(84 days)
Not Found
Not Found
No
The 510(k) summary describes a replacement battery pack, which is a passive component and does not inherently incorporate AI/ML. The document also explicitly states "Mentions AI, DNN, or ML: Not Found".
No
This device is a replacement battery pack for a monitor, not a therapeutic device itself.
No
The device is a replacement battery pack for a monitor, not the monitor itself. A battery pack does not perform diagnostic functions.
No
The device description clearly states it is a "Replacement battery pack," which is a hardware component, not software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is clearly stated as a "Replacement battery pack for MARQUETTE EAGLE MONITOR MODEL 4000". This is a power source for a medical device, not a product used in vitro (outside the body) to examine specimens derived from the human body for the purpose of providing information for diagnosis, monitoring, or compatibility testing.
- Device Description: The description confirms it's a "Replacement battery pack".
- Lack of IVD Characteristics: The document does not mention any of the typical characteristics of an IVD, such as:
- Analyzing biological specimens (blood, urine, tissue, etc.)
- Providing diagnostic information
- Using reagents or calibrators
- Performing tests on samples
The device is a component that powers a medical device (the monitor), but it does not perform any diagnostic function itself.
N/A
Intended Use / Indications for Use
Replacement battery pack for MARQUETTE EAGLE MONITOR MODEL 4000 This battery will be shipped to biomedical equipment technicians and or customers who request a replacement battery for the particular device(s) listed above
Product codes
DPS
Device Description
Not Found
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
biomedical equipment technicians and or customers who request a replacement battery for the particular device(s) listed above
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): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Not Found
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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).
0
Image /page/0/Picture/2 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo is a circular emblem with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized image of an eagle or bird-like figure with three wing-like shapes. The logo is presented in black and white.
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: K012263
Trade Name: Model N3024 replacement battery for Marquette Eagle Monitor 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.
1
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 E. Dillard III
James E. Dillard III Director Division of Cardiovascular and Respiratory Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
2
Applicant: National Custom Enterprises, Inc. (800) 328-3773
510(k) Number: K012263
Device Name:
Indications For Use: Replacement battery pack for
MARQUETTE EAGLE MONITOR MODEL 4000
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)
Dale Tull
Division of Cardiovascular & Respiratory Devices
510(k) Number K012263
Prescription Use (Per 21 CFR 801.109) OR
Over-The-Counter Use /