Strados Remote Electronic Stethoscope Platform (RESP)

K201077 · Strados Labs · DSH · Dec 20, 2020 · Cardiovascular

Device Facts

• Record ID: K201077
• Device Name: Strados Remote Electronic Stethoscope Platform (RESP)
• Applicant: Strados Labs
• Product Code: DSH · Cardiovascular
• Decision Date: Dec 20, 2020
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 870.2800
• Device Class: Class 2

Intended Use

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.

Device Story

The Strados RESP is a wearable, battery-operated electronic stethoscope platform used in healthcare settings. It consists of a wearable device (SWD) adhered to the patient's chest wall, a charging station, and a mobile application (SMA). The SWD passively records lung sounds, which are transmitted via Bluetooth to the SMA on a mobile device. Clinicians use the SMA to play back and review the recorded lung sounds to assist in clinical assessment. The device facilitates longitudinal monitoring of lung sounds, allowing clinicians to listen to recordings at their convenience, which supports clinical decision-making regarding respiratory status. The system is intended for prescription use only.

Clinical Evidence

No clinical data provided. Performance validation relied on non-clinical bench testing, including frequency response equivalence (20-2000Hz) against reference stethoscopes, functional testing, cleaning validation, ship testing, and biocompatibility testing per ISO 10993-1 (cytotoxicity, sensitization, and intracutaneous reactivity/irritation).

Technological Characteristics

Battery-operated wearable device; surface-contacting (intact skin); Bluetooth connectivity to mobile app; frequency response 20-2000Hz. Standards: IEC 60601-1, IEC 62366-1, IEC 62304, UL 62368-1, ISO 10993-1. Reusable device with disposable adhesive components.

Indications for Use

Indicated for adult patients in a healthcare setting for longitudinal acquisition, recording, and storage of lung sounds for clinician review and analysis.

Regulatory Classification

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.

Predicate Devices

• Vitalograph Model 7100 VitaloJAK (K110525)

Reference Devices

• 3M™ Littmann® Electronic Stethoscope Model 3200 (K083903)

Submission Summary (Full Text)

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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 ([e-mail]) or phone [phone] 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)

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.

Type of Use (Select one or both, as applicable)

| <div> <span> <span style="text-decoration: overline;">☑</span> Prescription Use (Part 21 CFR 801 Subpart D) </span> </div> |
|--------------------------------------------------------------------------------------------------------------------------------|
| <div> <span> <span style="text-decoration: overline;">☐</span> Over-The-Counter Use (21 CFR 801 Subpart C) </span> </div> |

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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.<br>1315 Walnut Street, Suite 1101<br>Philadelphia, PA 19107<br>Tel: (888) STRADOS |
|----------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Submission Contact: | Grace Powers, MS, MBA, RAC<br>Founder/Principal Consultant<br>Powers Regulatory Consulting<br>[e-mail] |
| Submission Date: | April 21, 2020 |
| Subject Device: | Trade Name: Strados Remote Electronic Stethoscope Platform (RESP)<br>Common Name: Medical magnetic tape recorder<br>Classification Name: Recorder, Magnetic Tape, Medical<br>Regulation: 21 CFR §870.2800<br>Regulatory Classification: Class 2<br>Product Code: DSH |
| Predicate Device:<br>Reference Device: | Vitalograph Model 7100 VitaloJAK (K110525)<br>3MTM Littmann® Electronic Stethoscope Model 3200 (K083903) |

#### Device Description

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.

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

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

### Intended Use/Indications for Use

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.

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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:<br>Strados RESP | Predicate Device: VitaloJAK<br>K110525 | Reference: Littmann Model 3200<br>K083903 |
|----------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Name | Strados Remote Electronic<br>Stethoscope Platform (RESP) | Vitalograph Model 7100- VitaloJAK | 3M™ Littmann® Electronic Stethoscope<br>Model 3200 |
| Manufacturer | Strados Labs, Inc. | Vitalograph (Ireland) Ltd. | 3M |
| Product Code | DSH | DSH | DQD |
| Regulation<br>Number | 21 CFR 870.2800 | 21 CFR 870.2800 | 21 CFR 870.1875 |
| Device<br>Classification<br>Name | Recorder, Magnetic Tape, Medical | Recorder, Magnetic Tape, Medical | Stethoscope, Electronic |
| Device<br>Classification | Class 2 | Class 2 | Class 2 |
| Indication for<br>Use | The RESP is a non-invasive battery-<br>operated device, including a wearable<br>component, intended to longitudinally<br>acquire, record, and store lung sounds<br>from adult patients in a healthcare<br>setting. The device stores the data for<br>later playback, review, and analysis by<br>a clinician on a mobile app. | The Model 7100 is a non-invasive<br>battery operated device intended to<br>acquire, record and store ambulatory<br>cough sounds from patients for up to<br>24 hours. The device stores the data<br>on a removable memory card for later<br>playback, review, and analysis of the<br>cough sounds on a windows based PC. | The 3M™ Littmann® Electronic<br>Stethoscope, Model 3200 is intended for<br>medical diagnostic purposes only. It may<br>be used for the detection and<br>amplification of sounds from the heart,<br>lungs, arteries, veins, and other internal<br>organs with the use of a selective<br>frequency. It can be used on any person<br>undergoing a physical assessment. |
| Age of Device<br>Use | Adults. | All ages. | All ages. |
| Principle of<br>Operation | Placement - The Strados RESP is<br>placed by a clinician and adhered to<br>the skin.<br>Recording - Lung sounds are recorded<br>by wearable per the App-selected | Placement- The VitaloJAK is adhered<br>to skin at the suprasternal notch.<br>Recording- A continuous recording is<br>started by a clinician on the device. | Placement - The Littmann is placed by<br>clinician similar to a traditional<br>stethoscope. |
| | Subject Device:<br>Strados RESP | Predicate Device: VitaloJAK<br>K110525 | Reference: Littmann Model 3200<br>K083903 |
| | recording mode. In a clinical setting, a<br>clinician configures the options and<br>initiates/stops sound capture<br>Transmission- Recordings are<br>transmitted to the Strados Mobile App<br>(SMA). Clinician can listen to<br>recordings at any time via the SMA. | Transmission- The data is retained on<br>board the device. After all data is<br>collected, the data is transferred via<br>USB cable through a PC to a web<br>portal.<br>Playback- No playback is provided to<br>the clinician. Coughs are counted by<br>VitaloJAK personnel.<br>Use-<br>The VitaloJAK is not intended for<br>immediate clinical action. | Recording - Lung sounds can be recorded<br>by pressing the physical buttons on the<br>device.<br>Transmission- Recordings can be<br>transmitted to an external device with<br>custom software. The device can also<br>save up to 12 recordings.<br>Playback- Recordings can be played back<br>audibly via the deice speaker and into the<br>device ear pieces. |
| Condition of<br>Use | 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.