(37 days)
The Camino® SPM-1 Intracranial Pressure Monitor is indicated for use when direct measurement of intracranial pressure (ICP) is clinically important.
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.
The Camino® SPM-1 Intracranial Pressure Monitor, based on the provided 510(k) summary, does not detail specific acceptance criteria or a dedicated study proving its performance against such criteria in the way a modern AI/ML device submission would. Instead, the submission relies on demonstrating substantial equivalence to a predicate device (Camino® Multi-Parameter Pressure Monitor, K962928) and general safety testing.
Here's a breakdown of the requested information based on the available text:
1. Table of Acceptance Criteria and Reported Device Performance:
The document does not explicitly state quantitative acceptance criteria or detailed performance metrics for the SPM-1. The primary claim for performance is its substantial equivalence to the predicate device, implying it performs equivalently.
| Acceptance Criteria Category | Specific Metric | Acceptance Criteria | Reported Device Performance |
|---|---|---|---|
| Performance | N/A | N/A | "The monitor design was technically sound and the product safe for its intended use." (Implied equivalent performance to predicate device) |
| Safety | N/A | N/A | "underwent numerous safety tests, including testing to IEC 60601-1 and UL 2601." |
2. Sample Size Used for the Test Set and Data Provenance:
The document does not describe a clinical "test set" with a specific sample size for performance evaluation in the context of analytical or clinical accuracy. The testing mentioned appears to be primarily engineering verification and validation testing for safety and functionality. No information is provided regarding data provenance (e.g., country of origin, retrospective/prospective).
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications of Those Experts:
Not applicable. The device is a physical Intracranial Pressure (ICP) monitor. Its "ground truth" would be the actual ICP measurements, which are obtained directly by the device, not by expert consensus on images or other diagnostic data.
4. Adjudication Method for the Test Set:
Not applicable. As noted above, there's no "test set" requiring adjudication of ground truth by multiple experts.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and the Effect Size of How Much Human Readers Improve with AI vs. Without AI Assistance:
Not applicable. The Camino® SPM-1 is a hardware device for measuring ICP, not an AI-assisted diagnostic tool or an algorithm that human readers would use to improve their interpretations. Therefore, an MRMC study and AI assistance effect size are not relevant to this device.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done:
Not applicable. This is a standalone medical device in the sense that it measures ICP directly. It's not an algorithm that functions without human interaction for its primary purpose of measurement, but it also doesn't involve "human-in-the-loop performance" in the context of AI interpretation. Its performance is inherent in its measurement capabilities.
7. The Type of Ground Truth Used:
The ground truth for an Intracranial Pressure Monitor is direct measurement of intracranial pressure. This is a physiological measurement, not an expert consensus, pathology, or outcomes data in the usual diagnostic sense. The accuracy of the device's measurement would be compared against a known standard or another highly accurate measurement method (e.g., in a laboratory setting). While not explicitly stated, general performance testing for such a device would involve calibration and accuracy checks against pressure standards.
8. The Sample Size for the Training Set:
Not applicable. The Camino® SPM-1 is an electromechanical device, not a machine learning or AI model. Therefore, it does not have a "training set" in the computational sense.
9. How the Ground Truth for the Training Set Was Established:
Not applicable, as there is no training set for this type of device.
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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 DeviceProduct 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.
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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.
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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
§ 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).