and listing (21 CFR Part 807): labeling (21 CFR Part 801): medical device reporting of medical devicerelated adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. 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
http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely,
Image /page/1/Picture/8 description: The image contains a signature and the name "Tina Kiang". The signature is a complex, looping design to the left of the name. Below the name is the character sequence "-s", which may be part of the signature or a separate element.
Tina Kiang, Ph.D. Acting Director Division of Anesthesiology. General Hospital, Respiratory, Infection Control, and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known) K161950
Device Name
Verifine® Common Type Insulin Pen Needle and Verifine® Safety Type Insulin Pen Needle
Indications for Use (Describe)
The Common Type Insulin Pen Needle is intended for use with pen injector device for subcutaneous injection of insulin.
The Safety Type Insulin Pen Needle is intended for use with pen injector device for subcutaneous injection of insulin. 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.
| Type of Use (Select one or both, as applicable) |
|---|
| ------------------------------------------------- |
| Production Use (Part 21 CFR 221.Subpart D) | |
|---|---|
| Test Strip Control Use (21 CFR 221.Subpart C) |
__ 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
Contact Details 1.
1.1 Applicant information
| Applicant Name | Promisemed Hangzhou Meditech Co.,Ltd. |
|---|---|
| Address | No.18 Haishu Road Future Sci-Tech Park, Yuhang District, Hangzhou, |
| China | |
| Phone No. | +86-571-86775619 |
| Fax No. | +86-571-88772985 |
| Contact person | Keshin Hu |
| Contact person's e-mail | keshin@promisemed.ca |
| Company e-mail | admin@promisemed.ca |
| Date Prepared | April 05, 2017 |
| Website | http://www.promisemed.ca/ |
1.2 Consultant information
| Name | Shenzhen Joyantech Consulting Co., Ltd
Image: [logo]
Image: [Chinese characters] |
|-------------------------|-----------------------------------------------------------------------------------------------------------------|
| Address | Room 1122, International Mayors Communication Centre, NO. 55
Shizhou middle road, Nanshan District, Shenzhen |
| Phone No. | +86-755-86069197 |
| Contact person | Elly Xu; Field Fu |
| Contact person's e-mail | elly@cefda.com; info@cefda.com |
| Website | http://www.cefda.com |
Device information 2.
| Trade name | Verifine® Common Type Insulin Pen Needle; Verifine® Safety Type
Insulin Pen Needle |
|---------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Common name | Insulin Pen Needle |
| Model | Common Type:IPN-29-12;IPN-30-8;IPN-31-4;IPN-31-5;IPN-31-6;
IPN-31-8;IPN-32-4;IPN-32-5; IPN-32-8; IPN-33-4
Safety Type:SPN-29-6;SPN-29-8;SPN-30-4;SPN-30-5;SPN-30-6;
SPN-30-8;SPN-31-4;SPN-31-5;SPN-31-6;SPN-31-8 |
| Classification | II |
| Classification name | Needle, Hypodermic, Single Lumen |
| Product code | FMI |
| Regulation No. | 880.5570 |
3. Legally Marketed Predicate Device
4
| Trade Name | Insulin Pen Needle |
|---|---|
| 510(k) Number | K133059 |
| Product Code | FMI |
| Manufacturer | Wenzhou Beipo Science & Technology Co., Ltd |
| Trade Name | Safe Block Pen Needle |
| 510(k) Number | K151311 |
| Product Code | FMI |
| Manufacturer | Artsana S.p.A Unit Production N°30, Via Saldarini Catelli 6/10, 22070 |
| Grandate COMO - ITALY |
Device Description 4.
The proposed product, 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 products have two types, common type and safety type. Both of the two types are sterile with a Sterility Assurance Level (SAL) of 104, non-pyrogenic and single-use devices. Each type has several models. Different models are distinguished by needle gauge and length.
The Common Type Insulin Pen Needle consists of needle shield, 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.
The Safety Type Insulin Pen Needle consists of needle shield, spring, housing, 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.
The user proceeds with inserting the needle into the skin manually. Safety Type Insulin Pen Needle is designed to reduce occurrence of accidental needle sticks from patient end of the needle by providing a shield that covers and locks the needle after use. 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.
Both the Common Type Insulin Pen Needle and the Safety Type Pen Needle are for OTC use, and they are external communication, blood indirect devices. The contact duration for both subjected devices is within 24h, and they belong to limited contact device according ISO 10993-1.
The dimension for both Common Type Insulin Pen Needle and the Safety Type Pen Needle are shown as below.
| Type | Model | Needle OD | Needle available
length |
|----------------|-----------|-----------|----------------------------|
| Common
Type | IPN-29-12 | 0.33mm | 12mm |
| | IPN-30-8 | 0.30mm | 8mm |
| | IPN-31-4 | 0.25mm | 4mm |
| | IPN-31-5 | 0.25mm | 5mm |
| | IPN-31-6 | 0.25mm | 6mm |
| | IPN-31-8 | 0.25mm | 8mm |
| | IPN-32-4 | 0.23mm | 4mm |
5
| IPN-32-5 | 0.23mm | 5mm | |
|---|---|---|---|
| IPN-32-8 | 0.23mm | 8mm | |
| IPN-33-4 | 0.20mm | 4mm | |
| Safety | |||
| Type | SPN-29-6 | 0.33mm | 6mm |
| SPN-29-8 | 0.33mm | 8mm | |
| SPN-30-4 | 0.30mm | 4mm | |
| SPN-30-5 | 0.30mm | 5mm | |
| SPN-30-6 | 0.30mm | 6mm | |
| SPN-30-8 | 0.30mm | 8mm | |
| SPN-31-4 | 0.25mm | 4mm | |
| SPN-31-5 | 0.25mm | 5mm | |
| SPN-31-6 | 0.25mm | 6mm | |
| SPN-31-8 | 0.25mm | 8mm |
5. Intended Use/Indication for Use
The Common Type Insulin Pen Needle is intended for use with pen injector device for subcutaneous injection of insulin.
The Safety Type Insulin Pen Needle is intended for use with pen injector device for subcutaneous injection of insulin.
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.
6. Substantial Equivalence Comparison
6.1 Comparison between Common Type Insulin Pen Needle and Predicate Device(K133059)
| Item | Proposed Device:
Common Type Insulin Pen
Needle | | Predicate Device:
Insulin Pen Needle
(K133059) | | Comments |
|------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--|----------|
| Product Code | FMI | | FMI | | Same |
| Intended Use | The Common Type Insulin Pen Needle is intended for use with pen injector device for subcutaneous injection of insulin. | | The Insulin Pen Needle is intended for use with pen injector devices for the subcutaneous injection of insulin. | | 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 |
6
SEC 005:001 510K Summary
Version:A/0
| Configuration | Needle Tube, Needle shield (Tube Sheath), Needle hub (Hub), Needle container (Hub Sheath), Sealing dialysis paper (Sealed Paper). | Needle Tube, Hub, Tube Sheath, Hub Sheath and Sealed Paper. | Same |
|---|---|---|---|
| Length | 4mm, 5mm, 6mm, 8mm, 12mm | 4mm, 5mm, 6mm, 8mm, 10mm, 12mm | Similar (* 1) |
| Needle Gauge | 29G/30G/31G/32G/33G | 29G/30G/31G/32G | Same |
| Tip configuration | Per ISO 11608-2, section 4.5, visually sharp at 2.5X magnification, designed to minimize coring and fragmentation | Per ISO 11608-2, section 4.5, visually sharp at 2.5X magnification, designed to minimize coring and fragmentation | Same |
| Material | Tube: 304 Stainless Steel | ||
| Needle hub: Polypropylene | Tube: 304 Stainless Steel | ||
| Hub: Polypropylene | Same | ||
| Performance | Complied with ISO 7864, ISO 9626, and ISO 11608-2 | Complied with ISO 7864, ISO 9626, and ISO 11608-2 | Same |
| Sterilization | SAL: 10-6 | ||
| Method: EO Sterilized | SAL: 10-6 | ||
| Method: EO Sterilized | 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
- Acute Systemic Toxicity: No systemic toxicity
- Hemolysis: No evidence of hemolysis
- Pyrogen: No pyrogen | 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: No pyrogen | Same |
*1: The needle tube lengths of the proposed device are covered by the predicate device. Compare to the predicate device, the proposed device has an additional 33G model insulin pen needle. 33G model for Insulin Pen Needle is a widely used in the market and had been approved in FDA (Such as K152410). On the other hand, the bench tests of Needle with 33G demonstrated conformances to ISO 7864, ISO 9626, and ISO 11608-2.
6.2 Comparison between Safety Type Insulin Pen Needle and Predicate Device(K151311)
7
SEC_005:001_510K Summary
| Item | Proposed Device:
Safety Type Insulin Pen
Needle | Predicate Device:
Insulin Pen Needle (K151311) | Comments |
|--------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------|
| Product Code | FMI | FMI | Same |
| Intended Use | The Safety Type Insulin Pen
Needle is intended for use with
pen injector device for
subcutaneous injection of
insulin.
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. | It is intended for use with pen
injector devices for the
injection of fluids, including
insulin.
Additionally the attached safety
shield automatically locks in
place and reduces the
occurrence of accidental sticks
from the patient end of the
needle. The shield also serves
to conceal the needle before
and after injection. | Similar(* 2) |
| Operating
Principle | 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. | 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 |
| Length | 4mm, 5mm, 6mm,
8mm(tolerance as per ISO
11608-2) | 5mm, 8mm(tolerance as per
ISO 11608-2) | Similar (* 3) |
| Gauge
Sharps Injury
Prevention
Features | G29, G30, G31
Safety shield | G31
Safety shield | Same |
| Configuration
and Material | Tube: Stainless Steel
Needle Hub: Polypropylene
Spring: Stainless Steel
Needle container(Primary
Container):PP
Needle/Safety shield: ABS | Cannula: Stainless Steel
Needle Hub: Polypropylene
Spring: Stainless Steel
Primary Container:HDPE
Shield:HDPE | Same
Same
Same
Different (* 4) |
| | | | |
| 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 |
| Sterilization | SAL: 10-6
Method: Irradiation Sterilized | SAL: 10-6
Method: EO Sterilized | Different (* 5) |
| 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
• Acute Systemic Toxicity: No systemic toxicity
• Hemolysis: No evidence of hemolysis
Pyrogen: No pyrogen | 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: No pyrogen | Same |
8
Version:A/0
-
2: The proposed device is intended to use with pen injector device for subcutaneous injection of insulin. Compare to proposed device, the predicate device is used for the injection of fluids, including insulin. The usage range of proposed device is included in the predicate device.
-
3: The length and the gauge is the specification of needle tube that has no relationship with the safety prevention features. The Insulin Pen Needle (K151311) has the tube diameter of 29G and 30G, it also has the tube length of 4mm and 6mm. These models of insulin pen needle are widely used in the market. Moreover, the bench tests of Needles with 29G, 30G and 4mm, 6mm demonstrated conformances to ISO 7864. ISO 9626. ISO 11608-2 and ISO 23908. Therefore the differences do not raise new concerns to establish substantial equivalence to the predicate.
-
4: Although the materials of safety shield and needle container between the proposed device and the predicate device are different, the ABS and PP are two kinds of materials that are widely used on medical device. Moreover, the biocompatibility test report of the proposed device demonstrate that subject device is biocompatible and the performance as intended.
-
5: Although the sterilization methods between the proposed device and the predicate device are different, but the radiation sterilization effect of the proposed device is proved by the Microbiological validation report of gamma radiation sterilization dose audit test report in VOL 014. The validation report showed that the sterilization effect of the proposed device can achieve a Sterility Assurance Level (SAL) of 10°, and the radiation dose audit test reports showed that the minimum gamma radiation dose to achieve a 10° SAL was acceptable according to ISO 11737-2:2012.
9
Non-clinical Testing 7.
All nonclinical testing performed on new devices is to demonstrate the substantial equivalence to the predicate devices. Tests setup and execution are performed in accordance with applicable standards. Results of the testing are demonstrating the standards and matching the performance of new devices to the predicate devices.
The following performance data were provided in support of the substantial equivalence determination.
| Test | Requirements | Results | |
|---|---|---|---|
| Materials | The needle shall be made of tubing materials specified in ISO 9626. | Passed | |
| Dimensions | The needles shall fit the test apparatus specified in item 7.3 of ISO 11608-2. | Passed | |
| Flow rate through the needle | The needles were tested in accordance with Annex A to ISO 11608-2. | Passed | |
| Bond between hub and needle tube | The union of the hub and needle tube shall not break when tested in accordance with Clause 9 of ISO 11608-2. | Passed | |
| Needle points | The needle points shall fulfill the 4.5 of ISO 11608-2. | Passed | |
| Freedom from defects | The needle points shall fulfil the requirements of ISO 7864:1993, 11.3. | Passed | |
| Lubrication | The needle tube should be lubricated at both patient end and the cartridge end. The lubrication shall fulfil the 4.7 of ISO 11608-2. | Passed | |
| Dislocation of measuring point patient end | Dislocation of the cannula point at the patient end shall be in accordance with Table 2 (ISO 11688-2) when tested in accordance with Clause 8 of ISO 11608-2. | Passed | |
| Functional compatibility with needle-based injected systems | Compatibility with any NIS shall be claimed only after testing in accordance with Clause 11 of ISO 11608-2. | Passed | |
| Easy of assemble and disassembly | Attachment of the needle shall be possible without removing the needle from its opened unit packaging. Compliance is checked according to the requirements of Clause 11 of ISO 11608-2. | Passed | |
| Biocompatibility | Cytotoxicity | ISO 10093-5 Biological evaluation of medical devices -Part 5: Tests for in vitro cytotoxicity | Passed |
| Sensitization | ISO 10993-10 Biological evaluation of medical devices -Part 10:Tests for irritation | Passed | |
| Intracutaneous | |||
| Reactivity | ISO 10993-10 Biological evaluation of | ||
| medical devices -Part 10:Tests for irritation | |||
| and skin sensitization | Passed | ||
| and skin sensitization | |||
| Haemocompatibility | ISO 10993-4 Biological evaluation of medical | ||
| devices Part 4: Selection of tests for | |||
| interactions with blood | |||
| ASTM F765 Standard Practice for | |||
| Assessment of Hemolytic Properties of | |||
| Materials | Passed | ||
| System toxicity | |||
| (acute) | ISO 10993-11:2006/(R)2010, Biological | ||
| evaluation of medical devices - Part 11: Tests | |||
| for systemic toxicity | Passed | ||
10
Simulated Clinical Use Testing
As for Safety Type Insulin Pen Needle, a simulated clinical use testing was conducted to verify the safety feature per FDA guidance document of Medical Devices with Sharps Injury Prevention Features. Based on the guidance, 600 subject devices were chosen in the simulated clinical use testing. There was no needlestick injuries occurred and zero failure of the protective feature in the testing.
8. Clinical Testing
Substantial equivalence does not depend on the clinical test data.
Conclusions 9.
Based on device comparison information and non-clinical bench testing, the proposed device is substantially equivalent to legally marketed predicate devices (K133059, K151311).