(85 days)
Not Found
Not Found
No
The description details a simple electrical extension cable with standard connectors and wiring, with no mention of computational processing, algorithms, or learning capabilities.
No
The device is described as an "electrical extension cable" used to transmit signals between a patient's lead and an external pacemaker or testing device. It does not exert a therapeutic effect itself but facilitates the operation of other medical equipment.
No
The device is described as an "electrical extension cable" used to transmit signals from or to patient-connected electrodes, connecting to an external pacemaker or testing device/analyzer. Its purpose is to facilitate the connection for monitoring or pacing, not to perform diagnostic analysis itself.
No
The device description clearly states it is a physical cable made of metallic wire with connectors, which are hardware components.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostic devices are used to examine specimens taken from the human body (like blood, urine, tissue) to provide information about a person's health. This testing is done outside of the body (in vitro).
- Device Function: The description clearly states that this device is an electrical extension cable used to transmit signals to or from patient-connected electrodes. It connects an external pacemaker or testing device directly to the patient's pacing leads.
- No Specimen Testing: There is no mention of this device being used to analyze any biological specimens. Its function is purely electrical signal transmission for a therapeutic or monitoring purpose directly on the patient.
Therefore, based on the provided information, this device falls under the category of a medical device used for direct patient connection and electrical signal management, not for in vitro diagnostic testing.
N/A
Intended Use / Indications for Use
CP Medical's Disposable Temporary Pacing Cable with safety connectors is indicated for use as an electrical extension cable used to transmit signal from, or power or excitation signal to, patient-connected electrodes. The cable is bipolar, providing alligator clips at the end of the cable that will be attached to the patient's lead, and a safety plug at the other end that allows electrical connection to the external pacemaker or testing device, i.e., analyzer. The alligator clips are color-coded and imprinted with the polarity: The red clips are positive (+) and the black clips are negative (-).
The cable is designed to carry a maximum electrical load of 300 volts, and will be compatible with most external pacemakers, pace analyzers, and patient pacing leads currently on the market.
The cable is a sterile or nonsterile, disposable device.
Product codes
DSA
Device Description
The CP Medical device consists of 22-gauge metallic wire and safety connectors for cardiovascular monitoring application.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
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)
Not Found
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
The predicate device is the Remington Medical, Inc. disposable Surgical Cable and the disposable Extension Cable for cardiovascular monitoring application.
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
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
SEP 1 9 2002
Summary of Safety and Effectiveness
In accordance with the Food and Drug Administration Rule to implement provisions of the Safe Medical Devices Act of 1990 and in conformance with 21 CFR 807, this is to serve as a Summary of Safety and Effectiveness for the proposed CP Medical CP-WIRE component device.
| Manufacturer: | CP Medical, Inc.
2414 NE Pacific Avenue
Portland, OR 97232
PHONE: (503) 232-1555
FAX: (503) 230-9993 |
|-------------------|------------------------------------------------------------------------------------------------------------------|
| Contact Person: | Mary Ann Greenawalt, Vice President
Legal & Regulatory Affairs |
| Device Name: | |
| Trade Name: | Disposable Temporary Pacing Cable |
| Common Name: | Component to diagnostic or physiological
monitoring devices |
| Proprietary name: | TBD |
| Classification: | Cable, Transducer and Electrode, Patient (including
Connector), Cardiovascular, DSA, Class II |
Date Prepared: June 25, 2002
- Predicate Device: The predicate device is the Remington Medical, Inc. disposable Surgical Cable and the disposable Extension Cable for cardiovascular monitoring application.
- Device Description: The CP Medical device consists of 22-gauge metallic wire and safety connectors for cardiovascular monitoring application.
- Intended Use: The CP Medical device, disposable temporary pacing cable, is intended to be used as an interface between various diagnostic and physiological monitoring devices (not manufactured by CP Medical) and disposable sensor devices (not manufactured by CP Medical) which are attached to a patient body. CP Medical disposable temporary pacing cable is limited by the Indications for Use of the connected diagnostic or physiological Monitoring Device.
- Indications: CP Medical's Disposable Temporary Pacing Cable with safety connectors is indicated for use as an electrical extension cable used to transmit signal from, or
1
power or excitation signal to patient-connected electrodes. The cable is bipolar, providing alligator clips at the end of the cable that will be attached to the patient's lead, and a safety plug at the other end that allows electrical connection to the external pacemaker or testing device (i.e., analyzer). The alligator clips are colorcoded and imprinted with the polarity: The red clips are positive (+) and the black clips are negative (-).
The cable is designed to carry a maximum electrical load of 300 volts, and will be compatible with most external pacemakers, pace analyzers, and patient pacinq leads currently on the market.
The cable is a sterile (or OEM non-sterile), disposable device.
- Comparison of Technological Characteristics. The proposed device, the disposable temporary pacing cable, is comprised of the same or similar material as the predicate device. Manufacture of this device, and QC testing, will be in substantial compliance with current ANSI/AAMI EC53:1995, EC53:1998 amendment, IEC 60601 subclause 56.3 and 21CFR 820 (QSR).
end
2
DEPARTMENT OF HEALTH & HUMAN SERVICES
Public Health Service
Image /page/2/Picture/2 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" around the perimeter. Inside the circle is a stylized symbol that resembles three human profiles facing to the right, with flowing lines connecting them.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
SEP 1 9 2002
CP Medical, Inc. c/o Ms. Mary Ann Greenawalt Director, Regulatory and Quality 836 NE 24" Avenue Portland, OR 97232
Re: K022075
Trade Name: Disposable Temporary Pacing Cable Regulation Number: 21 CFR 870.2900 Regulation Name: Cable, Transducer and Electrode, Patient Regulatory Class: Class II (two) Product Code: DSA Dated: June 25, 2002 Received: June 26, 2002
Dear Ms. Greenawalt:
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 - Ms. Mary Ann Greenawalt
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 (OS) 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 and additionally 21 CFR Part 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4646. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html
Sincerely yours,
NORTON
Bram D. Zuckerman, M.D. Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
Page 1 of 1 .
INDICATIONS FOR USE
| 510(k) (if known): | KO22075 |
|---|---|
| DEVICE Name: | Disposable Temporary Pacing Cable |
Indications for Use:
CP Medical's Disposable Temporary Pacing Cable with safety connectors is indicated for use as an electrical extension cable used to transmit signal from, or power or excitation signal to, patient-connected electrodes. The cable is bipolar, providing alligator clips at the end of the cable that will be attached to the patient's lead, and a safety plug at the other end that allows electrical connection to the external pacemaker or testing device, i.e., analyzer. The alligator clips are color-coded and imprinted with the polarity: The red clips are positive (+) and the black clips are negative (-).
The cable is designed to carry a maximum electrical load of 300 volts, and will be compatible with most external pacemakers, pace analyzers, and patient pacing leads currently on the market.
The cable is a sterile or nonsterile, disposable device.
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Prescription Use X OR Over-the-Counter Use __
Division of Cardiovascular & Respiratory Devices
510(k) Number K022075
Concurrence of CDRH, Office of Device Evaluation (ODE)