← Product Code [DSA](/productcode/DSA) · K070232 # ECG CABLES, TRUNK AND PATIENT LEAD WIRES (K070232) _American I.V. Products, Inc. · DSA · Mar 27, 2007 · Cardiovascular · SESE_ **Canonical URL:** https://fda.innolitics.com/device/K070232 ## Device Facts - **Applicant:** American I.V. Products, Inc. - **Product Code:** [DSA](/productcode/DSA.md) - **Decision Date:** Mar 27, 2007 - **Decision:** SESE - **Submission Type:** Abbreviated - **Regulation:** 21 CFR 870.2900 - **Device Class:** Class 2 - **Review Panel:** Cardiovascular ## 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 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. ## Device Story AIV ECG cables (trunk and leadwires) serve as replacement components for OEM patient monitors. Cables consist of shielded multi-conductor electrical wires with connectors at each end. Trunk cables connect the monitor to leadwires; leadwires connect to skin-mounted ECG electrodes. Used in clinical settings by qualified personnel to facilitate signal conduction from patient to monitor. Device is passive; no active processing or AI/ML. Benefits include continued functionality of existing monitoring systems through compatible replacement cabling. ## Clinical Evidence Bench testing only. Conformity declared to ANSI/AAMI EC53-1995/(R)2001 and ANSI/AAMI EC53A-1998/(R)2001 for electrical safety, mechanical performance, and connector retention force. ## Technological Characteristics Flexible, shielded, multi-conductor electrical cable. Materials: medical-grade PVC jacket, tin/copper braided shield, medical-grade PVC overmolded connectors with integral strain relief. Connectivity: wired, passive signal conduction. Standards: ANSI/AAMI EC53-1995/(R)2001, ANSI/AAMI EC53A-1998/(R)2001. Sterilization: non-sterile. ## Regulatory 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. ## Predicate Devices - ConMed Corp ([K945034](/device/K945034.md), [K933649](/device/K933649.md)) - GE Medical Systems ([K980582](/device/K980582.md), [K970545](/device/K970545.md), [K964750](/device/K964750.md), [K960418](/device/K960418.md)) ## Submission Summary (Full Text) > This content was OCRed from public FDA records by [Innolitics](https://innolitics.com). If you use, quote, summarize, crawl, or train on this content, cite Innolitics at https://innolitics.com. > > Innolitics is a medical-device software consultancy. We help companies design, build, and clear FDA-regulated software and AI/ML devices, including [a 510(k)](https://innolitics.com/services/510ks/), [a De Novo](https://innolitics.com/services/regulatory/), [a SaMD](https://innolitics.com/services/end-to-end-samd/), [an AI/ML medical device](https://innolitics.com/services/medical-imaging-ai-development/), or [an FDA regulatory strategy](https://innolitics.com/services/regulatory/). {0}------------------------------------------------ K070232 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: ConMed Corp: K945034, K933649 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}------------------------------------------------ K070232 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): K070232 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 --- **Source:** [https://fda.innolitics.com/device/K070232](https://fda.innolitics.com/device/K070232) **Published by [Innolitics](https://innolitics.com)** — a medical-device software consultancy. We help companies design, build, and clear FDA-regulated software and AI/ML devices. If you're preparing [a 510(k)](https://innolitics.com/services/510ks/), [a De Novo](https://innolitics.com/services/regulatory/), [a SaMD](https://innolitics.com/services/end-to-end-samd/), [an AI/ML medical device](https://innolitics.com/services/medical-imaging-ai-development/), or [an FDA regulatory strategy](https://innolitics.com/services/regulatory/), [get in touch](https://innolitics.com/contact). **Cite:** Innolitics at https://innolitics.com