The intended use of the Rooti Rx System is to allow a patient at home or in the workplace to record single-lead electrocardiography (ECG) data for post-analysis by medical professionals. The Rooti Rx device stores the ECG data, and the recorded data is transmitted to a medical professional's iOS device via Wi-Fi at a later time.
The device is not intended to be used on critical care patients. The Rooti Rx System is indicated for use on general care patients and on patients who are 21 years of age or older.

Device Description

Rooti Rx System is a wearable single lead ECG recording device, composed by Rooti Rx, patch, charging dock and Rooti Link. When operating Rooti Rx System, medical professionals should use disposable, off the shelf, standard ECG electrodes which are not claimed in the system.

AI/ML Overview

The provided text describes the Rooti Rx System, an ECG event recorder, and its comparison to a predicate device (Zephyr Technology, BIOMODULE 3-M1) to demonstrate substantial equivalence for FDA 510(k) clearance. However, the document does not contain specific acceptance criteria, a detailed study proving device performance against those criteria, or information on several of the requested points.

Here's a breakdown of what can be extracted and what information is missing based on the provided text:

Missing Information:

The document primarily focuses on demonstrating substantial equivalence to a predicate device. It does not explicitly state specific acceptance criteria for the Rooti Rx System's performance in terms of diagnostic accuracy or clinical utility. Consequently, it also does not detail a study proving device performance against such criteria.

Specifically, the following requested information is not available in the provided text:

A table of acceptance criteria and the reported device performance.
Sample size used for the test set and data provenance.
Number of experts used to establish the ground truth for the test set and their qualifications.
Adjudication method for the test set.
If a multi-reader, multi-case (MRMC) comparative effectiveness study was done, or the effect size of human readers with/without AI assistance.
If a standalone (algorithm only) performance study was done.
The type of ground truth used (e.g., expert consensus, pathology, outcomes data) for the test set.
Sample size for the training set.
How the ground truth for the training set was established.

Information Extracted from the Document:

Therefore, I can only provide limited details based on the available text:

A table of acceptance criteria and the reported device performance:

Acceptance Criteria for Substantial Equivalence: The primary "acceptance criteria" discussed in this document relate to demonstrating substantial equivalence to a predicate device (Zephyr Technology, BIOMODULE 3-M1) based on intended use, indications for use, and technological characteristics. The document implies that the device meets these criteria if the differences are "incidental and not significant which do not raise any new issues of safety or efficacy."
Reported Device Performance (Comparative Information): The document provides a comparison table between the Rooti Rx System and the predicate device. This is not "reported device performance" against explicit acceptance criteria in the typical sense of a clinical or performance study outcome, but rather a comparison of specifications.

Feature	Predicate Device (BIOMODULE 3-M1)	Rooti Rx System	Comparison
Intended Use	General Ward Monitoring (detecting, storing, transmitting physiological data)	Record single-lead ECG data for post-analysis by medical professionals	Similar
Indication For Use	Monitoring ambulatory patients in alternate care settings; general patient monitor	Record single-lead ECG data for post-analysis; for general care patients ≥21 years old	Similar
Data Storage Capacity	140 hrs	7 days	Rooti Rx System has more capacity
Method Of Application	Off the shelf adhesive electrode	Off the shelf adhesive electrode	Same
Number of ECG leads	1	1	Same
ECG resolution	12	24	Rooti Rx (implies higher resolution)
ECG sampling rate (Hz)	1000	500	Both are more than double the highest useful frequency component (40Hz).
Water resistant	Yes	Yes	Same
Data transmission	Wireless	Wireless	Same
Power source	Rechargeable battery	Rechargeable battery	Same
Weight (g)	33	14	Rooti Rx System is lighter
Dimensions (mm)	88 x 48 x 8	62 x 22.5 x 8.45	Rooti Rx System is smaller

Sample size used for the test set and the data provenance:
- Not specified. The document does not describe a clinical test set or its sample size or provenance for direct performance evaluation. The "performance testing results" mentioned in the Conclusion likely refer to bench testing or engineering verification against electrical and physical standards, rather than clinical performance for ECG interpretation accuracy.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not applicable / Not specified. No such information is provided as there's no described clinical test with expert-established ground truth.
Adjudication method for the test set:
- Not applicable / Not specified. No adjudication method is described.
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:
- No MRMC study described. The device is an ECG event recorder for post-analysis by medical professionals, implying that the device records the data for human interpretation, rather than providing AI-assisted diagnostic recommendations in a way that would alter human reader performance. The document focuses on the recording and transmission capabilities, not automated ECG interpretation.
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- No standalone algorithm performance described. The device's function is to record ECG data for post-analysis by medical professionals. It does not claim to perform automated diagnosis or interpretation independently.
The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- Not applicable / Not specified for a clinical test set. The substantial equivalence argument relies on the device acquiring and transmitting ECG data similarly to a predicate, not on a ground truth for diagnostic accuracy derived from a clinical population.
The sample size for the training set:
- Not applicable / Not specified. There is no mention of an AI algorithm or a training set for machine learning.
How the ground truth for the training set was established:
- Not applicable / Not specified. There is no mention of an AI algorithm or a training set for machine learning.

Summary from the provided text:

The information primarily indicates that the Rooti Rx System is a single-lead ECG event recorder designed for home or workplace use, allowing patients to record ECG data for later review by medical professionals. The filing aims to demonstrate its substantial equivalence to an existing predicate device (BIOMODULE 3-M1) by comparing its intended use, indications for use, and technological characteristics. The document asserts that any differences are not significant and do not raise new safety or efficacy concerns. It does not provide details on specific performance studies against clinical diagnostic accuracy acceptance criteria, nor does it describe any AI components or their validation.

Summary

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November 7, 2017

Rooti Labs Ltd. Ms. Sue Chuang Chief Operating Officer 5f-1, No.17, Zhouzi St., Neihu Dist. Taipei. 11493 TW

Re: K163694

Trade/Device Name: Rooti Rx System ECG Event Recorder, Rooti Link APP Software Regulation Number: 21 CFR 870.2910 Regulation Name: Radiofrequency Physiological Signal Transmitter And Receiver Regulatory Class: Class II Product Code: DRG Dated: December 9, 2016 Received: December 28, 2016

Dear Ms. Sue Chuang:

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. Iisting 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 of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in 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.

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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 (DICE) at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevicesforYou/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 (DICE) 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,

M.A. Hilleman

for 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) K163694

Device Name

Rooti Rx System ECG Event Recorder, Rooti Link APP Software

Indications for Use (Describe)

The intended use of the Rooti Rx System is to allow a patient at home or in the workplace to record single-lead electrocardiography (ECG) data for post-analysis by medical professionals. The Rooti Rx device stores the ECG data, and the recorded data is transmitted to a medical professional's iOS device via Wi-Fi at a later time.
The device is not intended to be used on critical care patients. The Rooti Rx System is indicated for use on general care patients and on patients who are 21 years of age or older.

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

This summary of 510(k) safety and effectiveness information is being submitted in accordance with the requirement of 21 CFR 807.92

1. Company Identification Rooti Labs Ltd. 5F-1, No.71, Zhouzi St., Neihu Dist., Taipei, Taiwan Tel: +886-2-2656-0618
1. Submitter's Name and Address Sue Chuang Email: sue.chuang@rootilabs.com Tel: +886-2-2656-0618

Device Trade Name: Rooti Rx System ECG Event Recorder, Rooti Link APP Software Product name: Rooti Rx System Model/Type name: Rooti Rx System ECG Event Recorder Regulation Number: 21 CFR 870.2910 Product Code: DRG Device Class: II

1. Predicate Device
  Zephyr Technology, BIOMODULE 3-M1, 510(k) number K123658.

5. Intended Use

The intended use of the Rooti Rx System is to allow a patient at home or in the workplace to record single-lead electrocardiography (ECG) data for post-analysis by medical professionals. The Rooti Rx device stores the ECG data, and the recorded

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data is transmitted to a medical professional's iOS device via Wi-Fi at a later time. - The device is not intended to be used on critical care patients. The Rooti Rx System is indicated for use on general care patients and on patients who are 21 years of age or older.

1. Device Desciption
  Rooti Rx System is a wearable single lead ECG recording device, composed by Rooti Rx, patch, charging dock and Rooti Link. When operating Rooti Rx System, medical professionals should use disposable, off the shelf, standard ECG electrodes which are not claimed in the system.
1. Compliance of Recognized Consensus Standard

USA Standard
NO.	RecognitionNumber	StandardDevelopingOrganization	StandardDesignationNumber And Date	Title of Standard
1	2-156	AAMI ANSI ISO	10993-1:2009/(R)2013	Biological Evaluation Of MedicalDevices - Part 1: Evaluation And TestingWithin A Risk Management Process
2	19-6	IEC	60601-1-11 Edition 1.02010-04	Medical Electrical Equipment - Part 1-11General Requirements For Basic SafetyAnd Essential Performance - CollateralStandard: Requirements For MedicalElectrical Equipment And MedicalElectrical Systems Used In The HomeHealthcare Environment [Including:
3	19-4	AAMI ANSI	ES60601-1:2005/(R)2012And A1:2012,	Technical Corrigendum 1 (2011)]C1:2009/(R)2012 And A2:2010/(R)2012(Consolidated Text) Medical ElectricalEquipment - Part 1: GeneralRequirements For Basic Safety AndEssential Performance (IEC60601-1:2005, MOD)
4	19-2	AAMI ANSI IEC	60601-1-2:2007/(R)2012	Medical Electrical Equipment - Part 1-2:General Requirements For Basic SafetyAnd Essential Performance - CollateralStandard: Electromagnetic CompatibilityRequirements And Tests (Edition 3)
5	3-127	AAMI ANSI IEC	60601-2-47:2012	Medical Electrical Equipment -- Part2-47: Particular Requirements For TheBasic Safety And Essential PerformanceOf Ambulatory ElectrocardiographicSystems

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8. Safety and Effectiveness Substantial Equivalence Comparison

Device Name	BIOMODULE 3-M1	Rooti Rx System	Comparison
Applicant	Zephyr Technology	Rooti Labs Limited	-
510(K) Number	K123658
RegulationNumber	870.2360	870.2910
Classification	Class II	Class II	-
Product Code	DRX	DRG	-
Intended Use	The intended use of the BioModule3-M1 is to provide a General WardMonitoring facility for detecting,storing and transmitting physiologicaldata to a qualified receiving station.The scientific concept on which thisdevice is based on the principle thatlow level electrical pulses from theheart are measurable of the surface ofthe skin. This device functions bycapturing these electrical pulses viaelectrodes and delivering thesesignals to sophisticated electronics forprocessing. The calibration isestablished by the factory and yieldsaccurate and calibrated signals thatcan maintain calibration over itsuseful life.	The intended use of the RootiRx System is to allow a patient athome or in the workplace to recordsingle-lead electrocardiography(ECG) data for post-analysis bymedical professionals. The Rooti Rxdevice stores the ECG data, and therecorded data is transmitted to amedical professional's iOS deviceviaWi-Fi at a later time.- The device is not intended to beused on critical care patients.The Rooti Rx System is indicated foruse on general care patients and onpatients who are 21 years of age orolder.	Similar
Indication ForUse	The BioModule 3-M1 is aphysiological monitoring telemetrydevice intended for monitoringambulatory patients in alternate caresettings. The device consists ofadhesive electrodes and an electronicsmodule. The device stores andtransmits vital sign data includingECG, heart rate, respiration rate, bodyorientation and activity. TheBioModule 3-M2 provides a facilityto detect and transmit single leadECG signals to be received byqualified instruments.The BioModule 3-M1 collects andtransmits measurements captured inalternate care settings as prescribedby the health care professional.Breathing rate values are accuratelytransmitted only during sedentaryperiods.The BioModule 3-M1 is indicated for	The intended use of the Rooti RxSystem is to allow a patient at home orin the workplace to record single-leadelectrocardiography (ECG) data forpost-analysis by medical professionals.The Rooti Rx device stores the ECGdata,and the recorded data istransmitted to a medicalprofessional's iOS device viaWi-Fi at a later time.- The device is not intended to beused on critical care patients.The Rooti Rx System is indicated foruse on general care patients and onpatients who are 21 years of age orolder.	Similar
	use as a general patient monitor to provide physiological information as part of general ward monitoring system.
Data Storage Capacity	140 hrs	7 days	Rooti Rx Systemhas more capacity
Method Of Application	Off the shelf adhesive electrode	Off the shelf adhesive electrode	Same
Number of ECG	1	1	Same
ECG resolution	12	24	Rooti Rx
ECG sampling rate (Hz)	1000	500	Both are more than double the highest useful frequency component (40Hz).
Water resistant	Yes	Yes	Same
Data transmission	wireless	wireless	Same
Power source	Rechargeable battery	Rechargeable battery	Same
Weight (g)	33	14	Rooti Rx System is lighter
Dimensions (mm)	88 x 48 x 8	62x22.5x8.45	Rooti Rx System is smaller

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9. Conclusion

Rooti Rx System is a wearable single lead ECG recording device, composed by Rooti Rx, Patch, Charging dock and Rooti Link. The intended use of the Rooti Rx System is

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to allow a patient at home or in the workplace to record single-lead electrocardiography (ECG) data for post-analysis by medical professionals. The Rooti Rx device stores the ECG data, and the recorded data is transmitted to a medical professional's iOS device via Wi-Fi at a later time.

According to the substantial equivalence discussion, the Rooti Rx System is substantially equivalent to the predicate devices in all respects. The intended use and the indication for use for the Rooti Rx System are substantially equivalent to the intended use and the indication for use for the predicate device. The performance testing results demonstrate that any differences in the technological characteristics between the devices are incidental and not significant which do not raise any new issues of safety or efficacy. Therefore, the Rooti Rx System is substantially equivalent to the predicate device

Regulation Number and Section

§ 870.2910 Radiofrequency physiological signal transmitter and receiver.

(a)
Identification. A radiofrequency physiological signal transmitter and receiver is a device used to condition a physiological signal so that it can be transmitted via radiofrequency from one location to another, e.g., a central monitoring station. The received signal is reconditioned by the device into its original format so that it can be displayed.(b)
Classification. Class II (performance standards).