SYNTHES (USA) COMPARTMENTAL PRESSURE MONITORING SYSTEM

K031555 · Synthes (Usa) · LXC · Jul 8, 2003 · OR

Device Facts

• Record ID: K031555
• Device Name: SYNTHES (USA) COMPARTMENTAL PRESSURE MONITORING SYSTEM
• Applicant: Synthes (Usa)
• Product Code: LXC · OR
• Decision Date: Jul 8, 2003
• Decision: SESE
• Submission Type: Traditional
• Device Class: Class U

Intended Use

The Synthes (USA) Compartmental Pressure Monitoring System is intended for the immediate or continuous measurement of intracompartmental pressures.

Device Story

System measures intracompartmental pressures; consists of hand-held monitor, re-sterilizable pressure measurement probe, and optional extension cable. Probe inserted into target compartment via user-supplied 14-gauge catheter. Monitor houses operational software and LCD display; powered by 9-volt battery. Used by clinicians to monitor compartment pressure; output displayed on LCD for clinical assessment of pressure levels. Facilitates diagnosis or management of conditions like compartment syndrome.

Clinical Evidence

No clinical data provided; substantial equivalence based on documentation of similarity to legally marketed devices.

Technological Characteristics

Hand-held monitor with LCD display; re-sterilizable pressure measurement probe; 9-volt battery powered; connects via 14-gauge catheter (user-supplied) or optional extension cable.

Indications for Use

Indicated for immediate or continuous measurement of intracompartmental pressures in patients requiring such monitoring.

Submission Summary (Full Text)

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K031555

### 3. Summary of Safety and Effectiveness Information [510(k) Summary]

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| | JUL 0 8 2003 |
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| Sponsor | Synthes (USA)<br>1690 Russell Road<br>Paoli, PA 19301<br>Lisa M. Boyle<br>[phone] |
| Name of the Device | Synthes (USA) Compartmental Pressure Monitoring System |
| Device Classification(s) | Class II - Monitor, Pressure, Intercompartmental |
| Device Description | The Synthes (USA) Compartmental Pressure Monitoring System<br>consists of a hand-held monitoring device, a re-sterilizable pressure<br>measurement probe, and an optional extension cable. The hand-held<br>monitoring device houses the operational software and the LCD<br>display. The pressure measurement probe connects directly to the<br>hand-held unit or can be attached using the optional extension cable.<br>A 9-volt battery powers the monitor. The probe is inserted into the<br>target compartment via a 14-gauge catheter supplied by the user. |
| Indications | The Synthes (USA) Compartmental Pressure Monitoring System is<br>intended for the immediate or continuous measurement of<br>intracompartmental pressures. |
| Substantial Equivalence | Documentation is provided which demonstrates that the Synthes<br>(USA) Compartmental Pressure Monitor is substantially equivalent<br>to other legally marketed devices. |

## CONFIDENTIAL

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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

JUL 0 8 2003

Ms. Lisa M. Boyle Regulatory Associate Synthes (USA) 1690 Russell Road P.O. Box 1766 Paoli, Pennsylvania 19301

Re: K031555

Trade/Device Name: Synthes (USA) Compartmental Pressure Monitoring System Regulatory Class: Unclassified Product Code: LXC Dated: May 15, 2003 Received: May 19, 2003

Dear Ms. Boyle:

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 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 (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 comply with 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 forth 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 - Ms. Lisa M. Boyle

This letter will allow you to begin marketing your device as described in your Section 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), please contact the Office of Compliance at [phone]. Additionally, for questions on the promotion and advertising of your device, please contact the Office 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 may be obtained 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/dsma/dsmamain.html

Sincerely yours,

Miriam C. Provost

Celia M. Witten, Ph.D., M.D. Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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#### 2. Indications for Use Statement

# KOSISSS 510(k) Number (if known):

Device Name: Synthes (USA) Compartmental Pressure Monitoring System

Indications for Use: The Synthes (USA) Compartmental Pressure Monitoring System is intended for the immediate or continuous measurement of intracompartmental pressures.

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| Concurrence of CDRH, Office of Device Evaluation (ODE) | |
|--------------------------------------------------------|-------------------------|
| Prescription Use<br>(Per 21 CFR 801.109) | OR Over-The-Counter Use |

Miriam C. Provost

(Division Sign-Off)

Division of General, Restorative

and Neurological Devices

| 510(k) Number | K031555 |
|---------------|---------|
|---------------|---------|

Synthes(USA) Compartmental Pressure Monitoring System 510(k) CONFIDENTIAL