The Codman HAKIM Precision Valve System is an implantable device that provides constant intraventricular pressure and drainage of cerebral spinal fluid (CSF) for the management of hydrocephalus.

The Codman HAKIM Programmable Valve System is an implantable device that provides constant intraventricular pressure and drainages of cerebral spinal fluid (CSF) for the management of hydrocephalus.

The Codman HOLTER Lumboperitoneal (LP) Shunt is indicated for shunting cerebrospinal fluid when the lumboperitoneal route is the procedure of choice in the treatment of communicating hydrocephalus.

The Codman HOLTER Atrial Catheters are indicated for use to shunt cerebrospinal fluid, when shunting of cerebrospinal fluid to the atrium is the procedure of choice in the treatment of hydrocephalus.

The Codman HOLTER Ventricular Catheters are indicated for use to gain access to the ventricles for diagnostic purposes and in the treatment of hydrocephalus.

The Codman Medos Ventricular Catheter is indicated 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 UNI-SHUNT System is indicated for use as a one-piece ventriculo-peritoneal shunt system for the palliative treatment of hydrocephalus. No other use is recommended.

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

Device Description

Codman HAKIM Precision and Programmable Valves:
The Codman HAKIM Precision and Programmable Valves are implantable devices that provide constant intraventricular pressure and drainage of cerebral spinal fluid (CSF) for the management of hydrocephalus. Both the Codman HAKIM Precision and Programmable Valves are pressure regulating valves which maintain intraventricular pressure at a constant level. The Codman HAKIM Precision valves are fixed pressure valves and are available in 5 different opening pressure ranges. The Codman HAKIM Programmable Valves, not having fixed pressures, permit non-invasive adjustment of the valve opening pressure. The Codman HAKIM Programmable Valves can be adjusted to 18 different opening pressure settings.

Codman HOLTER Catheters:
The HOLTER Catheter, is a barium-impregnated silicone rubber open-ended catheter. Two stainless steel Type "A" Fixation and Joining Connectors are included with each catheter to use in rejoining the catheter if it has been cut for lengthening or revision. The HOLTER Catheter, Salmon Design, is a barium-impregnated silicone rubber catheter. Four longitudinal slits (90° apart) near the closed distal tip of the catheter are for drainage of cerebrospinal fluid. Two stainless steel Type "A" Connectors are included with each catheter to use in rejoining the catheter if it has been cut for lengthening or revision.

Codman Medos Ventricular Catheter:
The Medos Ventricular Catheter is made from barium-impregnated silicone tubing. The catheter is 140 mm in length and is supplied with 24 inlet holes, 3 rows of 8 holes, at the proximal end. The catheter, with stainless steel stylet and right angle adapter, is supplied sterile.

UNI-SHUNT® System:
The UNI-SHUNT® system with Reservoir incorporates a double dome access port to facilitate injections and aspirations of CSF samples. It is a continuous length of barium-impregnated silicone tubing with an access reservoir made of self-sealing silicone which can be punctured with a 25 gauge or smaller Huber type needle.

Codman BACTISEAL Catheters:
The BACTISEAL Catheters are made of radiopaque (barium-impregnated) silicone tubing and are supplied sterile. BACTISEAL Catheters are subjected to a treatment process by which the silicone tubing is impregnated with rifampin and clindamycin hydrochloride. 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 stainless-steel stylet and right angle adapter are packaged with the ventricular catheter. The peritoneal catheter has a beveled tip at one end and the other end of the catheter has a flat tip. The catheter is 120 cm long and may be trimmed to the proper length.

AI/ML Overview

This document, K172022, primarily discusses the substantial equivalence of updated Codman Hydrocephalus Shunt Systems to previously cleared predicate devices. The changes noted are related to labeling updates for MRI compatibility and compliance with ISO 7197 standards for pressure flow characteristics. The performance data provided is entirely from bench testing; there are no human studies (clinical or multi-reader multi-case) described for proving device performance.

Therefore, many of the requested elements regarding human studies (like MRMC studies, expert ground truth adjudication, and clinical study sample sizes) are not applicable to this specific submission as presented in the document.

Here's the breakdown of the acceptance criteria and the study proving the device meets them, based on the provided text:

Acceptance Criteria and Reported Device Performance

The acceptance criteria and reported device performance are based on bench testing for various aspects of the device, primarily related to MRI safety and conformity to specific ISO and ASTM standards.

Standard	Acceptance Criteria	Reported Device Performance
ISO 7197	Characterize the pressure flow characteristics of the device per ISO 7197.	Pass – Pressure and Flow characteristic results added to the product IFUs.
ASTM F647	Characterize the long-term stability of the implantable shunt assemblies per ASTM F647. Mean difference of Post stability – pre-stability testing (P-Q post bursting pressure) must not be greater than 10 mmH2O at each pressure setting tested and must comply with PQ characteristic specifications in the IFU.	Pass – average difference less than 10mm H2O and results comply with characteristics provided in the IFU.
ASTM F2119	Image Artifact information was collected for the devices in both 1.5T and 3.0T MR environments. For each device, scans were made in three planes (sagittal, coronal, and axial) for using both gradient and spin echo sequences. Our labeling lists the worst-case image artifact for gradient echo sequencing. (Implied acceptance: artifacts are within acceptable limits for safe imaging and adequate information for labeling).	Pass – results added to MR Information in the product IFUs.
ASTM F2182	The acceptance criterion for this test was to characterize the implanted device increase in temperature after 15 minutes of continuous scanning (in both 1.5 T and 3.0 T MR environments). (Implied acceptance: temperature increase is within safe limits for human use).	Pass - results added to MR Information in the product IFUs.
ASTM F2052	This test assessed if the amount of magnetically induced force on the device is less than or equal to the force on the device due to gravity. The magnetically induced force for the devices was considered to meet the acceptance criteria in both 1.5T and 3.0T MR environment, thus supporting the MR Conditional claim. The maximum acceptable spatial gradient was determined on the basis of the component with the largest deflection, and is listed in our labeling. (Implied acceptance: magnetically induced force is not clinically significant such that it dislodges the device or causes harm).	Pass - results added to MR Information in the product IFUs.
ASTM F2213	This test assessed if the amount of magnetically induced torque on the device is less than or equal to the gravitational torque. The magnetically induced torque for the devices was considered to meet the acceptance criteria in both 1.5T and 3.0T MR environments, thus supporting the MR Conditional claim. (Implied acceptance: magnetically induced torque is not clinically significant such that it dislodges the device or causes harm, particularly with rotation).	Pass - results added to MR Information in the product IFUs.

Study Details for Device Performance

Sample size used for the test set and the data provenance:
- Sample Size: Not specified in terms of number of devices tested. The document refers to "the devices" being tested.
- Data Provenance: The studies are bench tests, meaning they were conducted in a laboratory setting. There is no information about country of origin for the data or whether it was retrospective or prospective.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not Applicable. Ground truth, in this context, would typically refer to clinical diagnosis or expert annotations for an AI/diagnostic device. This submission describes physical device testing against engineering standards. The "ground truth" is defined by the technical specifications outlined in the ASTM and ISO standards and the performance of the device against those specifications. No human experts were involved in establishing the "ground truth" for the bench tests.
Adjudication method (e.g. 2+1, 3+1, none) for the test set:
- Not Applicable. As this is bench testing against specified engineering criteria, there is no need for human adjudication of test results.
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. The document explicitly states "No clinical studies were required". This device is a hydrocephalus shunt system, not an AI, diagnostic imaging, or reader-assisted device.
If a standalone (i.e. algorithm only without human-in-the loop performance) was done:
- Not Applicable. This is a physical medical device (shunt system), not a software algorithm.
The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- The "ground truth" for these bench tests are the established engineering and safety specifications defined by the relevant ASTM and ISO standards (e.g., maximum allowable temperature increase, force/torque limits, pressure flow characteristics).
The sample size for the training set:
- Not Applicable. This 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. See point 7.

Summary

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

October 3, 2017

Codman & Shurtleff, Inc. Christopher Garete Regulatory Affairs Specialist II 325 Paramount Drive Raynham, Massachusetts 02767

Re: K172022

Trade/Device Name: Codman HAKIM Precision Valve System, Codman HAKIM Programmable Valve System, Codman HOLTER Lumboperitoneal (LP) Shunt, Codman HOLTER Atrial Catheters, Codman HOLTER Ventricular Catheters, Codman Medos Ventricular Catheter, UNI-SHUNT System, Codman BACTISEAL Catheters Regulation Number: 21 CFR 882.5550 Regulation Name: Central Nervous System Fluid Shunt and Components Regulatory Class: Class II Product Code: JXG Dated: June 30, 2017 Received: July 5, 2017

Dear Mr. Garete:

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 devicerelated 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 contact the Division of Industry and Consumer Education (DICE) 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. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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 Industry and Consumer Education (DICE) 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,

Carlos L. Pena -S)

Carlos L. Peña, PhD, MS Director Division of Neurological and Physical Medicine Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known) K172022

Device Name

Codman HAKIM Precision Valve System, Codman HAKIM Programmable Valve System, Codman HOLTER Lumboperitoneal (LP) Shunt, Codman HOLTER Atrial Catheters, Codman HOLTER Ventricular Catheters, Codman Medos Ventricular Catheter, UNI-SHUNT System, Codman BACTISEAL Catheters

Indications for Use (Describe)