AESCULAP SPIEGELBERG BRAIN PRESSURE MONITOR

K003759 · Aesculap, Inc. · GWM · Jun 28, 2001 · Neurology

Device Facts

• Record ID: K003759
• Device Name: AESCULAP SPIEGELBERG BRAIN PRESSURE MONITOR
• Applicant: Aesculap, Inc.
• Product Code: GWM · Neurology
• Decision Date: Jun 28, 2001
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 882.1620
• Device Class: Class 2

Intended Use

The Aesculap® - Spiegelberg Brain Pressure Monitoring System is indicated for use in those conditions where continuous monitoring of intracranial pressure is required. As dictated by clinical judgment, direct measurement of intracranial pressure (ICP) may be obtained from subdural, parenchymal or intraventricular probe locations.

Device Story

System provides continuous intracranial pressure (ICP) monitoring for clinical use. Device utilizes probes placed in subdural, parenchymal, or intraventricular locations to measure pressure. Unlike catheter-tip transducer systems, this device features an ICP monitor-based transducer. System includes auto-zero functionality and supports cerebral perfusion pressure (CPP) monitoring. Used by physicians in healthcare facilities to manage patients requiring ICP assessment; output assists clinical decision-making regarding neurological status and patient care.

Clinical Evidence

No clinical data provided. Substantial equivalence is based on bench testing, material standards compliance, and comparison to legally marketed predicate devices.

Technological Characteristics

Materials: Polyurethane. Sensing: Non-fluid coupling. Energy: Electrical (ICP monitor). Form factor: 3 probe locations, 6 styles. Features: Auto-zero, CPP monitoring. Sterilization: Ethylene Oxide. Standards: Compliance with biocompatibility and material standards (ASTM/ISO).

Indications for Use

Indicated for patients requiring continuous intracranial pressure (ICP) monitoring. ICP measurement may be obtained from subdural, parenchymal, or intraventricular locations based on clinical judgment.

Regulatory Classification

Identification

An intracranial pressure monitoring device is a device used for short-term monitoring and recording of intracranial pressures and pressure trends. The device includes the transducer, monitor, and interconnecting hardware.

Predicate Devices

• Codman Intracranial Pressure Monitor (K991222)
• Integra NeuroCare (K962928)

Submission Summary (Full Text)

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K002759

# JUN 2 8 2001

| Summary of Safety and Effectiveness Information | | AESCULAP INC. |
|-------------------------------------------------|----------------------------------------------------------|------------------|
| Premarket Notification, Section 510(k) | | FEBRUARY 9, 2001 |
| Regulatory Authority: | Safe Medical Devices Act of 1990, 21 CFR 807.92 | |
| Trade Name: | Aesculap® - Spiegelberg Brain Pressure Monitoring System | |
| Common Name(s): | Intracranial pressure monitor | |
| Classification Name(s): | Intracranial pressure monitoring device | |
| Establishment Name & Registration Number: | | |
| Name: | Aesculap® Inc. | |
| Number: | 2916714 | |

# & 882.1620 Intracranial pressure monitoring device.

(a) Identification. An intracranial pressure monitoring device is a device used for short-term monitoring and (a) rolling of intracranial pressures and pressure trends. The transducer, monitor, and interconnecting hardware.

(b) Classification. Class II (performance standards).

| Device Class: | Class II for all requested indications |
|-----------------------|----------------------------------------|
| Classification Panel: | Neurosurgical Devices Panel |
| Product Code(s): | 84GWM |

#### Applicant Name & Address:

Aesculap® Inc. 944 Marcon Blvd. Allentown, PA 18109 650.624.5070

## Company Contact:

Ms. Joyce Thomas Aesculap® Inc. 944 Marcon Blvd. Allentown, PA 18109 650.876.7000 voice - 650.876.0266 fax

#### Submission Correspondent:

Mr. David W. Schlerf Buckman Company, Inc. 200 Gregory Lane, Suite C -100 Pleasant Hill, CA 94523-3389 925.356.2640 - 925.356.2654 - fax

#### Special Controls:

The Aesculap® - Spiegelberg Brain Pressure Monitoring System complies with the following special controls:

(i) Compliance with material standards,

- (ii) Compliance with biocompatability standard, and
(iii) Labeling

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#### Labeling:

Lawelling:
The Aesculap® - Spiegelberg Brain Pressure Monitoring System discussed in this premarket The Hesculap® - Oplegelberg -Brain - Phegelberg and labeled with the Aesculap logo. The system will be marketed exclusively to healthcare facilities and physicians.

## Preamendments Device (legally marketed comparison device):

I readenoments Device (legally man letracranial Pressure Monitor (991222) and the Integra HESCOLAF® Inc. beatter that the "Countes are substantially equivalent. A basic feature comparison table for Newocale, Cannino (1972) 2011-05-120 Pressure Monitoring System is located at the end of this document.

## Summary Basis for Equivalence and Comparison Table:

Summary Dasis for Equilable product information concerning the referenced companson device, the Aesculap® - Spiegelberg Brain Pressure Monitoring System is similar in that:

- The devices have the same intended use and indications for use. .
- The devices are made of the same or substantially similar materials. .
- The devices have similar form, function, procedure and features. .
- Performance characteristics are suitable for the designated indications for use .

The use of ISO/QSR based process controls, testing, materials standards (ASTM and ISO) and the marked similarites of the referenced comparison device establishes that the Aesculap® - Spiegelberg Brain Pressure Monitoring System is substantially equivalent. Based on this, the anticipated clinical performance of the Aesculap® - Spiegelberg Brain Pressure Monitoring System is equivalent to the referenced system.

| FEATURE | Aesculap® - Spiegelberg Brain<br>Pressure Monitoring System | Integra<br>NeuroCare | Codman | SE? |
|------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------|------------------------------------|-------|
| Indications for<br>Use: | The AesculapⓇ - Spiegelberg Brain Pressure<br>Monitoring System is indicated for use in those<br>conditions where continuous monitoring of<br>intracranial pressure is required. As dictated by<br>clinical judgment, direct measurement of<br>intracranial pressure (ICP) may be obtained from<br>subdural, parenchymal or intraventricular probe<br>locations. | SAME | SAME | YES |
| Brain Probes: | 3 locations, 6 styles | 3 locations, 3 styles | 3 locations, 3 styles | 4 YES |
| Sterility: | Ethylene Oxide | SAME | SAME | YES |
| Non-fluid<br>coupling: | Yes | Yes | Yes | YES |
| Materials: | Polyurethane | Unknown | Nylon & titanium | YES |
| Auto Zero: | Yes | No | No | YES |
| Manufacturer: | Spiegelberg | Camino Neurocare | Codman | YES |
| Monitoring<br>Sites: | Dura<br>Parenchymal<br>Ventricular | SAME | Dura<br>Parenchymal<br>Ventricular | YES |
| Transducer<br>Location: | ICP Monitor | Catheter Tip | Catheter Tip | NO |
| CPP Monitor: | Yes | Yes | No | YES |
| Product Code:<br>K - Number: | 84GWM<br>Pending | SAME<br>K962928 | 84GWM<br>K991222 | YES |

#### Summary Comparison Table:

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Public Health Service

JUN 2 8 2001

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Aesculap, Inc. c/o Mr. David W. Schlerf Buckman Company, Inc. 200 Gregory Lane Suite C-100 Pleasant Hill, California 94523

Re: K003759

Trade/Device Name: Aesculap® - Spiegelberg Brain Pressure Monitoring System

Regulation Number: 882.1620 Regulatory Class: II Product Code: GWM Dated: June 11, 2001 Received: June 13, 2001

Dear Mr. Schlerf:

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 Regulations, Title 21, Parts 800 to 895. A 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 concerning your device in the Federal Register. Please note: this response to your premarket notification 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.

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Page 2 - Mr. David W. Schlerf

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 nonicate 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 11 you dosire specific arravitro diagnostic devices), please contact the Office of Compliance at additionally 60710 Iditionally, for questions on the promotion and advertising of your device, (Jease contact the Office of Compliance at [phone]. 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 mormation on your respeat its toll-free number [phone] or [phone] or at its internet address "http://www.fda.gov/cdrh/dsma/dsmamain.html".

Sincerely yours,

Mark McMullen

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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Page 1 - of

510(k) Number : K003759

Device Name(s): Aesculap® - Spiegelberg Brain Pressure Monitoring System

# Indications for Use:

The Aesculap® - Spiegelberg Brain Pressure Monitoring System is indicated for use in those conditions where continuous monitoring of intracranial pressure is required. As dictated by clinical judgment, direct measurement of intracranial pressure (ICP) may be obtained from subdural, parenchymal or intraventricular probe locations.

PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NECESSARY

| Concurrence of CDRH, Office of Device Evaluation (ODE) | <img alt="Signature" src="signature.png"/> |
|--------------------------------------------------------|-----------------------------------------------------------|
| | for (Division Sign-Off) |
| | Division of General, Restorative and Neurological Devices |
| 510(k) Number | K003759 |

| Prescription Use (Per 21 CFR 801.109) | <img alt="Check Mark" src="check_mark.png"/> | OR | Over-The-Counter Use (Optional format 1-2-96) |
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