(64 days)
Not Found
No
The device description and performance studies focus on mechanical and material properties, and there is no mention of AI, ML, or image processing. The device operates on the principles of common piston syringes.
No.
This device is an insulin pen needle, which is used for the administration of insulin; it does not directly provide therapy itself, but rather facilitates the delivery of a therapeutic substance.
No
The device, an insulin pen needle, is used for subcutaneous injection of insulin, which is a treatment delivery function, not a diagnostic one.
No
The device description clearly outlines physical components like a sterile cap, needle cap, needle hub, and blister paper, indicating it is a hardware device.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for "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 description details a needle and its components for injection. It does not describe any components or processes for analyzing biological samples.
- Lack of IVD Characteristics: IVD devices are used to examine specimens (like blood, urine, tissue) from the human body to provide information for diagnosis, monitoring, or screening. This device does not perform any such analysis.
This device is a medical device used for drug delivery, specifically insulin injection.
N/A
Intended Use / Indications for Use
These disposable sterilc insulin pen needles are intended for subcutaneous injection of insulin in the treatment of diabetes.
Product codes (comma separated list FDA assigned to the subject device)
FMI
Device Description
Feel Fine Insulin Pen Needle consists of a sterile cap, needle cap needle hub, which can be fixed with needle and blister paper. The sterile cap functions to maintain the sterility of the needle because sterile cap covers the needle hub and needle cap with blister paper sealed on the opening hole of sterile cap. The needle hub can be connected with pen. The necdle cap covers intended to provide physical protection to the needle tube. They are supplied with a sterile fluid path, (EO), nontoxic, and non pyrogenic, for single use only, disposable. The devices operate on the principles of common piston syringes.
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 (study type, sample size, AUC, MRMC, standalone performance, key results)
Bench tests were performed. Bench testing included biocompatibility, mechanical testing, sterility testing including EO residues. The tests demonstrated that the device is as safe, as effective, and performs in a substantially equivalent manner to the predicate device.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
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
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JUN - 4 2008
510(K) Summary for K080904 Feel Tech # 92-4 Haengjung-ri, Gwangdcok-myeon, Cheonan-si, Choong-nam Korea Tel. : 82-41-522-2446-8 Fax .: 82-41-522-2449 Contact person: Boo Sool Kim Date prepared: June 2, 2008
Trade Name: Feel Fine Insulin Pen Ncedle 1.
- Common Name: Pen needle 2.
- Classification Name: Syringe, piston, product code FMI, Regulation: 880.5570 3.
-
- Class of device: Class II.
- The legally marketed device to which we are claiming equivalence [807.92(a)(3)) : 5. B.Braun "one.clickTM needle", K033575.
- Description of device: Feel Fine Insulin Pen Needle consists of a sterile cap, needle cap 6. needle hub, which can be fixed with needle and blister paper. The sterile cap functions to maintain the sterility of the needle because sterile cap covers the needle hub and needle cap with blister paper sealed on the opening hole of sterile cap. The needle hub can be connected with pen. The necdle cap covers intended to provide physical protection to the needle tube. They are supplied with a sterile fluid path, (EO), nontoxic, and non pyrogenic, for single use only, disposable. The devices operate on the principles of common piston syringes.
- Intended use: These disposable sterilc insulin pen needles are intended for 7. subcutaneous injection of insulin in the treatment of diabetes.
- Technological characteristics: Feel Fine Insulin Pen Needles and the predicate devices 8. have identical technological characteristics and perform the same way as common piston syringes. These needles are EO sterilized.
- Performance: Bench tests were performed. Bench testing included biocompatibility, 9. mechanical testing, sterility testing including EO residues. 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 U.S. Department of Health & Human Services. The logo consists of a stylized eagle with its wings spread, and the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circle around the eagle. The eagle is black, and the text is also black.
Food and Drug Administration 9200 Corporate Bouievard Rockville MD 20850
JUN - 4 2008
Feel Tech C/O Mr. Daniel Kamm Principal Consultant Kamm & Associates P.O. Box 7007 Deerfield, Illinois 60015
Re: K080904
Trade/Device Name: Feel Fine Insulin Pen Needle Regulation Number: 21 CFR 880.5570 Regulation Name: Hypodermic Single Lumen Needle Regulatory Class: II Product Code: FMI Dated: March 28, 2008 Received: April 1, 2008
Dear Mr. Kamm:
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,
2
Page 2 - Mr. Kamm
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,
Clare
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): K080904
Feel Fine Insulin Pen Needle Device Name:
Indications For Use:
These disposable sterile insulin pen needles are intended for subcutaneous injection of insulin in the treatment of diabetes.
V Prescription Us (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)
Anthony O. Natan
(Division Sign-Off) Division of Anesthesiology, General Hospital Infection Control, Dental Devices
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510(k) Number: K4849994