(30 days)
No
The summary explicitly states "Mentions AI, DNN, or ML: Not Found" and describes the device as storing data for "later playback, review, and analysis by a clinician". There is no mention of automated analysis or algorithms that would suggest AI/ML.
No
The device is described as a non-invasive battery-operated device intended to acquire, record, and store lung sounds for later playback, review, and analysis by a clinician. It aids in diagnosis and monitoring, not treatment.
Yes
The device is intended to acquire, record, and store lung sounds for "later playback, review, and analysis by a clinician," which are activities performed to diagnose conditions.
No
The device description explicitly states it includes hardware components: the Strados Wearable Device (SWD), Strados Charging Station (SCS), external power supply, and Strados Patient Adhesive (SPA). While it uses a mobile application for control and playback, it is not solely software.
Based on the provided information, the Strados Remote Electronic Stethoscope Platform (RESP) is not an In Vitro Diagnostic (IVD) device.
Here's why:
- IVD Definition: IVD devices are used to examine specimens (like blood, urine, or tissue) taken from the human body to provide information about a person's health. This examination is performed in vitro (outside the body).
- Strados RESP Function: The Strados RESP is a non-invasive device that acquires, records, and stores lung sounds directly from the patient's chest wall. It does not analyze specimens taken from the body. Its purpose is to provide clinicians with acoustic data (lung sounds) for review and analysis.
The device's function aligns with that of a medical device used for physiological monitoring and data acquisition, not an IVD.
N/A
Intended Use / Indications for Use
The Strados Remote Electronic Stethoscope Platform (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 or outpatient setting including transition from healthcare setting to outpatient care without interruption. The device stores the data for later playback, review, and analysis by a clinician and comparison with earlier data from the same patient.
Product codes
DSH
Device Description
The Strados Remote Electronic Stethoscope Platform (RESP) is a non-invasive battery-operated device, including a wearable component, intended to longitudinally acquire, record, and store lung sounds from adult patients. The device stores the data for later playback, review, and analysis by a clinician and comparison with earlier data from the same patient. 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 airway sounds, including but not limited to cough, wheeze, rhonchi, rales, crackles, coarse (bronchial) breath sounds, quiet breathing, and chest wall movement onto internal memory. 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 and outpatient setting including the home.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
Adults.
Intended User / Care Setting
healthcare or outpatient setting including transition from healthcare setting to outpatient care without interruption.
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Non-Clinical Performance Data: The subject device was subject to non-clinical performance testing.
Additional Non-Clinical performance testing conducted for this submission includes:
- Frequency response equivalence testing
- Device Cleaning Testing
- Usability Testing
Clinical Performance Data: Clinical performance testing was performed to validate the quality of the subject device's recorded lung sounds when self-placed and recorded in an outpatient setting.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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).
0
Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: a symbol on the left and the FDA name on the right. The symbol on the left is a stylized image of a human figure, while the FDA name on the right is written in blue letters. The words "U.S. FOOD & DRUG ADMINISTRATION" are written in a clear, sans-serif font.
April 27, 2022
Strados Labs, Inc. % Prithul Bom Most Resonsible Person Regulatory Technology Services, LLC 1000 Westgate Drive. Suite 510k Saint Paul, Minnesota 55114
Re: K220893
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: March 25, 2022 Received: March 28, 2022
Dear Prithul Bom:
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
1
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,
For Brandon Blakely, Ph.D. Assistant Director DHT1C: Division of Sleep Disordered Breathing, Respiratory and Anesthesia Devices OHT1: Office of Ophthalmic, Anesthesia, Respiratory, ENT and Dental Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known) K220893
Device Name
Strados Remote Electronic Stethoscope Platform (RESP)
Indications for Use (Describe)
The Strados Remote Electronic Stethoscope Platform (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 or outpatient setting including transition from healthcare setting to outpatient care without interruption. The device stores the data for later playback, review, and analysis by a clinician and comparison with earlier data from the same patient.
| 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) |
CONTINUE ON A SEPARATE PAGE IF NEEDED.
This section applies only to requirements of the Paperwork Reduction Act of 1995.
DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.
The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:
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."
3
Image /page/3/Picture/2 description: The image contains the word "strados" in lowercase letters. The word is written in a simple, sans-serif font and is gray. Above the word is a graphic of several blue lines that are curved and parallel to each other.
Section 5 510(k) Summary
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 1101
Philadelphia, PA 19107
Tel: (888) STRADOS |
|---------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Submission Contact: | Grace Powers, MS, MBA, RAC
Founder/Principal Consultant
Powers Regulatory Consulting
grace@powersregulatory.com |
| Submission Date: | March 1, 2022 |
| Subject Device: | Trade Name: Strados Remote Electronic Stethoscope Platform (RESP)
Common Name: Medical magnetic tape recorder
Classification Name: Recorder, Magnetic Tape, Medical
Regulation: 21 CFR §870.2800
Regulatory Classification: Class 2
Product Code: DSH |
| Predicate Device: | Trade Name: Strados Remote Electronic Stethoscope Platform (RESP)
Common Name: Medical magnetic tape recorder
Classification Name: Recorder, Magnetic Tape, Medical
Regulation: 21 CFR §870.2800
Regulatory Classification: Class 2
Product Code: DSH
510(k): K201077 |
4
Device Description
The Strados Remote Electronic Stethoscope Platform (RESP) is a non-invasive battery-operated device, including a wearable component, intended to longitudinally acquire, record, and store lung sounds from adult patients. The device stores the data for later playback, review, and analysis by a clinician and comparison with earlier data from the same patient. 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 airway sounds, including but not limited to cough, wheeze, rhonchi, rales, crackles, coarse (bronchial) breath sounds, quiet breathing, and chest wall movement onto internal memory. 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 and outpatient setting including the home.
| Product Offering | Catalog Number | Contents |
|---|---|---|
| Strados Remote Electronic | ||
| Stethoscope Platform (RESP) | RESP1 | One system contains: |
| • Two (2) Strados Wearable Device | ||
| • Adhesives | ||
| • Charging Station with wall adaptor | ||
| • Labeling | ||
| Strados Wearable Device | SWD1 | Sold individually |
| Strados Patient Adhesives | SPA1 | Sold in a pack |
| Strados Charging Station | SCS1 | Sold individually. Contains Charging |
| Station and wall adapter | ||
| Strados Mobile Application | 540-00001 | Downloaded on a mobile device |
| Table 5-1: Strados Labs, Inc. Strados Remote Electronic Stethoscope Platform (RESP) |
|---|
| Product Offerings |
Intended Use/Indications for Use
The Strados Remote Electronic Stethoscope Platform (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 or outpatient setting including transition from healthcare setting to outpatient care without interruption. The device stores the data for later playback, review, and analysis by a clinician and comparison with earlier data from the same patient.
Technological Characteristics
An overview comparison of the Strados Remote Electronic Stethoscope Platform (RESP) (subject device) to the predicate device is presented in the table below.
5
| Table 5-2: Device Comparison | ||
|---|---|---|
| Subject Device: | ||
| Strados RESP | Predicate Device: | |
| Strados RESP K201077 | ||
| Name | Strados Remote Electronic Stethoscope Platform (RESP) | Strados Remote Electronic Stethoscope Platform (RESP) |
| Manufacturer | Strados Labs, Inc. | Strados Labs, Inc. |
| Product Code | DSH | DSH |
| Regulation Number | 21 CFR 870.2800 | 21 CFR 870.2800 |
| Device Classification Name | Recorder, Magnetic Tape, Medical | Recorder, Magnetic Tape, Medical |
| Device Classification | Class 2 | Class 2 |
| Indication for Use | The Strados Remote Electronic Stethoscope Platform (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 or outpatient setting including transition from healthcare setting to outpatient care without interruption. The device stores the data for later playback, review, and analysis by a clinician and comparison with earlier data from the same patient. | 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. |
| Age of Device Use | Adults. | Adults. |
| Principle of Operation | Placement - The Strados RESP is adhered in an area of interest by a clinician to the skin (Healthcare setting). Device placement is determined by the clinician. The patient places and replaces the device on themselves (Outpatient setting). | |
| Recording - Lung sounds are recorded by wearable and stored in internal storage. A clinician configures the options. | ||
| Transmission - Recordings are transmitted to the Strados Mobile App (SMA) from internal storage on the SWD. | ||
| Playback - Recordings can be played back via the SMA or Clinical Portal. | Placement - The Strados RESP is adhered in an area of interest by a clinician to the skin. | |
| Recording - Lung sounds are recorded by wearable and stored in internal storage. A clinician configures the options. | ||
| Transmission - Recordings are transmitted to the Strados Mobile App (SMA) from internal storage on the SWD. | ||
| Playback - Recordings can be played back via the SMA or Clinical Portal. | ||
| Condition of Use | Reusable | Reusable |
| Rx or OTC | Prescription Only | Prescription Only |
| Wearable | Yes | Yes |
Table 5-2: Device Comnarison
6
Section 5 510(k) Summary
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 60601-1-11:2015- Medical electrical equipment — Part 1-11: General requirements for basic safety and essential performance — Collateral standard: Requirements for medical electrical equipment and medical electrical systems used in the home healthcare environment
- . 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 for this submission includes:
- O Frequency response equivalence testing
- Device Cleaning Testing O
- Usability Testing O
Clinical Performance Data
Clinical performance testing was performed to validate the quality of the subject device's recorded lung sounds when self-placed and recorded in an outpatient setting.
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.