MEDTRONIC PS MEDICAL NIVEAU DRAINAGE SYSTEM, MEDTRONIC PS MEDICAL NIVEAU DRAINAGE SYSTEM POLE CLAMP, MEDTRONIC PS MEDICL

K983799 · Medtronic PS Medical · GWM · Jan 26, 1999 · Neurology

Device Facts

• Record ID: K983799
• Device Name: MEDTRONIC PS MEDICAL NIVEAU DRAINAGE SYSTEM, MEDTRONIC PS MEDICAL NIVEAU DRAINAGE SYSTEM POLE CLAMP, MEDTRONIC PS MEDICL
• Applicant: Medtronic PS Medical
• Product Code: GWM · Neurology
• Decision Date: Jan 26, 1999
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 882.1620
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

Draining and monitoring of CSF flow from the lateral ventricles or lumbar subarachnoid space is indicated in selected patients to 1. Reduce intracranial pressure (ICP), e.g. pre-intra- or postoperative; 2. Monitor CSF chemistry, cytology and physiology; 3. 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; 2. Subarachnoid hemorrhage graded III, IV or V preoperatively; 3. Reves syndrome or similar encephalopathies; 4. Hydrocephalus; 5. Intracranial hemorrhage 6. 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.

Device Story

System facilitates external CSF drainage and ICP monitoring; consists of reusable mounting panel with pressure scale (mmHg/cmH2O), pole clamp, and optional laser level for zero-reference at Foramen of Monro; disposable component includes patient line, graduated drip chamber, and drainage bag. Used in clinical settings by healthcare providers to manage intracranial pressure; provides visual pressure reference via scale; aids clinical decision-making regarding CSF management and therapeutic drainage; benefits patients by reducing intracranial volume/pressure and allowing monitoring of CSF physiology.

Clinical Evidence

No clinical data provided; substantial equivalence based on bench testing and design comparison to predicate devices.

Technological Characteristics

Reusable mounting panel with blue anodized finish; disposable fluid contact section includes nondistensible patient line, 50cc conical graduated drip chamber, and 500-800ml drainage bag. Features include laser leveling device, stopcocks, and non-latex injection sites. Sterilization via EtO.

Indications for Use

Indicated for patients requiring CSF drainage or ICP monitoring, including those with severe head injury, subarachnoid hemorrhage (grade III-V), Reye's syndrome, encephalopathies, hydrocephalus, intracranial hemorrhage, or space-occupying lesions requiring pre/post-operative evaluation.

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

• Codman External Drainage System (K954021)
• Clinical Neuro Systems MoniTorr (K920156)

Submission Summary (Full Text)

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JAN 26 1999

K983799

## 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 Corporation<br>125 Cremona Drive<br>Goleta CA, 93117<br>[phone] ext. 1776<br>Fax: [phone] |
| Contact Person: | Jeffrey Henderson |
| Date: | July 20, 1998 |
| Trade or Proprietary Name: | Medtronic PS Medical Niveau Drainage<br>System |
| Common usual or Classification Name: | Intracranial Pressure Monitoring Devices<br>(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
- 1. Reduce intracranial pressure (ICP), e.g. pre-intra- or postoperative;
- 2. Monitor CSF chemistry, cytology and physiology;
- 3. 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;

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- 2. Subarachnoid hemorrhage graded III, IV or V preoperatively;
- 3. Reves syndrome or similar encephalopathies;
- 4. Hydrocephalus;
- 5. Intracranial hemorrhage
- 6. 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 Niveau<br>Drainage System | Clinical Neuro Systems MoniTorr | Codman External Drainage System II |
|--------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Device<br>configuration/<br>contents | Locking bracket integral with<br>mounting panel | Pole mount bracket assembly,<br>braided cord and cord lock | Doubled 24 in. string w/Cord-loc®<br>locking mechanism |
| | Mounting panel main system<br>section with pressure scale in<br>mmHg and cmH20 | System Panel with instruction<br>label | 27 cm measuring backboard |
| | 50 cc Conical sliding graduated<br>flow chamber with<br>locking bracket and vent<br>system | 100 ml graduated chamber with<br>filter vent | 75 ml drip chamber with anti-reflux<br>valve and atmospheric vent |
| | Nondistensible blue striped<br>patient connection line | Nondistensible green striped<br>patient connection line | 157 cm patient line with two slide<br>clamps |
| | Two four way stopcocks | Two four way stopcocks | Two four way stopcocks<br>with female luer port |
| | One non-latex<br>injection/sampling sites | Two injection sites | Two latex injection/sampling sites |
| | 500 - 800 ml drainage bag<br>(removable) with volumetric<br>graduations, microbial filter and<br>drain port | 500ml drainage bag with valve<br>and drain port | 700 ml capacity graduated vinyl<br>collection bag |
| | Drainage bag connection line | | |
| | Laser leveling device | Line level | |
| Feature | Medtronic PS Medical Niveau<br>Drainage System | Clinical Neuro Systems MoniTorr | Codman External Drainage System<br>II |
| Sterility Method | EtO | EtO | not specified |
| Sterile | Sterile device with reusable<br>mounting panel section and<br>disposable fluid contact section | Sterile device with reusable<br>mounting panel section and<br>disposable fluid contact section | Sterile single use device |
| Intended Use | "Draining and monitoring of CSF flow from the<br>lateral ventricles or lumbar subarachnoid<br>space is indicated in selected patients to<br>Reduce intracranial pressure (ICP), e.g. pre-<br>intra- or postoperative; Monitor CSF<br>chemistry, cytology and physiology;<br>Provide temporary CSF drainage in patients<br>with infected cerebrospinal fluid shunts.<br>The monitoring of the intracranial pressure<br>(ICP) is indicated in selected patients with<br>Severe head injury; Subarachnoid<br>hemorrhage graded III, IV or V preoperatively;<br>Reyes syndrome or similar encephalopathies;<br>Hydrocephalus; Intracranial hemorrhage<br>Miscellaneous problems when drainage is to<br>be used as a therapeutic maneuver.<br>Monitoring can also be used to evaluate the<br>status pre-and postoperatively for space<br>occupying lesions." | "The MoniTorr system allows for drainage and<br>monitoring of CSF from the lateral ventricles of<br>the brain and the lumbar subarachnoid space<br>in selected patients to reduce intracranial<br>pressure (ICP), to monitor CSF, to provide<br>temporary drainage of CSF in patients with<br>infected CSF shunts, and the monitoring of<br>ICP." | "Use of the Codman External Drainage System II<br>is indicated for draining cerebrospinal fluid (CSF)<br>and other fluids of similar physical characteristics<br>as a means of reducing and controlling increased<br>intracranial volume and pressure when the<br>insertion of a permanent internal shunt is not<br>indicated." |

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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 [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" (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 [phone] or [phone] 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

- 1. Reduce intracranial pressure (ICP), e.g. pre-intra- or postoperative;
- 2. Monitor CSF chemistry, cvtology and physiology;
- 3. 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:
- 2. Subarachnoid hemorrhage graded III, IV or V preoperatively;
- 3. Reves syndrome or similar encephalopathies;
- 4. Hydrocephalus;
- 5. Intracranial hemorrhage
- 6. 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)