(6 days)
Not Found
No
The summary describes a simple mechanical device (insulin pen needles) and contains no mention of AI, ML, or any related concepts.
No.
The device is an insulin injection pen needle, which is used to deliver insulin, but it does not treat or cure a disease itself. It is an accessory to a therapeutic process.
No
Explanation: The device is described as an "Insulin Injection Pen Needle" intended for "hypodermic injection of insulin," which is a treatment delivery function, not a diagnostic one.
No
The device described is a physical medical device (insulin injection pen needles) and does not involve any software component.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for the "hypodermic injection of insulin into the body". This is a direct interaction with the patient's body for therapeutic purposes (delivering medication).
- IVD Definition: In vitro diagnostics are devices used to examine specimens (like blood, urine, or tissue) taken from the body to provide information about a person's health. They are used outside the body (in vitro).
- Device Description: The description confirms it's a needle for injection, not a device for analyzing biological samples.
The information provided clearly indicates this is a medical device for drug delivery, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
The Disetronic Penfine® Insulin Injection Pen Needles are intended for the hypodermic injection of insulin into the body when attached to an injector pen.
Product codes
FMI
Device Description
The Disetronic Penfine® Insulin Injection Pen Needles are the same sterile, nonpyrogenic, single use needles designed to be used with commercially available Injection Pens as the 6, 8, 10 and 12 mm Disetronic Penfine® Injection Pen Needles.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
body
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
Performance data has been generated in compliance with existing international standards and protocols and found equivalent to the predicate devices.
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).
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Image /page/0/Picture/0 description: The image shows the text 'K013782' in a handwritten style. The text appears to be a code or identifier, with the letter 'K' followed by a series of numerical digits. The handwriting is clear and legible, with a slight slant to the right.
Penfine® Insulin Injection Pen Needle (6, 8, 10, 12 mm) 510(k) for OTC Use
SUMMARY OF SAFETY AND EFFECTIVENESS 9.0
NOV 2 0 2001
"510(k) SUMMARY"
| Trade/Proprietary Name: | Disetronic Penfine® Insulin Injection Pen
Needle |
|-------------------------|-----------------------------------------------------|
| Common/Usual Name: | Insulin Injection Pen Needle |
| Classification Name: | Hypodermic Single Lumen Needle |
Comparison to Currently Marketed Devices
The Disetronic Penfine® Insulin Injection Pen Needles are substantially equivalent to the current Disetronic Penfine® Injection Pen Needles (K982399, K994197, K992399).
Device Description
The Disetronic Penfine® Insulin Injection Pen Needles are the same sterile, nonpyrogenic, single use needles designed to be used with commercially available Injection Pens as the 6, 8, 10 and 12 mm Disetronic Penfine® Injection Pen Needles.
Indications for Use
The Disetronic Penfine® Insulin Injection Pen Needles are intended for the hyoodermic injection of insulin into the body when attached to an injector pen.
Technological Characteristics
The technological characteristics are the same as the predicate devices.
Performance Data
Performance data has been generated in compliance with existing international standards and protocols and found equivalent to the predicate devices.
Conclusion
Based on the design equivalency and the functional and safety testing, Disetronic Medical Systems has determined that the Penfine® Insulin Injection Pen Needles are substantially equivalent to the devices currently marketed in the United States.
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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 circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an abstract image of an eagle or bird-like figure with three stylized wing segments.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
NOV 2 0 2001
Mr. David E. Chadwick Director, Regulatory Affairs/Quality Assurance Disetronic Medical Systems 5151 Program Avenue Saint Paul. Minnesota 55112-1014
Re: K013782
Trade/Device Name: Disetronic Penfine Insulin Injection Pen Needle Regulation Number: 880.5570 Regulation Name: Insulin Injection Pen Needle Regulatory Class: II Product Code: FMI Dated: November 12, 2001 Received: November 14, 2001
Dear Mr. Chadwick:
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.
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
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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 and additionally 21 CFR Part 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4618. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). Other general information on your responsibilities under the Act may be obtained 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/dsma/dsmamain.html
Sincerely yours,
Kj Wlatust
Timoth A. Ulatows Director Division of Dental, Infection Control and General Hospital Devices Office of Device Evaluation Center for Devices and Radiological Health
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Penfine® Insulin Injection Pen Needle (6, 8, 10, 12 mm) 510(k) for OTC Use
NOV 2 0 2001
INDICATIONS FOR USE STATEMENT
510(k) File Number:
Device Name:
Insulin Injection Pen Disetronic Penfine® Needle
Indications For Use:
The Disetronic Penfine® Insulin Injection Pen Needles are intended for the hypodermic injection of insulin into the body when attached to an injector pen.
PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED
| Concurrence of CDRH, Office of Device Evaluation (ODE) | |
|---|---|
| 'Division Sign-Off | |
| Division of Dental, Infection Control, and General Hospital Devices | |
| Number | K013782 |
Prescription Use (Per 21 CFR 801.109)
Over-The-Counter Use_ OR