CODMAN EDS 3 CSF EXTERNAL DRAINAGE SYSTEM, MODELS 82-1730, 82-1731, 82-1732, 82-1733, 82-1735, 82-1738

K061568 · Codman & Shurtleff, Inc. · JXG · Sep 29, 2006 · Neurology

Device Facts

• Record ID: K061568
• Device Name: CODMAN EDS 3 CSF EXTERNAL DRAINAGE SYSTEM, MODELS 82-1730, 82-1731, 82-1732, 82-1733, 82-1735, 82-1738
• Applicant: Codman & Shurtleff, Inc.
• Product Code: JXG · Neurology
• Decision Date: Sep 29, 2006
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 882.5550
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

Use of the CODMAN EDS 3 CSF External Drainage System is indicated for draining cerebrospinal fluid (CSF) and other fluids of similar physical characteristics as a means of reducing intracranial pressure and CSF volume when the insertion of a permanent, internal shunt is not indicated.

Device Story

The Codman EDS 3 is an external drainage system designed to collect cerebrospinal fluid (CSF) and similar fluids from a patient. It operates based on differential pressure between the device and the patient to control the rate of fluid collection. The system is used to reduce elevated intracranial pressure and CSF volume in clinical settings where a permanent internal shunt is not indicated. The device is operated by healthcare professionals. It functions as a passive collection system; it does not involve complex electronic processing or automated decision-making. The output is the physical collection of CSF, which allows clinicians to monitor and manage intracranial pressure, potentially benefiting patients by preventing complications associated with elevated pressure.

Clinical Evidence

Bench testing only. No clinical data provided.

Technological Characteristics

External CSF drainage system; operates via differential pressure; mechanical fluid collection; no electronic components or software; non-powered.

Indications for Use

Indicated for patients requiring drainage of cerebrospinal fluid (CSF) or similar fluids to reduce intracranial pressure and CSF volume when permanent internal shunting is not indicated.

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

• External Drainage System II (K902257)
• External Drainage System II (K910938)
• External Drainage System II (K954021)

Submission Summary (Full Text)

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Image /page/0/Picture/0 description: The image shows the logo for Codman, a Johnson & Johnson company. The word "Codman" is written in a large, bold font. Below the word "Codman" is the text "a Johnson & Johnson company" in a smaller font. The logo is simple and professional.

Ko 61568

SEP 29 2006

## 510(k) Summary

| Submitter: | Codman & Shurtleff, Inc. |
|------------|--------------------------|
| | 325 Paramount Drive |
| | Raynham, MA 02767-0350 |

Contact Person: Jocelyn Raposo Regulatory Affairs Specialist II Phone Number: [phone] Fax Number: [phone]

June 2, 2006 Date Prepared:

CODMAN® EDS 3™ CSF External Drainage System Proprietary Name: Common Name: External CSF Drainage System

Classification Name: Central nervous system fluid shunt and components

Predicate Device: K902257 External Drainage System II K910938 External Drainage System II K954021 External Drainage System II

Device Description: The EDS 3 system is designed to collect cerebral spinal fluid (CSF) and other fluids of similar physical characteristics from a patient at a controlled rate based on differential pressure between the device and the patient. Collecting CSF from the patient is performed in efforts to reduce elevated intracranial pressure (ICP).

- Intended Use: Use of the EDS 3 system is indicated for draining cerebrospinal fluid (CSF) and other fluids of similar characteristics as a means of reducing intracranial pressure and CSF volume when the insertion of a permanent, internal shunt is not indicated.
- Performance Data: The fundamental scientific technology of EDS 3 is the same as EDS II. Bench testing was performed for the EDS 3 system. The modified device was deemed acceptable according to the acceptance criteria; therefore, the safety and efficacy of the product was not affected.

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## DEPARTMENT OF HEALTH & HUMAN SERVICES

Public Health Service

Image /page/1/Picture/2 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized depiction of an eagle or bird-like figure, with three curved lines representing the body and wings. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES . USA" is arranged in a circular pattern around the bird symbol.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

## SEP 2 9 2006

Codman & Shurtleff, Inc. % Ms. Jocelyn Raposo Regulatory Affairs Specialist II 325 Paramount Drive Raynham, Massachusetts 02767-0350

Re: K061568

Trade/Device Name: Codman® 3" CSF External Drainage System with/without Ventricular Catheter Regulation Number: 21 CFR 882.5550 Regulation Name: Central nervous system fluid shunt and components Regulatory Class: II Product Code: JXG Dated: August 30, 2006 Received: September 1, 2006

Dear Ms. Raposo:

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. Jocelyn Raposo

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/industry/support/index.html.

Sincerely yours,

Mark N. Melkerso 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

Kob1568 510(k) Number (if known): ___________________________________________________________________________________________________________________________________________________ Codman® EDS 3™ CSF External Drainage System with/without Device Name: Ventricular Catheter Indications For Use: Use of the CODMAN EDS 3 CSF External Drainage System is indicated for draining cerebrospinal fluid (CSF) and other fluids of similar physical characteristics as a means of

reducing intracranial pressure and CSF volume when the insertion of a permanent, internal shunt is not indicated.

OR Over-The-Counter Use: Prescription Use: X (21 CFR 801 Subpart C) (Part 21 CFR 801 Subpart D)

(Please do not write below this line - continue on another page if needed)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Division Sign-Off) Division of General, Restorati and Neurological Devices

**510(k) Number** K061568/9

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