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.

AI/ML Overview

The provided text describes a 510(k) premarket notification for a disposable hypodermic needle named FEELject NEEDLES, seeking substantial equivalence to a predicate device. The information focuses on the regulatory submission process and general device characteristics, not on a detailed study proving performance against specific acceptance criteria.

Therefore, many of the requested sections about a detailed study simply cannot be filled from the provided text.

Here's what can be extracted and what information is missing:

1. A table of acceptance criteria and the reported device performance

Acceptance Criteria	Reported Device Performance
Biocompatibility	Passed (device is non-toxic)
Sterility	Passed (sterilized by EtO gas)
General Performance (Fluid injection/aspiration)	Performs in a substantially equivalent manner to the predicate device
Pyrogenicity	Passed (device is non-pyrogenic)

Missing Information:

Specific quantitative limits or thresholds for "acceptance criteria" for biocompatibility, sterility, or pyrogenicity are not provided. The document only states that tests were performed and the device passed or met the requirements.
Detailed performance metrics or quantitative results for fluid injection/aspiration are not provided. The phrase "performs in a substantially equivalent manner" is used.

2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

Missing Information:

Sample size for the test set: Not mentioned.
Data provenance: Not mentioned.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

Not Applicable / Missing Information:

This type of expert-driven ground truth establishment is typically relevant for diagnostic or image-analysis devices. For a hypodermic needle, "ground truth" would be objective measurements and qualitative assessments from bench testing and manufacturing standards, not expert adjudication in the same sense.
No experts are mentioned as being involved in establishing ground truth for the performance tests.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

Not Applicable / Missing Information:

Adjudication methods like 2+1 or 3+1 are used for subjective interpretations, often in clinical trials or image reading studies. This is not relevant for the type of bench testing described for a hypodermic needle.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

Not Applicable / Missing Information:

An MRMC study is relevant for diagnostic devices that involve human interpretation, often assisted by AI. This device is a hypodermic needle, and no AI component or human interpretation study is mentioned.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

Not Applicable / Missing Information:

This refers to AI algorithm performance. The FEELject NEEDLES is a physical medical device, not an algorithm.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

Type of Ground Truth: For the performance described, the ground truth would be based on standardized test methods and specifications for medical devices, specifically hypodermic needles. This includes established physical, chemical, and biological test methods to assess properties like biocompatibility, sterility, pyrogenicity, and mechanical integrity (e.g., sharpness, flow rate, hub-needle bond strength). The document implies adherence to these standards to achieve substantial equivalence.

Missing Information:

Specific details of these standards or how individual ground truth values were established for each test are not provided.

8. The sample size for the training set

Not Applicable / Missing Information:

Training sets are for machine learning algorithms. This device is a physical hypodermic needle, not an AI model.

9. How the ground truth for the training set was established

Not Applicable / Missing Information:

As above, training sets are not applicable to this device.

Summary

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510(k) Summary 5.

See 510(k) Summary, below.

1. Trade Name: FEELject NEEDLES

JAN 1 4 2010

1. Common Name: Disposable Hypodermic Needle. Classification Name: Single Lumen Hypodermic Needle. Product Code: FMI Regulation: 880.5570 Class of device : ClassII.
1. The legally marketed device to which we are claiming equivalence: BD Hypoint Needle (K070440)
1. 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.

1. Intended Use: FEELject NEEDLES is intended for use with syringes and injection devices for general purpose fluid injection/aspiration.
1. 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
1. 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.

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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.

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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

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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

Page 1 of 1

510(k) Number: K092831

Regulation Number and Section

§ 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).