(56 days)
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No
The device is a replacement battery pack and the summary contains no mention of AI or ML.
No
The device is a replacement battery pack for scales, which are weighing devices, not therapeutic devices.
No
This device is described as a "Replacement battery pack," not a device used for diagnosis. It powers scales, which may be used in healthcare settings, but the battery itself does not perform diagnostic functions.
No
The device is described as a "Replacement battery pack," which is a hardware component, not software.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is a "Replacement battery pack for SCALE-TRONIX MODEL... SCALES". This clearly indicates the device is a power source for scales, not a device used to examine specimens from the human body to provide information for diagnosis, monitoring, or screening.
- Device Description: The device is described as a "Replacement battery pack". This further reinforces its function as a power component.
- Lack of IVD Characteristics: The provided information does not mention any of the typical characteristics of an IVD, such as:
- Analyzing biological samples (blood, urine, tissue, etc.)
- Providing diagnostic information
- Using reagents or assays
Based on the provided information, this device is a replacement part for medical scales, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
Replacement battery pack for SCALE-TRONIX MODEL 48, 2001, 2009, 2700, 3003, 4004, 4800, 5005, 5700, 6006, 6500, 6700, 6006C & 20009 SCALES. 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
FMT
Device Description
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Mentions image processing
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Mentions AI, DNN, or ML
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Input Imaging Modality
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Anatomical Site
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Indicated Patient Age Range
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Intended User / Care Setting
biomedical equipment technicians and or customers who request a replacement battery
Description of the training set, sample size, data source, and annotation protocol
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Description of the test set, sample size, data source, and annotation protocol
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Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
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Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
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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.
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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.
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Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
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§ 880.5130 Infant radiant warmer.
(a)
Identification. The infant radiant warmer is a device consisting of an infrared heating element intended to be placed over an infant to maintain the infant's body temperature by means of radiant heat. The device may also contain a temperature monitoring sensor, a heat output control mechanism, and an alarm system (infant temperature, manual mode if present, and failure alarms) to alert operators of a temperature condition over or under the set temperature, manual mode time limits, and device component failure, respectively. The device may be placed over a pediatric hospital bed or it may be built into the bed as a complete unit.(b)
Classification. Class II (Special Controls):(1) The Association for the Advancement of Medical Instrumentation (AAMI) Voluntary Standard for the Infant Radiant Warmer;
(2) A prescription statement in accordance with § 801.109 of this chapter (restricted to use by or upon the order of qualified practitioners as determined by the States); and
(3) Labeling for use only in health care facilities and only by persons with specific training and experience in the use of the device.
0
Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized depiction of a human figure, represented by three curved lines forming a profile. The figure is enclosed within a circle, and the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged around the upper portion of the circle.
920-
Rock
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Mr. Donald Pelletier President National Custom Enterprises, Incorporated 1133 East Cliff Road Burnsville, Minnesota 55337
Re: K012229
Trade/Device Name: Scale-Tronix Model 48, 2001, 2009, 2700, 3003, 4004, 4800, 5005, 5700, 6006, 6500, 6700, 6006C & 20009 Scales Regulation Number: 880.5130 Regulation Name: Warmer, Infant Radiant-Accessory; Scale-Replacement Battery Regulatory Class: II Product Code: FMT Dated: July 10, 2001 Received: July 16, 2001
SEP 1 0 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.
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
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Page 2 - Mr. Pelletier
of the Act or any Federal statutes and regulations administered by other Federal agencies. or mo rot ormply 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 (section 531-542 of the Act; 21); CFR 1000-1050.
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- 4618 . 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 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
Timothy A. Ulatowski Director Director Division of Dental, Infection Control and General Hospital Devices Office of Device Evaluation Center for Devices and Radiological Health
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Applicant: National Custom Enterprises, Inc. (800) 328-3773
510(k) Number: |