CAMINO SINGLE PARAMETER MONITOR, MODEL SPM-1

K031086 · Integra Neurosciences · GWM · May 14, 2003 · Neurology

Device Facts

• Record ID: K031086
• Device Name: CAMINO SINGLE PARAMETER MONITOR, MODEL SPM-1
• Applicant: Integra Neurosciences
• Product Code: GWM · Neurology
• Decision Date: May 14, 2003
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 882.1620
• Device Class: Class 2

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.

Device Story

Camino SPM-1 is an intracranial pressure (ICP) monitor; modified version of Camino MPM-1. Device receives pressure signals from Camino 110-4 series ICP catheters; processes signals to provide continuous mean ICP display and high ICP alarm. Used in clinical settings by neurosurgeons; bedside monitor integration via non-sterile adapter cables. Lacks waveform display, temperature monitoring, and CPP calculation capabilities present in predicate. Provides real-time ICP data to assist clinical decision-making regarding patient neurological status.

Clinical Evidence

Bench testing only. Device underwent safety testing per IEC 60601-1 and UL 2601, alongside performance testing confirming technical soundness.

Technological Characteristics

Intracranial pressure monitor; utilizes Camino 110-4 series ICP catheters. Features continuous mean ICP display and high ICP alarm. Connectivity via PAC-2 Pre-Amp Cable and PMIO-SPM Patient Monitor Cable; interfaces with external bedside monitors via non-sterile adapter cables. Complies with IEC 60601-1 and UL 2601 standards.

Indications for Use

Indicated for use by qualified neurosurgeons when direct measurement of intracranial pressure (ICP) is clinically important.

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

• Camino® Multi-Parameter Pressure Monitor (K962928)

Submission Summary (Full Text)

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K031086

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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 [phone]

### 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,<br>cleared 12/20/96 under 510(k) K962928 |
| Common Name: | Intracranial Pressure Monitor |
| Classification Name: | Intracranial Pressure Monitoring Device<br>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.

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DEPARTMENT OF HEALTH & HUMAN SERVICES

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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 [phone]. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at [phone]. 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 [phone] or [phone] 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