(138 days)
Not Found
No
The summary describes a mechanical and electrical redesign of an ECG suction electrode system, with no mention of software, algorithms, or AI/ML capabilities.
No
The device is described as "designed for diagnostic purposes", not therapeutic purposes.
Yes
The "Intended Use / Indications for Use" section states: "It is designed for diagnostic purposes".
No
The device description explicitly details hardware components such as a reusable ECG suction electrode system, patient cable system, electrode assembly, and changes to power source (AC to DC), indicating it is a physical medical device, not software-only.
Based on the provided information, the Paljet-B patient cable system is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD definition: In Vitro Diagnostics are medical devices used to examine specimens taken from the human body, such as blood, urine, or tissue, to provide information for diagnosis, monitoring, or screening.
- Paljet-B function: The Paljet-B is an ECG suction electrode system. It works by applying electrodes to the patient's skin to measure electrical activity of the heart. This is a direct measurement from the patient's body, not an analysis of a specimen taken from the body.
- Intended Use: The intended use explicitly states it is "designed for diagnostic purposes" and is "compatible with all electrocardiographs." This aligns with the function of an ECG system, which is used for in-vivo (within the living body) diagnosis.
Therefore, the Paljet-B falls under the category of a medical device used for in-vivo diagnostic procedures, not an in-vitro diagnostic device.
N/A
Intended Use / Indications for 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.
Product codes
DRX
Device Description
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.
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)
WaveTracer
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 870.2360 Electrocardiograph electrode.
(a)
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.(b)
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.
0
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.
1
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.
Image /page/1/Picture/9 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle or bird symbol, with three curved lines forming the body and wings. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the bird symbol.
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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 (301) 594-4648. 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" (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 (800) 638-2041 or (301) 443-6597 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
3
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)
. .
Over-The-Counter Use