PCA-C1 series Patient Cable

{0}------------------------------------------------ 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. 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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 {2}------------------------------------------------ # Indications for Use 510(k) Number (if known) K200722 Device Name PCA-C100 Patient Cable Indications for Use (Describe) 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. | Type of Use (Select one or both, as applicable) | <span> <span style="padding-right: 20px;"> <input checked="true" type="checkbox"/> Prescription Use (Part 21 CFR 801 Subpart D) </span> <span> <input type="checkbox"/> Over-The-Counter Use (21 CFR 801 Subpart C) </span> </span> | |-------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| |-------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| CONTINUE ON A SEPARATE PAGE IF NEEDED. 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PCA-C100 Patient Cable Traditional 510(k) 510(k) Summary 510(k) Summary {4}------------------------------------------------ ## 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<br>(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: 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. {5}------------------------------------------------ #### 5.7 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: - 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 {6}------------------------------------------------ OT Medical, Inc. PCA-C100 Patient Cable e, #### ● 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-link<br>Electronics Tech Co., Ltd. | | | Trade Name | QT ECG | Cable / lead-wire | Substantial equivalence<br>determination | | 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 | Substantial<br>equivalence<br>determination | | Indications for<br>Use | PCA-C100 Patient Cable<br>is intended to be used<br>with QT ECG device. The<br>Patient Cable is used to<br>connect electrodes<br>placed at appropriate<br>sites on the patient to<br>an ECG device for<br>general diagnostic<br>evaluation by healthcare<br>professionals. | The Shenzhen Med-link<br>Cable / lead-wire are<br>intended to be used with<br>ECG, EKG, Sp02 and<br>Invasive Blood Pressure<br>monitoring devices. The<br>Cable / lead-wire are used<br>to connect electrodes,<br>catheters, and/or sensors<br>placed at appropriate sites<br>on the patient to a<br>monitoring device for<br>general monitoring and/or<br>diagnostic evaluation by<br>healthcare professional. | Equivalent<br>PCA-C100 Patient Cable<br>is used with a specified<br>ECG device (QT ECG) and<br>can not be used with a<br>defibrillator. The<br>predicate has various<br>types connect to various<br>devices, like ECG, EKG,<br>and Spo2 and invasive<br>blood pressure<br>monitoring devices.<br>The differences in<br>indications for use do<br>not change the device's<br>intended use to connect<br>electrodes placed at<br>appropriate sites on the<br>patient to a general<br>diagnostic evaluation<br>device by healthcare<br>professionals. | | Patent Usage | Reusable | Reusable | Identical | | Anatomical Site | The ECG cable attached<br>to sensors places at<br>standard specified<br>locations on the chest<br>wall. | The ECG and EKG cable<br>attached to sensors places<br>at standard specified<br>locations on the chest wall. | Identical | | Design /<br>Appearance | ECG and EKG Cable<br>with connector (lead<br>wire, electrode snapper) | ECG and EKG Cables with<br>various connectors<br>(monitor, truck / lead wire,<br>electrode grabber &<br>snapper) | Equivalent<br>PCA-C100 Patient Cable<br>differs in that it has only<br>one type to connect a<br>specified device (QT<br>ECG), and only one type<br>(snapper) to connect<br>with electrodes. | | Item | Subject Device | Predicate device | Substantial<br>equivalence<br>determination | | Cable Length | 550mm (limb lead)<br>350mm (chest lead) | Various specified<br>3060mm<br>(model:VA008BBA) | Equivalent<br>Since the main device<br>(QT ECG) is closer to<br>the patient, the cable<br>length is shorter than<br>the predicate device.<br>Both devices provide<br>adequate length to<br>connect with the main<br>device and electrode. | | Wire Material | Shielded & Unshielded<br>Copper with TPU Jacket | Shielded & Unshielded<br>Copper with PVC or TPU<br>Jacket | Identical | | Sterility | Non sterile | Non sterile | Identical | | Biocompatibility<br>Evaluation | All the patient contracting<br>materials are evaluated by<br>the biocompatibility<br>standard ISO 10993-5,<br>ISO 10993-10 | All the patient contracting<br>materials are evaluated by<br>the biocompatibility<br>standard ISO 10993-5, ISO<br>10993-10 | Identical | | Connector<br>Retention Force | ANSI/AAMI EC 53:2013 | ANSI/AAMI EC 53:1995 /<br>(R) 2001 | Identical | | Performance<br>and Safety | ANSI/AAMI EC 53:2013<br>and IEC 60601-1:2005 +<br>A1:2012 | ANSI/AAMI EC 53:1995 /<br>(R) 2001 and IEC 60601-<br>1:1998; AM1; A2:1995 | Identical | {7}------------------------------------------------ # QT Medical, Inc. PCA-C100 Patient Cable Traditional 510(k) 510(k) Summary {8}------------------------------------------------ Traditional 510(k) 510(k) Summary {9}------------------------------------------------ #### 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.