The 6 mm Disetronic Penfine® Injection Pen Needles are the same sterile, non-pyrogenic, single use needles designed to be used with commercially available Injection Pens as the 8, 10 and 12 mm Disetronic Penfine® Injection Pen Needles. The only difference is in the length of the cannula.

AI/ML Overview

The provided text describes a 510(k) submission for the Disetronic Penfine® Injection Pen Needle. This is a medical device clearance, not an AI/ML device, and therefore the requested information regarding acceptance criteria, study details, and AI/ML specific metrics (sample sizes for test/training sets, ground truth establishment, MRMC studies, standalone performance) does not directly apply in the way it would for an AI/ML device.

However, I can extract and present the information available in a format that aligns as closely as possible with your request, interpreting "acceptance criteria" as the basis for substantial equivalence for this type of medical device.

Key takeaway: This is a 510(k) for a physical medical device (pen needle), not an AI/ML device. Therefore, many of the requested AI/ML specific details are not applicable or provided.

1. Table of Acceptance Criteria and Reported Device Performance

For a 510(k) submission for a physical device, the "acceptance criteria" is typically demonstrating substantial equivalence to a predicate device. The "performance" is shown through engineering equivalence and safety/functional testing rather than diagnostic accuracy metrics.

Acceptance Criteria (Basis for Substantial Equivalence)	Reported Device Performance (Evidence Provided)
Design Equivalency to Predicate Device	The 6 mm Disetronic Penfine® Injection Pen Needles are the same sterile, non-pyrogenic, single-use needles designed to be used with commercially available injection pens as the 8, 10, and 12 mm Disetronic Penfine® Injection Pen Needles (K982399). The only difference is in the length of the cannula.
Technological Characteristics Equivalency	"The technological characteristics are the same as the predicate devices."
Functional and Safety Testing	"Performance data has been generated in compliance with existing international standards and protocols and found equivalent to the predicate devices."
Indications for Use Equivalency	Intended for "hypodermic injection of fluids into the body when attached to an injector pen," which is implicitly equivalent to the predicate.

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

Sample Size for Test Set: Not applicable in the context of an AI/ML test set. The submission refers to "performance data generated in compliance with existing international standards and protocols." This refers to engineering and quality control tests on the physical device, not an AI algorithm's performance on a dataset. Specific sample sizes for these standard tests are not provided in this summary.
Data Provenance: Not applicable in the context of an AI/ML dataset (e.g., country of origin, retrospective/prospective). The "data" refers to physical device testing.

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

Not applicable. This is not an AI/ML device requiring expert ground truth for image or data interpretation. The "ground truth" for a physical medical device involves meeting predefined engineering specifications and safety standards through physical testing.

4. Adjudication method for the test set

Not applicable. This is not an AI/ML device and does not involve adjudication of expert interpretations for a test set.

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 physical medical device (injection pen needle), not an AI/ML diagnostic or assistive device. Therefore, no MRMC study on human reader improvement with AI assistance was performed or is 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, not an algorithm.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

For physical medical devices, "ground truth" typically refers to established engineering specifications, material properties, sterility standards, functional performance metrics (e.g., fluid flow rate, needle sharpness, cannula integrity), and safety margins as defined by international standards and regulatory guidance. The summary states, "Performance data has been generated in compliance with existing international standards and protocols."

8. The sample size for the training set

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

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

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

Summary

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1994197

"510(k) SUMMARY"

Disetronic Penfine® Injection Pen Needle 8.1 Trade/Proprietary Name:

Iniection Pen Needle 8.2 Common/Usual Name:

8.3 Classification Name: Hypodermic Single Lumen Needle --

8.4 Comparison to Currently Marketed Devices

The 6 mm Disetronic Penfine® Injection Pen Needles are substantially equivalent to the 8, 10 and 12 mm Disetronic Penfine® Injection Pen Needles (K982399).

8.5 Device Description

8.6 Indications for Use

The Disetronic Penfine® Injection Pen Needles are intended for the hypodermic injection of fluids -into the body when attached to an injector pen.

8.7 Technological Characteristics

The technological characteristics are the same as the predicate devices.

8.8 Performance Data

Performance data has been generated in compliance with existing international standards and protocols and found equivalent to the predicate devices.

8.9 Conclusion

Based on the design equivalency and the functional and safety testing, Disetronic Medical Systems has determined that the Penfine® Iniection Pen Needles are substantially equivalent to the devices currently marketed in the United States.

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Image /page/1/Picture/1 description: The image is a black and white seal for the Department of Health & Human Services - USA. The seal is circular and contains the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. In the center of the seal is an abstract image of an eagle.

Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

DEC 2 9 1999

Mr. David E. Chadwick, Ph.D. Director, Regulatory Affairs Disetronic Medical Systems, Inc. 5151 Program Avenue St. Paul, Minnesota 55112-1014

Re : K994197

Trade Name: Disetronic Penfine® Injection Pen Needle Regulatory Class: II Product Code: FMI Dated: December 7, 1999 December 13, 1999 Received:

Dear Mr. Chadwick:

We have reviewed your Section 510 (k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to 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). 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.

If your device is classified (see above) into either class II (Special Controls) or class III (Premarket Approval), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Requlations, Title 21, Parts 800 to 895. ਉ substantially equivalent determination assumes compliance with the Good Manufacturing Practice for Medical Devices: General (GMP) regulation (21 CFR Part 820) and that, through periodic GMP inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any

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Page 2 - Mr. Chadwick

obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.

This letter will allow you to begin marketing your device as described in your 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.

If you desire specific advice for your device on our labeling requlation (21 CFR Part 801 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4692. Additionally, for questions on compriation as (advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to ene regaration" (21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its internet address "http://www.fda.gov/cdrh/dsmamain.html".

Sincerely yours,

Eleanor W Shippen

Timothy A. Ulatowski 1 197 Director Division of Dental, Infection Control and General Hospital Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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!NDICATIONS FOR USE STATEMENT

1499 41977

510(k) File Number:

Device Name:

Indications For Use:

Disetronic Penfine® Injection Pen Needle

The Disetronic Penfine® Injection Pen Needles are intended for the .. hypodermic injection of fluids into the body when attached to an injector pen.

PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED

Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use
(Per 21 CFR 801.19)

Over-The-Counter Use

Healed in Shunum

(Division Sign-Off) ·vision of Dental, Infection Control, · General Hospital Dev Nomber _______________________________________________________________________________________________________________________________________________________________________

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).