K Number
K082959
Device Name
PATIENT MONITORING CABLES FOR ECG, EKG, SPO2 AND BLOOD PRESSURE MONITORS
Date Cleared
2008-10-10

(7 days)

Product Code
Regulation Number
870.2900
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
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 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.
More Information

Not Found

No
The device description focuses on the physical components and function of cables and lead wires for signal transfer, with no mention of AI or ML technologies.

No
The device is described as patient cables and lead wires intended for use with monitoring devices (ECG, EKG, Spo2, BP) to transfer signals from electrodes to a patient monitor for general monitoring and/or diagnostic evaluation. It does not provide any therapeutic function.

Yes

The "Intended Use / Indications for Use" states that the cables are used for "general monitoring and/or diagnostic evaluation by health care professional." This indicates that the device can contribute to diagnostic processes.

No

The device description explicitly states it consists of physical components like connectors, shielded bulk cables, PVC cable jackets, and overmolded connectors, which are hardware.

Based on the provided information, this device is not an IVD (In Vitro Diagnostic).

Here's why:

  • Intended Use: The intended use clearly states that the cables and lead wires are used to connect sensors placed on the patient to a monitoring device for general monitoring and/or diagnostic evaluation. This involves collecting physiological signals from the patient's body.
  • Device Description: The description reinforces this by explaining that the cables transfer signals from electrodes to the patient monitor.
  • Definition of IVD: In vitro diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections.

This device is a medical device used for in vivo monitoring (monitoring within the living body), not for testing samples in vitro (in a lab setting).

N/A

Intended Use / 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.

Product codes (comma separated list FDA assigned to the subject device)

DSA

Device 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.

Mentions image processing

Not Found

Mentions AI, DNN, or ML

Not Found

Input Imaging Modality

Not Found

Anatomical Site

Attached to sensors places at standard specified locations on the chest wall

Indicated Patient Age Range

Not Found

Intended User / Care Setting

health care professional

Description of the training set, sample size, data source, and annotation protocol

Not Found

Description of the test set, sample size, data source, and annotation protocol

Not Found

Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)

  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.

Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)

Not Found

Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.

K992524

Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.

Not Found

Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).

Not Found

§ 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).

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: 86 755 26828795 Fax: 86 755 26697984 www. Unimed.cn Email: info@unimed.cn

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: 86 755 26828795 Fax: 86 755 26697984 Email: limingx@unimed.cn

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: 86 755 26828795 Fax: 86 755 26697984 www. Unimed.cn Email: info@unimed.cn

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 MedicalAdvantage medical
Intended useTo conduct impulse signals from the sensor to the
patient monitorSame
Patent UsageReusableSame
Anatomical SitesAttached to sensors places at standard specified
locations on the chest wallSame
Design/AppearanceCables with various connectors(monitor,
trunk/lead wire, electrode grabber & snapper)Same
Cable lengthVarious specified standard lengthsSame
Wire colorSnappers and grabbers color coded e.g, red,
white, green, black, brownSame
Wire materialTin copper/PVC jacketSame
SterilityUsed non-sterileSame
ConnectorRetention ForceANSI/AAMI EC53A-1998(R)2001
EC53A-1998(Amendment)Same
Electrical Performance
and SafetyANSI/AAMI EC53A-1998(R)2001Same

Comparison to Predicate Device:

Performance data and Conclusions:

  1. Unimed design is equivalent to predicate device design.
    1. Bench Testing demonstrates that Unimed devices perform as intended
    1. 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
  1. 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 (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,

[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: 86 755 26828795 Fax: 86 755 26697984 www. Unimed.cn Email: info@unimed.cn

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)
Signature for B Zuckerman10/10/07 iovascular Devices

Page1 of
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K082959 510(k) Number