(298 days)
No
The summary does not mention AI, ML, or related concepts, and the device description focuses on hardware components for direct ICP monitoring.
No
The device is intended for monitoring intracranial pressure, not for treating any condition.
Yes
The device is intended for "direct monitoring of intracranial pressure", which involves measuring a physiological parameter to aid in diagnosis or management of a condition.
No
The device description explicitly lists multiple hardware components, including a sensor, monitor, antenna, batteries, charger, and data receiver, in addition to software testing mentioned in the performance studies.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is "direct monitoring of intracranial pressure in intraparenchymal applications." This involves measuring a physiological parameter directly within the body.
- Device Description: The components described are a sensor, monitor, antenna, and related accessories for measuring and displaying pressure. These are typical components of a physiological monitoring system.
- Lack of In Vitro Activity: There is no mention of the device being used to examine specimens derived from the human body (like blood, urine, tissue, etc.) outside of the body. IVDs are specifically designed for testing these types of samples in a laboratory or point-of-care setting.
In summary, the Branchpoint AURA™ ICP Monitoring System is a device for in vivo (within the living body) monitoring, not in vitro (in glass/outside the body) diagnostic testing.
N/A
Intended Use / Indications for Use
The Branchpoint AURA™ ICP Monitoring System is intended for use by a qualified neurosurgeon in the direct monitoring of intracranial pressure in intraparenchymal applications.
Product codes
GWM
Device Description
The Branchpoint AURA™ ICP Monitoring System is a device intended for monitoring intracranial pressure (ICP). The Branchpoint AURA™ ICP Monitoring System is composed of the following three packages:
Package 1) AURA™ Sensor Tray (Model SP101-A)
- AURA™ Sensor (Model 10025G)
- Disposable Scalp Retractor (Model OS0001B)
- Disposable Drill Bit with Collar (Model 10008C)
- Disposable Torque Wrench (Model OS0004C)
- Disposable Antenna Holster (Model 10007A)
Package 2) AURA™ Monitor Pack (Model TK101-A)
- AURA™ Monitor (Model T0011B)
- AURA™ Antenna (Model T0010A)
- 2x Lithium-Ion 11v Rechargeable Batteries (Model T0032A)
- Two-bay battery charger (Model T0014A)
Package 3) AURA™ Data Receiver Pack (Model DG101-A)
- AURA™ Data Receiver (Model D0004B)
Package 1 of The Branchpoint AURA™ ICP Monitoring System is comprised of components which are described below, all of which are intended for SINGLE-USE ONLY:
AURA™ Sensor (Model 10025G)
The AURA™ Sensor is a strain gage pressure sensor that is placed at the standard location for ICP monitoring (Kocher's Point). The AURA™ Sensor is placed using the same procedure as predicate ICP monitors. The AURA™ Sensor has a catheter tip that extends into the parenchyma of the brain. The AURA™ Sensor does not contain a battery or power storage capacitor. It receives power inductively from the AURA™ Monitor (Model T0011B) through the AURA™ Antenna (Model T0010A). The exclusion of internal power storage in the AURA™ Sensor eliminates risks associated with batteries. The AURA™ Sensor is provided sterile (ethylene oxide) as part of the AURA™ Sensor Tray (Model SP101-A).
The AURA™ Sensor measures ICP and relays the data to the handheld AURA™ Monitor. The AURA™ Monitor is the primary user interface and displays a numerical ICP value on its screen. Optionally, the AURA™ Monitor also relays the ICP data to the AURA™ Data Receiver, which outputs the ICP waveform to standard patient bedside monitors.
Drill Bit with Collar (Model 10008C)
The drill bit with collar is used to drill the burr hole for the AURA™ Sensor. This is a class I device with product code HTW that is exempt from premarket notification per 21 CFR 888.4540 and is currently legally marketed in the United States. The drill bit has a diameter of 6.3 mm and has an adjustable collar to be used to help ensure proper drilling depth. The collar has a set-screw that can be adjusted by the user with the torque wrench for loosening and tightening. The drill bit and collar are manufactured from medical grade stainless steel (DIN 1.4021).
Torque Wrench (Model OS0004C)
The torque wrench allows the user to loosen and tighten the collar on the drill bit to limit the drilling depth. This is a class I device with product code HXC that is exempt from premarket notification per 21 CFR 888.4540 and is currently legally marketed in the United States. It is made of nickel plated chromium vanadium (DIN 1.4305).
Scalp Retractor (Model OS0001B)
The scalp retractor is a skin retractor that can be used during the placement of the AURA™ Sensor. This is a class I device with product code GAD that is exempt from premarket notification per 21 CFR 878.4800 and is currently legally marketed in the United States. It is constructed from medical grade stainless steel (DIN 1.4301, 1.4305 and 1.4021).
Antenna Holster (Model 10007A)
The antenna holster is designed to hold an AURA™ Antenna securely in place over an AURA™ Sensor in all possible positions. It is made of thermoplastic elastomer and affixes to the skin with an adhesive (hydrocolloid).
Package 2 of The Branchpoint AURA™ ICP Monitoring System is comprised of components which are described below:
AURA™ Monitor Pack (Model TK101-A)
The AURA™ Monitor Pack is provided non-sterile. The AURA™ Monitor (Model T0011B) handheld is the primary user interface device that connects to an AURA™ Antenna (Model T0010A). The AURA™ Antenna powers and receives ICP data streamed from the AURA™ Sensor. The AURA™ Monitor handheld controller displays numerical ICP on its screen. Optionally, the AURA™ Monitor can relay the ICP data to a nearby AURA™ Data Receiver. The AURA™ Monitor uses an externally replaceable lithium-ion battery pack that can be recharged in the charger provided in the AURA™ Monitor Pack (Model TK101-A). A fully-charged battery is capable of running the AURA™ Monitor for at least 8 hours. These devices are intended for reuse.
Package 3 of The Branchpoint AURA™ ICP Monitoring System is comprised of components which are described below:
AURA™ Data Receiver Pack (DG101-A)
The AURA™ Data Receiver Pack is provided non-sterile. The AURA™ Data Receiver receives ICP waveform data relayed by the AURA™ Monitor and outputs them to existing 3rd party patient monitors. The AURA™ Data Receiver plugs directly into the patient monitor's invasive blood pressure port, a port that is governed by AAMI BP22: 1994 (R) 2011 Blood Pressure Transducers (FDA recognition number 3-44). There are various 3rd party adapter cables currently available on the market that will allow the AURA™ Data Receiver to various 3rd party patient monitors and the AAMI BP22 standard ensures compatibility across different brands and models. The AURA™ Data Receiver does not contain a battery and does not need to be recharged; it is able to run from the excitation voltage provided by the invasive blood pressure port. The AURA™ Data Receiver is intended for reuse.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
parenchyma of the 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)
The following bench testing was conducted to support a determination of substantial equivalence to the predicate and to demonstrate performance. The non-clinical bench tests included:
- ICP Monitor performance testing prescribed by ANSI/AAMI NS28:1988(r)2010;
- Pressure measurement resolution testing;
- Barometric pressure compensation testing;
- System response time testing;
- Battery and charger performance testing;
- Electrical safety testing;
- Electromagnetic compatibility testing;
- Wireless power testing;
- Wireless data transmission testing;
- Wireless co-existence testing;
- Immunity to RFID testing;
- Specific absorption rate (SAR) simulation testing;
- Device mechanical integrity testing;
- Hardware reliability testing;
- Device insulation performance testing;
- Vibration and shock testing;
- Device operating temperature testing;
- Adhesion performance testing;
- Device environmental exposure testing;
- Labeling durability testing;
- System usability testing;
- Audio and alarm tone testing;
- Software testing;
- Sterilization validation testing; and
- Shelf-life and packaging testing.
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
Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
May 18, 2018
Branchpoint Technologies, Inc. Nicholas Hu Chief Operating Officer Contact Address
Re: K172209
Trade/Device Name: AURA ICP Monitoring System Regulation Number: 21 CFR 882.1620 Regulation Name: Intracranial Pressure Monitoring Device Regulatory Class: Class II Product Code: GWM Dated: April 19, 2018 Received: August 25, 2017
Dear Nicholas Hu:
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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to 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 comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
1
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
Michael J. Hoffmann -S
for Carlos L. Peña, PhD, MS Director Division of Neurological and Physical Medicine Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known) K172209
Device Name AURA™ ICP Monitoring System
Indications for Use (Describe)
The Branchpoint AURA™ ICP Monitoring System is intended for use by a qualified neurosurgeon in the direct monitoring of intracranial pressure in intraparenchymal applications.
| Type of Use (Select one or both, as applicable) | |
|---|---|
| ------------------------------------------------- | -- |
X Prescription Use (Part 21 CFR 801 Subpart D)
| Over-The-Counter Use (21 CFR 801 Subpart C)
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K172209 510(k) Summary
Submitter Information
Company Name: Contact Person: Address: Telephone Number: Date Prepared:
Branchpoint Technologies, Inc. Nicholas Hu 1 Technology Drive, Suite I-811, Irvine, CA 92618 (949) 829-1868 May 18th, 2018
Subject Device
| Trade Name: | AURA™ ICP Monitoring System |
|---|---|
| Common or Usual Name: | Intracranial Pressure Monitor |
| Classification: | Class II, Intracranial Pressure Monitoring Device |
| 21 CFR 882.1620 | |
| Product Code: | GWM |
Predicate Device
Primary Predicate:
Camino Slim Line ™ System K042728 21 CFR 882.1620, GWM
Device Description
The Branchpoint AURA™ ICP Monitoring System is a device intended for monitoring intracranial pressure (ICP). The Branchpoint AURA™ ICP Monitoring System is composed of the following three packages:
Package 1) AURA™ Sensor Tray (Model SP101-A)
- . AURA™ Sensor (Model 10025G)
- Disposable Scalp Retractor (Model OS0001B) ●
- Disposable Drill Bit with Collar (Model 10008C)
- Disposable Torque Wrench (Model OS0004C)
- . Disposable Antenna Holster (Model 10007A)
Package 2) AURA™ Monitor Pack (Model TK101-A)
- AURA™ Monitor (Model T0011B)
- AURA™ Antenna (Model T0010A) .
- . 2x Lithium-lon 11v Rechargeable Batteries (Model T0032A)
- Two-bay battery charger (Model T0014A) ●
Package 3) AURA™ Data Receiver Pack (Model DG101-A)
- . AURA™ Data Receiver (Model D0004B)
Package 1 of The Branchpoint AURA™ ICP Monitoring System is comprised of components which are described below, all of which are intended for SINGLE-USE ONLY:
AURA™ Sensor (Model 10025G)
The AURA™ Sensor is a strain gage pressure sensor that is placed at the standard location for ICP monitoring (Kocher's Point). The AURA™ Sensor is placed using the same procedure as predicate
4
ICP monitors. The AURA™ Sensor has a catheter tip that extends into the parenchyma of the brain. The AURA™ Sensor does not contain a battery or power storage capacitor. It receives power inductively from the AURA™ Monitor (Model T0011B) through the AURA™ Antenna (Model T0010A). The exclusion of internal power storage in the AURA™ Sensor eliminates risks associated with batteries. The AURA™ Sensor is provided sterile (ethylene oxide) as part of the AURA™ Sensor Tray (Model SP101-A).
The AURA™ Sensor measures ICP and relays the data to the handheld AURA™ Monitor. The AURA™ Monitor is the primary user interface and displays a numerical ICP value on its screen. Optionally, the AURA™ Monitor also relays the ICP data to the AURA™ Data Receiver, which outputs the ICP waveform to standard patient bedside monitors.
Drill Bit with Collar (Model 10008C)
The drill bit with collar is used to drill the burr hole for the AURA™ Sensor. This is a class I device with product code HTW that is exempt from premarket notification per 21 CFR 888.4540 and is currently legally marketed in the United States. The drill bit has a diameter of 6.3 mm and has an adjustable collar to be used to help ensure proper drilling depth. The collar has a set-screw that can be adjusted by the user with the torque wrench for loosening and tightening. The drill bit and collar are manufactured from medical grade stainless steel (DIN 1.4021).
Torque Wrench (Model OS0004C)
The torque wrench allows the user to loosen and tighten the collar on the drill bit to limit the drilling depth. This is a class I device with product code HXC that is exempt from premarket notification per 21 CFR 888.4540 and is currently legally marketed in the United States. It is made of nickel plated chromium vanadium (DIN 1.4305).
Scalp Retractor (Model OS0001B)
The scalp retractor is a skin retractor that can be used during the placement of the AURA™ Sensor. This is a class I device with product code GAD that is exempt from premarket notification per 21 CFR 878.4800 and is currently legally marketed in the United States. It is constructed from medical grade stainless steel (DIN 1.4301, 1.4305 and 1.4021).
Antenna Holster (Model 10007A)
The antenna holster is designed to hold an AURA™ Antenna securely in place over an AURA™ Sensor in all possible positions. It is made of thermoplastic elastomer and affixes to the skin with an adhesive (hydrocolloid).
Package 2 of The Branchpoint AURA™ ICP Monitoring System is comprised of components which are described below:
AURA™ Monitor Pack (Model TK101-A)
The AURA™ Monitor Pack is provided non-sterile. The AURA™ Monitor (Model T0011B) handheld is the primary user interface device that connects to an AURA™ Antenna (Model T0010A). The AURA™ Antenna powers and receives ICP data streamed from the AURA™ Sensor. The AURA™ Monitor handheld controller displays numerical ICP on its screen. Optionally, the AURA™ Monitor can relay the ICP data to a nearby AURA™ Data Receiver. The AURA™ Monitor uses an externally replaceable lithium-ion battery pack that can be recharged in the charger provided in the AURA™
5
Monitor Pack (Model TK101-A). A fully-charged battery is capable of running the AURA™ Monitor for at least 8 hours. These devices are intended for reuse.
Package 3 of The Branchpoint AURA™ ICP Monitoring System is comprised of components which are described below:
AURA™ Data Receiver Pack (DG101-A)
The AURA™ Data Receiver Pack is provided non-sterile. The AURA™ Data Receiver receives ICP waveform data relayed by the AURA™ Monitor and outputs them to existing 3rd party patient monitors. The AURA™ Data Receiver plugs directly into the patient monitor's invasive blood pressure port, a port that is governed by AAMI BP22: 1994 (R) 2011 Blood Pressure Transducers (FDA recognition number 3-44). There are various 3rd party adapter cables currently available on the market that will allow the AURA™ Data Receiver to various 3rd party patient monitors and the AAMI BP22 standard ensures compatibility across different brands and models. The AURA™ Data Receiver does not contain a battery and does not need to be recharged; it is able to run from the excitation voltage provided by the invasive blood pressure port. The AURA™ Data Receiver is intended for reuse.
Intended Use
The Branchpoint AURA™ ICP Monitoring System is intended for use by a qualified neurosurgeon in the direct monitoring of intracranial pressure in intraparenchymal applications.
Comparison of Technological Characteristics & Intended Use to Predicate Device
The table below presents a summary of the technological characteristics of the AURA™ ICP Monitoring System in comparison to the predicate device. The indications for use for the predicate device is similar to the indications for use for the AURA™ ICP Monitoring System. There are no major technological differences between the AURA™ ICP Monitoring System and predicate systems that raise new issues of safety or effectiveness. Thus, the AURA™ ICP Monitoring System is substantially equivalent to the predicate devices.
| Characteristic | AURA™ ICP Monitoring
System
K172209 Subject Device | Camino Slim Line ™ System
K042728
Predicate Device |
|---------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------|
| Measured Variable | ICP | ICP and intracranial temperature |
| Clinical Application | Parenchymal pressure
measurement | Parenchymal and sub-dural pressure
and temperature measurement |
| Mechanism for ICP
measurement | Solid state pressure sensor
for direct measurement | Solid state pressure sensor for direct
measurement |
| Classification Regulation | 21 CFR § 882.1620 | 21 CFR § 882.1620 |
| Classification Name
(Product Code) | GWM | GWM |
| Intended Use | For use by a qualified
neurosurgeon in the direct
monitoring of intracranial
pressure in
intraparenchymal
applications. | For use by a qualified neurosurgeon in
the direct monitoring of intracranial
pressure in both sub-dural and
intraparenchymal applications. |
| Catheter Construction | Polyurethane | Polyurethane |
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| Characteristic | AURA™ ICP Monitoring
System
K172209 Subject Device | Camino Slim Line ™ System
K042728
Predicate Device |
|---------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------|
| Catheter Dimensions | 2.5cm long x 2mm diameter | 10cm long x 1.35 diameter |
| Calibration Method | Stored calibration values in ICP sensor. | Stored calibration values in ICP sensor and manual zeroing. |
| Display Variables | ICP digital display and waveform | ICP digital display and waveform |
| Measurement Units for ICP | ICP in mmHg | ICP in mmHg |
| Sensor Connection to
Monitor | Data: Bluetooth low energy
(range = 7 m for monitor handheld and data receiver)
Power: Inductive coupling
(range = 1.5 cm for monitor antenna) | Direct, percutaneous cable connection |
| Sensor Power Source | Powered by monitor | Powered by monitor |
| Monitor Power Source | Battery | Battery or mains |
| Sterilization | Ethylene oxide (single use) | Ethylene oxide (single use) |
| Monitoring Duration | 10%. |
| Subcutaneous Implantation
ISO 10993-6 | No systemic toxicity: Macroscopic reaction of the
test article was not significant as compared to
control. Microscopically, test article is classified as a
slight irritant as compared to control. |
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| Test | Results |
|---|---|
| Brain Tissue Implantation | |
| ISO 10993-6 | No systemic toxicity: Neurobehavioral, gross |
| pathological and clinical reactions caused by the test | |
| article were not significant as compared to control. | |
| Histologically, test article is classified as having | |
| minimal or no reaction. | |
| Mediated Material Pyrogenicity | |
| ISO 10993-11 | Non pyrogenic: Temperature increase was – Test Methods, Routine |
| Monitoring, And Alternatives To Batch Testing | 14-360 |
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