Cardiart Electronic Stethoscope Model DS101 Omni-Steth Electronic Stethoscope Model Omni-Steth

Q: Who is the manufacturer of Cardiart Electronic Stethoscope Model DS101 Omni-Steth Electronic Stethoscope Model Omni-Steth?

Imediplus, Inc. filed the 510(k) submission for Cardiart Electronic Stethoscope Model DS101 Omni-Steth Electronic Stethoscope Model Omni-Steth (K182196).

Q: What is the FDA product code for Cardiart Electronic Stethoscope Model DS101 Omni-Steth Electronic Stethoscope Model Omni-Steth?

DQD. It is classified under 21 CFR 870.1875 as a Class 2 device in the Cardiovascular panel.

Q: What is the regulatory pathway for Cardiart Electronic Stethoscope Model DS101 Omni-Steth Electronic Stethoscope Model Omni-Steth?

510(k) clearance (submission type: Traditional).

Q: What are the predicate devices for Cardiart Electronic Stethoscope Model DS101 Omni-Steth Electronic Stethoscope Model Omni-Steth?

IMEDIPLUS Electronic Stethoscope DS3011A (K173663); 3M™ LITTMANN® ELECTRONIC STETHOSCOPE MODEL 3200 (K083903).

Q: Who can help prepare an FDA 510(k) submission like Cardiart Electronic Stethoscope Model DS101 Omni-Steth Electronic Stethoscope Model Omni-Steth?

Innolitics — a medical-device software consultancy — provides regulatory and engineering support for FDA 510(k) submissions. See https://innolitics.com/services/510ks/ or contact https://innolitics.com/contact.

K182196 · Imediplus, Inc. · DQD · Sep 11, 2018 · Cardiovascular

Device Facts

Record ID	K182196
Device Name	Cardiart Electronic Stethoscope Model DS101 Omni-Steth Electronic Stethoscope Model Omni-Steth
Applicant	Imediplus, Inc.
Product Code	DQD · Cardiovascular
Decision Date	Sep 11, 2018
Decision	SESE
Submission Type	Traditional
Regulation	21 CFR 870.1875
Device Class	Class 2
Attributes	Pediatric, 3rd-Party Reviewed

Intended Use

The Electronic Stethoscope DS101 is intended for the detection, and recording of sounds from the heart, lungs, anterior and posterior chest, abdomen, neck, limbs, arteries, veins and other internal organs with selective frequency ranges. And the stethoscope chest piece is designed for use with child, adolescent and adult patients. It is used for any subject undergoing a physical examination and intended only for medical diagnostic purposes in clinic or hospital. The Electronic Stethoscope Omni-Steth is intended for the detection, amplification and recording of sounds from the heart, lungs, anterior and posterior chest, abdomen, neck, limbs, arteries, veins and other internal organs with selective frequency ranges. And the stethoscope chest piece is designed for use with child, adolescent and adult patients. It is used for any subject undergoing a physical examination and intended only for medical diagnostic purposes in clinic or hospital.

Device Story

Electronic stethoscopes (DS101, Omni-Steth) capture acoustic signals from internal organs via chest piece; signals amplified/filtered by digital signal processor; output to bilateral headset and OLED display. Used by clinicians (physicians, nurses, etc.) in clinics/hospitals for physical exams. Features include three filter modes (Bell 20-200Hz, Diaphragm 100-500Hz, Wide 20-1000Hz), heart rate detection, and phonocardiogram display. Bluetooth connectivity enables raw audio data exchange with external PCs for storage/review via DS101-DM software. Device aids clinical decision-making by providing audible and visual representations of internal sounds. Benefits include improved auscultation efficiency and documentation of patient findings.

Clinical Evidence

No clinical data. Substantial equivalence supported by bench testing, including electrical safety, EMC, wireless coexistence, biocompatibility (ISO 10993-1), and usability testing (15 physicians, 15 nurses). Heart rate detection performance verified against predicates within 30-180 bpm range. Audio performance verified equivalent to predicates for frequencies below 1 kHz and across specified filter modes.

Technological Characteristics

Materials: Silicone diaphragm, brass alloy headset. Power: 2x AAA 1.2V batteries. Connectivity: Bluetooth wireless, standalone operation. Form factor: Handheld with 1.46" OLED display. IPX4 water resistance. Standards: ANSI/AAMI ES 60601-1, IEC 60601-1-2, IEC 60529, ANSI C63.27. Software: Moderate level of concern.

Indications for Use

Indicated for child, adolescent, and adult patients undergoing physical examination for medical diagnostic purposes in clinical or hospital settings. Used for detection, amplification, and recording of internal body sounds (heart, lungs, abdomen, etc.).

Regulatory Classification

Identification

Manual stethoscope: A mechanical device used to project the sounds associated with the heart, arteries, and veins and other internal organs. Electronic stethoscope: An electrically amplified device used to project the sounds associated with the heart, arteries, and veins and other internal organs.

Special Controls

*Classification.* Class II (special controls). The device, when it is a lung sound monitor, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 870.9.

Predicate Devices

IMEDIPLUS Electronic Stethoscope DS3011A (K173663)
3M™ LITTMANN® ELECTRONIC STETHOSCOPE MODEL 3200 (K083903)

Related Devices

K160023 — Electronic Stethoscope DS301 · Imediplus, Inc. · Sep 30, 2016
K173663 — Electronic Stethoscope DS3011A · Imediplus, Inc. · Aug 17, 2018
K212709 — VoqX Electronic Stethoscope · Sanolla , Ltd. · Mar 15, 2022
K121144 — ELECTRONIC STETHOSCOPE · Sharp Corporation · Sep 26, 2012
K050159 — MODIFICATION TO: 3M LITTMANN ELECTRONIC STETHOSCOPE, MODEL 3000 · 3M Company · Feb 22, 2005

Submission Summary (Full Text)

{0}------------------------------------------------ Image /page/0/Picture/0 description: The image contains 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, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue. September 11, 2018 Imediplus, Inc. % Dave Yungvirt CEO Third Party Review Group, LLC The Old Station House 24 Lackawanna Place Millburn, New Jersey 07041 Re: K182196 Trade/Device Name: Cardiart Electronic Stethoscope: Model DS101; Omni-Steth Electronic Stethoscope: Model Omni-Steth Regulation Number: 21 CFR 870.1875 Regulation Name: Stethoscope Regulatory Class: Class II Product Code: DQD Dated: August 11, 2018 Received: August 14, 2018 Dear Dave Yungvirt: 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/CombinationProducts/GuidanceRegulatoryInformation/ucm597488.htm); 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 http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm. 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/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). 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 (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100). Sincerely. # Stephen C. Browning -S5 for Bram D. Zuckerman, M.D. Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health Enclosure {2}------------------------------------------------ ## Indications for Use 510(k) Number (if known) K182196 ### Device Name Cardiart Electronic Stethoscope: Model DS101 Omni-Steth Electronic Stethoscope: Model Onmi-Steth ### Indications for Use (Describe) The Electronic Stethoscope DS101 is intended for the detection, and recording of sounds from the heart, lungs, anterior and posterior chest, abdomen, neck, limbs, arteries, veins and other internal organs with selective frequency ranges. And the stethoscope chest piece is designed for use with child, adolescent and adult patients. It is used for any subject undergoing a physical examination and intended only for medical diagnostic purposes in clinic or hospital. The Electronic Stethoscope Omni-Steth is intended for the detection, amplification and recording of sounds from the heart, lungs, anterior and posterior chest, abdomen, neck, limbs, arteries, veins and other internal organs with selective frequency ranges. And the stethoscope chest piece is designed for use with child, adolescent and adult patients. It is used for any subject undergoing a physical examination and intended only for medical diagnostic purposes in clinic or hospital. 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) | ☐ | ### 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}------------------------------------------------ ### 510(k) Number: K182196 #### SUBMITTER: - | Submitter's Name: | IMEDIPLUS INC. | |-------------------|-----------------------------------------------------------------------------------| | Address: | 2F, 12, ShengYi Rd. Sec. 2, Chupei City, Hsinchu County 30261, Taiwan (R.O.C.) | | Telephone: | +886-3-658-7700 | | Contact Name: | Moriah Hsieh | | Telephone: | +886-3-658-7700 ext #325 | | Fax: | +886-3-658-9535 | | Email: | moriah.hsieh@imediplus.com | | Date Prepared: | 24 August 2018 | ## II. DEVICE: | Trade Name and Model: | Cardiart Electronic Stethoscope: Model DS101 and Omni-Steth Electronic Stethoscope: Model Onmi-Steth | |---------------------------|---------------------------------------------------------------------------------------------------------| | Common or Usual Name: | Electronic Stethoscope | | Classification Number: | 870.1875 | | Classification Name: | Stethoscope | | Product Code: | DQD | | Product Class: | II | | Classification Panel: | Cardiovascular | ## III. PREDICATE DEVICE: | | Device Name | Manufacturer | Classification | |-----------------------------------|----------------------------------------------------|-------------------|-----------------| | Primary Predicate K173663 | IMEDIPLUS Electronic Stethoscope DS3011A | IMEDIPLUS INC. | DQD 870.1875 | | Secondary Predicate K083903 | 3M™ LITTMANN® ELECTRONIC STETHOSCOPE MODEL 3200 | 3M COMPANY | DQD 870.1875 | This Secondary Predicate K083903 with the same intended use, classification and product code as the proposed device is included to support the Bluetooth wireless technology that is implemented in the subject device for which scientific methods exists to evaluate this new technology as outlined in the FDA guidance "Radio Frequency Wireless Technology in Medical Devices" (Aug 14, 2013). ## IV. DEVICE DESCRIPTION The proposed Electronic Stethoscopes Models DS101 and Omni-Steth detect and {4}------------------------------------------------ display the sounds from the heart, lungs, anterior/posterior chest, abdomen, neck, limbs, arteries, veins and other internal organs from a patient's body. After amplifying and filtering, the sounds are also sent to the user's ears bilaterally through the active speaker embedded at the bottom of the stethoscopes. Sound processing is conducted with the aid of a digital signal processor. Power to the device is provided by two AAA1.2V batteries. The one-hand operable user interface consists of a full-color OLED display, the Record button, arrow keys, the OK button, and a tube connector to output sounds to the headset consisting of tubes and ear tips. The proposed devices can detect and display an acoustic based heart rate when presented with consistent heart sounds. In addition, using a Bluetooth wireless link, the proposed stethoscopes can exchange raw audio data with external devices such as personal computers. Note: The models DS101 and Omni-Steth are standalone devices and do not require Bluetooth data transfer to fulfill their intended use. The differences between the proposed stethoscope models DS101 and Omni-Steth are cosmetic: specifically, the design of top housing and keyboard layout. The OLED Display information are identical. | Trade Name | CaRDIART Electronic Stethoscope | Omni-Steth Electronic Stethoscope | |----------------------|----------------------------------------------------------|------------------------------------------------------------| | Model Name | DS101 | Omni-Steth | | Device Appearance | Image: Cardiart Electronic Stethoscope Device Appearance | Image: Omni-Steth Electronic Stethoscope Device Appearance | | Keyboard layout | Image: Cardiart Electronic Stethoscope Keyboard layout | Image: Omni-Steth Electronic Stethoscope Keyboard layout | {5}------------------------------------------------ #### V. INTENDED USE AND INDICATIONS FOR USE ### Cardiart Electronic Stethoscope (Model DS101) The Electronic Stethoscope DS101 is intended for the detection, amplification and recording of sounds from the heart, lungs, anterior and posterior chest, abdomen, neck, limbs, arteries, veins and other internal organs with selective frequency ranges. And the stethoscope chest piece is designed for use with child, adolescent and adult patients. It is used for any subject undergoing a physical examination and intended only for medical diaqnostic purposes in clinic or hospital. ### Omni-Steth Electronic Stethoscope (Model Omni-Steth) The Electronic Stethoscope Omni-Steth is intended for the detection, amplification and recording of sounds from the heart, lungs, anterior and posterior chest, abdomen, neck, limbs, arteries, veins and other internal organs with selective frequency ranges. And the stethoscope chest piece is designed for use with child, adolescent and adult patients. It is used for any subject undergoing a physical examination and intended only for medical diagnostic purposes in clinic or hospital. ## VI. COMPARISON OF TECHNOLOGICAL CHARACTERISTICS WITH THE PREDICATE DEVICE The technology of the proposed electronics stethoscopes Models DS101 and Omni-Steth are identical to the predicate IMEDIPLUS electronic stethoscope Model DS301 1A in terms of principle of operation, materials, design, user interface, frequency ranges, and auscultation organs. The following include the modifications to the previous design implemented in the proposed stethoscopes: - 1. New PCB (Printed Circuit Board) layout - 2. New housing with water resistance (IPX4) - 3. Rearrangement of the information on OLED display - 4. Data transmission via Bluetooth - 5. Two AAA 1.2V batteries as power supply - 6. Display of Phonocardiogram {6}------------------------------------------------ ## K182196 ## Page 4 of 11 ## Comparison table | Item S | Comparis on Items | Subject Device | | Secondary Predicate Device | Primary Predicate Device | Same/Similar ar Different /New | |-------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------| | 1 | Regulatory Regulatory No Classification | CARDIART Electronic Stethoscope (DS101) | Omni-Steth Electronic Stethoscope (Omni-Steth) | 3M 3200 (K083903) | DS3011A (K173663) | Same | | 2 | Power Source Batteries type | Two AAA battery | Two AAA battery | One AA battery | One NP-120 Lithium battery | Similar with 3M 3200 ; Different from DS3011A | | | Battery Life | > 7 Hours | > 7 Hours | 50-60 Hours | 24 Hours | Different | | | Special Adaptors | No | No | No | Yes | Same with 3M 3200 ; Different from DS3011A | | 3 | Features Binaural headset | Yes | Yes | Yes | Yes | Same | | | Chest- piece Technology | Single Sided | Single Sided | Single Sided | Single Sided | Same | | | Chest- piece Weight | 18g | 18g | 98g | 69g | Different | | | Clinical Area | Auscultation | Auscultation | Auscultation | Auscultation | Same | | | Diaphragm Diameter | 4.7cm | 4.7cm | 5.1cm | 4.1cm | Similar with 3M 3200 and | | | | | | | | DS3011A | | | Diaphragm Material | Silicone | Silicone | Polyurethane-Coated Silicone | Silicone | Same with DS3011A; Different from 3M 3200 | | | Ear-tips Type | Soft Sealing | Soft Sealing | Soft Sealing | Soft Sealing | Same | | | Headset Material | Brass alloy to electroplate | Brass alloy to electroplate | Wide diameter aerospace alloy / Anodized aluminum | Brass alloy to electroplate | Same with DS3011A | | | Length | 81 cm | 81 cm | 69 cm | 77 cm | Similar with DS3011A | | | Net Weight | 214g | 213g | 185 g | 304 g | Different | | | Tube Color | Black · Burgundy · Navy Blue | Black · Burgundy · Navy Blue | Black · Burgundy · Navy Blue | Black · Burgundy · Navy Blue | Same | | 4 | Intended Use | | | | | | | | Intended Use | The CARDIART Electronic Stethoscope is intended for the detection, amplification and recording of sounds from the heart, lungs, anterior and posterior chest, abdomen, neck, limbs, arteries, veins and other internal organs with selective frequency ranges. The stethoscope chest-piece is designed for use with child, adolescent and adult patients. It is used for any subject undergoing a physical examination and intended only for medical diagnostic purposes in clinic or hospital. | The Omni-Steth Electronic Stethoscope is intended for the detection, amplification and recording of sounds from the heart, lungs, anterior and posterior chest, abdomen, neck, limbs, arteries, veins and other internal organs with selective frequency ranges. The stethoscope chest-piece is designed for use with child, adolescent and adult patients. It is used for any subject undergoing a physical examination and intended only for medical diagnostic purposes in clinic or hospital. | 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 selective frequency ranges. It can be used on any person undergoing a physical assessment. | The IMEDIPLUS Electronic Stethoscope DS3011A is intended for the detection, amplification and recording of sounds from the heart, lungs, anterior and posterior chest, abdomen, neck, limbs, arteries, veins and other internal organs with selective frequency ranges. And the stethoscope chest- piece is designed for use with child, adolescent and adult patients. It is used for any subject undergoing a physical examination and intended only for | Same with DS3011A; similar to 3M 3200. The population is specific to child, adolescents and adults. | | | | | | | medical diagnostic purposes in clinic or hospital. | | | 5 | Functional | | | | | | | | Display Screen | OLED 1.46" Full Color | OLED 1.46" Full Color | LCD Monochrome | OLED 1.46" Full Color | Same with DS3011A; similar to 3M 3200. | | | Barcode Reader | No | No | No | Yes | Same with 3M 3200 | | | Three Filter Modes | Yes | Yes | Yes | Yes | Same | | | Frequency Range of Filter Mode | Bell (20-200 Hz), Diaphragm (100-500 Hz) and Wide (20- 1000Hz) | Bell (20-200 Hz), Diaphragm (100-500 Hz) and Wide (20- 1000Hz) | Bell (20-200 Hz), Diaphragm (100-500 Hz) and Extend range (20-2000 Hz) | Bell (20-200 Hz), Diaphragm (100-500 Hz) and Wide (20- 1000Hz) | Same with DS3011A ; Similar to 3M 3200 | | | Human Machine Interface | One-hand user interface for auscultation position selection, recording, and function selection. | One-hand user interface for auscultation position selection, recording, and function selection. | Yes | One-hand user interface for patient's ID scanning, auscultation position selection, recording, and function selection. | Similar with DS3011A | | | Recording Number of the sound track | Yes ( File name: Year+Month+Hour+Minute+Se cond) | Yes ( File name: Year+Month+Hour+Minute+Se cond) | Yes (File name: 00x)…