(56 days)
Not Found
No
The description focuses on fluid injection, pressure monitoring, and data display/storage, with no mention of AI/ML algorithms for analysis, prediction, or decision support.
No.
This device is used for diagnostic procedures (discography) to inject fluid and monitor pressure, not for therapy to treat a condition.
No.
The device injects fluid and monitors its pressure and volume, which are physiological parameters, but it does not diagnose a medical condition based on these measurements. It is a tool used during a diagnostic procedure (discography) to facilitate the procedure itself, not to provide a diagnosis from its own outputs. While it saves and displays data, this data aids the physician in their diagnostic process rather than providing a direct diagnosis from the device.
No
The device description explicitly states it is a "sterile, disposable device" used to inject fluid and measure pressure, indicating it includes hardware components beyond just software.
Based on the provided information, the Stryker Discmonitor is not an In Vitro Diagnostic (IVD) device.
Here's why:
- IVD devices are used to examine specimens derived from the human body. The Stryker Discmonitor is used to inject fluid into the human body (specifically, the intervertebral disc nucleus) and monitor the pressure of that fluid within the body.
- The intended use is a procedural aid, not a diagnostic test performed on a sample. The device assists in a discography procedure, which is a diagnostic imaging technique, but the device itself is not analyzing a biological sample to provide diagnostic information. It's measuring physical parameters (pressure, volume, time) during the procedure.
Therefore, the Stryker Discmonitor falls under the category of a medical device used in a diagnostic procedure, but it is not an IVD device.
N/A
Intended Use / Indications for Use
The Stryker Discmonitor is used to inject fluids into the intervertebral disc nucleus during discography procedures and monitor the pressure of that fluid.
Product codes (comma separated list FDA assigned to the subject device)
DXT, FMF
Device Description
The Stryker Discmonitor is a sterile, disposable device used to inject fluid into the intervertebral disc nucleus during discography procedures. The device will measure of the fluid and display it in a digital format. The physician can control the pressure of the fluid and the rate of injection using the device. As additional information, the device will also measure the volume of fluid injected into the disc and the amount of time each disc is pressurized. The device will save the pressure and volume over time during the procedure. The physician will be able to manually save key data points for each disc. These points may be recalled later and are highlighted on the printout in both a graphic and tabular format.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
intervertebral disc nucleus
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)
The Stryker Discmonitor does not raise any new safety and efficacy concerns when compared to similar devices already legally marketed. Therefore, the Stryker Discmonitor is substantially equivalent to these existing devices.
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.
Merit Medical 30ATM Monarch - K011811, Merit Medical Universal Fluid Dispensing Syringe - K973230, Merit Medical Intellisystem II Color Monitor - K993341, Physician Industries Accumeter - K033739, Atrion Medical QL™ Fluid Dispensing Syringe - K020333
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
§ 880.5860 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
MAY 1 8 2005
Koso753
4100 E. Milham Avenue Kalamazoo, MI 49001 t: 269 323 7700 f: 800 965 6505 www.stryker.com
Image /page/0/Picture/3 description: The image shows the word "Stryker" in a bold, sans-serif font. The letters are black, and the background is white. There is a registered trademark symbol to the right of the word.
Instruments
Summary of Safety and Effectiveness
Device Sponsor: Stryker Instruments 4100 E. Milham Avenue Kalamazoo, MI 49001 269-323-7700 Registration No .: 1811755
Device Name: Trade Name: Stryker Discmonitor Common Name: Discography Pressure Monitor Classification Name: Injector and Syringe, Angiographic 21 CFR§ 870.1650, DXT
Predicate Devices: Merit Medical 30ATM Monarch - K011811 Merit Medical Universal Fluid Dispensing Syringe - K973230 Merit Medical Intellisystem II Color Monitor - K993341 Physician Industries Accumeter - K033739 Atrion Medical QL™ Fluid Dispensing Syringe - K020333
Description: The Stryker Discmonitor is a sterile, disposable device used to inject fluid into the intervertebral disc nucleus during discography procedures. The device will measure of the fluid and display it in a digital format. The physician can control the pressure of the fluid and the rate of injection using the device. As additional information, the device will also measure the volume of fluid injected into the disc and the amount of time each disc is pressurized. The device will save the pressure and volume over time during the procedure. The physician will be able to manually save key data points for each disc. These points may be recalled later and are highlighted on the printout in both a graphic and tabular format.
Intended Use: The Stryker Discmonitor is used to inject fluids into the intervertebral disc nucleus during discography procedures and monitor the pressure of that fluid.
Substantial Equivalence (SE) Rational: The Stryker Discmonitor is equivalent in intended use, safety, and effectiveness to existing devices being marketed by Merit Medical.
Safety and Effectiveness: The Stryker Discmonitor does not raise any new safety and efficacy concerns when compared to similar devices already legally marketed. Therefore, the Stryker Discmonitor is substantially equivalent to these existing devices.
Signed:
Jean W. Sheppard
Jean W. Shepparo Regulatory Affairs Anal
Dated: May 6, 2005
1
Public Health Service
Image /page/1/Picture/2 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a stylized eagle with three lines representing its body and wings. The eagle is positioned to the right of the text "DEPARTMENT OF HEALTH AND HUMAN SERVICES . USA", which is arranged in a circular fashion around the logo.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
MAY 1 8 2005
Mr. Jean W. Sheppard Regulatory Analyst Stryker Instruments 4100 East Milham Avenue Kalamazoo, Michigan 49001
Re: K050753
Trade/Device Name: Styker Discmonitor Regulation Number: 21 CFR 880.5860 Regulation Name: Piston syringe Regulatory Class: II Product Code: FMF Dated: May 6, 2005 Received: May 10, 2005
Dear Mr. Sheppard:
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 r ou may, arons 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 of the Act or any Federal statutes and regulations administered by other Federal agencies. You must or un J vith 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 Orth 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.
2
Page 2 - Mr. Jean W. Sheppard
This letter will allow you to begin marketing your device as described in your Section 510(k) I mo letter will and hy a 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 11 you debite 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 (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours,
Signature
Miriam C. Provost, Ph.D. Acting Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
3
Koso753
Page__1
Indications for Use Statement
| 510(k) Number: | K050753 |
|---|---|
| ---------------- | --------- |
Device Name: Stryker Discmonitor
Indications For Use:
The Stryker Discmonitor is used to inject fluids into the intervertebral disc nucleus during discography procedures and monitor the pressure of that fluid.
Prescription Use AND/OR × (Per 21 CFR 801Subpart 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)
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Restorative
Dental Materials