The Clickfine and Penfine Classic Pen Needle are intended for use with pen injector devices for subcutaneous injection of fluids, including insulin and exenatide.

Device Description

The subject devices are sterile, non-pyrogenic, single use pen needles designed to be used with commercially available pen-injectors. The back end of the needle punctures the rubber injection port of the drug reservoir in the pen. When the injection is needed, the needle is inserted into the chosen site and the pen-injector delivers the fluid through the needle. The materials of construction, (siliconized stainless-steel needle encased in a polypropylene hub with a polypropylene protective cap) as well as the sterile packaging (a polypropylene outer protective container and the peel tab) which provides the sterile barrier and the manufacturing (which includes radiation sterilization) are unchanged from the currently marketed devices. They subject devices will be marketed in the same sizes as the predicate devices - 32 and 31 gauges and 4, 4.5, 5, 6, 8, 10, and 12 mm lengths.

AI/ML Overview

This FDA 510(k) summary focuses on the substantial equivalence of a medical device (pen needle) to a predicate device, rather than the performance of an AI/ML algorithm. Therefore, many of the requested categories related to AI/ML studies are not applicable.

Here's an analysis based on the provided text, addressing the applicable points:

1. Table of Acceptance Criteria and Reported Device Performance

Device Modification	Verification Activity	Acceptance Criteria	Results of Verification
Larger inner diameter of needle on 31 Gauge and 32 Gauge needles	Testing for resistance to breakage was conducted acc. ISO 9626:2016	When tested acc. Annex C of ISO 9626:2016, the tubing shall not show visible breakage when examined by normal or corrected vision after testing.	All samples tested met the acceptance criteria for resistance to breakage acc. ISO 9626:2016.
Larger inner diameter of needle on 31 Gauge and 32 Gauge needles	Testing for stiffness was conducted acc. ISO 9626:2016	The tubing shall show a maximum defined deflection when tested in accordance with annex B of ISO 9626:2016: max. deflection 0.22 mm for 32 G and max. 0.21 mm for 31 G.	All samples tested met the acceptance criteria for stiffness acc. ISO 9626:2016.

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

The document does not specify a numerical sample size for the tests. It states "All samples tested" for both breakage and stiffness, implying that a sufficient number was tested to meet the requirements of the specified ISO standards, but the exact number isn't provided. Data provenance is not applicable here as it's a physical device performance test, not a data-driven model.

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

Not applicable. Ground truth for physical device performance is established by standardized measurement methods defined by international standards (ISO). No human expert consensus for "ground truth" in this context is mentioned.

4. Adjudication method for the test set

Not applicable. The tests are pass/fail based on objective measurements against ISO standards. No adjudication method is described.

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 not an AI/ML device.

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

Not applicable. This is not an AI/ML device.

7. The type of ground truth used

The ground truth for the device's performance (breakage and stiffness) is defined by the objective measurement criteria and methodologies outlined in the referenced ISO standards (ISO 9626:2016).

8. The sample size for the training set

Not applicable. This is not an AI/ML device; there is no "training set."

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

Not applicable. This is not an AI/ML device; there is no "training set" or corresponding ground truth establishment process.

Summary

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510(k) Summary - File # K171984

8.1. Date prepared September 19, 2017

8.2. Submitter's information

Company Name:	Ypsomed AG
Company Address:	Brunnmattstrasse 6CH - 3401 Burgdorf, Switzerland
Contact Person:	Stephan AffolterHead of Quality System & Regulatory Affairs
Phone number:	0041-34 424 3382
Fax number:	0041-34 424 4122
Email:	stephan.affolter@ypsomed.com

Alternative contact

Company Name:	P/L Biomedical
Company Address:	10882 Stonington AvenueFort Myers, FL 33913, USA
Contact Person:	Lee Leichter
Phone number:	(239) 244-1448
Fax number:	(815) 550-0162
Email:	leichter@plbiomedical.com

8.3. Trade Name, Common Name, Classification

Trade Name:	Clickfine Pen Needle andPenfine Classic Pen Needle
Common Name:	Injection Pen Needle
Classification Name:	Hypodermic single lumen needle
Regulation Number:	21 CFR 880.5570
Regulatory Class:	Class II
Product Code	FMI

8.4. Identification of predicate Device(s)

The identified predicate device within this submission are as follows:
Manufacturer:	Ypsomed AG
Trade Name:	Clickfine Pen Needle andPenfine Classic Pen Needle
Common Name:	Injection Pen Needle
Classification Name:	Hypodermic single lumen needle
Regulation Number:	21 CFR 880.5570
Regulatory Class:	Class II
Product Code	FMI
FDA 510(k) #:	K150662

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8.5. Comparison with Predicate Devices:

The subject device has the same materials, fundamental scientific technology and device performance as the predicate device (K150662). The only difference is that the subject devices of the same gauge (outer diameter) will now have a larger inner diameter, i.e. extra thin walled needles according to ISO 9626:2016.

The table below provides a side by side comparison of the subject device compared to its predicate.

Characteristic	Predicate device	Subject device	Comments
Indications foruse	The Clickfine and PenfineClassic Pen Needle areintended for use with peninjector devices forsubcutaneous injection offluids, including insulin andexenatide.	The Clickfine and PenfineClassic Pen Needle areintended for use with peninjector devices forsubcutaneous injection offluids, including insulin andexenatide.	Unchanged
Needle length	4, 4.5, 5, 6, 8, 10, and 12 mm	4, 4.5, 5, 6, 8, 10, and 12 mm	Unchanged
Needle gauge	32, 31, 30 and 29 gauge	32, 31, 30 and 29 gauge	Unchanged
Needle outerdiameter	0.23 mm, 0.25, 0.3 and 0.33 mm	0.23 mm, 0.25, 0.3 and 0.33 mm	Unchanged
Needle innerdiameter	Normal walled needle:≥ 0.114 mm (31 gauge)≥ 0.133 mm (30 gauge)≥ 0.133 mm (29 gauge)Thin walled needle:≥ 0.105 mm (32 gauge)≥ 0.125 mm (31 gauge)≥ 0.165 mm (30 gauge)≥ 0.190 mm (29 gauge)	Normal walled needle:≥ 0.114 mm (31 gauge)≥ 0.133 mm (30 gauge)≥ 0.133 mm (29 gauge)Thin walled needle:≥ 0.105 mm (32 gauge)≥ 0.125 mm (31 gauge)≥ 0.165 mm (30 gauge)≥ 0.190 mm (29 gauge)	Unchanged
	n/a	Extra thin walled needle:≥ 0.146 mm (31 gauge),≥ 0.125 mm (32 gauge)	The needles havebeen modified tohave Extra thinwall tubing

8.6. Description of the Device

The materials of construction, (siliconized stainless-steel needle encased in a polypropylene hub with a polypropylene protective cap) as well as the sterile packaging (a polypropylene outer protective container and the peel tab) which provides the sterile barrier and the manufacturing (which includes radiation sterilization) are unchanged from the currently marketed devices. They subject devices will be marketed in the same

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sizes as the predicate devices - 32 and 31 gauges and 4, 4.5, 5, 6, 8, 10, and 12 mm lengths.

8.7. Indication for Use

The pen needles are intended for use with pen injector devices for subcutaneous injection of fluids, including insulin and exenatide.

8.8. Technological Characteristics

The predicate device Clickfine and the Penfine Classic pen needle are comprised of a siliconized stainless steel needle encased in a needle hub. An outer protective cap snaps onto the hub over the needle. This assembly fits into a larger outer protective container, which provides the sterile barrier along with the peel foil.

These characteristics remain the same for the proposed devices.

8.9. Substantial Equivalence

Performance testing:

All Subject Device Pen Needles have met the requirements of the relevant sections of the following standards recognized by FDA:

a) ISO 11608-2:2012 Needle based injection systems for medical use Requirements and test methods - Part 2: Needles
b) ISO 9626:2016 Stainless steel needle tubing for the manufacture of medical devices - Requirements and test methods
c) ISO 7864:2016 Sterile hypodermic needles for single use Requirements and test methods

The following risks were adequately addressed through design controls:

DeviceModification	Risks	VerificationActivity	AcceptanceCriteria	Results ofVerification
Larger inner diameter of needle on31 Gauge and 32 Gauge needles	Breakage of needle	Testing forresistance tobreakage wasconducted acc. ISO9626:2016	When tested acc. Annex Cof ISO 9626:2016, thetubing shall not showvisible breakage whenexamined by normal orcorrected vision aftertesting.	All samples tested met the acceptancecriteria for resistance to breakage acc. ISO9626:2016.
	Bending of needle	Testing for stiffnesswas conducted acc.ISO 9626:2016	The tubing shall show amaximum defineddeflection when tested inaccordance with annex Bof ISO 9626:2016:max. deflection 0.22 mmfor 32 G and max. 0.21mm for 31 G	All samples tested met the acceptancecriteria for stiffness acc. ISO 9626:2016.
Change in labeling to addinformation regarding increasedinner diameter	None	None Required.Changes do notimpact the safe oreffective use of theproduct	N/A	N/A

8.10. Conclusion

The verifications have shown evidence that the subject device pen needles meet the acceptance criteria of these standards. Based on the results it can be concluded that the subject device is substantially equivalent to the predicate device.

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October 11, 2017

Ypsomed AG % Lee Leichter President P/L Biomedical 10882 Stonington Avenue Fort Myers, Florida 33913

Re: K171984

Trade/Device Name: Clickfine Pen Needle, Penfine Classic Pen Needle Regulation Number: 21 CFR 880.5570 Regulation Name: Hypodermic Single Lumen Needle Regulatory Class: Class II Product Code: FMI Dated: September 8, 2017 Received: September 13, 2017

Dear Lee 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 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); good

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manufacturing practice requirements as set forth in the quality systems (OS) 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 Industry and Consumer Education (DICE) at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevicesforYou/Industry/default.htm. 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 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 Industry and Consumer Education (DICE) at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely,

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

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).