(37 days)
No
The device description and performance studies do not mention any AI or ML capabilities. The device is described as a monitor with basic display and alarm functions, a scaled-down version of a previous model.
No.
The device is an intracranial pressure monitor, which measures and displays ICP, but does not provide any therapy or treatment.
Yes
The device is indicated for use when direct measurement of intracranial pressure (ICP) is clinically important, which directly supports diagnosis and clinical decision-making.
No
The device description explicitly mentions hardware components such as circuit boards, cables, and catheters, indicating it is a physical medical device with integrated software, not a software-only device.
Based on the provided information, the Camino® SPM-1 Intracranial Pressure Monitor is not an IVD (In Vitro Diagnostic) device.
Here's why:
- IVD devices are used to examine specimens derived from the human body (like blood, urine, or tissue) in vitro (outside the body) to provide information for diagnosis, monitoring, or screening.
- The Camino® SPM-1 directly measures intracranial pressure in vivo (inside the body) using a catheter inserted into the intracranial space.
The device's function is to monitor a physiological parameter directly within the patient's body, not to analyze a sample taken from the patient.
N/A
Intended Use / Indications for Use
The Camino® SPM-1 Intracranial Pressure Monitor is indicated for use when direct measurement of intracranial pressure (ICP) is clinically important.
Product codes
GWM
Device Description
The SPM-1 is an intracranial pressure monitor which features continuous mean Intracranial Pressure (ICP) display, high ICP alarm, and bedside monitor capabilities. The SPM-1 is a modified MPM-1 ICP monitor. It contains the same circuit boards as the MPM-1 but with fewer components, based on the scaled down features (no waveform display, temperature monitoring or ability to calculate CPP).
The SPM-1 is supplied with a PAC-2 Pre-Amp Cable, and a PMIO-SPM Patient Monitor Cable. Non-sterile adapter cables (REF ICP-XX) are used to interface the PMIO-SPM cable to specific bedside monitors. These non-sterile cables come in many configurations, which facilitate data transfer between the PMIO-SPM cable and a specific brand of external bedside monitor.
The following Camino® 110-4 Series ICP catheters are intended to be used with the SPM-1: 110-4B (Ventricular Bolt Pressure Monitoring Kit), 110-4G (Post Craniotomy Subdural Pressure Monitoring Kit), 110-4HM (Micro Ventricular Bolt Pressure Monitoring Kit), and 110-4L (Intracranial Pressure Monitoring Catheter with Licox® IMC Bolt Fitting). The use of temperature catheters is not recommended with the SPM-1.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
The MPM-1 and SPM-1 are both intended to be used by a qualified NeuroSurgeon
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)
The SPM-1 underwent numerous safety tests, including testing to IEC 60601-1 and UL 2601.In addition, the SPM-1 was subjected to extensive performance testing. Results of the testing showed that the monitor design was technically sound and the product safe for its intended use.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
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).
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Image /page/0/Picture/1 description: The image shows the words "Page 1 of 2" in a handwritten-style font at the top. Below that, the word "CONFIDENTIAL" is printed in a bold, sans-serif font. The text suggests that the document is part of a multi-page report and contains sensitive information.
510(k) Premarket Notification Camino® Model SPM-1 Integra NeuroSciences
MAY 1 4 2003
Camino® Single Parameter Monitor
Model SPM -1
510(k) SUMMARY
Submitter's name and address:
Integra NeuroSciences 5955 Pacific Center Blvd. San Diego, CA 92121, USA
Contact person and telephone number:
Nancy A. Mathewson, Esq. Director, Regulatory Affairs (858) 622-2737
Date summary was prepared:
March 24, 2003
Name of the device:
| Proprietary Name: | |
|---|---|
| a. Modified: | Camino® Single Parameter Monitor, Model SPM - 1 |
| b. Unmodified: | Camino® Multi-Parameter Monitor Model MPM-1, |
| cleared 12/20/96 under 510(k) K962928 | |
| Common Name: | Intracranial Pressure Monitor |
| Classification Name: | Intracranial Pressure Monitoring Device |
| Product Code GWM, 21 CFR 882.1620 | |
| Classification Panel: | Neurology Device Panel |
Substantial Equivalence:
The predicate device is the Camino® Multi-Parameter Pressure Monitor, cleared to market under 510(k) K962928.
Device Description:
The SPM-1 is an intracranial pressure monitor which features continuous mean Intracranial Pressure (ICP) display, high ICP alarm, and bedside monitor capabilities. The SPM-1 is a modified MPM-1 ICP monitor. It contains the same circuit boards as the
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K031086 Page
CONFIDENTIAL
510(k) Premarket Notification Camino® Model SPM-1 Integra NeuroSciences
MPM-1 but with fewer components, based on the scaled down features (no waveform display, temperature monitoring or ability to calculate CPP).
The SPM-1 is supplied with a PAC-2 Pre-Amp Cable, and a PMIO-SPM Patient Monitor Cable. Non-sterile adapter cables (REF ICP-XX) are used to interface the PMIO-SPM cable to specific bedside monitors. These non-sterile cables come in many configurations, which facilitate data transfer between the PMIO-SPM cable and a specific brand of external bedside monitor.
The following Camino® 110-4 Series ICP catheters are intended to be used with the SPM-1: 110-4B (Ventricular Bolt Pressure Monitoring Kit), 110-4G (Post Craniotomy Subdural Pressure Monitoring Kit), 110-4HM (Micro Ventricular Bolt Pressure Monitoring Kit), and 110-4L (Intracranial Pressure Monitoring Catheter with Licox® IMC Bolt Fitting). The use of temperature catheters is not recommended with the SPM-1.
Statement of Intended Use:
The MPM-1 and SPM-1 are both intended to be used by a qualified NeuroSurgeon when the measurement of intracranial pressure (ICP) is considered clinically important.
Safety:
The SPM-1 underwent numerous safety tests, including testing to IEC 60601-1 and UL 2601.In addition, the SPM-1 was subjected to extensive performance testing. Results of the testing showed that the monitor design was technically sound and the product safe for its intended use.
The SPM-1 manufacturing process complies with the United States Food and Drug Administration and European Standards for the manufacturing of medical devices.
Conclusion:
In summary, the Camino® SPM-1 Intracranial Pressure Monitor described in this submission is substantially equivalent to the unmodified predicate device and the modifications made do not affect the intended use or fundamental scientific technology of the device.
2
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/2/Picture/1 description: The image shows the seal of the Department of Health & Human Services (HHS) of the United States. The seal features a stylized eagle with three lines representing its body and wings. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the eagle.
Public Health Service
MAY 1 4 2003
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Ms. Nancy A. Mathewson, Esq. Director, Regulatory Affairs Integra NeuroSciences 5955 Pacific Center Boulevard San Diego, California 92121
Re: K031086
Trade/Device Name: Camino® SPM-1 Intracranial Pressure Monitor Regulation Number: 21 CFR 882.1620 Regulation Name: Intracranial pressure monitoring device Regulatory Class: II Product Code: GWM Dated: March 24, 2003 Received: May 1, 2003
Dear Ms. Mathewson:
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.
3
Page 2 - Ms. Nancy A. Mathewson, Esq.
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 (301) 594-4659. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. 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 (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html
Sincerely yours,
Muriam 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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510(k) Premarket Notification Camino® Model SPM-1 Integra NeuroSciences
APPENDIX B
Indications for Use Statement
K031086 210(k) Number
Device Name: Camino® SPM-1 Intracranial Pressure Monitor
Indications The Camino® SPM-1 Intracranial Pressure Monitor is indicated for use when direct measurement of intracranial pressure (ICP) is clinically important.
Miriam C. Provost
Division Sign-Off) Division of General, Restorative and Neurological Devices
510(k) Number: K031086
PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED
Concurrence of CDRH, Office of Device Evaluation (ODE)
V Prescription Use (Per 21 CFR 801. 109)
OR
Over-The-Counter Use