The Codman-Medos Connector is for use in the treatment of hydrocephalus as a component of a shunt system when draining or shunting of cerebrospinal fluid (CSF) is indicated.

The Type A Fixation and Joining Connector is indicated for use in the joining and fixation of 1.2 rite Type P. Pixation and coming with nonabsorbable sutures in a surgical application.

The Type B Fixation and Joining Connector is indicated for use in the joining and fixation of 0.8 me rype b fixation and obling to 1.2 mm nominal I.D. silicone rubber tubing, and min fromman f.D. Billions fulls of the version in a surgical applical application.

The Ventriculostomy Reservoir Set is indicated for use to gain access to the cerebral ventricles or other intracranial cavities for the purpose of diagnostic studies or therapeutic drug administration with or without a shunting device. When used with the shunting device, the ventriculostomy reservoir is also indicated for use as the proximal fluid pathway.

The ACCU-FLO Three Way Connector can be utilized as a component in systems designed to The ACCO-FLO Three Way Ochniction our be unities into the right atium of the heart or the shunt cereorospinal had from the lateral vonthologime and fixation of approximately 1.3 mm peritoneal cavity, providing they are used in the joining aurrical application pentioneal cavily, providing they are about in the John's and surgical application.

The ACCU-FLO Connectors can be utilized as a component in systems designed to shunt The AOOO+ LO Ochhoolors our be anticles into the right atrium of the heart or the peritoneal cerebrospiral not from the joining and fixation of approximately 1.3 mm nominal I.D. silicone rubber tubing with nonabsorbable sutures in a surgical application.

The Cerebral Catheter-Reservoir is indicated for use as a component of a shunting system to The Gerebral Vatheter-1000Non in Indication for see and cavities for the purpose of diagnostic studies, therapeutic drug administration, or the diversion of fluid.

The In-Line Shunt Filter is indicated for use to filter particles that are larger than approximately The in Line Gham Mis suspected and when shunting is the procedure of choice in the treatment of hydrocephalus.

Device Description

The hydrocephalus accessories consist of connectors, reservoirs, and a filter. The connectors are made of stainless steel or plastic and are used in the joining and fixation of silicone rubber tubing. The reservoirs are made of silicone, stainless steel, and/or plastic and are used for the purpose of diagnostic studies or therapeutic drug administration. The filter is made of stainless steel and silicone and is used to filter particles.

AI/ML Overview

This submission describes a collection of Central Nervous System Fluid Shunt and Components, including various connectors, reservoirs, and a shunt filter.

Here's an analysis of the acceptance criteria and study data provided:

1. Table of Acceptance Criteria and Reported Device Performance:

The document focuses on the Magnetic Resonance (MR) safety of the devices. The acceptance criteria are implicit in adhering to established ASTM standards for MR safety. The reported performance demonstrates that the devices meet these standards.

Acceptance Criterion (Implicit)	Reported Device Performance
Adherence to ASTM F 2052 (MR-related heating)	Testing performed to ASTM F 2052, results contribute to overall MR Conditional/Safe determination. No specific numerical value for heating provided, but implies within acceptable limits for 3 Tesla MR systems.
Adherence to ASTM F 2213 (MR-related force and torque)	Testing performed to ASTM F 2213, results contribute to overall MR Conditional/Safe determination. No specific numerical value for force/torque provided, but implies within acceptable limits for 3 Tesla MR systems.
Adherence to ASTM F 2119 (MR-related artifacts)	Testing performed to ASTM F 2119, results contribute to overall MR Conditional/Safe determination. No specific numerical value for artifacts provided, but implies within acceptable limits for 3 Tesla MR systems.
Adherence to ASTM F 2182 (MR-related heating, force, torque)	Testing performed to ASTM F 2182, results contribute to overall MR Conditional/Safe determination. No specific numerical value for heating, force, or torque provided, but implies within acceptable limits for 3 Tesla MR systems.
Overall MR Safety Classification (ASTM F 2503)	Devices described as "MR Conditional" or "MR Safe" in 3-Tesla Magnetic Resonance Imaging (MRI) systems, according to ASTM F 2503. Devices made of silicone and plastic were determined to be "MR Safe" because they do not contain metallic or conducting materials, indicating zero risk for these specific components.
No added risk to the patient when exposed to a 3 Tesla MR system	"The test results demonstrate that there is no added risk to the patient when exposed to a 3 Tesla MR system."

2. Sample Size Used for the Test Set and Data Provenance:

Sample Size: The document does not specify the exact number of units or individual components tested for each ASTM standard. It simply states "Bench testing was performed according to the following MRI standards: ASTM F 2052, ASTM F 2213, ASTM F 2119, and ASTM F 2182." and that "The devices that are made of silicone and plastic were evaluated and determined to be MR Safe". However, given the nature of MR safety testing for medical devices, it typically involves a representative sample of each unique device type, material, and configuration that could potentially interact with the MR environment.
Data Provenance: The study is a retrospective bench-top study. The data provenance is internal to the manufacturer ("Bench testing was performed..."). There is no indication of country of origin of the data beyond the manufacturer's location (Raynham, MA, USA).

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts:

This information is not provided in the document. For MR safety testing, ground truth is established by objective measurements based on scientific principles and standardized test methods (ASTM standards) rather than expert consensus. The experts involved would typically be engineers or technicians with expertise in magnetic resonance and materials science who conduct the tests and interpret the results according to the specified ASTM protocols.

4. Adjudication Method for the Test Set:

This information is not applicable/not provided for this type of bench testing. Adjudication methods like 2+1 or 3+1 are used in clinical studies where human readers interpret data (e.g., radiology images) and disagreement among readers needs resolution. Here, the "ground truth" is determined by direct physical measurements against established standards.

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:

Not applicable. This submission is for a medical device (hydrocephalus shunt components) and their MR safety, not an AI or imaging diagnostic tool that would involve human readers or comparative effectiveness studies with AI assistance.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done:

Not applicable. This is not an algorithm or software device.

7. The Type of Ground Truth Used:

The ground truth used is based on objective physical measurements and adherence to internationally recognized ASTM standards for Magnetic Resonance safety (ASTM F 2052, ASTM F 2213, ASTM F 2119, ASTM F 2182, and ASTM F 2503). These standards define acceptable limits for device interaction with MR fields (e.g., heating, force, torque, artifacts).

8. The Sample Size for the Training Set:

Not applicable. This submission describes a physical medical device. There is no concept of a "training set" as would be found in machine learning or AI development. The device design and materials are based on established engineering principles and prior knowledge.

9. How the Ground Truth for the Training Set was Established:

Not applicable. As stated above, there is no training set for a physical medical device like this in the context of MR safety testing. The "ground truth" for the device's characteristics and safety (before testing) is established through its design specifications, material properties, and manufacturing processes, which are then validated through bench testing.

Summary

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510(k) SUMMARY

FEB 18 2011

Company Name:	Codman & Shurtleff, Inc.
Company Address:	325 Paramount DriveRaynham, MA 02767-0350
Phone:	(508) 828-3421
Fax:	(508) 828-2777
Contact Person:	Jocelyn Raposo, Senior Regulatory Affairs Specialist
Date:	October 4, 2010
Name of the Device:	Central Nervous System Fluid Shunt and Components
Propriety / Trade Name:	CODMAN® HOLTER® In-Line Shunt Filter, Hoffman DesignCODMAN® HOLTER® Cerebral Catheter-Reservoir, LeRov DesignCODMAN® ACCU-FLO® Straight Connector, Stainless SteelCODMAN® MEDOS® Straight ConnectorCODMAN® HOLTER® Type A Fixation and Joining ConnectorCODMAN® HOLTER® Type B Fixation and Joining ConnectorCODMAN® ACCU-FLO® Connector, Three Way, Stainless SteelCODMAN® HOLTER® RICKHAM® ReservoirCODMAN® HOLTER® SALMON™-RICKHAM® ReservoirCODMAN® ACCU-FLO® Right Angle Connector, Stainless SteelCODMAN® MEDOS® Right Angle ConnectorCODMAN® HOLTER® SELKER ReservoirCODMAN® ACCU-FLO® Straight Connector, PlasticCODMAN® ACCU-FLO® Connector, Three Way, PlasticCODMAN® ACCU-FLO® Right Angle Connector, Plastic
Common Name:	Hydrocephalus Shunt System Accessories
Classification:	Class II (JXG) per 21 CFR § 882.5550Central Nervous System Fluid Shunt and Components
Legally Marketed Device:	Preamendment - CODMAN® HOLTER® In-Line Shunt Filter,Hoffman DesignPreamendment - CODMAN® HOLTER® Cerebral Catheter-Reservoir, LeRoy DesignPreamendment – CODMAN® ACCU-FLO® Straight Connectors

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K944222	- CODMAN® MEDOS® Straight Connector
Preamendment	- CODMAN® HOLTER® Type A Fixation and Joining Connector
Preamendment	- CODMAN® HOLTER® Type B Fixation and Joining Connector
Preamendment	- CODMAN® ACCU-FLO® Connector, Three Way
Preamendment	- CODMAN® HOLTER® RICKHAM® Reservoir
Preamendment	- CODMAN® HOLTER® SALMON™-RICKHAM® Reservoir
Preamendment	- CODMAN® ACCU-FLO® Right Angle Connectors
K944222	- CODMAN® MEDOS® Right Angle Connector
Preamendment	- CODMAN® HOLTER® SELKER Reservoir
K973774	- CODMAN® ACCU-FLO® Straight Connector, Plastic
K973774	- CODMAN® ACCU-FLO® Connector, Three Way, Plastic
K973774	- CODMAN® ACCU-FLO® Right Angle Connector, Plastic
Device Description:	The hydrocephalus accessories consist of connectors, reservoirs, and a filter. The connectors are made of stainless steel or plastic and are used in the joining and fixation of silicone rubber tubing. The reservoirs are made of silicone, stainless steel, and/or plastic and are used for the purpose of diagnostic studies or therapeutic drug administration. The filter is made of stainless steel and silicone and is used to filter particles.
Intended Use:	The hydrocephalus accessories are intended for use with Codman's Hydrocephalus Shunt Systems.
Summary of technological characteristics of the proposed to the predicate device:
	No new technological characteristics are being introduced in comparison to the predicate devices. The technological characteristics of the devices remain the same. No changes are being made to the device design, materials, performance, or intended use.
Performance Data:	Bench testing was performed according to the following MRI standards: ASTM F 2052, ASTM F 2213, ASTM F 2119, and ASTM F 2182. The test results demonstrate that there is no added risk to the patient when exposed to a 3 Tesla MR system. The devices that are

made of silicone and plastic were evaluated and determined to be MR Safe since they do not contain metallic or conducting materials. The

…..

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K102961

results and evaluation conclude that the devices are MR Conditional or MR Safe in 3-Tesla Magnetic Resonance Imaging (MRI) systems according to ASTM F 2503 and are substantially equivalent to the predicate devices.

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Image /page/3/Picture/1 description: The image shows the logo for the Department of Health & Human Services (HHS). The logo features a stylized image of an eagle with three lines representing its wings and body. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the eagle.

Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002

Codman & Shurtleff. Inc. c/o Ms. Jocelyn Raposo Senior Regulatory Affairs Specialist 325 Paramount Drive Raynham, MA 02767-0350

FEB 1 8 2011

Re: K102961

Trade/Device Name: CODMAN® HOLTER® In-Line Shunt Filter, Hoffman Design CODMAN® HOLTER® Cerebral Catheter-Reservoir, LeRoy Design CODMAN® ACCU-FLO® Straight Connector, Stainless Steel CODMAN® MEDOS® Straight Connector CODMAN® HOLTER® Type A Fixation and Joining Connector CODMAN® HOLTER® Type B Fixation and Joining Connector CODMAN® ACCU-FLO® Connector, Three Way, Stainless Steel CODMAN® HOLTER® RICKHAM® Reservoir CODMAN® HOLTER® SALMON™-RICKMAN® Reservoir CODMAN® ACCU-FLO® Right Angle Connector, Stainless Steel CODMAN® MEDOS® Right Angle Connector CODMAN® HOLTER® SELKER Reservoir CODMAN® ACCU-FLO® Straight Connector, Plastic CODMAN® ACCU-FLO® Connector, Three Way, Plastic CODMAN® ACCU-FLO® Right Angle Connector, Plastic

Regulation Number: 21 CFR 882.5550 Regulation Name: Central nervous system fluid shunt and components Regulatory Class: II Product Code: JXG Dated: January 18, 2011 Received: January 19, 2011

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

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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.

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 of medical device-related adverse events) (21 CFR 803); 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.
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,

Tesia Alexander

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

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માળટવદા 510(k) Number (if known): __

Device Name:

CODMAN® MEDOS® Straight Connector CODMAN® MEDOS® Right Angle Connector

Indications for Use:

The Codman-Medos Connector is for use in the treatment of hydrocephalus as a component of a shunt system when draining or shunting of cerebrospinal fluid (CSF) is indicated.

Prescription Use (Part 21 CFR 801 Subpart D)

AND/OR

Over-The-Counter Use (Part 21 CFR 801 Subpart C)

JOE HUTTER

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

K102961 510(k) Number

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1102961 510(k) Number (if known):

Device Name:

CODMAN® HOLTER® Type A Fixation and Joining Connector

Indications for Use:

The Type A Fixation and Joining Connector is indicated for use in the joining and fixation of 1.2 rite Type P. Pixation and coming with nonabsorbable sutures in a surgical application.

Prescription Use
(Part 21 CFR 801 Subpart D)

AND/OR

Over-The-Counter Use _ (Part 21 CFR 801 Subpart C)

JOE HUTTER

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

510(k) Number K102961

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K102961 510(k) Number (if known): _

Device Name:

CODMAN® HOLTER® Type B Fixation and Joining Connector

Indications for Use:

Prescription Use (Part 21 CFR 801 Subpart D)

AND/OR

Over-The-Counter Use _ (Part 21 CFR 801 Subpart C)

JOE HUTTER

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

4102961 ^^^^ (^imber

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510(k) Number (if known): ____________________________________________________________________________________________________________________________________________________

Device Name:

CODMAN® HOLTER® SEL.KER Reservoir CODMAN® HOLTER® RICKHAM® Reservoir CODMAN® HOLTER® SAL.MON™-RICKHAM® Reservoir

Indications for Use:

· Prescription Use (Part 21 CFR 801 Subpart D)

AND/OR

Over-The-Counter Use (Part 21 CFR 801 Subpart C)

JOE HUTTER

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

4102a61 510(k) Number_

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510(k) Number (if known): ____________________________________________________________________________________________________________________________________________________

Device Name:

CODMAN® ACCU-FLO® Connector, Three Way (Stainless Steel and Plastic)

Indications for Use:

The ACCU-FLO Three Way Connector can be utilized as a component in systems designed to The ACCO-FLO Three Way Ochniction our be unities into the right atium of the heart or the shunt cereorospinal had from the lateral vonthologime and fixation of approximately 1.3 mm
peritoneal cavity, providing they are used in the joining aurrical application pentioneal cavily, providing they are about in the John's and surgical application.

Prescription Use
(Part 21 CFR 801 Subpart D) X

AND/OR

Over-The-Counter Use _ (Part 21 CFR 801 Subpart C)

JOE HUTTER

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

510(k) Number K102961

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ત્વજવદા 510(k) Number (if known): __

Device Name:

CODMAN® ACCU-FLO® Straight Connectors (Stainless Steel and Plastic) OODMAN® ACCU-FLO® Right Angle Connectors (Stainless Steel and Plastic)

Indications for Use:

× ´ Prescription Use (Part 21 CFR 801 Subpart D)

AND/OR

Over-The-Counter Use (Part 21 CFR 801 Subpart C)

JOE HUTTER

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

KID2961 510(k) Number_

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મા૦ટવદા 510(k) Number (if known): _

Device Name:

CODMAN® HOLTER® Cerebral Catheter Reservoir, Leroy Design

Indications for Use:

Prescription Use
X
(Part 21 CFR 801 Subpart D)

AND/OR

Over-The-Counter Use (Part 21 CFR 801 Subpart C)

Joe HUTTER

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

KIDZACI 510(k) Number.

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510(k) Number (if known): ____________________________________________________________________________________________________________________________________________________

Device Name:

CODMAN® HOLTER® In-Line Shunt Filter, Hoffman Design

Indications for Use:

Prescription Use
(Part 21 CFR 801 Subpart D) X

AND/OR

Over-The-Counter Use _ (Part 21 CFR 801 Subpart C)

JOE HUTTER

ision Sign-Off) · of Ophthalmic, Neurological and Ear, "Froat Devices

K102961 STUCK , Nomber __

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).