PATIENT CABLES FOR MONITORING, I.E., ECG, EKG, SPO2, AND BP INTERFACE CABLES AND LEADWIRES

K992524 · Advantage Medical Electronics, Inc. · DSA · Mar 1, 2000 · Cardiovascular

Device Facts

• Record ID: K992524
• Device Name: PATIENT CABLES FOR MONITORING, I.E., ECG, EKG, SPO2, AND BP INTERFACE CABLES AND LEADWIRES
• Applicant: Advantage Medical Electronics, Inc.
• Product Code: DSA · Cardiovascular
• Decision Date: Mar 1, 2000
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 870.2900
• Device Class: Class 2

Intended Use

Advantage Medical Cables and leadwires are used in conjunction with various patient monitoring equipment such as ECG, EKG, SpO2 and Blood Pressure equipment for short term diagnostic monitoring. They are not intended to be used in any manner other than as the connection between the monitoring equipment and the electrode pads to monitor the signals between the patient and the transmitter/receiver.

Device Story

Patient monitoring cables and leadwires; transmit physiological signals between patient electrodes and monitoring equipment (ECG, EKG, SpO2, blood pressure). Constructed from shielded/unshielded conductors, thermoplastic elastomer housing (polypropylene/TPR), and various connector types (DIN, snap, pinch). Used in clinical settings for short-term diagnostic monitoring. Cables connect monitoring device to patient-attached electrodes; facilitate signal acquisition for clinician review. Benefit: enables reliable signal transmission for patient monitoring.

Clinical Evidence

Bench testing only. Performance testing conducted comparing subject cables against OEM cables and Tronomed predicate cables. Cytotoxicity testing performed.

Technological Characteristics

Materials: FDA Grade thermoplastic elastomers (polypropylene, TPR). Construction: 3 or 5 conductor shielded/unshielded cables; crimp/solder terminations; injection molded connectors/yokes. Connectivity: Wired connection between monitoring equipment and patient electrodes. Standards: ISO 9002, EN 46002 quality system compliance.

Indications for Use

Indicated for use with ECG, EKG, SpO2, and blood pressure monitoring devices for short-term diagnostic monitoring of patients.

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

• Tronomed Cables

Submission Summary (Full Text)

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K992524

AR - 1 201

#### J. 510(k) SUMMARY

#### 510(k) Summarv

This summary of 510(k) safety and effectiveness information is being submitted in accordance with the requirements of 21 CFR §807.92.

| Contact Person: | Ken Kendricks<br>10630 Wiles Road<br>Coral Springs, FL 33067<br>Phone: [phone] Ext. 1012<br>Fax: [phone] | Date Prepared: | July 25, 1999 |
|-------------------------|------------------------------------------------------------------------------------------------------------------------|----------------|---------------|
| Trade Name: | Patient Monitoring Cables for ECG, EKG, SpO2 and Blood<br>Pressure Monitors. | | |
| Common Name: | Patient Cables and Leadwires | | |
| Product Classification: | Class II : Cardiolvascular 74 DSA, per 21 CFR section<br>870.2900, | | |

#### Description/Intended Use

Advantage Medical Cables are produced using purchased 5 conductor cable and single conductor leadwire, both shielded and un-shielded, which is cut to various lengths, terminated with the appropriate type terminals and housed in a protective covering made from different types of FDA Grade thermoplastic elastomers, (polypropylene and TPR), using an injection molding process and custom built molds to achieve the desired shape and size. The cito-toxticity test results are in Attachment J1.

The most common cable configuration is of a three or five conductor 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 three or five conductors terminated into a yoke assembly for the leadwires to attach on the other end. The leadwires may be permanently attached to the yoke or terminated on one end with a .060 diameter pin and over molded with the mating DIN style connector and a snap or pinch type connector on the other end for connection to the patient electrodes. The leadwires may be shielded or unshielded construction. See Attachment E2-1 Patient Cable Drawing CB-71330R, and Illustration E1.

Advantage Medical Cables and leadwires are used in conjunction with various patient monitoring equipment such as ECG, EKG, SpO2 and Blood Pressure equipment for short term diagnostic monitoring. They are not intended to be used in any manner other than as the connection between the monitoring equipment and the electrode pads to monitor the signals between the patient and the transmitter/receiver.

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## Testing

Performance testing has been performed using the different types of monitors from the original equipment manufacturers, the OEM cables, Tronomed Cables and Advantage Medical Cables as described in the Performance Testing section, Attachment K.

## Manufacturing Facility

Advantage Medical Cables, Inc., a division of Advantage Medical Electronics, Inc. (AME) is located at 10630 Wiles Road in Coral Springs, Florida 33076 and is housed in a 10,000 square foot fully air conditioned single story building. The molding and assembly areas are adequately lighted and are equipped with all the tools and equipment required to produce high quality cables and leadwires. Additional or special customer requirements are reviewed and tools and equipment purchased to meet their requirements.

AME is registered with the FDA as a manufacturer and refurbisher/rebuilder of medical equipment. number 1063285. A Class 1 CE mark has been applied for in order to sell AMC Cables and leadwires in the EEC.

All cables and leadwires are produced using a revision controlled engineering drawing and work order, see Attachment E2 & E5. Records are maintained for each manufacturing lot number and customer. Each cable is tested to ensure conformance to the customer or regulatory requirements. Traceability is sufficient to facilitate product recall if necessary using the lot numbers and shipping records.

All AMC equipment used for product acceptance testing is calibrated and traceable to NIST standards.

Advantage Medical Cable's quality system is in compliance with ISO 9002 and EN 46002. Internal and independent audits are conducted to ensure conformance to the quality manual and quality system procedures. Registration is scheduled for Q3/99.

All personnel are trained and/or qualified as applicable for the job assigned. Training records are maintained.

### Summary

As shown in the engineering drawings and the photographic illustrations, except for the color of the cable and leadwires and subtle differences in the shape of the molded connectors and yokes, the AMC cables are identical in their function and performance characteristics as to the Tronomed cables.

The products are manufactured on similar type equipment, with exception to the size and make of the machine, and under the same general manufacturing conditions with exception to size and location of the facilities.

The minor differences in the characteristics noted do not effect quality, safety or functionality of the cable and leadwires manufactured by AMC.

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Image /page/2/Picture/1 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo features a stylized image of an eagle with three heads, representing the department's mission to protect the health of all Americans and provide essential human services. The eagle is surrounded by the text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" in a circular arrangement.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

MAR - 1 2000

Mr. Kenneth E. Kendricks Vice President Advantage Medical Electronics, Inc. 10630 Wiles Road Coral Springs, FL 33076

K992524 Re: Trade Name: Patient Cables and Leads for Monitoring (i.e. ECG, SP02 and BP) Regulatory Class: (II) Product Code: 74 DSA Dated: December 9, 1999 Received: December 13, 1999

Mr. Kendricks: Dear

We have reviewed your Section 510(k) notification of intent to market the device referenced above and we 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). 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 aqainst misbranding and adulteration.

If your device is classified (see above) into either class II (Special Controls) or class III (Premarket Approval), 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 895. A substantially equivalent determination assumes compliance with the Current Good Manufacturing Practice requirements, as set forth in the Quality System Requlation (QS) for Medical Devices: General requlation (21 CFR Part 820) and that, through periodic QS inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in requlatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.

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Page 2 - Mr. Kenneth E. Kendricks:

This letter will allow you to begin marketing your device as described in your 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 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at [phone]. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number [phone] or [phone] or at its internet address "http://www.fda.gov/cdrh/dsma/dsmamain.html".

Sincerely yours,

Krown for Celain hatten

Celia M. Witten, Ph.D., M.D. Acting Director Division of Cardiovascular, Respiratory, and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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#### ్.. INDICATIONS FOR USE OF THE DEVICE

#### 510(k) Number: K992524

Device Name: Patient Monitoring Cables and Leadwires

### Indications for Use:

These patient cables and leadwires are intended to be used with ECG, EKG, Sp02 and Blood Pressure monitoring devices.

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Concurrence of CDRH, Office of Device Evaluation (ODE)

Min Hove-for Celia Watts

Division Sign-Off) Division of Cardiovascular, Respiratory, and Neurological Devi

510(k) Number K992524