(273 days)
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No
The provided text does not mention AI, ML, deep learning, or any related terms or concepts.
No
The device is described as a vital signs monitor, intended for measuring and transmitting patient data for diagnostic and monitoring purposes, not for treating a condition.
No
The device is a vital signs monitor that measures and transmits physiological data, which is used for monitoring rather than diagnosing a specific disease or condition.
No
The description explicitly states "The Halo vital signs monitor" and "The Halo monitor uses wired or wireless communications to transmit vital signs data". This language strongly implies a physical hardware device that performs the vital sign measurements, not just software processing data from another source. The anatomical sites mentioned (back of the cavum concha and the neck) further support the existence of a physical sensor component.
Based on the provided text, the Halo vital signs monitor is not an In Vitro Diagnostic (IVD) device.
Here's why:
- IVD devices are used to examine specimens derived from the human body. This typically involves things like blood, urine, tissue, etc., to provide information about a physiological state, health, or disease.
- The Halo vital signs monitor directly measures physiological parameters from the patient's body. It measures SpO2, pulse rate, respiratory rate, and temperature from the back of the cavum concha and the neck. These are direct measurements from the living patient, not from a specimen taken from the patient.
Therefore, the Halo vital signs monitor falls under the category of a patient monitoring device, not an IVD.
N/A
Intended Use / Indications for Use
The Halo vital signs monitor is a prescription device intended to be used as an adult patient monitor. It is indicated as a single- or multi-parameter vital signs monitor for SpO2 - pulse oximetry, pulse rate, respiratory rate, core body temperature, and skin temperature for spot-check measurements and continuous monitoring from the back of the cavum concha and the neck.
The Halo monitor may be used in hospitals, healthcare facilities, emergency medical transport, home healthcare settings, and other healthcare applications to include medical military settings in the field. The monitor is intended to be used in trauma scenarios, triage, motion, low perfusion, general monitoring, and telemedicine settings. It is reusable, transportable, and for use in all types of ambulances.
The Halo monitor uses wired or wireless communications to transmit vital signs data to a handheld or personal computer. The monitor is intended to be used by trained healthcare providers who are trained to interpret the vital signs readings and make appropriate medical interventions or patients who are und guidance of a medical professional or doctor. Alarms can be set with user-defined thresholds.
Product codes
DQA, DPZ, FLL
Device Description
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Mentions image processing
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Mentions AI, DNN, or ML
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Input Imaging Modality
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Anatomical Site
back of the cavum concha and the neck
Indicated Patient Age Range
adult
Intended User / Care Setting
trained healthcare providers who are trained to interpret the vital signs readings and make appropriate medical interventions or patients who are und guidance of a medical professional or doctor. Hospitals, healthcare facilities, emergency medical transport, home healthcare settings, and other healthcare applications to include medical military settings in the field.
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
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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)
Not Found
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 870.2700 Oximeter.
(a)
Identification. An oximeter is a device used to transmit radiation at a known wavelength(s) through blood and to measure the blood oxygen saturation based on the amount of reflected or scattered radiation. It may be used alone or in conjunction with a fiberoptic oximeter catheter.(b)
Classification. Class II (performance standards).
0
Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health & Human Services seal on the left and the FDA acronym along with the full name of the agency on the right. The FDA part of the logo is in blue, with the acronym in a square and the full name written out to the right of it.
May 16, 2024
Sempulse Corporation Matt Barrera Director of Medical Operations 3055 Hunter Road. Suite 175A San Marcos, Texas 78666
Re: K232495
Trade/Device Name: Sempulse Halo Vital Signs Monitor Regulation Number: 21 CFR 870.2700 Regulation Name: Oximeter Regulatory Class: Class II Product Code: DQA, DPZ, FLL Dated: April 12, 2024 Received: April 12, 2024
Dear Matt Barrera:
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 (the 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 available 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.
1
Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device" (https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download).
Your device is also subject to, among other requirements, the Quality System (QS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30. Design controls; 21 CFR 820.90. Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review, the QS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181).
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 Part 803) for devices or postmarketing safety reporting (21 CFR Part 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic.
2
See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
Bradley Q. Quinn -S
Bradley Quinn Assistant Director DHT1C: Division of Sleep Disordered Breathing, Respiratory and Anesthesia Devices OHT1: Office of Ophthalmic, Anesthesia, Respiratory, ENT and Dental Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
3
Indications for Use
510(k) Number (if known) K232495
Device Name Sempulse Halo Vital Signs Monitor
Indications for Use (Describe)
The Halo vital signs monitor is a prescription device intended to be used as an adult patient monitor. It is indicated as a single- or multi-parameter vital signs monitor for SpO2 - pulse oximetry, pulse rate, respiratory rate, core body temperature, and skin temperature for spot-check measurements and continuous monitoring from the back of the cavum concha and the neck.
The Halo monitor may be used in hospitals, healthcare facilities, emergency medical transport, home healthcare settings, and other healthcare applications to include medical military settings in the field. The monitor is intended to be used in trauma scenarios, triage, motion, low perfusion, general monitoring, and telemedicine settings. It is reusable, transportable, and for use in all types of ambulances.
The Halo monitor uses wired or wireless communications to transmit vital signs data to a handheld or personal computer. The monitor is intended to be used by trained healthcare providers who are trained to interpret the vital signs readings and make appropriate medical interventions or patients who are und guidance of a medical professional or doctor. Alarms can be set with user-defined thresholds.
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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