(77 days)
Not Found
No
The summary describes a simple mechanical device (pen needles) and explicitly states that AI, DNN, or ML were not found in the description.
No.
The needles are accessories for insulin injection which is a therapeutic treatment, but the needles themselves are delivery mechanisms, not therapeutic devices.
No
The device is a needle used for insulin injection, which is a treatment delivery method, not a diagnostic tool.
No
The device description clearly states it is a physical, sterile, single-use hypodermic needle, which is a hardware component.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for the subcutaneous injection of insulin. This is a direct administration of a substance into the body, not a test performed on a sample taken from the body.
- Device Description: The device is a needle designed for injection. IVD devices are typically used for analyzing samples like blood, urine, or tissue.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples, detecting analytes, or providing diagnostic information based on in vitro testing.
IVD devices are used to examine specimens derived from the human body to provide information for diagnostic, monitoring, or screening purposes. This device is a delivery mechanism for a therapeutic substance.
N/A
Intended Use / 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.
Product codes
FMI
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").
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
Not Found
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
Not Found
Key Metrics
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
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
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").
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
1
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.
2
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
3
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: ---------------------------------------------------------------------------------------------------------------------------------------------------------------