The RESP is a non-invasive battery-operated device, including a wearable component, intended to longitudinally acquire, record, and store lung sounds from adult patients in a healthcare setting. The device stores the data for later playback, review, and analysis by a clinician on a mobile app. The Strados Remote Electronic Stethoscope Platform (RESP) is comprised of the Strados Wearable Device (SWD), Strados Charging Station (SCS) and external power supply, and Strados Patient Adhesive (SPA) used to adhere the SWD to the patient. The SWD is controlled by a mobile device running the Strados Mobile Application (SMA) via Bluetooth connection. The Strados Wearable Device (SWD) sits on the chest wall and passively records the patient's lung sounds. The Strados Mobile App (SMA) on a smartphone allows playback of lung sounds from the wearable device in order for clinicians to listen to the patient's lung sounds. The device is used in a healthcare setting.

AI/ML Overview

The provided text does not contain information about acceptance criteria or a study that proves the device meets those criteria. It is an FDA 510(k) clearance letter and associated marketing submission documents for the Strados Remote Electronic Stethoscope Platform (RESP).

The document mainly focuses on establishing substantial equivalence to a predicate device, as required for 510(k) clearance. This involves comparing the device's indications for use, technological characteristics, and non-clinical performance data (e.g., electrical safety, biocompatibility, functional testing).

Therefore, I cannot provide the requested table and study details as they are not present in the provided text. The text explicitly states: "Clinical performance testing was performed to validate the quality of the subject device's recorded lung sounds." However, no details about this clinical performance testing, acceptance criteria, or specific study results are included in the provided document sections.

Summary

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Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, with the letters "FDA" in a blue square. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.

December 20, 2020

Strados Labs % Grace Powers Principal Consultant Powers Regulatory Consulting|64954 2451 Cumberland Parkway SE Suite 3740 Atlanta, Georgia 30339

Re: K201077

Trade/Device Name: Strados Remote Electronic Stethoscope Platform (RESP) Regulation Number: 21 CFR 870.2800 Regulation Name: Medical Magnetic Tape Recorder Regulatory Class: Class II Product Code: DSH Dated: November 23, 2020 Received: November 24, 2020

Dear Grace Powers:

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 statutes and regulations administered by other Federal agencies. You must comply with all the Act's

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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 (OS) 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 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. 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,

James J. Lee, Ph.D. Assistant Director DHT1C: Division of ENT, Sleep Disordered Breathing, Respiratory and Anesthesia Devices OHT1: Office of Ophthalmic, Anesthesia, Respiratory, ENT and Dental Devices Office of Product Evaluation and Ouality Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known) K201077

Device Name

Strados Remote Electronic Stethoscope Platform (RESP)

Indications for Use (Describe)

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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Image /page/3/Picture/2 description: The image shows the logo for Strados. The logo consists of the word "strados" in lowercase, gray, sans-serif font. Above the word is a graphic of several blue lines that are curved and parallel to each other, resembling sound waves or a stylized representation of a mountain range.

In accordance with 21 CFR §807.92 and the Safe Medical Devices Act of 1990, the following information is provided for the Strados RESP Traditional 510(k) premarket notification. The submission was prepared in accordance with the FDA guidance document, 'Format for Traditional and Abbreviated 510(k)s', issued on August 12, 2005.

Sponsor:	Strados Labs, Inc.1315 Walnut Street, Suite 1101Philadelphia, PA 19107Tel: (888) STRADOS
Submission Contact:	Grace Powers, MS, MBA, RACFounder/Principal ConsultantPowers Regulatory Consultinggrace@powersregulatory.com
Submission Date:	April 21, 2020
Subject Device:	Trade Name: Strados Remote Electronic Stethoscope Platform (RESP)Common Name: Medical magnetic tape recorderClassification Name: Recorder, Magnetic Tape, MedicalRegulation: 21 CFR §870.2800Regulatory Classification: Class 2Product Code: DSH
Predicate Device:Reference Device:	Vitalograph Model 7100 VitaloJAK (K110525)3MTM Littmann® Electronic Stethoscope Model 3200 (K083903)

Device Description

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Product Offering	Catalog Number	Contents
Strados Remote ElectronicStethoscope Platform (RESP)	RESP1	One system contains:• Two (2) Strados Wearable Device• Pack of 100 adhesives• Charging Station with wall adaptor• IFU
Strados Wearable Device	SWD1	Sold individually
Strados Patient Adhesives	SPA1	Sold as a pack of 100
Strados Charging Station	SCS1	Sold individually. Contains ChargingStation and wall adapter
Strados Mobile Application	540-00001	Downloaded on a mobile device(mobile device not provided)

Table 5-1: Strados Labs, Inc. Strados Remote Electronic Stethoscope Platform (RESP) ct Offer D

Intended Use/Indications for Use

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Traditional 510(k) – Strados Labs, Inc. Strados Remote Electronic Stethoscope Platform (RESP)

Technological Characteristics

The Strados Remote Electronic Stethoscope Platform (RESP) has similar technological characteristics as the predicate device, Vitalograph Model 7100 VitaloJAK via K110525. A comparison table including the reference device is provided below.

	Subject Device:Strados RESP	Predicate Device: VitaloJAKK110525	Reference: Littmann Model 3200K083903
Name	Strados Remote ElectronicStethoscope Platform (RESP)	Vitalograph Model 7100- VitaloJAK	3M™ Littmann® Electronic StethoscopeModel 3200
Manufacturer	Strados Labs, Inc.	Vitalograph (Ireland) Ltd.	3M
Product Code	DSH	DSH	DQD
RegulationNumber	21 CFR 870.2800	21 CFR 870.2800	21 CFR 870.1875
DeviceClassificationName	Recorder, Magnetic Tape, Medical	Recorder, Magnetic Tape, Medical	Stethoscope, Electronic
DeviceClassification	Class 2	Class 2	Class 2
Indication forUse	The RESP is a non-invasive battery-operated device, including a wearablecomponent, intended to longitudinallyacquire, record, and store lung soundsfrom adult patients in a healthcaresetting. The device stores the data forlater playback, review, and analysis bya clinician on a mobile app.	The Model 7100 is a non-invasivebattery operated device intended toacquire, record and store ambulatorycough sounds from patients for up to24 hours. The device stores the dataon a removable memory card for laterplayback, review, and analysis of thecough sounds on a windows based PC.	The 3M™ Littmann® ElectronicStethoscope, Model 3200 is intended formedical diagnostic purposes only. It maybe used for the detection andamplification of sounds from the heart,lungs, arteries, veins, and other internalorgans with the use of a selectivefrequency. It can be used on any personundergoing a physical assessment.
Age of DeviceUse	Adults.	All ages.	All ages.
Principle ofOperation	Placement - The Strados RESP isplaced by a clinician and adhered tothe skin.Recording - Lung sounds are recordedby wearable per the App-selected	Placement- The VitaloJAK is adheredto skin at the suprasternal notch.Recording- A continuous recording isstarted by a clinician on the device.	Placement - The Littmann is placed byclinician similar to a traditionalstethoscope.
	Subject Device:Strados RESP	Predicate Device: VitaloJAKK110525	Reference: Littmann Model 3200K083903
	recording mode. In a clinical setting, aclinician configures the options andinitiates/stops sound captureTransmission- Recordings aretransmitted to the Strados Mobile App(SMA). Clinician can listen torecordings at any time via the SMA.	Transmission- The data is retained onboard the device. After all data iscollected, the data is transferred viaUSB cable through a PC to a webportal.Playback- No playback is provided tothe clinician. Coughs are counted byVitaloJAK personnel.Use-The VitaloJAK is not intended forimmediate clinical action.	Recording - Lung sounds can be recordedby pressing the physical buttons on thedevice.Transmission- Recordings can betransmitted to an external device withcustom software. The device can alsosave up to 12 recordings.Playback- Recordings can be played backaudibly via the deice speaker and into thedevice ear pieces.
Condition ofUse	Reusable	Reusable	Reusable
Rx or OTC	Prescription Only	Prescription Only	Prescription Only
Wearable	Yes	Yes	No

Table 5-2: Device Comparison

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Traditional 510(k) – Strados Labs, Inc. Strados Remote Electronic Stethoscope Platform (RESP)

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Clinical Performance Data

Clinical performance testing was performed to validate the quality of the subject device's recorded lung sounds.

Non-Clinical Performance Data

The subject device was subject to non-clinical performance testing. There are no device-specific guidance documents, special controls document, and/or requirements in a device-specific regulation that is applicable to the subject device. A list of the standards, guidance and additional testing for all the devices is listed below:

. IEC 60601-1:2005, COR1:2006, COR2:2007, AMD1:2012- Medical electrical equipment - Part 1: General requirements for basic safety and essential performance
. AAMI/IEC 60601-1:2005 + AMD 1:2012- Medical electrical equipment - Part 1: General requirements for basic safety and essential performance
IEC 62366-1:2015- Medical devices — Part 1: Application of usability engineering to medical devices
IEC 62304:2006-Medical device software - Software life cycle processes
. UL 62368-1:2012- Audio/video, information and communication technology equipment - Part 1: Safety requirements

IEC 60601-1-6:2010- Medical electrical equipment - Part 1-6: General requirements for basic safety and essential performance - Collateral standard: Usability

Additional Non-Clinical performance testing conducted includes:
- Frequency response equivalence testing from 20 to 2000Hz against a reference 510(k) O cleared stethoscopes
- O Functional Testing
- o Validation of device cleaning instructions for likely use
- Ship Testing O

The Strados Wearable Device is considered as surface devices in contact with intact skin. The biocompatibility evaluation of the subject device was based on ISO 10993-1:2009 Biological evaluation of medical devices – Part 1: Evaluation and testing within a risk management process. This includes Cytotoxicity, Sensitization and Intracutaneous Reactivity/Irritation testing was passed.

Conclusion

The Strados Remote Electronic Stethoscope Platform (RESP) is substantially equivalent to the legally marketed predicate device as demonstrated by the similar indication for use, similar technologies and performance data, and does not raise different questions of safety and effectiveness.

Regulation Number and Section

§ 870.2800 Medical magnetic tape recorder.

(a)
Identification. A medical magnetic tape recorder is a device used to record and play back signals from, for example, physiological amplifiers, signal conditioners, or computers.(b)
Classification. Class II (performance standards).