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 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.

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.

AI/ML Overview

The provided document describes the 510(k) summary for AIV's ECG Cables, Trunk and Patient Lead Wires, seeking substantial equivalence to existing devices. As such, the study described here is NOT an AI/ML device study. The acceptance criteria and "device performance" in this context refer to engineering specifications and compliance with recognized standards for medical devices, rather than an AI model's predictive accuracy.

Here's the information extracted and formatted according to your request, with clarifications due to the nature of the device:

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria (Standard / Key Characteristic)	Reported Device Performance (Compliance / Equivalence)
Connector Retention Force (ANSI/AAMI EC53A-1998/(R)2001)	Declared conformity to standard; equivalent to predicates.
Electrical Performance and Safety (ANSI/AAMI EC53-1995/(R)2001)	Declared conformity to standard; equivalent to predicates.
Design/Appearance (Cables with various connectors)	Same as predicate devices.
Type of Construction (Flexible, shielded, multi-conductor)	Same as predicate devices.
Connector Design (Keyed, snap and grabber)	Same as predicate devices.
Cable Length (Various specified lengths)	Same as predicate devices.
Wire Colors (Snappers and grabbers color coded)	Same as predicate devices.
Wire Material (Braided shield, tin/copper with elastomer jacket)	Same as predicate devices.
Sterility (Used non-sterile)	Same as predicate devices.
Intended Use (Conduct impulse signals from electrode to patient monitor)	Same as predicate devices.
Patient Usage (Reusable)	Same as predicate devices.
Anatomical Sites (Attached to electrodes at specified locations on chest wall)	Same as predicate devices.
Technological Characteristics (Construction, materials)	Same as predicate devices.

2. Sample size used for the test set and the data provenance

Sample Size: Not explicitly stated as a "test set" in the context of an AI/ML study. The evaluation was based on bench testing of the AIV cables. The sample size for these physical tests is not specified in the provided summary.
Data Provenance: Not applicable in the sense of data origin for an AI model. This is a physical device and the "data" comes from bench testing of the manufactured cables.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

Not applicable. This is not an AI/ML device requiring expert ground truth for image interpretation or similar. The "ground truth" for these cables is compliance with engineering standards (ANSI/AAMI EC53 and EC53A) and functional equivalence to legally marketed predicate devices, assessed through bench testing. The evaluation was done by the manufacturer (AIV) and reviewed by the FDA.

4. Adjudication method for the test set

Not applicable. There was no "test set" requiring adjudication in the AI/ML sense. Compliance was determined by meeting consensus standards and demonstrating equivalence to predicate devices through bench testing.

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

No. This is not an AI/ML device. Therefore, no MRMC study with human readers or AI assistance was performed.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

Not applicable. This is not an algorithm. The "standalone performance" for this device would be its ability to physically and electrically perform its intended function (signal conduction) when bench tested, which was stated to be "as intended."

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)

The "ground truth" for this device is based on compliance with recognized consensus standards (ANSI/AAMI EC53 and EC53A) for electrical and mechanical performance, and demonstrated functional and technological equivalence to legally marketed predicate devices.

8. The sample size for the training set

Not applicable. This is not an AI/ML device, so there is no training set.

9. How the ground truth for the training set was established

Not applicable. There is no training set for this device.

Summary

{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:

{1}------------------------------------------------

K070232

Intended Use:

	AIV	ConMed	GEMedicalSystems
Intended Use	To conduct impulse signals from electrode tothe patient monitor.	Same	Same
Patient Usage	Reusable.	Same	Same
Anatomical Sites	Attached to electrodes placed at standardspecified 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 electricalcable.	Same	Same
Connector Design	Trunk cable connectors are keyed to fit theappropriate monitors and snap and grabberfor 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 elastomerjacket.	Same	Same
Sterility	Used non-sterile.	Same	Same
Connector RetentionForce	ANSI/AAMI EC53A-1998/(R)2001	Same	Same
Electrical Performanceand 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	FSR1390FSR1590	ConMed Trunk CableConMed Trunk Cable
EG11477	FSR367	ConMed Trunk Cable
EG11483	FSR1370	ConMed Trunk Cable
EG11484	FSR1539	ConMed Trunk Cable
EG11476	D8338IID8538	ConMed Trunk CableConMed Trunk Cable
EG11475	2017003-001	GE Medical Systems Trunk Cable
EG11487	FSP24-003RDA24-03II411203-001	ConMed LeadwireConMed LeadwireGE Medical Systems Leadwire
EG11488	FSA24-003RDL24-03II412682-001	ConMed LeadwireConMed LeadwireGE Medical Systems Leadwire
EG11485	FSP24-005DA24-05411202-001	ConMed LeadwireConMed LeadwireGE 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

Regulation Number and Section

§ 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).