(28 days)
Not Found
No
The summary describes a bioimpedance spectroscopy device using VIPS technology to measure electrical properties related to fluid volume changes. There is no mention of AI, ML, or related terms, nor are there descriptions of training or test sets typically associated with AI/ML development.
No.
The device is used to measure impedance ratios to aid in the assessment of cerebral fluid volume asymmetry, and is described as an "adjunct to standard methodologies for clinical evaluation" and an "aid to clinical assessment." These phrases indicate that the device provides information for diagnosis or assessment, rather than directly treating a condition.
Yes
The "Intended Use / Indications for Use" section states that the device is "indicated to measure impedance ratios to aid in the assessment of cerebral fluid volume asymmetry between the cerebral hemispheres in adult patients undergoing neurologic assessment." This indicates that the device provides information for medical assessment, which is the definition of a diagnostic device.
No
The device description explicitly states it is a "bioimpedance spectroscopy device" that uses "VIPS technology" and involves "an emitter antenna and a detector antenna." These components are hardware, indicating it is not a software-only device.
Based on the provided information, the Visor System is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD definition: In vitro diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections.
- Visor System's function: The Visor System is a bioimpedance spectroscopy device that measures electrical properties directly on the patient's head to assess cerebral fluid volume asymmetry. It does not analyze samples taken from the body.
Therefore, the Visor System falls under the category of a medical device used for direct patient monitoring and assessment, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
The Visor System is a bioimpedance spectroscopy device indicated to measure impedance ratios to aid in the assessment of cerebral fluid volume asymmetry between the cerebral hemispheres in adult patients undergoing neurologic assessment.
The Visor System is an adjunct to standard methodologies for clinical evaluation.
Product codes (comma separated list FDA assigned to the subject device)
QAF
Device Description
The Visor System is a bioimpedance spectroscopy device used to monitor patients who have conditions that predispose them to fluid volume changes. The device uses Volumetric Integral Phase-Shift Spectroscopy (VIPS) technology. Changes in the volume of fluids in the human skull can be detected by monitoring changes in electrical properties. VIPS technology measures the frequency response of the phase angle shift between an emitter antenna and a detector antenna, when placed on opposite sides of the head. The device is intended to be used as an aid to clinical assessment in conjunction with current standards of care.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
cerebral hemispheres (head/skull)
Indicated Patient Age Range
adult patients
Intended User / Care Setting
Not Found
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.
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.
Not Found
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
§ 870.2770 Impedance plethysmograph.
(a)
Identification. An impedance plethysmograph is a device used to estimate peripheral blood flow by measuring electrical impedance changes in a region of the body such as the arms and legs.(b)
Classification. Class II (special controls). The device, when it is a body composition analyzer which is not intended to diagnose or treat any medical condition, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 870.9.
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Image /page/0/Picture/0 description: The image contains two logos. The logo on the left is the Department of Health & Human Services - USA logo. The logo on the right is the FDA U.S. Food & Drug Administration logo. The FDA logo is in blue.
November 23, 2018
Cerebrotech Medical Systems, Inc. Dawnel Scott Director. RA/OA 1048 Serpentine Lane, Suite 301 Pleasanton, California 94566
Re: K182967
Trade/Device Name: Visor System Regulation Number: 21 CFR 870.2770 Regulation Name: Impedance Plethysmograph Regulatory Class: Class II Product Code: QAF Dated: October 25, 2018 Received: October 26, 2018
Dear Dawnel Scott:
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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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
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requirements, including, but not limited to: registration and listing (21 CFR Part 801); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/CombinationProducts/GuidanceRegulatoryInformation/ucm597488.html; good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
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 comprehensive regulatory information about mediation-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.
Xiaolin Zheng -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) K182967
Device Name Visor System
Indications for Use (Describe)
The Visor System is a bioimpedance spectroscopy device indicated to measure impedance ratios to aid in the assessment of cerebral fluid volume asymmetry between the cerebral hemispheres in adult patients undergoing neurologic assessment.
The Visor System is an adjunct to standard methodologies for clinical evaluation.
Type of Use (Select one or both, as applicable)
| Prescription Use (Part 21 CFR 801 Subpart D) | ☑ |
|---|---|
| Over-The-Counter Use (21 CFR 801 Subpart C) | ☐ |
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510(K) SUMMARY K182967
1. General Information
| Submission | |
|---|---|
| Sponsor: | Cerebrotech Medical Systems, Inc. |
| 1048 Serpentine Lane, Suite 301 | |
| Pleasanton, CA 94566 |
| Submission | |
|---|---|
| Contact: | Dawnel Scott |
| T 510-501-6571 | |
| F 925-399-5827 |
Date Prepared: November 20, 2018
2. Device Identification
| Device Name: | Visor™ System |
|---|---|
| Classification Name | Impedance Plethysmograph |
| Classification | |
| Regulation: | 21 CFR Part 870.2770 |
| Classification Panel: | Neurology |
| Product Code: | QAF |
| Device Class: | Class II |
3. Predicate Device
K171186, Cerebrotech CMS-5000, Impedance Plethysmograph, Cranial
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4. Device Description
The Visor System is a bioimpedance spectroscopy device used to monitor patients who have conditions that predispose them to fluid volume changes. The device uses Volumetric Integral Phase-Shift Spectroscopy (VIPS) technology. Changes in the volume of fluids in the human skull can be detected by monitoring changes in electrical properties. VIPS technology measures the frequency response of the phase angle shift between an emitter antenna and a detector antenna, when placed on opposite sides of the head. The device is intended to be used as an aid to clinical assessment in conjunction with current standards of care.
5. Indications for Use
The Visor System is a bioimpedance spectroscopy device indicated to measure impedance ratios to aid in the assessment of cerebral fluid volume asymmetry between the cerebral hemispheres in adult patients undergoing neurologic assessment.
The Visor System is an adjunct to standard methodologies for clinical evaluation.
6. Comparison of Technological Characteristics
The Visor System is the same device as the predicate with some modifications: smaller overall size and changing from a MacBook laptop to an Android tablet for the user interface.
7. Substantial Equivalence
The Visor System is the same device as the predicate with some modifications. The devices are substantially equivalent.
| ITEM | PREDICATE DEVICE
Visor System (previously
called CMS-5000) | SUBJECT DEVICE
Visor System (as modified) | Comments |
|-------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------|
| Sponsor | Cerebrotech Medical Systems, Inc. | Cerebrotech Medical Systems, Inc. | |
| 510 (k) Number | K171186 | K182967 | |
| CDRH
Classification | Class II | Class II | Same as Predicate |
| Product Code | QAF | QAF | Same as Predicate |
| Regulation
Name | Impedance Plethysmograph, Cranial | Impedance Plethysmograph, Cranial | Same as Predicate |
| Regulation
Number | 21 CFR Part 870.2770 | 21 CFR Part 870.2770 | Same as Predicate |
| ITEM | PREDICATE DEVICE
Visor System (previously called CMS-5000) | SUBJECT DEVICE
Visor System (as modified) | Comments |
| Indications for Use | The CMS-5000 is a bioimpedance spectroscopy device for use on adult human patients utilizing impedance ratios that are displayed as a B-DEX ratio as an aid in the assessment of fluid volume differences between the cerebral hemispheres in patients undergoing neurologic assessment.
The CMS-5000 is an adjunct to standard methodologies routinely used in the clinical evaluation of intracranial fluid distribution and is not intended to be a sole determinant. | The Visor System is a bioimpedance spectroscopy device indicated to measure impedance ratios to aid in the assessment of cerebral fluid volume asymmetry between the cerebral hemispheres in adult patients undergoing neurologic assessment.
The Visor System is an adjunct to standard methodologies for clinical evaluation. | Modified
See Note 1. |
| Monitoring Mode | Periodic. Baseline, then repeated as required | Periodic. Baseline, then repeated as required | Same as Predicate |
| Operating Principle | Multi-frequency Bioimpedance Spectroscopy | Multi-frequency Bioimpedance Spectroscopy | Same as Predicate |
| Software | Yes | Yes | Modified
See Note 2. |
| Type of Energy | Low-Power Radio Frequency Current | Low-Power Radio Frequency Current | Same as Predicate |
| Frequency Range | 30-310 MHz | 30-310 MHz | Same as Predicate |
| Displayed parameter | Bioimpedance ratio | Bioimpedance ratio | Same as Predicate |
| Device Configuration | Non-invasive, antenna modules and system controller | Non-invasive, antenna modules and system controller | Same as Predicate |
| Physical Dimensions | Weight: 1.1 lbs
Length: 9.6"
Width: 8.42"
Height: 3.26" | Weight: 1.1 lbs
Length: 9.0"
Width: 9.0"
Height: 2.8" | Modified
See Note 3. |
| Power Source | Rechargeable Battery | Rechargeable Battery | Modified
See Note 4. |
| Performance | Device detects and monitors bioimpedance ratios | Device detects and monitors bioimpedance ratios | Same as Predicate |
| ELECTRICAL REQUIREMENTS | | | |
| Voltage | 100-240 | 100-240 | Same as Predicate |
| Frequency | 50-60 Hz | 50-60 Hz | Same as Predicate |
| Current | 1A Apple MagSafe 2
Power Adapter (for
recharging Console)
0.2A Cell-Con plug
(Scanner Battery
Recharger) | 2.1A Power Adapter (for
charging the Tablet)
1A for the Scanner Battery
Charger | Modified
See Note: 5 |
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Indication for Use: The indication for use statement presented for the NOTE 1: subject device is a clarified version of the predicate indication statement. No substantial changes were made to the statement.
NOTE 2: Software: User interface software (CerebroScan) is included in a MacBook laptop for the predicate, whereas the software is included in a Tablet for the subject device. Verification of the CerebroScan software in the Tablet (Android platform) is provided in the 510(k) submission.
Physical dimensions: The subject device has a smaller profile. The user NOTE 3: interface is now contained on an Android Tablet rather than a MacBook laptop.
Image /page/6/Picture/4 description: The image shows a white mannequin head wearing a Cerebrotech Visor. The visor is white and gray, with orange accents. The visor is positioned on the mannequin's head so that it covers the forehead and eyes. The mannequin's head is facing forward and is set against a white background.
Figure 1a: Predicate Device
Image /page/6/Picture/6 description: The image shows a Cerebrotech Visor device on a mannequin head. The device is white and gray with orange accents. It is positioned on the mannequin's head, covering the forehead and temples. The device has a sleek, futuristic design and appears to be a medical or technological device.
Figure 1b: Subject Device
Power Source: Both the predicate and subject devices use rechargeable NOTE 4: Li-ion batteries. The battery in the predicate device was not removable whereas the battery for the subject device is removable. Both batteries are ISO 62133 certified.
Current: Both the predicate and subject devices use chargers as provided NOTE 5: by their manufacturer.
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8. Safety and Effectiveness information
The Visor System is the same device as the predicate with some modifications. It provides adjunct information about tissue fluid differences derived from bioimpedance ratios and does not replace standard diagnostic techniques, which may include physical examination, medical imaging, and professional judgment. The systems are therefore substantially equivalent.
9. Statement of Substantial Equivalence
The Visor System is the same device as the predicate with some modifications. The devices have the same intended use and the same technological characteristics.
10.Conclusion
The Cerebrotech Visor as modified is substantially equivalent to the predicate device. It shares the same indications for use, design features and functional characteristics and thus is substantially equivalent to the predicate device.