(11 days)
Not Found
No
The device description and intended use are purely mechanical for dispensing and storing pen needles, with no mention of any computational or learning capabilities.
No
The device is a dispenser and sharps container for insulin pen needles, not a device that provides therapy.
No
The device is a dispenser and sharps container for insulin pen needles, facilitating their transport, storage, dispensing, and safe disposal. It does not perform any diagnostic functions.
No
The device description clearly indicates a physical container designed to store and dispense insulin pen needles and act as a sharps container, which are hardware components.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is to transport, store, dispense, and safely dispose of insulin pen needles. This is a physical device for handling medical supplies, not for performing diagnostic tests on biological samples.
- Device Description: The description focuses on the physical container and its function in managing pen needles. There is no mention of analyzing biological samples or providing diagnostic information.
- Lack of IVD Characteristics: The document does not mention any of the typical characteristics of an IVD, such as:
- Analyzing biological samples (blood, urine, etc.)
- Detecting or measuring substances in biological samples
- Providing information for diagnosis, monitoring, or screening of diseases or conditions.
The device is a medical device, specifically a sharps container and dispenser, but it falls under a different regulatory category than IVDs.
N/A
Intended Use / Indications for Use
The UltiGuard Home Insulin Pen Needle Dispenser and Sharps Container by Ulti Med Inc. is intended to be used to transport, store and dispense insulin pen needles in the home. After use the used pen needle can be placed back into the container for safe storage and eventual disposal according to local regulations.
Product codes
MMK
Device Description
The UltiGuard Home Insulin Pen Needle Dispenser and Sharps Container contains 100 insulin pen needles. Pen needles can be removed from the dispenser as needed, and used pen needles can be removed and deposited back into the top of the container for safe storage. When all 100 pen needles have been used and discarded into the container, the container is disposed according to local regulations. The disposable pen needles and UltiGuard container are intended for single use only.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
home
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
The UltiGuard Home Insulin Pen Needle Dispenser and Sharps Container is substantially equivalent to the predicate device based on the descriptive data, compliance with standards, and indications for use.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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).
0
UltiGuard™ Home Insulin Pen Needle Dispenser and Sharps Container Traditional 510(k)
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
May 19, 2008
Date Prepared
JUN - 3 2008
Name of Device
| Common Name: | Sharps Container |
|---|---|
| Proprietary Name: | UltiGuard™ Home Insulin Pen Needle Dispenser and Sharps Container |
| Classification Name: | Hypodermic single lumen needles |
| Regulation: | 880.5570 |
| Class: | Class II |
| Product Code: | MMK |
Predicate Devices
The UltiGuard Home Insulin Pen Needle Dispenser and Sharps Container is substantially equivalent in intended use, function and basic composition to the currently marketed UltiGuard Home Insulin Syringe Dispenser and Sharps Container, K021983.
Device Description
The UltiGuard Home Insulin Pen Needle Dispenser and Sharps Container contains 100 insulin pen needles. Pen needles can be removed from the dispenser as needed, and used pen needles can be removed and deposited back into the top of the container for safe storage. When all 100 pen needles have been used and discarded into the container, the container is disposed according to local regulations. The disposable pen needles and UltiGuard container are intended for single use only.
Intended Use
The UltiGuard Home Insulin Pen Needle Dispenser and Sharps Container by Ulti Med Inc. is intended to be used to transport, store and dispense insulin pen needles in the home. After use the used pen needle can be placed back into the container for safe storage and eventual disposal according to local regulations.
Technological Characteristics
The UltiGuard Home Insulin Pen Needle Dispenser and Sharps Container has similar technological characteristics to the currently marketed predicate device listed above. The UltiGuard Home Insulin Pen Needle Dispenser and Sharps Container meets the following standards:
BS 7320 (1990), Specifications for Sharps Containers
ASTM F2132 (2001), Puncture Resistance of Materials Used in Containers for Discarded Medical Needles
1
UltiGuard™ Home Insulin Pen Needle Dispenser and Sharps Container Traditional 510(k)
Performance Data (non-clinical or clinical)
The UltiGuard Home Insulin Pen Needle Dispenser and Sharps Container is substantially equivalent to the predicate device based on the descriptive data, compliance with standards, and indications for use.
Conclusion
The technological characteristics and performance data for the UltiGuard Home Insulin Pen Needle Dispenser and Sharps Container demonstrate it is substantially equivalent to the predicate device.
2
Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features the department's name in a circular arrangement around a stylized eagle emblem. The eagle is depicted with flowing lines, suggesting movement and freedom. The text is in uppercase letters and is arranged to follow the curve of the circle.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
JUN - 3 2008
Ulti Med Incorporated C/O Mr. Mark Job Responsible Third Party Official Regulatory Technology Services, LLC 1394 25th Street NW Buffalo, Minnesota 55313
Re: K081449
Trade/Device Name: UltiGuard™ Home Insulin Pen Needle Dispenser and Sharps Container Regulation Number: 21 CFR 880.5570 Regulation Name: Hypodermic Single Lumen Needle Regulatory Class: II Product Code: MMK Dated: March 27, 2008 Received: May 23, 2008
Dear Mr. Job:
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.
3
Page 2 - Mr. Job
Please be advised that FDA's issuance of a substantial equivalence determination does not mcan 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); 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), please contact 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 Division 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,
Chiu-Ling, Ph.D.
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
4
UltiGuard™ Home Insulin Pen Needle Dispenser and Sharps Container Traditional 510(k)
Indications for Use
510(k) Number: Not assigned
Device Name: UltiGuard™ Home Insulin Pen Needle Dispenser and Sharps Container
Indications For Use:
The UltiGuard Home Insulin Pen Needle Dispenser and Sharps Container by Ulti Med Inc. is intended to be used to transport, store and dispense insulin pen needles in the home. After use the used pen needle can be placed back into the container for safe storage and eventual disposal according to local regulations.
Prescription Use (21 CFR 801.Subpart D) AND/OR
Over-The-Counter Use X (21 CFR 807 Subpart C)
PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED) Concurrence of CDRH, Office of Device Evaluation (ODE)
Shule A. Murphy
(Division Sign-Off)
Division of Anesthesiology, General Hospital Infection Control, Dental Devices
510(k) Number: K081449