(121 days)
Not Found
No
The device description and performance studies focus on the physical characteristics and basic functionality of a needle, with no mention of AI or ML.
No
Explanation: The device is a needle intended for general purpose fluid injection/aspiration, which is a diagnostic or procedural tool, not a therapeutic treatment itself.
No
The intended use states "general purpose fluid injection/aspiration," which does not involve diagnosing a condition. It is a device for administering or withdrawing fluids, not for identifying the nature of a disease or condition.
No
The device description clearly states it consists of a metal tube, a hub, and a needle cap, which are physical 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 "for general purpose fluid injection/aspiration." This describes a device used for introducing or removing fluids from the body, which is a direct interaction with the patient, not the testing of samples in vitro (outside the body).
- Device Description: The description details a needle for injection/aspiration, consistent with the intended use and not with a device designed for testing biological samples.
- Lack of IVD Indicators: There is no mention of analyzing biological samples, detecting analytes, or any other activities typically associated with in vitro diagnostics.
Therefore, FEELject NEEDLES is a medical device for injection/aspiration, not an IVD.
N/A
Intended Use / Indications for Use
FEELject NEEDLES is intended for use with syringes and injection devices for general purpose fluid injection/aspiration.
Product codes
FMI
Device Description
FEELject NEEDLES is intended for use with syringes and injection devices for general purpose fluid injection/aspiration. The device consists of a metal tube that is sharpened at one end and at the other end joined to a female connector (hub) The needle cap covers intended to provide physical protection to the needle tube.
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
Bench tests were performed. Bench testing included biocompatibility, sterility testing. The tests demonstrated that the device is as safe , as effective and performs in a substantially equivalent manner to the predicate device.
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
510(k) Summary 5.
See 510(k) Summary, below.
1. Trade Name: FEELject NEEDLES
JAN 1 4 2010
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- Common Name: Disposable Hypodermic Needle. Classification Name: Single Lumen Hypodermic Needle. Product Code: FMI Regulation: 880.5570 Class of device : ClassII.
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- The legally marketed device to which we are claiming equivalence: BD Hypoint Needle (K070440)
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- Description of device:
FEELject NEEDLES is intended for use with syringes and injection devices for general purpose fluid injection/aspiration.
. The device consists of a metal tube that is sharpened at one end and at the other end joined to a female connector (hub)
The needle cap covers intended to provide physical protection to the needle tube.
-
- Intended Use: FEELject NEEDLES is intended for use with syringes and injection devices for general purpose fluid injection/aspiration.
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- Technological Characteristics: FEELject NEEDLES and the predicate device have identical technological characteristics and perform the same way as common hypodermic Needle. FEELject NEEDLES are offered in various gauge sizes and needle lengths They are sterilized by EtO gas FEEL ject NEEDLES are Non-toxic, Non-Pyrogenic disposable and intended for single use
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- Performance: Bench tests were performed.
Bench testing included biocompatibility, sterility testing.
The tests demonstrated that the device is as safe , as effective and performs in a substantially equivalent manner to the predicate device.
1
Image /page/1/Picture/1 description: The image shows the logo for the Department of Health & Human Services (HHS). The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" around the perimeter. Inside the circle is a stylized image of an eagle, which is a common symbol of the United States. The eagle is depicted with its wings spread, and its body is formed by three curved lines.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room W-066-0609 Silver Spring, MD 20993-0002
Feel Tech Corporation C/O Mr. Peter Chun President 300 Atwood Pittsburgh, Pennsylvania 15213
JAN 1 4 2010
Re: K092831
Trade/Device Name: FEELject NEEDLES Regulation Number: 21CFR 880.5570 Regulation Name: Hypodermic Single Lumen Needle Regulatory Class: II Product Code: FMI Dated: August 18, 2009 Received: September 14, 2009
Dear Mr. Chun:
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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to 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.
2
Page 2- Mr. Chun
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); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); 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.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to
http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to
http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
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) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.
Sincerely yours.
Cathorn Q. water
nthony D. Watson, BS, MS, MBA 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): K09 .
Device Name: FEELject NEEDLES
Indications For Use: FEEL ject NEEDLES is intended for use with syringes and injection devices for general purpose fluid injection/aspiration.
Prescription Use X (Part 21 CFR 801 Subpart D) AND/OR
Over-The-Counter Use (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)
Clawki
(Division Sign-Off) Division of Anesthesiology, General Hospital Infection Control, Dental Devices
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510(k) Number: K092831