ACURA ELITE GRAVITY COMPENSATING RESERVOIR

K030468 · Phoenix Biomedical Corp. · JXG · Oct 15, 2003 · Neurology

Device Facts

• Record ID: K030468
• Device Name: ACURA ELITE GRAVITY COMPENSATING RESERVOIR
• Applicant: Phoenix Biomedical Corp.
• Product Code: JXG · Neurology
• Decision Date: Oct 15, 2003
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 882.5550
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

This device is intended for implantation over either right or left frontal horn, in conjunction with a ventricles for the purpose of diagnostic studies, therapeutic drug access to the cord/or diversion of cerebrospinal fluid.

Device Story

Acura Elite Gravity Compensating Reservoir is an implantable component of a cerebrospinal fluid (CSF) shunt system. It is surgically implanted over the frontal horn of the ventricle. The device provides a reservoir for diagnostic sampling of CSF, therapeutic drug administration, and regulation of CSF flow. It functions as a gravity-compensating mechanism to manage intracranial pressure. Used by neurosurgeons in clinical settings. The device assists in managing hydrocephalus or other conditions requiring CSF diversion or access.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

Implantable reservoir for CSF shunt systems. Gravity-compensating mechanism. Class II device (21 CFR 882.5550).

Indications for Use

Indicated for patients requiring cerebrospinal fluid (CSF) diversion, diagnostic access, or therapeutic drug delivery via a ventricular shunt system. Implantation site is the right or left frontal horn.

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.

Submission Summary (Full Text)

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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

## OCT 1 5 2003

Ms. Courtney Smith Regulatory Affairs Manager Phoenix Biomedical Corporation P.O. Box 80390 Valley Forge, Pennsylvania 19484

Re: K030468

Trade/Device Name: Acura Elite Gravity Compensating Reservoir Regulation Number: 21 CFR 882.5550) Regulation Name: Central nervous system fluid shunt and components Regulatory Class: II Product Code: JXG Dated: August 18, 2003 Received: August 18, 2003

Dear Ms. Smith:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate 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) that do not require approval of a premarket approval application (PMA). 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 (PMA), 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 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 that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

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Page 2 - Ms. Courtney Smith

This letter will allow you to begin marketing your device as described in your Section 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), please contact the Office of Compliance at [phone]. 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 Manufacturers, International and Consumer Assistance at its toll-free number [phone] or [phone] or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html

Sincerely yours.

Mark A. Millman

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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Page of

510(k) NUMBER (IF KNOWN) : DEVICE NAME : Accura Elite Gravity Compensating Reservoir INDICATIONS FOR USE:

## Accura Elite Gravity Compensating Reservoir

## Intended Use/ Indications:

This device is intended for implantation over either right or left frontal horn, in This device is miended for implantation over shirt system for use as a means of conjunction with a ventricles for the purpose of diagnostic studies, therapeutic drug access to the cord/or diversion of cerebrospinal fluid.

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED.)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use
OR
Over-The-Counter-Use
(Per 21 CFR 801.109)
(Optional Format 1-2-96)

(Division Sign-Off)
Division of General. Restorative
and Neurological Devices

510(k) Number K030468