BECKER EXTERNAL DRAINAGE AND MONITORING SYSTEM

K984053 · Medtronic PS Medical · JXG · Feb 4, 1999 · Neurology

Device Facts

• Record ID: K984053
• Device Name: BECKER EXTERNAL DRAINAGE AND MONITORING SYSTEM
• Applicant: Medtronic PS Medical
• Product Code: JXG · Neurology
• Decision Date: Feb 4, 1999
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 882.5550
• 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 reduce intracranial pressure (ICP), e.g. preintra- 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 hemormage graded III, IV or V preoperatively; Reyes syndrome or similar encephalopathies; hydrocephalus; intracranial hemorrhage or 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.

Device Story

Becker EDMS is a closed system for draining and monitoring cerebrospinal fluid (CSF) from lateral ventricles or lumbar subarachnoid space. System components include a non-distensible patient connection line, stopcock, mounting panel, injection sites, and a removable drainage bag with microbial filter. A graduated 50 cc flow chamber with drip former and conical bottom allows for volumetric measurement of CSF. Used in clinical settings by neurosurgeons and clinical staff to manage intracranial pressure (ICP) and monitor CSF chemistry/physiology. By providing temporary drainage and pressure monitoring, the device assists in therapeutic management of neurological conditions and post-operative status. Output is visual (fluid level in chamber/bag) and allows clinicians to assess patient intracranial status and adjust drainage therapy accordingly.

Clinical Evidence

No clinical data provided; substantial equivalence is based on design, material, and performance characteristic comparisons to the predicate device.

Technological Characteristics

System includes non-distensible patient connection line, stopcock, mounting panel, non-latex injection sites, and drainage bag with microbial filter. Features a graduated 50 cc flow chamber with drip former and conical bottom. Materials are consistent with currently marketed devices. Non-electronic, mechanical system.

Indications for Use

Indicated for patients requiring CSF drainage or ICP monitoring, including those with severe head injury, subarachnoid hemorrhage (grade III-V), Reyes syndrome, encephalopathies, hydrocephalus, intracranial hemorrhage, space-occupying lesions, or infected CSF shunts.

Regulatory Classification

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.

Predicate Devices

• Codman External Drainage System II (K902257, K920938)

Submission Summary (Full Text)

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#### Safety and Effectiveness Summary ll.

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## Determination of substantial equivalence

The ICP monitoring device and method were first described in an article published in 1973. Over the years the device has come into widespread use.

Medtronic PS Medical has, with input from neurosurgeons, developed a device design, which is considered to be equivalent to the predicate Codman External Drainage System II (K902257, 19249383 The Medtronic PS Medical Becker EDMS is a complete closed system indicated for the draining and monitoring of CSF flow from the lateral ventricles or lumbar subarachnoid space.

K910938 - listed incorrectly throughout Medtronic PS Medical considers the Medtronic PS Medical Becker EDMS to be substantially equivalent to the Codman External Drainage System II (K902257, K920938), currently in commercial distribution. The predicate device is used 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 needed. A comparison of the Codman External Drainage System II and the Medtronic PS Medical Becker EDMS is included in Tables 1 and 2.

Medtronic PS Medical considers the Becker EDMS to be safe, effective and substantially equivalent in indications, physical characteristics and performance to the noted predicate device. Evidence of this is provided in predicate device product labeling (Attachment 2).

#### Device Name

Medtronic PS Medical Becker External Drainage and Monitoring System (Becker EDMS).

## Predicate Device(s)

Codman External Drainage System II (K902257, K920938)

#### Device Description

The Medtronic PS Medical Becker EDMS is indicated for the draining and monitoring of CSF flow from the lateral ventricles or lumbar subarachnoid space. The Becker EDMS is substantially equivalent in indications, materials of fabrication, performance characteristics and design specifications as compared with the predicate device, Codman External Drainage System II.

The materials utilized in the Becker EDMS are not substantially different to those used in currently marketed products. The Becker EDMS is comprised of a nondistensible blue striped (proximal end) patient connection line, patient line stopcock, mounting panel/main system section, three non-latex iniection sites, and a removable drainage bag with approximate volumetric graduations and microbial filter. A graduated 50 cc

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flow chamber with drip former and conical bottom and locking bracket is included on the main system section.

A comparison of the Becker EDMS and predicate device is provided in Table 1.

# Intended Use

The Medtronic PS Medical Becker EDMS will be indicated for use as follows: "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. preintra- 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 hemormage graded III, IV or V preoperatively; Reyes syndrome or similar encephalopathies; hydrocephalus; intracranial hemorrhage or 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."

Draft Medtronic PS Medical product labeling and product literature for the Medtronic PS Medical Becker EDMS is included (Attachment 1).

## Intended Use predicate device

The predicate device Codman External Drainage System II is indicated for use as follows:

"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."

Product literature for the predicate Codman External Drainage System II is included (Attachment 2).

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Image /page/2/Picture/1 description: The image shows the seal of the U.S. Department of Health & Human Services. The seal is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an abstract image of an eagle or bird-like figure, composed of three curved lines that suggest feathers or wings.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

4 1999 FEB

Mr. Jeffrey Henderson Vice President, Quality Medtronic PS Medical 125 Cremona Drive Goleta, California 93117-5500

Re: K984053 Becker External Drainage and Monitoring System Regulatory Class: II Product Code: JXG November 3 1998 Dated: Received: November 6, 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 The general controls provisions of the Act 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 Requlations, 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 (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic (QS) inspections, the Food and Drug Failure to Administration (FDA) will verify such assumptions. 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 your 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,

Russell S. Page

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: Becker External Drainage and Monitoring System (EDMS)

510(k) Number (if known):

984053

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. preintra- 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 hemorthage graded III, IV or V preoperatively; Reyes syndrome or similar encephalopathies; hydrocephalus; intracranial hemorrhage or 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)

Nino Panzera for J2P

(Division Sign-Off) Division of Cardiovascular, Respiratory, and Neurological Devices 510(k) Number_ 3 3 40 3

Over the Counter Use: or Prescription Use: (Per 21 CFR 801.109)

(optional format 1-2-96)