(60 days)
Not Found
No
The device is a simple lead wire for transmitting ECG signals and the description does not mention any AI/ML capabilities or related terms.
No
The device is used to transmit ECG signals for monitoring and diagnostic evaluation, not to treat a condition.
Yes
The device is explicitly stated to be used for "diagnostic evaluation" and "diagnostic purposes" in both the "Intended Use / Indications for Use" and "Device Description" sections.
No
The device description explicitly states it is comprised of physical components (patient end termination, leadwire, patient leadwire connector) and is used to transmit physical signals (ECG signals) via a physical connection to electrodes and an ECG monitor. This indicates a hardware device, not software only.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In vitro diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections.
- Device Function: The description clearly states that the ECG Disposable Lead Wires are used to connect electrodes placed on the patient's body to an ECG machine. They transmit electrical signals from the body's surface.
- No Sample Analysis: There is no mention of analyzing any biological samples from the patient. The device is a physical connection for transmitting electrical signals.
Therefore, the function and intended use of this device fall outside the scope of in vitro diagnostics. It is a medical device used for physiological monitoring.
N/A
Intended Use / Indications for Use
The ECG Disposable Lead Wires are intended to be used with ECG. The lead wire 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
DSA
Device Description
The ECG Disposable Lead Wires are comprised of patient end termination, leadwire and patient leadwire 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 lead wire connector plugs into one end of the external trunk cable which are 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 or extremities
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
Non clinical tests were conducted to verify that the proposed device met all design specifications and was Substantially Equivalent (SE) to the predicate device. The test results demonstrated that the proposed device complies with the following standards:
- ISO 10993-1:2009 Biological evaluation of medical devices- Part 1: Evaluation and testing within a risk management process
- ISO 10993-5:2009 Biological Evaluation of Medical Devices- Part 5: Tests For In Vitro Cytotoxicity.
- ISO 10993-10:2010 Biological Evaluation of Medical Devices- Part 10: Tests for Irritation and A Skin Sensitization.
- AAMI/ANSI EC53: 2013 ECG Trunk Cables and Patient Leadwires
- IEC 60601-1:2005+CORR.1: 2006+CORR. 2:2007+AM1: 2012, Medical Electrical Equipment -Part 1: General Requirements For Basic Safety And Essential Performance
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
No clinical study is included in this submission.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
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
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized caduceus symbol, which is often associated with healthcare. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" are arranged in a circular pattern around the symbol.
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
April 24, 2017
APK Technology Co., Ltd. % Ms. Diana Hong General Manager Mid-link Consulting Co., Ltd. P.O. Box 120-119 Shanghai, 200120 CN
Re: K170536
Trade/Device Name: ECG Disposable Lead Wires Regulation Number: 21 CFR 870.2900 Regulation Name: Patient Transducer And Electrode Cable (Including Connector) Regulatory Class: Class II Product Code: DSA Dated: February 20, 2017 Received: February 23, 2017
Dear Ms. Diana Hong:
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 yours,
M.A. Hillemann
for
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) K170536
Device Name ECG Disposable Lead Wires
Indications for Use (Describe)
The ECG Disposable Lead Wires are intended to be used with ECG. The lead wire 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) | |
|---|---|
| ☑ Prescription Use (Part 21 CFR 801 Subpart D) | □ Over-The-Counter Use (21 CFR 801 Subpart C) |
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3
K170536
Page 1 of 5
510(k) Summary
This 510(k) Summary is being submitted in accordance with requirements of Title 21, CFR Section 807.92.
The assigned 510(k) Number: K170536
-
- Date of Preparation: 03/02/2017
-
- Sponsor Identification
APK Technology Co., Ltd.
6Floor, B2 Building, Industry of Hengfeng, Hezhou, Xixiang, Bao'an Distric, Shenzhen, China
Establishment Registration Number: 3007699081
Contact Person: Caifang Wang Position: Management Representative Tel: +86-755-27325581 Fax: +86-755-27325585 Email: caifang@apk-technology.com
-
- Designated Submission Correspondent
Ms. Diana Hong (Primary Contact Person) Ms. Ying Fu (Alternative Contact Person)
- Designated Submission Correspondent
Mid-Link Consulting Co., Ltd
P.O. Box 120-119, Shanghai, 200120, China
Tel: +86-21-22815850, Fax: 240-238-7587 Email: info@mid-link.net
4
K170536 Page 2 of 5
Trade Name: ECG Disposable Lead Wires Common Name: ECG Wire
Regulatory Information
Classification Name: Cable, Transducer and Electrode, Patient, (Including Connector) Classification: II; Product Code: DSA Regulation Number: 870.2900 Review Panel: Cardiovascular
Indication for Use:
The ECG Disposable Lead Wires are intended to be used with ECG. The lead wire 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.
Device Description
The ECG Disposable Lead Wires are comprised of patient end termination, leadwire and patient leadwire 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 lead wire connector plugs into one end of the external trunk cable which are plug into an ECG monitor.
- Identification of Predicate Device 4.
510(k) Number: K120010 Product Name: Cable/lead-wire
5. Non-Clinical Test Conclusion
Non clinical tests were conducted to verify that the proposed device met all design specifications and was Substantially Equivalent (SE) to the predicate device. The test results demonstrated that the proposed device complies with the following standards:
5
K170536 Page 3 of 5
-
ISO 10993-1:2009 Biological evaluation of medical devices- Part 1: Evaluation and testing within a risk management process
-
ISO 10993-5:2009 Biological Evaluation of Medical Devices- Part 5: Tests For In Vitro Cytotoxicity.
- ISO 10993-10:2010 Biological Evaluation of Medical Devices- Part 10: Tests for Irritation and A Skin Sensitization.
-
AAMI/ANSI EC53: 2013 ECG Trunk Cables and Patient Leadwires
-
IEC 60601-1:2005+CORR.1: 2006+CORR. 2:2007+AM1: 2012, Medical Electrical Equipment -Part 1: General Requirements For Basic Safety And Essential Performance
-
- Clinical Test Conclusion
No clinical study is included in this submission.
6
K170536 Page 4 of 5
7. Substantially Equivalent (SE) Comparison
| Item | Proposed Device | Predicate Device
K120010 | Remark | | |
|-----------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------|------------------------------------------------------|------|
| Product Code | DSA | DSA | SE | | |
| Regulation
Number | 870.2900 | 870.2900 | SE | | |
| Classification | II | II | SE | | |
| Indication for
Use | The ECG Disposable Lead Wires
are intended to be used with ECG.
The lead wire 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. | Similar | | |
| Anatomical sites | Attached to electrodes placed at
standard specified locations on
chest wall or extremities | Attached to electrodes placed at
standard specified locations on
chest wall | Similar | | |
| Patient end
termination | Clip, Snap | Clip, Snap | Same | | |
| Leadwire
material | Polyvinyl chloride (PVC) | Shielded & Unshielded Copper
with PVC or TPU Jacket | Similar | | |
| Sterile | Non sterile | Non sterile | Same | | |
| Biocompatibility | Cytotoxicity
Skin Irritation
Sensitization | No cytotoxicity
No irritation
No sensitization | Cytotoxicity
Skin Irritation
Sensitization | No cytotoxicity
No irritation
No sensitization | Same |
| 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 | Same | | |
Table 1 Comparison of Technology Characteristics
7
- Substantially Equivalent (SE) Conclusion 8.
Based on the comparison and analysis above, the proposed devices are determined to be Substantially Equivalent (SE) to the predicate devices.