The 31 gauge 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 29 and 30 gauge Disetronic PenFine® Injection Pen Needles. The only difference is in the thickness of the cannula.

AI/ML Overview

The provided text describes a 510(k) submission (K982399) for a 31 gauge Disetronic PenFine® injection Pen Needle. This is a medical device, specifically a hypodermic single lumen needle, and the submission focuses on demonstrating substantial equivalence to existing predicate devices, not on proving new clinical performance. Therefore, many of the typical acceptance criteria and study details for AI/device performance are not applicable here.

Here's a breakdown of the requested information based on the provided text:

1. A table of acceptance criteria and the reported device performance

For a medical device like this, acceptance criteria typically involve demonstrating safety and effectiveness by meeting engineering specifications, biocompatibility standards, and functional requirements comparable to predicate devices. The document doesn't provide a table of specific numerical acceptance criteria from the submission. Instead, the "performance" demonstrated is substantial equivalence to legally marketed predicate devices based on design and functional testing.

Acceptance Criteria (Implied)	Reported Device Performance
Design Equivalency: Same sterile, non-pyrogenic, single use needle design.	"The 31 gauge 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 29 and 30 gauge Disetronic PenFine® Injection Pen Needles."
Material/Technological Characteristic Equivalency: Similar materials, manufacturing processes, and technological features.	"The technological characteristics are the same as the predicate devices."
Functional & Safety Equivalence: Performs comparably in intended use, with no new safety concerns.	"Performance data has been generated in compliance with existing international standards and protocols and found equivalent to the predicate devices.""Based on the design equivalency and the functional and safety testing, Disetronic Medical Systems has determined that the PenFine® Injection Pen Needles are substantially equivalent to the devices currently marketed in the United States."
Indicated Use Equivalency: Intended for the same use as predicate devices.	"The Disetronic PenFine® Injection Pen Needles are intended for the hypodermic injection of fluids into the body when attached to an automatic injector pen." (Matches predicate indications)

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

The document does not specify a "test set" in the context of clinical performance data involving patient samples or diagnostic accuracy. The performance data mentioned refers to engineering and functional testing. There is no information on sample size or data provenance (country of origin, retrospective/prospective) for such a "test set."

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

This is not applicable. The submission is for a physical medical device (injection pen needle), not a diagnostic algorithm or AI system that requires expert-established ground truth on a test set of data.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

This is not applicable. There is no "test set" in the context of evaluating diagnostic performance or classifying data points for ground truth.

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. MRMC studies are used for evaluating diagnostic imaging systems or AI systems that assist human readers. This submission is for an injection pen needle.

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

This is not applicable. This device is an injection pen needle, which is a physical medical device, not an algorithm.

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

This is not applicable. For a physical device like an injection pen needle, "ground truth" would relate to its physical properties, sterility, and functional performance, verified through laboratory testing and engineering standards, not through methods like expert consensus on medical images or pathology results.

8. The sample size for the training set

This is not applicable. There is no "training set" for an injection pen needle. The device is manufactured based on design specifications and quality control.

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

This is not applicable. As there is no training set, there is no ground truth for it to be established.

Summary

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K982399

AUG 6 1998

8.0 SUMMARY OF SAFETY AND EFFECTIVENESS

"510(k) SUMMARY"

8.1 Trade/Proprietary Name: 31 Gauge Disetronic PenFine® injection Pen Needle

8.2 Common/Usual Name: Injection Pen Needle

8.3 Classification Name: Hypodermic Single Lumen Needle

. .

8.4 Comparison to Currently Marketed Devices

The 31 gauge Disetronic PenFine® Injection Pen Needles are substantially equivalent to the 29 and 30 gauge Disetronic PenFine® Injection Pen Needles (K973339) and the Becton Dickinson B-D Ultra-Fine II Injection Pen Needles (K970737).

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 automatic 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® Injection 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 shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is an abstract symbol resembling three stylized human profiles facing right, with flowing lines beneath them.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

AUG 6 1998

Mr. Patrik De Haes ·President and CEO Disetronic Medical Systems, Incorporated 5201 East River Road, Suite 312 Minneapolis, Minnesota 55421-1014

K982399 Re : Disetronic PenFine® Injection Pen Needle Trade Name: Requlatory Class: II Product Code: FMI Dated: July 2, 1998 July 10, 1998 Received:

Dear Mr. De Haes:

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 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). 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 Current Good Manufacturing Practice requirements, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic QS 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 Please note: concerning your device in the Federal Reqister. this response to your premarket notification submission does not affect any obligation you might have under sections 531

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Page 2 - Mr. De Haes

through 542 of the Act for devices under the Electronic emoduct Radiation Control provisions, or other Federal laws or requlations.

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 regulation (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 the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR 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/dsma/dsmamain.html".

Sincerely yours,

Olin S. L/or
Timothy A. Ulatowski

Timothy A. Ulatowski 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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INDICATIONS FOR USE

510(k) File Number:

,Device Name:

Disetronic PenFine® Injection Pen Needle

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.

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Patricia Cuccenti
(Division Sign-Off)

Division of Dental, Infection Control, and General Hospital Devices 510(k) Number _

Prescription Use V (Per 21 CFR 801.109)

Over-The-Counter Use _________________________________________________________________________________________________________________________________________________________

(Optional Format 1-2-96)

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).