The Biolog™ 3000i Electrocardiograph with BLY-501 Adaptor detects an ECG using a single lead patient cable or alternatively can receive ECG data detected by the Micromedical 12 Lead Simultaneous Cable. The Biolog™ 3000i Electrocardiograph can record the ECG, display the ECG signal on a built-in LCD screen, and download the recorded ECG data to a PC running CardioView 3000 software or to the Micromedical Printer Interface. The device contains proprietary software algorithms to detect an ECG signal or receive ECG data from a patient cable, remove unwanted interference from the ECG signal, store the signal into memory, and download it to peripheral devices. The device includes a Biolog™ 3000i Electrocardiograph, a User's Manual, a BLY-501 Adaptor, and accessories. It is intended for use with the Medtronic Physio Control LIFEPAK 500 defibrillator to visually display the patient's ECG to the user of the LIFEPAK 500 defibrillator.

Device Description

The proposed device is an ABS plastic docking station for the Biolog™ 3000i electrocardiograph that allows the Biolog™ 3000i electrocardiograph to be connected to a LIFEPAK 500 defibrillator. The defibrillator does not have a visual display, and the connection to the Biolog™ 3000 electrocardiograph allows the patient's EKG to be visually displayed on the Biolog™ 3000i electrocardiograph to enhance the usability of the defribrillator.

AI/ML Overview

This 510(k) summary (K012540) for the BLY-501 Adaptor for Biolog™ 3000i electrocardiograph provides very limited information regarding detailed acceptance criteria or a comprehensive study demonstrating direct performance metrics.

Here's an analysis of the provided text, structured to address your questions, while acknowledging the inherent limitations of the available information:

Analysis of Acceptance Criteria and Study Details:

This submission is for an adaptor (BLY-501) that enables connectivity between an existing electrocardiograph (Biolog™ 3000i) and a defibrillator (LIFEPAK 500). The primary function of the adaptor is to allow the ECG signal, already detected and processed by the Biolog™ 3000i, to be visually displayed on the Biolog™ 3000i's screen when connected to the defibrillator. The adaptor itself does not perform any signal analysis or algorithm-based detection. Therefore, the "acceptance criteria" and "study" described are focused on the functionality and safety of this connectivity, rather than on algorithmic performance as typically seen in submissions for AI-powered diagnostic devices.

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria	Reported Device Performance
Functional Connectivity: The BLY-501 Adaptor must successfully connect to the Biolog™ 3000i electrocardiograph and the LIFEPAK 500 defibrillator.	The nonclinical testing "verified that the modified device displayed acceptable performance" regarding the modification. This implies that the connection was successful and allowed for the intended visual display of the ECG.
ECG Signal Display: When connected, the BLY-501 Adaptor must enable the visual display of the patient's ECG (detected by the Biolog™ 3000i) on the Biolog™ 3000i's built-in LCD screen.	"Testing verified that the modified device displayed acceptable performance." The stated intended use is "to visually display the patient's ECG to the user of the LIFEPAK 500 defibrillator," indicating this function was achieved.
Maintain Safety and Performance of Predicate Device: The addition of the BLY-501 Adaptor must not adversely affect the safety or performance characteristics of the predicate Biolog™ 3000i electrocardiograph or the LIFEPAK 500 defibrillator.	"The technological features of the BLY-501 do not differ significantly from the Biolog™ 3000i electrocardiograph." The nonclinical testing confirmed "acceptable performance." This implies no negative impact on existing devices.

2. Sample size used for the test set and the data provenance

Test Set Sample Size: Not explicitly mentioned. The document states "Nonclinical testing was performed," but does not specify the number of devices or test scenarios involved. Given the nature of an adaptor, the "test set" would likely involve a limited number of physical units subjected to functional tests.
Data Provenance: Not explicitly mentioned. Since it's nonclinical testing for device functionality, it would have been conducted in a lab or testing facility rather than with patient data.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

Number of Experts: Not applicable or not mentioned. For a simple connectivity adaptor, "ground truth" as it pertains to clinical interpretation would not be relevant. The "ground truth" for the nonclinical tests would be defined by engineering specifications and functional requirements (e.g., "does the ECG display correctly?").
Qualifications of Experts: Not applicable or not mentioned. Testing personnel would likely be engineers or technicians ensuring functional specifications are met.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

Adjudication Method: Not applicable. Adjudication methods like 2+1 or 3+1 are used for clinical judgment in complex diagnostic tasks. For functional testing of an adaptor, the assessment is typically binary (pass/fail) against engineering specifications.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

MRMC Study: No, an MRMC study was not done.
Effect Size: Not applicable. This device is purely for displaying an already detected ECG; it does not involve AI or assist human readers with diagnostic interpretation in the way an AI algorithm would. Its purpose is to make pre-existing information accessible.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

Standalone Study: The device itself (the BLY-501 Adaptor) does not contain a diagnostic algorithm. The Biolog™ 3000i electrocardiograph contains "proprietary software algorithms to detect an ECG signal or receive ECG data from a patient cable, remove unwanted interference from the ECG signal, store the signal into memory," but the performance of those algorithms is not the subject of this particular 510(k) submission, which is only for the adaptor. The adaptor simply facilitates the display of the Biolog™ 3000i's output. Therefore, a standalone algorithm performance study for the adaptor was not applicable and not performed.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)

Type of Ground Truth: For the nonclinical testing of the BLY-501 Adaptor, the "ground truth" would be defined by the functional and electrical specifications of the Biolog™ 3000i and LIFEPAK 500 equipment and the adaptor itself. This would involve ensuring correct electrical connections, signal integrity, and proper display. It does not involve medical ground truth like expert consensus or pathology, as the adaptor is not an interpretive device.

8. The sample size for the training set

Training Set Sample Size: Not applicable. The BLY-501 Adaptor is a hardware component (an ABS plastic docking station) that enables connectivity. It does not use machine learning or AI, and therefore, no "training set" is required.

9. How the ground truth for the training set was established

Ground Truth for Training Set: Not applicable, as there is no training set for this device.

Summary

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K012540

SEP 2 6 2001

510(k) SUMMARY

Submitted by:

Micromedical Industries Ltd

Date Prepared:

August 6, 2001

Proposed Device:

BLY-501 Adaptor for Biolog™ 3000i electrocardiograph

Predicate Device:

Biolog™ 3000i electrocardiograph

Device Description:

Statement of Intended Use:

The Biolog™ 3000i Electrocardiograph with BLY-501 Adaptor detects an ECG using a single lead patient cable or alternatively can receive ECG data detected by the Micromedical 12 Lead Simultaneous Cable. The Biolog™ 3000i Electrocardiograph can record the ECG, display the ECG signal on a built-in LCD screen, and download the recorded ECG data to a PC running Cardio View 3000 software or to the Micromedical Printer Interface. The device contains proprietary software algorithms to detect an ECG signal or receive ECG data from a patient cable, remove unwanted interference from the ECG signal, store the signal into memory, and download it to peripheral devices. The device includes a Biolog™ 3000i Electrocardiograph, a User's Manual, a BLY-501 Adaptor, and accessories. It is intended for use with the Medironic Physio Control LIFEPAK 500 defibrillator to visually display the patient's ECG to the user of the LIFEPAK 500 defibrillator.

CONFIDENTIAL

MicroMedical Industries Ltd.

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Summary of Technological Characteristics or New Device to Predicate Devices

The technological features of the BLY-501 do not differ significantly from the Biolog™ 3000i electrocardiograph. The predicate device and the modified device are identical with the exception that the modified device has the connectivity feature of the BLY-501 Adaptor to allow it to connect to a LIFPAK 500 defibrillator to allow a visual reading of the patient's EKG.

Discussion of Nonclinical Tests; Conclusions Drawn from Nonclinical Tests

Nonclinical testing was performed to evaluate the modification to the predicate device. Testing verified that the modified device displayed acceptable performance.

CONFIDENTIAL

MicroMedical Industries Ltd.

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Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an abstract symbol that resembles an eagle or bird in flight, composed of three curved lines.

Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

SEP 2 6 2001

Mr. Stephen Cresswell MicroMedical Industries, Ltd. 11 Technology Drive Labrador, Queensland 4215 Australia

Re: K012540 Trade Name: BLY-501 Adapter Regulation Number: 21 CFR 870.2340 Regulation Name: Electrocardiograph Regulatory Class: II (two) Product Code: 74 DPS Dated: September 17, 2001 Received: September 18, 2001

Dear Mr. Cresswell:

We have reviewed your Section 510(k) notification of intent to market the device referenced above and we 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). You may, therefore, market the device, subject to the general controls provisions of the Act. 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.

If your device is classified (see above) into either class II (Special Controls) or class III (Premarket Approval), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 895. A substantially equivalent determination assumes compliance with the Current Good Manufacturing Practice requirements, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic QS inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, FDA may publish

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Page 2 - Mr. Stephen Creswell

response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.

This letter will allow you to begin marketing your device as described in your 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4646. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its internet address "http://www.fda.gov/cdrh/dsma/dsmamain.html".

Sincerely yours.

James E. Dillard III

Director Division of Cardiovascular and Respiratory Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Indication for Use

K012540 Not Available 510(k) Number:

Biolog™ 3000i Electrocardiograph with BLY-501 Adaptor Device Name:

Indication for Use:

(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)
Division of Cardiovascular & Respiratory Devices

510(k) Number	K012540
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Prescription Use(Per 21 CFR 801.109)	X
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Over-The-Counter Use
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CONFIDENTIAL

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).