(62 days)
Not Found
No
The device description and intended use clearly state that these are replacement ECG cables. There is no mention of any computational processing, algorithms, or learning capabilities. The function is purely signal conduction.
No
Explanation: The device is described as ECG cables that facilitate the conduction of signals between the patient and a monitoring device for diagnostic and monitoring purposes. It does not perform any therapeutic function.
Yes
Explanation: The "Intended Use / Indications for Use" section states that these devices are "intended to be used with various electrocardiograph recorders/monitors for both diagnostic and monitoring purposes."
No
The device description explicitly states that the device consists of physical components: "connectors on each cable end and a shielded bulk cable." It also mentions "medical grade PVC cable jacket with medical grade PVC overmolded connectors." This indicates a hardware device, not a software-only device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostic devices are used to examine specimens taken from the human body (like blood, urine, tissue) to provide information about a person's health. This testing is done outside of the body.
- Device Function: The described device is an ECG cable. Its function is to transmit electrical signals from electrodes placed on the patient's skin to an ECG monitor. This is a direct connection to the patient's body and involves the measurement of physiological signals within the body.
- Intended Use: The intended use clearly states it's for use with electrocardiograph recorders/monitors for diagnostic and monitoring purposes, facilitating the conduction of signals between the patient and the monitoring device. This is not about analyzing a sample taken from the patient.
Therefore, the device is a medical device used for physiological monitoring, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
These devices are intended to be used with various electrocardiograph recorders/monitors for both diagnostic and monitoring purposes. They are solely intended to be used between the disposable electrodes (not manufactured by AIV) in contact with the patient's skin and the recording/monitoring device (not manufactured by AIV). These cables are used by qualified personnel in the field of clinical medicine (not manufactured by AIV). These are limited by the Indications for Use of the connected recording/monitoring device. No other usage is intended for the trunk cables or leadwires.
Product codes
DSA
Device Description
AIV's Electrocardiograph (ECG) cables (also sometimes referred to as trunk or leadwires) are replacements for similar cables manufactured by the Original Equipment Manufacturers (OEM) and other third party after market manufacturers for their respective monitors. The Trunk Cables connect the OEM patient monitor to the patient leadwires connect the trunk cable to the skin mounted ECG electrodes.
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 Trunk Cables have limited skin contact with the patient, while the Leadwires attached on the patient's chest have more continuous skin contact.
The AIV cables use the same type of construction and have the same technological characteristics as the predicate devices. They use a medical grade PVC cable jacket with medical grade PVC overmolded connectors with an integral strain relief.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Attached to electrodes placed at standard specified locations on chest wall.
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Used by qualified personnel in the field of clinical medicine.
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)
- AIV design is equivalent to predicate device design.
- Bench Testing demonstrates that the AIV devices perform as intended.
- The company has declared conformity to consensus standard ANSI/AAMI EC53-1995/(R)2001 and its attachment EC53A-1998/(R)2001 relating to Electrical/Safety/Mechanical.
- These devices do not raise new issues of safety and effectiveness, nor do they alter the fundamental technology of the predicate devices.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
K945034, K933649, K980582, K970545, K964750, K960418
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 870.2900 Patient transducer and electrode cable (including connector).
(a)
Identification. A patient transducer and electrode cable (including connector) is an electrical conductor used to transmit signals from, or power or excitation signals to, patient-connected electrodes or transducers.(b)
Classification. Class II (performance standards).
0
MAR 2 7 2007.
Image /page/0/Picture/2 description: The image shows the logo for AIV, which is a black star above the letters "aiv" in a stylized font. Below the logo is the text "Supporting Clinical Engineering Worldwide". The logo is simple and professional, and the text is clear and concise.
Appendix C Page 1 of 2
510(k) Summary
Submitter Information:
American IV Products, Inc. 7485 Shipley Avenue Harmans, MD 21077
Contact:
John Taylor Director of Engineering Telephone: 410-787-1300 ext. 131 Fax: 410-787-1337 e-mail: itaylor@aiv-inc.com
Date Prepared:
January 19, 2007
Product Name:
Classification Name: Cable, Transducer and Electrode, Patient, (Including Connector) Common Name: ECG Cables, Trunk and Patient Lead Wires Proprietary Name: ECG Cables, Trunk and Patient Lead Wires
Predicate Device:
These AIV devices are substantially equivalent to the following legally marketed devices:
FSR1311, FSR565, FSR1303, FSR1534, FSR1390, FSR1590, FSR367, FSR1370, FSR1539, D8338II. D8538. FSP24-003R. DA24-0311. FSA24-003R. DL24-0311. FSP24-005R. DA24-05. FSA24-005R, DL24-05
GE Medical Systems: K980582, K970545, K964750, K960418
2017003-001, 411203-001, 411202-001, 412682-001, 412681-001
Description:
AlV's Electrocardioaraph (ECG) cables (also sometimes referred to as trunk or leadwires) are replacements for similar cables manufactured by the Original Equipment Manufacturers (OEM) and other third party after market manufacturers for their respective monitors. The Trunk Cables connect the OEM patient monitor to the patient leadwires connect the trunk cable to the skin mounted ECG electrodes.
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 Trunk Cables have limited skin contact with the patient, while the Leadwires attached on the patient's chest have more continuous skin contact.
1
The AIV cables use the same type of construction and have the same technological characteristics as the predicate devices. They use a medical grade PVC cable jacket with medical grade PVC overmolded connectors with an integral strain relief.
Intended Use:
These devices are intended to be used with various electrocardiograph recorders/monitors for both diagnostic and monitoring purposes. 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. AIV cables are limited by the Indications for Use of the connected recording/monitoring device.
| | AIV | ConMed | GE
Medical
Systems |
|--------------------------------------|-------------------------------------------------------------------------------------------------------------|--------|--------------------------|
| Intended Use | To conduct impulse signals from electrode to
the patient monitor. | Same | Same |
| Patient Usage | Reusable. | Same | Same |
| Anatomical Sites | Attached to electrodes placed at standard
specified locations on chest wall. | Same | Same |
| Design/Appearance | Cables with various connectors (monitor,
trunk/leadwire, electrode grabber & snapper. | Same | Same |
| Type of Construction | Flexible, shielded, multi conductor electrical
cable. | Same | Same |
| Connector Design | Trunk cable connectors are keyed to fit the
appropriate monitors and snap and grabber
for electrodes. | Same | Same |
| Cable Length | Various specified lengths. | Same | Same |
| Wire Colors | Snappers and grabbers color coded e.g. red,
white, green, black, brown. | Same | Same |
| Wire Material | Braided shield, tin/copper with elastomer
jacket. | Same | Same |
| Sterility | Used non-sterile. | Same | Same |
| Connector Retention
Force | ANSI/AAMI EC53A-1998/(R)2001 | Same | Same |
| Electrical Performance
and Safety | ANSI/AAMI EC53-1995/(R)2001 | Same | Same |
Comparison to Predicate Device:
Performance Data and Conclusions:
- AIV design is equivalent to predicate device design. .
- Bench Testing demonstrates that the AIV devices perform as intended. .
- The company has declared conformity to consensus standard ANSI/AAMI EC53-. 1995/(R)2001 and its attachment EC53A-1998/(R)2001 relating to Electrical/Safety/Mechanical
- . These devices do not raise new issues of safety and effectiveness, nor do they alter the fundamental technology of the predicate devices.
2
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
MAR 2 7 2007
American IV Products, Inc. c/o Dr. John Taylor Director of Engineering 7485 Shipley Ave. Harmans, MD 21077
Re: K070232
Trade/Device Name: Regulation Number: 21 CFR 870.2900 Regulation Name: Transducer and Electrode Patient Cable (Including Connector) Regulatory Class: Class II Product Code: DSA Dated: January 19, 2007 Received: January 24, 2007
Dear Dr. Taylor:
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.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such 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.
3
Page 2 - Dr. John Taylor
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); 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. This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Office of Compliance at 240-276-0120. Also, please note the regulation entitled. "Misbranding by reference to premarket notification" (21CFR Part 807.97). 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 (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours.
B.J.mumo for
Bram D. Zuckerman, M.D. Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
Indications for Use
510(k) Number (if known):
Page 1 of 2
ECG Cables, Trunk and Patient Lead Wires Device Name:
Indications For Use:
These devices are intended to be used with various electrocardiograph recorders/monitors for both rheoo are hoo and monitoring purposes. They are solely intended to be used between the disposable electrodes (not manufactured by AIV) in contact with the patient's skin and the recording/monitoring device (not manufactured by AIV). These cables are used by qualified personnel in the field of de nee (not manufactures by A.V). Theose ure limited by the Indications for Use of the connected recording/monitoring device. No other usage is intended for the trunk cables or leadwires.
| AIV Part # | Predicate Part # | Predicate Manufacturer |
|---|---|---|
| EG11481 | FSR1311 | ConMed Trunk Cable |
| EG11482 | FSR565 | ConMed Trunk Cable |
| EG11479 | FSR1303 | ConMed Trunk Cable |
| EG11480 | FSR1534 | ConMed Trunk Cable |
| EG11478 | FSR1390 | |
| FSR1590 | ConMed Trunk Cable | |
| ConMed Trunk Cable | ||
| EG11477 | FSR367 | ConMed Trunk Cable |
| EG11483 | FSR1370 | ConMed Trunk Cable |
| EG11484 | FSR1539 | ConMed Trunk Cable |
| EG11476 | D8338II | |
| D8538 | ConMed Trunk Cable | |
| ConMed Trunk Cable | ||
| EG11475 | 2017003-001 | GE Medical Systems Trunk Cable |
| EG11487 | FSP24-003R | |
| DA24-03II | ||
| 411203-001 | ConMed Leadwire | |
| ConMed Leadwire | ||
| GE Medical Systems Leadwire | ||
| EG11488 | FSA24-003R | |
| DL24-03II | ||
| 412682-001 | ConMed Leadwire | |
| ConMed Leadwire | ||
| GE Medical Systems Leadwire | ||
| EG11485 | FSP24-005 | |
| DA24-05 | ||
| 411202-001 | ConMed Leadwire | |
| ConMed Leadwire | ||
| GE Medical Systems Leadwire |
7485 Shipley Avenue · Harmans, MD · 21077 · USA · p 800.990.2911 · f 410.787.1337 · www.aiv-inc.com
5
Appendix B Page 2 of 2
Indications for Use
Page 2 of 2
EG11486
FSA24-005 DL24-05 412681-005 ConMed Leadwire ConMed Leadwire GE Medical Systems Leadwire
Prescription Use X (Part 21 CFR 801 Subpart D) AND/OR
Over-The-Counter Use (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)
Blaine
(Division Sign-Off)
Division of Cardiovascular Devices
510(k) Number K070232