(138 days)
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.
The Paljet-B patient cable system is a reusable ECG suction electrode system. The entire electrode assembly was redesigned 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. 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. Many changes were made in the mechanical aspects of the machine, however the basic operational aspect of the Paljet is unchanged from the Wavetracer.
The provided 510(k) summary for the "Venturi suction electrode patient cable system - PALJET-B" does not contain information about acceptance criteria or a study that proves the device meets specific performance criteria in the way a modern AI/ML device submission would.
Instead, this 1998 submission focuses on establishing substantial equivalence to a predicate device (the WaveTracer) based on the operational aspects and intended use rather than detailed performance metrics derived from clinical studies. The rationale for equivalence is primarily based on:
- Redesign for the American market: Changes made to materials (non-patient contacting), elimination of sharp edges, change from AC to DC power, reduced weight, and enhanced portability.
- Unchanged basic operational aspect: The core function of the device is stated to be unchanged from the predicate WaveTracer.
- Identical Indications For Use: Both devices are designed as reusable ECG suction electrode systems for diagnostic purposes, compatible with all electrocardiographs on the U.S. market.
Therefore, many of the requested elements for describing acceptance criteria and a study proving device performance (especially those related to AI/ML or comparative effectiveness studies) are not applicable or present in this document.
Here's an attempt to answer the questions based only on the provided text, supplemented by general knowledge about 510(k) submissions of that era:
510(k) Summary Analysis for PALJET-B
1. Table of Acceptance Criteria and Reported Device Performance
Not explicitly stated in the provided document. In 1998, for this type of device, acceptance criteria were typically demonstrated by meeting recognized standards (e.g., electrical safety, biocompatibility if applicable), and demonstrating that the device performed its intended function comparably to a predicate. The document implies that the device performance is equivalent to the predicate, the WaveTracer, for its stated diagnostic purpose.
| Acceptance Criterion (Implied) | Reported Device Performance |
|---|---|
| Basic Operational Equivalence(Performs as an ECG suction electrode system for diagnostic purposes) | "the basic operational aspect of the Paljet is unchanged from the Wavetracer." |
| Compatibility with ECGs(Compatible with all electrocardiographs on the U.S. market) | "It is designed for diagnostic purposes and is compatible with all electrocardiographs on the U.S. market." |
| Safety Improvements(Elimination of sharp edges, non-patient contacting materials for improved reliability) | "elimination of any sharp edges on the contact surfaces that came into contact with human skin," "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." |
| Design Improvements(Reduced weight, enhanced portability, DC power source) | "reduced the weight and eliminated the hanging arm configuration to enhance the portability aspects of the new device." Changed from AC to DC power. |
2. Sample size used for the test set and the data provenance
No specific test set or data provenance (e.g., country of origin, retrospective/prospective) is mentioned for a performance study. Equivalence is primarily argued through design comparisons to the predicate.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
Not applicable. No ground truth establishment for a test set is described.
4. Adjudication method for the test set
Not applicable. No test set requiring adjudication is described.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
Not applicable. This device is an ECG electrode system, not an AI/ML diagnostic tool, and no MRMC study is mentioned.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This device is not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
Not applicable. No formal ground truth for performance evaluation is described. The "ground truth" for demonstrating equivalence largely rests on the predicate device's established performance and the fundamental operational similarity.
8. The sample size for the training set
Not applicable. This device is not an AI/ML algorithm requiring a training set.
9. How the ground truth for the training set was established
Not applicable. This device is not an AI/ML algorithm.
Summary of Approach for this Device (1998):
The 510(k) submission for the PALJET-B relies on demonstrating "substantial equivalence" to a legally marketed predicate device (WaveTracer) as per the regulations of that time. This typically involved:
- Comparison of Indications for Use: Showing they are identical or very similar.
- Comparison of Technological Characteristics: Explaining any differences and demonstrating they do not raise new questions of safety or efficacy. In this case, material changes (non-patient contact), power source changes, and mechanical redesigns were explained as improvements that maintained or enhanced safety and effectiveness without altering the fundamental operational principle.
- Performance Data (if applicable): While not detailed here, for devices like ECG electrodes, performance data would typically focus on aspects like electrical specifications, signal integrity, biocompatibility (if patient-contacting materials changed significantly), and possibly limited clinical testing to show equivalent signal acquisition. The provided summary states the "basic operational aspect...is unchanged," which implicitly covers the primary performance characteristic of an ECG electrode.
This document clearly pre-dates the regulatory considerations and study expectations for AI/ML devices. Therefore, a direct comparison using the requested structure is largely incongruent with the information provided.
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510k Summary
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Trade name Venturi suction electrode patient cable system. .
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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 (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
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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
§ 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.