(16 days)
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 heath care professional.
Med-link Cable / Lead-wire 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. The cables are used to transfer the signals from the electrodes to the patient monitor. The Med-link cables use the same type of constructions and have the same technological characteristics as the predicate devices. They use a medical grade PVC and TPU cable jacket with medical grade PVC and ABS over molded connectors with integral relief.
Here's the analysis of the provided text regarding acceptance criteria and the supporting study for the medical device:
Device: Cable / lead-wire (ECG, EKG, SpO2 and Invasive Blood Pressure) manufactured by Shenzhen Med-link Electronics Tech Co., Ltd.
1. Table of Acceptance Criteria and Reported Device Performance
The submission primarily focuses on demonstrating substantial equivalence to predicate devices through various safety and performance standards. The acceptance criteria are defined by compliance with these standards, and the reported performance confirms this compliance.
| Acceptance Criteria (Standard) | Reported Device Performance |
|---|---|
| Biocompatibility: | |
| ISO 10993-5:1999 (Cytotoxicity) | Non-toxic |
| ISO 10993-10:2002/Amd1:2006 (Irritation & Delayed-Type Hypersensitivity) | Non-sensitizing and non-irritating |
| Electrical Safety: | |
| IEC 60601-1:1998; Am1; A2:1995 (General requirements for safety) | Complies with applicable clauses |
| ECG Cable Performance: | |
| ANSI/AAMI EC53:1995/(R) 2001 (ECG cables and leadwires) | Complies with applicable clauses |
| ANSI/AAMI EC53:1995/(R) 2001 (for trunk cable lead wires) | Complies with applicable clauses |
| DIN 42-802 (Interconnection between patient lead-wires and trunk cable) | Complies with requirements |
| FDA Regulation: | |
| FDA 21CFR Part 898 Final rule | Complies |
| Bench Testing (General Safety and Performance) | Met requirements for safety and performance standards and intended use |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size for Test Set: The document does not specify a numerical sample size for the test set. It states that "Med-Link Cable / Lead-wire" were tested according to various standards and "Performance Bench testing was conducted on the Shenzhen Med-link cable / lead-wire according with established protocols." This implies testing of a representative number of cable/lead-wire units to ensure compliance with each standard.
- Data Provenance: The data is internally generated by the manufacturer (Shenzhen Med-link Electronics Tech Co., Ltd.) through "Performance Bench testing." No information about the country of origin of the data itself (beyond the manufacturer's location in China) or whether it's retrospective or prospective is explicitly stated. However, given it's bench testing for a premarket submission, it would be prospective data generated for the purpose of demonstrating compliance.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications
This section is not applicable to this submission. The "ground truth" here is defined by compliance with established international and national medical device standards (ISO, IEC, ANSI/AAMI, FDA regulations). The testing involves objective measurements against these predefined criteria, not subjective expert judgment that would require establishing a ground truth via consensus.
4. Adjudication Method for the Test Set
This section is not applicable. As the testing involves objective measurements against predefined standards, there is no need for an adjudication method by experts. The results are either compliant or non-compliant with the specified technical requirements.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done
No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done. This type of study is typically used for diagnostic imaging devices where human readers interpret results, often with and without AI assistance. This submission describes an ECG/EKG/SpO2/IBP cable and lead-wire device, which does not involve human interpretation of diagnostic images or AI assistance in that context.
6. If a Standalone Study (Algorithm Only Without Human-in-the-Loop Performance) Was Done
This section is not applicable. The device is a passive accessory (cable/lead-wire) for monitoring devices, not an algorithm or AI system. Therefore, the concept of "standalone (algorithm only)" performance does not apply. The tests performed (biocompatibility, electrical safety, bench testing) assess the device's inherent physical and electrical properties.
7. The Type of Ground Truth Used
The "ground truth" used for this device is compliance with established international and national medical device standards and regulations. These include:
- ISO 10993-5:1999 (Cytotoxicity)
- ISO 10993-10:2002/Amd1:2006 (Irritation & Delayed-Type Hypersensitivity)
- IEC 60601-1:1998; Am1; A2:1995 (Medical electrical equipment - General requirements for safety)
- ANSI/AAMI EC53:1995/(R) 2001 (ECG cables and leadwires)
- FDA 21CFR Part 898 Final rule
- DIN 42-802 (for specific interconnection requirements)
These standards define the objective performance and safety benchmarks that the device must meet.
8. The Sample Size for the Training Set
This section is not applicable. The device is a hardware component (cable/lead-wire), not an AI/ML algorithm that requires a "training set."
9. How the Ground Truth for the Training Set Was Established
This section is not applicable for the same reason as point 8.
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K120010 510(K) Summary
This summary of 510(k) safety and effectiveness information is being submitted in accordance with the requirements of 21 CFR§807.92.
| Submission Date: | 20 March 2011 |
|---|---|
| Submitter: | Shenzhen Med-link Electronics Tech Co., Ltd.Building 2, HuaFu Ind. Park, HuaWang Road, LongHua, BaoAn ,District 518109 Shenzhen City, P.R.China |
| Submitter Contact: | Maolin YeGeneral ManagerPhone Number: 011 86 (755) 61568827Fax Number: 011 86 (755) 61120755E-mail Address: User18@med-linket.com |
| Manufacturing Site: | Shenzhen Med-link Electronics Tech Co., Ltd.Build 2, HuaFu Ind. Park, HuaWang Road, LongHua, BaoAn ,District 518109 Shenzhen City, P.R.China |
| Official Contact: | Eric ZhanShenzhen Med-link Electronics Tech Co., Ltd.Build 2, HuaFu Ind. Park, HuaWang Road, LongHua, BaoAn ,District 518109 Shenzhen City, P.R.ChinaPhone Number: 011 86 (755) 61120299 ext 815E-mail Address: User22@med-linket.com |
| Trade Name: | Cable / lead-wire (ECG, EKG, SpO2 and Invasive BloodPressure), models as below table: |
| DeviceName / Type | |
| Device Model | |
| ECG cable andlead-wires | |
| EA003S5A, EA010C5A, EA007C5A, EA050C5A,EA023C5A, EA035C3A, EA066S3A, EA009S5A,EC021-5AI, EC040S5A, EE007-5AI, EE051C5A,ED023-3AI, ED040C3A, ED040C5A, ED023-5AI,EP055-6AI, EP035S3A, EL009-5AI, EL040S5A,EC072M5I, EC072M5A, EC072S5I, EC072S5A | |
| EKG cable andlead-wires | |
| VA008BBA, VA018BCA, VA005BBA, VA001BNA,VA021BBA, VA025BAA, VE008-BAI, VE008BNA, | |
| Invasive BloodPressure cables | |
| X0014A, X0014B, X0015A, X0015B, X0018D,X0018F, | |
| SpO2adapter cables | |
| S0052BC-L, S0036BC-L, S0014OH-L, S0099BC-L,S0002NE-L, S0020CO-L, S0125CO-L, S0010NE-L,S0026OX-L, S0117OX-L, S0005NI-L, S0015OX-L,S0003OX-L, S0072BC-L, S0004NE-L |
Common Name:
Cable / lead-wire
Classification Name:
Patient Transducer and electrode cable (including connector)
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| ClassificationRegulation: | 21 CFR 870.2900 | ||
|---|---|---|---|
| Product Code: | DSA | ||
| SubstantiallyEquivalentDevices: | Shenzhen Med-linkProduct Group | Predicate510(k) Number | PredicateManufacturer |
| Cable / Lead-wire | K082959 | Unimed MedicalSupplies Inc. | |
| Cable / Lead-wire | K992524 | Advantage MedicalCables, Inc | |
| Device Description: | Med-link Cable / Lead-wire with specific various lengths are thereplacements for similar cables manufactured by OriginalEquipment Manufacturers (OEM) and other third party aftermarket manufacturers for their respective monitors.These cables consist of connectors on each cable end and ashielded bulk cable. The cables are used to transfer the signalsfrom the electrodes to the patient monitor.The Med-link cables use the same type of constructions and havethe same technological characteristics as the predicate devices.They use a medical grade PVC and TPU cable jacket with medicalgrade PVC and ABS over molded connectors with integral relief. | ||
| Intended Use: | Shenzhen Med-link Cable / lead-wire are intended to be usedwith ECG, EKG, SpO2 and Invasive Blood Pressure monitoringdevices. The Cable / lead-wire are used to connect electrodes,catheters, and/or sensors placed at appropriate sites on thepatient to a monitoring device for general monitoring and/ordiagnostic evaluation by heath care professional. | ||
| TechnologyComparison: | Med-Link Cable / Lead-wire employ the same technologicalcharacteristics as the predicate device to determine the signalsbetween the patient and monitoring Device.This method is characteristic of all Cable / Lead-wire that is thesubject of this submission as well as the predicate device. | ||
| Performance Testing: | |||
| BiocompatibilityTesting | Patient contact with materials used in Med-Link Cable/ lead-wire were tested in accordance withISO 10993-5:1999 Biological evaluation of medical devices -Part 5: Tests for in vitro cytotoxicity and ISO10993-10:2002/Amd1:2006 Biological evaluation of medicaldevices - Part 10: Tests for irritation and delayed-typehypersensitivity - Amendment 1.Test results indicated that the patient contact material were |
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non-toxic, non-sensitizing and non-irritating. Med-Link Cable / Lead-wire tested in accordance with Electrical Safety applicable clause of IEC 60601-1:1998; Aml; A2:1995, Medical electrical equipment-Part 1: General requirements for safety. ANSI/AAMI EC53:1995/(R) 2001 ECG cables and leadwires and FDA 21CFR Part 898 Final rule. Med-Link Cable / Lead-wire were tested in accordance Lead-wire to with ANIS/AAMI EC53:1995 5/(R) 2001 ECG cables and trunk cable lead wires to ensure that the cable assemblies where the interconnection patient lead wires are separable from the trunk cable with a single unshielded conductor lead wire, the interconnection between the patient lead-wires and the trunk cable whether meet the requirements of DIN 42-802. Test results indicated that the cable / lead-wires comply with the applicable clause of the Standard. Clinical performance testing is not required and was not Performance performed to demonstrate safety and effectiveness of the Testing - Clinical Shenzhen Med-link cable / lead-wire. Not Applicable: The Shenzhen Med-link cable / lead-wire are Shelf Life Testing intended to be reusable. Performance Bench testing was conducted on the Shenzhen Med-link cable Testing - Bench / lead-wire according with established protocols and test results confirm that the final product met the requirements for the safety and performance standards and its intended use. Performance Animal performance testing is not required and was not Testing -Animal performed to demonstrate safety and effectiveness of the Shenzhen Med-link cable / lead-wire.
Comparison to Predicate Device:
The results of Comparison to Predicate Device as following:
Table 1—Comparison of cable / lead-wires has the same or similar technological characteristics as the predicate device. Table 2—Comparison of Med-link cable / lead-wire has different technological characteristics from the predicate device.
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Table 1--- Comparison of cable / lead-wires has the same or similar technological characteristics as the predicate device.
| Comparison Item | Shenzhen Med-link | Advantage medical | Unimed Medical |
|---|---|---|---|
| Indications | 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 heath care professional. | These patient cables and leadwires are intended to be used with ECG, EKG, SpO2 and Blood Pressure monitoring devices. | 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 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 heath care professional. |
| Patent Usage | Reusable | Reusable | Reusable |
| Anatomical Sites | The ECG and EKG cable attached to sensors places at standard specified locations on the chest wall. | The ECG and EKG cable attached to sensors places at standard specified locations on the chest wall. | The ECG and EKG cable attached to sensors places at standard specified locations on the chest wall. |
| Design / Appearance | ECG and EKG Cables with various connectors (monitor, trunk / lead wire, electrode grabber & snapper)Invasive Blood Pressure cables with various connectors (Yoke type: Utah 4pin, Instrument connector: Spacelabs 6 Pin etc.)SpO2 adapter cables with various connectors for connect for the OEM Instrument connector of SpO2 monitor and SpO2 probe. (DB9F, Din 8Pin and Philips etc.) | ECG and EKG Cables with various connectors (monitor, trunk / lead wire, electrode grabber & snapper)Invasive Blood Pressure cables with various connectors (Yoke type: Utah 4pin, Instrument connector: Spacelabs 6 Pin etc.)SpO2 adapter cables with various connectors for connect for the OEM Instrument connector of SpO2 monitor and SpO2 probe. (DB9F, Din 8Pin and Philips round 8Pin etc.) | ECG and EKG Cables with various connectors (monitor, trunk / lead wire, electrode grabber & snapper)Invasive Blood Pressure cables with various connectors (Yoke type: Utah 4pin, Instrument connector: Spacelabs 6 Pin etc.)SpO2 adapter cables with various connectors for connect for the OEM Instrument connector of SpO2 monitor and SpO2 probe. (DB9F, Din 8Pin and Philips round 8Pin etc.) |
| round 8Pin etc.) | |||
| Cable length | Various specifiedstandard lengths | Various specifiedstandard lengths | Various specifiedstandard lengths |
| Wirematerial | Shielded &Unshielded Copperwith PVC or TPUJacket | Shielded & UnshieldedCopper with PVC Jacket | Shielded & UnshieldedCopper with PVC Jacket |
| Sterility | Non sterile | Non sterile | Non sterile |
| ConnectorRetentionForce | ANSI / AAMI EC53:1995 /(R) 2001 | ANIS/AAMI EC53-1995 | ANIS / AAMIEC53A-1998(R)2001EC53A-1998(Amendment) |
| ElectricalPerformanceand Safety | ANSI / AAMI EC53:1995 /(R) 2001 andIEC 60601-1:1998;Am1; A2:1995 | ANSI / AAMIEC53-1995 and IEC60601-1:1998;Am1;A2:1995 | ANSI / AAMIEC53A-1998(R) 2001and IEC 60601-1:1998; Am1; A2:1995 |
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Table 2-Comparison of Med-link cable / lead-wire has different technological characteristics from the predicate device.
| Item | Med-linkmodels | Predicatedevice Model | Contrast results | |||
|---|---|---|---|---|---|---|
| AMC | UnimedMedical | Med-link | AMC | UnimedMedical | ||
| Cablelength | EA003S5A | CB-72500R/90 | 2540S | L:3.6m | L:3.0m | L:3.4m |
| EC021-5AI | CB-82516R | / | L:2.7m | L:3.0m | / | |
| EC040S5A | LW-26000MX/5A | D5-90S | L:1.0m | L:0.74m | L:0.9m | |
| EC072M5A | W-26000MX/5A | D5-90S | L:0.72m | L:0.74m | L:0.9m | |
| VA008BBA | / | E10-MQ12-B | L:3.06m | / | L:3.7m | |
| VE008-BAI | CB-5110006 | / | L:2.2m | L:3.0m | / | |
| X0015B | CB-91068 | BC-6P-UT | L:3.6m | L:3.0m | L: 4.0m | |
| S0052BC-L | CB-A400-1004A | / | L:2.4m | L:3.0m | / | |
| S00150X-L | CB-A400-1006VM | U708-40 | L:2.4m | L:2.4m | L:2.2m |
Conclusion:
- Shenzhen Med-link design is equivalent to predicate devices cleared to market under . 510(k) K082959 and K992524.
- Electrical safety and bench Testing confirms that Subject device performs as intended. .
- The proposed device does not raise new issues of safety and effectiveness. .
- The proposed device is deemed safe and effective for its intended use. .
- The bench testing can be fully proved that the different wire length of subject device . detailed as table 2 which have not produce new issue to affect the safety and effectiveness.
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Image /page/5/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo features a stylized eagle with three stripes representing the department's mission. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the eagle.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002
JAN 1 9 2012
Shenzhen Med-Link Electronics Tech., Co., Ltd. c/o Ms. Paula Wilkerson Responsible Third Party Official Intertek Testing Services NA 2307 E. Aurora Rd., Unit B7 Twinsburg, OH 44087
K120010 Re:
Trade/Device Name: Cable/Lead-Wire (ECG, EKG, SpO2 and Invasive Blood Pressure) Regulatory Number: 21 CFR 870.2900 Regulation Name: Patient transducer and electrode cable (including connector) Regulatory Class: II (two) Product Code: DSA Dated: December 20, 2011 Received: January 3, 2012
Dear Ms. Wilkerson:
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 for use sualed in the encreated of the enactment date of the Medical Device Amendments, or to conninered prior to 1118) 2017-11-11 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 I ou may, merelore, mance of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.
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.
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Page 2 - Ms. Paula Wilkerson
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-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 go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR 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 Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.
Sincerely yours,
D. Zadeh, M.D.
Bram D. Zuckerman, M.D. Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known):
K 120010
Device Name:
Cable / lead-wire (ECG, EKG, SpO2 and Invasive Blood Pressure), models
as below table:
| DeviceName / Type | Device Model |
|---|---|
| ECG cable andlead-wires | EA003S5A, EA010C5A, EA007C5A, EA050C5A,EA023C5A, EA035C3A, EA066S3A, EA009S5A,EC021-5AI, EC040S5A, EE007-5AI, EE051C5A,ED023-3AI, ED040C3A, ED040C5A, ED023-5AI,EP055-6AI, EP035S3A, EL009-5AI, EL040S5A,EC072M5I, EC072M5A, EC072S5I, EC072S5A |
| EKG cable andlead-wires | VA008BBA, VA018BCA, VA005BBA, VA001BNA,VA021BBA, VA025BAA, VE008-BAI, VE008BNA, |
| Invasive BloodPressure cables | X0014A, X0014B, X0015A, X0015B, X0018D,X0018F, |
| SpO2adapter cables | S0052BC-L, S0036BC-L, S0014OH-L, S0099BC-L,S0002NE-L, S0020CO-L, S0125CO-L, S0010NE-L,S0026OX-L, S0117OX-L, S0005NI-L, S0015OX-L,S0003OX-L, S0072BC-L, S0004NE-L |
Indications of Use:
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 heath care professional.
Prescription Use __ V__
AND/OR
Over-The-Counter Use_
(Part 21 CFR 801 Subparts D)
(21 CFR 807 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
(Division Sign-Off)
Division of Cardiovascular Devices.
| 510(k) Number | K 120010 |
|---|---|
| --------------- | ---------- |
Page 1 of 1Page 1 of 1
§ 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).