(237 days)
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.
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 common 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 provided document is a 510(k) premarket notification for the MPS-Oxiport device, which is an intracranial pressure (ICP) monitoring device. This type of regulatory submission focuses on demonstrating substantial equivalence to a predicate device, rather than providing extensive clinical study data to prove performance against specific acceptance criteria.
Therefore, the document does not contain a detailed study proving the device meets acceptance criteria in the way one would expect for a more complex or novel device requiring rigorous clinical validation. Instead, it relies on demonstrating that its characteristics are similar enough to existing, legally marketed devices.
Here's an analysis based on the information provided, highlighting the absence of some requested elements due to the nature of a 510(k) submission for a substantially equivalent device:
1. A table of acceptance criteria and the reported device performance
This document does not present a formal table of "acceptance criteria" and "reported device performance" with quantitative metrics (e.g., accuracy, precision) as would be found in a clinical study report for a new device. Instead, it compares the device's characteristics to predicate devices to demonstrate equivalence.
| Characteristic | Predicate Device (ACT II/III or Licox) | MPS-Oxiport (submitted device) | Comparison for Equivalence (Implicit "Acceptance") |
|---|---|---|---|
| Bolt diameter | 0.250" | 0.250" | Equivalent |
| Bolt material | Polycarbonate | Titanium | Different, but likely deemed equivalent in function |
| Skull Attachment | Ribs | Screw thread | Different, but likely deemed equivalent in function |
| Catheter OD | 3.3 mm (ACT III) | 2.25 mm | Smaller, but noted as similar in system |
| Sensor length | 9 mm (ACT II) | 37 mm | Different length, but bladder volume unchanged, and diameter decreased, length increased - implies functional equivalence maintained |
| Pressure catheter bladder | Butyl (ACT III) | Butyl | Equivalent |
| Depth of bladder in brain | 6-8 cm (ACT III) | 6-8 cm | Equivalent |
| Probe guide diameter | 1.3 mm (Licox 765) | 1.3 mm | Equivalent |
| Probe guide length | Extends from top of cap to distal end of bolt (ACT II) / Extends beyond dura (Licox) | Extends 3 mm beyond the distal end of bolt (Polyimide) | Different in material/extent, but compared to Licox guides which also extend beyond dura. Implicitly deemed equivalent in function for guiding probes to undisturbed tissue. |
| Ventricular Catheter Length | 9" (ACT II) | 9" | Equivalent |
| Ventricular Catheter OD | 10 Fr (ACT III) | 7.5 mm (smaller diameter) | Different, but noted as similar in system |
| Drainage lumen ID | 1.8 mm² (ACT III) | 1.6 mm² | Smaller, but assumed to maintain drain capability |
| Catheter material | Tecoflex (ACT III) | Tecoflex | Equivalent |
| Depth of catheter in brain | 6-8 cm (ACT II/III) | 6-8 cm | Equivalent |
| Compatible probe diameter | 0.7 to 0.9 mm (ACT II) | 0.7 to 0.9 mm | Equivalent |
The "acceptance criteria" here are implicitly that the MPS-Oxiport device's characteristics are sufficiently similar to the predicate devices or that any differences do not raise new questions of safety or effectiveness. The "reported device performance" is the description of the MPS-Oxiport's physical and functional characteristics.
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Not Applicable. This document does not describe a clinical study with a test set of patients/data to evaluate algorithmic performance. It's a medical device submission based on substantial equivalence to existing devices, relying on engineering comparison and functional descriptions rather than clinical data from a "test set."
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
- Not Applicable. There is no "test set" of data requiring expert-established ground truth in this submission.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not Applicable. There is no "test set" of data requiring adjudication in this submission.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
- No. This is not an AI-assisted device, nor does the submission describe an MRMC study.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Not Applicable. This is a physical medical device, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- Not Applicable. No ground truth data (in a clinical study sense) is presented as the basis for device validation. The "ground truth" for the submission is the established safety and effectiveness of the existing predicate devices.
8. The sample size for the training set
- Not Applicable. This is a physical medical device, not a machine learning algorithm that requires a "training set."
9. How the ground truth for the training set was established
- Not Applicable. As above, no training set or associated ground truth.
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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 DeviceCFR 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.The diameter decreased andlength 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 extendsfrom top of cap todistal end of bolt | Polyimide guide tubes extend3 mm beyond the distal endof bolt | Licox guide tubes extendbeyond 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 (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
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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 ____________________________________________________________________________________________________________________________________________________________________
§ 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).