ECG CABLES, TRUNK AND PATIENT LEAD WIRES

K070232 · American I.V. Products, Inc. · DSA · Mar 27, 2007 · Cardiovascular

Device Facts

• Record ID: K070232
• Device Name: ECG CABLES, TRUNK AND PATIENT LEAD WIRES
• Applicant: American I.V. Products, Inc.
• Product Code: DSA · Cardiovascular
• Decision Date: Mar 27, 2007
• Decision: SESE
• Submission Type: Abbreviated
• Regulation: 21 CFR 870.2900
• Device Class: Class 2

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.

Indications for Use

Indicated for use with electrocardiograph recorders/monitors for diagnostic and monitoring purposes. Used by qualified personnel to conduct signals between skin-mounted electrodes and monitoring equipment. Patient population is defined by the connected recording/monitoring device.

Regulatory Classification

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, K933649)
• GE Medical Systems (K980582, K970545, K964750, K960418)

Submission Summary (Full Text)

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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: [phone] ext. 131 Fax: [phone] e-mail: [e-mail]

## 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.

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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<br>Medical<br>Systems |
|--------------------------------------|-------------------------------------------------------------------------------------------------------------|--------|--------------------------|
| Intended Use | To conduct impulse signals from electrode to<br>the patient monitor. | Same | Same |
| Patient Usage | Reusable. | Same | Same |
| Anatomical Sites | Attached to electrodes placed at standard<br>specified locations on chest wall. | Same | Same |
| Design/Appearance | Cables with various connectors (monitor,<br>trunk/leadwire, electrode grabber & snapper. | Same | Same |
| Type of Construction | Flexible, shielded, multi conductor electrical<br>cable. | Same | Same |
| Connector Design | Trunk cable connectors are keyed to fit the<br>appropriate monitors and snap and grabber<br>for electrodes. | Same | Same |
| Cable Length | Various specified lengths. | Same | Same |
| Wire Colors | Snappers and grabbers color coded e.g. red,<br>white, green, black, brown. | Same | Same |
| Wire Material | Braided shield, tin/copper with elastomer<br>jacket. | Same | Same |
| Sterility | Used non-sterile. | Same | Same |
| Connector Retention<br>Force | ANSI/AAMI EC53A-1998/(R)2001 | Same | Same |
| Electrical Performance<br>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.

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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.

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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 [phone] or [phone] 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

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# 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<br>FSR1590 | ConMed Trunk Cable<br>ConMed Trunk Cable |
| EG11477 | FSR367 | ConMed Trunk Cable |
| EG11483 | FSR1370 | ConMed Trunk Cable |
| EG11484 | FSR1539 | ConMed Trunk Cable |
| EG11476 | D8338II<br>D8538 | ConMed Trunk Cable<br>ConMed Trunk Cable |
| EG11475 | 2017003-001 | GE Medical Systems Trunk Cable |
| EG11487 | FSP24-003R<br>DA24-03II<br>411203-001 | ConMed Leadwire<br>ConMed Leadwire<br>GE Medical Systems Leadwire |
| EG11488 | FSA24-003R<br>DL24-03II<br>412682-001 | ConMed Leadwire<br>ConMed Leadwire<br>GE Medical Systems Leadwire |
| EG11485 | FSP24-005<br>DA24-05<br>411202-001 | ConMed Leadwire<br>ConMed Leadwire<br>GE Medical Systems Leadwire |

7485 Shipley Avenue · Harmans, MD · 21077 · USA · p 800.990.2911 · f 410.787.1337 · www.aiv-inc.com

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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