The Codman BACTISEAL™ EVD Catheter Set is indicated for gaining access to the ventricles of the brain and can be used with dimensionally compatible devices for draining cerebrospinal fluid (CSF) and other fluids of similar physical characteristics as a means of reducing intracranial pressure and CSF volume.

Device Description

Codman BACTISEAL™ EVD Catheter Sets are manufactured from radiopaque silicone rubber which is then impregnated with rifampicin and clindamycin hydrochloride in order to render the device resistant to colonization of most gram positive organisms.

AI/ML Overview

The provided text does not contain information about "acceptance criteria" in the traditional sense of performance metrics for an AI/device, nor does it detail a study proving the device meets such criteria with the specific elements requested (sample sizes, ground truth establishment, expert qualifications, etc.).

Instead, this document is a 510(k) summary for a medical device called the "Codman BACTISEAL™ EVD Catheter Sets," which is a ventricular catheter. The document focuses on demonstrating substantial equivalence to predicate devices rather than proving performance against specific acceptance criteria through a standalone study with human readers or an algorithm.

Here's a breakdown of what is available based on your request, and what is not:

A table of acceptance criteria and the reported device performance:
- Not provided. The document states that "All testing results demonstrated the substantial equivalence of the product to commercially distributed devices for the same intended use." However, it does not list specific numerical acceptance criteria (e.g., sensitivity, specificity, accuracy) or quantitative performance statistics. The testing performed was related to "performance and in vitro testing" and "biocompatibility studies," which are general categories.
Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective):
- Not provided. The document mentions "clinical data" but gives no details about the sample size, type of study (retrospective/prospective), or data provenance.
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):
- Not provided. The concept of "ground truth" as typically applied to AI performance evaluation is not relevant here, as this is a physical medical device. The "clinical data" mentioned would likely refer to outcomes in patients, but no details are given about how these outcomes were assessed or by whom.
Adjudication method (e.g. 2+1, 3+1, none) for the test set:
- Not provided. This is not applicable to the type of device and testing described.
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:
- Not provided. This is not an AI device, and no MRMC study is mentioned. The device itself is a catheter, not an imaging or diagnostic tool that would be used by human readers to interpret results.
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Not provided. This is not an AI device.
The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- The document refers to "clinical data" and "biocompatibility studies." For a device like a catheter, "ground truth" would relate to its physical performance (e.g., drainage effectiveness, material integrity) and patient outcomes (e.g., infection rates, CSF diversion success, reduction in intracranial pressure). It's implied that these aspects were evaluated, but the specific methods for establishing "ground truth" (e.g., how infection was confirmed, how CSF drainage was measured accurately) are not detailed.
The sample size for the training set:
- Not provided. This is not an AI device, so there is no "training set."
How the ground truth for the training set was established:
- Not provided. Not an AI device, so no training set or associated ground truth.

Summary of available information regarding device testing:

The device's safety and effectiveness were evaluated through:

"extensive performance and in vitro testing"
"biocompatibility studies in accordance with ISO10993-Part 1"
"clinical data"

The purpose of this testing was to demonstrate substantial equivalence to legally marketed predicate devices, specifically:

Codman BACTISEAL™ Catheters
Codman External Drainage Ventricular Catheter Set
Cook Inc. SPECTRUM® Ventricular Catheter

The basis for substantial equivalence was "similarity to the predicate devices in intended use, materials, design, and dimensions," in addition to the testing results. The text does not elaborate on specific acceptance criteria or detailed study methodologies beyond these general categories.

Summary

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JUL 2 9 2002

ATTACHMENT A

K 021653

510(k) Summary Codman BACTISEAL™ EVD Catheter Sets

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

Contact Person

Kathy Wunder Regulatory Affairs Specialist Telephone Number: (508) 880-8351 Fax Number: (508) 828-3212

Name of Device

Codman BACTISEAL™ EVD Catheter Sets Proprietary Name: Common Name: Ventricular catheters Classification Name: Catheter, Ventricular

Device Classification

Ventricular Catheters are Class II devices per 21 CFR § 882.4100 (84 JXG).

Statement of Substantial Equivalence

Codman BACTISEAL™ EVD Catheter Sets are substantially equivalent to Codman BACTISEAL™ Catheters, Codman External Drainage Ventricular Catheter Set and Cook Inc. SPECTRUM® Ventricular Catheter, based on the subject device's similarity to the predicate devices in intended use, materials, design, and dimensions.

Indications for Use

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Physical Description

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Device Testing

Safety of this device to predicate products relied on extensive performance and in vitro testing, biocompatibility studies in accordance with ISO10993-Part 1, and clinical data. All testing results demonstrated the substantial equivalence of the product to commercially distributed devices for the same intended use.

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Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" arranged around the perimeter. Inside the circle is a stylized design featuring three human profiles facing to the right, with flowing lines suggesting movement or connection.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

JUL 2 9 2002

Ms. Kathy Wunder Regulatory Affairs Specialist Codman & Shurtleff, Inc. 325 Paramount Drive Raynham, Massachusetts 02767-0350

Re: K021653

Trade/Device Name: Codman BACTISEAL™ EVD Catheter Set Regulation Number: 21 CFR 882.5550 Regulation Name: Central Nervous System Fluid Shunt and Components Regulatory Class: Class II Product Code: JXG Dated: May 17, 2002 Received: May 20, 2002

Dear Ms. Wunder:

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. Kathy Wunder

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 and additionally 21 CFR Part 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4659. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97), Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html

Sincerely yours,

Mark N Milla

ia 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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510(k) Number (if known) Device Name

02165 TM EVD Codman BACTISE Catheter Set

Indications For Use:

(Please do not write below this line - Continue on another page if necessary) Concurrence of CDRH, Office of Device Evaluation (ODE)

Mark N Milkman

Division Sign-Off Division of General, Restorative and Neurological Devices

510(k) Number _

Prescription Use A (Per 21 CFR §801.109)

Over-the-Counter Use

(Optional Format 1-2-96)

Regulation Number and Section

§ 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).