(90 days)
Not Found
No
The device description and intended use focus on mechanical components and pressure regulation for CSF drainage. There is no mention of AI, ML, or any computational analysis of data for decision-making or control.
Yes
This device is a therapeutic device because its intended use is to manage hydrocephalus by providing constant intraventricular pressure and drainage of cerebral spinal fluid, which is a treatment for the condition.
No
The devices described are primarily for the management and treatment of hydrocephalus by shunting cerebrospinal fluid. While one catheter (Codman HOLTER Ventricular Catheters) is mentioned for "diagnostic purposes" in addition to treatment, the core function of the system as a whole (valves, shunts, catheters) is therapeutic (draining CSF) rather than diagnostic. The "diagnostic purposes" for the ventricular catheters likely refer to their use to access the ventricles for sampling or pressure measurement, which is a means to diagnosis, but the device itself is not performing the diagnosis.
No
The device description clearly outlines multiple hardware components including implantable valves, catheters made of silicone rubber, and connectors. There is no mention of software as a primary or standalone component.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use/Indications for Use: The intended use clearly states that these devices are implantable systems for managing hydrocephalus by draining cerebrospinal fluid (CSF). This is a therapeutic intervention, not a diagnostic test performed in vitro (outside the body).
- Device Description: The descriptions detail the physical components of the shunt systems (valves, catheters, reservoirs) designed for implantation and fluid drainage. There is no mention of reagents, test strips, or any components used to analyze biological samples in vitro.
- Lack of IVD Characteristics: The document does not mention any of the typical characteristics of an IVD, such as:
- Analyzing biological samples (blood, urine, CSF for diagnostic purposes)
- Detecting specific analytes (proteins, genes, etc.)
- Providing diagnostic information about a patient's condition based on sample analysis.
The devices described are surgical implants used to treat a medical condition (hydrocephalus) by physically managing fluid flow within the body. This falls under the category of medical devices, but not specifically In Vitro Diagnostic devices.
N/A
Intended Use / Indications for Use
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.
Product codes
JXG
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.
Hydrocephalus is a condition caused by the excessive accumulation of CSF in the ventricles of the brain due to a disturbance of CSF secretion, flow, or absorption which causes a rise in intracranial pressure (ICP). To relieve ICP, CSF can be diverted through a shunting device, such as the Codman HAKIM Precision or Programmable Valve, to another body cavity where it is absorbed and subsequently excreted.
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Intraventricular, brain, atrium, lumboperitoneal
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Bench Testing:
Non-clinical testing was successfully performed to support the proposed MRI labeling information and the ISO 7197 compliance.
| Standard | Acceptance Criteria | Result |
|---|---|---|
| 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 H20 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. | 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). | 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. | 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. | Pass - results added to MR Information in the product IFUs. |
Sterilization: No sterilization studies were performed as there are no changes to the subject devices when compared to the predicates in regards to materials, design, sterilization methods, or SAL. Appropriate sterilization verification was achieved on the predicate devices.
Shelf-Life Testing: No shelf life studies were performed as there are no changes to the subject device when compared to the predicate in regards to materials, design, packaging, or manufacturing processes. Appropriate shelf life verification was achieved based on the predicate devices.
Biocompatibility Testing: No biocompatibility studies were performed as there are no changes to the subject device when compared to the predicate in regards to materials, design, or manufacturing processes. Appropriate biocompatibility verification was achieved on the predicate devices.
Animal Studies: No animal studies were required as appropriate verification and validation of the design modifications were achieved based on the similarities of the proposed device to the predicate device, and from results of bench testing.
Clinical Studies: No clinical studies were required as appropriate verification and validation of the design modifications were achieved based on the similarities of the proposed device to the predicate device, and from results of bench testing.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Preamendment – HOLTER Catheters and UNI-SHUNT System, K944222 – Codman HAKIM Shunt System & Ventricular Catheter, K973774 – Codman HAKIM Micro Precision Valve, K974739 – Codman HAKIM Programmable Valve System, K980778 – Codman HAKIM Micro Programmable Valve, K992173 – Codman SiphonGuard CSF Control Device, K020667 – Codman HAKIM Shunt System, K041296 – Modification to HAKIM Precision Valve System, K053350 – Modification to Codman HAKIM Shunt System, K102589 – Codman BACTISEAL Catheters, K122118 – Modification to Codman HAKIM Shunt System
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 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).
0
Image /page/0/Picture/2 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo features a stylized caduceus symbol, which is often associated with healthcare. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular pattern around the symbol.
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.
1
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
2
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)
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.
Type of Use (Select one or both, as applicable)
| Prescription Use (Part 21 CFR 801 Subpart D) | Over-The-Counter Use (21 CFR 801 Subpart C) |
|---|---|
| ---------------------------------------------- | --------------------------------------------- |
Prescription Use (Part 21 CFR 801 Subpart D)
| | Over-The-Counter Use (21 CFR 801 Subpart C)
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510(k) Summary
I. Submitter Codman & Shurtleff, Inc. 325 Paramount Drive Raynham, MA 02767
Contact: Christopher Garete Phone: (508) 977-3869 Fax: (508) 977-6979
Date of Submission: June 16, 2017
| II. Device(s) | |
|---|---|
| --------------- | -- |
| Device Proprietary Name(s) | 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 |
|----------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Common Name | Hydrocephalus Shunt System |
| Classification Name | Central Nervous System Fluid Shunt and Components
(21 CFR 882.5550) |
| Regulatory Classification | II |
| Product Code | JXG |
III. Predicate The predicate devices for this submission have been cleared by the FDA Device(s) under:
| Preamendment – HOLTER Catheters and UNI-SHUNT System |
|---|
| K944222 – Codman HAKIM Shunt System & Ventricular Catheter |
| K973774 – Codman HAKIM Micro Precision Valve |
| K974739 – Codman HAKIM Programmable Valve System |
| K980778 – Codman HAKIM Micro Programmable Valve |
| K992173 – Codman SiphonGuard CSF Control Device |
| K020667 – Codman HAKIM Shunt System |
| K041296 – Modification to HAKIM Precision Valve System |
| K053350 – Modification to Codman HAKIM Shunt System |
| K102589 – Codman BACTISEAL Catheters |
| K122118 – Modification to Codman HAKIM Shunt System |
4
IV. Device Codman HAKIM Precision and Programmable Valves: Description
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.
Hydrocephalus is a condition caused by the excessive accumulation of CSF in the ventricles of the brain due to a disturbance of CSF secretion, flow, or absorption which causes a rise in intracranial pressure (ICP). To relieve ICP, CSF can be diverted through a shunting device, such as the Codman HAKIM Precision or Programmable Valve, to another body cavity where it is absorbed and subsequently excreted.
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:
5
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.
V. Indications The Codman HAKIM Precision Valve System is an implantable device that for Use 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 lumbo-peritoneal route is the procedure of choice in the treatment of communicating hydrocephalus.
6
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 ventriculoperitoneal 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.
VI. Comparison The HAKIM Precision Valves, HAKIM Programmable Valves, HOLTER to Predicate Medos Ventricular Catheter, Catheter, UNI-SHUNT Svstem. Catheters. and Device(s) BACTISEAL Catheters (hereafter to be referred to as "Codman Hydrocephalus Valves, Catheters & Accessories") are substantially equivalent to their predicate devices. The subject devices have the same indications for use and clinical utility, design principles, materials, sterilization, and packaging as the predicate devices.
The only difference between the predicate and proposed devices is the labeling and IFU. Codman has added the MRI Conditional information to all the impacted products per ASTM F 2503. The HAKIM Precision Valves, HAKIM Programmable Valves, HOLTER Catheters, and UNI-SHUNT System IFU and Labels are also being revised to identify pressure flow or closing pressure characteristics per ISO 7197: 2009. For the slit valves, (HOLTER Catheters and UNI-SHUNT System) closing pressure is identified instead of operating pressure. ISO 7197:2009 section 4.6 describes pressure flow testing, but compliance can also be established by relaying what is most prevalent for product functionality. For the slit valves, the closing pressure values are more prevalent for product functionality.
7
The following performance data has been provided in support of the VII. Performance substantial equivalence determination. All testing was performed on final Data sterile devices unless otherwise specified.
8
Bench Testing
Non-clinical testing was successfully performed to support the proposed MRI labeling information and the ISO 7197 compliance.
| Bench Testing Summary | ||
|---|---|---|
| Standard | Acceptance Criteria | Result |
| 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 H20 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 | Pass – results added to MR Information in the product IFUs. |
| sequencing. | ||
| 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). | 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. | 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 | Pass - results added to | |
| MR Information in the | ||
| product IFUs. | ||
| devices was considered | ||
| to meet the acceptance | ||
| criteria in both 1.5T | ||
| and 3.0T MR | ||
| environments, thus | ||
| supporting the MR | ||
| Conditional claim. |
9
10
Sterilization
No sterilization studies were performed as there are no changes to the subject devices when compared to the predicates in regards to materials, design, sterilization methods, or SAL. Appropriate sterilization verification was achieved on the predicate devices.
Shelf-Life Testing
No shelf life studies were performed as there are no changes to the subject device when compared to the predicate in regards to materials, design, packaging, or manufacturing processes. Appropriate shelf life verification was achieved based on the predicate devices.
Biocompatibility Testing
No biocompatibility studies were performed as there are no changes to the subject device when compared to the predicate in regards to materials, design, or manufacturing processes. Appropriate biocompatibility verification was achieved on the predicate devices.
Animal Studies
No animal studies were required as appropriate verification and validation of the design modifications were achieved based on the similarities of the proposed device to the predicate device, and from results of bench testing.
Clinical Studies
No clinical studies were required as appropriate verification and validation of the design modifications were achieved based on the similarities of the proposed device to the predicate device, and from results of bench testing.
VIII. The proposed Hydrocephalus Valves, Catheters & Accessories, as identified Conclusion within this submission, are substantially equivalent to the currently marketed
11
Hydrocephalus Valves, Catheters & Accessories. The MRI testing and ISO 7197 testing did not raise new questions of safety and effectiveness.
The addition of MRI safety and pressure/flow characteristic information to the labeling does not alter the indications for use, intended use, materials of composition, manufacturing and sterilization process, or the fundamental scientific technology of the devices.