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.

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.

AI/ML Overview

Here's an analysis of the provided text regarding the acceptance criteria and study for the ACT III Ventricular Catheter, structured according to your requested information.

It's important to note that the provided documents are a 510(k) summary and an FDA clearance letter from 2001/2002, which predate many of the detailed reporting requirements for AI/ML devices specified in your request (e.g., MRMC studies, detailed training set information, specific expert qualifications for ground truth). Therefore, some information may not be directly available or applicable in the provided text.

Acceptance Criteria and Device Performance Study for ACT III Ventricular Catheter

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria (Implied)	Reported Device Performance
Intended Use: Device senses intracranial pressure and drains CSF.	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.
Performance Standard (ICP Monitoring): Compliance with AAMI standards for intracranial pressure monitoring, as modified for air column devices.	"Pressure monitoring system was tested according to AAMI requirements as modified for an air column device. The system passed all testing requirements."
Biocompatibility: Use of biocompatible materials suitable for the intended application.	"It uses materials that have been shown to be biocompatible and function well in the intended application."
Safety (Parts Integrity): No parts should come loose and be left in the patient.	"Laboratory testing and basic design assure that no parts will come loose and be left in the patient."
Ease of Use/Calibration: System is easy to use and does not require a special interface instrument; transducer calibration can be checked at any time.	"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."
Comparative Performance (ICP Waveform): Faithfully follows ventricular value and waveform. (Implied from animal testing)	"Test of the device vs. a ventricular catheter in a pig shows the device faithfully follows the ventricular value and waveform."

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

Sample Size: Not explicitly stated in terms of a specific number for a clinical "test set" as one might expect for a modern AI/ML device. The testing described is primarily laboratory testing and an animal study.
- For the animal study: "Test of the device vs. a ventricular catheter in a pig shows the device faithfully follows the ventricular value and waveform." The number of pigs is not specified.
- For laboratory testing: "Pressure monitoring system was tested according to AAMI requirements as modified for an air column device. The system passed all testing requirements." The number of test instances or samples is not specified.
Data Provenance:
- Animal Study: Animal model (pig).
- Laboratory Testing: Conducted in a laboratory setting.
- Both are prospective as experimental tests performed for the purpose of the submission.

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

The concept of "experts establishing ground truth" in the context of human interpretation for a test set (common in AI/ML performance studies) is not applicable to this device and its testing.
Ground truth for the described tests was established through:
- Direct physiological measurement in the animal model.
- Engineering and metrological standards in the laboratory setting for pressure monitoring.
The device's intended use specifies placement "by a qualified neurosurgeon," implying their expertise in clinical application, but not in establishing ground truth for device performance testing in this context.

4. Adjudication Method for the Test Set

Not applicable. As the device is a sensing and drainage catheter, the "test set" here refers to physical and physiological performance evaluation, not human interpretation requiring adjudication.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done, and the effect size of how much human readers improve with AI vs without AI assistance

No. An MRMC comparative effectiveness study is not applicable to this device. This is a medical device for intracranial pressure monitoring and CSF drainage, not an AI-powered diagnostic or assistive tool that would involve human readers or AI assistance.

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

This question is not directly applicable in the context of an intracranial pressure monitoring catheter. The "performance" being evaluated is the physical and electrical function of the catheter system itself, independent of a human's interpretation of its output in an "algorithm only" sense. The device is the "standalone" entity in its functional testing.

7. The Type of Ground Truth Used

Physiological measurements: In the animal study, the "ventricular value and waveform" served as the physiological ground truth that the device was compared against.
Engineering and metrology standards: For the pressure monitoring system, the AAMI requirements, modified for an air column device, provided the objective ground truth against which the system's performance was measured.

8. The Sample Size for the Training Set

Not applicable. This device is a physical medical device (catheter) and does not involve AI/ML algorithms that require a "training set."

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

Not applicable. As there is no AI/ML component, there is no "training set" or corresponding ground truth establishment in this context.

Summary

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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

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.

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CONFIDENTIAL

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 lumendiameter	1.5 mm (typical of conventional ventricularcatheters)	Not stated
Catheter material	Urethane	Silicone
Electrical interface	Direct connection to patient monitor.	Electro-optical converter connected to patientmonitor
Trouble shooting.	Transducer of ACT III can be removed at anytime to rezero monitor or replace sensor.	Predicate sensor is part of thecatheter 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.

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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.

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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.

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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

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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)

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_________________________________________________________________________________________________________________________________________________________________

Regulation Number and Section

§ 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).