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<15).

The SpassageQ is an adjunct to and is not intended to replace vital signs monitoring. The device is intended to provide additional information for use during patient monitoring in a healthcare facility. The device is not intended for making clinical decisions regarding patient treatment or for diagnostic purposes.

The device is intended for an adult population.

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.
· 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.
· Extract 6 vital signs from the patient data and store them in the database.
The Glasgow Coma Scale (GCS) of a patient is stored in the database when a user submits it.
· SpassageQ calculates the qSOFA score automatically and stores the result in the database.
· SpassageQ delivers 6 vital signs, qSOFA score, GCS to users.
· 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.

AI/ML Overview

This FDA 510(k) summary for the SpassageQ device does not explicitly describe acceptance criteria or a dedicated study for proving the device meets performance claims through clinical evaluation.

The document states that "Clinical testing was not needed in this 510(k) to support the substantial equivalence of the subject device to the predicate device." Therefore, information regarding acceptance criteria, reported performance, sample sizes, ground truth establishment, or multi-reader studies for device performance evaluation is absent from this submission.

The "Performance Data" section primarily focuses on non-clinical performance and adherence to various ISO and IEC standards related to risk management, software lifecycle, usability, and alarm systems. These are essential for software development and safety but do not assess the accuracy or effectiveness of the qSOFA score calculation itself directly against a clinical outcome.

Based on the provided text, here's what can be extracted and what cannot:

1. A table of acceptance criteria and the reported device performance

Cannot be provided. The document does not define specific acceptance criteria for the qSOFA score calculation's accuracy or outcome prediction. It also does not report specific performance metrics for the device's ability to identify patients at greater risk for a poor outcome, as no clinical performance study was submitted.

2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

Cannot be provided. No clinical test set description is available. The device receives patient data from "already cleared patient monitoring devices."

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g., radiologist with 10 years of experience)

Cannot be provided. No clinical test set with expert-established ground truth was presented.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

Cannot be provided. No clinical test set with ground truth adjudication was presented.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

Cannot be provided. No MRMC study was conducted or reported.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

Partially answerable, but not with performance metrics. The SpassageQ is a standalone software device that calculates the qSOFA score automatically. However, there's no reported standalone performance study assessing its accuracy against a clinical ground truth. The device effectively performs its function (calculating qSOFA) as a standalone algorithm based on input vital signs.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

Cannot be provided for device performance. No ground truth for evaluating the qSOFA score's predictive ability was used in a performance study for this 510(k). The qSOFA score itself is a standardized calculation based on specific vital sign thresholds, and the "ground truth" for its calculation is simply correct arithmetic. The clinical relevance of the qSOFA score is established in medical literature, not via a specific clinical study for this device's submission.

8. The sample size for the training set

Cannot be provided. The SpassageQ calculates a rule-based score (qSOFA) and does not appear to use a machine learning model that requires a "training set" in the traditional sense. Its function is based on predefined criteria (SBP ≤ 100 mmHg, RR ≥ 22 bpm, GCS < 15).

9. How the ground truth for the training set was established

Not applicable. As the device calculates a rule-based score (qSOFA), there is no training set or ground truth establishment for a machine learning model. The qSOFA criteria themselves are the "ground truth" for the calculation.

Summary of what's described in the document regarding Device Performance:

The SpassageQ's performance data focused on non-clinical aspects:

System-level tests: To verify the software's functionality and that it calculates data as expected.
Performance tests: Likely referring to software performance (e.g., speed, reliability) rather than clinical accuracy.
Safety testing based on hazard analysis: To identify potential risks.
Cybersecurity issues: Addressed to ensure data security.
Adherence to standards: ISO 14971 (risk management), IEC 62304 (software life-cycle), IEC 60601-1-6 & IEC 62366-1 (usability), IEC 60601-1-8 (alarm systems).

The document explicitly states "Clinical testing was not needed in this 510(k) to support the substantial equivalence of the subject device to the predicate device." This indicates that the FDA considered the device's function (calculating a well-established score) and its non-clinical performance sufficient to demonstrate substantial equivalence without requiring a specific clinical validation study of the qSOFA score's predictive accuracy by the device itself. The clinical utility of the qSOFA score is presumed based on existing medical literature.

Summary

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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 device is intended for an adult population.

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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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.
· Extract 6 vital signs from the patient data and store them in the database.
The Glasgow Coma Scale (GCS) of a patient is stored in the database when a user submits it.
· SpassageQ calculates the qSOFA score automatically and stores the result in the database.
· SpassageQ delivers 6 vital signs, qSOFA score, GCS to users.
· 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<15). The score ranges from 0 to 3 points. The presence of 2 or more gSOFA points near the onset of infection is associated with a greater risk of death. These are outcomes that are more common in infected patients who may be septic than those with uncomplicated infection. Based upon these findings, the Third International Consensus Definitions for Sepsis recommends qSOFA as a simple prompt to identify infected patients who are likely to be septic.

5. 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<15).

The SpassageQ is an adjunct to and is not intended to replace vital signs monitoring.

The Spassage() is intended to provide additional information for use during patient monitoring in a healthcare facility. The Spassage() is not intended for making clinical decisions regarding patient treatment or for diagnostic purposes.

The device is intended for an adult population.

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6. COMPARISON OF TECHNOLOGICAL CHARACTERISTICS WITH THE PREDICATE DEVICE

Features	Proposed DeviceSpassageQ	Predicate DeviceBiovitals Analytics Engine	Comparison
General Characteristics
Applicant	Spass	Biofourmis	-
510(k) Number	K230386	K183182	-
Classification	Class II,21 CFR 870.2300	Class II,21 CFR 870.2300	Similar
Product code	PLB	PLB	Similar
Intended Use	Patient Monitor (with alarm)	Patient Monitor (without alarms)	Similar except alarmingfeature
Indications forUse	The SpassageQ is intended to be used with patient data from already cleared patient monitoring devices which measure including respiratory rate, systolic blood pressure, and Glasgow Coma Scale (GCS) in patients being monitored in a healthcare facility. The device provides the 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 (GCS<15).The SpassageQ is an adjunct to and is not intended to replace vital signs monitoring.The SpassageQ is intended to provide additional information for use during patient monitoring in a healthcare facility. The SpassageQ is not intended for making clinical decisions regarding patient	The Biovitals Analytic Engine (BA Engine) is intended to be used with continuous biometric data from already cleared sensors measuring heart rate, respiratory rate, and activity in ambulatory patients being monitored in a healthcare facility or at home, during periods of minimal activity. The device learns the correlation between multiple vital signs during the patient's daily activity and builds an individualized biometric signature which is dynamically updated based on incoming data. The device computes a time series Biovitals Index (BI), which reflects changes in the patient's measured vital signs from their measured baseline, which is derived from the individualized biometric signature of the patient.The BA Engine is a cloud-based software engine, intended to be an adjunct to and is not intended to replace vital signs monitoring. The BI is intended for daily intermittent, retrospective review by a qualified practitioner. The BA	SimilarBoth devices are intended to provide an index to a physician based on a patient's vital signs, and to provide additional information during patient monitoring.Neither device is intended to replace vital signs monitoring, nor to provide a diagnosis to the physician.
Features	Proposed DeviceSpassageQ	Predicate DeviceBiovitals Analytics Engine	Comparison
	treatment or for diagnosticpurposes.The device is intended for anadult population.	Engine is intended to provideadditional information for useduring routine patientmonitoring. The BI is notintended for making clinicaldecisions regarding patienttreatment or for diagnosticpurposes.The device is intended for anadult population.
PatientPopulation &Environment	Bedside Non-pediatric	Ambulatory Non-pediatric	Intended for the samepopulation but underdifferent environment Itdoes not raise newquestions of safety andeffectiveness.
Technological Characteristics
Components	Intranet Web-based Softwareonly	Cloud-based software only	SimilarAll they are standalonesoftware device. Thedifference is theiroperating platform. Theseminor difference does notraise new questions ofsafety and effectiveness.
Index Produced	Non-linear combination of vitalparameters	Non-linear combination of vitalparameters	Similar
Index Meaning	Index represents how differentthe relationships among thepatient's vital signs are withrespect to normality.The presence of 2 or moreqSOFA points indicates patientswith suspected infectionaccording to the ThirdInternational ConsensusDefinitions for Sepsis.	Index represents how differentthe relationships among thepatient's vital signs are withrespect to normality.A BI less than or equal to 0.3indicates that there has beenlittle or no change in therelationship among the patient'svital signs as compared tobaseline. A BI value greaterthan 0.3 and less than or equal to0.7 reflects moderate change,and a BI value greater than 0.7reflects significant change in the	SimilarWhile the devices have adifferent interpretation ofthe index, the usage of theindex is similar, notraising new questions ofsafety and effectiveness.
Features	Proposed DeviceSpassageQ	Predicate DeviceBiovitals Analytics Engine	Comparison
		relationship among the patient'svital signs as compared tobaseline.
IndexAlgorithmNormality	Normality is defined asthepatient's qSOFA assessmentresult (qSOFA score < 2)	Normality is definedasthepatient's own baseline.	SimilarWhile the index used forgetting results are not thesame, it still reflects thesame relationship amongvital signs. This differencedoes not raisenewquestions of safety andeffectiveness.
Index Display	Single numeric value of latestindexTable	Single numeric value oflatest indexTrend graphs	SimilarIt does not raise differentquestions of safety andeffectiveness.
Vital SignsData Source	Vital sign data stored in thedatabase which are from FDAcleared Patient Monitors	FDA cleared Patient Monitors and Clinical InformationSystems	SimilarThe subject device usesdata indirectly from FDAcleared patient monitorsby obtaining the datathrough integration withHL7 gateway system.The predicate device enables use of datacaptured directly fromFDA cleared patientmonitors.Since the actual datasource is the same, thisdifference does not raisenew questions of safetyand effectiveness.
Alarm System	Yes	No	Different

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Spass Inc. Traditional 510(K)
SpassageQ

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7. PERFORMANCE DATA

The following performance data were provided in support of the substantial equivalence determination.

Non-clinical Performance

Testing involves system-level tests, performance tests and safety testing based on hazard analysis. Cybersecurity issues have been addressed. In addition to the verification testing activities executed by Spass Inc. to establish the performance and functionality of SpassageQ and the predicate devices, several standards were utilized:

ISO 14971:2019, Medical devices - Application of risk management to medical devices

IEC 62304:2006+A1:2015, Medical device software - Software life-cycle processes

IEC 60601-1-6:2010. General requirements for basic safety and essential performance - Collateral standard: Usability

IEC 62366-1:2015, Medical devices - Application of usability engineering to medical devices

IEC 60601-1-8:2020, Medical Electrical Equipment - Part 1-8: General Requirements For Basic Safety And Essential Performance - Collateral Standard: General Requirements, Tests And Guidance For Alarm Systems In Medical Electrical Equipment And Medical Electrical Systems

Clinical Performance

Clinical testing was not needed in this 510(k) to support the substantial equivalence of the subject device to the predicate device.

8. CONCLUSIONS

The subject device Spassage Q uses the same and similar technology that is used in the predicate K183282 device's Biovitals Analytics Engine. Differences between the proposed device device do not raise new types of questions regarding safety and effectiveness, and performance testing supports that the proposed device can be used as safectively for the proposed indications for use as the predicate device. The SpassageQ is considered to be substantially equivalent to the predicate K183282.

Regulation Number and Section

§ 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).