(242 days)
No
The description focuses on data acquisition, recording, storage, and playback for clinician review. There is no mention of automated analysis, pattern recognition, or any technology that would typically involve AI/ML for interpretation or diagnosis.
No.
The device is intended to acquire, record, and store lung sounds for review and analysis by a clinician, which is a diagnostic function, not a therapeutic one.
No
The device is limited to acquiring, recording, and storing lung sounds for later playback, review, and analysis by a clinician. It does not perform any diagnostic function itself.
No
The device description explicitly states it includes hardware components: a wearable device, charging station, external power supply, and patient adhesive. It is not solely software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices used to perform tests on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections. These tests are performed outside of the body (in vitro).
- Device Function: The RESP device acquires, records, and stores lung sounds directly from the patient's chest wall. This is a non-invasive process that involves listening to sounds produced within the body. It does not involve analyzing samples taken from the body.
- Intended Use: The intended use is to acquire, record, and store lung sounds for later playback, review, and analysis by a clinician. This is a form of physical examination and data collection, not an in vitro diagnostic test.
The device functions more like an electronic stethoscope with recording capabilities, which is a diagnostic tool used for physical examination, not an IVD. The predicate and reference devices listed (electronic stethoscopes) further support this classification.
N/A
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.
Product codes
DSH
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
chest wall
Indicated Patient Age Range
Adults.
Intended User / Care Setting
Clinician; healthcare setting.
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)
Clinical performance testing was performed to validate the quality of the subject device's recorded lung sounds.
Non-Clinical performance testing conducted includes:
- Frequency response equivalence testing from 20 to 2000Hz against a reference 510(k) cleared stethoscopes
- Functional Testing
- Validation of device cleaning instructions for likely use
- Ship Testing
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.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
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).
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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
1
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
2
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)
| ☑ 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 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: | April 21, 2020 |
| 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:
Reference Device: | Vitalograph Model 7100 VitaloJAK (K110525)
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.
4
| Product Offering | Catalog Number | Contents |
|---|---|---|
| Strados Remote Electronic | ||
| Stethoscope 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 Charging |
| Station 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
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.
5
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: VitaloJAK
K110525 | Reference: Littmann Model 3200
K083903 |
|----------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Name | Strados Remote Electronic
Stethoscope Platform (RESP) | Vitalograph Model 7100- VitaloJAK | 3M™ Littmann® Electronic Stethoscope
Model 3200 |
| Manufacturer | Strados Labs, Inc. | Vitalograph (Ireland) Ltd. | 3M |
| Product Code | DSH | DSH | DQD |
| Regulation
Number | 21 CFR 870.2800 | 21 CFR 870.2800 | 21 CFR 870.1875 |
| Device
Classification
Name | Recorder, Magnetic Tape, Medical | Recorder, Magnetic Tape, Medical | Stethoscope, Electronic |
| Device
Classification | Class 2 | Class 2 | Class 2 |
| Indication 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. | The Model 7100 is a non-invasive
battery operated device intended to
acquire, record and store ambulatory
cough sounds from patients for up to
24 hours. The device stores the data
on a removable memory card for later
playback, review, and analysis of the
cough sounds on a windows based PC. | The 3M™ Littmann® Electronic
Stethoscope, Model 3200 is intended for
medical diagnostic purposes only. It may
be used for the detection and
amplification of sounds from the heart,
lungs, arteries, veins, and other internal
organs with the use of a selective
frequency. It can be used on any person
undergoing a physical assessment. |
| Age of Device
Use | Adults. | All ages. | All ages. |
| Principle of
Operation | Placement - The Strados RESP is
placed by a clinician and adhered to
the skin.
Recording - Lung sounds are recorded
by wearable per the App-selected | Placement- The VitaloJAK is adhered
to skin at the suprasternal notch.
Recording- A continuous recording is
started by a clinician on the device. | Placement - The Littmann is placed by
clinician similar to a traditional
stethoscope. |
| | Subject Device:
Strados RESP | Predicate Device: VitaloJAK
K110525 | Reference: Littmann Model 3200
K083903 |
| | recording mode. In a clinical setting, a
clinician configures the options and
initiates/stops sound capture
Transmission- Recordings are
transmitted to the Strados Mobile App
(SMA). Clinician can listen to
recordings at any time via the SMA. | Transmission- The data is retained on
board the device. After all data is
collected, the data is transferred via
USB cable through a PC to a web
portal.
Playback- No playback is provided to
the clinician. Coughs are counted by
VitaloJAK personnel.
Use-
The VitaloJAK is not intended for
immediate clinical action. | Recording - Lung sounds can be recorded
by pressing the physical buttons on the
device.
Transmission- Recordings can be
transmitted to an external device with
custom software. The device can also
save up to 12 recordings.
Playback- Recordings can be played back
audibly via the deice speaker and into the
device ear pieces. |
| Condition of
Use | Reusable | Reusable | Reusable |
| Rx or OTC | Prescription Only | Prescription Only | Prescription Only |
| Wearable | Yes | Yes | No |
Table 5-2: Device Comparison
6
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.