CODMAN® BACTISEAL® Endoscopic Ventricular Catheter is designed for use in the treatment of hydrocephalus when shunting cerebrospinal fluid (CSF) from the ventricles of the brain.

Device Description

The BACTISEAL Endoscopic Ventricular Catheter is designed to be placed with an endoscope, which functions as the stylet. The endoscope will enable visualization of catheter placement. The tip of the catheter has been slit to allow passage of the endoscope through the catheter tip.

The BACTISEAL ventricular and peritoneal catheters are made of radiopaque (bariumimpregnated) silicone tubing and are subjected to a treatment process by which the tubing is impregnated with rifampin and clindamycin hydrochloride.

The ventricular catheter has an inner diameter of 1.4 mm and an outer diameter of 2.7 mm. The catheter is 14 cm in length and is supplied with 24 inlet holes (3 rows of 8 holes) at the proximal end. Depth marks have been added to the catheter (one dot at 5 cm and two dots at 10 cm). A right angle adapter is included.

A 120 cm peritoneal catheter is included in the Bactiseal Endoscopic Ventricular Kit along with the ventricular catheter described above. The peritoneal catheter has an inner diameter of 1.0 mm and an outer diameter of 2.2 mm. The catheter can be trimmed to length as needed.

AI/ML Overview

Here's a breakdown of the acceptance criteria and the study information based on the provided 510(k) summary for the CODMAN® BACTISEAL® Endoscopic Ventricular Catheter:

Acceptance Criteria and Device Performance

Acceptance Criteria Category	Specific Criteria	Reported Device Performance
Functional Performance	Device allows passage of an endoscope through the slit.	"Bench testing demonstrated that the slit design allows passage of an endoscope through the slit."
Design Conformance	Conforms to its design specifications.	"The Bactiseal Endoscopic Ventricular Catheter conforms to its design specifications..."
Intended Use	Performs according to its description and intended use.	"...device performs according to its description and intended use..."
Safety & Effectiveness	Supports the safety and effectiveness of the device.	"...supports the safety and effectiveness of the device."
Substantial Equivalence	Substantially equivalent to commercially distributed devices for the same intended use.	"...is substantially equivalent to the commercially distributed devices for the same intended use."
Material Equivalence	Technological characteristics are the same as the predicate device (Codman® Bactiseal® Catheters).	"The technological characteristics of the proposed devices are the exact same as the Codman® Bactiseal® Catheters predicate device."
Design Equivalence	Design modification (slit) is the same as the ventricular catheter in the predicate (Codman® Neuroguide Endoscopic Placement Catheter).	"The design modification adds a slit to this device which is the same as the ventricular catheter in the predicate Codman® Neuroguide Endoscopic Placement Catheter."

Study Details

Here's a summary of the study details based on the provided document:

Sample Size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective):
- The document mentions "Bench testing" but does not specify a sample size for the test set, nor does it provide details on data provenance (country of origin, retrospective/prospective).
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 applicable / Not provided. The study described is bench testing, not a clinical study involving experts establishing ground truth for a test set of clinical data.
Adjudication method (e.g. 2+1, 3+1, none) for the test set:
- Not applicable / Not provided. This information is irrelevant for the described bench testing.
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:
- No. An MRMC comparative effectiveness study was not conducted. This device is a medical catheter, not an AI-based diagnostic tool.
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- No. This device is a medical catheter and does not involve an algorithm or AI. The performance validated was the physical function of the catheter.
The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- The "ground truth" for this device's performance was the physical demonstration and observation that "the slit design allows passage of an endoscope through the slit." This is a purely functional physical test.
The sample size for the training set:
- Not applicable / Not provided. This device is a physical medical device, not a machine learning model, so there is no concept of a "training set."
How the ground truth for the training set was established:
- Not applicable / Not provided. As there is no training set, this question is not relevant.

Summary

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W11075

510(k) Summary

MAY - 9 2011

A. Submitter Information
Submitter's name:	Codman & Shurtleff, Inc.
Address:	325 Paramount DriveRaynham, MA 02767
Telephone:	508-880-8349
Fax:	508-977-6428
Contact Person:	Sharon McDermott
Date of Submission:	March 17, 2011
B. Trade/Device Name:	CODMAN ® BACTISEAL® Endoscopic Ventricular CatheterCODMAN ® BACTISEAL® Endoscopic Ventricular Catheter Kit
Common Name:	Hydrocephalus catheters
Classification Name:	Shunt, Central Nervous System and Components
Regulatory Class:	Class II per 21 CFR § 882.5550
Product Code:	JXG
C. Predicate Device:	Codman® Neuroguide Endoscopic Placement Catheter (K934196)Codman® Bactiseal ® Catheters (K003322)

The BACTISEAL Endoscopic Ventricular Catheter is designed D. Device Description: to be placed with an endoscope, which functions as the stylet. The endoscope will enable visualization of catheter placement. The tip of the catheter has been slit to allow passage of the endoscope through the catheter tip.

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K110751

CODMAN® BACTISEAL® Endoscopic Ventricular Catheter is E. Intended Use: designed for use in the treatment of hydrocephalus when shunting cerebrospinal fluid (CSF) from the ventricles of the brain.

F. Summary of technological characteristics of the proposed to the predicate device.

The technological characteristics of the proposed devices are the exact same as the Codman® Bactiseal® Catheters predicate device. The design modification adds a slit to this device which is the same as the ventricular catheter in the predicate Codman® Neuroguide Endoscopic Placement Catheter. CODMAN® BACTISEAL® Endoscopic Ventricular Catheter is substantially equivalent to the predicate devices based on intended use, performance characteristics, materials, and principles of operation.

G. Performance Data

ﺔ--

Bench testingdemonstrated that the slit design allows passage of an endoscope through the slit. The device performs according to its description and intended use and supports the safety and effectiveness of the device. The Bactiseal Endoscopic Ventricualar Catheter conforms to its design specifications and is substantially equivalent to the commercially distributed devices for the same intended use.

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Food and Drug Administration 10903 New Hampshire Avenue Document Control Room W-066-0609 Silver Spring, MD 20993-0002

Codman & Shurtleff, Inc .. C/O Sharon McDermott Senior Regulatory Affairs Specialist 325 Paramount Drive Raynham MA 02767-0350

9 2011 MAY

Re: K110751

Trade/Device Name: Codman® Bactiseal Endoscopic Ventricular Catheter Regulation Number: 21 CFR 882.5550 Regulation Name: Central nervous system fluid shunt and components Regulatory Class: Class II Product Code: JXG Dated: March 17, 2011 Received: March 18, 2011

Dear Ms. McDermott:

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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to 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.

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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); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled. "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to

http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

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 (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely yours,

Eatheron for

Malvina B. Eydelman, M.D. Director Division of Ophthalmic, Neurological, and Ear. Nose and Throat Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known):

Codman® BACTISEAL® Endoscopic Ventricular Catheter Device Name:

Indications For Use:

CODMAN® BACTISEAL® Endoscopic Ventricular Catheter is designed for use in the treatment of hydrocephalus when shunting cerebrospinal fluid (CSF) from the ventricles of the brain.

Prescription Use _____________________________________________________________________________________________________________________________________________________________ (Part 21 CFR 801 Subpart D) AND/OR

Over-The-Counter Use _________________________________________________________________________________________________________________________________________________________ (21 CFR 807 Subpart C)

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

JOE HUTTER

(Division Sign-Off) Division of Ophthalmic, Neurological and Ear, Nose and Throat Devices

510(k) Number K110751

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).