(84 days)
Replacement battery pack for MARQUETTE MAC 8, MAC PERSONAL & MAC STRESS This battery will be shipped to biomedical equipment technicians and or customers who request a replacement battery for the particular device(s) listed above
Replacement battery for Marquette Mac8, and Mac Stress
The provided text is an FDA 510(k) clearance letter for a replacement battery pack. It does not contain information about acceptance criteria or a study proving device performance in the context of an AI/ML medical device. Therefore, I cannot generate the requested table and study details.
The letter explicitly states: "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..." This indicates that the clearance is based on substantial equivalence to existing devices, not on a new clinical study demonstrating specific performance metrics against pre-defined acceptance criteria for a novel device or AI algorithm.
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Image /page/0/Picture/2 description: The image is a black and white circular logo. The logo features a stylized eagle with three wing strokes, symbolizing health and human services. Encircling the eagle is text that reads "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA". The text is arranged along the perimeter of the circle, with the eagle positioned in the center.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
OCT 1 0 2001
Mr. Don Pelletier National Custom Enterprises, Inc. 1133 E. Cliff Rd. Burnsville, MN 55337
Re: K012264
Trade Name: Model N3043IWC replacement battery for Marquette Mac8, and Mac Stress Regulation Number: 21 CFR 870.2340 Regulation Name: Electrocardiograph Regulatory Class: Class II (two) Product Code: DPS Dated: July 12, 2001 Received: July 18, 2001
Dear Mr. Pelletier:
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.
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Page 2 - Mr. Don Pelletier
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 (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 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,
James F. Dillard III
James E. Dillard III Director Division of Cardiovascular and Respiratory Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Applicant: National Custom Enterprises, Inc. (800) 328-3773
510(k) Number: _ K012264
N3043IWC Device Name:
Indications For Use: Replacement battery pack for
MARQUETTE MAC 8, MAC PERSONAL & MAC STRESS
This battery will be shipped to biomedical equipment technicians and or customers who request a replacement battery for the particular device(s) listed above
Concurrence of CDRH, Office of Device Evaluation (ODE)
NoleTech
Division of Cardiology Respiratory Devices
510(k) Number K012264
Prescription Use (Per 21 CFR 801.109) OR
Over-The-Counter Use
§ 870.2340 Electrocardiograph.
(a)
Identification. An electrocardiograph is a device used to process the electrical signal transmitted through two or more electrocardiograph electrodes and to produce a visual display of the electrical signal produced by the heart.(b)
Classification. Class II (performance standards).