(27 days)
No
The summary describes a simple mechanical injection pen needle and makes no mention of AI or ML.
No.
The device is an injection pen needle used for drug delivery, not for treating any specific condition itself.
No
The device is described as an "Injection Pen Needles" intended for "hypodermic injection of fluids into the body". This indicates its function is to deliver substances, not to diagnose conditions.
No
The device is a physical medical device (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 fluids into the body". This describes a device used on the body for delivering substances, not for testing samples from the body to diagnose conditions.
- Device Description: The description focuses on the physical characteristics of a needle used for injection.
- Lack of IVD Characteristics: There is no mention of analyzing samples (blood, urine, tissue, etc.), detecting analytes, or providing diagnostic information.
IVD devices are used to examine specimens derived from the human body to provide information for the diagnosis, prevention, monitoring, treatment, or alleviation of disease. This device does not fit that description.
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 automatic injector pen.
Product codes
FMI
Device Description
The 31 gauge 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 29 and 30 gauge Disetronic PenFine® Injection Pen Needles. The only difference is in the thickness 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
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Performance data has been generated in compliance with existing international standards and protocols and found equivalent to the predicate devices.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
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
AUG 6 1998
8.0 SUMMARY OF SAFETY AND EFFECTIVENESS
"510(k) SUMMARY"
8.1 Trade/Proprietary Name: 31 Gauge Disetronic PenFine® injection Pen Needle
8.2 Common/Usual Name: Injection Pen Needle
8.3 Classification Name: Hypodermic Single Lumen Needle
. .
8.4 Comparison to Currently Marketed Devices
The 31 gauge Disetronic PenFine® Injection Pen Needles are substantially equivalent to the 29 and 30 gauge Disetronic PenFine® Injection Pen Needles (K973339) and the Becton Dickinson B-D Ultra-Fine II Injection Pen Needles (K970737).
8.5 Device Description
The 31 gauge 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 29 and 30 gauge Disetronic PenFine® Injection Pen Needles. The only difference is in the thickness 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 automatic 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® Injection Pen Needles are substantially equivalent to the devices currently marketed in the United States.
1
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" arranged around the perimeter. Inside the circle is an abstract symbol resembling three stylized human profiles facing right, with flowing lines beneath them.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
AUG 6 1998
Mr. Patrik De Haes ·President and CEO Disetronic Medical Systems, Incorporated 5201 East River Road, Suite 312 Minneapolis, Minnesota 55421-1014
K982399 Re : Disetronic PenFine® Injection Pen Needle Trade Name: Requlatory Class: II Product Code: FMI Dated: July 2, 1998 July 10, 1998 Received:
Dear Mr. De Haes:
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 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). 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 Current Good Manufacturing Practice requirements, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic QS 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 Please note: concerning your device in the Federal Reqister. this response to your premarket notification submission does not affect any obligation you might have under sections 531
2
Page 2 - Mr. De Haes
through 542 of the Act for devices under the Electronic emoduct Radiation Control provisions, or other Federal laws or requlations.
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 regulation (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 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 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/dsma/dsmamain.html".
Sincerely yours,
Olin S. L/or
Timothy A. Ulatowski
Timothy A. Ulatowski Director Division of Dental, Infection Control, and General Hospital Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure ... ... ..
3
INDICATIONS FOR USE
510(k) File Number:
,Device Name:
Disetronic PenFine® Injection Pen Needle
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.
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Patricia Cuccenti
(Division Sign-Off)
Division of Dental, Infection Control, and General Hospital Devices 510(k) Number _
Prescription Use V (Per 21 CFR 801.109)
OR
Over-The-Counter Use _________________________________________________________________________________________________________________________________________________________
(Optional Format 1-2-96)