The use of the ACT II MP Monitoring System by a qualified neurosurgeon is indicated when direct measurement of intracranial pressure in patients is required and when the patient may require CSF drainage in the course of their care or when data from a second parameter may be deemed useful in optimum patient management.

Device Description

The ICP monitor uses a bolt anchored in the skull. The bolt holds an air-column catheter with a flaccid bladder on the distal end. The proximal end of the catheter is attached to a pressure transducer placed in the distal end of a standard cable. The cable can be attached directly to any patient monitor. The ICP monitoring technology is based on Boyle's law. The bladder volume changes to accommodate PTV =P2V2 The pressure in the bladder, catheter and transducer thereby mirrors that of ICP. The air required to activate the bladder is introduced into the bladder when a piston on the proximal end of the catheter is joined to a cylinder on the transducer housing. The bladder air is replaced once per shift by removing and replacing the transducer housing on the piston.

A probe guide is incorporated into the cap placed on the bolt at the factory and into the cap that accompanies the drainage catheter. The guides direct the path of a probe inserted through the cap/bolt. The guide tube does not enter the brain but stops just above the drill hole. Both caps provide a compression fitting that secures and seals the probe to the cap.

The catheter is a single lumen catheter. A preloaded stylet is used for catheter insertion and placement. A luer connector is provided to connect the catheter to a standard CSF collection system.

The bolt provides an access port through which a ventricular catheter can be introduced if drainage is needed. Should drainage of CSF be indicated, the top cap of the bolt is removed and the ACT II Ventricular Catheter is inserted into a ventricle. Once the catheter is in place, a preinstalled elastomeric sleeve and compression cap are moved down the catheter to the bolt. The cap compresses the sleeve against the bolt and catheter anchors the catheter in place.

AI/ML Overview

Here's a breakdown of the acceptance criteria and study information for the ACT II MP ICP Monitoring System, based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

Characteristic	Acceptance Criteria	Reported Device Performance
Mechanical Integrity	No parts come loose and are left in the patient.	Basic design assures no parts come loose. Interference rib design provides a secure fit. Compression fitting secures probe and provides effective seal.
Biocompatibility	Materials in contact with the body are biocompatible.	Materials for ACT II MP ICP Monitoring System and ACT II MP Ventricular Catheter are biocompatible, based on testing from the predicate ACT II ICP Monitoring System and ACT II Ventricular Catheter.
Accuracy	Meets AAMI performance standards.	ICP monitoring system meets AAMI standards for accuracy and performance.
Ease of Use (Mounting)	Catheter held in place by a compression device.	Catheter is mounted in a bolt and held by a compression device, similar to the predicate probe introduction device.
Setup	No preconditioning or calibration beyond transducer.	No preconditioning or calibration beyond normal 2-second transducer zero. Transducer connects directly to patient monitor.
Operating Life	Bladder air replaced every shift.	IFU requires bladder air replacement every shift; this is done by disconnecting/reconnecting the transducer.
Troubleshooting	Transducer function and patient monitor zero can be checked at any time.	Transducer function and patient monitor zero can be checked at any time (unlike other in-situ systems).
ICP Monitoring	Faithfully follows ventricular pressure and waveform.	Animal test data shows the device faithfully follows ventricular pressure and waveform.
Bolt Anchoring	Bolt is securely anchored in the skull.	Animal test data shows the bolt is securely anchored in the skull.
Biocompatibility (Bolt)	Met ISO 10993-1-1994 and FDA General Program Memorandum No. G95-1.	Biocompatibility of the ACT II ICP Monitoring System related to the bolt was tested and met the specified standards.
Probe Guide	Guide tube does not enter the brain; directs path.	The guide tube does not enter the brain, stopping above the dura. It directs the path of an inserted probe.

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

The provided text does not specify a sample size for a test set or the data provenance (e.g., country of origin, retrospective/prospective) for a clinical study related to this specific modification (the MP version).

The text mentions:

"Animal test data of the subject device vs. a ventricular catheter shows the device faithfully follows the ventricular pressure and waveform and that the bolt is securely anchored in the skull." This implies animal testing was conducted.
"Laboratory testing has shown that the ACT II MP ICP Monitoring System... are safe in the following areas: Mechanical integrity; Biocompatibility." This refers to laboratory tests, not human clinical trials.

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

This information is not provided in the document. The study described is primarily animal and laboratory testing, not a human clinical trial where expert-established ground truth would be relevant in the same way (e.g., for diagnostic accuracy).

4. Adjudication Method for the Test Set

This information is not provided. Given the nature of the described animal and laboratory testing, an adjudication method like 2+1 or 3+1 (typically used in human reader studies for diagnostic accuracy) would not be applicable.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

A multi-reader multi-case (MRMC) comparative effectiveness study was not mentioned or described in the provided text. The device is a medical monitoring system, not an AI diagnostic tool primarily aimed at improving human reader performance.

6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study

This is not applicable as the device described is a physical intracranial pressure monitoring system and associated components, not a software algorithm.

7. Type of Ground Truth Used

Based on the text, the ground truth for the performance evaluation comes from:

Physiological measurements in animal models (e.g., actual ventricular pressure and waveform).
Laboratory test results (e.g., mechanical integrity tests, biocompatibility tests against ISO standards).
Consensus standards (AAMI performance standards for accuracy).

8. Sample Size for the Training Set

This is not applicable. The device is a physical medical device, not an AI/ML algorithm that requires a training set.

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

This is not applicable for the same reason as above (not an AI/ML algorithm).

Summary

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K013005
1/4

510(k) Summary Section 2.0

2.1 Submitted by InnerSpace FAX 949 752 8673 Phone 949 752 8672 2293 South Pullman Street, Suite A Santa Ana, CA. 92705 Contact: Donald E. Bobo ext 12 Prepared Sept. 4, 2001

This submittal covers a modification to ACT II, 510(k) K010422. The modification adds the This Submittan Covers a mountedated to 10 110 the device and into the brain via a guide tube. The ability to hisen a momitoring proov and one of thing. The submittal is therefore identical to proce is new in the guide table of a compressed to incorporating a guide tube and STOR) 11010 122 except for changes in labeling related to model number and compression thing and except for changes and naragraphs or portions of a paragraph that have indications for use. In order to cash 500k) K010422 submittal, new text has been changed to this color for ease of locating new material.

The modification incorporates a guide tube and compression fitting in the bolt cap to allow The modification and retention of a probe . 7 to .9 mm (028 to .036") in diameter. The device is the miser.on and recention of a prooo .. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . capable of measuring ICP and a second parameter such as tissue pO2.

The MP system is essentially unchanged from ACT II 510(k) K010422 other than placing a The Mr "Systom is ease.inaily concertain cap and bolt changes that provide proper guide tube in the cap and moorporating e catheter. There are two caps, the cap that comes on anginnent of the factory and the drainage catheter cap that comes with the drainage catheter the ook from are factory. Both caps provide a guide tube that directs the path of a probe inserted through the cap/bolt. The guide tube does not enter the brain. It simply guides an inserted unvage to a point above the dura. The cap and guide tube are similar in function to the prooc to a point access the assactived in predicate device 510(k) K002765- by Licox. The rest of the mirodator kits doserious in prodicate device 510(k) K010422 - ACT II by InnerSpace

For ease of reading, ACT II will be referred to throughout as the basic system and the MP version of ACT II, as the MP.

ICP Monitoring Device Name 2.2

Trade name 2.2.1
2.2.2 Common name
Classification name 2.2.2

ACT II MP ICP Monitoring System Intracranial Pressure Monitoring Device Intracranial Pressure Monitoring Device CFR 882.1620 (84GWM)

Ventricular Catheter Name 2.3

Trade name 2.3.1
Common name 2.3.2
Classification name 2.3.3

ACT II MP Ventricular Catheter Ventricular Catheter Ventricular Catheter CFR 882.4100 (84HCA)

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2.4 Equivalent device

The ACT II MP ICP Monitoring System is a substantially equivalent device to the ACT II ICP Monitoring System 510(k) K010422 by InnerSpace and to the introducer kits described in 510(k) K002765 by Licox.

2.5 Description of the ICP Monitoring Device

2.6 Description of the probe guide

2.7 Description of the Ventricular Catheter

The catheter is a single lumen catheter. A preloaded stylet is used for catheter insertion and placement. A luer connector is provided to connect the catheter to a standard CSF collection system.

The intent of the basic system design is to provide a minimally invasive ICP monitoring device to which a drainage capability can be added if needed. The intent of the MP system is to add a probe guide to the basic system. The probe guide can be seen in the graphics following the text of Section 5. For purposes of clarity, the graphics portraying the approved predicate device will be identified as the basic device. The graphics of the new device will be identified to as the MP device. A catheter capable of measuring another parameter, such as tissue oxygen, that may be inserted into the brain through the cap will be referred to as a probe.

Pressure sensor

The pressure sensor, its mounting and use are unchanged

Transducer housing

The housing that engages the bolt is unchanged.

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2.7 Intended Use of the Device

The device is to be used in patients who require continuous ICP monitoring, who may require drainage of CSF and who may require monitoring of a second parameter such as tissue oxygen.

2.8 Device Characteristics vs. Predicate Device The characteristics of the Basic device vs. the MP device are shown in Table 1.

Table 1
Characteristic	ACT II Basic	ACT II MP	Comment
Bolt diameter	.250"	.250"	No change
Skull Attachment	Ribs	Ribs	No change
Pressure sensor OD	1.5 mm	1.5 mm	No change
Pressure catheter bladder mount	PVC	PVC	No change
Pressure catheter bladder	Butyl	Butyl	No change
Microbore tube material in brain(housed within bladder)	Polyimide	Polyimide	No change
Depth of bladder in brain	1.3 cm	1.3 cm	No change
Probe guide (not in the brain)	N/A	Stainless steel	New feature
Ventricular Catheter OD	2.5 mm	2.5 mm	No change
Ventricular Catheter ID	1.5 mm	1.5 mm	No change.
Catheter material	Tecoflex EG-80A	Tecoflex EG-80A	No change
Depth of ventricular catheterin brain	6-8 cm	6-8 cm	No change
Bacteria barrier	Betadine on bolt/skull	Betadine on bolt/skull	No change
Probe catheter diameter	N/A	0.7 to 0.9 mm	See Note

Table

Note: The introducer kit in predicate device 510(k) K002765 receives an oxygen probe 0.8 mm diameter.

2.9 Animal and Laboratory testing:

The subject device meets AAMI performance standards. .
t Animal test data of the subject device vs. a ventricular catheter shows the device faithfully follows the ventricular pressure and waveform and that the bolt is securely anchored in the skull.

The biocompatibility of the ACT II ICP Monitoring System related to the bolt was tested per ISO 10993-1-1994 Biological Evaluation of Medical Devices - Part 1: Guidance on the Selection of Tests and the FDA General Program Memorandum No. G95-1. The material used in the catheter is Tecoflex EG-80A.

Conclusion

The ACT II MP ICP Monitoring System, in combination with the ISM -3000 series cable, and the ACT II MP Ventricular Catheter are equivalent to the predicate devices (510(k) K010422 and 510(k) K002765) because:

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1 2014 12 12

Intended Use

The system has the same basic intended use, namely to sense intracranial pressure The System has the sume busic interestion accommodates the introduction of a probe and drain CST if necode. The right if the doctor deems the resultant data beneficial to patient management.

Safety

Laboratory testing has shown that the ACT II MP ICP Monitoring System, the Laboratory testing has each and the ISM -3000 series cable or pigtail are safe in the following areas:

· Mechanical integrity · Laboratory testing and basic design assure that no parts will come loose and be left in the patient. The interference rib design provides a secure come foose and on the profession fitting is capable of securing a probe and providing an effective seal.

The materials used in the ACT II MP ICP Monitoring · Biocompatibility System and ACT II MP Ventricular Catheter that come in contact with the body System and ACT II ICP Monitoring System and ACT II ICP Monitoring System and ACT II Ventricular Catheter.

Effectiveness

The ICP monitoring system meets AAMI standards for accuracy and · Accuracy performance.

The catheter is mounted in a bolt, as is the predicate device ICP · Ease of use · Lase of use - The caced into the bolt is held in place by a compression device in the same manner as the predicate probe introduction device.

· Set up There is no need to precondition or calibrate the system beyond the normal 2 Sec a - The transducer. The transducer connects directly to any patient monitor.

· Operating life · The IFU requires that the air in the bladder be replaced every shift. . Operating mr - The 11 - The (disconnecting) and replacing (reconnecting) the transducer to the piston.

· Trouble-shooting · Unlike other in-situ systems, the transducer function and patient monitor zero can be checked at any time.

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Image /page/4/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a stylized eagle with its wings spread, enclosed in a circle. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged around the top half of the circle.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

8 2002 MAR

Mr. Don Bobo Innerspace 2293 South Pullman Street Suite A Santa Ana, California 92705

Re: K013005

Trade/Device Name: ACT II MP ICP Monitoring System Regulation Number: 21 CFR 882.4100 Regulation Name: Intracranial Pressure Monitoring Devices Regulatory Class: Class II Product Code: HCA Dated: January 14, 2002 Received: January 23, 2002

Dear Mr. Bobo:

We have reviewed your Section 510(k) premarket notification of intent to market the device we nave roview your betermined 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 conimer to provision of reassified 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 I ou may, atterest 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 If your de rio to such additional controls. Existing major regulations affecting your device can may or babyer to basil as a subsidians, Title 21, Parts 800 to 898. In addition, FDA may 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 1 toase be deviloed that I Dr o resum that your device complies with other requirements of the Act that I Dri has Intact a and regulations administered by other Federal agencies. You must or any I caeaal suatures and regeranents, including, but not limited to: registration and listing (21 Comply with an the Act 8 requirements of the manufacturing practice requirements as set OF R Fart 607), accems (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. Don Bobo

This letter will allow you to begin marketing your device as described in your Section 510(k) I mis letter will and w you've begal finding of substantial equivalence of your device to a legally premated notification: "The 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 11 you dostre specific arrist arrastic devices), please contact the Office of additionally 21 01 1 1 1 1 1 1 1 1 2 1 1 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 -Compinates at (301) 597 - the Office of Compliance at (301) 594-4639. Also, please note the your actitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). Other general information on your responsibilities under the Act may be obtained from the Oiner gonetal 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,

iriam C. Provost

for 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

210(k) Number Device Name

013005
ACT II MP ICP Monitoring system

Indications

The use of the ACT II MP Monitoring System For Use Indications by a qualified neurosurgeon is indicated when direct measurement of intracranial pressure in oy a quantion incursours and when the patient may require CSF drainage in the course of their care or when data from a second parameter may be deemed useful in optimum patient management.

Please do not write below this line

Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use (Per 21 CFR 801.109)

Over-The Counter Use _________________________________________________________________________________________________________________________________________________________

Miriam C. Provost

Division of General. Restorative and Neurological Devices

510(k) Number K013005

Regulation Number and Section

§ 882.4100 Ventricular catheter.

(a)
Identification. A ventricular catheter is a device used to gain access to the cavities of the brain for injection of material into, or removal of material from, the brain.(b)
Classification. Class II (performance standards).