ULTI GUARD HOME INSULIN SYRINGE CONTAINER

• K Number: K021983
• Device Name: ULTI GUARD HOME INSULIN SYRINGE CONTAINER
• Manufacturer: ULTI MED, INC.
• Date Cleared: 2002-09-16 ( 90 days)
• Product Code: MMK
• Regulation Number: 880.5570
• Type: Traditional
• Panel: General Hospital
• Reference & Predicate Devices: N/A
• Predicate For: K081449

Intended Use

The Ulti Guard Home Insulin Syringe Dispenser and Sharps Container by Ulti Med Inc. is intended to be used to transport, store and dispense insulin syringes in the home. After use the syringes are to be deposited into the container for safe storage and eventual disposal according to local regulations.

Device Description

The Ulti Guard Home syringe contains 100 UltiCare insulin syringes. Syringes can be selectively removed as needed, and used syringes conveniently deposited back into the top of the container for safe storage. Ulti Guard syringes and container are single use only.

AI/ML Overview

The provided 510(k) summary for the UltiGuard Home Insulin Syringe Dispenser and Sharps Container describes a device designed for the safe dispensing, storage, and disposal of insulin syringes in the home.

Here's an analysis of the acceptance criteria and the study as described in the document:

1. Table of Acceptance Criteria and Reported Device Performance

Performance Metric	Acceptance Criteria (Implied)	Reported Device Performance
Impact Resistance	Acceptable performance (to ensure integrity during use/disposal)	Tested with acceptable results
Puncture Resistance	Acceptable performance (to prevent sharps from protruding)	Tested with acceptable results
Leak Resistance	Acceptable performance (to contain any residual fluid)	Tested with acceptable results
Sharps Access	Acceptable (presumably to safely allow depositing sharps, but prevent accidental access)	Tested with acceptable results
Stability	Acceptable (to remain upright and secure during use)	Tested with acceptable results

2. Sample Size Used for the Test Set and Data Provenance

The document does not explicitly state the sample size used for each test (Impact Resistance, Puncture Resistance, etc.). It only mentions that the device "has been tested."

The data provenance is not specified. It is presumed to be from Ulti Med Inc.'s internal testing labs, but the country of origin is not mentioned, nor is it explicitly stated whether the tests were retrospective or prospective, though performance testing for a 510(k) is typically prospective.

3. Number of Experts Used to Establish Ground Truth and Qualifications

This information is not applicable to the type of device and study being described. For a physical medical device like a sharps container, "ground truth" is established by performance against pre-defined engineering and safety standards, not by expert interpretation of data.

4. Adjudication Method for the Test Set

This is not applicable. Adjudication methods like "2+1" or "3+1" are used in studies involving expert review of medical images or other clinical data where there might be inter-reader variability. For physical device performance testing, the results are typically objectively measured against established criteria.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was Done

No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done. This type of study is relevant for diagnostic devices (e.g., AI in radiology) where human readers interpret medical cases. The UltiGuard is a physical sharps container and dispenser, not a diagnostic device.

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

No, a standalone study was not done. This concept applies to AI algorithms. The UltiGuard is a physical device, and its performance is assessed directly, not through an algorithm.

7. The Type of Ground Truth Used

The "ground truth" for this device's performance is based on objective engineering and safety standards related to the physical properties of a sharps container. These standards dictate how a container must perform under specific conditions (e.g., what force it must withstand without puncturing, how much liquid it can contain without leaking). The document states that the device was tested for "Impact Resistance, Puncture Resistance, Leak Resistance Sharps Access and Stability," implying that these tests were conducted against established regulatory or industry benchmarks for such devices.

8. The Sample Size for the Training Set

This is not applicable. The UltiGuard is a physical medical device, not an AI model or algorithm that requires a training set.

9. How the Ground Truth for the Training Set was Established

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

Summary

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SEP 1 6 2002

510(k) Number: K021983 UltiGuard Home Insulin Syringe Dispenser and Sharps Container

510(k) Summary of Safety and Effectiveness

• 1. The submitter of this submission is: Ulti Med Inc. 287 E. Sixth Street St. Paul, MN 55101 Telephone [phone] Fax [phone]
     The contact person is: Charles W. Erickson e-mail: [e-mail]

On this 10th day of September, 2002.

• 2. The trade name of the package shall be "Ulti Guard Home Insulin Syringe Dispenser and Sharps Container".
• The Ulti Guard Home Insulin Syringe Dispenser and Sharps Container has the 3) comparable intended use as the pre marketed Becton Dickinson Home Sharps Container.
• 4. The Ulti Guard Home Insulin Syringe Dispenser and Sharps Container has been tested with acceptable results for Impact Resistance, Puncture Resistance, Leak Resistance Sharps Access and Stability.
• Ulti Guard Home syringe contains 100 UltiCare insulin syringes. Syringes can 5) be selectively removed as needed, and used syringes conveniently deposited back into the top of the container for safe storage. Ulti Guard syringes and container are single use only.
• The intended use is for the storage and disposal of insulin syringes. 6)
• The UltiGuard Home syringe container differs from the predicate device as the disposal 7) container is sold with the syringes. As syringes are removed and used, the container has the purpose of safely storing the used syringes. This promotes the convenient and safe disposal of used syringes in the home.

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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 is circular and contains the text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" around the perimeter. Inside the circle is an abstract symbol that resembles a stylized caduceus or a representation of human figures.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

SEP 1 6 2002

Mr. Charles Erickson President Ulti Med, Incorporated 287 East Sixth Street Saint Paul, Minnesota 55101

Re: K021983

Trade/Device Name: Ulti Guard Home Insulin Syringe Dispenser and Sharps Container Regulation Number: 880.5570 Regulation Name: Hypodermic Single Lumen Needle Regulatory Class: II Product Code: MMK Dated: August 28, 2002 Received: August 29, 2002

Dear Mr. Erickson:

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.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such 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.

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Page 2 - Mr. Erickson

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); 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.

This letter will allow you to begin marketing your device as described in your Section 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 21 CFR Part 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at [phone]. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number [phone] or [phone] or at its Internet address http://www.fda.qov/cdrh/dsma/dsmamain.html

Sincerely yours,

Suain Ranes

ヶ Timothy A. Ulatowski 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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510(k) Number: K021983 UltiGuard Home Insulin Syringe Dispenser and Sharps Container

Indication of Use Statement

The Ulti Guard Home Insulin Syringe Dispenser and Sharps Container by Ulti Med Inc. is a The Ulti Guard Home Insultif Syrings Disponse insulins viringes in the home. After use the intended to be used to transport, store and disponse thanks of to be and eventual disposal according to local regulations.

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use X (Pcr 21 CFR 801.109)

OR

Over-The-Counter Use

(Optional Format 1-2-96)

Riu li tai lin

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

510(k) Number. KC 3 19 8 3

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).