(182 days)
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Not Found
No
The 510(k) summary describes a simple mechanical pen needle for insulin injection and contains no mention of AI, ML, or related concepts like image processing or performance studies typically associated with AI/ML devices.
No.
The device is a pen needle for insulin injection, which is a drug delivery device and not a therapeutic device itself.
No
The device is described as a pen needle for the subcutaneous injection of insulin, indicating a therapeutic or drug delivery purpose, not one that diagnoses conditions.
No
The device description clearly states "Stat Medical Pen Needle," which is a physical, single-use hardware device intended for injection. It is not software.
Based on the provided information, the Stat Medical Pen Needle 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: It's a "Pen Needle," which is a physical device used for injection.
- Lack of IVD Characteristics: The description does not mention any of the typical characteristics of an IVD, such as:
- Testing of biological samples (blood, urine, tissue, etc.)
- Detection or measurement of substances in samples
- Diagnosis, monitoring, or screening of diseases based on sample analysis
IVDs are devices used to examine specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes. The Stat Medical Pen Needle is a delivery device, not a diagnostic one.
N/A
Intended Use / Indications for Use
The Stat Medical Pen Needle is a single use device intended for use with a pen injector device for the subcutaneous injection of insulin.
Product codes
FMI
Device Description
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Mentions image processing
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Mentions AI, DNN, or ML
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Input Imaging Modality
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Anatomical Site
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Indicated Patient Age Range
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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
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Key Metrics
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Predicate Device(s)
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Reference Device(s)
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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
Image /page/0/Picture/1 description: The image is a black and white seal for the Department of Health & Human Services - USA. The seal is circular with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. In the center of the seal is a stylized image of a bird.
APR 2 2 2005
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Emergo Group, Incorporated C/O Mr. Paul Brooks Responsible Third Party Official BSI, Incorporated 12110 Sunset Hills Road, Suite 200 Reston, Virginia 20190
Re: K042917
Trade/Device Name: Stat Medical Pen Needle Regulation Number: 21 CFR 880.5570 Regulation Name: Hypodermic Single Lumen Needle Regulatory Class: II Product Code: FMI Dated: April 7, 2005 Received: April 8, 2005
Dear Mr. Brooks:
We have reviewed your Section 510(k) premarket notification of intent to market the device we nave reviewed your becalent be oces) the device is substantially equivalent (for the referenced above and nave determined to legally marketed predicate devices marketed in indications for use stated in the encreases in the enactment date of the Medical Device interstate comments, or to thay 20, 1978, as secured in accordance with the provisions of Amendinents, of to devrees mat news Act (Act) that do not require approval of a premarket the Federal Food, Drug, and Cosmetic Pool , Love, Lore, subject to the general approval application (1 Mr.). I The general controls provisions of the Act include controls provisions of the rec. "The genting of devices, good manufacturing practice, requirements for and prohibitions against misbranding and adulteration.
If your device is classified (see above) into either class II (Special Controls) or class III If your device is classified (see above) into crontrols. Existing major regulations affecting (PMA), it may oe subject to suer additions, Title 21, Parts 800 to 898. In the Colors your device can be found in the South no announcements concerning your device in the Federal Register.
1
Page 2 - Mr. Brooks
Please be advised that FDA's issuance of a substantial equivalence determination does not Please be advisod that I DA b issuance on that your device complies with other requirements mean that ITDA nas made a decommanent and regulations administered by other Federal agencies. of the Act of ally rederal statutes and regarments, including, but not limited to: registration You must comply with an all also hot s rog 21 CFR Part 801); good manufacturing practice and listing (21 CFR Pat 607), laceling (QS) regulation (21 CFR Pat 820); and if requirents as set forth in the quality by start of Steans (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) This letter will anow you to began manisting of substantial equivalence of your device to a premiarket notification. This Printers 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 desire specific at 150 for your we 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 illay obtain other general micromational and Consumer Assistance at its toll-free Dribber (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours,
Jenite y. M. Mchane O md.
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
2
510(k) Number (if known): ____________________________________________________________________________________________________________________________________________________
Device Name: Stat Medical Pen Needle
Indications for Use:
The Stat Medical Pen Needle is a single use device intended for use with a pen injector device for the subcutaneous injection of insulin.
ﺒ
X Prescription Use only
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
(Optional Format 3-10-98)
(Posted July 1, 1998)
Chir Vm
vision Sign-Off , General Hospital, vision of Anesthesiology Intection Control, Den
510(k) Number: