The Ypsomed Clickfine 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 needles are used by peeling back the peel tab and suapping or screwing the hub onto the threaded end of the pen injector. The back end of the cannula punctures the rubber injection port of the drug reservoir in the peninjector. 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 fluid through the needle. The protective cap is replaced and the needle is then removed, safely discarded and replaced with a new needle.

AI/ML Overview

Here's the analysis of the provided text regarding the acceptance criteria and study for the Clickfine Pen Needle, formatted as requested:

Acceptance Criteria and Device Performance for Clickfine Pen Needle

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria (from Standards)	Device Performance (Reported)
ISO 11608-2:2012 Needle based injection systems for medical use - Requirements and test methods -- Part 2: Needles	"The Clickfine Pen Needles have met the requirements of the relevant sections of the following standards: ISO 11608-2:2012... 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."
ISO 9626:1991/Amd.1:2001 Stainless steel needle tubing for the manufacture of medical devices	"The Clickfine Pen Needles have met the requirements of the relevant sections of the following standards: ...ISO 9626:1991/Amd.1:2001... 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."
ISO 7864:1993 Sterile hypodermic needles for single use	"The Clickfine Pen Needles have met the requirements of the relevant sections of the following standards: ...ISO 7864:1993... 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."

2. Sample size used for the test set and the data provenance

The document does not explicitly state the specific sample sizes used for testing against the ISO standards. It generally refers to "relevant assessments" and "verifications." The data provenance is internal to Ypsomed AG, implying it's company-generated data, but the country of origin of the actual tests or whether it was retrospective or prospective is not specified.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

This information is not provided in the document. The "ground truth" here would be the objective measurements and adherence to the technical specifications outlined in the ISO standards, not expert human interpretation.

4. Adjudication method for the test set

This is not applicable as the "adjudication" is based on objective measurements against the quantitative and qualitative requirements of the listed ISO standards, not on human interpretation or consensus.

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

A multi-reader multi-case (MRMC) study is not relevant or mentioned in this document. This device is a physical medical device (hypodermic pen needle), not an AI-powered diagnostic or assistive technology.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

This is not applicable. The device is a physical pen needle, not an algorithm. Performance is assessed through physical and material testing.

7. The type of ground truth used

The "ground truth" used for this device is the objective technical specifications and performance requirements outlined in the referenced international standards (ISO 11608-2:2012, ISO 9626:1991/Amd.1:2001, ISO 7864:1993). This would involve laboratory testing and measurements to ensure the needle meets criteria for things like sterility, dimensions, material strength, penetration force, and compatibility.

8. The sample size for the training set

This is not applicable. There is no "training set" in the context of this traditional medical device. No machine learning or AI algorithm development is described.

9. How the ground truth for the training set was established

This is not applicable, as there is no training set for this device.

Summary

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K122969

OCT
2 5 2012

7. Summary of Safety and Effectiveness

"510(K) SUMMARY"

Submitted by/ Contact Person:

Dr. Benjamin Reinmann Vice President Quality Management & Regulatory Affairs Ypsomed AG Brunnmattstrasse 6 CH - 3401 Burgdorf Switzerland Tel. 0041-3442441111 Fax 0041-344244122 E-mail: benjamin.reinmann@ypsomed.com

Date Prepared: Date Revised:

September 24, 2012 October 24, 2012

7.1 Trade/Proprietary Name: Clickfine 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.

CFR Reference: 880.5570 . Procode: FMI

7.5 Purpose of Submission: To expand the product line to include smaller needles including a 4 mm, 32 gauge needle.
7.6 Substantial Equivalence: The Ypsomed Clickfine Pen Needles are substantially equivalent to the Clickfine Pen Needles (K100436). The equivalence is supported by the attached documentation.
7.7 Device Description
The Ypsomed Clickfine 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 needles are used by peeling back the peel tab and suapping or screwing the hub onto the threaded end of the pen injector. The back end of the cannula punctures the rubber injection port of the drug reservoir in the peninjector. 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

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needed, the inner protective cap is removed and the needle is inserted into the chosen site. The pen-injector automatically delivers the fluid through the needle. The protective cap is replaced and the needle is then removed, safely discarded and replaced with a new needle.

7.8 Intended Use

The intended use of the modified device remains the same as the predicate device Clickfine Pen Needles (K100436):

The Ypsomed Clickfine Pen Needles are intended for the hypodermic injection of insulin into the body when attached to an injection pen.

7.9 Technological Characteristics

The technological characteristics have not changed.

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 Pen Needles have met the requirements of the relevant sections of the following standards:

. ISO 11608-2:2012 Needle based injection systems for medical use -
Requirements and test methods -- Part 2: Needles .
. 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

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.

7.11 Conclusion

Ypsomed AG concludes based on the information presented that the modified product is substantially equivalent to the current product legally marketed in the USA is substantially equivalent to the current product legally marketed in the USA.

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Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized eagle with three curved lines representing its wings. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular pattern around the eagle.

Food and Drug Administration 10903 New Hampshire Avenue Document Control Room-WO66-G609 Silver Spring, MD 20993-0002

P/L Biomedical Mr. Lee Leichter 10882 Stonington Avenue Fort Myers, Florida 33913

OCT
25 2012

Re: K122969

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: September 24, 2012 Received: September 26, 2012

Dear Mr. Leichter:

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 Eederal Register.

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Page 2- Mr. Leichter

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 b. nunt

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):

K122969

Device Name:

Clickfine Pen Needle

Indications For Use.

The Clickfine pen needle is intended for the hypodermic injection of insulin into the body when attached to an injection pen.

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)

hid. Wli. for RZC Oct 24, 2012

(Division Sign-Off) (Division Sign-On)
Division of Anesthesiology, General Hospital Infection Control, Dental Devices

510(k) Number:

page 23 of 43

Regulation Number and Section

§ 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).