(358 days)
The Clickfine AutoProtect pen needle is intended for the hypodermic injection of fluids into the body when attached to an injection pen. Additionally, after withdrawal of the pen needle from the body, the attached needle safety shield will automatically cover the needle to minimize the risk of accidental needlestick.
The Ypsomed Clickfine AutoProtect Pen Needles are sterile, non-pyrogenic, single use needles designed to be used with commercially available pen-injectors for the administration of prescribed fluids. Each needle is individually packaged in a sealed protective container with a peel tab. The pen needle is used by peeling back the peel tab and snapping the housing onto the threaded end of the pen-injector. The back end of the cannula punctures the septum of the drug reservoir in the pen-injector. The outer protective cap is then removed. When the injection is needed the needle is inserted into the chosen site. While inserting the needle into the safety shield glides into the housing enabling the needle to penetrate the skin barrier and into the subcutaneous tissue. While the safety shield glides into the housing the safety mechanism will be activated. The pen-injector delivers the medicinal product through the needle. After the injection, in order to remove the needle from the skin, the user moves the pen injector away from the skin. As the pen and needle is moved away from the skin, the safety shield glides back in its initial position, completely covering the needle, where it will remain locked. The safety shield is designed to automatically cover the needle (provide passive protection) to minimize the risk of accidental needle-stick injury. Once the Clickfine AutoProtect pen needle is in the locked mode, it can no longer be used. The red safety lock indicator tells the user that the safety lock has been activated. The needle is detached from the injection device and disposed of in accordance with local regulations. For each subsequent iniection, another disposable needle must be used.
The provided text is a 510(k) summary for a medical device (Clickfine AutoProtect Pen Needle) and describes its safety and effectiveness based on compliance with various standards, rather than a study comparing its performance against specific acceptance criteria with quantifiable metrics. Therefore, it is not possible to fully answer your request in the format you provided, as the document does not contain the specific statistical results, sample sizes for test sets, expert qualifications, or adjudication methods typically found in a clinical study report for AI/CAD devices.
However, I can extract the information that is present and indicate where information is missing.
Here's an attempt to structure the available information, noting the missing elements:
Device: Clickfine AutoProtect Pen Needle
Description of Device: The Ypsomed Clickfine AutoProtect Pen Needle is a sterile, non-pyrogenic, single-use needle designed for use with pen-injectors to administer prescribed fluids. Its key feature is an automatic safety shield that covers the needle after withdrawal from the skin to minimize the risk of accidental needle-stick injury. Once locked, the needle cannot be reused, and a red indicator confirms activation of the safety lock.
Intended Use: The Ypsomed Clickfine AutoProtect Pen Needles are intended for the hypodermic injection of fluids into the body when attached to an injection pen. Additionally, after withdrawal of the pen needle from the body, the attached needle safety shield automatically covers the needle to minimize the risk of accidental needlestick.
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria Category | Specific Criteria (Derived from Standards) | Reported Device Performance |
|---|---|---|
| Mechanical/Physical Performance | ISO 11608-2:2000 Pen-injectors for medical use Part 2: Needles Requirements and test methods (Specific metrics not provided in summary) | "The Clickfine AutoProtect pen needles have met the requirements of the relevant sections of [ISO 11608-2:2000...]" "The verifications have shown evidence that the Clickfine AutoProtect 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." |
| Material Composition | ISO 9626:1991/Amd.1:2001 Stainless steel needle tubing for the manufacture of medical devices (Specific metrics not provided in summary) | "The Clickfine AutoProtect pen needles have met the requirements of the relevant sections of [ISO 9626:1991Amd.1:2001...]" "The verifications have shown evidence that the Clickfine AutoProtect 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." |
| Sterility & Single Use | ISO 7864:1993 Sterile hypodermic needles for single use (Specific metrics not provided in summary) | "The Clickfine AutoProtect pen needles have met the requirements of the relevant sections of [ISO 7864:1993...]" "The verifications have shown evidence that the Clickfine AutoProtect 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." |
| Biocompatibility | ISO 10993-1:2009 Biological evaluation of medical devices Part 1: Evaluation and testing within a risk management system (Specific metrics not provided in summary) | "The Clickfine AutoProtect pen needles have met the requirements of the relevant sections of [ISO 10993-1:2009...]" "The verifications have shown evidence that the Clickfine AutoProtect 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." |
| Seal Integrity | Seal Integrity of Sterile Barrier (Specific criteria not provided in summary) | "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. The Clickfine AutoProtect pen needles have met the requirements of the relevant sections of [Seal Integrity of Sterile barrier]" "The verifications have shown evidence that the Clickfine AutoProtect 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." |
| Sharps Injury Protection (Safety Mechanism) | ISO/FDIS 23908 (N156) Sharps injury protection Requirements and test methods - Sharps protection features for single-use hypodermic needles, catheters, introducers for catheters and needles used for blood sampling (Specific metrics not provided in summary, but implies successful activation and locking) | "The Clickfine AutoProtect pen needles have met the requirements of the relevant sections of [ISO/FDIS 23908 (N156)...]" "The verifications have shown evidence that the Clickfine AutoProtect 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." |
| Simulated Use (Sharps Injury Prevention) | Simulated Use Studies per FDA Guidance for Industry and FDA Staff Medical Devices with Sharps Injury Prevention Features, dated August 9, 2005 (Specific metrics like activation rate, accidental sticks not provided in summary) | "The Clickfine AutoProtect pen needles have met the requirements of the relevant sections of [Simulated Use Studies per FDA Guidance...]" "The verifications have shown evidence that the Clickfine AutoProtect 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." |
As this is a 510(k) for a physical medical device and not an AI/CAD system, several of your requested points are not applicable or the information is not provided because such studies are not typically performed for this type of device.
2. Sample size used for the test set and the data provenance:
- Sample size: Not specified. The document states "Ypsomed has performed the relevant assessments specified in the following international and internal standards and protocols." The specific number of devices tested for each standard is not provided.
- Data provenance: Not explicitly stated, but implying tests were conducted in accordance with international standards (ISO) and FDA guidance, likely in a controlled laboratory setting or clinical simulation. It is a prospective assessment of newly produced devices.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not applicable in the context of device performance testing against engineering standards. "Ground truth" here refers to the specifications and requirements defined by the referenced ISO standards and FDA guidance. Experts would be involved in developing those standards and subsequently in conducting and interpreting the tests, but no specific number or qualifications are mentioned for this particular submission.
4. Adjudication method for the test set:
- Not applicable in the context of device performance testing against engineering standards. Testing against standards is typically objective measurement against predefined technical specifications.
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 device is a physical pen needle with an automatic safety mechanism, not an AI/CAD system that assists human readers in interpreting medical images or data.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:
- Not applicable. This is a physical medical device, not an algorithm. The "standalone" performance refers to the device's inherent functional characteristics, specifically its ability to perform injections and activate its safety mechanism as designed. This was assessed through compliance with the listed standards and simulated use studies.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- The "ground truth" for this device's performance is established by the requirements and test methods defined in the cited international standards (ISO) and FDA guidance documents. These standards set the benchmarks for sterility, material properties, mechanical function, biocompatibility, and sharps injury prevention features. Compliance is demonstrated through objective physical and biological testing.
8. The sample size for the training set:
- Not applicable. This device is not an AI/machine learning model, so there is no "training set."
9. How the ground truth for the training set was established:
- Not applicable. As there is no training set for an AI/ML model, this question is irrelevant.
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7. Summary of Safety and Effectiveness
JAN 2 6 2012
"510(K) SUMMARY"
| Submitted By/ Contact Person: | Dr. Manfred MäderSenior Vice PresidentQuality Management & Regulatory AffairsYpsomed AGBrunnmattstrasse 6CH - 3401 BurgdorfSwitzerlandTel. 0041-344244111Fax 0041-344244122E-mail: manfred.maeder@ypsomed.com |
|---|---|
| Date Prepared: | January 28, 2011 |
| 7.1. Trade/Proprietary Name: | Clickfine AutoProtect Pen Needle |
| 7.2. Common/Usual Name: | Injection Pen Needle |
| 7.3. Classification Name: | Hypodermic single lumen needle |
| 7.4. Classification: | FDA has classified Hypodermic single lumen needles in Class II. Final 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 |
7.5. Purpose of Submission: To establish the substantial equivalence of the modified Y psomed Clickfine AutoProtect Pen Needles to the Clickfine Pen Needles cleared for
legal marketing in the USA per 510(k) file K102108.
- 7.6. Substantial Equivalence: The Ypsomed Clickfine AutoProtect Pen Needles are substantially equivalent to the Clickfine Pen Needles (K102108). The equivalence is supported by the attached documentation.
- 7.7. Device Description
The Ypsomed Clickfine AutoProtect Pen Needles are sterile, non-pyrogenic, single use needles designed to be used with commercially available pen-injectors for the administration of prescribed fluids. Each needle is individually packaged in a sealed protective container with a peel tab. The pen needle is used by peeling back the peel tab and snapping the housing onto the threaded end of the pen-injector. The back end of the cannula punctures the septum of the drug reservoir in the pen-injector. The outer protective cap is then removed. When the injection is needed the needle is inserted into
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the chosen site. While inserting the needle into the safety shield glides into the housing enabling the needle to penetrate the skin barrier and into the subcutaneous tissue. While the safety shield glides into the housing the safety mechanism will be activated. The pen-injector delivers the medicinal product through the needle.
After the injection, in order to remove the needle from the skin, the user moves the pen injector away from the skin. As the pen and needle is moved away from the skin, the safety shield glides back in its initial position, completely covering the needle, where it will remain locked. The safety shield is designed to automatically cover the needle (provide passive protection) to minimize the risk of accidental needle-stick injury. Once the Clickfine AutoProtect pen needle is in the locked mode, it can no longer be used. The red safety lock indicator tells the user that the safety lock has been activated. The needle is detached from the injection device and disposed of in accordance with local regulations. For each subsequent iniection, another disposable needle must be used.
- 7.8. Intended Use
The intended use of the modified device remains the same as the predicate device (Clickfine Pen Needles, K102108):
The Ypsomed Clickfine AutoProtect Pen Needles are intended for the hypodermic injection of fluids into the body when attached to an injection pen.
Additionally, after withdrawal of the pen needle from the body, the attached needle safety shield automatically covers the needle to minimize the risk of accidental needlestick.
7.9. Technological Characteristics
The Clickfine AutoProtect pen needle is considered substantial equivalent to K102108, Clickfine pen needle, in intended use (intended for use with pen-injectors for the hypodermic injection of fluids) and in the device's operating principles. The addition of the needle safety function does not affect the intended use or alter the fundamental scientific technology of the device but improves the safety of the product.
7.10. Performance and Safety Data
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 AutoProtect 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 10993-1:2009 Biological evaluation of medical devices Part 1: Evaluation . and testing within a risk management system
- Seal Integrity of Sterile barrier .
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- ISO/FDIS 23908 (N156) Sharps injury protection Requirements and test . methods - Sharps protection features for single-use hypodermic needles, catheters, introducers for catheters and needles used for blood sampling
- Simulated Use Studies per FDA Guidance for Industry and FDA Staff Medical . Devices with Sharps Injury Prevention Features, dated August 9, 2005
The verifications have shown evidence that the Clickfine AutoProtect 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.
7.11. Conclusion
Y psomed AG concludes based on the information presented that the modified product is substantially equivalent to the current product legally approved in the USA.
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DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle with three tail feathers, representing the department's mission to protect the health of all Americans and provide essential human services. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES-USA" is arranged in a circular fashion around the eagle.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002
Mr. Andre Sauter Regulatory Affairs Manager Quality System & Regulatory Affairs Ypsomed AG Brunnmattstrasse 6 Burgdorff SWITZERLAND CH-3401
JAN 2 6 2012
Re: K110312
Trade/Device Name: Clickfine AutoProtect Pen Needle Regulation Number: 21 CFR 880.5570 Regulation Name: Hypodermic Single Lumen Needle Regulatory Class: II Product Code: FMI Dated: January 20, 2012 Received: January 23, 2012
Dear Mr. Sauter:
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. Sauter
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,
Susan Runner
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 AutoProtect Pen Needle
The Clickfine AutoProtect pen needle is intended for the hypodermic injection of fluids into the body when attached to an injection pen.
Additionally, after withdrawal of the pen needle from the body, the attached needle safety shield will automatically cover the needle to minimize the risk of accidental needlestick.
Prescription Use X (Part 21 CFR 801 Subpart D)
.
AND/OR
Over-The-Counter Use (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)
Cr. RZW
(Division Sign-Off) Division of Anesthesiology, General Hospital Infection Control, Dental Devices
K110312 510(k) Number:
§ 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).