(416 days)
Not Found
No
The device description and intended use focus on a mechanical differential pressure valve for shunting CSF, with no mention of AI or ML capabilities.
Yes
The device is used in the "treatment of patients with communicating hydrocephalus," indicating a therapeutic purpose.
Yes
The "Intended Use / Indications for Use" section states: "The shunt may be used for diagnosis, evaluation or treatment of normal pressure communicating hydrocephalus."
No
The device description explicitly states that the devices are "implantable devices" and describes physical components like "differential pressure valves" and an "antechamber," indicating it is a hardware medical device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states that the device is an implantable device used to shunt cerebrospinal fluid from one part of the body to another for the treatment of hydrocephalus. This is a therapeutic intervention performed in vivo (within the living body).
- Device Description: The description reinforces that it is an implantable device designed to manage fluid flow within the body.
- Lack of IVD Characteristics: An IVD device is used to examine specimens (like blood, urine, or CSF) in vitro (outside the body) to provide information for diagnosis, monitoring, or screening. This device does not perform any such analysis of specimens. While the antechamber allows for CSF sampling, the device itself is not performing the diagnostic test on the sample.
Therefore, the Horizontal-Vertical Lumbar Valve Systems and Spetzler Lumbar-Peritoneal Shunt systems are not IVD devices. They are implantable medical devices used for therapeutic purposes.
N/A
Intended Use / Indications for Use
Horizontal-Vertical Lumbar Valve Systems
Horizontal-Vertical Lumbar Valve Systems are implantable devices used in the treatment of patients with communicating hydrocephalus to shunt cerebrospinal fluid (CSF) from the lumbar subarachnoid region to the peritoneal cavity. They provide controlled intraventricular pressure and CSF drainage in patients with hydrocephalus. The antechamber can be electively mounted in line with the Valve Unit to allow for CSF sampling or injections in the subarachnoid space.
Spetzler Lumbar Peritoneal Shunt Systems
Percutaneous lumbar peritoneal shunting may be utilized in the treatment of communicating hydrocephalus. The Spetzler Shunt systems are designed to shunt CSF from the lumbar subarachnoid space to the peritoneal cavity.
The shunt may be used for diagnosis, evaluation or treatment of normal pressure communicating hydrocephalus.
A percutaneous lumbar peritoneal shunt is also useful in the management of persistent cerebrospinal fluid fistulas, bulging cranial and suboccipital decompressions and in transient CSF absorption defects, e.g. post-meningitic or post-hemorrhagic hydrocephalus.
The In-Line Valve, available as a separate component of the system, is indicated for use where added resistance is desired to alleviate symptoms of low pressure in the small percentage of patients who, after normal drainage and in the normal course of treatment, develop such symptoms.
Product codes
JXG
Device Description
The Horizontal-Vertical Lumbar Valve and the Spetzler Lumbar-Peritoneal Shunt systems are implantable devices used in the treatment of patients with communicating hydrocephalus to shunt cerebrospinal fluid (CSF) from the lumbar subarachnoid region to the peritoneal cavity. Both are differential pressure valves designed to open when the difference between ventricular or lumbar pressure and outlet cavity pressure exceeds a certain threshold.
The primary issues affecting the safety and compatibility of passive implants in the MR environment concern magnetically induced displacement force and torque, radio frequency (RF) heating, and image artifacts. The addition of MRI Safety information to the labeling is intended to provide for safe use of the shunt systems by clarifying the conditions required to safely use these devices in an MR environment in a readily available, clear and concise manner, to healthcare providers.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
lumbar subarachnoid region, peritoneal cavity, ventricular, lumbar
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
The Horizontal-Vertical Lumbar Valve Systems and Spetzler Lumbar Peritoneal Shunt Systems are identical in design. performance, and materials of composition to the currently marketed predicate systems. Since the proposed shunts and accessories are identical to the currently marketed shunts and accessories, all performance testing to the performance of the predicate devices also supports the proposed devices, and remains unchanged. Additional bench testing was performed to determine the safe use conditions for these products in the MR environment, as described below. Testing was also performed to confirm that the performance of these devices remains the same after use in an MR environment.
DESIGN VERIFICATION TEST
Magnetically Induced Displacement Force Test ASTM F2052: The amount of magnetically induced force on the device shall be less than or equal to the force on the device due to gravity.
Magnetically Induced Torque Test ASTM F2213: The amount of magnetically induced torque on the device shall be less than or equal to the gravitational torque.
RF Heating Test ASTM F 2182: No portion of the implanted device shall exhibit an increase in temperature of more than 2°C at a SAR of 2W/kg.
Image Artifact Test ASTM F2119: There is no acceptance criterion as per ASTM standard; this test is performed to gather information relating to image artifacts caused by the device. This information can be included in labeling.
The non-clinical testing has demonstrated that the Horizontal-Vertical Lumbar Valve Systems and Spetzler Lumbar Peritoneal Shunt Systems are MR Conditional, as defined in the ASTM 2503-05 Standard, "Standard Practice for Marking Medical Devices and other items for Safety in the Magnetic Resonance Environment." This classification is appropriate for "an item which has been demonstrated to pose no known hazards in specific MR environment with specified conditions.
Key Metrics
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
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/1 description: The image shows the word "INTEGRA" in bold, black letters. Below the word "INTEGRA" is the phrase "LIMIT UNCERTAINTY" in smaller, black letters. To the right of the word "INTEGRA" is a design of four black squares of different sizes stacked on top of each other.
510(k) Summary
JUL - 7 2011
1. Contact Details
Applicant Name: Integra LifeSciences Corporation 311 Enterprise Drive Plainsboro, NJ 08536, USA Telephone: (609) 654-2873 Facsimile: (609) 275-9445
Contact Person: Donna Millisky Manager, Regulatory Affairs E-Mail: donna.millisky@integralife.com
Date Prepared: June 23, 2011
2. Device Name
Horizontal-Vertical Lumbar Valve Systems Tradename: Spetzler™ Lumbar Peritoneal Shunt Systems
Common Name: Hydrocephalus Shunts
Classification Name: Shunt, Central Nervous System and Components, JXG
3. Legally Marketed Predicate Device(s)
| 510(k) Number | Product Code | Trade Name | Manufacturer |
|---|---|---|---|
| K944595 | JXG | Cordis Horizontal-Vertical | |
| Valve System | Integra LifeSciences | ||
| (Previously Cordis Corp.) | |||
| K811288 | JXG | Spetzler Lumbar-Peritoneal | |
| Systems | Integra LifeSciences | ||
| (Previously American | |||
| Heyer-Schulte Corp.) | |||
| K871685 | JXG | Heyer-Schulte Spetzler | |
| Lumbar-Peritoneal Shunt | |||
| Systems | Integra LifeSciences | ||
| (Previously American | |||
| Heyer-Schulte Corp.) |
1
4. Device Description
The Horizontal-Vertical Lumbar Valve and the Spetzler Lumbar-Peritoneal Shunt systems are implantable devices used in the treatment of patients with communicating hydrocephalus to shunt cerebrospinal fluid (CSF) from the lumbar subarachnoid region to the peritoneal cavity. Both are differential pressure valves designed to open when the difference between ventricular or lumbar pressure and outlet cavity pressure exceeds a certain threshold.
The primary issues affecting the safety and compatibility of passive implants in the MR environment concern magnetically induced displacement force and torque, radio frequency (RF) heating, and image artifacts. The addition of MRI Safety information to the labeling is intended to provide for safe use of the shunt systems by clarifying the conditions required to safely use these devices in an MR environment in a readily available, clear and concise manner, to healthcare providers.
5. Intended Use/Indications for use
Horizontal-Vertical Lumbar Valve Systems
Horizontal-Vertical Lumbar Valve Systems are implantable devices used in the treatment of patients with communicating hydrocephalus to shunt cerebrospinal fluid (CSF) from the lumbar subarachnoid region to the peritoneal cavity. They provide controlled intraventricular pressure and CSF drainage in patients with hydrocephalus. The antechamber can be electively mounted in line with the Valve Unit to allow for CSF sampling or injections in the subarachnoid space.
Spetzler Lumbar Peritoneal Shunt Systems
Percutaneous lumbar peritoneal shunting may be utilized in the treatment of communicating hydrocephalus. The Spetzler Shunt systems are designed to shunt CSF from the lumbar subarachnoid space to the peritoneal cavity.
The shunt may be used for diagnosis, evaluation or treatment of normal pressure communicating hydrocephalus.
A percutaneous lumbar peritoneal shunt is also useful in the management of persistent cerebrospinal fluid fistulas, bulging cranial and suboccipital decompressions and in transient CSF absorption defects, e.g. post-meningitic or post-hemorrhagic hydrocephalus.
The In-Line Valve, available as a separate component of the system, is indicated for use where added resistance is desired to alleviate symptoms of low pressure in the small percentage of patients who, after normal drainage and in the normal course of treatment, develop such symptoms.
2
6. Substantial Equivalence Comparison
The Horizontal-Vertical Lumbar Valve and the Spetzler Lumbar-Peritoneal Shunt systems are identical to currently marketed predicate Horizontal-Vertical Lumbar Valve and Spetzler Lumbar-Peritoneal Shunt systems except for a labeling revision to add MRI safety information for the safe use of the devices in an MR environment.
| Feature | Predicate Horizontal-Vertical
Lumbar Valve System (K944595) | Horizontal-Vertical Lumbar
Valve System |
|---------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------|
| Indications for Use | Implantable system used in the treatment of patients with communicating hydrocephalus, to shunt CSF from the lumbar subarachnoid region to the peritoneal cavity. | Same as Predicate Horizontal-Vertical Lumbar Valve System |
| Incorporates the same basic design and utilizes the same operating principle | Differential pressure valve with two balls in cone valve mechanisms: a spring actuated (lower) pressure mechanism and a gravity-actuated (higher) pressure mechanism. Flow direction identified by an arrow on the stainless steel modulus | Same as Predicate Horizontal-Vertical Lumbar Valve System |
| Performance Specifications | Six pressure ranges with closing pressures between 50 and 125 mmH2O in the horizontal position and between 170 and 445 mmH2O in the vertical position. | Same as Predicate Horizontal-Vertical Lumbar Valve System |
| MRI Safe | Integra NeuroSciences tests indicate that MRI exposure does not affect pressure valve settings. No significant forces or temperature changes were noticed during MRI exposure. | MR Conditional |
| Biocompatible | Yes | Same as Predicate Horizontal-Vertical Lumbar Valve System |
| Feature | Predicate Spetzler Lumbar
Peritoneal Shunt Systems
(K811288 and K871685) | Spetzler Lumbar Peritoneal
Shunt Systems |
| Indications for Use | Percutaneous lumbar peritoneal
shunting may be utilized in the
treatment of communicating
hydrocephalus. It is designed to
shunt CSF from the lumbar
subarachnoid space to the
peritoneal cavity. | Same as Predicate Spetzler
Lumbar Peritoneal Shunt
Systems |
| | The shunt may be used for
diagnosis, evaluation or treatment
of normal pressure communicating
hydrocephalus. | |
| | A percutaneous lumbar peritoneal
shunt is also useful in the
management of persistent
cerebrospinal fluid fistulas, bulging
cranial and suboccipital
decompressions and in transient
CSF absorption defects, e.g. post-
meningitic or post-hemorrhagic
hydrocephalus. | |
| | The In-Line Valve, available as a
separate component of the system,
is indicated for use where added
resistance is desired to alleviate
symptoms of low pressure in the
small percentage of patients who,
after normal drainage and in the
normal course of treatment, develop
such symptoms. | |
| Incorporates the same
basic design and
utilizes the same
operating principle | Pressure control is achieved
through a combination of the
double slit valve at the peritoneal
end and the small inner diameter
catheter | Same as Predicate Spetzler
Lumbar Peritoneal Shunt
Systems |
| Performance
Specifications | Six systems with pressure ranges
with closing pressures between 50
and 400 mmHgH20 | Same as Predicate Spetzler
Lumbar Peritoneal Shunt
Systems |
| MRI Safe | No claim | MR Conditional |
| Biocompatible | Yes | Same as Predicate Spetzler
Lumbar Peritoneal Shunt
Systems |
3
·
4
7. Non-Clinical Testing
The Horizontal-Vertical Lumbar Valve Systems and Spetzler Lumbar Peritoneal Shunt Systems are identical in design. performance, and materials of composition to the currently marketed predicate systems. Since the proposed shunts and accessories are identical to the currently marketed shunts and accessories, all performance testing to the performance of the predicate devices also supports the proposed devices, and remains unchanged. Additional bench testing was performed to determine the safe use conditions for these products in the MR environment, as described below. Testing was also performed to confirm that the performance of these devices remains the same after use in an MR environment.
| DESIGN
| VERIFICATION TEST | Acceptance |
|---|---|
| Visual Inspection | All test samples shall be complete and free of visible damage. |
| Magnetically Induced | |
| Displacement Force Test | |
| ASTM F2052 | The amount of magnetically induced force on the device shall be less |
| than or equal to the force on the device due to gravity. | |
| Magnetically Induced | |
| Torque Test | |
| ASTM F2213 | The amount of magnetically induced torque on the device shall be |
| less than or equal to the gravitational torque. | |
| RF Heating Test | |
| ASTM F 2182 | No portion of the implanted device shall exhibit an increase in |
| temperature of more than 2°C at a SAR of 2W/kg. | |
| Image Artifact Test | |
| ASTM F2119 | There is no acceptance criterion as per ASTM standard; this test is |
| performed to gather information relating to image artifacts caused by | |
| the device. This information can be included in labeling. |
The non-clinical testing has demonstrated that the Horizontal-Vertical Lumbar Valve Systems and Spetzler Lumbar Peritoneal Shunt Systems are MR Conditional, as defined in the ASTM 2503-05 Standard, "Standard Practice for Marking Medical Devices and other items for Safety in the Magnetic Resonance Environment." This classification is appropriate for "an item which has been demonstrated to pose no known hazards in specific MR environment with specified conditions.
8. Clinical Testing
Clinical testing was not applicable for this modification.
5
9. Conclusions
The conclusions drawn from the nonclinical testing demonstrate that both the Horizontal-Vertical Lumbar Valve Systems and the Spetzler Lumbar Peritoneal Shunt Systems, with the addition of MRI Safety information in the labeling, are as safe and effective, and perform at least as safely and effectively, as the legally marketed predicate devices.
6
Image /page/6/Picture/1 description: The image shows the seal of the Department of Health & Human Services USA. The seal is circular and contains the department's name around the perimeter. In the center of the seal is an abstract image of a bird-like figure with three tail feathers.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002
Integra Life Sciences Corporation c/o Ms. Donna Millisky Manager, Corporate Regulatory Affairs 311 Enterprise Drive Plainsboro, NJ 08536
JUL - 7 2011
Re: K101381
Trade/Device Name: Integra Horizontal-Vertical Lumbar Valve Systems and Spetzler Lumbar Peritoneal Shunt Systems Regulation Number: 21 CFR 882.5550 Regulation Name: Central nervous system fluid shunt and components Regulatory Class: Class II Product Code: JXG Dated: May 9, 2011 Received: May 10, 2011
Dear Ms. Millisky:
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.
7
Page 2 - Ms. Donna Millisky
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 (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,
Melvin R. Feldmann, M.D.
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
8
510(k) Number: KIOl38)
Device Name: Horizontal-Vertical Lumbar Valve Systems
Indications for Use:
Horizontal-Vertical Lumbar Valve Systems are implantable devices used in the treatment of patients with communicating hydrocephalus to shunt cerebrospinal fluid (CSF) from the lumbar subarachnoid region to the peritoneal cavity. They provide controlled intraventricular pressure and CSF drainage in patients with hydrocephalus. The antechamber can be electively mounted in line with the Valve Unit to allow for CSF sampling or injections in the subarachnoid space.
Prescription Use X (Part 21 CFR 801 Subpart D) AND/OR
Over-The-Counter-Use (Part 21 CFR 801 Subpart C)
PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED
Concurrence of CDRH, Office of Device Evaluation (ODE)
(Division Sign-Off) Division of Ophthalmic, Neurological and Ear, Nose and Throat Devices
510(k) Number K10138/
9
INDICATIONS FOR USE STATEMENT
510(k) Number: K10/38
Device Name: Spetzler" Lumbar Peritoneal Shunt Systems
Indications for Use:
Percutaneous lumbar peritoneal shunting may be utilized in the treatment of communicating hydrocephalus. It is designed to shunt CSF from the lumbar subarachnoid space to the peritoneal cavity.
The shunt may be used for diagnosis, evaluation or treatment of normal pressure communicating hydrocephalus.
A percutaneous lumbar peritoneal shunt is also useful in the management of persistent cerebrospinal fluid fistulas, bulging cranial and suboccipital decompressions and in transient CSF absorption defects, e.g. post-meningitic or post-hemorrhagic hydrocephalus.
The In-Line Valve, available as a separate component of the system, is indicated for use where added resistance is desired to alleviate symptoms of low pressure in the small percentage of patients who, after normal drainage and in the normal course of treatment, develop such symptoms.
Prescription Use × (Part 21 CFR 801 Subpart D) AND/OR
Over-The-Counter-Use (Part 21 CFR 801 Subpart C)
PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED
| Concurrence of CDRH, Office of Device Evaluation (ODE) | |
|---|---|
| (Division Sign-Off) | |
| Division of Ophthalmic, Neurological and Ear, | |
| Nose and Throat Devices |
510(k) Number K101381