(73 days)
The Clickfine pen needle is intended for the hypodermic injection of insulin into the body when attached to a peninjector.
The Ypsomed Clickfine Pen Needles are sterile, non-pyrogenic, single use needles designed to be used with commercially available pen-injectors for insulin administration. Each needle is individually packaged in a sealed protective container with peel tab. The pen needles are used by peeling back the peel tab and snapping the while per table threaded end of the pen injector. The back end of the cannula punctures the rubber injection port of the drug reservoir in the pen-injector. The outer protective cap is then removed. The inner protective cap will remain over the needle until the insulin is ready to be injected. When the injection is needed, the inner protective cap is removed and the needle is inserted into the chosen site. The pen-injector automatically delivers the insulin through the needle. The protective cap is replaced and the needle is then removed, safely discarded and replaced with a new needle.
The provided text describes the 510(k) summary for the Ypsomed Clickfine Pen Needle. This document focuses on demonstrating substantial equivalence to a predicate device rather than a comprehensive study proving new acceptance criteria for a novel AI-powered medical device.
Therefore, many of the requested points regarding AI, ground truth, experts, and specific clinical study designs are not applicable or cannot be extracted from this text. The information below is based only on the provided document.
Here's the information that can be extracted from the provided text, formatted as requested:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria / Standard | Reported Device Performance |
|---|---|
| ISO 11608-2:2000 Pen-injectors for medical use Part 2: Needles Requirements and test methods | Met the requirements of relevant sections |
| ISO 9626:1991/Amd.1:2001 Stainless steel needle tubing for the manufacture of medical devices | Met the requirements of relevant sections |
| ISO 7864:1993 Sterile hypodermic needles for single use | Met the requirements of relevant sections |
| ISO 10993-1:2003 Biological evaluation of medical devices Part 1: Evaluation and testing | Met the requirements of relevant sections |
| Puncture resistance of outer cap | Equivalent to Unmodified Device |
| Seal Integrity of Sterile barrier | Equivalent to Unmodified Device |
2. Sample size used for the test set and the data provenance:
- The document states "Ypsomed has performed the relevant assessments specified in the following international and internal standards and protocols and confirmed compliance of the modified devices and equivalence to the predicate devices."
- However, specific sample sizes for these tests are not provided in the document.
- The data provenance (e.g., country of origin, retrospective/prospective) is not specified in the document.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- This information is not applicable as the document describes testing against international standards for a physical medical device, not an AI or imaging device requiring expert ground truth in the traditional sense. The "ground truth" here is the pass/fail criteria of the specified standards.
4. Adjudication method for the test set:
- This is not applicable for the type of testing described (compliance with international standards for a physical device). The tests would likely have objective pass/fail criteria based on measurements.
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:
- This is not applicable. The device is a pen needle, not an AI-powered diagnostic tool. No AI component is mentioned.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done:
- This is not applicable. The device is a pen needle, not an algorithm.
7. The type of ground truth used:
- For the physical tests described, the "ground truth" is defined by the acceptance criteria and test methods specified in the cited international standards (e.g., ISO 11608-2, ISO 9626, ISO 7864, ISO 10993-1), as well as internal standards and protocols. Implicitly, functional equivalence to the predicate device (Disetronic Penfine Insulin Injection Pen Needles, K013782) also serves as a comparative benchmark.
8. The sample size for the training set:
- This is not applicable as the device is a physical pen needle, not an AI or machine learning model. There is no concept of a "training set" in this context.
9. How the ground truth for the training set was established:
- This is not applicable for the reasons stated in point 8.
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APR 3 0 2010
7. Summary of Safety and Effectiveness
"510(K) SUMMARY"
Submitted By:
Dr. Manfred Mäder Senior Vice President Quality Management & Regulatory Affairs Ypsomed AG
April 26, 2010 Date Prepared:
Trade/Proprietary Name: 7.1
Clickfine Pen Needle
Injection Pen Needle
Common/Usual Name: 7.2
7.3 Classification Name: Hypodermic single lumen needle
- Classification: FDA has classified Hypodermic single lumen needles in Class II. Final 7.4 Order was published in the Federal Register on October 21, 1980 after review by the General Hospital and Personal Use Devices Classification Panel.
Panel: 80
Procode: FMI
- Purpose of Submission: To establish the substantial equivalence of the modified 7.5 Y psomed Clickfine Pen Needles to the currently marketed Disetronic Penfine Insulin Injection Pen Needles.
Substantial Equivalence: The Ypsomed Clickfine Pen Needles are substantially equivalent to the Disetronic Penfine Insulin Injection Pen Needles (K013782). The equivalence is supported by the attached documentation.
7.6 Device Description
The Ypsomed Clickfine Pen Needles are sterile, non-pyrogenic, single use needles designed to be used with commercially available pen-injectors for insulin administration. Each needle is individually packaged in a sealed protective container with peel tab. The pen needles are used by peeling back the peel tab and snapping the while per table threaded end of the pen injector. The back end of the cannula punctures the rubber injection port of the drug reservoir in the pen-injector. The outer protective cap is then removed. The inner protective cap will remain over the needle until the insulin is ready to be injected. When the injection is needed, the inner protective cap is removed and the needle is inserted into the chosen site. The pen-injector automatically delivers the insulin through the needle. The protective cap is replaced and the needle is then removed, safely discarded and replaced with a new needle.
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- 7.7 Intended Use
The intended use of the modified device remains the same as the predicate device (Disetronic Penfine Insulin Injection Pen Needles, K013782): The Ypsomed Clickfine Pen Needles are intended for the hypodermic injection of insulin into the body when attached to an injection pen.
Technological Characteristics 7.8
The technological characteristics have not changed.
Performance and Safety Data 7.9
Y psomed has performed the relevant assessments specified in the following international and internal standards and protocols and confirmed compliance of the modified devices and equivalence to the predicate devices.
The Clickfine Pen Needles have met the requirements of the relevant sections of the following standards:
- ISO 11608-2:2000 Pen-injectors for medical use Part 2: Needles Requirements . and test methods
- ISO 9626:1991/Amd.1:2001 Stainless steel needle tubing for the manufacture of . medical devices
- ISO 7864:1993 Sterile hypodermic needles for single use .
- ISO 10993-1:2003 Biological evaluation of medical devices Part 1: Evaluation ● and testing
- Puncture resistance of outer cap Equivalent to Unmodified Device .
- Seal Integrity of Sterile barrier Equivalent to Unmodified Device .
The verifications have shown evidence that the Clickfine Pen Needles meet the acceptance criteria of these standards. Based on the results it can be concluded that the device performance and safety are acceptable for the product.
7.10 Conclusion
Y psomed AG concludes based on the information presented that the modified product is substantially equivalent to the current product legally marketed in the USA.
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DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/2/Picture/1 description: The image shows the seal of the Department of Health & Human Services - USA. The seal is circular, with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized image of a bird, possibly an eagle, with its wings spread. The bird is composed of three curved lines, giving it a modern and abstract appearance.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002
Dr. Manfred Mader Senior Vice President YPSOMED AG Brunnmattstrasse 6 Burgdorf, Switzerland CH-3401
APR 3 0 . 2010
Re: K100436
Trade/Device Name: Clickfine Pen Needle Regulation Number: 21 CFR 880.5570 Regulation Name: Hypodermic Single Lumen Needle Regulatory Class: II Product Code: FMI Dated: March 26, 2010 Received: April 1, 2010
Dear Dr. Manfred Mader:
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.
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Page 2 - Mr. Manfred Mader
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 go to
http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. 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,
Anthony O. iselan
Anthony D. Watson, B.S., M.S., M.B.A. Director
Division of Anesthesiology, General Hospital, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known):
Device Name:
Indications For Use:
Clickfine Pen Needle
The Clickfine pen needle is intended for the hypodermic injection of insulin into the body when attached to a peninjector.
Prescription Use (Part 21 CFR 801 Subpart D) AND/OR
Over-The-Counter Use _ X (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
(Division Sign-Off)
Division of Anesthesiology, General Hospital Infection Control, Dentai Devices
510(k) Number: _ K/00 436
page 31 of 44
§ 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).