Predicate Devices

Reference Devices

AI/ML (Artificial Intelligence / Machine Learning)

No
The document explicitly states "Mentions AI, DNN, or ML: Not Found" and does not provide any information about training or test sets, which are typical for AI/ML models. The "automatic diagnosis" mentioned is likely based on traditional algorithms, not AI/ML.

Therapeutic

No.
The device is intended to acquire, record, and interpret ECG information, providing diagnostic analysis rather than directly treating a condition.

Diagnostic

Yes

The description explicitly states, "The Cardio P1 Analysis System... provides 12-lead ECG and interpretive analysis" and "It not only provides parameters necessary for diagnosis, patient's ECG record and automatic diagnosis". This indicates its role in providing information for diagnostic purposes.

SaMD (Software as a Medical Device)

No

The device description explicitly states it is "12-channel ECG (Electrocardiogram) recording equipment that measures and records the patient's ECG," indicating it includes hardware for acquiring the ECG signal.

IVD (In Vitro Diagnostic)

Based on the provided information, the Cardio P1 Analysis System is not an In Vitro Diagnostic (IVD) device.

Here's why:

IVD Definition: In Vitro Diagnostics are devices intended for use in the collection, preparation, and examination of specimens taken from the human body (such as blood, urine, tissue) to obtain information for diagnostic or monitoring purposes.
Cardio P1 Function: The Cardio P1 system directly measures and records electrical activity from the patient's body (ECG) through electrodes placed on the skin. It does not analyze specimens taken from the body.
Intended Use: The intended use clearly states it acquires and records ECG information from patients and provides interpretive analysis based on that electrical signal.

Therefore, the Cardio P1 is a medical device that performs a physiological measurement, but it does not fit the definition of an In Vitro Diagnostic device.

PCCP (Predetermined Change Control Plan) Authorized

N/A

Overview

Intended Use / Indications for Use

The Cardio P1 Analysis System is intended to acquire, and record ECG information from adult and pediatric populations. Pediatric population is defined as patients between the ages from 3 and less than 16 years. 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 a qualified medical professional along with other relevant clinical information. Sending ECG data to and from the Hospital Information System is optional. The Cardio P1 is intended to be used by personnel trained in hospitals or medical professional facilities under the direct supervision of a licensed healthcare practitioner.

Product codes

DPS

Device Description

Cardio P1 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 user-oriented design enables ECG examination with a single push of a button.

The Cardio P1 is installed on a standalone PC. For all configurations, an independent PC is used that can be positioned for patient convenience.

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

Adult and pediatric populations. Pediatric population is defined as patients between the ages from 3 and less than 16 years.

Intended User / Care Setting

personnel trained in hospitals or medical professional facilities under the direct supervision of a licensed healthcare practitioner.

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 Test Summary

1. Electrical Safety, Electromagnetic Compatibility and Performance: The Cardio P1 comply with the electrical safety and electromagnetic compatibility requirements established by the standards.
- Testing to confirm compliance with IEC 60601-1:2005/AMD1:2012 . Medical electrical equipment - Part 1: General requirements for basic safety and essential performance
- Testing to confirm compliance with IEC 60601-1-2:2014 Medical electrical equipment - Part 1-2: General requirements for basic safety and essential performance - Collateral Standard: Electromagnetic disturbances -Requirements and tests
- Testing to confirm compliance with IEC 60601-1-6:2010 . Medical electrical equipment - Part 1-6: General requirements for basic safety and essential performance - Collateral standard: Usability
- Testing to confirm compliance with IEC 60601-2-25: 2011 Medical electrical equipment - Part 2-25: Particular requirements for the safety of electrocardiographs
- ANSI AAMI EC53
1. Software Validation
  The Cardio P1 contain moderate level of concern software and firmware. The software was designed and developed according to a software development process and was verified and validated.
  Software information is provided in accordance with FDA guidance:
- Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices: Guidance for Industry and FDA Staff
- Postmarket Management of Cybersecurity in Medical Devices: Guidance for Industry and Food and Drug Administration Staff
1. Biocompatibility
  Most of the contents are prepared by being referenced the following standards:
- Cytotoxicity test by EN ISO 10993-5
- Sensitization test by EN ISO 10993-10
- Intracutaneous reactivity test by ISO 10993-10
- #95-1 Biocompatibility Flow Chart for Selection of Toxicity tests for 510(k)s, FDA.

Clinical Test Summary
Clinical testing is not required

Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)

Not Found

Predicate Device(s)

K220535

Reference Device(s)

Not Found

Predetermined Change Control Plan (PCCP) - All Relevant Information

Not Found

Regulation Number and Section

§ 870.2340 Electrocardiograph.

(a)
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.(b)
Classification. Class II (performance standards).

Summary

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Image /page/0/Picture/0 description: The image contains 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 in blue and includes the letters "FDA" followed by the words "U.S. FOOD & DRUG ADMINISTRATION" stacked on top of each other.

November 9, 2023

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

Re: K231150

Trade/Device Name: Cardio P1 Regulation Number: 21 CFR 870.2340 Regulation Name: Electrocardiograph Regulatory Class: Class II Product Code: DPS Dated: October 13, 2023 Received: October 13, 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" (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).

1

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 QS 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 (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).

Sincerely,

Stephen C. Browning -S

for

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) K231150

Device Name Cardio P1

Indications for Use (Describe)

The Cardio P1 Analysis System is intended to acquire, and record ECG information from adult and pediatric populations. Pediatric population is defined as patients between the ages from 3 and less than 16 years. 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 a qualified medical professional along with other relevant clinical information. Sending ECG data to and from the Hospital Information System is optional. The Cardio P1 is intended to be used by personnel trained in hospitals or medical professional facilities under the direct supervision of a licensed healthcare practitioner.

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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510(k) Summary

[As required by 21 CFR 807.92]

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

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.: +82-2-6292-6410 ●
Fax No.: +82-2-6499-7788
. Email Address: kepark@ebionet.com
Registration No.: 3003681187 ●

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

Trade/Device Name	Cardio P1
K Number	K231150
Common Name	Electrocardiograph
Regulation Number	870.2340
Regulation Name	Electrocardiograph
Regulation Class	2
Product Code	DPS

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

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

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: 2
DPS / BZG ● Product Code:

The predicate device has not been subject to a design-related recall.

5. Description of the Device [21 CFR 807.92a]

Cardio P1 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 user-oriented design enables ECG examination with a single push of a button.

The Cardio P1 is installed on a standalone PC. For all configurations, an independent PC is used that can be positioned for patient convenience.

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

The Cardio P1 Analysis System is intended to acquire, analyze, display, and record ECG information from adult and pediatric populations. Pediatric population is defined as patients between the ages from 3 and less than 16 years.

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 P1 is intended to be used by personnel trained in hospitals or medical professional facilities under the direct supervision of a licensed healthcare practitioner.

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Image /page/5/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 letters are rounded and connected, giving the word a smooth and modern appearance. The overall design is simple and clean, with a focus on readability.

7. Determination of Substantial Equivalence

The Cardio10 is substantially equivalent to legally marketed predicate devices with respect to indications for use and technology characteristics.

Comparison of Proposed Device to Predicate Device K220535

	Proposed Device	Predicate Device
Product Name	Cardio P1	Cardio10
510(k) Number	K231150	K220535
Manufacturer	Bionet Co., Ltd.	Bionet Co., Ltd.
Product Code	DPS	DPS / BZG
Device Class	2	2
Indications for
Use	The Cardio P1 Analysis System is
intended to acquire, analyze, display,
and record ECG information from
adult and pediatric populations.
Pediatric population is defined as
patients between the ages from 3 and
less than 16 years.
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 P1 is intended to
be used by personnel trained in
hospitals or medical professional
facilities under the direct supervision
of a licensed healthcare practitioner.	The Cardio10 ECG Analysis System is
intended to acquire, analyze, display,
and record electrocardiographic
information from adult and pediatric
populations.
Pediatric population is defined as
patients between the ages from 3 and
less than 16 years.
Basic systems deliver 12 lead ECG's,
interpretive analysis, and can be
upgraded to provide software analysis
options such as a high resolution
signal averaging of QRS and P wave
portions of the electrocardiogram. The
12-lead ECG interpretive algorithm
provides a computer-generated
analysis of potential patient cardiac
abnormalities, which must be
confirmed by a physician with other
relevant clinical information.
Transmission and reception of ECG
data to and from a central ECG
cardiovascular information system is
optional.
	Proposed Device	Predicate Device
		The Cardio10 is intended to be used
under the direct supervision of a
licensed healthcare practitioner, by
trained operators in a hospital or
medical professional's facility.
Cardio10 is intended for prescription
		use only to conduct diagnostic
spirometry testing of adults and
pediatric patients, 5 years and older,
in general practice, specialty
physician, and hospital settings. The
device is intended to be used as a
spirometer which measures patient
respiratory parameters including FVC,
COPD, SVC, MVV.
Data storage	According to connected PC
specifications	Internal Storage for 500 data : Built in
memory
Dimension	- 90.75(W) x 103.5(D) x 24.93(H)mm

Approx. 110g | 1) Main Body
300(W) x 299(H) x 123(D) mm
(monitor tilt down)
300(W) x 299(H) x 237(D)mm
(monitor tilt up)296
Approx.4kg

Spiro Handle

48(W) x 39(D) x 201(H) mm
Approx. 250g |
| Target
Population | Adult and pediatric patients | Adult and pediatric patients |
| ECG | | |
| ECG Leads | Simultaneous 12 channel ECG and
acquisition | Simultaneous 12 channel ECG and
acquisition |
| Gain | 2.5, 5, 10, 20, Auto (I~~aVF: 10, V1~~V6: | 2.5, 5, 10, 20, Auto (I~~aVF: 10, V1~~V6: |
| | Proposed Device | Predicate Device |
| | 5) mm/mV | 5) mm/mV |
| Sampling Rate | Analysis Sampling Rate – 500Hz
Digital Sampling Rate -8,000Hz | Analysis Sampling Rate – 500Hz
Digital Sampling Rate -8,000Hz |
| Filters | AC (50/60 Hz, -20dB or better),
Muscle (2535Hz, -3dB or better),
Baseline Drift (0.05Hz, 0.1Hz, 0.2Hz,
-3dB or better),
Low Pass Filter(off, 40Hz, 100Hz,
150Hz) | AC (50/60 Hz, -20dB or better),
Muscle (2535Hz, -3dB or better),
Base line drift (0.05Hz, 0.1Hz, 0.2Hz,
-3dB or better),
Low pass filter(off, 40Hz, 100Hz,
150Hz) |
| Patient data | ID, Name, Date of Birth, Age, Gender,
Height, Weight, Race, Smoke,
Department, Room No., Study Desc.,
Accession No., Referring Physician | ID, Name, Date of Birth, Age, Gender,
Height, Weight, Race, Smoke,
Department, Room no., Study desc.,
Accession No., Referring Physician |
| Basic
Measurement | Heart Rate (30300bpm ±3bpm),
PR/RR Int, QRS Dur, QT/QTc Int,
P-R-T axis, SV1/RV5/R+S Amp
Bionet ECG analysis algorithm(V 3.26) | Heart rate (30300bpm ±3), PR/RR Int,
QRS dur., QT/QTc int.,
P-R-T axis, SV1/RV5/R+S amp.
Bionet ECG analysis algorithm(V 3.26) |

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Image /page/6/Picture/0 description: The image shows the word "bionet" in a stylized font. The first three letters, "bio", are in a light blue color. The last three letters, "net", are in black.

7

The Cardio P1 and predicate devices are same in intended use, their target population and technical characteristics includes ECG leads, Gain, Sampling rate, filters, patient data, measurement, etc.

Differences between Cardio P1 and the predicate device such as Data storage, dimension do not raise any new concerns with respect to safety or effectiveness. The spirometer function of the predicate device is an optional function that does not affect its main function, ECG. The proposed device and predicate device are both designed to meet the IEC 60601-2-25.

Non-Clinical Test Summary

1. Electrical Safety, Electromagnetic Compatibility and Performance:
  The Cardio P1 comply with the electrical safety and electromagnetic compatibility requirements established by the standards.

8

Image /page/8/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 connected and form a single word.

Testing to confirm compliance with IEC 60601-1:2005/AMD1:2012 . Medical electrical equipment - Part 1: General requirements for basic safety and essential performance
Testing to confirm compliance with IEC 60601-1-2:2014 ●

Medical electrical equipment - Part 1-2: General requirements for basic safety and essential performance - Collateral Standard: Electromagnetic disturbances -Requirements and tests

Testing to confirm compliance with IEC 60601-1-6:2010 . Medical electrical equipment - Part 1-6: General requirements for basic safety and essential performance - Collateral standard: Usability
. Testing to confirm compliance with IEC 60601-2-25: 2011 Medical electrical equipment - Part 2-25: Particular requirements for the safety of electrocardiographs
ANSI AAMI EC53 ●
1. Software Validation

The Cardio P1 contain moderate level of concern software and firmware. The software was designed and developed according to a software development process and was verified and validated.

Software information is provided in accordance with FDA guidance:

Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices: Guidance for Industry and FDA Staff
Postmarket Management of Cybersecurity in Medical Devices: Guidance for Industry and Food and Drug Administration Staff
1. Biocompatibility

Most of the contents are prepared by being referenced the following standards:

Cytotoxicity test by EN ISO 10993-5
Sensitization test by EN ISO 10993-10
Intracutaneous reactivity test by ISO 10993-10 ●

#95-1 Biocompatibility Flow Chart for Selection of Toxicity tests for 510(k)s, FDA.

9

Image /page/9/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 rounded and have a modern appearance. The word is presented horizontally.

Clinical Test Summary

Clinical testing is not required

8. Substantial Equivalence [21 CFR 807.92(b)(1) and 807.92]

The non-clinical testing demonstrates the subject device (Cardio P1) is substantially equivalent in terms of technological characteristics to the predicate device (K220535).

Conclusion [21 CFR 807.92(b)(3)] 9.

The Cardio P1 has same intended use and technical characteristics to the predicate device. Based on the information summarized above, the Cardio P1 is substantially equivalent to the predicate device and does not raise any new questions regarding safety or effectiveness.