(320 days)
Integral-Process Medical Patient Cable and Leadwire Systems are intended to be used with various electrocardiograph recorders/monitors for both diagnostic and monitoring purposes such as ECG, EKG, SpO2 and Blood Pressure equipment. They are solely intended to be used between the electrode in contact with the patient's skin and the recording/monitoring device. This cabling facilitates the conduction of signals between the patient and the monitoring device. Integral-Process Medical Patient Cable and Leadwire Systems are limited by the Indications for Use of the connected recording/monitoring device.
Integral-Process Medical Patient Cable and Leadwire Systems are electrical cables interfacing and connecting transducers/sensors/electrodes placed on patients, to monitoring/recording/diagnostic devices/equipment is commonly located in hospitals, doctor's offices, emergency vehicles, as well as in home use. This cabling facilitates the conduction of signals between the patient and the monitoring/recording/diagnostic device. Integral-Process manufactures all type of interfacing transducer and patient cables, as replacement cables and/or as sub-contractor of main brands. These Medical Patient Cable and Leadwire systems are divided into 3 categories: 1) Electrocardiograph (EKG/ECG) cables, 2) SpO2 cables, and 3) IBPT cables.
The provided text describes a 510(k) premarket notification for "Integral-Process Medical Patient and Leadwire Systems." This document focuses on demonstrating substantial equivalence to existing predicate devices, rather than presenting a study to prove acceptance criteria for a novel device performance.
Therefore, many of the requested sections (e.g., sample sizes for test/training sets, number of experts, adjudication methods, MRMC studies, standalone performance, type of ground truth used, how ground truth for training was established) are not applicable in this context, as they pertain to performance studies typically conducted for new or significantly modified devices, especially those involving AI/ML.
This submission is about establishing that a cable and leadwire system performs comparably to already approved cables.
Here's an analysis based on the provided document:
1. Table of Acceptance Criteria and Reported Device Performance
The device (Integral-Process Medical Patient Cable and Leadwire Systems) is a Class II medical device (Product Code: DSA, Regulation Number: 21 CFR 870.2900 - Cable, Transducer and Electrode, Patient, (Including Connector)).
For such devices seeking 510(k) clearance, acceptance criteria are generally met by demonstrating conformance to recognized consensus standards and by showing substantial equivalence to legally marketed predicate devices. The "performance" in this context refers to the device's ability to facilitate signal conduction and meet safety/electrical requirements, rather than a diagnostic or clinical performance metric.
| Acceptance Criteria (Standards Conformance) | Reported Device Performance (Summary) |
|---|---|
| Electrical Performance & Safety: | Demonstrated conformance to relevant electrical safety and performance standards. |
| ANSI / AAMI EC53:1995 (R)2001 | |
| IEC 60601-1:1998; Am1; A2:1995 | |
| 21CFR898 (Electrode Lead Wires) | |
| AAMI/ANSI EC53:2013 (ECG Cables) | |
| IEC 60601-2-25:2011 (Electrocardiographs) | |
| IEC 60601-2-27:2011/AC1:2012 (ECG Monitoring) | |
| IEC 60601-2-34:2011 (IBP Monitoring) | |
| IEC 60601-2-49 2011 (Multi-function Monitoring) | |
| Biocompatibility: | Demonstrated conformance to relevant biocompatibility standards for skin-contact components. |
| ISO 10993-1 (Evaluation & Testing) | |
| ISO 10993-5 (In Vitro Cytotoxicity) | |
| ISO 10993-10 (Irritation & Sensitization) | |
| Risk Management: | Application of risk management processes per ISO 14971. |
| ISO 14971 2007 | |
| Quality System: | Manufacturing practices comply with quality system standards. |
| cGMP (21 CFR 820) | |
| ISO 13485:2012 / 2003 | |
| Mechanical Performance: | Demonstrated conformance to connector retention force standards. |
| ANSI / AAMI EC53A:1998 (R)2001 |
Explanation of "Study that Proves the Device Meets the Acceptance Criteria":
The document explicitly states: "Other effectiveness and safety compliance (electrical safety and biocompatibility of skin-contact components) to required standards and requirements are demonstrated in the market authorization file." This indicates that the "study" for these acceptance criteria involved testing against the listed consensus standards. While the specific test results are not detailed in this summary, the claim is that they exist in the full submission. The main "proof" of meeting acceptance criteria for a 510(k) is demonstrating that the device is "as safe, as effective for their intended use and perform as well as or better than the legally marketed devices." This is achieved through a comparison to predicate devices and showing conformance to recognized standards.
2. Sample Size Used for the Test Set and the Data Provenance:
- Test Set Sample Size: The document mentions that while there are around 1260 part numbers for cables, "a limited quantity of samples to have a good representation of the total range" was selected for comparison. This "sampling" approach is used to represent the different categories of connectors (monitor side, intermediate, yoke side leadwires, patient side leadwires). The specific number of each type of cable tested is not explicitly stated, but several examples are given in the comparison table (e.g., 72512-US, 70626NGJ3-US, 90797IP).
- Data Provenance: Not applicable for device performance testing here. The studies mentioned are primarily standard compliance tests on manufactured devices, not clinical data from patients. The manufacturer (INTEGRAL PROCESS SAS) is based in France.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and the Qualifications of Those Experts:
- Not applicable. This submission involves physical device testing against engineering and safety standards and a comparison against the technical characteristics of predicate devices. It does not involve human interpretation of medical images or data requiring expert "ground truth."
4. Adjudication Method for the Test Set:
- Not applicable. As there is no expert interpretation or human element involved in establishing "ground truth" for this type of device, an adjudication method is irrelevant.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:
- Not applicable. This device is a passive cable and leadwire system, not an AI or imaging device that would involve human readers or diagnostic interpretation.
6. If a Standalone (i.e. algorithm only without human-in-the loop performance) was done:
- Not applicable. This device is a cable system and does not contain an algorithm.
7. The Type of Ground Truth Used:
- For the purpose of establishing substantial equivalence and meeting safety/performance criteria, the "ground truth" is derived from:
- Consensus Standards: The requirements and methodologies defined in national and international standards (e.g., AAMI, IEC, ISO).
- Predicate Device Characteristics: The established design features, materials, and performance specifications of legally marketed predicate devices.
- Engineering Test Results: Measurements and observations from physical and electrical tests conducted on the Integral-Process cables themselves, demonstrating their conformity to established specifications.
8. The Sample Size for the Training Set:
- Not applicable. This is not an AI/ML device that requires a training set.
9. How the Ground Truth for the Training Set Was Established:
- Not applicable. As above, no training set for an algorithm is involved.
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Public Health Service
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Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
INTEGRAL PROCESS SAS Virginie Grondin Quality & Regulatory Affairs Manager 12 Rue Des Cayennes Po Box B.P. 20310 Conflans Sainte Honorine, 78703 Fr
Re: K162768
Trade/Device Name: Integral-Process Medical Patient and Leadwire systems: ECG trunk cables, ECG leadwires, SpO - sensors interface cables and IBP transducers interface cables Regulation Number: 21 CFR 870.2900 Regulation Name: Cable, Transducer and Electrode, Patient, (Including Connector) Regulatory Class: Class II Product Code: DSA Dated: July 7, 2017 Received: July 13, 2017
Dear Virginie Grondin:
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
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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 devicerelated adverse events) (21 CFR 803); good 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.
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.
M.A. Hillemann
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) K162768
Device Name
Integral-Process Medical Patient Cable and Leadwire Systems: ECG trunk cables, ECG leadwires, SpO2 sensors interface cables and IBP
Indications for Use (Describe)
Integral-Process Medical Patient Cable and Leadwire Systems are intended to be used with various electrocardiograph recorders/monitors for both diagnostic and monitoring purposes such as ECG, EKG, SpO2 and Blood Pressure equipment. They are solely intended to be used between the electrode in contact with the patient's skin and the recording/monitoring device. This cabling facilitates the conduction of signals between and the monitoring device. Integral-Process Medical Patient Cable and Leadwire Systems are limited by the Indications for Use of the connected recording/monitoring device.
| 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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510(k) Summary
Administrative:
| Submitter: | INTEGRAL PROCESS SAS |
|---|---|
| Z.A. des Boutries | |
| 12, rue des Cayennes, B.P. 310 | |
| 78703 CONFLANS SAINTE HONORINE CEDEX, FRANCE | |
| Tel : +33 1 39 72 66 66 - Fax : +33 1 39 72 61 61 | |
| Contact : | Virginie Grondin, Quality Manager, Official Correspondent |
| Tel : +33 1 39 72 11 77 | |
| e-mail : vgrondin@integral-process.com |
Establishment Registration Number: 3004762958
Date of preparation: July 21, 2016
I. Device Name:
| Classification Name: | Cable, transducer and electrode, patient, (including connector) |
|---|---|
| Regulation description | Patient transducer and electrode cable (including connector) |
| Common/Usual Name: | Patient cables and Leadwires |
| Trade Name: | Integral-Process Medical Patient and Leadwire systems: ECG trunkcables, ECG leadwires, SpO2 sensors interface cables and IBPtransducers interface cables. |
| Classification: | Class II |
|---|---|
| Registration #: | 870.2900 |
| Product Code: | DSA |
II. Predicate Devices:
We have to consider the legally marketed closest existing devices to the Integral Process Medical Patient Cable and Leadwire Systems submitted devices and we will separate the following aspects:
Functionality (indication); Patient Usage; Positioning of the EKG/ECG Leadwires; Design and Shape; Cable Length; Materials; Sterility; Mechanical and Electrical Performance and Safety.
List of Predicate Devices:
| Substantial Equivalence | K # | Manufacturer / Current marketer | Device I/D |
|---|---|---|---|
| EKG/ECG, SpO2, IBP Cables | K120010 | Shenzhen Med-link ElectronicsTech Co., Ltd.Building2, HuaFu Ind. Park, HuaWang Road,LongHua, BaoAn,District 518109 Shenzhen City, P.R.China | Cable/ lead-wire (ECG, EKG, SpO2 and Invasive Blood Pressure) (*) |
| EKG/ECG, SpO2, IBP Cables | K992524 | Advantage Medical Cables, Inc.10630 Wiles RoadCoral Springs, FL 33076 USA | Patient Monitoring Cables for ECG, EKG, Sp02 and Blood Pressure Monitors (*) |
| EKG/ECG, SpO2, IBP Cables | K082959 | Unimed Medical Supplies, Inc.No.37, Yanshan Road, ShekouShenzhen, 518067 China | Patient monitoring Cables for ECG, EKG,Spo2 and Blood Pressure Monitors ()() Multiple ReferencesSee detailed catalogues and tablesAttachment I & III |
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| Comparison item | Integral-ProcessMedical Patient Cableand Leadwire systems | Shenzhen Med-link | Advantage medical | Unimed Medical |
|---|---|---|---|---|
| K# | t.b.d. | K120010 | K992524 | K082959 |
| Indication | Integral-Process MedicalPatient Cable andLeadwire Systems areintended to be used withvariouselectrocardiographrecorders/monitors forboth diagnostic andmonitoring purposessuch as ECG, EKG,SpO2 and BloodPressure equipment.They are solely intendedto be used between theelectrode in contact withthe patient's skin and therecording/monitoringdevice. This cablingfacilitates the conductionof signals between thepatient and themonitoring device.Integral-Process MedicalPatient Cable andLeadwire Systems arelimited by the Indicationsfor Use of the connectedrecording/monitoringdevice. | Shenzhen Med-linkCable / lead-wire areintended to be used withECG, EKG, Sp02 andInvasive Blood Pressuremonitoring devices. TheCable / lead-wire areused to connectelectrodes, catheters,and/or sensors placed atappropriate sites on thepatient to a monitoringdevice for generalmonitoring andfordiagnostic evaluation byheath care professional. | These patient cablesand leadwires areintended to be usedwith ECG, EKG, Sp02and Blood Pressuremonitoring devices. | The Unimed patientcables and lead wiresare intended to be usedwith ECG, EKG, sp02and BP monitoringdevices. The patientcables and lead wireare used to connectelectrodes, catheters,and / or sensors placedat appropriate sites onthe patient to amonitoring device forgeneral monitoringand/or diagnosticevaluation by heathcare professional. |
| Patient Usage | Reusable | Reusable | Reusable | Reusable |
| Anatomical Sites | The leadwire isconnected to the ECG orEKG electrodes placed atstandard specifiedlocations on the patientlimbs and/or chest. | The ECG and EKGcable are attached tosensors placed atstandard specifiedlocations on the chestwall. | The ECG and EKGcable are attached tosensors placed atstandard specifiedlocations on the chestwall. | The ECG and EKGcable are attached tosensors placed atstandard specifiedlocations on the chestwall. |
| Design | ECG and EKG cables /leadwires have variousdesigned connectors(monitor, trunk yokes,lead wire, electrodegrabber, snap andbanana) | ECG and EKG Cableswith various connectors(monitor, trunk / leadwire, electrode grabber& snapper) | ECG and EKG Cableswith various connectors(monitor, trunk / leadwire, electrode grabber& snapper) | ECG and EKG Cableswith various connectors(monitor, trunk / leadwire, electrode grabber& snapper) |
| Integral Process invasiveblood pressure cable hasvarious connectors (Yoketype: on the transducerside, instrumentconnector on the otherside. | Invasive Blood Pressurecables with variousconnectors (Yoke type:Utah 4pin, Instrumentconnector: Spacelabs 6Pin etc.) | Invasive BloodPressure cables withvarious connectors(Yoke type: Utah 4pin,Instrument connector:Spacelabs 6 Pin etc.) | Invasive BloodPressure cables withvarious connectors(Yoke type: Utah 4pin,Instrument connector:Spacelabs 6 Pin etc.) | |
| Comparison item | Integral-ProcessMedical Patient Cableand Leadwire systems | Shenzhen Med-link | Advantage medical | Unimed Medical |
| Integral Process SpO2cable has variousconnectors to connectthe OEM instrumentconnector of SpO2monitor and SpO2 probe.(DB9, Din 8Pin, Philips,etc.) | SpO2 adapter cableswith various connectorsfor connect for the OEMInstrument connector ofSp02 monitor and Sp02probe. (DB9, Din 8Pinand Philips round 8Pinetc.) | SpO2 adapter cableswith various connectorsfor connect for theOEM Instrumentconnector of Sp02monitor and Sp02probe. (DB9, Din 8Pinand Philips round 8Pinetc.) | SpO2 adapter cableswith various connectorsfor connect for theOEM Instrumentconnector of Sp02monitor and SpO2probe. (DB9, Din 8Pinand Philips round 8Pinetc.) | |
| Integral Process MedicalPatient Cable andLeadwire Systems covera much larger range ofdevices combining ontheir both sides all type ofconnectors than theselected predicatedevices, without alteringeither intended use or thetransfer signalfunctionality. | ||||
| Cable Lengths | Various specifiedstandard lengths | Various specifiedstandard lengths | Various specifiedstandard lengths | Various specifiedstandard lengths |
| Wire material | Shielded & UnshieldedCopper; medical gradeTPU cable jacket withmedical grade PAovermolded connectorswith integral strain relief. | Shielded & UnshieldedCopper with PVC orTPU Jacket | Shielded & UnshieldedCopper with PVCJacket | Shielded & UnshieldedCopper with PVCJacket |
| Sterility | Non-sterile | Non-sterile | Non-sterile | Non-sterile |
| Connector Retention Force | ANSI / AAMIEC53A:1998 (R)2001 | ANSI / AAMI EC53:1995(R)2001 | ANSI / AAMIEC53:1995 | ANSI / AAMIEC53A:1998 (R)2001EC53A-1998(Amendment) |
| Electrical Performance andSafety | ANSI / AAMI EC53:1995(R)2001 | ANSI / AAMI EC53:1995(R)2001 and IEC 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 |
Comparison of cable / lead-wires has the same or similar technological characteristics as the Predicates:
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Representative samples of INTEGRAL PROCESS range of patient cables:
Although the total amount of the different cables presented in this submission is around 1260 part numbers we need a limited quantity of samples to have a good representation of the total range.
If we consider that cables have two ends and often an intermediate yoke we have defined 4 categories of connectors:
- Monitor side connectors
All the INTEGRAL PROCESS cables connectors on monitor side can be represented with 8 types of connectors (From MC1 to MC8)
- Intermediate connectors (Trunk cable yoke, IPB or SpO2 sensor side connector) All connectors can be represented with 8 different types of connectors (From YC1 to YC8).
Premarket notification: Integral-Process, Medical Patient Cable and Leadwire Systems
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3) Yoke side leadwires connectors
Four different types of connectors represent all the different leadwires connectors to the trunk cable yoke (From LY1 to LY4).
4) Patient side leadwires connexions
Four different types of connectors [Banana, Snap, Clip (with metal conductor) and Carbon Clip]. Those ends are on the patient side of the one piece ECG cables and of the detachable leadwires.
| Integral-ProcessCable P/N | Description(Connected Medical Equipment) | PredicateReference | PredicateName & K# | Monitorsideconnector | Middleconnexion | Connector betweenLeadwireandTrunkcableyoke | PatientSideConnector |
|---|---|---|---|---|---|---|---|
| 72279-US | NIHON KOHDEN CARDIOFAX OLDGENERATION 5151-5303 | CB-72353P | AdvantageK992524 | MC1 | YC4 | Banana | |
| 71710-US | GE-MAC 1100 - 1200 MAC 400-600-800 | CB-721001R/1 | // | MC2 | YC2 | ||
| 72512-US | MEDTRONICPHYSIOCONTROLLIFEPAK 12 | CB-721007R/1 | // | MC3 | YC4 | Clip | |
| 90797IP | MINDRAY DATASCOPEBENEVIEW T5 - T8 IPM9800 D6 | S0125CO-L** | ShenzenK120010 | MC4 | YC5 | ||
| 72240-US | NIHON KOHDEN BSM 2103-4103K | CB-713600 | AdvantageK992524 | MC5 | YC1 | ||
| 88769 | DRAEGER SIEMENS | CB-91018 | // | MC7 | YC7 | ||
| 87550 | GE EAGLE TRAM | BC-MC-MX1* | UnimedK082959 | MC6 | YC6 | ||
| IPC71040 | BARD ELECTROPHYSIOLOGYUNIT | CB-721020R/1 | AdvantageK992524 | MC8 | YC3 | ||
| 90766IP | PHILIPS M3 - M4 - VSM MMS MP2à MP70 | CB-A400-1006VM | // | MC4 | YC8 | ||
| 71796-US | PHILIPS ECG100/200 Serie | CB-721014R/1 | // | MC2 | YC3 | Snap | |
| 70626NGJ3-US | 3 Leadwires for IP Trunk cables | LW-3090R24/3A | // | LY1 | Snap | ||
| 70686NG-US | Single IP Radiolucent leadwire | LW-2300051/XA | // | LY3carbon | Clipcarbon | ||
| 70822 | 3 Leadwires for IP paediatric trunkcable | LW-2090029/3A | // | LY2 | Snap | ||
| 70683HPJ3-US | 3 Leadwires for PHILIPS AcquisitionBox: M1663A - M1668A - M1669A– M1949A | LW-2090S51/3A | // | LY3 | Clip | ||
| 70646WAJ10-US | 3 Leadwires WELCH ALLYNACQUISITION BOX: CP100 -CP200 | EG040S5A** | ShenzenK120010 | LY4 | Clip |
Substantial Equivalence by Selected (Sampling) References:
| SubstantialEquivalence | Integral ProcessDevice P/N | Predicate Device P/N | K # | Manufacturer / Current marketer |
|---|---|---|---|---|
| ECG one piece andtrunk cables | 72512-US72240-USIPC71040 | CB-721007R /1CB-713600CB-721020R/1 | K992524 | Advantage Medical Cables Inc. (AMC) |
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| SubstantialEquivalence | Integral ProcessDevice P/N | Predicate Device P/N | K # | Manufacturer / Current marketer |
|---|---|---|---|---|
| ECG leadwires | 70626NGJ3-US | LW-3090R24/3A | K992524 | Advantage Medical Cables Inc. (AMC) |
| 70686NG-US | LW-2300051/XA | |||
| 70822 | LW-2090029/3A | |||
| 70683HPJ3-US | LW-2090S51/3A | |||
| ECG leadwires(cont) | 70646WAJ10-US | EG040S5A | K120010 | Shenzhen Med-link Electronics TechCO., Ltd. |
| EKG cables andleadwires | 72279-US | CB-72353P | K992524 | Advantage Medical Cables Inc. (AMC) |
| 71710-US | CB-721001R/1 | |||
| 71796-US | CB-721014R/1 | |||
| SpO2 sensorinterface cables | 90797IP | S0125CO-L | K120010 | Shenzhen Med-link Electronics TechCO., Ltd. |
| 90766IP | CB-A400-1006VM | K992524 | Advantage Medical Cables Inc. (AMC) | |
| IBP transducerinterface cables | 88769 | CB-91018 | K992524 | Advantage Medical Cables Inc. (AMC) |
| 87550 | BC-MC-MX1 | K082959 | Unlined Medical supplies Inc |
III. Device Description:
Integral-Process Medical Patient Cable and Leadwire Systems are electrical cables interfacing and connecting transducers/sensors/electrodes placed on patients, to monitoring/recording/diagnostic devices/equipment is commonly located in hospitals, doctor's offices, emergency vehicles, as well as in home use.
This cabling facilitates the conduction of signals between the patient and the monitoring/recording/diagnostic device.
Original Equipment Manufacturers (OEM) of either sides: e.g. sensors/captors/electrodes and monitoring/recording/diagnostic devices may be identical or different depending on source and period of supplies.
Integral-Process manufactures all type of interfacing transducer and patient cables, as replacement cables and/or as sub-contractor of main brands.
We can divide these Medical Patient Cable and Leadwire systems in 3 categories:
- Electrocardiograph (EKG/ECG) cables (also sometimes referred to as trunk or lead wires) are replacements for similar cables manufactured by the OEM and other third party after market manufacturers for their respective monitors. The Trunk Cables connect the OEM patient monitor to the patient Lead Wires. The lead wires connect the trunk cable to the skin-mounted ECG electrodes. Additional Trunk Cables have a specific connector for Integral-Process proprietary pre-wired and harnessed electrode systems IP-SET
The most common cable configuration is of a 3, 5 or 10 conductors cable with a metal or plastic connector terminated on one end by crimp or solder method, using various keyway configurations depending on the make and model of the monitor, for connection to the monitoring device, and the 3, 5 or 10 conductors terminated into a connector or yoke assembly either for standard lead wires or for an IP-SET pre wired harness to attach on the other hand.
IP-SET® prewired harnessed electrodes are the object of a separate premarket notification file. (K101685)
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Standard lead wires may be permanently attached to the yoke or terminated on one end with a 0.60 diameter pin and over molded with the mating DIN style connector and a snap or pinch type connector on the other hand for connection to the patient electrodes.
- and 3) SpO2 and IBPT cables are connecting directly patient transducers and sensors to monitoring/recording/diagnostic equipment. The Integral Process manufactures a much larger range of cables combining on their both sides (Equipment, all type of patient connectors) than the selected predicate devices, without altering either intended use or the transfer signal functionality.
Although the total amount of the different cables presented in this submission is around 1260 part numbers we selected a limited quantity of samples to have a good representation of the total range, as shown above (Predicate Device Comparison)
IV Conformance Standards
Standards Applicable to Company
| cGMP (21 CFR 820) | QSR - Manufacturing |
|---|---|
| ISO 13485:2012 / 2003 | Quality System for Medical Device Manufacturing |
Standards Applicable to Product
| 21CFR898 | PERFORMANCE STANDARD FOR ELECTRODE LEADWIRES AND PATIENT CABLES |
|---|---|
| AAMI/ANSI EC53:2013 | ECG Cables and Lead Wires |
| ISO 14971 2007 | Medical devices - Application of risk management to medicaldevices |
| IEC 60601-1: 1988 +A1 1991+A2 1995§ -56.3IEC 60601-12005 / 2012 | Medical electrical equipment - Part 1: General requirementsfor basic safety and essential performance: - ConnectorsMedical electrical equipment - Part 1: General |
| IEC 60601-2-25:2011 | Particular requirements for the basic safety and essentialperformance of electrocardiographs |
| IEC 60601-2-27:2011/AC1:2012 | Particular requirements for the basic safety and essentialperformance of electrocardiographic monitoring equipment |
| ISO 80601-2-61:2011 | Particular requirements for basic safetyand essential performance of pulse oximeter equipment |
| IEC 60601-2-34:2011 | Particular requirements for the basic safety and essentialperformance of invasive blood pressure monitoringequipment |
| IEC 60601-2-49 2011 | Particular requirements for the basic safety and essentialperformance of multi-function patient monitoring equipment |
| ISO 10993-1 | Biological evaluation of medical devices Part 1: Evaluationand testing |
| ISO 10993-5 | Biological evaluation of medical devices Part 5: Tests for invitro cytotoxicity |
Premarket notification: Integral-Process, Medical Patient Cable and Leadwire Systems
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Biological evaluation of medical devices Part 10: Tests for ISO 10993-10 irritation and skin sensitization
V Indications for Use
Integral-Process Medical Patient Cable and Leadwire Systems are intended to be used with various electrocardiograph recorders/monitors for both diagnostic and monitoring purposes such as ECG, EKG, SpO2 and Blood Pressure equipment. They are solely intended to be used between the electrode in contact with the patient's skin and the recording/monitoring device. This cabling facilitates the conduction of signals between the patient and the monitoring device. Integral-Process Medical Patient Cable and Leadwire Systems are limited by the Indications for Use of the connected recording/monitoring device.
VI Comparison of Technological Characteristics
The Reusable Integral-Process Medical Patient Cable and Leadwire Systems are identical in function, and have the same intended use as the legally marketed disposable patient cables and leadwires that are intended to be used with ECG, EKG, Sp02 and Blood Pressure monitoring devices, from Shenzhen Med-link Electronics Tech CO., Ltd. (K120010), Unimed Medical Supplies Inc. (K082959) and Advantage Medical Cables Inc. (AMC) (K992524).
Other effectiveness and safety compliance (electrical safety and biocompatibility of skin-contact components) to required standards and requirements are demonstrated in the market authorization file.
Accordingly Integral-Process concluded that the Integral Process Medical Patient Cable and Leadwire Systems are as safe, as effective for their intended use and perform as well as or better than the legally marketed devices that are intended to be used with ECG, EKG, SpO2 and Blood Pressure monitoring devices.
§ 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).