MPS (OR MPS-T)

K041838 · Innerspace, Inc. · GWM · Mar 1, 2005 · Neurology

Device Facts

• Record ID: K041838
• Device Name: MPS (OR MPS-T)
• Applicant: Innerspace, Inc.
• Product Code: GWM · Neurology
• Decision Date: Mar 1, 2005
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 882.1620
• Device Class: Class 2

Intended Use

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 other parameters such as tissue oxygen.

Device Story

MPS-Oxiport is a multi-parameter system for neurosurgical use; consists of bolt, slidable insert, and ventricular catheter. System enables simultaneous CSF drainage, ICP sensing, and placement of auxiliary probes (e.g., oxygen, temperature). Catheter inserted into ventricle; insert moved into bolt bore to form seal via o-ring. Polyimide guide tubes in insert direct probes into brain tissue at angle to bolt axis to reach undisturbed tissue. Pressure sensing utilizes air-filled bladder at distal end of catheter; bladder connected to air tube and transducer housing; pressure changes conveyed to external patient monitor. Device used by neurosurgeons in clinical settings. Benefits include integrated monitoring and drainage capabilities in single access point.

Clinical Evidence

No clinical data provided. Substantial equivalence is based on technological characteristics and design comparisons to predicate devices.

Technological Characteristics

Bolt: Titanium, screw-thread attachment. Catheter: Tecoflex, 7.5 mm OD, two-lumen. Sensing: Air-filled butyl bladder. Probe guides: Polyimide, 1.3 mm diameter. Connectivity: Connects to external patient monitor via transducer housing. Sterilization: Not specified.

Indications for Use

Indicated for patients requiring continuous intracranial pressure (ICP) monitoring, cerebrospinal fluid (CSF) drainage, and/or monitoring of additional parameters (e.g., tissue oxygen) as deemed useful by a qualified neurosurgeon for patient management.

Regulatory Classification

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.

Predicate Devices

• ACT II MP (K013005)
• ACT III (K013705)
• Licox oxygen monitoring system (K002765)

Submission Summary (Full Text)

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K04i838

# MAR 1 - 2005

#### 510(k) Summary Section 2.0

- 2.1 Submitted by InnerSpace 949 752 8673 Phone [phone] FAX 2293 South Pullman Street, Suite A Santa Ana, CA. 92705 Contact: Donald E. Bobo ext 12
MPS- Oxiport is a system capable of draining CSF, sensing ICP and receiving 2.2 two monitoring probes such as oxygen or temperature. MPS stands for Multiple Parameter System.

The system consists of bolt, a bolt insert and a ventricular catheter. A slidable insert is The syatin commal on the catheter at the factory. After the catheter is situated in a ventricle, the insert is moved down the catheter and into the throat of the bolt. The insert has an o-ring that forms a seal with the bolt. It also has two guide tubes. The guide tubes allow the surgeon to place probes such as an oxygen or temperature sensor in the insert has a fixation element that joins the insert to the bolt and three pigtails with Toughy-Borst fittings to fix the monitoring probes and the ventricular catheter to the insert.

#### 2.2 ICP Monitoring Device Name

| Trade name | MPS- Oxiport |
|---------------------|-----------------------------------------------------------------|
| Common name | Intracranial Pressure Monitoring Device |
| Classification name | Intracranial Pressure Monitoring Device<br>CFR 882.1620 (84GWM) |

| 2.3 | Ventricular Catheter Name | |
|-----|---------------------------|----------------------|
| | Trade name | Ventricular Catheter |
| | Common name | Ventricular Catheter |
| | Classification name | Ventricular Catheter |
| | | CFR 882.4100 (84HCA |

#### 2.4 Equivalent device

The bolt system is substantially equivalent to ACT II MP plus covered in 510-K 013005. The 005 device is a bolt that can receive the ventricular catheter of ACT III (705) and hold a second parameter probe.

The pressure sensing system used is the same as that used in ACT III. It is covered in 510-K 013705 (705).

The drainage catheter system is similar to that used in 705 except the catheter size is smaller.

The MPS- OXIPORT bolt guide tubes are similar to that described in ACT II MP (005). The guide tubes are substantially equivalent to guide tubes described in Licox (002765) as regards having the tubes extend beyond the dura .

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# 2.5 Description of the Catheter's ICP Monitoring capability

The pressure sensing system elements are identical to that used in ACT III (705). An air tube is placed in the second lumen of a two-lumen ventricular catheter and bonded to the distal ond of the lumen. A flaccid bladder affixed to the distal end of the catheter is folded over the side of catheter and attached to the catheter wall. The proximal end of the air tube exits the catheter near its proximal end and is terminated in a piston. The bladder is activated when the piston is inserted into the cylinder of a transducer housing. The bladder and tube convey changes in ICP to a transducer in the transducer housing. The ICP reading is displayed on a patient monitor.

## 2.6 Description of the ventricular catheter

Other than being of smaller diameter, the catheter is the same as the ACT III catheter (705). A bolt is screwed into the drill hole. The ventricular catheter is then inserted into a ventricle. A slidable insert placed near the proximal end of the catheter is moved into the bore of the bolt. The insert has a fixation feature that anchors the insert to the bolt and a compression fitting to hold the catheter in place.

### 2.7 Description of the probe guides

Two polyimide probe guides are incorporated into the bolt insert. The probe guides direct the path of probe inserted into the brain. Oxygen probes must be placed in undisturbed tissue. The guide tubes have a deflector which cause a probe to enter the brain at an angle to the bolt axis and thereby move to undisturbed tissue. The distal end of the guide tubes extend to a point just below the dura. The proximal end of each guide tube has a polyurethane piggail with a luer fitting that provides a means of joining the probe to the pigtail

### 2.8 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 other parameters such as tissue oxygen.

#### 2.9 Device Characteristics vs. Predicate Device

Column 2 in table 1 identifies whether the comparison is to ACT II (005) or ACT III (705). The guide tube length predicate is based on the Licox oxygen monitoring system, 765.

| Characteristic | | Predicate Device | MPS- OXIPORT | Comment |
|-----------------------------|-----|--------------------------------------------------------------------|-----------------------------------------------------------------------|------------------------------------------------------------------------------|
| Bolt diameter | II | .250" | .250 | |
| Bolt material | II | Polycarbonate | Titanium | |
| Skull Attachment | II | Ribs | Screw thread | |
| Catheter OD | III | 3.3 mm | 2.25 mm | |
| Sensor length | II | 9 mm | 37 mm | Bladder volume unchanged.<br>The diameter decreased and<br>length increased. |
| Pressure catheter bladder | III | Butyl | Butyl | |
| Depth of bladder in brain | III | 6-8 cm | 6-8 cm | |
| Probe guide diameter | | 1.3 mm | 1.3 mm | Ref Lico765 |
| Probe guide length | II | Ti guide tubes extends<br>from top of cap to<br>distal end of bolt | Polyimide guide tubes extend<br>3 mm beyond the distal end<br>of bolt | Licox guide tubes extend<br>beyond the dura |
| Ventricular Catheter Length | II | 9" | 9" | |
| Ventricular Catheter OD | III | 10 Fr | 7.5 mm | |

Tahle 1

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| Drainage lumen ID | | | |
|----------------------------|---------------|---------------|--|
| III | $1.8 mm^2$ | $1.6 mm^2$ | |
| Catheter material | | | |
| III | Tecoflex | Tecoflex | |
| Depth of catheter in brain | | | |
| II/I | 6-8 cm | 6-8 cm | |
| Compatible probe diameter | | | |
| II | 0.7 to 0.9 mm | 0.7 to 0.9 mm | |

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/3/Picture/1 description: The image shows the seal of the Department of Health and Human Services (HHS) of the United States. The seal features the department's name encircling a symbol. The symbol is a stylized representation of an eagle or bird-like figure, with three curved lines forming its body and wings.

Public Health Service

MAR 1 - 2005

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Mr. Donald E. Bobo InnerSpace, Inc. 2933 South Pullman Street, Suite A Santa Ana, California 92705

Re: K041838

Trade/Device Name: MPS Regulation Number: 21 CFR 882.1620 Regulation Name: Intracranial pressure monitoring device Regulatory Class: II Product Code: GWM Dated: February 3, 2005 Received: February 14, 2005

Dear Mr. Bobo:

We have reviewed your Section 510(k) premarket notification of intent to market the device We have reviewed your Section - ro(x) premained in the manufacted in interests in interests referenced above and have determined the arresed predicate devices marketed in interstate for use stated in the encrosule) to regally mancted provice Amendments, or to commerce prior to May 28, 1776, the encordance with the provisions of the Federal Food. Drug.
devices that have been reclassified in accordance with the provisions of the UMA devices that have been recialsmed in accordance while approval approval application (PMA).
and Cosmetic Act (Act) that do not require approval of a premarket of the Act ... L and Cosmelle Act (Act) that do not require appt to the general controls provisions of the Act. The You may, therefore, market the act include requirements for annual registration, listing of general controls provisions of the rist 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 device is classified (see above) me existing major regulations affecting your device can be may be subject to suen additions, Title 21, Parts 800 to 898. In addition, FDA may be found in the Code of Peaces oncerning your device in the Federal Register.

Please be advised that FDA's issuance of a substantial equivalence determination docs not mean Please be advised that 1177 s issuated of a vademice complies with other requirements of the Act that 117A has made a determinations administered by other Federal agencies. You must of ally rederal statutes and regaranents, including, but not limited to: registration and listing (21 comply with an the Act stequirements, moraling, workans, and manufacturing practice requirements as set CrK Part 807), labeling (21 CFR Part 807), good manager (20); and If applicable. the clectronic (200) 1950 form in the quality systems (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 bection 510(k) This letter will anow you to begin mainentig your antial equivalence of your device to a legally premarket notification. The PDF miding of casomination 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), please If you desire specific advice for Joan as not 100 mease note the regulation entitled, Colliati the Office of Comphance in (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the Division of Small other general International and Consumer Assistance at its toll-free number (800) 638-204 or [phone] or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely yours,

Miriam C. Parrott

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

51Q(k) Number (if known):

K041838

Device Name: MPS MPS -T

Indications For Use:

The use of MPS (or MPS-T) by a qualified neurosurgeon is indicated when direct measurement of intracranial pressure is clinically important, when the patient may require CSF drainage in the course of their care and when data from a second or third parameter may be deemed useful in optimum patient management.

Muriam C. Provost

(Division Sign-Off) Division of General. Restorative, and Neurological Devices

510(k) Number_________________________________________________________________________________________________________________________________________________________________

Prescription Use _____________________________________________________________________________________________________________________________________________________________

(Part 21 CFR 801 Subpart D)

(21 CFR 807 Subpart c )

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Over-The-Counter Use ____________

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