(90 days)
Draining and monitoring of CSF flow from the lateral ventricles or lumbar subarachnoid space is indicated in selected patients to
- Reduce intracranial pressure (ICP), e.g. pre-intra- or postoperative;
- Monitor CSF chemistry, cytology and physiology;
- Provide temporary CSF drainage in patients with infected cerebrospinal fluid shunts.
The monitoring of the intracranial pressure (ICP) is indicated in selected patients with - Severe head injury;
- Subarachnoid hemorrhage graded III, IV or V preoperatively;
- Reves syndrome or similar encephalopathies;
- Hydrocephalus;
- Intracranial hemorrhage
- Miscellaneous problems when drainage is to be used as a therapeutic maneuver. Monitoring can also be used to evaluate the status pre-and postoperatively for space occupying lesions.
The reusable portion of the system is comprised of a pressure scale, mounting clamp and optional laser level. All components of the reusable device are integrated during manufacture. The scale has a blue anodized finish with contrasting pressure scale. Down the center of the scale is a track for the disposable device to be retained. The scale is integrated into a pole clamp that has been ergonomically designed to facilitate use. An optional laser device may be attached to the pole clamp. It is used to obtain a zero pressure reference with the patients Foramen of Monro.
The disposable device is comprised of three basic elements: a patient line that is attached to an externalized CSF drainage catheter, graduated drip chamber, and drainage bag. The drip chamber has an integrated mounting bracket that is inserted into the track on the reusable scale.
The Medtronic PS Medical Niveau Drainage System is deemed substantially equivalent to predicate devices, but the provided text does not contain detailed acceptance criteria, device performance data from specific studies, or any information regarding AI components.
Here's a breakdown of the requested information based on the provided document:
1. Table of Acceptance Criteria and Reported Device Performance:
The provided document does not explicitly state specific acceptance criteria or report detailed device performance metrics from a study (e.g., accuracy, precision, sensitivity, specificity, flow rates, ICP measurement accuracy, etc.). The document focuses on demonstrating substantial equivalence to predicate devices based on intended use, technological comparison of features, and materials.
The table below outlines the comparison of features, which is presented as evidence of substantial equivalence rather than a direct performance against acceptance criteria.
| Feature Comparison | Medtronic PS Medical Niveau Drainage System | Clinical Neuro Systems MoniTorr | Codman External Drainage System II |
|---|---|---|---|
| Device Configuration/Contents | |||
| Locking bracket | Integral with mounting panel | Pole mount bracket assembly, braided cord and cord lock | Doubled 24 in. string w/Cord-loc® locking mechanism |
| Mounting panel | Main system section with pressure scale in mmHg and cmH2O | System Panel with instruction label | 27 cm measuring backboard |
| Drip Chamber | 50 cc Conical sliding graduated flow chamber with locking bracket and vent system | 100 ml graduated chamber with filter vent | 75 ml drip chamber with anti-reflux valve and atmospheric vent |
| Patient line | Nondistensible blue striped patient connection line | Nondistensible green striped patient connection line | 157 cm patient line with two slide clamps |
| Stopcocks | Two four-way stopcocks | Two four-way stopcocks | Two four-way stopcocks with female luer port |
| Injection/Sampling Sites | One non-latex injection/sampling site | Two injection sites | Two latex injection/sampling sites |
| Drainage Bag | 500 - 800 ml drainage bag (removable) with volumetric graduations, microbial filter, and drain port | 500ml drainage bag with valve and drain port | 700 ml capacity graduated vinyl collection bag |
| Drainage Bag connection line | Present | Not specified | Not specified |
| Leveling device | Laser leveling device | Line level | Not specified |
| Sterility Method | EtO | EtO | Not specified |
| Sterile | Sterile device with reusable mounting panel section and disposable fluid contact section | Sterile device with reusable mounting panel section and disposable fluid contact section | Sterile single use device |
2. Sample size used for the test set and the data provenance:
The provided document does not mention any specific test set, sample size, or data provenance (e.g., country of origin, retrospective/prospective study) for evaluating the device's performance. The submission relies on a comparison to predicate devices rather than independent clinical testing data of the Niveau Drainage System against specific performance criteria.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
This information is not applicable as the document does not describe a study involving a test set that required expert-established ground truth.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set:
This information is not applicable as the document does not describe a study involving a test set that required adjudication.
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 information is not applicable. The provided document is for a medical device (drainage system) and makes no mention of Artificial Intelligence (AI) or any MRMC studies involving human readers or AI assistance.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done:
This information is not applicable as the device is a physical medical drainage system, not an algorithm, and the document makes no mention of AI.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc):
This information is not applicable as the document does not describe a study that required the establishment of a ground truth for evaluating the device's performance. The basis for approval is substantial equivalence to existing predicate devices.
8. The sample size for the training set:
This information is not applicable, as there is no mention of an algorithm or a training set in the document.
9. How the ground truth for the training set was established:
This information is not applicable, as there is no mention of an algorithm or a training set in the document.
In summary, the provided document is a 510(k) premarket notification for a medical device (intracranial pressure monitoring and CSF drainage system) that primarily demonstrates substantial equivalence to existing predicate devices. It does not contain information about clinical studies with specific performance metrics, acceptance criteria for those metrics, or any methodologies related to AI or ground truth establishment.
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JAN 26 1999
Safety and Effectiveness Summary X.
This summary of safety and effectiveness is submitted in accordance with the requirements of SMDA 1990 and 21 CFR 882.1620
| Establishment Registration Number: | 2021898 |
|---|---|
| Address of Manufacturer: | Medtronic PS Medical Corporation125 Cremona DriveGoleta CA, 93117(805) 968-1546 ext. 1776Fax: (805) 968-5038 |
| Contact Person: | Jeffrey Henderson |
| Date: | July 20, 1998 |
| Trade or Proprietary Name: | Medtronic PS Medical Niveau DrainageSystem |
| Common usual or Classification Name: | Intracranial Pressure Monitoring Devices(882.1620) |
Predicate Device Identification:
Codman External Drainage System (K954021), Clinical Neuro Systems MoniTorr (K920156)
Description:
The reusable portion of the system is
comprised of a pressure scale, mounting clamp and optional laser level. All components of the reusable device are integrated during manufacture. The scale has a blue anodized finish with contrasting pressure scale. Down the center of the scale is a track for the disposable device to be retained. The scale is integrated into a pole clamp that has been ergonomically designed to facilitate use. An optional laser device may be attached to the pole clamp. It is used to obtain a zero pressure reference with the patients Foramen of Monro.
The disposable device is comprised of three basic elements: a patient line that is attached to an externalized CSF drainage catheter, graduated drip chamber, and drainage bag. The drip chamber has an integrated mounting bracket that is inserted into the track on the reusable scale.
Intended Use:
"Draining and monitoring of CSF flow from the
- lateral ventricles or lumbar subarachnoid space is indicated in selected patients to
-
- Reduce intracranial pressure (ICP), e.g. pre-intra- or postoperative;
-
- Monitor CSF chemistry, cytology and physiology;
-
- Provide temporary CSF drainage in patients with infected cerebrospinal fluid shunts.
The monitoring of the intracranial pressure (ICP) is indicated in selected patients with 1. Severe head injury;
{1}------------------------------------------------
-
- Subarachnoid hemorrhage graded III, IV or V preoperatively;
-
- Reves syndrome or similar encephalopathies;
-
- Hydrocephalus;
-
- Intracranial hemorrhage
-
- Miscellaneous problems when drainage is to be used as a therapeutic maneuver. Monitoring can also be used to evaluate the status pre-and postoperatively for space occupving lesions."
"The MoniTorr system allows for drainage and Intended Use predicate device: 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."
"Use of the Codman External Drainage System II is indicated for draining cerebrospinal fluid (CSF) and other fluids of similar physical characteristics as a means of reducing and controlling increased intracranial volume and pressure when the insertion of a permanent internal shunt is not indicated."
Medtronic PS Medical submits that the Technological comparison: materials of fabrication, intended uses, performance characteristics and design specifications of the Niveau Drainage System are substantially equivalent to those of the predicate devices. Based upon the summary above, Medtronic PS Medical determines substantial equivalence, safety, and efficacy of the Niveau Drainage System based upon the predicate and currently marketed devices.
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| Feature | Medtronic PS Medical NiveauDrainage System | Clinical Neuro Systems MoniTorr | Codman External Drainage System II |
|---|---|---|---|
| Deviceconfiguration/contents | Locking bracket integral withmounting panel | Pole mount bracket assembly,braided cord and cord lock | Doubled 24 in. string w/Cord-loc®locking mechanism |
| Mounting panel main systemsection with pressure scale inmmHg and cmH20 | System Panel with instructionlabel | 27 cm measuring backboard | |
| 50 cc Conical sliding graduatedflow chamber withlocking bracket and ventsystem | 100 ml graduated chamber withfilter vent | 75 ml drip chamber with anti-refluxvalve and atmospheric vent | |
| Nondistensible blue stripedpatient connection line | Nondistensible green stripedpatient connection line | 157 cm patient line with two slideclamps | |
| Two four way stopcocks | Two four way stopcocks | Two four way stopcockswith female luer port | |
| One non-latexinjection/sampling sites | Two injection sites | Two latex injection/sampling sites | |
| 500 - 800 ml drainage bag(removable) with volumetricgraduations, microbial filter anddrain port | 500ml drainage bag with valveand drain port | 700 ml capacity graduated vinylcollection bag | |
| Drainage bag connection line | |||
| Laser leveling device | Line level | ||
| Feature | Medtronic PS Medical NiveauDrainage System | Clinical Neuro Systems MoniTorr | Codman External Drainage SystemII |
| Sterility Method | EtO | EtO | not specified |
| Sterile | Sterile device with reusablemounting panel section anddisposable fluid contact section | Sterile device with reusablemounting panel section anddisposable fluid contact section | Sterile single use device |
| Intended Use | "Draining and monitoring of CSF flow from thelateral ventricles or lumbar subarachnoidspace is indicated in selected patients toReduce intracranial pressure (ICP), e.g. pre-intra- or postoperative; Monitor CSFchemistry, cytology and physiology;Provide temporary CSF drainage in patientswith infected cerebrospinal fluid shunts.The monitoring of the intracranial pressure(ICP) is indicated in selected patients withSevere head injury; Subarachnoidhemorrhage graded III, IV or V preoperatively;Reyes syndrome or similar encephalopathies;Hydrocephalus; Intracranial hemorrhageMiscellaneous problems when drainage is tobe used as a therapeutic maneuver.Monitoring can also be used to evaluate thestatus pre-and postoperatively for spaceoccupying lesions." | "The MoniTorr system allows for drainage andmonitoring of CSF from the lateral ventricles ofthe brain and the lumbar subarachnoid spacein selected patients to reduce intracranialpressure (ICP), to monitor CSF, to providetemporary drainage of CSF in patients withinfected CSF shunts, and the monitoring ofICP." | "Use of the Codman External Drainage System IIis indicated for draining cerebrospinal fluid (CSF)and other fluids of similar physical characteristicsas a means of reducing and controlling increasedintracranial volume and pressure when theinsertion of a permanent internal shunt is notindicated." |
.
:
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Image /page/4/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is a stylized symbol that resembles an abstract representation of a human figure or a caduceus, which is a symbol often associated with healthcare.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
JAN 26 1999
Mr. Jeffrey Henderson Vice President, Quality Medtronic PS Medical 125 Cremona Drive Goleta, California 93117
Re: K983799
Trade Name: Medtronic PS Medical Niveau Drainage System Regulatory Class: II Product Code: JXG and GWM Dated: October 23, 1998 Received: October 28, 1998
Dear Mr. Henderson:
We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to 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). 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 (Premarket Approval), 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 895. A substantially equivalent determination assumes compliance with the current Good Manufacturing Practice requirement, as set forth in the Quality System Regulation (OS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic (QS) inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.
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Page 2 - Mr. Jeffrey Henderson
This letter will allow you to begin marketing your device as described in your 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 vour device to proceed to the market.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4595. 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" (21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its internet address "http://www.fda.gov/cdrh/dsmamain.html".
Sincerely yours,
Celia M. Witten, Ph.D., M.D.
Director Division of General and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Device Name: Niveau Drainage System
510(k) Number (if known):
Indications for Use:
"Draining and monitoring of CSF flow from the lateral ventricles or lumbar subarachnoid space is indicated in selected patients to
-
- Reduce intracranial pressure (ICP), e.g. pre-intra- or postoperative;
-
- Monitor CSF chemistry, cvtology and physiology;
-
- Provide temporary CSF drainage in patients with infected cerebrospinal fluid shunts.
The monitoring of the intracranial pressure (ICP) is indicated in selected patients with
-
- Severe head injury:
-
- Subarachnoid hemorrhage graded III, IV or V preoperatively;
-
- Reves syndrome or similar encephalopathies;
-
- Hydrocephalus;
-
- Intracranial hemorrhage
-
- Miscellaneous problems when drainage is to be used as a therapeutic maneuver. Monitoring can also be used to evaluate the status pre-and postoperatively for space occupying lesions."
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
CONCURRENCE OF CDRH, OFFICE OF DEVICE EVALUATION (ODE)
ACD
Division Sign-Off) Division of General Restorative Devices 510(k) Number
Prescription Use:
(Per 21 CFR 801.109) X
(optional format 1-2-96)
§ 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).