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 Description

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

AI/ML Overview

This 510(k) submission, K003759, for the Aesculap® - Spiegelberg Brain Pressure Monitoring System, is a premarket notification for a Class II medical device. As such, it relies on demonstrating substantial equivalence to a predicate device rather than providing extensive clinical study data with acceptance criteria for device performance. The document focuses on comparing features and intended use with existing legally marketed devices.

Therefore, many of the requested elements typically found in studies proving device performance against specific acceptance criteria (such as sample size for test sets, number of experts for ground truth, adjudication methods, MRMC studies, standalone performance, training set details) are not applicable or not provided in this type of submission.

Here's a breakdown of the available information:

1. A table of acceptance criteria and the reported device performance

The submission does not present explicit acceptance criteria for device performance in terms of numerical thresholds for accuracy, precision, sensitivity, or specificity. Instead, the "acceptance criteria" are implicitly met by demonstrating substantial equivalence to an existing predicate device based on features, intended use, and existing standards.

The table below summarizes the comparison with predicate devices, highlighting features to demonstrate this equivalence, which serves as the basis for "acceptance" in a 510(k) submission.

Feature	Aesculap® - Spiegelberg Brain Pressure Monitoring System	Integra NeuroCare Predicate	Codman Predicate	Substantially Equivalent (SE)?
Indications for Use	The device is indicated for use in conditions where continuous monitoring of intracranial pressure is required. Direct measurement of ICP may be obtained from subdural, parenchymal, or intraventricular probe locations.	SAME	SAME	YES
Brain Probes	3 locations, 6 styles	3 locations, 3 styles	3 locations, 3 styles	YES
Sterility	Ethylene Oxide	SAME	SAME	YES
Non-fluid coupling	Yes	Yes	Yes	YES
Materials	Polyurethane	Unknown	Nylon & titanium	YES
Auto Zero	Yes	No	No	YES
Manufacturer	Spiegelberg	Camino Neurocare	Codman	YES
Monitoring Sites	Dura, Parenchymal, Ventricular	SAME	Dura, Parenchymal, Ventricular	YES
Transducer Location	ICP Monitor	Catheter Tip	Catheter Tip	NO
CPP Monitor	Yes	Yes	No	YES
Product Code / K-Number	84GWM / Pending (K003759)	84GWM / K962928 (Integra NeuroCare)	84GWM / K991222 (Codman Neuoscan Monitor)	YES

Note: The "NO" for Transducer Location indicates a difference but does not prevent substantial equivalence if the overall performance and safety are comparable, which is implicitly argued for in the submission.

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

This information is not provided in the document. As this is a 510(k) submission primarily relying on substantial equivalence, detailed performance studies with test sets in the context of clinical data are generally not required or presented in the same way as a PMA submission. The "test" for this device is the comparison of its features and intended use to predicate devices, and adherence to specific controls (material, biocompatibility, labeling) and QSR.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

This information is not provided. Ground truth establishment by experts for a clinical test set is not applicable to this type of 510(k) submission.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

This information is not provided and is not applicable to this type of 510(k) submission.

5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

An MRMC study is not applicable to this device. This is a brain pressure monitoring system, not an AI or imaging diagnostic device that involves human readers or AI assistance.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

This is not applicable. The device is an intracranial pressure monitoring system, not an algorithm, and its function involves direct measurement, not an AI prediction or diagnostic algorithm.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

The "ground truth" in this context is the safety and effectiveness established for the predicate devices through their prior marketing clearance. The new device is deemed equivalent because its fundamental characteristics match those of already approved devices, implying similar safety and effectiveness. No new ground truth was established for this submission.

8. The sample size for the training set

This information is not applicable as there is no mention of a "training set" for an algorithm in this submission.

9. How the ground truth for the training set was established

This information is not applicable as there is no mention of a "training set" for an algorithm in this submission.

In summary, the K003759 submission for the Aesculap® - Spiegelberg Brain Pressure Monitoring System demonstrates "acceptance" by establishing substantial equivalence to legally marketed predicate devices, focusing on comparable intended use, materials, features, and adherence to regulatory controls, rather than through new clinical performance studies with explicit acceptance criteria and statistical outcomes.

Summary

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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 BrainPressure Monitoring System	IntegraNeuroCare	Codman	SE?
Indications forUse:	The AesculapⓇ - Spiegelberg Brain PressureMonitoring System is indicated for use in thoseconditions where continuous monitoring ofintracranial pressure is required. As dictated byclinical judgment, direct measurement ofintracranial pressure (ICP) may be obtained fromsubdural, parenchymal or intraventricular probelocations.	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-fluidcoupling:	Yes	Yes	Yes	YES
Materials:	Polyurethane	Unknown	Nylon & titanium	YES
Auto Zero:	Yes	No	No	YES
Manufacturer:	Spiegelberg	Camino Neurocare	Codman	YES
MonitoringSites:	DuraParenchymalVentricular	SAME	DuraParenchymalVentricular	YES
TransducerLocation:	ICP Monitor	Catheter Tip	Catheter Tip	NO
CPP Monitor:	Yes	Yes	No	YES
Product Code:K - Number:	84GWMPending	SAMEK962928	84GWMK991222	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 (301) 594-4639. 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 (800) 638-2041 or (301) 443-6597 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:

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

Concurrence of CDRH, Office of Device Evaluation (ODE)
	for (Division Sign-Off)
	Division of General, Restorative and Neurological Devices
510(k) Number	K003759

Prescription Use (Per 21 CFR 801.109)		OR	Over-The-Counter Use (Optional format 1-2-96)
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Regulation Number and Section

§ 882.1620 Intracranial pressure monitoring device.

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