(237 days)
510-K 013005, 510-K 013705
002765
No
The description focuses on the mechanical and sensing capabilities of the device (draining CSF, sensing ICP, receiving monitoring probes) and does not mention any computational or analytical functions that would suggest the use of AI or ML.
No.
The device drains CSF, senses ICP, and receives monitoring probes but does not directly treat a disease or condition. Its primary function is monitoring and drainage rather than active therapy.
Yes
The device is described as "sensing ICP" (Intracranial Pressure) and receiving "two monitoring probes such as oxygen or temperature," which are all measurements for diagnostic purposes in "optimum patient management."
No
The device description clearly outlines physical components like a bolt, bolt insert, ventricular catheter, and guide tubes, indicating it is a hardware-based medical device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices used to perform tests on samples taken from the human body (like blood, urine, tissue) to provide information about a person's health. These tests are performed outside the body.
- Device Function: The description clearly states the device is used for:
- Draining CSF (Cerebrospinal Fluid)
- Sensing ICP (Intracranial Pressure)
- Receiving monitoring probes (oxygen, temperature)
These functions involve direct interaction with the patient's body (inserting a catheter into the ventricle, sensing pressure within the skull, receiving probes that are likely placed within the body). This is an in vivo application, not an in vitro one.
The device is a surgical and monitoring system used directly on the patient, not a laboratory test performed on a sample.
N/A
Intended Use / Indications for 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.
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.
Product codes (comma separated list FDA assigned to the subject device)
GWM
Device Description
MPS- Oxiport is a system capable of draining CSF, sensing ICP and receiving 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.
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.
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.
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
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)
Not Found
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.
510-K 013005, 510-K 013705
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.
002765
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
K04i838
MAR 1 - 2005
510(k) Summary Section 2.0
- 2.1 Submitted by InnerSpace 949 752 8673 Phone 949 752 8672 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 |
| 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 .
1
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. |
| The diameter decreased and | ||||
| 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 | ||
| from top of cap to | ||||
| distal end of bolt | Polyimide guide tubes extend | |||
| 3 mm beyond the distal end | ||||
| of bolt | Licox guide tubes extend | |||
| beyond the dura | ||||
| Ventricular Catheter Length | II | 9" | 9" | |
| Ventricular Catheter OD | III | 10 Fr | 7.5 mm |
Tahle 1
2
| 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 |
3
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.
4
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 (301) 443-6597 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
5
Indications for Use
51Q(k) Number (if known):
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 ____________
Page 1 of ____________________________________________________________________________________________________________________________________________________________________