(174 days)
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Not Found
No
The summary describes a device for remote viewing and review of standard physiological data and waveforms, with no mention of AI, ML, image processing, or performance studies typically associated with AI/ML algorithms.
No
This device is intended for viewing and reviewing patient data, and requesting consultations. It does not perform any therapeutic function and is explicitly stated to display data captured by other medical devices.
No
Explanation: The device is described as displaying physiologic data captured by other medical devices and allowing remote viewing and consultation. It does not perform any diagnostic function itself but rather facilitates the review of data that may be used for diagnosis by clinicians.
Yes
The device is described as "device software" and its function is to display data captured by other medical devices. There is no mention of any hardware component being part of this specific device submission.
Based on the provided information, this device 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. They are used to provide information for diagnosis, monitoring, or screening.
- Device Function: The intended use and description of this device clearly indicate that it is used to remotely view and review physiological data that has already been captured by other medical devices. It is a tool for clinicians to access and interpret existing patient data, not to perform tests on biological samples.
- Lack of IVD Characteristics: The description does not mention any analysis of biological samples, chemical reactions, or any other processes typically associated with in vitro diagnostics.
Therefore, this device falls under the category of a medical device used for patient monitoring and data display, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
This device is intended to be used by clinicians for the following purposes:
- To view the near real-time waveforms remotely
- To remotely review other standard or critical near real-time patient data from the monitored system
- To provide a request for remote consultation regarding a patient's waveform or other data
This device software can display the following the physiologic data captured by other medical devices:
- ECG Waveform
- Heart Rate Monitored
- Respiratory Rate
- Oxygen Saturation
- Intracranial Pressure
- Central Venous Pressure
- Pulmonary Capillary Wedge Pressure
- Cardiac Index
- Cardiac Output
- Cerebral Perfusion Pressure
- Systolic Blood Pressure Invasive
- Mean Arterial Pressure Invasive
- Diastolic Blood Pressure Invasive
- Systolic Blood Pressure Cuff
- Mean Arterial Pressure Cuff
- Diastolic Blood Pressure Cuff
Contraindications
This device is intended for use by clinicians when they cannot be at the hospital. This device is intended for use by clinicians as a diagnostic aid, and not as a replacement for direct viewing of any of the monitoring devices from which it obtains its data.
Product codes (comma separated list FDA assigned to the subject device)
MSX
Device Description
information is generated by other medical devices and patient information system, and not by this device. This device captures this information from these other systems and displays it for clinicians.
Mentions image processing
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Mentions AI, DNN, or ML
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Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
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Intended User / Care Setting
Clinicians, remote from the hospital.
Description of the training set, sample size, data source, and annotation protocol
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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.)
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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.
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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).
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§ 870.2300 Cardiac monitor (including cardiotachometer and rate alarm).
(a)
Identification. A cardiac monitor (including cardiotachometer and rate alarm) is a device used to measure the heart rate from an analog signal produced by an electrocardiograph, vectorcardiograph, or blood pressure monitor. This device may sound an alarm when the heart rate falls outside preset upper and lower limits.(b)
Classification. Class II (performance standards).
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Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
September 19, 2016
Airstrip Technologies, Inc. % Curtis Egan Ouality, Regulator and Design Engineer Certified Compliance Solutions, Inc. 11665 Avena Place #203 San Diego, California 92128-2504
Re: K160862
Trade/Device Name: Airstrip ONE Web Client Regulation Number: 21 CFR 870.2300 Regulation Name: Cardiac Monitor (Including Cardiotachometer and Rate Alarm) Regulatory Class: Class II Product Code: MSX Dated: August 17, 2016 Received: August 18, 2016
Dear Curtis Egan:
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 (reporting of medical devicerelated adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in
1
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.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. 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.
You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely yours.
Mude Yellman
for
Bram D. Zuckerman, M.D. Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known) K160862
Device Name AirStrip One Web Client
Indications for Use (Describe)
information is generated by other medical devices and patient information system, and not by this device captures this information from these other systems and displays it for clinicians.
This device is intended to be used by clinicians for the following purposes:
- · To view the near real-time waveforms remotely
- · To remotely review other standard or critical near real-time patient data from the monitored system
- · To provide a request for remote consultation regarding a patient's waveform or other data
This device software can display the following the physiologic data captured by other medical devices:
- · ECG Waveform
- · Heart Rate Monitored
- · Respiratory Rate
- · Oxygen Saturation
- · Intracranial Pressure
- · Central Venous Pressure
- · Pulmonary Capillary Wedge Pressure
- Cardiac Index
- Cardiac Output
- · Cerebral Perfusion Pressure
- · Systolic Blood Pressure Invasive
- · Mean Arterial Pressure Invasive
- Diastolic Blood Pressure Invasive
- · Systolic Blood Pressure Cuff
- · Mean Arterial Pressure Cuff
- · Diastolic Blood Pressure Cuff
Contraindications
This device is intended for use by clinicians when they cannot be at the hospital. This device is intended for use by clinicians as a diagnostic aid, and not as a replacement for direct viewing of any of the monitoring devices from which it obtains its data.
Type of Use (Select one or both, as applicable)
ال Prescription Use (Part 21 CFR 801 Subpart D)
_ Over-The-Counter Use (21 CFR 801 Subpart C)
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