(151 days)
The Insulin Pen Needle is intended for use with pen injector devices for the subcutaneous injection of insulin.
The proposed device, Insulin Pen Needle, is a single-use device, which is designed for use with a pen injector for the subcutaneous injection of insulin. It consists of needle tube, hub, tube sheath and sealed paper. The hub can be connected screwed onto the insulin pen. The Insulin Pen Needle is offered in various gauge sized and length. They are provided sterilized with Sterility Assurance Level (SAL) of 10-6.
The provided text describes a 510(k) summary for an Insulin Pen Needle, focusing on its substantial equivalence to a predicate device rather than a study proving performance against specific acceptance criteria. This type of submission relies on demonstrating that the new device is as safe and effective as a legally marketed device, primarily through non-clinical testing and comparison to existing standards.
Therefore, many of the requested elements for describing an acceptance criteria study (such as sample sizes for test sets, expert-established ground truth, adjudication methods, MRMC studies, and standalone performance) are not applicable or detailed in this document.
Here's an breakdown based on the provided information:
1. Table of Acceptance Criteria and Reported Device Performance
The document does not explicitly present a table of acceptance criteria with corresponding performance results in the typical sense of a clinical or performance study. Instead, it states that the device 'complies with' various ISO and ASTM standards, which inherently define performance requirements. The performance specification for the proposed device is listed as "Comply with ISO 7864, ISO 9626, and ISO 11608-2."
Implicit Acceptance Criteria and Reported Performance (derived from compliance with standards and comparison table):
| Acceptance Criteria (Standard Compliance) | Reported Device Performance |
|---|---|
| ISO 7864 (Sterile hypodermic needles) | Complies with standard |
| ISO 9626 (Stainless steel needle tubing) | Complies with standard |
| ISO 11608-2 (Needle-based injection systems) | Complies with standard |
| ISO 10993-7 (Ethylene oxide sterilization residuals) | Complies with standard |
| ASTM F88/F88M-09 (Seal Strength) | Complies with standard |
| ISO 11737-2 (Sterilization microbiological methods) | Complies with standard |
| USP 35-NF30:2012 <85> (Bacterial Endotoxins Test) | Complies with standard |
| Sterility Assurance Level (SAL): 10-6 | SAL: 10-6 |
| Shelf Life: 5 years | 5 years |
| Material (Tube: 304 Stainless Steel) | 304 Stainless Steel |
| Material (Hub: Polypropylene) | Polypropylene |
2. Sample size used for the test set and the data provenance
The document indicates "Non clinical tests were conducted to verify that the proposed device met all design specifications," but it does not specify the sample sizes used for these tests. The data provenance is not explicitly stated in terms of country of origin for specific test results, but the sponsor is located in China. The tests are non-clinical (laboratory-based) rather than retrospective or prospective human clinical data.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
Not applicable. This document describes non-clinical performance testing against established engineering standards (ISO, ASTM, USP). There is no "ground truth" in the clinical sense established by human experts for a test set. The standards themselves define the "ground truth" for performance.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable. As the tests are non-clinical, there is no need for expert adjudication.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
Not applicable. This is a medical device (Insulin Pen Needle), not an AI-powered diagnostic or interpretive system. Therefore, an MRMC study related to AI assistance is not relevant.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
Not applicable. This is a physical medical device. There is no "algorithm only" performance to evaluate.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
For the non-clinical tests described, the "ground truth" is defined by the specifications and requirements set forth in the referenced international standards (ISO 7864, ISO 9626, ISO 11608-2, ISO 10993-7, ASTM F88/F88M-09, ISO 11737-2, USP 35-NF30:2012). The device's performance is compared against these engineering and manufacturing benchmarks.
8. The sample size for the training set
Not applicable. This pertains to non-clinical device testing and manufacturing compliance, not a machine learning model that requires a training set.
9. How the ground truth for the training set was established
Not applicable. There is no training set mentioned in the context of this device submission.
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FEB 2 5 2014
Section 3 510(k) Summary
This 510(k) Summary of 510(k) safety and effectiveness information is being submitted in accordance with requirements of SMDA 1990 and Title 21, CFR Section 807.92.
The assigned 510(k) Number:
- Date of Submission: 09/10/2013 l .
- Sponsor Identification 2.
Wenzhou Wuzhou Import & Export Co., Ltd. Room 1703 Fortune Center Chezhan Avenue Wenzhou, Zhejiang Province, 325000, China
Establishment Registration Number: 9681901
Contact Person: Bingyi Xiang Position: General Manager Tel: +86-577-88868068 Fax: +86-577-88868065 Email: birrell wetd@yahoo.com
-
- Submission Correspondent
Ms. Diana Hong & Mr. Lee Fu Mid-Link Consulting Co., Ltd P.O. Box 120-119 Shanghai, 200120, China Tel: +86-21-22815850 Fax: 240-238-7587 Email: info@mid-link.net
- Submission Correspondent
.
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- Proposed Device Identification 4.
Proposed Device Name: Insulin Pen Needle Proposed Device Common Name: Insulin Pen Needle
Regulatory Information: Classification Name: Needle, Hypodermic, Single Lumen; Classification: 2; Product Code: FMI; Regulation Number: 21 CFR 880.5570; Review Panel: General Hospital;
Intended Use Statement:
The Insulin Pen Needle is intended for use with pen injector devices for the subcutaneous injection of insulin.
- Predicate Device Identification 5.
510(k) Number: K120690 Product Name: insulin pen needle Manufacturer: Tiger Medical Products Ltd.
6. Device Description
The proposed device, Insulin Pen Needle, is a single-use device, which is designed for use with a pen injector for the subcutaneous injection of insulin. It consists of needle tube, hub, tube sheath and sealed paper. The hub can be connected screwed onto the insulin pen.
The Insulin Pen Needle is offered in various gauge sized and length.
They are provided sterilized with Sterility Assurance Level (SAL) of 10-6.
-
- Non-Clinical Test Conclusion
Non clinical tests were conducted to verify that the proposed device met all design specifications as was Substantially Equivalent (SE) to the predicate device. The test results demonstrated that the proposed device complies with the following standards:
- Non-Clinical Test Conclusion
ISO 7864 Third edition 1993-05-15, Sterile hypodermic needles for single use. ISO 9626 First edition 1991-09-01, AMENDMENT 1 2001-06-01 Stainless steel needle tubing for the
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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 10993-7:2008(R) 2012, Biological evaluation of medical devices - Part 7: Ethylene oxide sterilization residuals
ASTM F88/F88M-09, Standard Test Method for Seal Strength of Flexible Barrier Materials.
ISO 11737-2:2009, Sterilization of medical devices -- Microbiological methods -- Part 2: Tests of sterility performed in the definition, validation and maintenance of a sterilization process.
USP 35-NF30:2012, <85> Bacterial Endotoxins Test.
- Substantially Equivalent (SE) Conclusion 8.
The following table compares the DEVICE to the predicate device with respect to intended use, technological characteristics and principles of operation, etc.
| Item | Proposed Device | Predicate Device |
|---|---|---|
| Product Code | FMI | Same |
| Regulation Number | 21 CFR 880.5570 | Same |
| Class | Class II | Same |
| Intended Use | The Insulin Pen Needle is intended for usewith pen injector devices for thesubcutaneous injection of insulin. | Same |
| Configuration | Needle Tube, Hub, Tube Sheath, Hub Sheathand Sealed Paper | Similar |
| Operation mode | Manual | Same |
| Needle Gauge | 29G/30G/31G/32G | Same |
| Performancespecification | Comply with ISO 7864, ISO 9626, and ISO11608-2 | Same |
| Material | Tube: 304 Stainless Steel | Same |
| Hub: Polypropylene | Same | |
| Sterilization | SAL:10-6 | Same |
| EO Sterilized | Same | |
| Shelf Life | 5 years | Same |
| Single Use | Yes | Same |
| Labeling and Labels | Meet FDA requirements | Same |
Table 3-1 Comparison of Technology Characteristics
The proposed device, Insulin Pen Needle, is determined to be Substantially Equivalent (SE) to the predicate device, insulin pen needle (K120690), in respect of safety and effectiveness.
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Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G6 Silver Spring, MD 20993-0002
February 25, 2014
Wenzhou Wuzhou Import & Export Company, Limited C/O Ms. Diana Hong General Manager Mid-Link Consulting Company, Limited P.O. Box 120-119 Shanghai, 200120 CHINA
Re: K133058
Trade/Device Name: Insulin Pen Needle Regulation Number: 21 CFR 880.5570 Regulation Name: Hypodermic Single Lumen Needle Regulatory Class: II Product Code: FMI Dated: September 18, 2013 Received: September 27, 2013
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. 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 from 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.
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Page 2 - Ms. Hong
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 (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) 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 Small Manufacturers, International and Consumer Assistance at its tollfree number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.goy/MedicalDevices/ResourcesforYou/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR 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 Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.
Sincerely yours,
Image /page/4/Picture/7 description: The image contains the words Kwame Ulmer-S. The words are in a bold, sans-serif font. The letters are black, and the background is white. The letters are arranged in two rows, with Kwame on the top row and Ulmer-S on the bottom row. The letters are slightly overlapping each other. The image is slightly blurry.
for
Erin I. Keith, M.S. Acting Director Division of Anesthesiology, General Hospital, Respiratory, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration
Indications for Use
Form Approved: OMB No. 0910-0120 Expiration Date: December 31, 2013 See PRA Statement on last page.
510(k) Number (if known) K133058
Device Name Insulin Pen Needle
Indications for Use (Describe)
The Insulin Pen Needle is intended for use with pen injector devices for the subcutaneous injection of insulin.
Type of Use (Select one or both, as applicable)
Prescription Use (Part 21 CFR 801 Subpart D)
5
[x] Over-The-Counter Use (21 CFR 801 Subpart C)
Please do not write Below This Line - continue on a separate page if needed.
CHE RESEARCH PORTEDAL FORFORFOALUSE ONLY FORFORFORIUSE ONLY CONTROLLERS OF CONSTITUTION OF
Concurrence of Center for Devices and Radiological Health (CDRH) (Signature)
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Digitally signed by Richard C. Chapman Date: 2014.02.25 12:54:03 -05'00'
FORM FDA 3881 (9/13)
§ 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).