(53 days)
The Patient Monitoring Cables are intended to be used with ECG, EKG, Spo2 and BP monitoring devices. The Patient Monitoring Cables are used to connect electrodes, catheters, and/or sensors placed at appropriate sites on the patient to a monitoring device for general monitoring and/or diagnostic evaluation by heath care professional.
Patient Monitoring Cables are the replacements for similar cables manufactured by Original Equipment Manufacturers (OEM) for their respective monitors. It is a non-patient-contact, insulated, shielded, electrical cord with a connector (plug) at both ends designed to transmit electrical power and/or signal (data) between medical devices (e.g., to connect ECG electrodes, SpO2 sensor, IBP transducer to a patient monitor). It is not intended to connect to the mains (i.e., not a mains power cable), does not generate any type of power and/or signal, and has no additional non-electrical conducting or processing functionality.
This document does not contain an AI/ML device study. Instead, it is a 510(k) premarket notification for Patient Monitoring Cables. The filing asserts substantial equivalence to predicate devices (K082959 and K142489) based on the fact that the subject device's cables are "exactly the same" and "identical" to the predicate devices.
Therefore, the requested information about acceptance criteria, device performance, sample sizes, expert ground truth, adjudication methods, MRMC studies, standalone performance, and training set details for an AI/ML device study is not applicable to this submission.
The document primarily discusses:
- Intended Use: Patient Monitoring Cables are used with ECG, EKG, SpO2, and BP monitoring devices to connect electrodes, catheters, and/or sensors to a monitoring device for general monitoring and/or diagnostic evaluation by healthcare professionals.
- Comparison to Predicate Devices: The submission states that the subject device is "exactly the same" as the predicate devices in terms of intended use, design/appearance, cable length, material, usage (reusable and disposable), sterility, and conformance to standards (IEC 60601-1, EC53, ISO 10993-5, -10).
- Non-clinical Test Data: The device meets recognized standards for safety (IEC 60601-1), performance (ANSI AAMI EC53), and biocompatibility (ISO 10993-1, -5, -10). Biocompatibility tests for cytotoxicity, sensitization, and skin irritation were conducted on the proposed device, showing no adverse effects.
- Clinical Test Data: No clinical testing was deemed necessary because the subject and predicate devices are stated to be "exactly the same."
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February 5, 2021
JKH USA, LLC Bill Dai Manager 14271 Jeffrey Rd. #246 Irvine, California 92620
Re: K203635
Trade/Device Name: Patient Monitoring Cables Regulation Number: 21 CFR 870.2900 Regulation Name: Patient Transducer And Electrode Cable (Including Connector) Regulatory Class: Class II Product Code: DSA Dated: December 9, 2020 Received: December 14, 2020
Dear Bill Dai:
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 statutes and regulations administered by other Federal agencies. You must comply with all the Act's
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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 (OS) 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) N/A
Device Name Patient Monitoring Cables
Indications for Use (Describe)
The Patient Monitoring Cables are intended to be used with ECG, EKG, Spo2 and BP monitoring devices. The Patient Monitoring Cables are used to connect electrodes, catheters, and/or sensors placed at appropriate sites on the patient to a monitoring device for general monitoring and/or diagnostic evaluation by heath care professional.
| Type of Use (Select one or both, as applicable) | |
|---|---|
| X Prescription Use (Part 21 CFR 801 Subpart D) | Over-The-Counter Use (21 CFR 801 Subpart C) |
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510(k) Summary
| Submitter: | Name: JKH USA, LLC | |
|---|---|---|
| Mailing Address: 14271 Jeffrey Rd. #246, Irvine, CA 92620 | ||
| Contact Person: | Name: Bill Quanqin Dai | |
| Phone Number: 909-929-9896 | ||
| Email Address: Bill@jkhUSA.com | ||
| Date Prepared: | 12/09/2020 | |
| Device Trade Name: | Patient Monitoring Cables | |
| Device Common Name: | Cable, Transducer and Electrode, Patient, (Including Connector) | |
| Model: | PDX-2595, PDX-90S, PMQ-2586, PMQ3-90P, PMQ5-90P, PAA-2585,PAA5-90P, P2540S, PD5-90S, PE1O-HP-B, PE10-MQ12-B, PU708-01,PU708-21, PU708-40, PBC-6P-UT, PHT3-90DS, PDG5-90DS,PSMB3-90DP, PHPA5-90DP, P2385DS, PMR5-90DS, PAP5-90DS,PMQ3-90DS, PNKB6-90DS, PD3-90DS, PAAB5-90DS, PDT5-90DS,P2586DP, PMQB6-90DS, PAAB3-90DP, PAP6-90DS, PDG3-90DP,PAT5-90DP, PMR5-90DP, PDT3-90DS, PDG6-90DS, PAT3-90DS,P2396DS, P2386DP, PHT5-90DS, PSM5-90DS, P2585DP, PNKB3-90DS,PD5-90DP, PAP3-90DP, P2596DS, P2312DP, P2512DP, PHP3-90DS,PMQ5-90DS | |
| Classification Names: | Cable, Transducer and Electrode, Patient, (Including Connector) | |
| Regulation Number: | 21 CFR 870.2900 | |
| Product Code: | DSA | |
| Predicate Device 1: | ||
| 510(k) Number: | K082959 | |
| Device Name: | Patient monitoring Cables for ECG, EKG, SpO2 and Blood Pressure | |
| Monitors | ||
| Manufacturer: | UNIMED MEDICAL SUPPLIES INC | |
| Predicate Device 2: | ||
| 510(k) Number: | K142489 | |
| Device Name: | Unimed Disposable ECG Lead Wires | |
| Manufacturer: | UNIMED MEDICAL SUPPLIES INC |
Description of Devices:
Patient Monitoring Cables are the replacements for similar cables manufactured by Original Equipment Manufacturers (OEM) for their respective monitors.
It is a non-patient-contact, insulated, shielded, electrical cord with a connector (plug) at both ends designed to transmit electrical power and/or signal (data) between medical devices (e.g., to connect ECG electrodes, SpO2 sensor, IBP transducer to a patient monitor). It is not intended to connect to the mains (i.e., not a mains power cable), does not generate any type of power and/or signal, and has no additional non-electrical conducting or processing
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functionality.
Intended Use:
The Patient Monitoring Cables are intended to be used with ECG, EKG, Spo2 and BP monitoring devices. The Patient Monitoring Cables are used to connect electrodes, catheters, and/or sensors placed at appropriate sites on the patient to a monitoring device for general monitoring and/or diagnostic evaluation by heath care professional.
Comparison to predicate device:
The subject and predicate devices are exactly the same, and there is no any difference between them.
| Description | Subject Device | Predicate Device (K082959 andK142489) | |
|---|---|---|---|
| Intended use | The Patient Monitoring Cables areintended to be used with ECG, EKG,Spo2 and BP monitoring devices. ThePatient Monitoring Cables are usedto connect electrodes, catheters,and/or sensors placed at appropriatesites on the patient to a monitoringdevice for general monitoring and/ordiagnostic evaluation by heath careprofessional. | The Unimed patient cables and leadwires are intended to be used withECG, EKG, Spo2 and BP monitoringdevices. The patient cables and leadwires are used to connect electrodes,catheters, and/or sensors placed atappropriate sites on the patient to amonitoring device for generalmonitoring and/or diagnosticevaluation by heath care professional. | |
| Prescription/over-the-counter use | Prescription | Prescription | |
| Design/Appearance | Cables with variousconnectors(monitor,trunk/lead wire, electrode grabber &snapper) | Cables with variousconnectors(monitor,trunk/lead wire, electrode grabber &snapper) | |
| Cable length | Various specified standard lengths | Various specified standard lengths | |
| Material | Tin copper, PA66, PVC, ABS | Tin copper, PA66, PVC, ABS | |
| Usage | Reusable and disposable | Reusable and disposable | |
| Sterile | Non-sterile | Non-sterile | |
| Conformancestandard | IEC60601-1(Safety) | IEC 60601-1(Safety) | |
| EC53(Performance) | EC53(Performance) | ||
| ISO 10993-5, -10(Biocompatibility) | ISO 10993-5, -10(Biocompatibility) |
Table 1 Substantial Equivalence Table
Non-clinical test data:
The subject device meets the following the recognized standards:
- IEC 60601-1 Medical Electrical Equipment-Part 1: General Requirements for Safety
- ANSI AAMI EC53 ECG trunk cables and patient lead wires
- ISO 10993-1 Biological evaluation of medical devices-Part 1: Evaluation and testing within
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a risk management process
- ISO 10993-5, Biological evaluation of medical devices-Part 5: Tests for In Vitro cytotoxicity
- ISO 10993-10, Biological evaluation of medical devices-Part 10: Tests for irritation and delayed-type hypersensitivity
The proposed device belongs to skin contact, and the contact duration is less than 30d. Biocompatibility tests have been conducted on proposed device, including cytotoxicity, sensitization, and skin irritation. The test results show that the proposed device has no cytotoxicity, sensitization, or skin irritation.
Clinical test data:
The subject and predicate devices are exactly the same. Since the cables are identical, no further clinical testing is necessary..
Substantial Equivalence:
The subject and predicate devices are exactly the same. The cables are identical to the cleared version and are not modified. Therefore, the subject device is substantially equivalent to the predicate device
§ 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).