(53 days)
Not Found
No
The device description explicitly states it has "no additional non-electrical conducting or processing functionality" and the summary does not mention any AI/ML terms or related concepts like image processing, training/test sets, or performance metrics typically associated with AI/ML algorithms.
No
Explanation: The device is a cable that transmits electrical signals between monitoring devices and the patient. It does not generate any power or signal, nor does it have any therapeutic function; its purpose is solely for monitoring and diagnostic evaluation.
No
Explanation: The device described is a Patient Monitoring Cable, which transmits electrical signals between patient sensors/electrodes and a monitoring device. It does not perform any diagnostic evaluation itself; it merely facilitates the connection to devices that may be used for diagnostic evaluation by a healthcare professional.
No
The device description explicitly states it is an electrical cord with connectors, designed to transmit electrical power and/or signal between medical devices. This describes a physical hardware component, not software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices used to examine specimens taken from the human body (like blood, urine, or tissue) to provide information about a person's health. This testing is done outside of the body (in vitro).
- Device Function: The description clearly states that the Patient Monitoring Cables are used to connect sensors and electrodes placed on the patient to a monitoring device. They transmit electrical signals from the patient's body to the monitor.
- Lack of Specimen Testing: There is no mention of the device being used to test any biological specimens taken from the patient.
The device is a component used in patient monitoring, which is a form of in vivo (within the living body) measurement and monitoring.
N/A
Intended Use / Indications for 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.
Product codes (comma separated list FDA assigned to the subject device)
DSA
Device Description
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.
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
Not Found
Intended User / Care Setting
health care professional
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)
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 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.
The subject and predicate devices are exactly the same. Since the cables are identical, no further clinical testing is necessary.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 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).
0
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 features the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue text.
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
1
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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3
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
4
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 and
K142489) | |
|-------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------|
| 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. | The Unimed patient cables and lead
wires are intended to be used with
ECG, EKG, Spo2 and BP monitoring
devices. The patient cables and lead
wires 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. | |
| | Prescription/
over-the-counter use | Prescription | Prescription |
| | Design/Appearance | Cables with various
connectors(monitor,
trunk/lead wire, electrode grabber &
snapper) | Cables with various
connectors(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 | |
| Conformance
standard | 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
5
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