(26 days)
The MoniTorr ICP™ External CSF Drainage and Monitoring Systems allow for drainage and monitoring of CSF from the lateral ventricles of the brain and the lumbar subarachnoid space in selected patients to reduce intracranial pressure (ICP), to monitor CSF, to provide temporary drainage of CSF in patients with infected CSF shunts, and the monitoring of ICP.
The Integra Pole Mount Assemblies are utilized with the MoniTorr ICP™ External Drainage and Monitoring Systems to provide support and alignment on an I.V. Pole.
The Integra Pole Mount Assembly has been modified to include a line level and a laser level. The MoniTorr ICP™ External CSF Drainage and Monitoring Systems can be used with a pole mount assembly. The Integra Pole Mount Assemblies are designed provide support and alignment to the MoniTorr ICP™ External CSF Drainage and Monitoring Systems on an I.V. Pole. The Integra Pole Mount Assemblies are designed to be reusable. The reusable Integra Pole Mount Assembly is comprised of a graduated rail with a grooved profile to support the sliding bracket which facilitates setting the pressure level while using the disposable external drainage system. The Pole Mount Assembly is aligned with the patient's anatomical reference point by using a pointer, line level or laser.
The MoniTorr ICP™ External CSF Drainage and Monitoring Systems are designed to externally drain cerebrospinal fluid (CSF) from the lateral ventricles of the brain or the lumbar subarachnoid space to a drainage bag in selected patients. The systems connect to a ventricular or lumbar catheter via a luer connection to a patient line and ultimately to a drainage bag. In most of the systems, the patient line is connected to a graduated burette that is then connected to the drainage bag. CSF can be collected and measured in the burette and subsequently emptied into the drainage bag by opening the stopcock placed in line between the burette and the drainage bag. In systems with this burette, an antimicrobial vent is included in the burette cap. This antimicrobial vent allows air to enter the burette to facilitate drainage from the burette to the drainage bag while protecting the system from microbial contamination. These systems are designed for single use only.
This 510(k) pertains to a device modification for the Integra MoniTorr ICP™ External CSF Drainage and Monitoring Systems. The modification involves adding a line level and a laser level to the Integra Pole Mount Assembly, an accessory used with the drainage system. This submission claims substantial equivalence to previously cleared versions of the device (K920156 and K022554) and does not contain detailed information about specific acceptance criteria and performance studies in the provided text.
Based on the provided text, the device is a Class II medical device (Central Nervous System Shunt and Components JXG). For Class II devices modified through a Special 510(k), the focus is often on demonstrating that the modifications do not alter the fundamental safety and effectiveness of the device and that the new features (like the laser level) comply with relevant standards.
Here's an analysis based on the available information:
1. Table of acceptance criteria and the reported device performance:
The provided document does not explicitly state quantitative acceptance criteria or detailed performance data for the MoniTorr ICP™ External CSF Drainage and Monitoring Systems or its modified pole mount assembly. The submission focuses on demonstrating compliance of the modified component (the laser level) with existing safety standards.
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Not explicitly stated in the document. The submission focuses on establishing substantial equivalence and compliance with laser safety standards for the modified component. | Not explicitly stated in the document. The submission claims the modified device is substantially equivalent to predicate devices. |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective):
The document does not mention a test set with a specific sample size or data provenance for evaluating the performance of the MoniTorr ICP™ External CSF Drainage and Monitoring Systems or its modified pole mount assembly. This is an accessory modification submission, and testing likely focused on the modified component's compliance with safety standards rather than a clinical performance study.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience):
The document does not mention experts or ground truth establishment for a test set. This type of evaluation is not typical for a device modification focused on an accessory like a pole mount with a laser level, where the primary concern is the safe operation and compliance of the new feature.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:
The document does not mention any adjudication method for a test set, as no specific clinical test set is described.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:
This device is not an AI-powered diagnostic or interpretive system. Therefore, an MRMC comparative effectiveness study is not applicable and was not performed.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
This device is a physical medical device for CSF drainage and monitoring, not an algorithm. Therefore, standalone algorithm performance is not applicable and was not done.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
The concept of "ground truth" as typically applied to diagnostic or interpretive algorithms is not relevant for this physical device modification. The "truth" here would relate to the laser level accurately indicating alignment, and the device continuing to safely and effectively drain and monitor CSF as intended by the predicate devices.
8. The sample size for the training set:
As this is a physical device modification, not an AI or machine learning algorithm, there is no training set in the traditional 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 modification.
Summary of what the document does provide regarding safety and compliance:
The submission focuses on the safety and compliance of the added laser level on the Integra Pole Mount Assembly.
- The laser level is categorized as a Class II Laser and is stated to comply with 21 CFR 1040.10 and 1040.11, with deviations pursuant to Laser Notice No. 50 dated July 26, 2001.
- It is also stated to be "fully compliant with the following standards":
- BS EN 60601-1-2 (1993)
- EN 60601-1-2 (2003)
- EN 61000-4-2 (1995)
- EN 61000-4-3 (1996) above 1 GHz
- EN 61000-4-8 (1993) in accordance with EN 60601-1-2 (2001)
These standards are related to medical electrical equipment, electromagnetic compatibility, and laser product safety. The "study" proving the device meets criteria in this context would be the testing and documentation demonstrating adherence to these specific regulatory and international standards for the laser component, along with a substantial equivalence argument for the overall device's continued safety and effectiveness with the modification. The 510(k) clearance itself (K062599) confirms that the FDA reviewed these claims and found the device substantially equivalent.
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Integra NeuroSciences
Special 510(k): Device Modification
MoniTorr ICP™ External CSF Drainage and Monitoring Systems
Page 1 of 2
MoniTorr ICP™ External CSF Drainage and Monitoring Systems
510(k) SUMMARY
Submitter's name and address:
SEP 2 7 2006
Integra NeuroSciences 311 Enterprise Drive Plainsboro, NJ 08536
Contact person and telephone number:
Darlene M. Welsh, RAC Sr. Regulatory Affairs Project Manager Telephone: 609-936-2307 Facsimile: 609-275-9445
Date summary was prepared:
August 30, 2006
Name of the device:
| Proprietary Name: | MoniTorr ICP™ External CSF Drainage and Monitoring Systems |
|---|---|
| Common Name: | External Cerebrospinal Fluid Drainage and Monitoring System |
| Classification Name: | Central Nervous System Shunt and Components JXG |
Substantial Equivalence:
The MoniTorr ICPTM External CSF Drainage and Monitoring Systems are substantially equivalent in function and intended use to the unmodified MoniTorr™ External CSF Drainage and Monitoring Systems which have been cleared to market under Premarket Notification 510(k)'s K920156 and K022554.
Intended use:
The MoniTorr ICPTM External CSF Drainage and Monitoring Systems allow for drainage and monitoring of CSF from the lateral ventricles of the brain and the lumbar subarachnoid space in selected patients to reduce intracranial pressure (ICP), to monitor CSF, to provide temporary drainage of CSF in patients with infected CSF shunts, and the monitoring of ICP.
The Integra Pole Mount Assemblies are utilized with the MoniTorr ICP™ External Drainage and Monitoring Systems to provide support and alignment on an I.V. Pole.
Device Description:
The Integra Pole Mount Assembly has been modified to include a line level and a laser level. The MoniTorr ICP™ External CSF Drainage and Monitoring Systems can be used
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Kob 25-99
Page 2 of 2
Integra NeuroSciences Special 510(k): Device Modification MoniTorr ICPTM External CSF Drainage and Monitoring Systems
with a pole mount assembly. The Integra Pole Mount Assemblies are designed provide support and alignment to the MoniTorr ICP™ External CSF Drainage and Monitoring Systems on an I.V. Pole. The Integra Pole Mount Assemblies are designed to be reusable. The reusable Integra Pole Mount Assembly is comprised of a graduated rail with a grooved profile to support the sliding bracket which facilitates setting the pressure level while using the disposable external drainage system. The Pole Mount Assembly is aligned with the patient's anatomical reference point by using a pointer, line level or laser.
The MoniTorr ICP™ External CSF Drainage and Monitoring Systems are designed to externally drain cerebrospinal fluid (CSF) from the lateral ventricles of the brain or the lumbar subarachnoid space to a drainage bag in selected patients. The systems connect to a ventricular or lumbar catheter via a luer connection to a patient line and ultimately to a drainage bag. In most of the systems, the patient line is connected to a graduated burette that is then connected to the drainage bag. CSF can be collected and measured in the burette and subsequently emptied into the drainage bag by opening the stopcock placed in line between the burette and the drainage bag. In systems with this burette, an antimicrobial vent is included in the burette cap. This antimicrobial vent allows air to enter the burette to facilitate drainage from the burette to the drainage bag while protecting the system from microbial contamination. These systems are designed for single use only.
Safety
The Integra Pole Mount Assemblies are accessories for the MoniTorr ICP™ External CSF Drainage and Monitoring Systems. Alignment can be achieved through the use of a line level or laser level. The laser level is a Class II Laser and complies with 21 CFR 1040.10 and 1040.11 except for deviations pursuant to Laser Notice No. 50 dated July 26, 2001.
The laser is fully compliant with the following standards:
BS EN 60601-1-2 (1993) EN 60601-1-2 (2003) EN 61000-4-2 (1995) EN 61000-4-3 (1996) above 1 GHz EN 61000-4-8 (1993) in accordance with EN 60601-1-2 (2001)
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Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a stylized eagle with three stripes forming its body and head. The eagle is facing right. The text "DEPARTMENT OF HEALTH AND HUMAN SERVICES - USA" is arranged in a circular fashion around the eagle.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
SEP 2 7 2006
Integra NeuroSciences % Darlene M. Welsh, RAC Senior Regulatory Affairs Project Manager 311 Enterprise Drive Plainsboro, New Jersey 08536
Re: K062599
K002.577
Trade/Device Name: MoniTorr ICP™ External Drainage and Monitoring System Regulation Number: 21 CFR 882.5550 Regulation Name: Central nervous system fluid shunt components Regulatory Class: Class II Product Code: JXG Dated: August 31, 2006 Received: September 1, 2006
Dear Ms. Welsh:
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 enclosure) to regard) at the Medical Device Amendments, or to conninerec prof to May 20, 1978, the excordance with the provisions of the Federal Food, Drug, devices mat nave been recuired in assere approval of a premarket approval application (PMA). alle Cosmetic Act (1107 market the device, subject to the general controls provisions of the Act. The 1 ou may, merclore, market the Act include requirements for annual registration, listing of general controls provisions of the rice 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 is classified (500 a0070) als. Existing major regulations affecting your device can
may be subject to such additional controls. Existing major regulations of may be subject to such additional controller s, 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 Prease be advised that I Dri s issuated of a badewines with other requirements of the Act that TDA has made a dolorimiation administered by other Federal agencies. You must of any Peteral statures and regalations and limited to: registration and listing (21 comply with an the Act s requirements) newslag, which and securing practice requirements as set CTN Fall 807), adomig (21 CFR Part 820); and if applicable, the electronic .
forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, 1950 rorth in the quality systems (Sections 531-542 of the Act); 21 CFR 1000-1050.
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Page 2 - Darlene M. Welsh, RAC
This letter will allow you to begin marketing your device as described in your Section 510(k) This tetter will anow you to oegin manies.ing 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 (24 CFR Part 801), please If you desire specific darioliance 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 other geleral information on your responser Assistance at its toll-free number (800) 638-2041 or (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours,
far Dale
Mark N. Melkerson 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 STATEMENT
# 510(k) Number: [K062599](https://510k.innolitics.com/device/K062599)
Device Name: MoniTorr ICP™ External CSF Drainage and Monitoring Systems
# Indications for Use:
The MoniTorr ICP™ External CSF Drainage and Monitoring Systems allow for drainage and monitoring of CSF from the lateral ventricles of the brain and the lumbar subarachnoid space in selected patients to reduce intracranial pressure (ICP), to monitor CSF, to provide temporary drainage of CSF in patients with infected CSF shunts, and to monitor ICP.
ription Us (Part 21 CFR 801 Subpart D
AND/OR
Over-The-Counter Use (21 CFR 807 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
(Division Sign-Off) Division of General, Restorative, and Neurological Devices
510(k) Number [K062155](https://510k.innolitics.com/device/K062155)
§ 882.5550 Central nervous system fluid shunt and components.
(a)
Identification. A central nervous system fluid shunt is a device or combination of devices used to divert fluid from the brain or other part of the central nervous system to an internal delivery site or an external receptacle for the purpose of relieving elevated intracranial pressure or fluid volume (e.g., due to hydrocephalus). Components of a central nervous system shunt include catheters, valved catheters, valves, connectors, and other accessory components intended to facilitate use of the shunt or evaluation of a patient with a shunt.(b)
Classification. Class II (performance standards).