PALJET-B

K973663 · Golden Gate Bio-Device · DRX · Feb 10, 1998 · Cardiovascular

Device Facts

• Record ID: K973663
• Device Name: PALJET-B
• Applicant: Golden Gate Bio-Device
• Product Code: DRX · Cardiovascular
• Decision Date: Feb 10, 1998
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 870.2360
• Device Class: Class 2

Intended Use

The Paljet-B patient cable system is a reusable ECG suction electrode system. It is designed for diagnostic purposes and is compatible with all electrocardiographs on the U.S. market.

Device Story

The Paljet-B is a reusable ECG suction electrode patient cable system used for diagnostic electrocardiography. It functions as an interface between the patient's skin and an electrocardiograph machine to capture cardiac electrical signals. The device features a redesigned electrode assembly with plastic components that do not contact the patient, and contact surfaces engineered to eliminate sharp edges for improved safety. Compared to the predicate, the system transitioned from an AC to a DC power source, reduced overall weight, and removed the hanging arm configuration to enhance portability. It is intended for use by clinicians in a diagnostic setting. The output is an ECG signal transmitted to the electrocardiograph for physician interpretation to aid in cardiac diagnosis.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

Reusable ECG suction electrode system. Materials: Plastic (non-patient contact). Power: DC source. Form factor: Portable, handheld electrode assembly. Connectivity: Compatible with standard electrocardiographs. Sterilization: Not specified.

Indications for Use

Indicated for diagnostic ECG monitoring in patients requiring electrocardiographic assessment. Compatible with all U.S. market electrocardiographs.

Regulatory Classification

Identification

An electrocardiograph electrode is the electrical conductor which is applied to the surface of the body to transmit the electrical signal at the body surface to a processor that produces an electrocardiogram or vectorcardiogram.

Special Controls

*Classification.* Class II (special controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 870.9. The special control for this device is the FDA guidance document entitled “Class II Special Controls Guidance Document: Electrocardiograph Electrodes.” See § 870.1(e) for availability information of guidance documents.

Predicate Devices

• WaveTracer (Medi-Globe, Inc.)

Submission Summary (Full Text)

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## 510k Summary

- Trade name Venturi suction electrode patient cable system. .
- Common Name - PALJET-B

-

FEB 1 0 1998

- Classification name Electrode Electrocardiograph .
- Class II Medical Device ------------------------------------------------------------------------------------------------------------------------------------------------------●

The legally marketed device that we are claiming equivalence to is called the WaveTracer this was marketed by Medi-Globe, Inc. We bought the rights to this device along with their existing inventory in 1995. Over time we determined that the configuration of that device the (WT) WaveTracer was not appropriate for the American market so we began a program of reconfiguration to satisfy the criteria that was determined appropriate.

We subsequently redesigned the entire electrode assembly using some different materials ( these materials never come in contact with the patient and are made of plastic) these provided for a more reliable electrode. Also a safer electrode because of the elimination of any sharp edges on the contact surfaces that came into contact with human skin. We changed from an AC power source to DC power source reduced the weight and eliminated the hanging arm configuration to enhance the portability aspects of the new device. We made many changes in the mechanical aspects of the machine , however the basic operational aspect of the Paljet is unchanged from the Wavetracer. It is with this fact in mind that we feel that the two systems are equivalent.

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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20856

FEB 1 0 1998

Mr. Mark J. Hastings Golden Gate Bio-Devices® 22030 Idena Avenue Castro Valley, CA 94546

K973663 Re: Trade Name: PALJET-B Regulatory Class: II 74 DRX Product Code: November 13, 1997 Dated: November 20, 1997 Received:

Dear Mr. Hastings:

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 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 against 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 A substantially equivalent determination assumes compliance to 895. with the Good Manufacturing Practice for Medical Devices: -- General ---(GMP) regulation (21 CFR Part 820) and that, through periodic GMP inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP requlation 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. Mark J. Hastings

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" (21 CFR 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/dsmamain.html".

Sincerely yours,

Thomas J. Callahan

Thomas J. Callahan, Ph.D. Director Division of Cardiovascular, Respiratory, and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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510(k) Number (if known): K973663 Paljet Patient Cable System Device Name: The Paljet-B patient cable system is a reusable ECG suction Indications For Use: electrode system. It is designed for diagnostic purposes and is compatible with all electrocardiographs on the U.S. market.

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Deak, Telle

Division Sign-Off Division of Cardiovascular, Respiratory, and Neurological De 510(k) Number

Prescription Use -- -- ---X--------------------------------------------(Per 21 CFR 801.109)

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**Over-The-Counter Use**