(632 days)
Not Found
No
The device description and intended use focus solely on the physical cable system for transmitting ECG signals, with no mention of data processing or analysis capabilities that would typically involve AI/ML. The performance studies are focused on biological evaluation and electrical safety, not algorithmic performance.
No.
The device is described as a cable system used to connect electrodes, catheters, and/or sensors to a monitoring device for generating monitoring and/or diagnostic evaluation, indicating it is for diagnosis and monitoring, not therapy.
No
This device is a cable system that transfers signals from electrodes to an ECG monitoring device. It facilitates monitoring and diagnostic evaluation, but it is not the diagnostic device itself; it is an accessory to one.
No
The device description explicitly states it is a "Disposable Cable System" made of physical materials (PVC, PP) with connectors and bulk cable, designed to transfer signals from electrodes to a monitor. This is a hardware component, not software only.
Based on the provided information, the SureLead Disposable Cable System is not an In Vitro Diagnostic (IVD) device.
Here's why:
- Intended Use: The intended use is to connect electrodes, catheters, and/or sensors on a patient to an ECG monitoring device for generating monitoring and/or diagnostic evaluation by a health care professional. This describes a device used in vivo (on a living patient) to transmit physiological signals.
- Device Description: The description details a cable system designed to transfer signals from electrodes on the patient to a monitor. This aligns with an in vivo application.
- Lack of IVD Characteristics: IVD devices are typically used to examine specimens derived from the human body (like blood, urine, tissue) in vitro (outside the body) to provide information for diagnosis, monitoring, or screening. The SureLead system does not perform this function.
- Predicate Device: The predicate device (K170536) is also described as a "Cable/Lead-Wire (ECG)," which is consistent with an in vivo ECG monitoring accessory, not an IVD.
Therefore, the SureLead Disposable Cable System is an accessory for in vivo ECG monitoring, not an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The SureLead Disposable Cable System is intended to be used with ECG monitoring devices. The SureLead Disposable Cable System is used to connect electrodes, catheters, and/or sensors placed at appropriate sites on the patient to a monitoring device for generating monitoring and/or diagnostic evaluation by a health care professional.
Product codes (comma separated list FDA assigned to the subject device)
DSA
Device Description
The SureLead Disposable Cable System with specific various lengths are the replacements for similar cables manufactured by Original Equipment Manufacturers (OEM) and other third-party after-market manufacturers for their respective monitors. These cables consist of connectors on each cable end and a shielded bulk cable. These cables are used to transfer the signals from the electrodes to the patient monitor. The SureLead Disposable Cable System uses the same type of construction and have the same technological characteristics as the predicate device. The SureLead Disposable Cable System is made of medical grade PVC and PP cable jacket with medical grade PVC and PP over molded connectors with integral relief.
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)
Non clinical tests were conducted to verify that the proposed device met all design specifications and was Substantially Equivalent (SE) to the predicate device (K170536). 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 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
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 shows the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health and Human Services logo on the left and the FDA logo on the right. The FDA logo is a blue square with the letters "FDA" in white, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue.
January 17, 2020
Authentic Medical Ricky Souza CEO 4470 Yankee Hill Rd., Ste 100 Rocklin, California 95677
Re: K181089
Trade/Device Name: SureLead Disposable Cable System Regulation Number: 21 CFR 870.2900 Regulation Name: Patient Transducer and Electrode Cable (Including Connector) Regulatory Class: Class II Product Code: DSA Dated: December 10, 2019 Received: December 11, 2019
Dear Ricky Souza:
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 Assistant Director (Acting) 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) K181089
Device Name SureLead Disposable Cable System
Indications for Use (Describe)
The SureLead Disposable Cable System is intended to be used with ECG monitoring devices. The SureLead Disposable Cable System is used to connect electrodes, catheters, and/or sensors placed at appropriate sites on the patient to a monitoring device for generating monitoring and/or diagnostic evaluation by a 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)
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3
SureLead Disposable Cable System Traditional 510(k)
SureLead Disposable Cable System Premarket Notification 510(k) Summary
| DATE PREPARED | 19 APR 2018 |
|---|---|
| MANUFACTURER | Authentic Medical |
| CONTACT PERSON | Ricky Souza |
| Position: CEO/President | |
| Tel: (916) 952- 6498 | |
| Fax: (916) 644-6015 | |
| Email: rsouza@authenticmed.com | |
| PANEL CODE | Cardiovascular |
| CLASSIFICATION | Patient Transducer and Electrode Cable (Including |
| Connector) | |
| CLASS | Class II (Class 2) |
| COMMON NAME | Cable / Lead-wire |
| TRADE NAME | SureLead Disposable Cable System |
| PREDICATE DEVICES | K170536 Cable/Lead-Wire (ECG). |
| Identification of | |
| Proposed Device | Trade Name: Surelead Disposable cable system |
| Common Name: cable/lead-wire |
DEVICE DESCRIPTION
The SureLead Disposable Cable System with specific various lengths are the replacements for similar cables manufactured by Original Equipment Manufacturers (OEM) and other third-party after-market manufacturers for their respective monitors. These cables consist of connectors on each cable end and a shielded bulk cable. These cables are used to transfer the signals from the electrodes to the patient monitor. The SureLead Disposable Cable System uses the same type of construction and have the same technological characteristics as the predicate device. The SureLead Disposable Cable System is made of medical grade PVC and PP cable jacket with medical grade PVC and PP over molded connectors with integral relief.
INDICATIONS FOR USE
The SureLead Disposable Cable System is intended to be used with ECG monitoring devices. The SureLead Disposable Cable System is used to connect electrodes, catheters, and/or sensors placed at appropriate sites on the patient to a monitoring device for generating monitoring and/or diagnostic evaluation by a health care professional.
TECHNOLOGICAL CHARACTERISTICS AND SUBSTANTIAL EQUIVALENCE
The SureLead Disposable Cable System, is substantially equivalent to the Predicate device (K170536) intended use / indications for use, materials, technological characteristics, and labelling.
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PERFORMANCE DATA
Non clinical tests were conducted to verify that the proposed device met all design specifications and was Substantially Equivalent (SE) to the predicate device (K170536). 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 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
SUBSTANTIAL EQUIVALENCE DISCUSSION
The SureLead Disposable Cable System, (Subject Device) is substantially equivalent to K 170536 ECG Disposable Cable / lead-wire (Predicate Device).
The Subject device and Predicate Device:
- Have nearly Identical Indications for Use
- Are provided non-sterile with steam sterilization instructions
- · Use similar cable lengths and the same materials
Table 1 is provided here to show the comparison.
| | Proposed Device | Predicate Device
K170536 | Remarks |
|-------------------------------|--------------------------------------------------------------------|--------------------------------------------------------------------|---------|
| Manufacturer | Authentic Medical | APK Technology
Co., Ltd | - |
| 510(k) number | K181089 | K170536
Cable/Lead-wire | - |
| Classification
Regulation | 21 CFR Part 870.2900 | 21 CFR Part 870.2900 | SE |
| Panel | Cardiovascular | Cardiovascular | SE |
| Common Name | Cable / Lead-wire | Cable / Lead-wire | SE |
| Device
Classification Name | Patient transducer
and electrode cable
(including connector) | Patient transducer
and electrode cable
(including connector) | SE |
| Product Code | DSA | DSA | SE |
| Class | Class II (Class 2) | Class II (Class 2) | SE |
Table 1: Substantial Equivalence Summary Table
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| Indications for Use | The SureLead | The APK ECG | SE |
|---|---|---|---|
| Disposable Cable | |||
| System is intended to | |||
| be used with ECG | |||
| monitoring devices. | |||
| The SureLead Cable | |||
| System is used to | |||
| connect electrodes, | |||
| catheters, and/or | |||
| sensors placed at | |||
| appropriate sites on the | |||
| patient to a monitoring | |||
| device for generating, | |||
| monitoring, and/or | |||
| diagnostic evaluation | |||
| by a health care | |||
| professional. | 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. | |||
| Sterility and Shelf-life | Provided non-sterile. | ||
| No shelf-life | Provided non-sterile. | ||
| No shelf-life | SE | ||
| Single Patient Use | Yes | Yes | SE |
| Wire Materials | Shielded&Unshielded | ||
| Copper with PVC or | |||
| PP Jacket | Polyvinyl Chloride | ||
| (PVC) | Analysis 3 | ||
| Connectors | Medical grade | ||
| PVC and PP over | |||
| molded connectors | |||
| with integral relief. | Medical grade PVC | ||
| and ABS over | |||
| molded connectors | |||
| with integral relief. | Analysis 3 | ||
| Cable Length | |||
| (Minimum) | 10 Centimeters | 0.72 Meters | Analysis 2 |
| Cable Length | |||
| (Maximum) | 11 Foot (3.35 Meters) | 3.6 Meters | Analysis 2 |
| Patient end | |||
| termination type | Clip | Clip , snap | Analysis 4 |
| Number of leadwires | 3,5,6 | Unknown | Analysis 5 |
| Disposable or | |||
| reusable | Disposable | Disposable | SE |
The Subject Device and the Predicate Device are substantially equivalent. The minor differences are:
Analysis (2) The minimum SureLead Cable System (Subject Device) has a shorter minimum cable length and a shorter maximum cable length. These differences are negligible.
Analysis (3) The material of proposed device is different from predicate device. However, the biocompatibility for proposed device has been evaluated and the test result conform with requirements of ISO 10993 standards. Therefore, this difference does not affect substantially equivalence.
6
Analysis (4) The patient end termination type of proposed device is Clip while that of predicated device is Clip or snap, yet the electric performance and safety for proposed device has been tested per IEC 60601-1 and EC 53 and the test result is acceptable. Therefore, this difference does not affect substantially equivalence.
Analysis (5) The subject device is available in 3, 5 ,6 leadwire type, while the leadwire number for predicate device is unknown and the substantially equivalence cannot be determined. However, the electric performance and safety for proposed device has been tested per IEC 60601-1 and EC 53 and the test result is acceptable. Therefore, this difference does not affect substantially equivalence.
CONCLUSION
The Intended Use and Indications for Use of the SureLead Disposable Cable System (subject device) and the Predicate Device, Cable / Lead-wire (Premarket Notification K170536) are substantially equivalent. The technological characteristics, components and materials used for the Predicate Device and the Subject Device are the same. The Subject Device, SureLead Disposable Cable System is substantially equivalent to the Predicate Device, Cable / Lead-wire (Premarket Notification K170536), a legally marketed device.