(305 days)
Not Found
Not Found
No
The device description focuses on mechanical and pneumatic principles for pressure measurement and CSF drainage. There is no mention of AI, ML, or any computational analysis of data beyond standard pressure monitoring.
No.
The device is used for measuring intracranial pressure and CSF drainage, which are diagnostic and supportive functions rather than therapeutic.
Yes
Explanation: The device is described as providing "direct measurement of the intracranial pressure," which is used to diagnose conditions related to intracranial pressure. The device "faithfully follows the ventricular value and waveform," indicating its role in measuring and monitoring a physiological parameter for diagnostic purposes.
No
The device description clearly details physical components including a catheter, external pressure transducer, air tube, bladder, piston, and transducer housing. It also describes a CSF drainage function via a dedicated lumen. These are all hardware components, not software.
Based on the provided information, this device is not an In Vitro Diagnostic (IVD).
Here's why:
- Intended Use: The intended use is for the direct measurement of intracranial pressure and CSF drainage within the patient's body. This is an in vivo application.
- Device Description: The device is a catheter designed to be inserted into the brain to measure pressure and drain fluid directly from the ventricles. This is a surgical device used for direct physiological monitoring and intervention.
- Lack of IVD Characteristics: IVDs are used to examine specimens (like blood, urine, tissue) outside of the body to provide information about a patient's health. This device does not process or analyze biological specimens in vitro.
Therefore, the ACT III Ventricular Catheter is a medical device used for in vivo monitoring and drainage, not an In Vitro Diagnostic.
N/A
Intended Use / Indications for Use
The use of a ACT III Ventricular Catheter by a qualified neurosurgeon is indicated when direct measurement of the intracranial pressure is clinically important and when the patient may require CSF drainage in the course of care.
Product codes (comma separated list FDA assigned to the subject device)
GWM
Device Description
The ACT III Ventricular Catheter consists of a 10 Fr. ventricular catheter in combination with an external pressure transducer. The catheter has two lumens. One lumen drains CSF. The second lumen transmits ICP from the brain to the external transducer by means of an air tube within the lumen. The air tube communicates with a flaccid bladder on the distal end of the catheter. The bladder's volume and internal pressure change according to P1 V = P2 V2. The catheter's proximal end terminates in a piston with an o-ring. The piston is joined to an external transducer. The pressure seen by the bladder/catheter/transducer mirrors the pressure in the brain.
The CSF drainage function is provided by a dedicated lumen within the catheter. The CSF drainage function is typical of ventricular catheters. The length of the catheter fenestrated with radial holes is the same length as that provided by a conventional drainage catheter. The active drainage length of the catheter is preserved by mounting the bladder on the side of the catheter on a segment not penetrated by radial holes.
The technique used to place a ventricular catheter is the same as that used to place a conventional ventricular catheter. Once the distal end of the catheter is placed in the brain, the proximal end of the catheter is placed in the sheath of a trocar and tunneled beneath the scalp in a forward direction. The proximal end of the catheter is bifurcated in order to separate the air lumen and drainage lumen.
It is desirable to keep the size of the proximal end of the catheter small and thereby minimize the diameter of the trocar sheath passed beneath the scalp.
The size of the proximal end of the catheter has been minimized by the use of a tube-within-a-lumen design. In this design, a dedicated air tube is inserted into a lumen which, to distinguish it from the drainage lumen, will be referred to hereafter as the second lumen. The air tube is bonded to the distal end of the second lumen. The tube then exits the sidewall of the second lumen near the proximal end of the catheter. This construction allows the air tube to separate from the main catheter without the use of a molded bifurcation. As will be seen in the drawings, the concept provides a proximal configuration much smaller than a conventional molded bifurcation.
Once tunneled beneath the scalp, the air tube is pneumatically connected the transducer. The transducer is mounted within a special transducer housing that features a cylinder designed to engage the catheter's piston. The bladder is activated when the piston on the end of the air tube is placed in the cylinder. Connecting the piston to the cvlinder causes the air in the cylinder to be injected into the bladder. The bladder air is restored once per shift by removing and replacing the transducer housing. The transducer is incorporated into to a standard patient monitoring cable. The cable can be connected to a patient monitor without the need for a special intermediate instrument.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
brain
Indicated Patient Age Range
Not Found
Intended User / Care Setting
qualified neurosurgeon
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)
Animal and Laboratory testing:
Test of the device vs. a ventricular catheter in a pig shows the device faithfully follows the ventricular value and waveform.
Pressure monitoring system was tested according to AAMI requirements as modified for an air column device. The system passed all testing requirements.
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.
Not Found
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
§ 882.1620 Intracranial pressure monitoring device.
(a)
Identification. An intracranial pressure monitoring device is a device used for short-term monitoring and recording of intracranial pressures and pressure trends. The device includes the transducer, monitor, and interconnecting hardware.(b)
Classification. Class II (performance standards).
0
CONFIDENTIAL
013705
Section 2.0 510(k) Summary
Submitted by 2.1 InnerSpace 2293 South Pullman Street, Suite A Santa Ana, CA. 92705 Phone 949 752 8672 FAX 949 752 8673 Contact Donald E. Bobo, ext 12 Prepared Nov.5, 2001
- 2.2 Device Name ACT III Ventricular Catheter Trade name
2.2.1 Pressure Monitoring Function Intracranial Pressure Monitoring Device Common name Intracranial Pressure Monitoring Device 882.1620 Classification name
Drainage Catheter Function 2.2.2 Common name Ventricular Drainage Catheter Classification name Ventricular Catheter 882.4100
2.3 Equivalent device
The equivalent device to the ACT III Ventricular Catheter is the Camino VENTRIX® True Tech Ventricular Tunneling Pressure Monitoring Kit NL960-V.
2.4 Description of Device
The ACT III Ventricular Catheter consists of a 10 Fr. ventricular catheter in combination with an external pressure transducer. The catheter has two lumens. One lumen drains CSF. The second lumen transmits ICP from the brain to the external transducer by means of an air tube within the lumen. The air tube communicates with a flaccid bladder on the distal end of the catheter. The bladder's volume and internal pressure change according to P1 V = P2 V2. The catheter's proximal end terminates in a piston with an o-ring. The piston is joined to an external transducer. The pressure seen by the bladder/catheter/transducer mirrors the pressure in the brain.
The CSF drainage function is provided by a dedicated lumen within the catheter. The CSF drainage function is typical of ventricular catheters. The length of the catheter fenestrated with radial holes is the same length as that provided by a conventional drainage catheter. The active drainage length of the catheter is preserved by mounting the bladder on the side of the catheter on a segment not penetrated by radial holes.
The technique used to place a ventricular catheter is the same as that used to place a conventional ventricular catheter. Once the distal end of the catheter is placed in the brain, the proximal end of the catheter is placed in the sheath of a trocar and tunneled beneath the scalp in a forward direction. The proximal end of the catheter is bifurcated in order to separate the air lumen and drainage lumen.
It is desirable to keep the size of the proximal end of the catheter small and thereby minimize the diameter of the trocar sheath passed beneath the scalp.
1
CONFIDENTIAL
The size of the proximal end of the catheter has been minimized by the use of a tube-within-a-lumen design. In this design, a dedicated air tube is inserted into a lumen which, to distinguish it from the drainage lumen, will be referred to hereafter as the second lumen. The air tube is bonded to the distal end of the second lumen. The tube then exits the sidewall of the second lumen near the proximal end of the catheter. This construction allows the air tube to separate from the main catheter without the use of a molded bifurcation. As will be seen in the drawings, the concept provides a proximal configuration much smaller than a conventional molded bifurcation.
Once tunneled beneath the scalp, the air tube is pneumatically connected the transducer. The transducer is mounted within a special transducer housing that features a cylinder designed to engage the catheter's piston. The bladder is activated when the piston on the end of the air tube is placed in the cylinder. Connecting the piston to the cvlinder causes the air in the cylinder to be injected into the bladder. The bladder air is restored once per shift by removing and replacing the transducer housing. The transducer is incorporated into to a standard patient monitoring cable. The cable can be connected to a patient monitor without the need for a special intermediate instrument.
2.5 Intended Use of the Device
The use of the ACT III Ventricular Catheter by a qualified neurosurgeon is indicated when direct measurement of the intracranial pressure is clinically important and when the patient may require CSF drainage in the course of care.
2.6 Device Characteristics vs. Predicate Device
The essential characteristics of the ISM device vs. the predicate device are shown in the following table.
Characteristic | ACT III Ventricular Catheter | Predicate Device |
---|---|---|
Tunneling direction | Forward (Traditional) | Reverse |
Catheter diameter | 10 Fr. | 10 Fr. |
Drainage lumen | ||
diameter | 1.5 mm (typical of conventional ventricular | |
catheters) | Not stated | |
Catheter material | Urethane | Silicone |
Electrical interface | Direct connection to patient monitor. | Electro-optical converter connected to patient |
monitor | ||
Trouble shooting. | Transducer of ACT III can be removed at any | |
time to rezero monitor or replace sensor. | Predicate sensor is part of the | |
catheter and is not removable. | ||
Calibration | Zero transducer at patient monitor | Calibration of instrument required |
2.7 Animal and Laboratory testing:
Test of the device vs. a ventricular catheter in a pig shows the device faithfully follows the ● ventricular value and waveform.
Pressure monitoring system was tested according to AAMI requirements as modified for an ● air column device. The system passed all testing requirements.
2
CONFIDENTIAL
2.8 Conclusion
The ACT III Ventricular Catheter, in combination with the ISM-3000 series cable, is equivalent to the predicate device because:
It has the same intended use, namely to sense intracranial pressure and drain CSF.
The system performance complies with AMMI standards for intracranial pressure monitoring, modified to reflect the characteristics of the technology used.
It uses materials that have been shown to be biocompatible and function well in the intended application.
Laboratory testing and basic design assure that no parts will come loose and be left in the patient.
The components are biocompatible and the catheter is a typical 10 Fr. size.
The system is easy to use and does not require the use or calibration of an interface instrument between the system and a patient monitor.
Unlike any other self-referencing in vivo ICP monitor now on the market, the calibration of the transducer can be checked at anytime.
3
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized caduceus symbol, which is a staff with two snakes entwined around it. The caduceus is positioned to the right of the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA", which is arranged in a circular fashion around the symbol. The logo is black and white.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
9 2002
Innerspace, Inc. Donald E. Bobo President 2933 South Pullman Street, Suite A Santa Ana, California 92705
Re: K013705
Trade/Device Name: ACT III Ventricular Catheter Regulation Number: 882.1620 Regulation Name: Intracranial pressure monitoring device Regulatory Class: Class II Product Code: GWM Dated: June 7, 2002 Received: June 11, 2002
Dear Mr. Bobo:
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.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such 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 mav 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); 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.
4
Page 2 - Mr. Donald E. Bobo
This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801 and additionally 21 CFR Part 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4659. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html
Sincerely, yours,
Sincerely yours,
Celia M. Witten, Ph.D., M.D.
Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
5
Indications for Use Statement
··
510(k) Number
Device Name ACT III Ventricular Catheter
Indications For Use Indications The use of a ACT III Ventricular Catheter by a qualified neurosurgeon is indicated when direct measurement of the intracranial pressure is clinically important and when the patient may require CSF drainage in the course of care.
Please do not write below this line
Concurrence of CDRH, Office of Device Evaluation (ODE)
Or
Prescription Use (7 (Per 21 CFR 801.1099
Over-The Counter Use
Hyde Purdy
Division Sign-Off) Division of General, Restorative and Neurological Devices
510(k) Number_________________________________________________________________________________________________________________________________________________________________