(16 days)
Not Found
No
The device description and intended use are for a simple mechanical injection pen needle, with no mention of AI/ML or related concepts.
No
The device is described as an injection pen needle, which is used for the delivery of fluids, not for the treatment or diagnosis of a disease itself. It facilitates the action of a therapeutic substance, but is not therapeutic on its own.
No
Explanation: The device is described as injection pen needles for hypodermic injection of fluids, which is a therapeutic function, not a diagnostic one.
No
The device description clearly states it is a physical needle intended for hypodermic injection, which is a hardware component.
Based on the provided text, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for the "hypodermic injection of fluids into the body". This describes a device used for administering substances into the body, not for examining samples from the body to diagnose conditions.
- Device Description: The description focuses on the physical characteristics of a needle designed for injection pens. There is no mention of analyzing biological samples or performing diagnostic tests.
- Lack of IVD Characteristics: The text does not mention any of the typical characteristics of an IVD, such as:
- Analyzing blood, urine, tissue, or other biological samples.
- Detecting or measuring specific substances (analytes) in samples.
- Providing information for diagnosis, monitoring, or screening of diseases.
Therefore, the Disetronic Penfine® Injection Pen Needles are a medical device used for drug delivery, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
The Disetronic Penfine® Injection Pen Needles are intended for the hypodermic injection of fluids into the body when attached to an injector pen.
Product codes
FMI
Device Description
The 6 mm Disetronic Penfine® Injection Pen Needles are the same sterile, non-pyrogenic, single use needles designed to be used with commercially available Injection Pens as the 8, 10 and 12 mm Disetronic Penfine® Injection Pen Needles. The only difference is in the length of the cannula.
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
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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).
0
1994197
"510(k) SUMMARY"
Disetronic Penfine® Injection Pen Needle 8.1 Trade/Proprietary Name:
Iniection Pen Needle 8.2 Common/Usual Name:
8.3 Classification Name: Hypodermic Single Lumen Needle --
8.4 Comparison to Currently Marketed Devices
The 6 mm Disetronic Penfine® Injection Pen Needles are substantially equivalent to the 8, 10 and 12 mm Disetronic Penfine® Injection Pen Needles (K982399).
8.5 Device Description
The 6 mm Disetronic Penfine® Injection Pen Needles are the same sterile, non-pyrogenic, single use needles designed to be used with commercially available Injection Pens as the 8, 10 and 12 mm Disetronic Penfine® Injection Pen Needles. The only difference is in the length of the cannula.
8.6 Indications for Use
The Disetronic Penfine® Injection Pen Needles are intended for the hypodermic injection of fluids -into the body when attached to an injector pen.
8.7 Technological Characteristics
The technological characteristics are the same as the predicate devices.
8.8 Performance Data
Performance data has been generated in compliance with existing international standards and protocols and found equivalent to the predicate devices.
8.9 Conclusion
Based on the design equivalency and the functional and safety testing, Disetronic Medical Systems has determined that the Penfine® Iniection Pen Needles are substantially equivalent to the devices currently marketed in the United States.
1
Image /page/1/Picture/1 description: The image is a black and white seal for the Department of Health & Human Services - USA. The seal is circular and contains the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. In the center of the seal is an abstract image of an eagle.
Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
DEC 2 9 1999
Mr. David E. Chadwick, Ph.D. Director, Regulatory Affairs Disetronic Medical Systems, Inc. 5151 Program Avenue St. Paul, Minnesota 55112-1014
Re : K994197
Trade Name: Disetronic Penfine® Injection Pen Needle Regulatory Class: II Product Code: FMI Dated: December 7, 1999 December 13, 1999 Received:
Dear Mr. Chadwick:
We have reviewed your Section 510 (k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to 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). 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 (Premarket Approval), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Requlations, Title 21, Parts 800 to 895. ਉ substantially equivalent determination assumes compliance with the Good Manufacturing Practice for Medical Devices: General (GMP) regulation (21 CFR Part 820) and that, through periodic GMP inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any
2
Page 2 - Mr. Chadwick
obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.
This letter will allow you to begin marketing your device as described in your 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 requlation (21 CFR Part 801 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4692. Additionally, for questions on compriation as (advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to ene regaration" (21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its internet address "http://www.fda.gov/cdrh/dsmamain.html".
Sincerely yours,
Eleanor W Shippen
Timothy A. Ulatowski 1 197 Director Division of Dental, Infection Control and General Hospital Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
3
!NDICATIONS FOR USE STATEMENT
1499 41977
510(k) File Number:
Device Name:
Indications For Use:
Disetronic Penfine® Injection Pen Needle
The Disetronic Penfine® Injection Pen Needles are intended for the .. hypodermic injection of fluids 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)
Prescription Use
(Per 21 CFR 801.19)
OR
Over-The-Counter Use
Healed in Shunum
(Division Sign-Off) ·vision of Dental, Infection Control, · General Hospital Dev Nomber _______________________________________________________________________________________________________________________________________________________________________