(166 days)
Not Found
No
The device description and intended use are limited to the physical components (cable and leadwires) for transmitting ECG signals. There is no mention of any software, algorithms, or data processing that would suggest the use of AI or ML. The performance studies focus on electrical and biocompatibility standards, not algorithmic performance.
No
The device is described as an "ECG Cable/Leadwires" that transmits ECG signals for diagnostic and monitoring purposes. Its function is to connect electrodes to an ECG monitor, which is for signal acquisition not therapy.
Yes
The device description explicitly states, "The device is used to transmit ECG signals from electrodes which are affixed to the patient's body for both diagnostic and monitoring purposes." The intended use also mentions "diagnostic evaluation by health care professional."
No
The device description explicitly states it is comprised of physical components (Plug, cable/leadwires, and connector) and is used to transmit physical signals (ECG signals) via these components. It is a hardware accessory for an ECG monitor.
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, tissue) to provide information about a person's health. This testing is done outside of the body ("in vitro").
- Device Function: The ECG Cable/Leadwires is used to transmit electrical signals from electrodes placed on the patient's body to an ECG monitor. It is a component of a system that measures physiological signals directly from the patient.
- Intended Use: The intended use clearly states it's for connecting electrodes on the patient to an ECG for monitoring and diagnostic evaluation. This is a direct measurement of a physiological process within the body.
Therefore, since the device interacts directly with the patient's body to acquire physiological signals rather than analyzing specimens taken from the body, it falls outside the definition of an In Vitro Diagnostic.
N/A
Intended Use / Indications for Use
The ECG Cable/Leadwires is intended to be used with ECG. The ECG Cable/Leadwires is used to connect electrodes placed at appropriate sites on the patient to ECG for general monitoring and/or diagnostic evaluation by health care professional.
Product codes (comma separated list FDA assigned to the subject device)
DSA
Device Description
The ECG Cable/Leadwires is comprised of Plug, cable/leadwires and connector. The device is used to transmit ECG signals from electrodes which are affixed to the patient's body for both diagnostic and monitoring purposes. Each lead wire is attached to ECG patient electrodes. The leadwires connector plugs into one end of the external trunk cable which is plug into an ECG monitor.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Attached to electrodes placed at standard specified locations on chest wall
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)
Nonclinical tests were conducted to demonstrate conformity to the following standards: IEC 60601-1:2005+CORR.1:2006+CORR.2007+A1:2012 (Medical Electrical Equipment - Part 1: General Requirements For Basic Safety And Essential Performance), AAMI / ANSI EC53:2013 (ECG Trunk Cables and Patient Leadwires), and ISO 10993-1:2009 (Biological Evaluation Of Medical Devices - Part 1: Evaluation And Testing Within A Risk Management Process), specifically for biocompatibility (No cytotoxicity, No irritation, No sensitization) and Electrical Performance and Safety.
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). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
February 28, 2018
Shenzhen Coreray Technology Co., Ltd. % Field Fu Consultant Shenzhen Joyantech Consulting Co., Ltd. No. 55 Shizhou zhong Road Nanshan District, Shenzhen Guangdong, China 518100
Re: K172797
Trade/Device Name: ECG Cable/Leadwires Regulation Number: 21 CFR 870.2900 Regulation Name: Patient transducer and electrode cable (including connector) Regulatory Class: Class II Product Code: DSA Dated: January 24, 2018 Received: January 30, 2018
Dear Field Fu:
We have reviewed vour 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. 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 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); good
1
manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820); 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 http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). 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 (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
M.A. Wilhelmsen
for Bram D. Zuckerman, M.D. Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
2
DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Druq Administration
Indications for Use
510(k) Number (if known) K172797
Device Name ECG Cable/Leadwires
Indications for Use (Describe)
The ECG Cable/Leadwires is intended to be used with ECG. The ECG Cable/Leadwires is used to connect electrodes placed at appropriate sites on the patient to ECG for general monitoring and/or diagnostic evaluation by health 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)
PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON A SEPARATE PAGE IF NEEDED.
FOR FDA USE ONLY
Concurrence of Center for Devices and Radiological Health (CDRH) (Signature)
3
This section applies only to requirements of the Paperwork Reduction Act of 1995.
DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.
The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:
Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov
"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."
4
VOL 05 510(k) Summary
This summary of 510(k) safety and effectiveness information is submitted As Required by requirements of SMDA and 21 CFR § 807.92.
5.1 Administrative Information
| Date of Summary
| prepared | Aug 17, 2017 |
|---|---|
| Manufacturer | |
| information | Company title: Shenzhen Coreray Technology |
| Co., Ltd | |
| Company address: | |
| ChuangYe Technology Park, 1th Dong Huan | |
| Road, Longhua New District, Shenzhen, 510000 | |
| P.R China. P.C.:518109 | |
| Contact person: Simon Fan | |
| Phone: +86-755-28839229 | |
| Fax: +86-755-28839229 | |
| E-mail: manager@core-ray.com | |
| Submission | |
| Correspondent | Shenzhen Joyantech Consulting Co., Ltd. |
| Address: Room 1122#, International Mayors | |
| Communication Centre, NO. 55 Shizhou middle | |
| road , Nanshan District, Shenzhen | |
| Contact person: Mr. Field Fu | |
| E-Mail: field@cefda.com; cefda13485@163.com |
Establishment registration number
5.2 Device Information
Type of 510(k) Traditional submission: Trade Name: ECG Cable/Leadwires Model: Classification name: | Cable, Transducer And Electrode, Patient,
5
(Including Connector) Cardiovascular Review Panel: Product Code: DSA Device Class: -870.2900 Requlation Number:
5.3 Predicate Device Information
SHENZHEN MED-LINK ELECTRONICS TECH CO., Sponsor: LTD. Device: CABLE/ LEAD-WIRE K120010 510(K) Number:
5.4 Device Description
The ECG Cable/Leadwires is comprised of Plug, cable/leadwires and connector. The device is used to transmit ECG signals from electrodes which are affixed to the patient's body for both diagnostic and monitoring purposes. Each lead wire is attached to ECG patient electrodes. The leadwires connector plugs into one end of the external trunk cable which is plug into an ECG monitor.
5.5 Intended Use/ Indications for Use
The ECG Cable/Leadwires is intended to be used with ECG. The ECG Cable/Leadwires is used to connect electrodes placed at appropriate sites on the patient to ECG for general monitoring and/or diagnostic evaluation by health care professional.
5.6 Technological characteristics of the subject device compared to the predicate device
Predicate Device Information:
| 510(K) No.: | K120010 |
|---|---|
| Common name: | Cable / lead-wire |
| Classification name: | Cable, Transducer and Electrode, Patient, (Including Connector) |
| Production regulation: | 21 CFR §870.2900 |
6
| Product code: | DSA |
|---|---|
| Panel: | Cardiovascular |
| Elements of
Comparison | Proposed device | Predicate device
K120010 | Remarks |
|-----------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------|
| Product Code | DSA | DSA | Same |
| Regulation
Number | 870.2900 | 870.2900 | Same |
| Classification | II | II | Same |
| Indication for Use | Shenzhen Coreray ECG
Cable/Leadwires is intended to
be used with ECG. The ECG
Cable/Leadwires is used to
connect electrodes placed at
appropriate sites on the patient
to ECG for general monitoring
and/or diagnostic evaluation by
health care professional. | Shenzhen Med-link
Cable/lead-wire are intended
to be used with ECG, EKG,
SpO2 and invasive Blood
Pressure monitoring devices.
The Cable/lead-wire 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
health care professional. | Same as
ECG/EK
G cable/
lead-
wire. |
| Patent Usage | Reusable | Reusable | Same |
| Anatomical sites | Attached to electrodes placed
at standard specified locations
on chest wall | Attached to electrodes placed
at standard specified locations
on chest wall | Same |
| Patient end
termination | Clip, Snap | Clip, Snap | same |
| Leadwire
material | TPU | Shielded & Unshielded Copper
with PVC or TPU Jacket | TPU is
same. |
| Sterile | Non sterile | Non sterile | same |
| Biocompatibility | No cytotoxicity,
No irritation,
No sensitization | No cytotoxicity,
No irritation,
No sensitization | SE |
| Electrical
Performance and
Safety | Comply with AAMI/ANSI
EC53: 2013 IEC 60601-
1:2005+CORR.1: 2006+CORR.
2:2007+AM1: 2012 | Comply with ANSI/AAMI EC
53:1995/(R)2001 IEC 60601-
1:1998: Am1: A2:1995 | SE |
Comparison to predicate device:
5.7 Brief discussion of the nonclinical tests
ECG Cable/Leadwires conforms to the following standards:
7
IEC 60601-1:2005+CORR.1:2006+CORR.2007+A1:2012 Medical Electrical Equipment - Part 1: General Requirements For Basic Safety And Essential Performance.
AAMI / ANSI EC53:2013, ECG Trunk Cables and Patient Leadwires.
ISO 10993-1:2009, Biological Evaluation Of Medical Devices - Part 1: Evaluation And Testing Within A Risk Management Process.
5.8 Brief discussion of clinical tests
N/A.
5.9 Other information (such as required by FDA guidance/Test) N/A.
5.10 Conclusions
Based on the above information, the subject device and the predicate device have the same intended use and same technological characteristics; we conclude the subject device, ECG Cable/ Leadwires, is substantially equivalent to the predicate device.