(25 days)
The Mactrode® 3 is intended for use on adult patients during an ECG electrocardiogram test. The Mactrode® 3 is applied to the patient's skin. The Mactrode® 3 is intended to be used for less than one hour. The Mactrode® 3 is for single patient use.
The Mactrode® 3 is intended to be used under the direct supervision of a licensed healthcare practitioner or by personnel trained in its proper use. The Mactrode® 3 is intended for use in a professional medical facility, such as a hospital, clinic or doctor's office.
The Mactrode® 3 is an electrocardiograph electrode. The Mactrode® 3 is triangular in shape providing multiple alternate connection areas. The Mactrode® 3 is a pre-gelled electrode that is disposable and is not sterile.
The provided text is for a 510(k) summary for a medical device called Mactrode® 3, an electrocardiograph electrode. It describes the device, its intended use, and states that it performs as well as the predicate device. However, the document does not contain details about specific acceptance criteria, a detailed study proving performance against those criteria, or the specific quantitative metrics requested in your prompt (e.g., performance values, sample sizes for test/training sets, expert methods for ground truth, MRMC studies, or standalone performance).
The "Test Summary" section in the 510(k) Summary states: "The Mactrode® 3 complies with the voluntary standards as detailed in Section 9 of this submission. The following quality assurance measures were applied to the development of the system: Risk Analysis, Technical Reviews, Design Reviews, Unit level Testing, Performance Testing, Safety Testing."
This indicates that a study was performed (referred to as "Performance Testing" and "Safety Testing"), but it does not provide the results or the methodology for these tests. The conclusion only states that the device is "as safe, as effective, and performs as well as the predicate device."
Therefore, I cannot populate the table or answer the specific questions about the study design, sample sizes, ground truth, or expert involvement as this information is not present in the provided document. The document primarily focuses on regulatory approval based on demonstrating substantial equivalence to a predicate device (K902176 Silver Mactrode®), rather than providing a detailed clinical or performance study report with specific quantitative outcomes.
{0}------------------------------------------------
7 2006 APR
Section 2 Summary
| 510(k) Summary of Safety and Effectiveness | |
|---|---|
| Date: | March 10, 2006 |
| Submitter: | GE Medical Systems Information Technologies8200 West Tower AvenueMilwaukee, WI 53223 USA |
| Contact Person: | Karen RussellRegulatory Affairs SpecialistGE Medical Systems Information TechnologiesPhone: 414-362-3166Fax: 414-362-2585 |
| Device: Trade Name: | Mactrode® 3 |
| Common/Usual Name: | Electrocardiograph electrode |
| Classification Names:21 CFR 870.2360 | Electrocardiograph Electrode DRX |
| Predicate Device: | K902176 Silver Mactrode® |
| Device Description: | The Mactrode® 3 is an electrocardiograph electrode. The Mactrode® 3 is triangular in shape providing multiple alternate connection areas. The Mactrode® 3 is a pre-gelled electrode that is disposable and is not sterile. |
| Intended Use: | The Mactrode® 3 is intended for use on adult patients during an ECG electrocardiogram test. The Mactrode® 3 is applied to the patient's skin. The Mactrode® 3 is intended to be used for less than one hour. The Mactrode® 3 is for single patient use.The Mactrode® 3 is intended to be used under the direct supervision of a licensed healthcare practitioner or by personnel trained in its proper use. The Mactrode® 3 is intended for use in a professional medical facility, such as a hospital, clinic or doctor's office. |
| Technology: | The Mactrode® 3 employs the same functional technology as the predicate device. |
| Test Summary: | The Mactrode® 3 complies with the voluntary standards as detailed in Section 9 of this submission. The following quality assurance measures were applied to the development of the system:Risk Analysis Technical Reviews Design Reviews Unit level Testing Performance Testing Safety Testing |
| Conclusion: | The results of these measurements demonstrated that the Mactrode® 3 is as safe, as effective, and performs as well as the predicate device |
Image /page/0/Picture/4 description: The image shows the handwritten words "page" and "1 of 1". The words are written in a cursive style. There is also a scribbled area in the bottom right corner of the image.
:
{1}------------------------------------------------
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/1/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services (HHS). The logo features a stylized caduceus, which is a symbol often associated with healthcare. The caduceus is depicted with three lines forming a wing-like shape. The text "DEPARTMENT OF HEALTH AND HUMAN SERVICES" is arranged in a circular pattern around the caduceus.
Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
7 2006 APR
GE Medical Systems Information Technologies c/o Karen Russell Regulatory Affairs Specialist 8200 West Tower Avenue Milwaukee, WI 53223
Re: K060661
Trade Name: Mactrode® 3 Regulation Number: 21 CFR 870.2360 Regulation Name: Electrograph Electrode Regulatory Class: Class II (two) Product Code: DRX Dated: March 10, 2006 Received: March 13, 2006
Dear Ms. Russell:
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. Ilsting 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 FIDA'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
{2}------------------------------------------------
Page 2 - Ms. Karen Russell
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 (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 proceed 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 (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours,
Bermunacob
Bram D. Zuckerman, M.D. Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
{3}------------------------------------------------
KOPO661 510(k) Number (if known):
Page 1 of 1
Device Name: Mactrode® 3
Indications For Use:
The Mactrode® 3 is intended for use on adult patients during an ECG electrocardiogram test. The Mactrode® 3 is applied to the patient's skin. The Mactrode® 3 is intended to be used for less than one hour. The Mactrode® 3 is for single patient use.
The Mactrode® 3 is intended to be used under the direct supervision of a licensed healthcare practitioner or by personnel trained in its proper use. The Mactrode® 3 is intended for use in a professional medical facility, such as a hospital, clinic or doctor's office.
Prescription Use X (Per 21 CFR 801.109 Subpart D) 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)
B. Humma
Division Slan-C Olvision of Card
§ 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.