(320 days)
Not Found
No
The device description and intended use clearly define the device as electrical cables and leadwire systems for signal conduction, with no mention of AI or ML capabilities. The "Mentions AI, DNN, or ML" section explicitly states "Not Found".
No
The device is described as facilitating the conduction of signals between a patient and monitoring/recording/diagnostic devices. It does not provide any treatment or therapeutic action itself.
No
This device is described as "Medical Patient Cable and Leadwire Systems" that facilitate the conduction of signals between the patient and a recording/monitoring/diagnostic device. It is an accessory for diagnostic devices, but not a diagnostic device itself.
No
The device is described as electrical cables and leadwire systems, which are physical hardware components used to connect electrodes to monitoring devices. The description explicitly mentions "electrical cables interfacing and connecting transducers/sensors/electrodes placed on patients."
Based on the provided text, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD definition: In Vitro Diagnostics are medical devices used to perform tests 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 Integral-Process Medical Patient Cable and Leadwire Systems are electrical cables that connect electrodes/sensors placed on the patient's skin to monitoring/recording devices. They facilitate the conduction of signals from the patient.
- No mention of samples: There is no mention of the device being used to test samples taken from the patient.
- Intended Use: The intended use is for diagnostic and monitoring purposes with various electrocardiograph recorders/monitors, SpO2, and Blood Pressure equipment. These are devices that measure physiological signals directly from the patient.
Therefore, the device is an external medical device used for connecting a patient to monitoring equipment, not for performing tests on in vitro samples.
N/A
Intended Use / 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 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.
Product codes (comma separated list FDA assigned to the subject device)
DSA
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)
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)
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
The leadwire is connected to the ECG or EKG electrodes placed at standard specified locations on the patient limbs and/or chest.
Indicated Patient Age Range
Not Found
Intended User / Care Setting
commonly located in hospitals, doctor's offices, emergency vehicles, as well as in home use.
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)
Not Found
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
Public Health Service
Image /page/0/Picture/2 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is a stylized image of three human profiles facing to the right, resembling a family.
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
1
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
2
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) |
CONTINUE ON A SEPARATE PAGE IF NEEDED.
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3
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 trunk |
| cables, ECG leadwires, SpO2 sensors interface cables and IBP | |
| transducers 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 Road | |||
| Coral 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, Shekou | |||
| Shenzhen, 518067 China | Patient monitoring Cables for ECG, EKG,Spo2 and Blood Pressure Monitors (*) | ||
| (*) Multiple References | |||
| See detailed catalogues and tables | |||
| Attachment I & III |
4
| Comparison item | Integral-Process
Medical Patient Cable
and Leadwire systems | Shenzhen Med-link | Advantage medical | Unimed Medical |
|--------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| K# | t.b.d. | K120010 | K992524 | K082959 |
| Indication | 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. | Shenzhen Med-link
Cable / lead-wire are
intended to be used with
ECG, EKG, Sp02 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 andfor
diagnostic evaluation by
heath care professional. | These patient cables
and leadwires are
intended to be used
with ECG, EKG, Sp02
and Blood Pressure
monitoring devices. | The Unimed patient
cables and lead wires
are intended to be used
with ECG, EKG, sp02
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. |
| Patient Usage | Reusable | Reusable | Reusable | Reusable |
| Anatomical Sites | The leadwire is
connected to the ECG or
EKG electrodes placed at
standard specified
locations on the patient
limbs and/or chest. | The ECG and EKG
cable are attached to
sensors placed at
standard specified
locations on the chest
wall. | The ECG and EKG
cable are attached to
sensors placed at
standard specified
locations on the chest
wall. | The ECG and EKG
cable are attached to
sensors placed at
standard specified
locations on the chest
wall. |
| Design | ECG and EKG cables /
leadwires have various
designed connectors
(monitor, trunk yokes,
lead wire, electrode
grabber, snap and
banana) | ECG and EKG Cables
with various connectors
(monitor, trunk / lead
wire, electrode grabber
& snapper) | ECG and EKG Cables
with various connectors
(monitor, trunk / lead
wire, electrode grabber
& snapper) | ECG and EKG Cables
with various connectors
(monitor, trunk / lead
wire, electrode grabber
& snapper) |
| | Integral Process invasive
blood pressure cable has
various connectors (Yoke
type: on the transducer
side, instrument
connector on the other
side. | Invasive Blood Pressure
cables with various
connectors (Yoke type:
Utah 4pin, Instrument
connector: Spacelabs 6
Pin etc.) | Invasive Blood
Pressure cables with
various connectors
(Yoke type: Utah 4pin,
Instrument connector:
Spacelabs 6 Pin etc.) | Invasive Blood
Pressure cables with
various connectors
(Yoke type: Utah 4pin,
Instrument connector:
Spacelabs 6 Pin etc.) |
| Comparison item | Integral-Process
Medical Patient Cable
and Leadwire systems | Shenzhen Med-link | Advantage medical | Unimed Medical |
| | Integral Process SpO2
cable has various
connectors to connect
the OEM instrument
connector of SpO2
monitor and SpO2 probe.
(DB9, Din 8Pin, Philips,
etc.) | SpO2 adapter cables
with various connectors
for connect for the OEM
Instrument connector of
Sp02 monitor and Sp02
probe. (DB9, Din 8Pin
and Philips round 8Pin
etc.) | SpO2 adapter cables
with various connectors
for connect for the
OEM Instrument
connector of Sp02
monitor and Sp02
probe. (DB9, Din 8Pin
and Philips round 8Pin
etc.) | SpO2 adapter cables
with various connectors
for connect for the
OEM Instrument
connector of Sp02
monitor and SpO2
probe. (DB9, Din 8Pin
and Philips round 8Pin
etc.) |
| | Integral Process Medical
Patient Cable and
Leadwire Systems cover
a much larger range of
devices combining on
their both sides all type of
connectors than the
selected predicate
devices, without altering
either intended use or the
transfer signal
functionality. | | | |
| Cable Lengths | Various specified
standard lengths | Various specified
standard lengths | Various specified
standard lengths | Various specified
standard lengths |
| Wire material | Shielded & Unshielded
Copper; medical grade
TPU cable jacket with
medical grade PA
overmolded connectors
with integral strain relief. | Shielded & Unshielded
Copper with PVC or
TPU Jacket | Shielded & Unshielded
Copper with PVC
Jacket | Shielded & Unshielded
Copper with PVC
Jacket |
| Sterility | Non-sterile | Non-sterile | Non-sterile | Non-sterile |
| Connector Retention Force | ANSI / AAMI
EC53A:1998 (R)2001 | ANSI / AAMI EC53:1995
(R)2001 | ANSI / AAMI
EC53:1995 | ANSI / AAMI
EC53A:1998 (R)2001
EC53A-1998
(Amendment) |
| Electrical Performance and
Safety | ANSI / AAMI EC53:1995
(R)2001 | ANSI / AAMI EC53:1995
(R)2001 and IEC 60601-
1:1998; Am1; A2:1995 | ANSI / AAMI
EC53:1995 and IEC
60601-1:1998; Am1;
A2:1995 | ANSI / AAMI
EC53A:1998 (R)2001
and IEC 60601-1:1998;
Am1: A2:1995 |
Comparison of cable / lead-wires has the same or similar technological characteristics as the Predicates:
5
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
6
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-
Process
Cable P/N | Description
(Connected Medical Equipment) | Predicate
Reference | Predicate
Name & K# | Monitor
side
connect
or | Middle
connexi
on | Connecto
r between
Leadwire
and
Trunk
cable
yoke | Patient
Side
Connect
or |
|-----------------------------------|----------------------------------------------------------------------------------|------------------------|------------------------|----------------------------------|-------------------------|--------------------------------------------------------------------|----------------------------------|
| 72279-US | NIHON KOHDEN CARDIOFAX OLD
GENERATION 5151-5303 | CB-72353P | Advantage
K992524 | MC1 | YC4 | | Banana |
| 71710-US | GE-MAC 1100 - 1200 MAC 400-
600-800 | CB-
721001R/1 | // | MC2 | YC2 | | |
| 72512-US | MEDTRONIC
PHYSIOCONTROLLIFEPAK 12 | CB-721007R
/1 | // | MC3 | YC4 | | Clip |
| 90797IP | MINDRAY DATASCOPE
BENEVIEW T5 - T8 IPM9800 D6 | S0125CO-L** | Shenzen
K120010 | MC4 | YC5 | | |
| 72240-US | NIHON KOHDEN BSM 2103-4103K | CB-713600 | Advantage
K992524 | MC5 | YC1 | | |
| 88769 | DRAEGER SIEMENS | CB-91018 | // | MC7 | YC7 | | |
| 87550 | GE EAGLE TRAM | BC-MC-MX1* | Unimed
K082959 | MC6 | YC6 | | |
| IPC71040 | BARD ELECTROPHYSIOLOGY
UNIT | CB-
721020R/1 | Advantage
K992524 | MC8 | YC3 | | |
| 90766IP | PHILIPS M3 - M4 - VSM MMS MP2
à MP70 | CB-A400-
1006VM | // | MC4 | YC8 | | |
| 71796-US | PHILIPS ECG100/200 Serie | CB-
721014R/1 | // | MC2 | YC3 | | Snap |
| 70626NGJ
3-US | 3 Leadwires for IP Trunk cables | LW-
3090R24/3A | // | | | LY1 | Snap |
| 70686NG-
US | Single IP Radiolucent leadwire | LW-
2300051/XA | // | | | LY3
carbon | Clip
carbon |
| 70822 | 3 Leadwires for IP paediatric trunk
cable | LW-
2090029/3A | // | | | LY2 | Snap |
| 70683HPJ
3-US | 3 Leadwires for PHILIPS Acquisition
Box: M1663A - M1668A - M1669A
– M1949A | LW-
2090S51/3A | // | | | LY3 | Clip |
| 70646WA
J10-US | 3 Leadwires WELCH ALLYN
ACQUISITION BOX: CP100 -
CP200 | EG040S5A** | Shenzen
K120010 | | | LY4 | Clip |
Substantial Equivalence by Selected (Sampling) References:
| Substantial
Equivalence | Integral Process
Device P/N | Predicate Device P/N | K # | Manufacturer / Current marketer |
|-----------------------------------|----------------------------------|--------------------------------------------|---------|-------------------------------------|
| ECG one piece and
trunk cables | 72512-US
72240-US
IPC71040 | CB-721007R /1
CB-713600
CB-721020R/1 | K992524 | Advantage Medical Cables Inc. (AMC) |
7
| Substantial
Equivalence | Integral Process
Device 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 Tech
CO., Ltd. |
| EKG cables and
leadwires | 72279-US | CB-72353P | K992524 | Advantage Medical Cables Inc. (AMC) |
| | 71710-US | CB-721001R/1 | | |
| | 71796-US | CB-721014R/1 | | |
| SpO2 sensor
interface cables | 90797IP | S0125CO-L | K120010 | Shenzhen Med-link Electronics Tech
CO., Ltd. |
| | 90766IP | CB-A400-1006VM | K992524 | Advantage Medical Cables Inc. (AMC) |
| IBP transducer
interface 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)
8
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 LEAD
WIRES AND PATIENT CABLES |
|---------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| AAMI/ANSI EC53:2013 | ECG Cables and Lead Wires |
| ISO 14971 2007 | Medical devices - Application of risk management to medical
devices |
| IEC 60601-1: 1988 +A1 1991
+A2 1995
§ -56.3
IEC 60601-1
2005 / 2012 | Medical electrical equipment - Part 1: General requirements
for basic safety and essential performance: - Connectors
Medical electrical equipment - Part 1: General |
| IEC 60601-2-25:2011 | Particular requirements for the basic safety and essential
performance of electrocardiographs |
| IEC 60601-2-27:2011/AC1:2012 | Particular requirements for the basic safety and essential
performance of electrocardiographic monitoring equipment |
| ISO 80601-2-61:2011 | Particular requirements for basic safety
and essential performance of pulse oximeter equipment |
| IEC 60601-2-34:2011 | Particular requirements for the basic safety and essential
performance of invasive blood pressure monitoring
equipment |
| IEC 60601-2-49 2011 | Particular requirements for the basic safety and essential
performance of multi-function patient monitoring equipment |
| ISO 10993-1 | Biological evaluation of medical devices Part 1: Evaluation
and testing |
| ISO 10993-5 | Biological evaluation of medical devices Part 5: Tests for in
vitro cytotoxicity |
Premarket notification: Integral-Process, Medical Patient Cable and Leadwire Systems
9
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.