(204 days)
Not Found
No
The summary describes a standard intracranial pressure monitoring system with a transducer, monitor, and hardware. There is no mention of AI, ML, image processing, or any data analysis beyond basic pressure monitoring and trend display.
No.
The device is used for monitoring and measuring intracranial pressure, which is a diagnostic function, not a therapeutic intervention.
Yes
The device is described as a "Brain Pressure Monitoring System" used for "continuous monitoring of intracranial pressure." Monitoring a physiological parameter to assess a patient's condition falls under the definition of a diagnostic device. The "Indications for Use" explicitly states it's for "conditions where continuous monitoring of intracranial pressure is required," implying its use in diagnosis or management decisions.
No
The device description explicitly mentions "transducer, monitor, and interconnecting hardware," indicating it includes physical components beyond just software.
Based on the provided information, the Aesculap® - Spiegelberg Brain Pressure Monitoring System is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections.
- Device Function: The description clearly states that this device is used for continuous monitoring of intracranial pressure by directly measuring pressure from subdural, parenchymal, or intraventricular probe locations within the brain. This is a direct measurement within the body, not a test performed on a sample outside the body.
- Anatomical Site: The anatomical site is the brain, indicating an in-vivo measurement.
Therefore, this device falls under the category of a medical device used for physiological monitoring, not an IVD.
N/A
Intended Use / 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.
Product codes (comma separated list FDA assigned to the subject device)
84GWM
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Brain (subdural, parenchymal or intraventricular probe locations)
Indicated Patient Age Range
Not Found
Intended User / Care Setting
healthcare facilities and physicians
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)
Not Found
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.
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
§ 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).
0
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
1
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
Pressure Monitoring System | Integra
NeuroCare | Codman | SE? |
|------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------|------------------------------------|-------|
| 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. | 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
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 | SAME
K962928 | 84GWM
K991222 | YES |
Summary Comparison Table:
2
Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized image of an eagle with three heads, representing the department's mission to protect the health of all Americans and provide essential human services.
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.
3
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:
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) | |
|---|---|
| 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) | |
|---|---|---|---|
| --------------------------------------- | ---------------------------------------------- | ---- | ----------------------------------------------- |