STRYKER DISCMONITOR

K050753 · Stryker Instruments · FMF · May 18, 2005 · General Hospital

Device Facts

• Record ID: K050753
• Device Name: STRYKER DISCMONITOR
• Applicant: Stryker Instruments
• Product Code: FMF · General Hospital
• Decision Date: May 18, 2005
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 880.5860
• Device Class: Class 2

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.

Device Story

Stryker Discmonitor is a sterile, disposable device for discography procedures. It functions as an injector and pressure monitor for fluid delivery into the intervertebral disc nucleus. The device measures fluid pressure, injection volume, and pressurization duration. It features digital display capabilities and allows physicians to manually save key data points during the procedure. Data is stored and can be recalled for output in graphic and tabular formats via a printout. Used in clinical settings by physicians to control injection rates and pressures, the device assists in clinical decision-making by providing objective monitoring of discography parameters.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

Sterile, disposable device. Functions as a piston syringe (21 CFR 880.5860) with integrated digital pressure and volume monitoring. Includes data logging and printout capabilities for graphic and tabular reporting.

Indications for Use

Indicated for use in discography procedures to inject fluids into the intervertebral disc nucleus and monitor fluid pressure.

Regulatory Classification

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.

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)

Submission Summary (Full Text)

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MAY 1 8 2005

Koso753

4100 E. Milham Avenue Kalamazoo, MI 49001 t: 269 323 7700 f: 800 965 6505 www.stryker.com

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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

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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.

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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 [phone] . 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 [phone] or [phone] 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

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Koso753

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## 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)

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Concurrence of CDRH, Office of Device Evaluation (ODE)

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Restorative
Dental Materials

K050753