(356 days)
Not Found
No
The description focuses on the physical components (cables and lead wires) for transmitting ECG signals and does not mention any software or algorithms that would process or interpret data using AI/ML. The "Mentions AI, DNN, or ML" section is explicitly marked as "Not Found".
No.
The device is described as a patient cable and lead wires for transmitting ECG signals for diagnostic and monitoring purposes, not for treating a condition.
Yes
The "Intended Use / Indications for Use" section explicitly states that the device is "intended for use... for measurement of a patient's ECG for both diagnostic and monitoring purposes."
No
The device description explicitly mentions "patient cable and lead wires including trunk cable and leadwires," which are physical hardware components used for transmitting signals.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for measuring a patient's ECG for diagnostic and monitoring purposes. This involves measuring electrical signals from the body, not analyzing samples taken from the body (like blood, urine, or tissue).
- Device Description: The device is described as cables and lead wires that transmit signals from surface electrodes to monitoring/diagnostic equipment. This is a physical connection for signal transmission, not a device that performs a test on a biological sample.
- Lack of IVD Characteristics: The description does not mention any of the typical characteristics of an IVD, such as:
- Analyzing biological samples (blood, urine, etc.)
- Detecting or measuring substances within those samples
- Performing chemical, immunological, or molecular tests
The device is clearly intended for in vivo use (on the living body) to acquire physiological signals, which is characteristic of a medical device used for monitoring and diagnosis, but not an IVD.
N/A
Intended Use / Indications for Use
The subject device is intended for use only by trained healthcare professionals for measurement of a patient's ECG for both diagnostic and monitoring purposes. Use is limited by the indications for use of the connected monitoring or diagnostic equipment.
Product codes
DSA
Device Description
The Caremed patient cable and lead wires including trunk cable and leadwires, are intended use for transmitting signals from patient surface electrodes to various electrocardiograph recorders/monitors for both diagnostic and monitoring purposes. The type of devices are common to both industry and to most medical establishments. The system is designed to provide a family of lead wires that will link the patient and the compatible patient trunk cable system.
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 and extremities
Indicated Patient Age Range
Not Found
Intended User / Care Setting
trained healthcare professionals
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
The subject device meets the following the recognized standards:
- ANSI/ANMM EC53-1995 (R)2001, R(2008) ECG Cables and Leadwires ● (except4.3.1)
- ANSI/AAMI EC13 Cardiac monitors, heart rate meters and alarms (only product markings, chapter 4.1.1.5),2002
- Part 898: Performance Standard for Electrode Lead Wires and Patient Cables ●
- IEC 60601-1 Medical Electrical Equipment-Part 1: General Requirements for Safety, 1988+A1:1991+A2:1995
- ISO 10993-5, Biological evaluation of medical devices-Part 5: Tests for In Vitro cytotoxicity, 2009
- ISO 10993-10, Biological evaluation of medical devices-Part 10: Tests for irritation and delayed-type hypersensitivity, 2010
Key Metrics
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
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/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features the department's name in a circular arrangement around a stylized symbol. The symbol consists of three abstract human profiles facing to the right, stacked on top of each other. The profiles are depicted with simple, curved lines, creating a sense of unity and connection.
October 24, 2016
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
Shenzhen Caremed Medical Technology Co., Ltd. Xinlin Xiao, QA Manager Zone B. 3/f. 11 Building, Hebei Industrial Area, Longhua Office, Longhua New D Shenzhen, 518021 CHINA
Re: K153188
Trade/Device Name: Caremed Patient Cable and Leadwires, Models: 2585P, MQB5-90S, MQ-2586, E10R-SH1-N, E10R-MQ and MQ10-LN Regulation Number: 21 CFR 870.2900 Regulation Name: Patient Transducer And Electrode Cable (Including Connector) Regulatory Class: Class II Product Code: DSA Dated: September 2, 2016 Received: September 16, 2016
Dear Xinlin Xiao:
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. 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 (reporting of medical device
1
related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. 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.
You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely.
Mada Jellman
for
Bram D. Zuckerman, M.D. Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known) K153188
Device Name
Caremed patient cable and leadwires, Models 2585P, MQB5-90S, MQ-2586, E10R-SH1-N, E10R-MQ, MQ10-LN
Indications for Use (Describe)
The subject device is intended for use only by trained healthcare professionals for measurement of a patient's ECG for both diagnostic and monitoring purposes. Use is limited by the indications for use of the connected monitoring or diagnostic equipment.
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) |
|---|---|
| ---------------------------------------------------------------------------------------------------------- | --------------------------------------------------------------------------------------------------------- |
CONTINUE ON A SEPARATE PAGE IF NEEDED.
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3
Image /page/3/Picture/1 description: The image shows the logo for Caremed. The logo consists of the letters "CM" in red and gray, followed by the word "caremed" in red. Below the word "caremed" are two Chinese characters in gray. The logo is simple and modern, and the colors are eye-catching.
Section 5
510(K) Summary
1. Prepared Date: 2016/9/2
2. Submitter Information
| Name | Shenzhen Caremed Medical Technology Co., Ltd. |
|---|---|
| Address | Zone B, 3/F, 11 Building, Hebei Industrial Area, Longhua office, Longhua New District, Shenzhen,China |
| Tel | 0086-755-27184369 |
| Fax | 0086-755-27186486 |
3. Contact Person
| Contact person | Xinlin Xiao |
|---|---|
| Title | QA manager |
| Address | Zone B, 3/F, 11 Building, Hebei Industrial Area, Longhua office, Longhua New District, Shenzhen, China |
| Tel | 0086-755-27184369 |
| Fax | 0086-755-27186486 |
| cm001@szcaremed.com |
4. Proposed Device Information
| Trade Name | Caremed patient cable and leadwires |
|---|---|
| Model | 2585P, MQB5-90S, MQ-2586, E10R-SH1-N, E10R-MQ, MQ10-LN |
| Common name | Patient Transducer and electrode cable (including connector) |
| Regulatory class | II |
| Production regulation | 21 CFR §870.2900 |
| Product code | DSA |
| Panel | Cardiovascular |
5. Predicate Device Information
| 510(K)No. | Trade Name/model | Submitter |
|---|---|---|
| K142489 | Unimed Disposable ECG lead wires | Unimed Medical |
| Supplies,Inc. |
6. Device description
The Caremed patient cable and lead wires including trunk cable and leadwires, are intended use for transmitting signals from patient surface electrodes to various
Caremed patient cable and lead wires -510(k) Submission
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Image /page/4/Picture/1 description: The image shows the logo for Caremed. The logo consists of a stylized "CM" in red and gray, followed by the word "caremed" in red. Below the word "caremed" are two Chinese characters in gray.
electrocardiograph recorders/monitors for both diagnostic and monitoring purposes. The type of devices are common to both industry and to most medical establishments. The system is designed to provide a family of lead wires that will link the patient and the compatible patient trunk cable system.
7. Intended use
The subject device is intended for use only by trained healthcare professionals for measurement of a patient's ECG for both diagnostic and monitoring purposes. Use is limited by the indications for use of the connected monitoring or diagnostic equipment.
| Comparison
item | Subject Device
Applied present | Predicate Device
K142489 |
|------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Intended use
&Indications
for Use | The subject device are intended
for use only by trained healthcare
professionals for measurement of
a patient's ECG for both
diagnostic and monitoring
purposes. Use is limited by the
indications for use of the
connected monitoring or
diagnostic equipment. | The unimed disposable ECG lead
wires are intended for use only by
trained healthcare professionals
for measurement of a patient's
ECG for both diagnostic and
monitoring purposes. Use is
limited by the indications for use
of the connected monitoring or
diagnostic equipment. These
leadwires are intended for
short-term use only (an average
patient stay of 5 days). |
| Anatomical
Sites | Attached to electrodes placed at
standard specified locations on
chest wall and
extremities | Attached to electrodes placed at
standard specified locations on
chest wall and
extremities |
| Design
/Appearance | Cables with
"grabber,snap&needle"
configuration of ECG electrode
connector (distal connector) and
common "header" connection
(proximal connector) | Cables with "grabber/snap"
configuration of ECG electrode
connector (distal connector) and
common "header" connection
(proximal connector) |
| Sterility | Supplied non-sterile | Supplied non-sterile |
| Usage | Reusable | Single patient use |
| Material | PA66,PVC,ABS | PA66,PVC,ABS |
| Cable Length | 0.9m/3.4m/2.5m/2.4m | 0.9m/3.4m |
| Caremed patient cable and lead wires -510(k) Submission
Page 2 of 4 | | |
8. Comparison to predicate device
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Image /page/5/Picture/1 description: The image shows the logo for Caremed. The logo consists of a stylized "CM" in red and gray, followed by the word "caremed" in red. Below the word "caremed" are two Chinese characters.
| Cable
Construction | Flexible shielded multi conductor
electrical cable | Flexible shielded multi conductor
electrical cable |
|---------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------|
| Wire Color | Grey | White |
| Leadwire
Construction | Shielded copper leadwire with
polymer jacket | Shielded copper leadwire with
polymer jacket |
| Lead number | 5&10 | 3,5&6 |
| Proximal
connector
Design | Compatible to MultiLink
yoke design | Compatible to MultiLink
yoke design |
| Distal
connector
Design | "Grabber","Snap"&"Needle"elect
rode
connectors
labeled
LL(red),RA(white),RL(green),LA(
black)&,V(brown) or socket
connecting with lead wires | "Grabber"or"Snap"electrode
connectors are labeled
LL(red),RA(white),RL(green),LA(
black)&,V(brown) |
| Conformance
standard | IEC60601-1(Safety)
EC53(Performance)
ISO10993-5,-10(Biocompatibilit
y) | IEC60601-1(Safety)
EC53(Performance)
ISO10993-5,-10(Biocompatibilit
y) |
From the comparison form above, both devices have the same Intended use &Indications for Use Anatomical Sites, Design /Appearance, Sterility, Material,Cable Construction,& Conformance standard.
But in Usage,cable length, Lead number& Distal connector Design item,both devices have some difference,But these units meet the requirements of EC53 and IEC60601-1, so these difference does not bring any safety and effectiveness problem.
9. Clinical test data
Not applied
10. Substantial Equivalence Statement
The subject device meets the following the recognized standards:
- ANSI/ANMM EC53-1995 (R)2001, R(2008) ECG Cables and Leadwires ● (except4.3.1)
- ANSI/AAMI EC13 Cardiac monitors, heart rate meters and alarms (only product markings, chapter 4.1.1.5),2002
- Part 898: Performance Standard for Electrode Lead Wires and Patient Cables ●
- IEC 60601-1 Medical Electrical Equipment-Part 1: General Requirements for Safety, 1988+A1:1991+A2:1995
- ISO 10993-5, Biological evaluation of medical devices-Part 5: Tests for In Vitro cytotoxicity, 2009
- ISO 10993-10, Biological evaluation of medical devices-Part 10: Tests for irritation and delayed-type hypersensitivity, 2010
Caremed patient cable and lead wires -510(k) Submission
6
Image /page/6/Picture/1 description: The image shows the logo for Caremed. The logo consists of a stylized "CM" in red and gray, followed by the word "caremed" in red, and two Chinese characters in gray below. The logo is simple and modern, and the colors are eye-catching.
11. Discussion
Based on the comparison ,analysis, and the submitted performance data, the proposed device is claimed to be Substantially Equivalent (SE) to the predicate devices in K142489.