Cardio Q50, Cardio Q70

K231160 · Bionet Co., Ltd. · DPS · Dec 15, 2023 · Cardiovascular

Device Facts

• Record ID: K231160
• Device Name: Cardio Q50, Cardio Q70
• Applicant: Bionet Co., Ltd.
• Product Code: DPS · Cardiovascular
• Decision Date: Dec 15, 2023
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 870.2340
• Device Class: Class 2
• Attributes: Pediatric

Intended Use

The Cardio Q50 / Cardio Q70 ECG Analysis System is intended to acquire, analyze, display and record ECG information from adult and pediatric populations. Bionet Algorithm - 3 years or older / Glasgow Algorithm - 0 years or older The system provides 12-lead ECG and interpretive analysis. The 12-Lead ECG interpretation algorithm provides analytical information about the patient's heart condition, which must be confirmed by a qualified medical professional along with other relevant clinical information. Sending and receiving ECG data to and from the Hospital Information System is optional. The Cardio Q50 / Cardio Q70 is intended to be used by personnel trained in hospitals or medical professional facilities under the direct supervision of a licensed healthcare practitioner. In addition, the Cardio Q50 / Cardio Q70 is intended for prescription use only to perform spirometry diagnostic tests in adults and pediatic patients aged 5 and older in general practice, specialist and hospital settings is intended to be used what measures patient respiratory parameters including FVC, FEV1/FEV6, SVC, MVV

Device Story

12-channel ECG recording system; measures/records patient ECG; provides interpretive analysis; optional spirometry diagnostic testing. Inputs: ECG signals via patient cable; respiratory flow/volume via spirometer handle. Processing: Bionet and Glasgow ECG interpretation algorithms; differential pressure method for spirometry. Outputs: ECG traces, interpretive reports, spirometry parameters (FVC, FEV1/FEV6, SVC, MVV). Used in hospitals/clinics by trained personnel under physician supervision. Data stored internally or transmitted to PC/Hospital Information System. Benefits: aids cardiac/respiratory diagnosis; improves chart management efficiency; portable via optional battery.

Clinical Evidence

No clinical data. Bench testing only, including electrical safety (IEC 60601-1), electromagnetic compatibility (IEC 60601-1-2), usability (IEC 60601-1-6), ECG performance (IEC 60601-2-25), and spirometry performance (ISO 26782, ISO 23747). Biocompatibility testing performed per EN ISO 10993-5 and 10993-10.

Technological Characteristics

12-lead ECG and spirometer. Materials: Biocompatible per ISO 10993. Sensing: Differential pressure (spirometry). Energy: AC or internal rechargeable Li-ion battery (10.8V, 6500mA). Connectivity: USB/Network data transfer. Software: Firmware-based. Standards: IEC 60601-1, IEC 60601-2-25, ISO 26782, ISO 23747, ANSI AAMI EC53.

Indications for Use

Indicated for adult and pediatric patients (ECG: Bionet algorithm ≥3 years, Glasgow algorithm ≥0 years; Spirometry: ≥5 years) for ECG acquisition/analysis and respiratory parameter measurement (FVC, FEV1/FEV6, SVC, MVV) in hospitals, clinics, and general practice.

Regulatory Classification

Identification

An electrocardiograph is a device used to process the electrical signal transmitted through two or more electrocardiograph electrodes and to produce a visual display of the electrical signal produced by the heart.

Predicate Devices

• Cardio10 (K220535)

Reference Devices

• ECG100+, ECG200+ (K160840)

Submission Summary (Full Text)

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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: the Department of Health & Human Services logo on the left and the FDA logo on the right. The FDA logo is a blue square with the letters "FDA" in white, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue.

December 15, 2023

Bionet Co., Ltd. Kyungeun Park Assistant Manager 5F, 61 Digital-ro 31 gil, Guro-gu Seoul, 08375 Korea. South

Re: K231160

Trade/Device Name: Cardio Q50, Cardio Q70 Regulation Number: 21 CFR 870.2340 Regulation Name: Electrocardiograph Regulatory Class: Class II Product Code: DPS, BZG Dated: November 17, 2023 Received: November 17, 2023

Dear Kyungeun Park:

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 (the 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 available 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.

Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device"

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(https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download).

Your device is also subject to, among other requirements, the Quality System (QS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30. Design controls; 21 CFR 820.90. Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review. the OS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181).

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 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 Part 803) for devices or postmarketing safety reporting (21 CFR Part 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 Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050.

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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.

# Jennifer W. Shih -S

Jennifer Shih Kozen Assistant Director Division of Cardiac Electrophysiology, Diagnostics and Monitoring Devices Office of Cardiovascular Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health

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## Indications for Use

510(k) Number (if known) K231160

Device Name Cardio 050. Cardio 070

#### Indications for Use (Describe)

The Cardio Q50 / Cardio Q70 ECG Analysis System is intended to acquire, analyze, display and record ECG information from adult and pediatric populations.

* Bionet Algorithm - 3 years or older / Glasgow Algorithm - 0 years or older

The system provides 12-lead ECG and interpretive analysis.

The 12-Lead ECG interpretation algorithm provides analytical information about the patient's heart condition, which must be confirmed by a qualified medical professional along with other relevant clinical information.

Sending and receiving ECG data to and from the Hospital Information System is optional.

The Cardio Q50 / Cardio Q70 is intended to be used by personnel trained in hospitals or medical professional facilities under the direct supervision of a licensed healthcare practitioner.

In addition, the Cardio Q50 / Cardio Q70 is intended for prescription use only to perform spirometry diagnostic tests in adults and pediatic patients aged 5 and older in general practice, specialist and hospital settings is intended to be used what measures patient respiratory parameters including FVC, FEV1/FEV6, SVC, MVV

| 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/0 description: The image shows the word "bionet" in a stylized font. The first three letters, "bio", are in a light blue color, while the last three letters, "net", are in black. The font is rounded and sans-serif, giving the word a modern and clean appearance. The letters are closely spaced, creating a compact and unified design.

# 510(k) Summary

[As required by 21 CFR 807.92]

### 1. Date Prepared [21 CFR 807.92(a)(a)]

April 14, 2023

#### Submitter's Information [21 CFR 807.92(a)(1)] 2.

- Name of Manufacturer: Bionet Co., Ltd. ●
- Address: 5F, 61 Digital-ro 31 gil, Guro-gu, Seoul, Republic of Korea 08375 ●
- Contact Name: Kyungeun Park / Assistant Manager ●
- Telephone No.: [phone] ●
- Fax No.: [phone]
- Email Address: [e-mail] ●
- Registration No.: 3003681187 ●

#### 3. Trade Name, Regulation Name, Classification [21 CFR 807.92(a)(2)]

| Trade/Device Name | Cardio Q50, Cardio Q70 |
|-------------------|--------------------------------------------|
| K Number | K231160 |
| Common Name | Electrocardiograph & Spirometer |
| Regulation Number | 870.2340 / 868.1840 |
| Regulation Name | Electrocardiograph / Diagnostic spirometer |
| Regulation Class | 2 |
| Product Code | DPS / BZG |

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#### K231160

#### 4. Identification of Predicate Device(s) [21 CFR 807.92[a)(3)[

The identified predicate devices within this submission are shown as follow;

Primary Predicate device

- 510(k) Number: K220535 ●
- Applicant: Bionet Co., Ltd.
- Trade/Device Name Cardio10 ●
- Regulation Number 870.2340 / 868.1840
- Regulation Name: Electrocardiograph / Diagnostic spirometer
- . Regulation Class: ನ
- Product Code: DPS / BZG .

Reference device

●

●

| ● | 510(k) Number: | K160840 |
|---|-------------------|--------------------|
| ● | Applicant: | Cardioline S.p.A |
| ● | Trade/Device Name | ECG100+, ECG200+ |
| ● | Regulation Number | 870.2340 |
| ● | Regulation Name: | Electrocardiograph |
| ● | Regulation Class: | 2 |
| ● | Product Code: | DPS |

The predicate device and reference device have not been subject to a design-related recall.

#### 5. Description of the Device [21 CFR 807.92(a)(4)]

Cardio Q50 / Cardio Q70 is a 12-channel ECG (Electrocardiogram) recording equipment that measures and records the patient's ECG. It not only provides parameters necessary for diagnosis, patient's ECG record and automatic diagnosis, but also increases chart management efficiency by providing ECG records and printing reports when patient or user information is entered. At the same time, it can transmit the saved data to a PC for file management. Its useroriented design enables ECG examination with a single push of a button. It saves, transfers and prints the data that has been acquired by automatic diagnosis.

It provides the user with the necessary parameters, which are necessary for patient diagnosis, along with the spirometry record. After spirometry tests, you can print out a report on A4/letter paper together with the spirometer record to efficiently manage the patient's or user's chart. The stored data is forwarded to a PC that is in charge of managing digital files. In addition, the battery pack, which can be stored inside as an optional component, ensures high portability and makes it possible to inspect or use the equipment in an emergency.

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Image /page/5/Picture/0 description: The image shows the word "bionet" in a sans-serif font. The first three letters, "bio", are in a light blue color, while the last three letters, "net", are in black. The letters are all lowercase and connected, giving the impression of a single word.

#### 6. Indications for use [21 CFR 807.92(a)(5)]

The Cardio 050 / Cardio 070 ECG Analysis System is intended to acquire, analyze, display and record ECG information from adult and pediatric populations.

* Bionet Algorithm - 3 years or older / Glasgow Algorithm - 0 years or older

The system provides 12-lead ECG and interpretive analysis.

The 12-Lead ECG interpretation algorithm provides analytical information about the patient's heart condition, which must be confirmed by a qualified medical professional along with other relevant clinical information.

Sending and receiving ECG data to and from the Hospital Information System is optional.

The Cardio Q50 / Cardio Q70 is intended to be used by personnel trained in hospitals or medical professional facilities under the direct supervision of a licensed healthcare practitioner.

In addition. the Cardio 050 / Cardio 070 is intended for prescription use only to perform spirometry diagnostic tests in adults and pediatric patients aged 5 and older in general practice, specialist and hospital settings. The device is intended to be used what measures patient respiratory parameters including FVC, FEV1/FEV6, SVC, MVV.

#### Determination of Substantial Equivalence 7.

The Cardio Q50, Cardio Q70 is substantially equivalent to legally marketed predicate device and reference device with respect to indications for use and technology characteristics.

| | Proposed Device | Predicate Device | Reference device |
|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Product Name | Cardio Q50, Cardio Q70 | Cardio10 | ECG100+, ECG200+ |
| 510(k)<br>Number | K231160 | K220535 | K160840 |
| Manufacturer | Bionet Co., Ltd. | Bionet Co., Ltd. | Cardioline S.p.A |
| Product Code | DPS / BZG | DPS / BZG | DPS |
| Device Class | 2 | 2 | 2 |
| Common specification | | | |
| Indications<br>for Use | The Cardio Q50 / Cardio Q70<br>ECG Analysis System is<br>intended to acquire, analyze,<br>display and record ECG<br>information from adult and<br>pediatric populations.<br>* Bionet Algorithm - 3 years<br>or older / Glasgow Algorithm<br>- 0 years or older<br>The system provides 12-lead<br>ECG and interpretive<br>analysis. | The Cardio10 ECG Analysis<br>System is intended to<br>acquire, analyze, display, and<br>record electrocardiographic<br>information from adult and<br>pediatric populations.<br>Pediatric population is<br>defined as patients between<br>the ages from 3 and less than<br>16 years.<br>Basic systems deliver 12 lead<br>ECG's, interpretive analysis, | ECGxxx(z)(+) is a high-<br>performance, multi-<br>channel, interpretative<br>resting electrocardiograph.<br>The ECG signal is acquired<br>with a 10-wires patient<br>cable and is displayed in<br>real time on a LCD screen<br>integrated in the device.<br>The electrocardiograph<br>can analyse and store the<br>ECG traces, send them to<br>an external peripheral via |
| | | K231160 | |
| Proposed Device | Predicate Device | Reference device | |
| The 12-Lead ECG<br>interpretation algorithm<br>provides analytical<br>information about the<br>patient's heart condition,<br>which must be confirmed by<br>a qualified medical<br>professional along with other<br>relevant clinical information.<br>Sending and receiving ECG<br>data to and from the Hospital<br>Information System is<br>optional.<br>The Cardio Q50 / Cardio Q70<br>is intended to be used by<br>personnel trained in<br>hospitals or medical<br>professional facilities under<br>the direct supervision of a<br>licensed healthcare<br>practitioner.<br>In addition, the Cardio Q50 /<br>Cardio Q70 is intended for<br>prescription use only to<br>perform spirometry<br>diagnostic tests in adults and<br>pediatric patients aged 5 and<br>older in general practice,<br>specialist and hospital<br>settings. The device is<br>intended to be used what<br>measures patient respiratory<br>parameters including FVC.<br>FEV1/FEV6, SVC, MVV | and can be upgraded to<br>provide software analysis<br>options such as a high<br>resolution signal averaging of<br>QRS and P wave portions of<br>the electrocardiogram. The<br>12-lead ECG interpretive<br>algorithm provides a<br>computer-generated analysis<br>of potential patient cardiac<br>abnormalities, which must<br>be confirmed by a physician<br>with other relevant clinical<br>information.<br>Transmission and reception<br>of ECG data to and from a<br>central ECG cardiovascular<br>information system is<br>optional.<br>The Cardio10 is intended to<br>be used under the direct<br>supervision of a licensed<br>healthcare practitioner, by<br>trained operators in a<br>hospital or medical<br>professional's facility.<br>Cardio10 is intended for<br>prescription use only to<br>conduct diagnostic<br>spirometry testing of adults<br>and pediatric patients, 5<br>years and older, in general<br>practice, specialty physician,<br>and hospital settings. The<br>device is intended to be used<br>as a spirometer which<br>measures patient respiratory<br>parameters including FVC,<br>COPD, SVC, MVV. | network or via USB, print<br>the 12 lead ECG in<br>automatic or manual mode<br>by means of a thermal<br>printer. ECGxxx(z)(+) is<br>intended for assessment<br>and diagnosis of cardiac<br>functions. In any case the<br>results of analysis<br>performed by the<br>electrocardiograph must<br>be validated by a Physician.<br>ECGxxx(z)(+) is intended<br>for use in hospitals, in<br>medical clinics and<br>doctor's offices of any size.<br>- The device is indicated<br>for use to acquire, analyse,<br>display and print<br>electrocardiograms. - The<br>device is intended to<br>provide the physician with<br>an automatic<br>interpretation of the ECG<br>to be reviewed by a<br>physician. - The device is<br>indicated for use in a<br>clinical setting, by a<br>physician or by trained<br>personnel who are acting<br>on the orders of a licensed<br>physician. It is not<br>intended as a sole means of<br>diagnosis. - The<br>interpretations of ECG<br>offered by the device are<br>only significant when used<br>in conjunction with a<br>physician overread as well<br>as consideration of all<br>other relevant patient data.<br>- The device is indicated<br>for use on adult and<br>pediatric populations. -<br>The device is not intended<br>to be used as a vital signs<br>physiological monitor. | |
| | Proposed Device | Predicate Device | Reference device |
| Battery | Replaceable and<br>Rechargeable Lithium Ion,<br>10.8V, 6500mA | Replaceable and<br>Rechargeable Lithium Ion,<br>10.8V, 6500mA | Internal rechargeable batte<br>ry (NiMH), 12Vdc 2200 mA<br>h |
| | 10 hours of normal use or<br>print 350 ECG (12 channel<br>format at 25mm/s and<br>10mm/mV) or Spiro pages.<br>Battery recharge to full | 10 hours of normal use or<br>print 350 ECG(12 channel<br>format at 25mm/s and<br>10mm/mV) or Spiro pages.<br>Battery recharge to full | |
| | capacity in 3 hours. (The<br>device is turned off) | capacity in 3hours. (The<br>device is turned off) | |
| Data storage | Internal Storage for 500<br>Data : Built- in Memory | Internal Storage for 500<br>data : Built in memory | Up to 100 ECGs |
| Dimension | 1) Main Body<br>- 286(W) x 350(D) x 140(H)<br>mm (Cardio Q50)<br>- 286(W) x 350(D) x 144(H)<br>mm (Cardio Q70) | 1) Main Body<br>- 300(W) x 299(H) x 123(D)<br>mm (monitor tilt down)<br>- 300(W) x 299(H) x<br>237(D)mm | 285 x 204 x 65 mm<br>1.8kg |
|…