(78 days)
The LICOX PMO Brain Oxygen Monitoring System measures intracranial oxygen and temperature and is intended as an adjunct monitor of trends of these parameters, indicating the perfusion status of cerebral tissue local to sensor placement. LICOX System values are relative within an individual, and should not be used as the sole basis for decisions as to diagnosis or therapy. It is intended to provide data additional to that obtained by current clinical practice in cases where hypoxia or ischemia are a concern.
The LICOX PMO System consists of a combined oxygen and temperature probe, the PMO Interface Device and cranial access accessories.
The provided text is a 510(k) summary for the LICOX PMO Brain Oxygen Monitoring System. This submission focuses on demonstrating substantial equivalence to a predicate device rather than presenting a de novo study with explicit acceptance criteria and performance data for a new device. Therefore, a direct response to some of the requested points, especially concerning "acceptance criteria," "study that proves the device meets the acceptance criteria," "sample size for the test set," "number of experts," "adjudication method," "MRMC study," "standalone algorithm performance," and "ground truth type," cannot be fully answered from the given document as these are typically part of a comprehensive clinical study report for a novel medical device or a new indication that doesn't claim substantial equivalence.
However, I can extract information related to the device's capabilities and how it compares to its predicate, which serves as the "proof" of its suitability for market under 510(k) regulations.
Here's a breakdown based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
Since this is a 510(k) for substantial equivalence, the "acceptance criteria" are implied by demonstrating that the new device (LICOX PMO) has equivalent performance characteristics to the legally marketed predicate device (LICOX Brain Oxygen Monitoring System K002765). The performance data cited is primarily for the predicate device, and the new device is stated to be "identical" where applicable.
| Acceptance Criteria (Implied from Predicate) | Reported Device Performance (LICOX PMO) / Predicate Performance |
|---|---|
| In Vitro Accuracy, PbtO2 | |
| 0-20 mm Hg | $\pm$ 2.0mmHg (Identical to predicate) |
| 21-50 mm Hg | $\pm$ 10% (Identical to predicate) |
| > 51 mm Hg | $\pm$ 13% (Identical to predicate) |
| Temperature Sensing Technology | Type K thermocouple incorporated into the CC1.P1 probe (Specific to PMO, but predicate also uses Type K) |
| In Vitro Accuracy, Temperature | N.A. (Not explicitly stated for PMO, but predicate is $\pm$ 0.2°C) |
| Sterility | Sterile (Identical to predicate) |
| Single-use | Yes (Identical to predicate) |
| Monitoring Duration | 5 days (Identical to predicate) |
| Tissue Contacting Material | Polyethylene (Identical to predicate) |
| O2 Sensing Technology | Clark Cell (Identical to predicate) |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size for Test Set: Not applicable/not explicitly provided. The submission relies on "extensive performance testing" and comparison to a predicate device, rather than a clinical trial with a defined test set for a new claim.
- Data Provenance: Not explicitly stated as retrospective or prospective clinical data from a specific country for a novel study. The document primarily refers to the substantial equivalence comparison and in-vitro accuracy of the predicate.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications
- Not applicable/not provided. This type of information is typically associated with clinical studies involving subjective interpretation (e.g., imaging) requiring expert consensus for ground truth establishment. This device measures physiological parameters directly.
4. Adjudication Method for the Test Set
- Not applicable/not provided. As mentioned above, this typically pertains to studies where interpretations are subjective and require consensus.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done
- No, a MRMC comparative effectiveness study was not done. The LICOX PMO is a physiological monitoring device, not an imaging interpretation or diagnostic algorithm that would typically benefit from an MRMC study. The comparison is between devices, not human readers with and without AI assistance.
6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Was Done
- Not applicable in the context of an "algorithm only" study. The LICOX PMO is a measurement device that provides raw data (oxygen and temperature readings). Its "performance" is its accuracy in these measurements, which is evaluated in vitro. It does not contain an AI algorithm for interpretation or diagnosis.
7. The Type of Ground Truth Used
- For the in vitro accuracy, the ground truth would be established by controlled laboratory measurements using traceable standards for oxygen partial pressure and temperature. The document specifically mentions "In Vitro Accuracy" for PbtO2 and Temperature, indicating that these were measured against known, accurate values in a laboratory setting. This is a form of direct measurement against a reference standard.
8. The Sample Size for the Training Set
- Not applicable/not provided. The device is not an AI/ML algorithm that requires a training set. Its engineering is based on established physical principles (Clark Cell for oxygen, Type K thermocouple for temperature).
9. How the Ground Truth for the Training Set Was Established
- Not applicable. No training set for an AI/ML algorithm is mentioned.
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LICOX PMO Brain Oxygen Monitoring System, 510 (K) SUMMARY
Submitter's name and address:
Integra LifeSciences, dba Integra NeuroSciences 311 Enterprise Drive Plainsboro, NJ 08536, USA
Contact person and telephone number:
Nancy A. Mathewson, Esq. Director, Regulatory Affairs (858) 455-1115 ext. 185
Date summary was prepared:
January 29, 2004
Name of the device:
Proprietary Name: Common Name: Classification Name: LICOX PMO Brain Oxygen Monitoring System Brain Oxygen and temperature monitoring device Intracranial Pressure Monitoring Device, 21 CFR 882.1620, 84GWM Neurology Device Panel
Classification Panel:
Substantial Equivalence:
The features of the LICOX PMO System are substantially equivalent to those of a legally marketed predicate device, the LICOX Brain Oxygen Monitoring System, which was cleared to market under 510(k) K002765 and 510(k) K020558.
Both devices were designed and are manufactured by the same company, GMSmbH, Kiel-Mielkendorf, Germany, which is an Integra LifeSciences/Integra NeuroSciences Company.
Device Description:
The LICOX PMO System consists of a combined oxygen and temperature probe, the PMO Interface Device and cranial access accessories. The following is a list of products covered by this submission, grouped into the following categories: Disposables, PMO Interface Device and associated cables. The list does not
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include minor accessories such as cables or convenience kits that are combinations of items listed below.
| Model Numbers and Description | ||
|---|---|---|
| ModelNumber | Product Description | |
| Disposables | CC1.P1 | Combined Oxygen and Temperature Sensing Probe |
| IP1 | Introducer Kit with Bolt, for use with CC1.P1Oxygen/Temperature Probe | |
| IP2 | Introducer Kit, two way, for CC1.P1.Oxygen/Temperature Probe and an ICP Probe | |
| VK5.2 | Introducer Kit, trocar/sleeve for tunneled placement ofthe CC1.P1 | |
| PMOInterfaceDevice | PMO.BOX | Patient monitor interface |
| MonitorAccessories | BC10.PMO | Connects the CC1.P1 to the existing LICOX Monitor,AC3 |
Table 1 LICOX PMO Brain Oxygen Monitoring System dal Numbers and Description
Statement of Intended Use:
The LICOX PMO Brain Oxygen Monitoring System measures intracranial oxygen and temperature and is intended as an adjunct monitor of trends of these parameters, indicating the perfusion status of cerebral tissue local to sensor placement. LICOX System values are relative within an individual, and should not be used as the sole basis for decisions as to diagnosis or therapy. It is intended to provide data additional to that obtained by current clinical practice in cases where hypoxia or ischemia are a concern.
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| LICOXBrain Oxygen MonitoringSystem(K002765) | LICOX PMO Brain OxygenMonitoring System | |
|---|---|---|
| Indications | The LICOX Brain Oxygen MonitoringSystem measures intracranial oxygenand temperature and is intended as anadjunct monitor of trends of theseparameters, indicating the perfusionstatus of cerebral tissue local to sensorplacement. LICOX System values arerelative within an individual, andshould not be used as the sole basis fordecisions as to diagnosis or therapy. Itis intended to provide data additionalto that obtained by current clinicalpractice in cases where hypoxia orischemia are a concern. | Identical to the currently marketedLICOX Brain Oxygen MonitoringSystem. |
| Anatomical Site | Brain parenchyma | Identical to the currently marketedLICOX Brain Oxygen MonitoringSystem. |
| TargetPopulation | Head trauma, craniotomy, withpossible hypoxia or ischemia. | Identical to the currently marketedLICOX Brain Oxygen MonitoringSystem. |
| LICOX CMP Monitor | LICOX PMO Interface Device | |
| Operation | Analog with Microprocessor | Analog only |
| Screen | Alpha-numeric | None |
| Monitoring | Continuous | Identical to the currently marketedLICOX Brain Oxygen MonitoringSystem. |
| Power Supply | Custom A/C-D/C Supply | Powered by battery or excitationvoltage of patient bedside monitor |
| Data output | Serial and Analog | Analog only |
| Dimensions | 34 cm x 32 cm x 8.5 cm | 8 cm x 18cm x 4.5 cm |
| Weight | 4.2 kg | 2.7 kg |
| Case material | Plastic | Plastic |
| OperatingTemperature | +10°C to +40°C | Identical to the currently marketedLICOX Brain Oxygen MonitoringSystem. |
| LICOX Sensor | LICOX PMO Sensor | |
| Parameters | Brain PbtO2Temperature | Brain PbtO2 |
| Sterility | Sterile | Identical to the currently marketedLICOX Brain Oxygen MonitoringSystem. |
| Single-use | Yes | Identical to the currently marketedLICOX Brain Oxygen MonitoringSystem. |
| LICOXBrain Oxygen MonitoringSystem(K002765) | LICOX PMO Brain OxygenMonitoring System | |
| Single-use | Yes | Identical to the currently marketedLICOX Brain Oxygen MonitoringSystem. |
| Monitoringduration | 5 days | Identical to the currently marketedLICOX Brain Oxygen MonitoringSystem. |
| Tissuecontactingmaterial | Polyethylene | Identical to the currently marketedLICOX Brain Oxygen MonitoringSystem. |
| O2 Sensingtechnology | Clark Cell | Identical to the currently marketedLICOX Brain Oxygen MonitoringSystem. |
| Outsidediameter | 0.8 mm | 0.65 to 1.3 mm |
| Patient Access | Introducer and Bolt Kit, tunnelingtrocar and sheath | Introducer and bolt kit, tunnelingtrocar and sheath |
| Calibration | Smart Card calibrated to each oxygensensor during manufacture, SmartCard read by monitor at time of use | Calibration information stored withinthe connector and calibratesautomatically when connected to thePMO Interface Device. OrIdentical to the currently marketedLICOX Brain Oxygen MonitoringSystem when used with the LICOXCMP monitor. |
| In VitroAccuracy,PbtO2 | $\pm$ 2.0mmHg (0-20 mm Hg)$\pm$ 10% (21 mm Hg-50 mm Hg)$\pm$ 13% > 51 mm Hg | Identical to the currently marketedLICOX Brain Oxygen MonitoringSystem. |
| LICOX Temperature Sensor | LICO PMO Sensor | |
| TemperatureSensingTechnology | Type K thermocouple as part of theC8.B temperature probe | Type K thermocouple incorporatedinto the CC1.P1 probe |
| In VitroAccuracy,Temperature | $\pm$ 0.2°C | N.A |
Comparison of technological characteristics to the predicate device:
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Safety
Biocompatibility studies were conducted per FDA G95-1 and ISO 10993 and have demonstrated that the materials used to manufacture the LICOX oxygen / temperature sensing probe, probe introducer, bolt and tunneling sheath are safe for their intended use.
In addition, the LICOX PMO Brain Oxygen Monitoring System was subjected to extensive performance testing. Results of the testing showed that the probe design was technically sound and the product safe for its intended use.
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The LICOX PMO Brain Oxygen Monitoring System manufacturing process complies with the United States Food and Drug Administration and European Standards for the manufacturing of medical devices.
Conclusion:
Management of the neurological recovery of patients who suffer a traumatic brain injury or undergo brain surgery may be aided by the use of monitoring systems such as the LICOX PMO Brain Oxygen Monitoring System. When used in conjunction with the existing armamentarium, direct monitoring of the Partial Pressure of Oxygen in brain provides the clinician with an additional significant parameter that can be used to avoid secondary insult and improve recovery.
The LICOX PMO Brain Oxygen Monitoring System is substantially equivalent to the predicate devices delineated in the submission and the requirements for a Premarket Notification 510(k) as defined in 21 CFR, Part 807.
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DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/5/Picture/1 description: The image is a seal for the Department of Health & Human Services - USA. The seal is circular and contains the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. In the center of the seal is an abstract symbol that resembles an eagle or bird in flight.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
APR 2 0 2004
Ms. Nancy A. Mathewson, Esq. Director, Regulatory Affairs Integra LifeSciences Corporation 311 Enterprise Drive Plainsboro, New Jersey 08536
Re: K040235
Trade/Device Name: LICOX PMO Brain Oxygen Monitoring System Regulation Number: 21 CFR 882.1620 Regulation Name: Intracranial pressure monitoring device Regulatory Class: II Product Code: GWM Dated: January 29, 2004 Received: February 2, 2004
Dear Ms. Mathewson:
We have reviewed your Section 510(k) premarket notification of intent to market the device we nave reviewed your bection of the 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 encreated of the enactment date of the Medical Device Amendments, or 10 commerce prior to May 20, 1970, the enaordance with the provisions of the Federal Food, Drug, de rices that have been require approval of a premarket approval application (PMA). and Cosmetter rest (rece) that as nevice, subject to the general controls provisions of the Act. The I ou may, therefore, mance the act include requirements for annual registration, listing of general controll provision practice, labeling, and prohibitions against misbranding and adultcration.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it If your device is elasbition (voor accres) ols. Existing major regulations affecting your device can thay be subject to saterial Regulations, Title 21, Parts 800 to 898. In addition, FDA may be found in the councements concerning your device in the Federal Register.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean i Ticase oc advised that I Dri instan that your device complies with other requirements of the Act that 11.71 has mates and regulations administered by other Federal agencies. You must of any I cacial statutes and regaraments, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set CIN in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic form in the quant) by became (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) This letter will anow you to oegin manketing your and equivalence of your device to a legally premarket nothleation: "The PDA maing of cation 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 If you desire specific advice ior your as (301) 594-4659. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). You may obtain . Missuallung by telefoned to premaintentibilities under the Act from the Division of Small other general 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,
iriam 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):
Device Name: LICOX PMO Brain Oxygen Monitoring System
Indications For Use: The LICOX PMO Brain Oxygen Monitoring System measures intracranial oxygen and temperature and is intended as an adjunct monitor of trends of these parameters, indicating the perfusion status of cerebral tissue local to sensor placement. LICOX System values are relative within an individual, and should not be used as the sole basis for decisions as to diagnosis or therapy. It is intended to provide data for doctories as to obtained by current clinical practice in cases where hypoxia or ischemia are a concern.
Prescription Use _ X
AND/OR
Over-The-Counter Use
(Part 21 CFR 801 Subpart D)
(21 CFR 807 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Miriam C. Provost
(Division Sign-Off) Division of General, Restorative, and Neurological Devices
Page 1 of 1
510(k) Number K640235
§ 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).