(218 days)
Not Found
Not Found
No
The description focuses solely on temperature control for storage and does not mention any AI/ML components or functionalities.
No.
Explanation: The device is designed to store and maintain the temperature of drugs and I.V. solutions, which are therapeutic, but the device itself does not directly treat or diagnose a disease or condition. It is a storage device.
No
Explanation: The device is a Controlled Temperature Cabinet System for storing and maintaining the temperature of drugs and I.V. solutions. It does not perform any diagnostic functions.
No
The device description clearly states "Controlled Temperature Cabinet System," which implies a physical hardware component (the cabinet) designed to maintain temperature. The intended use also describes storing drugs and I.V. solutions within this cabinet.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is to store and maintain the temperature of drugs and I.V. solutions. This is a storage and environmental control function, not a diagnostic test performed on biological samples in vitro (outside the body).
- Device Description: The device is described as a "Controlled Temperature Cabinet System," which aligns with its storage function.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples, detecting analytes, or providing diagnostic information.
IVD devices are used to examine specimens derived from the human body (like blood, urine, tissue) to provide information for diagnosis, monitoring, or screening. This device does not perform any such function.
N/A
Intended Use / Indications for Use
The Medical Products, Inc. Controlled Temperature Cabinet Systems are designed to store and transport medical products in the ambulance or mobile vehicle environment to temperatures between 21º to 26ºC or 35º to 40ºC.
The Controlled Temperature Cabinet Systems must be ordered by temperature range. For drugs the range is 21º to 26ºC and for I.V. solutions the temperature range is 35ºC to 40ºC.
Warning: The owner of the ambulance or mobile vehicle should contact the manufacturer of the products to be placed inside the cabinets and obtain guidelines for exposing their product to temperatures other than those stated on the I.V. solution bag/bottle or drug container.
Product codes
LDQ
Device Description
Not Found
Mentions image processing
Not Found
Mentions AI, DNN, or ML
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Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
ambulance or mobile vehicle environment
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 for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
N/A
0
Image /page/0/Picture/2 description: The image shows the seal of the Department of Health & Human Services - USA. The seal features a stylized eagle with three stripes representing the three levels of government: federal, state, and local. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular pattern around the eagle.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
7 1998 MAY
Medical Products, Incorporated C/O Mr. E.J Smith President Smith Associates P.O. Box 4341 Crofton, Maryland 2114-4341
Re : K973747 Controlled Temperature Cabinet System Trade Name: Unclassified Requlatory Class: Product Code: LDQ Dated: March 24, 1998 Received: March 26, 1998
Dear Mr. Smith:
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 The general controls provisions of the Act 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 Requlations, Title 21, Parts 800 to 895. A - 1. substantially equivalent determination assumes compliance with the Good Manufacturing Practice for Medical Devices: General (GMP) requlation (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 regulation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Reqister. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of
1
Page 2 - Mr. Smith
the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.
This letter will allow you to begin marketing your device as described in your 510(k) premarket notification. The FDA acberibod in your bio (i) providence 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) 594-4692. 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,
Timothy A. Ulatowski Directbr Division of Dental, Infection Control, and General Hospital Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Page 1 of 1
510(k) Number (if known):
Device Name: Controlled Temperature Cabinet System
Classification Panel: 80LGZ, General Hospital
Indications for Use:
The Medical Products, Inc. Controlled Temperature Cabiner Systems are designed to store and I he Moutan's roducts, the. Comrowin the ambulance or mobile vehicle environment to temperatures between 21º to 26ºC or 35º to 40ºC.
The Controlled Temperature Cabinet Systems must be ordered by temperature range. For drugs the range is 210 to 26°C and for I.V. solutions the temperature range is 35°co 40°C.
Warning: The owner of the ambulance or mobile vehicle should contact the manufacturer of the products to be placed inside the cabinets and obtain guidelines for exposing their product to temperatures other than those stated on the I.V. solution bag/bottle or drug container.
(PLEASE DO NOT WRITE BELOW THIS LINE- CONTINUE ON ANOTHER PAGE IF NEEDED)
| Concurrence of CDRH, Office of Device Evaluation (ODE) |
|---|
| -------------------------------------------------------- |
| Prescription Use | or | Over-the-Counter Use | |
|---|---|---|---|
| ------------------ | -- | ---- | ---------------------- |
| (Division Sign-Off) Patricia Cucerda Division of Dental, Infection Control, and General Hospital Devices | |
|---|---|
| 510(k) Number | K973747 |