PCA-C100 Patient Cable is intended to be used with QT ECG device. The Patient Cable is used to connect electrodes placed at appropriate sites on the patient to an ECG device for general diagnostic evaluation by healthcare professionals.

Device Description

The PCA-C100 Patient Cable is a reusable ECG patient cable that is used to transmit cardiac electrical signals (ECG) from electrodes, which are affixed to the patient's body for both diagnostic purposes. The PCA-C100 Patient Cable is a crucial part of the system used diagnose the cardiac electrical signal (ECG). It allows a safe connection between the electrodes on the patient and QT ECG (K180157). The PCA-C100 Patient Cable is composed of three components: Snap - Connected with Leadwire and commercial ECG electrode. Leadwire - fitted with Trunk, and connected with ten Snaps. Trunk - Fitted with two ends: one of them connects the QT ECG (K180157); and the other end connects the Leadwires.

AI/ML Overview

The document provided is a 510(k) Summary for the PCA-C100 Patient Cable, which is a medical device for transmitting cardiac electrical signals. This type of device is relatively simple and does not involve AI or complex diagnostic algorithms, so many of the requested criteria (like ground truth, expert consensus, MRMC studies, or training/test set details) are not applicable.

Based on the provided information, here's a summary of the acceptance criteria and the study proving the device meets those criteria:

Device: PCA-C100 Patient Cable
Intended Use: To connect electrodes placed at appropriate sites on the patient to an ECG device (specifically QT ECG device, K180157) for general diagnostic evaluation by healthcare professionals.

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria are generally based on compliance with recognized medical device standards for electrical safety, biocompatibility, and performance for patient cables. The reported device performance indicates successful compliance with these standards.

Acceptance Criteria Category	Specific Standard/Test	Acceptance Criteria (Implicit)	Reported Device Performance
Biocompatibility	In Vitro Cytotoxicity Test	Pass (non-cytotoxic)	Met the requirements
	White Rabbit Skin Irritation Test	Pass (non-irritating)	Met the requirements
	Skin Sensitization Study (Maximization Test)	Pass (non-sensitizing)	Met the requirements
Electrical Safety	ANSI AAMI EC53:2013 (ECG Trunk Cables And Patient Leadwires)	Compliance with standard electrical safety requirements	Met the requirements
	ANSI AAMI 60601-1: ES60601-1:2005/(R)2012 And A1:2012 C1:2009/(R)2012 And A2:2010/(R)2012 (Consolidated Text) Medical Electrical Equipment - Part 1: General Requirements For Basic Safety And Essential Performance	Compliance with general requirements for basic safety and essential performance	Met the requirements
Performance	Safety and Essential Performance of Electrocardiographs	Compliance with relevant performance aspects for ECG patient cables	Met the requirements
	Leadwires to trunk cable interconnection (ANSI AAMI EC53:2013)	Secure and proper interconnection	Met the requirements
	Bench Performance Testing	Met established protocols and requirements	Met the requirements
Connector Retention Force	ANSI/AAMI EC 53:2013	Retention force within specified limits	Met the requirements

2. Sample Size Used for the Test Set and Data Provenance

The document does not specify a "test set" in the context of diagnostic performance evaluation with a dataset of patient cases because this device is a patient cable, not a diagnostic algorithm.

Sample Size: The testing was conducted on physical samples of the PCA-C100 Patient Cable. The exact number of samples used for each test (biocompatibility, electrical safety, performance) is not specified in this summary document.
Data Provenance: Not applicable in the context of patient data for a diagnostic algorithm. The tests were performed in a laboratory setting on the device itself.

3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications

Not applicable. This device is a passive patient cable, not a diagnostic algorithm that requires expert interpretation for establishing ground truth on patient data. Ground truth, in this context, refers to the verifiable correctness of the device's physical and electrical properties against established standards.

4. Adjudication Method for the Test Set

Not applicable for this type of device. Adjudication methods like 2+1 or 3+1 are used in studies involving human interpretation or AI output review, which is not relevant for a patient cable.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done

No, an MRMC comparative effectiveness study was not done. Such studies are typically performed for diagnostic imaging or analytical devices where human readers interpret results, sometimes with and without AI assistance, to assess diagnostic accuracy or efficiency. This is not applicable to a patient cable.

6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Was Done

Not applicable. This device is a patient cable, not an algorithm.

7. The Type of Ground Truth Used

The "ground truth" for this device's performance evaluation is established by objective measurements and assessments against recognized industry standards and scientific principles during non-clinical (bench) testing. For example:

Biocompatibility: In-vitro and in-vivo tests to determine the material's interaction with biological systems according to ISO 10993 standards.
Electrical Safety: Measurements of electrical parameters (e.g., leakage current, impedance) compared against limits specified in IEC 60601-1 and ANSI AAMI EC53.
Performance: Functional testing to ensure proper signal transmission and mechanical integrity according to ANSI AAMI EC53.

8. The Sample Size for the Training Set

Not applicable. This device is a hardware component and does not utilize machine learning or AI, therefore it does not have a "training set."

9. How the Ground Truth for the Training Set Was Established

Not applicable. As there is no training set for an AI algorithm, no ground truth needed to be established for it.

Summary

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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: a symbol on the left and the FDA name on the right. The symbol on the left is a stylized image of a human figure, while the FDA name on the right is written in blue letters. The words "U.S. FOOD & DRUG ADMINISTRATION" are written in a clear, sans-serif font.

June 3, 2021

QT Medical, Inc. Ruey-Kang Chang CEO 1360 Valley Vista Dr., Suite 203 Diamond Bar, California 91765

Re: K200722

Trade/Device Name: PCA-C1 series Patient Cable Regulation Number: 21 CFR 870.2900 Regulation Name: Patient Transducer And Electrode Cable (Including Connector) Regulatory Class: Class II Product Code: DSA Dated: May 19, 2021 Received: June 1, 2021

Dear Ruey-Kang Chang:

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

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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/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 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,

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

Enclosure

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Indications for Use

510(k) Number (if known) K200722

Device Name

PCA-C100 Patient Cable

Indications for Use (Describe)

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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QT Medical, Inc. PCA-C100 Patient Cable Traditional 510(k) 510(k) Summary

510(k) Summary

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510(k) SUMMARY

5.1	Type of Submission:	Traditional 510(k)
5.2	Date of Summary:	02/20/2020
5.3	Submitter:	QT Medical, Inc.
	Address:	1360 Valley Vista Dr., Suite 203, Diamond Bar, CA 91765, USA
	Phone:	+1 909 323 0007
	Fax:	+1 310 755 3108
	Contact:	Ruey-Kang Chang
		(rk.chang@qtmedical.com)

5.4 Identification of the Device:

Proprietary/Trade name:	PCA-C100 Patient Cable
Classification Product Code:	DSA
Regulation Number:	870.2900
Regulation Description:	Patient transducer and electrode cable(including connector).
Review Panel:	Cardiovascular
Device Class:	II

ર્સ્ડ Identification of the Predicate Device:

Predicate Device Name:	Cable / lead-wire
Manufacturer:	Shenzhen Med-link Electronics Tech Co., Ltd.
Classification Product Code:	DSA
Regulation number:	870.2900
Device Class:	II
510(k) Number:	K120010

5.6 Indications for Use of the Device

Indication for Use:

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5.7 Device Description

The PCA-C100 Patient Cable is a crucial part of the system used diagnose the cardiac electrical signal (ECG). It allows a safe connection between the electrodes on the patient and QT ECG (K180157).

The PCA-C100 Patient Cable is composed of three components:

. Snap - Connected with Leadwire and commercial ECG electrode.
. Leadwire - fitted with Trunk, and connected with ten Snaps.
. Trunk - Fitted with two ends:
- ם one of them connects the QT ECG (K180157); and
- ם the other end connects the Leadwires.

5.8 Non-clinical Testing

A series of safety and performance tests were conducted on the subject device, PCA-C100 Patient Cable.

● Biocompatibility

In Vitro Cytotoxicity Test
White Rabbit Skin Irritation Test
Skin Sensitization Study (Maximization Test) i

. Electromagnetic compatibility and electrical safety tests

Electrical Safty Test
- ANSI AAMI EC53:2013

ECG Trunk Cables And Patient Leadwires

ANSI AAMI 60601-1: ES60601-1:2005/(R)2012 And A1:2012
C1:2009/(R)2012 And A2:2010/(R)2012 (Consolidated Text) Medical Electrical Equipment - Part 1 : General Requirements For Basic Safety And Essential Performance (IEC 60601-1:2005, MOD)
Safety and Essential Performance of Electrocardiographs
. Leadwires to trunk cable interconnection
- ANSI AAMI EC53:2013, ECG Trunk Cables And Patient Leadwires

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OT Medical, Inc. PCA-C100 Patient Cable

● Performance & Shelf life

Shelf life testing is not applicable since the PCA-C100 Patient Cable is reusable.
Performance testing - Bench was conducted on the PCA-C100 Patient Cable according with established protocols and test results confirm that the final product met the requirements for the safety and performance standards and it's intended use.
Performance testing - Clinical is not required and was not performed to demonstrate safty and effectiveness of PCA-C100 Patient Cable.
Performance testing - Animal is not required and was not performed to demonstrate safty and effectiveness of PCA-C100 Patient Cable.

All the test results demonstrate PCA-C100 Patient Cable meets the requirements of its predefined acceptance criteria and intended use, and is substantially equivalent to the predicate device.

5.9 Substantial Equivalence Determination

The PCA-C100 Patient Cable submitted in this 510(k) file is substantially equivalent in intended use, technology/mechanism of action, safety and performance to the cleared device, Cable / lead-wire (K120010). Differences between the devices cited in this section do not raise any new issue of substantial equivalence.

Item	Subject device	Predicate device
Manufacturer	QT Medical, Inc.	Shenzhen Med-linkElectronics Tech Co., Ltd.
Trade Name	QT ECG	Cable / lead-wire	Substantial equivalencedetermination
Common Name	Cable / lead-wire	Cable / lead-wire
Device Model	PCA-C100	VA018BCA
510(k) No.	(to be assigned)	K120010
Product Code	DSA	DSA	Identical
Regulation Number	870.2900	870.2900	Identical
Item	Subject Device	Predicate device	Substantialequivalencedetermination
Indications forUse	PCA-C100 Patient Cableis intended to be usedwith QT ECG device. ThePatient Cable is used toconnect electrodesplaced at appropriatesites on the patient toan ECG device forgeneral diagnosticevaluation by healthcareprofessionals.	The Shenzhen Med-linkCable / lead-wire areintended to be used withECG, EKG, Sp02 andInvasive Blood Pressuremonitoring devices. TheCable / lead-wire are usedto connect electrodes,catheters, and/or sensorsplaced at appropriate siteson the patient to amonitoring device forgeneral monitoring and/ordiagnostic evaluation byhealthcare professional.	EquivalentPCA-C100 Patient Cableis used with a specifiedECG device (QT ECG) andcan not be used with adefibrillator. Thepredicate has varioustypes connect to variousdevices, like ECG, EKG,and Spo2 and invasiveblood pressuremonitoring devices.The differences inindications for use donot change the device'sintended use to connectelectrodes placed atappropriate sites on thepatient to a generaldiagnostic evaluationdevice by healthcareprofessionals.
Patent Usage	Reusable	Reusable	Identical
Anatomical Site	The ECG cable attachedto sensors places atstandard specifiedlocations on the chestwall.	The ECG and EKG cableattached to sensors placesat standard specifiedlocations on the chest wall.	Identical
Design /Appearance	ECG and EKG Cablewith connector (leadwire, electrode snapper)	ECG and EKG Cables withvarious connectors(monitor, truck / lead wire,electrode grabber &snapper)	EquivalentPCA-C100 Patient Cablediffers in that it has onlyone type to connect aspecified device (QTECG), and only one type(snapper) to connectwith electrodes.
Item	Subject Device	Predicate device	Substantialequivalencedetermination
Cable Length	550mm (limb lead)350mm (chest lead)	Various specified3060mm(model:VA008BBA)	EquivalentSince the main device(QT ECG) is closer tothe patient, the cablelength is shorter thanthe predicate device.Both devices provideadequate length toconnect with the maindevice and electrode.
Wire Material	Shielded & UnshieldedCopper with TPU Jacket	Shielded & UnshieldedCopper with PVC or TPUJacket	Identical
Sterility	Non sterile	Non sterile	Identical
BiocompatibilityEvaluation	All the patient contractingmaterials are evaluated bythe biocompatibilitystandard ISO 10993-5,ISO 10993-10	All the patient contractingmaterials are evaluated bythe biocompatibilitystandard ISO 10993-5, ISO10993-10	Identical
ConnectorRetention Force	ANSI/AAMI EC 53:2013	ANSI/AAMI EC 53:1995 /(R) 2001	Identical
Performanceand Safety	ANSI/AAMI EC 53:2013and IEC 60601-1:2005 +A1:2012	ANSI/AAMI EC 53:1995 /(R) 2001 and IEC 60601-1:1998; AM1; A2:1995	Identical

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QT Medical, Inc. PCA-C100 Patient Cable

Traditional 510(k) 510(k) Summary

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Traditional 510(k) 510(k) Summary

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5.10 Similarity and Difference

The PCA-C100 Patient Cable has been compared with "Cable/Lead-Wire ". The subject device has the same intended use, technology/mechanism of action, safety and performance as the predicate device. Although there are some specifications that are different between two devices, the performance test and usability test have been completed to demonstrate that the differences between these parameters would not impact the safety and effectiveness of the subject device. The subject device has undergone safety and performance tests, and the results complied with the test requests. Therefore, the difference between the subject device and the predicate device did not raise any problem of substantial equivalence. The subject device is substantially equivalent to the predicate device in intended use, safety and performance claims.

5.11 Conclusion

In conclusion, QT Medical, Inc. believes that PCA-C100 Patient Cable is as safe and as effective as the predicate, and thus, is substantially equivalent to the predicate device.

Regulation Number and Section

§ 870.2900 Patient transducer and electrode cable (including connector).

(a)
Identification. A patient transducer and electrode cable (including connector) is an electrical conductor used to transmit signals from, or power or excitation signals to, patient-connected electrodes or transducers.(b)
Classification. Class II (performance standards).