(106 days)
Not Found
No
The device description and performance studies focus on the physical characteristics, sterility, and mechanical performance of a disposable insulin pen needle, with no mention of software, algorithms, or AI/ML capabilities.
No.
The device is an insulin pen needle for subcutaneous drug delivery, not a therapeutic device itself. Its function is to administer a therapeutic substance, but it doesn't provide therapy on its own.
No
Explanation: The device is an insulin pen needle, which is used for the subcutaneous injection of insulin. It is explicitly described as a tool for administering treatment, not for diagnosing a condition.
No
The device description clearly outlines physical components (sterile cap, needle cap, needle hub, needle tube) and manufacturing processes (ETO sterilization), indicating it is a hardware medical device.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is "subcutaneous injection of insulin in the treatment of diabetes." This describes a device used to administer a substance into the body, not to perform a test on a sample taken from the body.
- Device Description: The description details a needle and its components for injection. There is no mention of reagents, samples (like blood, urine, etc.), or any process for analyzing a biological sample.
- IVD Definition: In Vitro Diagnostics are medical devices used to perform tests on samples taken from the human body to provide information for diagnosis, monitoring, or treatment. This device does not fit that definition.
This device is a medical device used for drug delivery, specifically insulin injection.
N/A
Intended Use / Indications for Use
For the subcutaneous injection of insulin in the treatment of diabetes.
The Top Fine® disposable sterile 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
Top Fine® insulin pen needle consists of a sterile cap, a needle cap, and a needle hub which holds the needle. Blister papers the cap. The sterile cap maintains sterility the 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 screwed onto the pen. The needle cap cover is intended to provide physical protection to the needle tube. The device is for single patient single time use. The pens come in three sizes, 29 gauge, 30 gauge, and 31 gauge. They are ETO sterilized, non toxic and nonpyrogenic.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
subcutaneous
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)
Both bench and clinical tests were performed. Bench testing included biocompatibility, mechanical testing, sterility testing including EO residues. Clinical testing was performed to determine adequacy of instructions for use, the range of patient population, performance characteristics, and reliability. The results were satisfactory and revealed no concerns over safety and effectiveness as compared to predicate devices. 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).
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K063466 Page 1 of 1
510(K) Summary MAR 0 2 2007 Daejin Tech Medical Manufacturing Co., Ltd. 536-70 Kumkwang-Ri KumKwang-Myun, Ansung-Si, Kyunggi-Do, Korea Contact person: Simon Bang, President Tel : 82-31-671-2161 Fax : 82-31-671-2162 Date prepared: November 13, 2006
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- Trade Name: Top Fine® Insulin Pen Common Name: Insulin syringe Classification Name: Syringe, piston, product code FMI, Regulation: 880.5570 Class of device: Class II.
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- Description of device: Top Fine® insulin pen needle consists of a sterile cap, a needle cap, and a needle hub which holds the needle. Blister papers the cap. The sterile cap maintains sterility the 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 screwed onto the pen. The needle cap cover is intended to provide physical protection to the needle tube. The device is for single patient single time use. The pens come in three sizes, 29 gauge, 30 gauge, and 31 gauge. They are ETO sterilized, non toxic and nonpyrogenic.
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- Intended use: For the subcutaneous injection of insulin in the treatment of diabetes.
- ನ. Technological characteristics: The Top Fine® Insulin Pen needles and the predicate devices have identical technological characteristics and perform the same way.
- Performance: Both bench and clinical tests were performed. Bench testing 6. included biocompatibility, mechanical testing, sterility testing including EO residues. Clinical testing was performed to determine adequacy of instructions for use, the range of patient population, performance characteristics, and reliability. The results were satisfactory and revealed no concerns over safety and effectiveness as compared to predicate devices. 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 U.S. Department of Health & Human Services. The logo is a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES . USA" arranged around the perimeter. Inside the circle is an abstract image of an eagle or bird-like figure, depicted with stylized lines.
MAR 0 2 2007
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Daejin Tech Medical Manufacturing Company Limited C/O Mr. Daniel Kamm. P.E. Regulatory Engineer Kamm & Associates P.O. Box 7007 Deerfield, Illinois 60015
Re: K063466
Trade/Device Name: Top Fine® Insulin Pen Regulation Number: 21 CFR 880.5570 Regulation Name: Hypodermic Single Lumen Needle Regulatory Class: II Product Code: FMI Dated: February 20, 2007 Received: February 23, 2007
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.
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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 (OS) 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 (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours,
Soulette y. Michael 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
3
Indications for Use
510(k) Number (if known):
Device Name: Top Fine® Insulin Pen
Indications For Use:
The Top Fine® disposable sterile insulin pen needles are intended for subcutaneous injection of insulin in the treatment of diabetes..
Prescription Use _X AND/OR (Part 21 CFR 801 Subpart D)
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)
Chr
Division of Anesthesiology, General Hospital
Infection Control, Dental Devices
SO(k) Number: K463441
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