The UltiCare disposable pen needles are used with insulin pen injector devices for the subcutaneous injection of insulin in the treatment of diabetes.

Device Description

The UltiCare Disposable Pen Needles are sterile, single-use, type A, hypodermic single lumen needles designed for use with insulin pen injector devices. The UltiCare Disposable Pen Needles consist of a double-ended cannula, a needle hub, a needle shield and the needle primary container. The UltiCare Disposable Pen Needles are non-toxic and nonpyrogenic, and are available in a variety of needle sizes (29 gauge to 31 gauge) and lengths (3/16" to 1/2").

AI/ML Overview

The provided text is related to a 510(k) submission for UltiCare Disposable Pen Needles and discusses substantial equivalence, not detailed acceptance criteria or a study proving device performance in the way typically required for AI/ML-based diagnostic devices.

The document states that the UltiCare Disposable Pen Needles are "substantially equivalent in intended use, function and basic composition" to predicate devices, and that they "meet the following standards: ISO 11608-2, ISO 9626, ISO 7864." These ISO standards themselves contain specific requirements and test methods that, if met, serve as the de facto acceptance criteria and the "study" demonstrating their fulfillment.

However, the 510(k) summary does not provide the detailed results of these tests, sample sizes, ground truth establishment, or expert involvement as would be required for a performance study of a device that requires image analysis or complex expert interpretation. This is because pen needles are physical medical devices with established performance characteristics defined by international standards for manufacturing and materials, rather than devices that use algorithms to process and interpret data.

Therefore, for your current request format, much of the information you've asked for is not applicable or not explicitly detailed in this type of regulatory submission for this specific physical device.

Here's an attempt to answer your questions based on the provided text, while acknowledging its limitations for an AI/ML context:

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria are implicitly the requirements outlined in the specified ISO standards. The "reported device performance" is the statement that the device "meets" these standards, indicating compliance.

Acceptance Criteria (Implicit)	Reported Device Performance
ISO 11608-2: Pen-injectors for Medical Use - Part 2: Needles - Requirements and Test Methods	The UltiCare Disposable Pen Needles meet this standard.
ISO 9626: Stainless Steel Needle Tubing for Manufacture of Medical Devices	The UltiCare Disposable Pen Needles meet this standard.
ISO 7864: Sterile Hypodermic Needles for Single Use	The UltiCare Disposable Pen Needles meet this standard.

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

Sample Size: Not specified in the provided document. The sample sizes would be determined by the testing protocols within the ISO standards, but the specific numbers for this submission are not given.
Data Provenance: Not applicable in the context of clinical data for AI. For physical device testing against ISO standards, the tests are typically performed in a laboratory setting by the manufacturer or a certified testing facility to evaluate manufacturing quality and material properties. The country of origin of the data would be the location of the manufacturing or testing facility.

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

This is not applicable for this type of device and regulatory submission. "Ground truth" in the context of expert consensus is relevant for diagnostic devices interpreting complex data (e.g., medical images, pathology slides). For pen needles, the "ground truth" is established by direct physical measurements, material science tests, and sterility tests performed according to the ISO standards. There isn't a need for expert consensus on an interpretation.

4. Adjudication method for the test set

This is not applicable as there is no expert interpretation or consensus-based ground truth being established. The "adjudication" is whether the device's physical and material properties meet the objective, quantifiable requirements of the ISO standards.

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

No, this was not done. This type of study is completely irrelevant for a physical medical device like a pen needle. MRMC studies are designed for diagnostic support systems, particularly those involving human interpretation of complex data with or without AI assistance.

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

No, this was not done. Again, this concept applies to AI/ML algorithms, not to a physical medical device like a pen needle.

7. The type of ground truth used

The "ground truth" for pen needles is based on objective, quantifiable physical and material properties, and sterility parameters as defined by the referenced ISO standards (e.g., needle gauge, length, material composition, penetration force, cannula integrity, sterility). It is not pathology, outcomes data, or expert consensus in the diagnostic sense.

8. The sample size for the training set

Not applicable. This device does not involve an AI/ML algorithm that requires a "training set."

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

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

Summary

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K050464

Confidential

Date Prepared

21 February 2004

MAY 1 1 2005

510(k) Summary

Submitter

Ulti Med Inc. 287 East Sixth Street St. Paul, Minnesota Contact Person: Thomas E. Erickson

Telephone: (651) 291-7909 Fax: (651) 291-7074

Name of Device

Common Name:	Pen Needles
Proprietary Name:	UltiCare™ Disposable Pen Needles (sizes varying between 31 Gauge x 3/16" and 29 Gauge x 1/2")
Classification Name:	Hypodermic single lumen needles
Regulation:	880.5570
Class:	Class II
Product Code:	FMI

Predicate Devices

The UltiCare Disposable Pen Needles are substantially equivalent in intended use, function and basic composition to the currently marketed Becton Dickinson B-D Ultra-Fine III Pen Needle; Model 31 gauge x 3/16", K002938, and to the Becton Dickinson B-D Ultra-Fine Original Pen Needle (29 gauge x 1/2"), K031200.

Device Description

Intended Use

The UltiCare disposable pen needles are used with insulin pen injector devices for the subcutaneous injection of insulin in the treatment of diabetes.

Technological Characteristics

The UltiCare Disposable Pen Needles have similar technological characteristics to the currently marketed predicate devices listed above. The UltiCare Disposable Pen Needles meet the following standards:

ISO 11608-2, Pen-injectors for Medical Use - Part 2: Needles - Requirements and Test Methods

ISO 9626, Stainless Steel Needle Tubing for Manufacture of Medical Devices ISO 7864, Sterile Hypodermic Needles for Single Use

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Image /page/1/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a stylized caduceus symbol, which features a staff with a snake winding around it, and the text "DEPARTMENT OF HEALTH AND HUMAN SERVICES . USA" arranged in a circular pattern around the symbol. The text is in all caps and is smaller than the caduceus symbol.

Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

MAY 1 1 2005

Ulti Med, Incorporated C/O Ms. Carole Stamp Principal Regulatory and Quality Advisor Regulatory and Clinical Research Institute, Incorporated 5353 Wayzata Boulevard, Suite 505 Minneapolis, Minnesota 55416-1334

Re: K050464

Trade/Device Name: UltiCare Disposable Pen Needles Regulation Number: 880.5570 Regulation Name: Hypodermic Single Lumen Needle Regulatory Class: II Product Code: FMI Dated: February 21, 2005 Received: February 25, 2005

Dear Ms. Stamp:

We have reviewed your Section 510(k) premarket notification of intent to market the device we nave roviewed your 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 mersule comments, or to devices that have been reclassified in accordance with the provisions of Amendinens, or to act , sod Cosmetic Act (Act) that do not require approval of a premarket the rederal I vou, Drag, and Osou may, therefore, market the device, subject to the general approvisions of the Act. The general controls provisions of the Act include controls providents or a 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 II your device is classified (best additional controls. Existing major regulations affecting (1 MA), it may of subject to tack adata f Federal Regulations, Title 21, Parts 800 to 898. In your device can be found in the evas nouncements concerning your device in the Federal Register.

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Page 2 - Ms. Stamp

Please be advised that FDA's issuance of a substantial equivalence determination does not I lease to advisod that 12 a determination that your device complies with other requirements mean that I DA nas made statutes and regulations administered by other Federal agencies. of the Fler of ally I ouchar backs requirements, including, but not limited to: registration I ou intest compry with a 807); labeling (21 CFR Part 801); good manufacturing practice allu listing (21 CF Rev or )) - systems (QS) regulation (21 CFR Part 820); and if requirements as set form in are quadiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

This letter will allow you to begin marketing your device as described in your Section 510(k) rms fet 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), If you don't the Office of Compliance at (240) 276-0115. Also, please note the regulation entitled "Misbranding by reference to premarket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the may obtain of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely yours,

Sautte y. Mchian O.M.S.

Chiu Lin, Ph.D. 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):

K 050464

Device Name: UltiCare™ Disposable Pen Needles

Indications for Use:

The UltiCare disposable pen needles are used with insulin pen injector devices for the subcutaneous injection of insulin in the treatment of diabetes.

ﭘﮭ

Prescription Use V (21 CFR 801 Subpart C) (Part 21 CFR 801 Subpart D)

AND/OR Over-The-Counter Use

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Ats on

Traditional 510(k) Ulti Med Inc.

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

240(K) Mumber: ---------------------------------------------------------------------------------------------------------------------------------------------------------------

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).