(171 days)
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Not Found
No
The summary describes a mechanical syringe used for a physical technique and contains no mention of AI, ML, image processing, or data analysis.
No
The device is used for detection and confirmation of needle placement, not for treating a disease or condition.
Yes
Explanation: The device is used for "detection and confirmation of the placement of the epidural needle into the epidural space", which involves identifying a physiological state or condition (the location of the needle). This falls under the definition of a diagnostic device.
No
The description clearly states "THE LOSS OF RESISTANCE SYRINGE IS INTENDED TO BE USED...", indicating a physical syringe, which is a hardware component.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In vitro diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections. They are used to diagnose, monitor, or screen for health issues.
- Device Intended Use: The intended use of this device is to detect and confirm the placement of an epidural needle in vivo (within the body) using the loss of resistance technique. This is a physical technique performed directly on the patient, not on a sample taken from the patient.
Therefore, the function and application of this syringe fall outside the scope of in vitro diagnostics.
N/A
Intended Use / Indications for Use
THE LOSS OF RESISTANCE SYNINGE 15 INTENDED TO BE USED FOR THE DEFECTION AND CONFERMATION OF THE PLACEMENT OF THE ERIDORAL NEEDLE INTO THE EPIDURAL SPACE PRIOR TO EPINORAL ANDINESIAN THIS SYRINGE IS INTENDED FOR THE LOSS OF RESISTANCE TECHNIQUE ONLY IT IS NOT INTENDED FOR ASPIRATION OR INVECTION,
Product codes
FMF
Device Description
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Mentions image processing
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Mentions AI, DNN, or ML
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Input Imaging Modality
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Anatomical Site
EPIDURAL SPACE
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
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Description of the test set, sample size, data source, and annotation protocol
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Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
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Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
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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.
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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.
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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).
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§ 880.5860 Piston syringe.
(a)
Identification. A piston syringe is a device intended for medical purposes that consists of a calibrated hollow barrel and a movable plunger. At one end of the barrel there is a male connector (nozzle) for fitting the female connector (hub) of a hypodermic single lumen needle. The device is used to inject fluids into, or withdraw fluids from, the body.(b)
Classification. Class II (performance standards).
0
Image /page/0/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 a stylized design of three human profiles facing right, with flowing lines representing movement or progress.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
JUN 2 4 1999
TE ME NA S.A.R.L. c/o Mr. Donald F. Ryan 21981 U.S. 19N Clearwater, Florida 33765
K990020 Re : TE ME NA Loss of Resistance Syringe, 10CC Trade Name: Requlatory Class: II Product Code: FMF March 11, 1999 Dated: Received: April 5, 1999
Dear Mr. Ryan:
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 The general controls provisions of the Act of the Act. include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions aqainst 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 requlations affecting your device can be found in the Code of Federal Requlations, Title 21, Parts 800 to 895. ਸ substantially equivalent determination assumes compliance with the Good Manufacturing Practice for Medical Devices: General (GMP) requlation (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.
1
Paqe 2 - Mr. Ryan
this response to your premarket notification Please note: submission does not affect any 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 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" (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,
Timothy A. Ulatowski
Director
Division of Dental, Infection Control, and General Hospital Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
2
510(k) Number (if known): K 990020
Device Name: Loss OF RESISTANCE SYRINGE
Indications For Use:
THE LOSS OF RESISTANCE SYNINGE 15 INTENDED TO BE USED FOR THE DEFECTION AND CONFERMATION OF THE PLACEMENT OF THE ERIDORAL NEEDLE INTO THE EPIDURAL SPACE PRIOR TO EPINORAL ANDINESIAN THIS SYRINGE IS INTENDED FOR THE LOSS OF RESISTANCE TECHNIQUE ONLY IT IS NOT INTENDED FOR ASPIRATION OR INVECTION,
(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 801.109)
ાર
Over-The-Counter Use__________________________________________________________________________________________________________________________________________________________
(Optional Format 1-2-96)
Patricia Cascente
Division of Dental, Infection Cont and G eneral Hospital D 510(k) Number
EXHIBIT I