(115 days)
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.
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).
The provided document is limited in detail regarding the specific acceptance criteria and study data for the CODMAN® EDS 3™ CSF External Drainage System. The document states that the fundamental scientific technology of EDS 3 is the same as EDS II and that "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." However, the exact acceptance criteria and the detailed results of this bench testing are not provided.
Therefore, much of the requested information cannot be extracted from this document.
Here's a summary of what can be inferred or directly stated from the provided text:
1. A table of acceptance criteria and the reported device performance
The document does not provide a table of acceptance criteria or specific reported device performance metrics. It only states that the device was "deemed acceptable according to the acceptance criteria."
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
This information is not available in the provided text. The term "bench testing" suggests a controlled laboratory environment, but details about sample size or data origin are absent.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
This information is not available in the provided text. The testing appears to be bench testing, not clinical human-based evaluation requiring expert ground truth for interpretation.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
This information is not available in the provided text.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
This information is not applicable and not available in the provided text. The device is a CSF external drainage system, not an AI-assisted diagnostic tool for which MRMC studies are typically conducted.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
This information is not applicable and not available in the provided text. The device is a physical system, not an algorithm. Bench testing would assess its standalone mechanical and fluid dynamic performance.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
This information is not explicitly stated. For bench testing of a medical device, the "ground truth" would typically refer to established engineering and medical standards for fluid dynamics, biocompatibility, and mechanical integrity, rather than clinical outcomes or expert consensus on images.
8. The sample size for the training set
This information is not applicable and not available in the provided text. The device is not an AI/ML algorithm that requires a training set.
9. How the ground truth for the training set was established
This information is not applicable and not available in the provided text. The device is not an AI/ML algorithm.
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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.
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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 (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
Page _ of _
§ 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).