(121 days)
Not Found
No
The device description explicitly states it uses an "automated algorithm to calculate data and generate qSOFA score". The qSOFA score calculation is a simple, rule-based algorithm based on three specific criteria (blood pressure, respiratory rate, GCS). There is no mention of learning, training data, or complex pattern recognition characteristic of AI/ML. The "Mentions AI, DNN, or ML" section also indicates "Not Found".
No.
The SpassageQ is an adjunct to patient monitoring that provides qSOFA scores to indicate risk; it is not intended for clinical decisions regarding treatment or diagnosis, which would typically be associated with a therapeutic device.
No
The "Intended Use / Indications for Use" section explicitly states, "The device is not intended for making clinical decisions regarding patient treatment or for diagnostic purposes."
Yes
The device description explicitly states that the SpassageQ "consists of" software components (automated algorithm, HL7 message receiver, qSOFA score module, web-based dashboard) and describes a workflow that is entirely software-based, processing data received from other devices. There is no mention of any hardware components being part of the SpassageQ device itself.
Based on the provided information, the SpassageQ is not an In Vitro Diagnostic (IVD).
Here's why:
- IVDs are used to examine specimens derived from the human body. The SpassageQ uses patient data (respiratory rate, blood pressure, GCS) from already cleared patient monitoring devices. It does not directly analyze biological samples like blood, urine, or tissue.
- The intended use explicitly states it's not for diagnostic purposes. The description says, "The device is not intended for making clinical decisions regarding patient treatment or for diagnostic purposes." IVDs are specifically designed to aid in diagnosis.
- The device provides a score based on clinical parameters, not laboratory test results. The qSOFA score is calculated from vital signs and a clinical assessment (GCS), not from in vitro tests.
The SpassageQ is a software device that processes and presents clinical data to provide a risk score as an adjunct to patient monitoring. This falls outside the definition of an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The SpassageQ is intended to be used with patient data from already cleared patient monitoring devices which measure respiratory rate, systolic blood pressure, and Glasgow Coma Scale (GCS) in patients being monitored in a healthcare facility. The device provides qSOFA score (also known as quickSOFA) which indicates patients with suspected infection who are at greater risk for a poor outcome. It uses three criteria, assigning one point for low blood pressure (SBP_100 mmHg), high respiratory rate (≥22 breaths per min), or altered mentation (Glasgow coma scale
§ 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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June 15, 2023
Spass Inc. % Edward Park CEO Radios LLC 4408 Tortuga Ln McKinney, Texas 75070
Re: K230386
Trade/Device Name: SpassageQ Regulation Number: 21 CFR 870.2300 Regulation Name: Cardiac Monitor (Including Cardiotachometer And Rate Alarm) Regulatory Class: Class II Product Code: PLB Dated: May 17, 2023 Received: May 17, 2023
Dear Edward Park:
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
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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) for devices or postmarketing safety reporting (21 CFR 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 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 https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
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/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. 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,
Robert T. Kazmierski -S
for LCDR Stephen Browning
Assistant Director Division of Cardiac Electrophysiology, Diagnostics, and Monitoring Devices Office of Cardiovascular Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known) K230386
Device Name SpassageQ
Indications for Use (Describe)
The SpassageQ is intended to be used with patient data from already cleared patient monitoring devices which measure respiratory rate, systolic blood pressure, and Glasgow Coma Scale (GCS) in patients being monitored in a healthcare facility. The device provides qSOFA score (also known as quickSOFA) which indicates patients with suspected infection who are at greater risk for a poor outcome. It uses three criteria, assigning one point for low blood pressure (SBP_100 mmHg), high respiratory rate (≥22 breaths per min), or altered mentation (Glasgow coma scale Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov
"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."
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Spass Inc. Traditional 510(K) SpassageQ
Section 5. 510(K) Summary
In accordance with the Food and Drug Administration Rule to implement provisions of the Safe Medical Devices Act of 1990 and in conformance with 21 CFR Part 807, this information serves as a 510k Summary for the use of the SpassageQ .
1. SUBMITTER
| Submitter Name: | Spass Inc. |
|---|---|
| Address: | Unit 905, 396 World cup buk-ro, Mapo-gu, Seoul, Republic of Korea |
| Phone: | +82 70-8888-2227 |
| Fax: | +82 303-3443-6089 |
| Contact Person Name: | Edward Park |
| Address: | 4408 Tortuga Ln, McKinney Texas 75070 USA |
| Phone: | +1 972-800-0044 |
| E-mail address: | lightenbridge@gmail.com |
2. DEVICE
| Device Name: | SpassageQ |
|---|---|
| Common Name: | Vital Sign Analysis Software |
| Classification Name: | Cardiac Monitor (Including Cardiotachometer And Rate Alarm) |
| Product Code | PLB |
| Regulation Number: | 21 CFR 870.2300 |
| Regulatory Class: | Class II |
| Classification Panel: | Cardiovascular |
3. PREDICATE DEVICE
| 510(k) number: | |
|---|---|
| Trade name: | |
| Product Code / Classification: | |
| Company Name: |
K183282 Biovitals Analytics Engine PLB / Class II, 21 CFR 870.2300 Biofourmis
4. DEVICE DESCRIPTION
The SpassageQ consists of:
- An automated algorithm to calculate data and generate qSOFA score and alarm when it is needed.
- · An HL7 message receiver to handle incoming connection attempts from HL7 gateway systems, parse HL7 messages, and check the validity of HL7 messages.
- · A qSOFA score module to calculate patients' qSOFA scores and offer their last 72 hours history data.
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· A web-based dashboard to render patients' qSOFA scores in a visually distinctive way depending on their value and enable intended users to be notified of patients with suspected infection.
The SpassageQ system works in the following sequence: -
· Receive patient data from the HL7 gateway system.
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· Extract 6 vital signs from the patient data and store them in the database.
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The Glasgow Coma Scale (GCS) of a patient is stored in the database when a user submits it.
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· SpassageQ calculates the qSOFA score automatically and stores the result in the database.
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· SpassageQ delivers 6 vital signs, qSOFA score, GCS to users.
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· When the patient's qSOFA score is 2 points or higher, the users are notified of the patient through a visual alarm, and the alarm shall be reviewed by the qualified practitioner.
Interpretation of qSOFA score:
The qSOFA score (also known as quickSOFA) is a bedside prompt that may identify patients with suspected infection who are at greater risk for a poor outcome. It uses three criteria, assigning one point for low blood pressure (SBP_100 mmHg), high respiratory rate (≥22 breaths per min), or altered mentation (Glasgow coma scale