(68 days)
Not Found
Not Found
No
The summary describes a standard hypodermic needle and contains no mention of AI, ML, image processing, or any related concepts.
No
The device is a needle intended for fluid injection and removal, not for treating a disease or condition.
No
Explanation: The device is described as a sterile hypodermic needle intended for the injection and removal of fluids, which are therapeutic or procedural functions, not diagnostic. There is no mention of using the device to identify or analyze a medical condition.
No
The device is described as a sterile hypodermic single lumen needle, which is a physical hardware component, not software.
Based on the provided information, the DepotOne device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states that the device is a needle for the injection and removal of fluids from below the surface of the skin in humans. This describes a direct interaction with the human body for therapeutic or diagnostic purposes in vivo (within the living organism).
- IVD Definition: In vitro diagnostics (IVDs) are medical devices used to perform tests on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections. These tests are performed outside the body (in vitro).
The DepotOne device's function is to facilitate the delivery or removal of substances directly into or from the body, which is not the purpose of an IVD.
N/A
Intended Use / Indications for Use
DepotOne is a sterile hypodermic single lumen needle intended for the injection and removal of fluids from below the surface of the skin in humans. The needle is intended to interface with the male luer connector of a syringe or intravascular administration set. The needle is intended for single use only.
Product codes
FMI
Device Description
Not Found
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
below the surface of the skin in humans
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 (study type, sample size, AUC, MRMC, standalone performance, key results)
Not Found
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Not Found
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
Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a stylized eagle with three stripes forming its body and wing. The eagle is positioned to the right of a circular seal that contains the text "DEPARTMENT OF HEALTH AND HUMAN SERVICES - USA" around the perimeter.
JUN 2 1 2006
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Mr. Mervyn Little Device Development Director Imprint Pharmaceuticals, Limited 53 Langton Road East Molesey, Surrey KT8 2HX United Kingdom
Re: K061032
Trade/Device Name: DepotOne™ Regulation Number: 880.5570 Regulation Name: Hypodermic Single Lumen Needle Regulatory Class: II Product Code: FMI Dated: May 31, 2006 Received: June 1, 2006
Dear Mr. Little:
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.
1
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. 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.
Syndie Y. Mickens DMD
Shirlie Y. Mickens, 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
2
LOCLOS2
102
Indication for Use
510(k) Number
Device Name:
DepotOne™
Intended Use
DepotOne is a sterile hypodermic single lumen needle intended for the injection and removal of fluids from below the surface of the skin in humans. The needle is intended to interface with the male luer connector of a syringe or intravascular administration set. The needle is intended for single use only.
Prescription Use X (Per 21 CFR 801.Subpart D)
AND/OR
Over-The-Counter Use (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
R.C. Chapman for Aon 6/20/2006
of Anaesthesiology, General Hospital.
ion Control, Dental Devices
Number: K061032