(284 days)
Not Found
No
The device description and performance studies focus on the mechanical and material properties of a safety insulin needle, with no mention of AI or ML components.
No.
The device is a safety insulin needle intended for subcutaneous injection of insulin, which is a delivery device and not a therapeutic device.
No
Explanation: The device is an insulin needle intended for subcutaneous injection of insulin, which is a therapeutic rather than a diagnostic function.
No
The device description explicitly lists physical components such as needle tube, hub, safety protective cover, etc., indicating it is a hardware 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." 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 components (needle tube, hub, safety protective cover, etc.) are all related to the physical act of injection. There are no components described that would be used for analyzing a biological sample.
- Lack of IVD Characteristics: IVD devices are typically used to examine specimens derived from the human body (like blood, urine, tissue) to provide information for diagnosis, monitoring, or screening. This device does not perform any such analysis.
The device is a medical device used for drug delivery, specifically insulin injection.
N/A
Intended Use / Indications for Use
The safety insulin needle for single use is intended for use with pen injector devices for the subcutaneous injection of insulin.
The Safety insulin needle for single use is intended for use with pen injector devices for the subcutaneous injection of insulin.
Product codes
FMI
Device Description
The proposed device, Safety insulin needle for single use is intended for use with pen injector devices for the subcutaneous injection of insulin. It consists of needle tube, hub, safety protective cover, self-destruction seat, spring, hub sheath, safety seat and sealed paper.
The Safety insulin needle for single use is offered in various gauge sized and length.
The proposed device is available in EO sterilized to achieve a Sterility Assurance Level (SAL) of 10°.
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)
Non-clinical tests were conducted to verify that the proposed device met all design specifications in order to demonstrate that the subject device is Substantially Equivalent (SE) to the predicate device. The test results demonstrated that the proposed device complies with the following standards:
-
ISO 7864:2016, Sterile hypodermic needles for single use.
-
ISO 9626:2016, Stainless steel needle tubing for the manufacture of medical devices.
-
ISO 11608-2 Second edition 2012-04-01, Needle-based injection systems for medical use -Requirements and test methods - Part 2: Needles
-
ISO 10993-1:2009 Biological evaluation of medical devices -Part 1: Evaluation and testing within a risk management process
-
ISO 10993-4:2017, Biological Evaluation of Medical Device, Part 4: Selection of test for Interactions with Blood.
-
ISO 10993-5: 2009(R), Biological evaluation of medical devices -- Part 5: Tests for In Vitro cytotoxicity.
-
ISO 10993-10:2010, Biological evaluation of medical devices - Part 10: Tests for irritation and skin sensitization
-
ISO 10993-11:2006 Biological evaluation of medical devices-Part 11: Tests for systemic toxicity
-
ISO 10993-7:2008 Biological Evaluation of Medical Devices-Part 7: Ethylene Oxide Sterilization Residuals.
- ASTM F88/F88M-15 Standard Test Method for Seal Strength of Flexible Barrier Materials. >
-
ASTM F1929-15 Standard Test Method for Detecting Seal Leaks in Porous Medical Packaging by Dye Penetration
- ♪ USP Bacterial Endotoxins Test
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/0 description: The image contains the logos of the Department of Health & Human Services and the Food and Drug Administration (FDA). The Department of Health & Human Services logo is on the left, and the FDA logo is on the right. The FDA logo includes the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue text.
Berpu Medical Technology Co., Ltd % Diana Hong General Manager Mid-Link Consulting Co., Ltd P.O. Box 120-119 Shanghai. 200120 Cn
Re: K181447
Trade/Device Name: Safety insulin needle for single use Regulation Number: 21 CFR 880.5570 Regulation Name: Hypodermic single lumen needle Regulatory Class: Class II Product Code: FMI Dated: February 7, 2019 Received: February 12, 2019
Dear Ms. Hong:
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/cdrl/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 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
1
devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/CombinationProducts/GuidanceRegulatoryInformation/ucm597488.html; 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 http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm.
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/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). 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 (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely.
Sarah B. Mollo -S
for 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) K181447
Device Name Safety insulin needle for single use
Indications for Use (Describe)
The safety insulin needle for single use is intended for use with pen injector devices for the subcutaneous injection of insulin.
Prescription Use (Part 21 CFR 801 Subpart D)
|X | Over-The-Counter Use (21 CFR 801 Subpart C)
CONTINUE ON A SEPARATE PAGE IF NEEDED.
This section applies only to requirements of the Paperwork Reduction Act of 1995.
DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.
The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:
Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff@fda.hhs.gov
"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."
3
510(k) Summary
K181447
This 510(k) Summary is being submitted in accordance with requirements of Title 21, CFR Section 807.92.
-
- Date of Preparation: 01/23/2019
-
- Sponsor Identification
BERPU MEDICAL TECHNOLOGY CO., LTD NO.14 Xingji Road, Yongxing Street, Longwan District, 325000, Wenzhou, Zhejiang Province
Establishment Registration Number: 3004496829
Contact Person: Jundong Tan Position: Management Representative Tel: +86-577-86651999 Fax: +86-577-86630389 Email: BERPU@BERPU.COM
-
- Designated Submission Correspondent
Ms. Diana Hong (Primary Contact Person) Mr. Lee Fu (Alternative Contact Person)
- Designated Submission Correspondent
Mid-Link Consulting Co., Ltd P.O. Box 120-119, Shanghai, 200120, China
Tel: +86-21-22815850, Fax: 360-925-3199 Email: info@mid-link.net
4
4. Identification of Proposed Device
Trade Name: Safety insulin needle for single use
Regulatory Information: Classification Name: Hypodermic single lumen needle Classification: II Product Code: FMI Regulation Number: 21 CFR 880.5570 Review Panel: General Hospital
Intended Use Statement:
The Safety insulin needle for single use is intended for use with pen injector devices for the subcutaneous injection of insulin.
Indications for Use:
The Safety insulin needle for single use is intended for use with pen injector devices for the subcutaneous injection of insulin.
Device Description
The proposed device, Safety insulin needle for single use is intended for use with pen injector devices for the subcutaneous injection of insulin. It consists of needle tube, hub, safety protective cover, self-destruction seat, spring, hub sheath, safety seat and sealed paper.
The Safety insulin needle for single use is offered in various gauge sized and length.
The proposed device is available in EO sterilized to achieve a Sterility Assurance Level (SAL) of 10°.
-
- Identification of Predicate Device
510(k) Number: K152514 Product Name: Clickfine AutoProtect Pen Needle
- Identification of Predicate Device
Non-Clinical Test Conclusion 6.
Non-clinical tests were conducted to verify that the proposed device met all design specifications in order to demonstrate that the subject device is Substantially Equivalent (SE) to the predicate device. The test results demonstrated that the proposed device complies with the following standards:
5
-
ISO 7864:2016, Sterile hypodermic needles for single use.
-
ISO 9626:2016, Stainless steel needle tubing for the manufacture of medical devices.
-
ISO 11608-2 Second edition 2012-04-01, Needle-based injection systems for medical use -Requirements and test methods - Part 2: Needles
-
ISO 10993-1:2009 Biological evaluation of medical devices -Part 1: Evaluation and testing within a risk management process
-
ISO 10993-4:2017, Biological Evaluation of Medical Device, Part 4: Selection of test for Interactions with Blood.
-
ISO 10993-5: 2009(R), Biological evaluation of medical devices -- Part 5: Tests for In Vitro cytotoxicity.
-
ISO 10993-10:2010, Biological evaluation of medical devices - Part 10: Tests for irritation and skin sensitization
-
ISO 10993-11:2006 Biological evaluation of medical devices-Part 11: Tests for systemic toxicity
-
ISO 10993-7:2008 Biological Evaluation of Medical Devices-Part 7: Ethylene Oxide Sterilization Residuals.
- ASTM F88/F88M-15 Standard Test Method for Seal Strength of Flexible Barrier Materials. >
-
ASTM F1929-15 Standard Test Method for Detecting Seal Leaks in Porous Medical Packaging by Dye Penetration
- ♪ USP Bacterial Endotoxins Test
-
- Clinical Test Conclusion
No clinical study is included in this submission.
Substantially Equivalent (SE) Comparison 8.
Table 1 General Comparison
| Item | Proposed Device | Predicate Device
K152514 | Remark |
|---------------------|-----------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------|
| Product Code | FMI | FMI | SE |
| Regulation Number | 21 CFR 880.5570 | 21 CFR 880.5570 | SE |
| Class | II | II | SE |
| Indications for Use | The Safety insulin needle for single use is intended for use with pen injector devices for the subcutaneous injection of insulin. | The Clickfine AutoProtect Pen Needle is intended for use with pen injector devices for subcutaneous injection of fluids, including insulin and exenatide. Additionally, the attached safety shield automatically locks in place and reduces the occurrence of accidental needle | SE
Analysis 1 |
6
| | | sticks from the patient end of
the needle. The shield also
serves to hide the needle before
and after injection. | |
|----------------|-------------------------------|---------------------------------------------------------------------------------------------------------------------------|------------|
| Configuration | Needle Tube | Needle Tube | SE |
| | Hub | Hub | Analysis 2 |
| | Safety protective cover | Needle shield | |
| | Self-destruction seat | Housing | |
| | Spring | Spring | |
| | Hub sheath | Outer protective container | |
| | Safety seat | Safety lock indicator | |
| | Sealed paper | Peel tab | |
| Operation Mode | For manual use only | For manual use only | SE |
| Label/Labeling | Complied with 21 CFR part 801 | Complied with 21 CFR part 801 | SE |
SE Analysis 1 - Indications for Use
The Indications for Use of the proposed device are different to that of predicate device. The difference is that the Indications for Use of predicate device include subcutaneous injection of exenatide while the proposed device does not. However, the indications for use of proposed device are completely included by those of the predicate. Additionally, the attached safety shield has the same role during the clinical application as that of the predicate device, although it is not expressed in the indications for use of the proposed device. Therefore, this difference will not affect the Substantial Equivalence (SE) between the proposed and predicate device.
SE Analysis 2 - Configuration
The components name of proposed device are different to that of the predicate, however, the components share the same configuration and function. Therefore, this difference in name will not affect the Substantial Equivalence (SE) between the proposed and predicate device.
| Item | Proposed Device | Predicate Device
K152514 | Remark |
|--------------------|----------------------------------|---------------------------------|------------|
| Needle Gauge | 29G, 30G, 31G, 32G,
33G, 34G | 29G, 30G, 31G | Analysis 3 |
| Needle Length | 4mm, 5mm, 6mm,
8mm | 5mm, 6mm, 8mm | Analysis 4 |
| Wall type | Thin-walled
Extra-thin-walled | Regular walled
Thin-walled | Analysis 5 |
| Needle Performance | Complied with
ISO 7864:2016, | Complied with
ISO 7864: 1993 | SE |
| Table 2 Performance Comparison | |
|---|---|
7
| ISO 9626:2016, | ISO 9626: 1991 | |
|---|---|---|
| ISO 11608-2 | ISO 11608-2 |
Analysis 3 - Needle Gauge
The subject device includes higher needle gauges than that of predicate devices. This difference in needle size will not raise new questions of safety and effectiveness. In addition, all the needle sizes of proposed device have been tested and met ISO 7864 and ISO 9626 standards requirements. Therefore, this difference will not affect the Substantial Equivalence (SE) between the proposed and predicate device.
Analysis 4 - Needle length
The proposed device has an additional needle length than the of predicate device. This difference in needle size will not raise new questions of safety and effectiveness. In addition, all the needle lengths of the proposed device have been validated and tested and met the ISO 9626 standards requirements. Therefore, this difference will not affect the Substantially Equivalency (SE) between the proposed and predicate device.
Analysis 5 - Wall type
The wall thickness of the proposed device is different than the predicate device. the needles including both wall thickness (i.e. thin-walled and extra-thin-walled) of proposed device have been tested and the test results comply with ISO 7864 and ISO 9626 standards requirements. Therefore, this difference will not affect the Substantial Equivalence (SE) between the proposed and predicate device.
| Item | Proposed Device | Predicate Device
K152514 | Remark |
|--------------------------|---------------------------------|-----------------------------|---------------|
| Patient-contact material | | | |
| Hub | Polypropylene | Stainless Steel | SE |
| Needle tube | 304 Stainless Steel | Polypropylene | Analysis 6 |
| Safety seat | Polypropylene | Polypropylene | |
| Safety protective cover | MABS | MBS | |
| Biocompatibility | | | |
| Cytotoxicity | No cytotoxicity | Conforms to ISO | SE |
| Irritation | No intracutaneous
reactivity | 10993
series standard | Analysis 6 |
| Sensitization | No skin sensitization | | |
| Systemic Toxicity | No systemic toxicity | | |
| Hemolysis | No Hemolysis | | |
| Pyrogen | No Pyrogen | | |
| Sterilization | EO Sterilization | Gamma irradiation | SE Analysis 7 |
Table 3 Safety Comparison
8
| SAL | 10-6 | 10-6 | SE |
|---|---|---|---|
| Single Use | Yes | Yes | SE |
| Endotoxin Limit | 20EU per device | 20EU per device | SE |
Analysis 6 - Patient-contact Material and Biocompatibility
Although the material of proposed and the predicate device is different, the patient-contact material of the proposed device material conforms to the ISO 10993 series of standards. Therefore, this difference will not affect the Substantial Equivalence (SE) between the proposed and predicate device.
Analysis 7 - Sterilization
The proposed and predicate devices are sterilized by different method. However, the sterilization parameter for proposed device was established per ISO11135 to achieve the SAL of 10-6. Therefore, this difference will not affect the Substantial Equivalence (SE) between the proposed and predicate device.
9. Substantially Equivalent (SE) Conclusion
Based on the comparison and analysis of differences above, the proposed devices are determined to be Substantially Equivalent (SE) to the predicate device.