(21 days)
The Camino Slim-Line™ Intracranial Monitoring System has been designed for use by a qualified neurosurgeon in the direct monitoring of intracranial pressure in both sub-dural and intraparenchymal applications.
The Camino Slim-Line™ system consists of a single-use 1.3mm diameter parenchymal and sub-dural catheter for the real-time measurement of intracran pressure (ICP) and an in-line cable monitor for the display of measured pressure. The Camino Slim-Line™ monitor can be connected to an external patient monitoring system to relay ICP measurements. ICP is monitored directly by a solid state sensor mounted on the side of the Camino Slim-Line™ ICP catheter close to its tip. The sensor is precalibrated in the factory with probe identification and calibration values stored within each probe and there is no requirement for the user to calibrate the probe before use. The Camino Slim-Line™ monitor uses a small LCD display to show the measured ICP continuously in real time, both in digital form and as a real-time trace. The monitor can relay this measured information to an external patient monitoring system. In parenchymal applications, the Camino Slim-Line™ ICP catheter is used with an ing single-use Camino cranial access port or bolt, and an existing C ence procedure kit for cranial access. For Sub-dural applie eTM ICP catheter may be used with an existing tunneling trocar and convenience procedure kit for cranial access.
The provided document (K042728) describes the Camino Slim-Line™ Intracranial Pressure Monitoring System. It mainly focuses on demonstrating substantial equivalence to predicate devices rather than presenting a detailed study with specific acceptance criteria and performance metrics for a novel technology.
However, based on the information provided, we can infer the acceptance criteria and the type of study rather than a detailed performance report. The document states: "In vitro testing shows that the device meets similar performance specifications for the predicate devices." This implies that the acceptance criteria are largely derived from the performance specifications of the predicate devices.
Reconstructed Information based on the provided text:
Acceptance Criteria and Study Details for Camino Slim-Line™ Intracranial Pressure Monitoring System
The regulatory submission for the Camino Slim-Line™ system centered on demonstrating substantial equivalence to existing legally marketed devices. This means that the "acceptance criteria" were primarily focused on showing that the new device performs similarly in terms of its core functionality (intracranial pressure measurement) as its predecessors and does not raise new safety or effectiveness concerns.
The study that "proves" the device meets these criteria is the in vitro testing mentioned, which aimed to show comparable performance to the predicate devices.
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criterion (Inferred from Predicate Equivalence) | Reported Device Performance (Inferred from "in vitro testing") |
|---|---|
| Intended Use: Direct monitoring of intracranial pressure in both sub-dural and intraparenchymal applications. | Device is designed for this intended use and, through in vitro testing, demonstrated capability congruent with this use. No new issues of safety or effectiveness identified. |
| Principles of Operation: Measurement of ICP via a solid-state sensor. | Operates on similar principles as predicate devices. In vitro testing demonstrated functionality. |
| Materials: Use of biocompatible materials suitable for intracranial implantation. | Similar construction (implied similar materials) to predicate devices. |
| Design: 1.3mm diameter catheter, in-line cable monitor, LCD display. | Design features are described, and in vitro testing would have verified basic functionality of these components. |
| Performance Specifications (e.g., accuracy, stability, drift, response time specific to ICP measurement): Implicitly similar to predicate devices K013930, K914479, K853864. | "In vitro testing shows that the device meets similar performance specifications for the predicate devices." (Exact numerical specifications are not provided in this document but would have been part of the underlying testing.) |
| Pre-calibration: Factory pre-calibration with probe identification and calibration values stored within each probe. | Functionality verified during in vitro testing (implied). |
| Safety: No new issues of safety or effectiveness. | Determined through comparison to predicate devices and in vitro testing. |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size for Test Set: Not specified in the provided document. The term "in vitro testing" suggests laboratory-based testing, which would involve a certain number of devices or scenarios.
- Data Provenance: The "in vitro testing" was conducted by Novus Monitoring Ltd, the submitter, as part of their R&D and regulatory submission process. The country of origin for the data is likely United Kingdom, where Novus Monitoring Ltd is based. The testing would be prospective in nature, as it was conducted specifically to support the regulatory submission.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of those Experts
- This type of information is generally not relevant for an in vitro performance assessment of a physical measurement device like an ICP monitor. Ground truth for in vitro testing typically relies on calibrated reference standards or highly accurate laboratory equipment, not human expert consensus for interpretation.
- The document mentions the intended user is a "qualified neurosurgeon," but this relates to clinical use, not the establishment of ground truth for device performance testing itself.
4. Adjudication Method for the Test Set
- Not applicable. Adjudication methods (like 2+1, 3+1) are used when human interpretation of data (e.g., images) forms the ground truth, particularly in studies involving diagnostic aids. For an in vitro test of an ICP monitor, measurement against a reference standard is the method, not adjudication.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done
- No, an MRMC comparative effectiveness study was not done. This type of study is typically performed for diagnostic imaging devices where human readers interpret medical images, and the AI's assistance is evaluated against human performance. The Camino Slim-Line™ is a direct measurement device, not an imaging device that requires human interpretation in the same way.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done
- Yes, effectively, a standalone performance assessment was done. The "in vitro testing" described would be a standalone evaluation of the device's ability to accurately measure ICP against known reference pressures or conditions, without a human user actively interpreting or modifying the device's output. The device itself (sensor and monitor) forms the "algorithm only" in this context of a direct measurement device.
7. The Type of Ground Truth Used
- The ground truth for the "in vitro testing" would be established using calibrated reference standards or highly precise laboratory equipment capable of generating and measuring known pressures under controlled conditions. This ensures the accuracy, linearity, and stability of the ICP monitor's readings. It is not based on expert consensus, pathology, or outcomes data, which are more relevant for diagnostic or clinical efficacy studies.
8. The Sample Size for the Training Set
- Not applicable. This device is a direct measurement hardware system, not an AI/ML-based diagnostic algorithm that requires a "training set" in the conventional sense of machine learning. The device is pre-calibrated in the factory, meaning its internal settings and performance characteristics are established through manufacturing processes and engineering calibration, not through training on a dataset.
9. How the Ground Truth for the Training Set was Established
- Not applicable. As explained above, there is no "training set" for this type of device. The accuracy and calibration are established through engineering design, factory calibration procedures, and quality control checks against physical reference standards.
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OCT 2 2 2004
510(k) Summary KO42728 September 29th 2004
Submitter 1
Novus Monitoring Ltd Greenways Abbotts Ann, Andover Hampshire, SP11 7BH United Kingdom
| Contact Person: | Prof. Peter F Gibson |
|---|---|
| Telephone: | +44 1264 711080 |
| Facsimile: | +44 1264 711083 |
Name of Device 2
| Proprietary Name: | Camino Slim-Line™ Intracranial Pressure MonitoringSystem, comprising:a) Camino Slim-Line™ monitorb) Camino Slim-Line™ parenchymal and sub-dural ICP catheter |
|---|---|
| Common Name: | a) Intracranial Pressuremonitorb) Parenchymal and sub-dural catheter forintracranial pressure measurement |
| Device Classification: | Intracranial pressure monitoring devices have been placed inClass II as per 21 CFR Regulation Number 882.1620 andassigned the Product Code GWM. |
Predicate Devices 3
The components of the Camino Slim-Line™ system are substantially equivalent to the following legally marketed devices:
| K013930 | NeuroSensor™ System |
|---|---|
| K914479 | Codman ICP monitoring system and Microsensor™ ICPtransducer |
| K853864 | Camino Intracranial Pressure Monitoring Kit |
This statement is based on the subject device's similarity to the predicate devices in intended use, materials, design and principles of operation.
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Device Description
The Camino Slim-Line™ system consists of a single-use 1.3mm diameter parenchymal and sub-dural catheter for the real-time measurement of intracran pressure (ICP) and an in-line cable monitor for the display of measured pressure. The Camino Slim-Line™ monitor can be connected to an external patient monitoring system to relay ICP measurements.
ICP is monitored directly by a solid state sensor mounted on the side of the Camino Slim-Line™ ICP catheter close to its tip. The sensor is precalibrated in the factory with probe identification and calibration values stored within each probe and there is no requirement for the user to calibrate the probe before use.
The Camino Slim-Line™ monitor uses a small LCD display to show the measured ICP continuously in real time, both in digital form and as a real-time trace. The monitor can relay this measured information to an external patient monitoring system.
In parenchymal applications, the Camino Slim-Line™ ICP catheter is used with an ing single-use Camino cranial access port or bolt, and an existing C ence procedure kit for cranial access. For Sub-dural applie eTM ICP catheter may be used with an existing tunneling trocar and convenience procedure kit for cranial access.
Intended Use
The Camino Slim-Line™ system has been designed for use by a qualific neurosurgeon in the dire monitoring of intracranial pressure in both subintraparenchymal applications.
Summary of Substantial Equivalence
The Camino Slim-Line™ Intracranial Monitoring System is similar in struction, materials, intended use and performance characteristic In vitro testing shows that the device meets similar per se for the predicate devices. No new issues of sa iced by using this 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 - USA. The seal features a stylized eagle with three stripes extending from its head, symbolizing health and human services. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the eagle.
Public Health Service
OCT 2 2 2004
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Novus Monitoring Ltd c/o Ms. Judith E. O'Grady Senior Vice President, Regulatory Affairs Integra LifeSciences Corporation 311 Enterprise Drive Plainsboro, New Jersey 08536
Re: K042728
K042720
Trade/Device Name: Camino Slim-Line™ Intracranial Pressure Monitoring System Regulation Number: 21 CFR 882.1620 Regulation Name: Intracranial pressure monitoring device Regulatory Class: II Product Code: GWM Dated: September 30, 2004 Received: October 1, 2004
Dear Ms. O'Grady:
We have reviewed your Section 510(k) premarket notification of intent to market the device we nave reviewed your becasin b r (s) pe device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate for use stated in the enactment date of the enactment date of the Medical Device Amendments, or to conninered processified in accordance with the provisions of the Federal Food, Drug, de vices that have been rocksonied in avire approval of a premarket approval application (PMA). and Cosmetic Act (71ct) that ac not required to the general controls provisions of the Act. The r ou may, increrere, mass of the Act include requirements for annual registration, listing of general controll pro reversive, 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 if your device to such additional controls. Existing major regulations affecting your device can may be subject to back as a sublimations, 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 I hat FDA has made a determination that your device complies with other requirements of the Act that I 197 Has made a and regulations administered by other Federal agencies. You must or any I odetar bated and stequirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set of I rat 007), as extens (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. Judith E. O'Grady
This letter will allow you to begin marketing your device as described in your Section 510(k) rms retet notification. The FDA finding of substantial equivalence of your device to a legally premailed nevice 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), pleasc 11 Jou dome of Compliance at (240) 276-0115. 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 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,
Miriam 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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Indications for Use
510(k) Number (if Known): |くOY2728
Camino Slim-Line™ Intracranial Pressure Monitoring Device Name: System The Camino Slim-Line™ Intracranial Monitoring Indications for Use: System has been designed for use by a qualified neurosurgeon in the direct monitoring of intracranial pressure in both sub-dural and intraparenchymal applications.
Prescription Use __ (Part 21 CFR 801 Subpart D)
AND/OR
Over-The-Counter Use _________________________________________________________________________________________________________________________________________________________ (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH Office of Device Evaluation (ODE)
Muriam C Provost
(Division Sign-Off) Division of General, Restorative, and Neurological Devices
510(k) Number_________________________________________________________________________________________________________________________________________________________________
§ 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).