PATIENT MONITORING CABLES FOR ECG, EKG, SPO2 AND BLOOD PRESSURE MONITORS

K082959 · Unimed Medical Supplies, Inc. · DSA · Oct 10, 2008 · Cardiovascular

Device Facts

• Record ID: K082959
• Device Name: PATIENT MONITORING CABLES FOR ECG, EKG, SPO2 AND BLOOD PRESSURE MONITORS
• Applicant: Unimed Medical Supplies, Inc.
• Product Code: DSA · Cardiovascular
• Decision Date: Oct 10, 2008
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 870.2900
• Device Class: Class 2
• Attributes: 3rd-Party Reviewed

Intended Use

The Unimed patient cables and lead wires are intended to be used with ECG, EKG, Spo2 and BP monitoring devices. The patient cables and lead wires are used to connect electrodes, catheters, and/or sensors placed at appropriate sites on the patient to a monitoring device for general monitoring and/or diagnostic evaluation by heath care professional.

Device Story

Device consists of reusable patient cables and lead wires; functions as interface between patient-attached sensors (electrodes, catheters) and monitoring equipment (ECG, EKG, SpO2, BP). Cables feature shielded bulk wire, medical-grade PVC jackets, and overmolded connectors with integral strain relief. Used in clinical settings by healthcare professionals to facilitate signal transmission from patient to monitor. Provides physical connection path for physiological data acquisition; does not perform signal processing or analysis. Benefits include compatibility with various OEM monitoring systems, allowing for replacement of worn or damaged cables to maintain continuous patient monitoring.

Clinical Evidence

Bench testing only. Conformity declared to ANSI/AAMI EC53-1995(R)2001 and EC53A-1998(R)2001 for electrical safety and mechanical performance.

Technological Characteristics

Reusable patient cables and lead wires. Materials: Tin copper conductors with medical-grade PVC jacket and overmolded PVC connectors. Connectivity: Wired interface between sensors and monitors. Standards: ANSI/AAMI EC53A-1998(R)2001 for connector retention and electrical safety. Non-sterile.

Indications for Use

Indicated for use with ECG, EKG, SpO2, and blood pressure monitoring devices to connect electrodes, catheters, or sensors to a monitor for general monitoring or diagnostic evaluation by healthcare professionals.

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

• Advantage Medical Cables (K992524)

Submission Summary (Full Text)

{0}------------------------------------------------

K082959
PI/2

Image /page/0/Picture/2 description: The image shows a logo with the text "Med Uni" stacked on top of each other. The logo is contained within a rounded rectangle with a thick black border. There is a horizontal line below the logo, and the text "Section 3" is located below the line. The text is in a simple, sans-serif font.

Unmedical Medical Supplies Inc No. 37, Yanshan Road, Shekou, Shenzhen, China 518067 Tel: [phone] Fax: [phone] www. Unimed.cn Email: [e-mail]

510(K) submission

Page 1 of 2(section 3)

#### Section

## 510(K) Summary

#### Submitter Information:

Unimed Medical supplies Inc No.37, yanshan Road, Shekou, Shenzhen, China 518067

#### Contact:

Liming Xue President Tel: [phone] Fax: [phone] Email: [e-mail]

Date Prepared: June 18, 2008

Trade Name: Patient monitoring Cables for ECG, EKG,Spo2 and Blood Pressure Monitors Common Name: Patient Cables and Lead wires Product Classification: Class II: Cardiovascular 74 DSA, per 21 CFR section 870.2900

#### Predicate Device:

Advantage Medical Cables: K992524

#### Description:

Unimed's most common cable lead wire configuration ECG cables with specific various length are the replacements for similar cables manufactured by Original Equipment Manufacturers(OEM) and other third party after market manufacturers for their respective monitors.

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 Unimed cables use the same type of constructions 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 integral relief.

#### Intended Use:

The Unimed patient cables and lead wires are intended to be used with ECG, EKG, Spo2 and BP monitoring devices. The patient cables and lead wires are used to connect electrodes, catheters, and/or sensors placed at appropriate sites on the patient to a monitoring device for general monitoring and/or diagnostic evaluation by heath care professional.

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

K082959
P 2/2

Image /page/1/Picture/1 description: The image shows a logo with the text "Med Uni" stacked on top of each other. The text is in a bold, sans-serif font and is white with a black outline. The logo is contained within a rounded rectangle with a thick black border. There is a horizontal line below the logo.

Unmedical Medical Supplies Inc No. 37, Yanshan Road, Shekou, Shenzhen, China 518067 Tel: [phone] Fax: [phone] www. Unimed.cn Email: [e-mail]

510(K) submission

Page 2 of 2

#### Manufacturing Facility:

Unimed Medical Supplies inc is the China based manufacturer and distributor of medical cables and accessories. 2500 square meter facility is equipped with all tools and equipments required to produce high quality cables and lead wires.

Unimed is a CE certificated of Class II products and ISO13485-2003 full quality management registered company.

| | Unimed Medical | Advantage medical |
|--------------------------------------|------------------------------------------------------------------------------------------|-------------------|
| Intended use | To conduct impulse signals from the sensor to the<br>patient monitor | Same |
| Patent Usage | Reusable | Same |
| Anatomical Sites | Attached to sensors places at standard specified<br>locations on the chest wall | Same |
| Design/Appearance | Cables with various connectors(monitor,<br>trunk/lead wire, electrode grabber & snapper) | Same |
| Cable length | Various specified standard lengths | Same |
| Wire color | Snappers and grabbers color coded e.g, red,<br>white, green, black, brown | Same |
| Wire material | Tin copper/PVC jacket | Same |
| Sterility | Used non-sterile | Same |
| ConnectorRetention Force | ANSI/AAMI EC53A-1998(R)2001<br>EC53A-1998(Amendment) | Same |
| Electrical Performance<br>and Safety | ANSI/AAMI EC53A-1998(R)2001 | Same |

#### Comparison to Predicate Device:

#### Performance data and Conclusions:

1. Unimed design is equivalent to predicate device design.

- 2. Bench Testing demonstrates that Unimed devices perform as intended
- 3. The company has declares conformity to consensus standard ANSI/AAMI EC53-1995(R)2001 and its attachment EC53A-1998(R) 2001 relating to Electrical/Safety/Mechanical

4. These devices do not raise new issues of safety and effectiveness, nor do they alter the fundamental technology of the predicate devices.

{2}------------------------------------------------

Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle with three bars representing the agency's mission of promoting health, well-being, and human services. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the eagle symbol.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

# OCT 1 0 2008

Unimed Medical Supplies Inc. c/o Intertek Testing Services NA, Inc. Mr. Jay Y. Kogoma Responsible Third Party Official 2307 E. Aurora Road, Unit B7 Twinsburg, OH 44087

Re: K082959

Trade/Device Name: Patient Cable and Lead Wire for ECG, EKG, Spo2 and Blood Pressure Monitors Regulation Number: 21 CFR 870.2900 Regulation Name: Patient Transducer and electrode cable (including connector) Regulatory Class: Class II (two) Product Code: DSA Dated: October 1, 2008 Received: October 3, 2008

Dear Mr. Kogoma:

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. 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

{3}------------------------------------------------

Page 2 - Mr. Jay Y. Kogoma

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 procced 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 [phone]. 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,

[signature]

Bram D. Zuckerman, M.D. Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

{4}------------------------------------------------

510(K) submission

Image /page/4/Picture/1 description: The image shows a logo with the words "Med Uni" stacked on top of each other. The logo is contained within a rounded rectangle with a thick border. The text is bold and appears to be in a sans-serif font. The background of the logo is a textured pattern, possibly a halftone or similar effect.

Unmedical Medical Supplies Inc No. 37, Yanshan Road, Shekou, Shenzhen, China 518067 Tel: [phone] Fax: [phone] www. Unimed.cn Email: [e-mail]

Section 2

Page 1 of 1(section 2)

Applicant Name: Unimed Medical Supplies Inc

### 510(k) Number:

Device Name: Patient Cable and Lead wire for ECG, EKG, Spo2 and Blood Pressure Monitors.

Model numbers:

DX-2595,DX-90S,MQ-2586,MQ3-90P,MQ5-90P,AA-2585,AA5-90P,2540S, D5-90S,E10-HP-B,E10-MQ12-B,U708-01,U708-21,U708-40,BC-6P-UT

# Indications for Use

The Unimed patient cables and lead wires are intended to be used with ECG, EKG, Spo2 and BP monitoring devices. The patient cables and lead wires are used to connect electrodes, catheters, and/or sensors placed at appropriate sites on the patient to a monitoring device for general monitoring and/or diagnostic evaluation by heath care professional.

Prescription Use X (Part 21 CFR 801 Subpart D) AND/OR

Over-The-Counter Use (21 CFR 801 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)
 for B Zuckerman10/10/07 iovascular Devices

| Page | 1 of |
|------|------|
|------|------|

K082959 510(k) Number