(249 days)
No
The device description focuses on mechanical and physical components for pressure measurement and CSF drainage. There is no mention of AI/ML terms, image processing, or data analysis that would suggest the use of such technologies.
No.
The device is used for direct measurement of intracranial pressure and CSF drainage, which are diagnostic and monitoring functions, not therapeutic interventions.
Yes
Explanation: The device is used for "direct measurement of intracranial pressure," which is a physiological parameter measured to understand a patient's medical condition. This measurement provides information used in diagnosis and patient management.
No
The device description details a physical catheter with multiple lumens, a cage, a bladder, a transfer tube, and a manifold, indicating it is a hardware device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states the device is used for "direct measurement of intracranial pressure" and "CSF drainage." These are measurements taken within the body (in vivo), not on samples of bodily fluids or tissues outside the body (in vitro).
- Device Description: The description details a catheter with lumens for drainage, temperature sensing, and pressure sensing, designed for insertion into the brain. This is consistent with an in vivo monitoring and drainage device.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue, etc.) or performing tests on these samples outside the body.
Therefore, the Hummingbird HUMV-500 or HUMV-500MR is an in vivo medical device for intracranial pressure monitoring and CSF drainage, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
The use of a Hummingbird HUMV-500 or HUMV-500MR 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, when data from one or more parameters may be deemed useful in providing optimum patient management and, in the case of the Hummingbird-500MR, when an MRI may be indicated.
Product codes
GWM
Device Description
The modified device includes:
- An 8, 9 and 10 Fr. model will be added to the line. The user will CSF drainage select a Fr. size appropriate for the expected level of debris or clots in the CSF. The catheter body is made of polyurethane rather than silicone. A polyurethane catheter is stronger than silicone and can therefore be extruded with a thinner wall. The drainage lumen of a multi-lumen urethane catheter is therefore as larger than a single lumen silicone catheter as can be seen in the following table. The MPS catheter has three lumens, a drainage lumen, a thermocouple lumen and an air column lumen.
- Continuous Pressure: An MPS catheter has a thin-wall tube termed the cage attached to its distal end. The cage holds the pressure-sensing bladder and provides the inlet holes through which CSF enters the catheter. If the inlet holes become partially clogged, the pressure drop across the holes can create a lower pressure in the cage than the pressure in the brain. In order to get a true ICP reading, the staff must momentarily stop CSF drainage to eliminate the pressure drop. The Continuous Pressure model eliminates the affect of clogged intet holes on the ICP reading by inserting a partition into the cage that separates cage into two compartments, an upper compartment for the sensing bladder and a lower compartment for CSF inflow. A transfer tube passing through the bladder compartment conveys CSF from the inflow compartment to the drainage lumen of the catheter. The bladder, now isolated from pressure in the lower compartment, is not affected by pressure changes in the inlet hole compartment due to clogged inlet holes. The addition of a transfer tube to the cage requires an increase in the overall catheter diameter by 1/2 to 1 Fr. depending on the catheter Fr. size.
- Manifold modification: The manifold of the approved device has two probe ports. The diameter of one of the ports has been increased to allow the passage of either a flow or dialysis probe. Both probes are slightly larger than anticipated in the original manifold design. One probe has been enlarged to accommodate the larger probe. The distal body of the manifold has been extended 1 cm to both accommodate the diameter change and improve the distal end profile for insertion into the brain.
- MRI: The dash T (-T = temperature) catheters of the approved device have an integrated temperature sensor that will be heated by an RF field. The thermocouple of the MRI Conditional catheters has been placed in a removable probe. The probe is removed prior to an MRI and replaced after. The temperature probe is placed in a polyimide tube that has been inserted into a dedicated lumen in the catheter. Both the tube and lumen ends are closed. The temperature probe can therefore be inserted and removed as often as need be as there is no body or fluid contact and therefore no sterility issue. Absent the thermocouple probe, the catheter and the manifold are plastic and therefore MRI safe. The bolt of the Hummingbird HUMV-500MR was subjected radio frequency induced heating. The bolt was found to be "MR Conditional" as defined by ASTM F2503, Standard Practice for Marketing Medical Devices and Other Items for Safety in the Magnetic Resonance Environment using a 1.5 and 3.0 Tesla MR system.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
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)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
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
Ko 72379
SUMMARY OF SAFETY AND EFFECTIVENESS DATA
Submitted by: InnerSpace 1622 Edinger Ave. Suite C, Tustin CA 92780 Ph 714 259 7900 Fax 714 259 7999
APR 2 9 2008
Contact person: Don Bobo (dbobo@innerspacemedical.com)
Approved 510K Device Name: MPS Oxi-port and MPS Oxi-port-T (T= temperature)
New Device Names:
MPS Hummingbird - (CP) XX2 Fr. (Manifold accepts an oxygen probe.) MPS Hummingbird Plus - (CP) XX Fr. (Manifold accepts both an oxygen probe and a flow or dialysis probe)
1 The letters CP will be added to the name of models that offer Continuous Pressure measurement while draining. 2 XX is a placeholder for the specific Fr sizes offered.
Devices that are MRI compatible will have the words "MRI Conditional" under the device name
Predicate Devices
Predicate device related to Function and Design:
K041838 - Concurrence date 03/01/2005 - Product code GWM: Device, Monitoring, Intracranial Pressure. The catheter uses an air column and bladder to couple ICP to an external transducer. It provides two probe ports.
Predicate device related to temperature sensing in a ventricular catheter
K962928 - Camino. K041838 -InnerSpace.
Predicate device related to the larger size of catheters used in trauma patients: Camino, Codman and others have a number of pre-amendment ventricular catheters with an OD ranging from 7.5 to 11.5 Fr.
Predicate device related to sensing pressure in parenchyma tissue K003905 -InnerSpace
Modified Device
1 An 8, 9 and 10 Fr. model will be added to the line. The user will CSF drainage select a Fr. size appropriate for the expected level of debris or clots in the CSF. The following table compares the cross section area of the drainage lumen of MPS catheters to several Camino ventricular catheters now on the market. The catheter body is made of polyurethane rather than silicone. A polyurethane catheter is stronger than silicone and can therefore be extruded with a thinner wall. The drainage lumen of a multi-lumen urethane catheter is therefore as larger than a single lumen silicone catheter as can be seen in the following table. The MPS catheter has three lumens, a drainage lumen, a thermocouple lumen and an air column lumen.
P. 1 of 3
1
| Device names | Fr | OD | Drainage Lumen
Sq. in. $10^{-3}$ |
|----------------|-----|-------|-------------------------------------|
| MPS | 8.1 | 0.106 | 3.46 |
| Camino Large 2 | 8.1 | 0.106 | 1.96 |
| MPS | 9.0 | 0.117 | 4.91 |
| Camino Large 1 | 9.2 | 0.120 | 2.37 |
থ Continuous Pressure An MPS catheter has a thin-wall tube termed the cage attached to its distal end. The cage holds the pressure-sensing bladder and provides the inlet holes through which CSF enters the catheter. If the inlet holes become partially clogged, the pressure drop across the holes can create a lower pressure in the cage than the pressure in the brain. In order to get a true ICP reading, the staff must momentarily stop CSF drainage to eliminate the pressure drop. The Continuous Pressure model eliminates the affect of clogged intet holes on the ICP reading by inserting a partition into the cage that separates cage into two compartments, an upper compartment for the sensing bladder and a lower compartment for CSF inflow. A transfer tube passing through the bladder compartment conveys CSF from the inflow compartment to the drainage lumen of the catheter. The bladder, now isolated from pressure in the lower compartment, is not affected by pressure changes in the inlet hole compartment due to clogged inlet holes. The addition of a transfer tube to the cage requires an increase in the overall catheter diameter by 1/2 to 1 Fr. depending on the catheter Fr. size.
3 Manifold modification. The manifold of the approved device has two probe ports. The diameter of one of the ports has been increased to allow the passage of either a flow or dialysis probe. Both probes are slightly larger than anticipated in the original manifold design. One probe has been enlarged to accommodate the larger probe. The distal body of the manifold has been extended 1 cm to both accommodate the diameter change and improve the distal end profile for insertion into the brain.
| Port diameters | Port 1 | Port 2 |
|---|---|---|
| Approved device | .056" | .056" |
| Modified device | .056" | .063" |
4 MRI The dash T (-T = temperature) catheters of the approved device have an integrated temperature sensor that will be heated by an RF field. The thermocouple of the MRI Conditional catheters has been placed in a removable probe. The probe is removed prior to an MRI and replaced after. The temperature probe is placed in a polyimide tube that has been inserted into a dedicated lumen in the catheter. Both the tube and lumen ends are closed. The temperature probe can therefore be inserted and removed as often as need be as there is no body or fluid contact and therefore no sterility issue. Absent the thermocouple probe, the catheter and the manifold are plastic and therefore MRI safe. The bolt of the Hummingbird HUMV-500MR was subjected radio frequency induced heating. The bolt was found to be "MR Conditional" as defined by ASTM F2503, Standard Practice for Marketing Medical Devices and Other Items for Safety in the Magnetic Resonance Environment using a 1.5 and 3.0 Tesla MR system.
2
5 Indications for Use
The use of a Hummingbird HUMV-500 or HUMV-500MR 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, when data from one or more parameters may be deemed useful in providing optimum patient management and, in the case of the Hummingbird-500MR, when an MRI may be indicated.
$\rho*{3,d*3}$
3
Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized caduceus, which is a symbol often associated with medicine and healthcare. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular pattern around the caduceus.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Innerspace, Inc. % Mr. Don Bobo 1622 Edinger Avenue, Suite C Tustin, California 92780
APR 2 9 2008
Re: K072379
Trade/Device Name: Hummingbird HUMV-500MR Regulation Number: 21 CFR 882.1620 Regulation Name: Intracranial pressure monitoring device Regulatory Class: II Product Code: GWM Dated: April 25, 2008 Received: April 25, 2008
Dear Mr. Bono:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined 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 devices that have been reclassified 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 general controls 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 may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, 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 that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must or unf 1 vith all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set forth in the quality systems (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.
4
Page 2 - Mr. Don Bobo
This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in 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), please contact the Center for Devices and Radiological Health's (CDRH's) Office of Compliance at (240) 276-0115. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometric's (OSB's) Division of Postmarket Surveillance at (240) 276-3474. For questions regarding of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at (240) 276-3464. You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely vours.
Mark M. Millman
Mark N. Melkerson Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
5
Indications for Use
510(k) Number (if known): K072379
Hummingbird HUMV-500 and 500 MR Device Name:
Indications For Use
The use of a Hummingbird HUMV-500 or HUMV-500MR 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, when data from one or more parameters may be deemed useful in providing optimum patient management and, in the case of the Hummingbird-500MR, when an MRI may be indicated.
× Prescription Use (Part 21 CFR 801 Subpart D)
AND/OR
Over-The-Counter Use (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)
Neil McAld for man
Division Sign Division of General, Restorative, and Neurological Devices
510(k) Number K072379