ACT 11 MP VENTRICULAR CATHETER

K013005 · Innerspace, Inc. · HCA · Mar 8, 2002 · Neurology

Device Facts

• Record ID: K013005
• Device Name: ACT 11 MP VENTRICULAR CATHETER
• Applicant: Innerspace, Inc.
• Product Code: HCA · Neurology
• Decision Date: Mar 8, 2002
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 882.4100
• Device Class: Class 2

Intended Use

The use of the ACT II MP Monitoring System by a qualified neurosurgeon is indicated when direct measurement of intracranial pressure 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 Story

The ACT II MP ICP Monitoring System is a minimally invasive device for continuous intracranial pressure (ICP) monitoring. It utilizes a skull-anchored bolt containing an air-column catheter with a distal flaccid bladder. The system operates on Boyle's Law; bladder volume changes in response to ICP, which is transmitted via air to a proximal pressure transducer. The transducer connects to standard patient monitors. The MP version adds a guide tube and compression fitting to the bolt cap, allowing for the insertion and retention of a secondary probe (0.7–0.9 mm diameter) for parameters like tissue oxygen, without the guide tube entering the brain. The device is used in clinical settings by neurosurgeons. The healthcare provider monitors ICP waveforms and values to guide patient management. The system allows for optional CSF drainage via a ventricular catheter. Benefits include real-time ICP monitoring and the ability to integrate multi-parameter sensing in a single access point.

Clinical Evidence

No clinical data. Evidence consists of bench testing and animal testing. Bench testing confirmed the device meets AAMI performance standards for accuracy and mechanical integrity. Biocompatibility was evaluated per ISO 10993-1-1994 and FDA G95-1. Animal testing demonstrated that the device faithfully follows ventricular pressure and waveforms and that the bolt remains securely anchored in the skull.

Technological Characteristics

Bolt-anchored air-column catheter system. Materials: Tecoflex EG-80A (catheter), PVC (bladder mount), Butyl (bladder), Polyimide (microbore tube), Stainless steel (probe guide). Sensing principle: Boyle's Law (air-filled bladder). Dimensions: 1.5 mm pressure sensor OD, 2.5 mm ventricular catheter OD. Connectivity: Direct connection to standard patient monitors via transducer cable. Sterilization: Not specified. Software: None (mechanical/pneumatic system).

Indications for Use

Indicated for patients requiring continuous intracranial pressure (ICP) monitoring, potential CSF drainage, or monitoring of a second parameter (e.g., tissue oxygen) as determined by a qualified neurosurgeon.

Regulatory Classification

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.

Predicate Devices

• ACT II ICP Monitoring System (K010422)
• Licox introducer kits (K002765)

Submission Summary (Full Text)

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K013005
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## 510(k) Summary Section 2.0

2.1 Submitted by InnerSpace FAX [phone] Phone [phone] 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

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

## 2.6 Description of the probe guide

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.

## 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 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.

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<br>(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 catheter<br>in 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 [phone]. 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 [phone] or [phone] 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)

Or

Over-The Counter Use _________________________________________________________________________________________________________________________________________________________

Miriam C. Provost

Division of General. Restorative and Neurological Devices

510(k) Number K013005