(115 days)
No
The summary describes a mechanical system for draining CSF based on differential pressure and does not mention any AI/ML terms or image processing.
Yes
The device is used to reduce intracranial pressure and CSF volume, which are therapeutic interventions for patient health.
No
The device is described as an "External Drainage System" used for draining cerebrospinal fluid to reduce intracranial pressure. Its function is to collect fluid at a controlled rate, which is a therapeutic intervention, not a diagnostic one.
No
The device description explicitly states it is a "system" designed to "collect cerebral spinal fluid (CSF)" and mentions "differential pressure between the device and the patient," indicating a physical hardware component for fluid collection and pressure sensing.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is to drain cerebrospinal fluid (CSF) and other fluids from a patient to reduce intracranial pressure. This is a therapeutic intervention performed on the patient, not a test performed on a sample of the patient's body outside of the body to diagnose a condition.
- Device Description: The description focuses on collecting fluid from the patient at a controlled rate based on pressure, again indicating a direct interaction with the patient's body.
- Lack of IVD Characteristics: There is no mention of analyzing a sample, detecting analytes, or providing diagnostic information based on the fluid collected. The purpose is drainage and pressure reduction, not diagnosis.
IVD devices are used to examine specimens derived from the human body (like blood, urine, tissue) to provide information for the diagnosis, monitoring, or treatment of a disease or condition. This device does not fit that description.
N/A
Intended Use / Indications for 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.
Product codes
JXG
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).
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
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.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
K902257 External Drainage System II, K910938 External Drainage System II, K954021 External Drainage System II
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 882.5550 Central nervous system fluid shunt and components.
(a)
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.(b)
Classification. Class II (performance standards).
0
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: (508) 828-3421 Fax Number: (508) 828-2777
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.
1
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 (240) 276-0115. 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 (800) 638-2041 or (240) 276-3150 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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