(16 days)
Not Found
Not Found
No
The summary describes a simple warming mattress using chemical activation, with no mention of AI or ML technologies.
Yes
The device is described as providing "warm therapy that helps maintain infant body temperature," which is a therapeutic function.
No
The device is described as providing warm therapy to maintain infant body temperature, which is a therapeutic function, not a diagnostic one. It does not identify or detect a disease or condition.
No
The device description clearly states it is a physical mattress made of LDPE film and containing sodium acetate, indicating it is a hardware device, not software.
Based on the provided information, the DeRoyal Industries Inc. Infant Transport Mattress is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is to "assist in maintaining infant body temperature." This is a therapeutic function, not a diagnostic one.
- Device Description: The description details a physical device containing sodium acetate for warmth, not a reagent or instrument used to examine specimens from the human body.
- Lack of IVD Characteristics: The description does not mention any of the typical characteristics of an IVD, such as:
- Analyzing biological samples (blood, urine, tissue, etc.)
- Detecting or measuring substances in the body
- Providing information for diagnosis, monitoring, or screening
IVDs are used to perform tests on samples taken from the body to provide information about a person's health status. The Infant Transport Mattress acts on the body to provide warmth.
N/A
Intended Use / Indications for Use
The DeRoyal Industries, Inc. Infant Transport Mattress is indicated for use to assist in maintaining infant body temperature.
Product codes
IMD
Device Description
The DeRoyal Industries, Inc. Infant Transport Mattress is a device intended for medical purposes to provide warm therapy that helps maintain infant body temperature. Device Design/Materials UsedPhysical Properties: The DeRoyal Infant Transport Mattress is designed similar to those marketed by other manufacturers. The pouch is comprised of a low-density polyethylene (LDPE) film bag which contains the activation ingredient, sodium acetate (food grade).
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
infant
Intended User / Care Setting
Not Found
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)
Prism Technologies
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 890.5710 Hot or cold disposable pack.
(a)
Identification. A hot or cold disposable pack is a device intended for medical purposes that consists of a sealed plastic bag incorporating chemicals that, upon activation, provides hot or cold therapy for body surfaces.(b)
Classification. Class I (general controls). Except when intended for use on infants, the device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to § 890.9.
0
DeRoyal Industries, Inc. Infant Transport Mattress
FEB 2 6 1998
510(k) Summary
SUMMARY OF THE SAFETY AND EFFECTIVENESS INFORMATION UPON WHICH AN EQUIVALENCE DETERMINATION COULD BE BASED
SUBMITTER INFORMATION
| NAME: | DeRoyal Industries, Inc. | TELEPHONE: | (423) 938-7828 |
|---|---|---|---|
| ADDRESS: | 200 DeBusk Lane | ||
| Powell, TN 37849 | CONTACT: | Camille Matlock | |
| DATE OF PREPARATION: | February 9, 1998 |
DEVICE NAMES
NAME: COMMON/USUAL NAME: CLASSIFICATION NAME (if known): DeRoyal Industries, Inc. Infant Transport Mattress . Infant Transport Mattress Pack, Hot, Chemical
PREDICATE OR LEGALLY MARKETED DEVICES
Prism Technologies
DEVICE DESCRIPTION
The DeRoyal Industries, Inc. Infant Transport Mattress is a device intended for medical purposes to provide warm therapy that helps maintain infant body temperature.
Device Design/Materials UsedPhysical Properties: The DeRoyal Infant Transport Mattress is designed similar to those marketed by other manufacturers. The pouch is comprised of a low-density polyethylene (LDPE) film bag which contains the activation ingredient, sodium acetate (food grade).
DEVICE INTENDED USE
The DeRoyal Industries, Inc. Infant Transport Mattress is indicated for use to assist in maintaining infant body temperature.
TECHNOLOGICAL COMPARISON WITH PREDICATE OR LEGALLY MARKETED DEVICE(S)
| Characteristic | DeRoyal Device | Other Devices |
|---|---|---|
| Pouch Dimension | Approximately 16" X 9.5" | Approximately 13" X 9" |
| Pouch Material | LDPE | LDPE or |
| Other Similar Material | ||
| Active Ingredient | Sodium Acetate (Food Grade) | Sodium Acetate (Food Grade) |
| Trigger | Internally Located | Internally Located |
| Sterility | Non-Sterile | Non-Sterile |
| Approximate Temperature | ||
| Achieved at Activation | 105° F | 104° F |
1
Image /page/1/Picture/1 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo features a stylized image of three human profiles facing to the right. The profiles are stacked on top of each other, with the top profile being the largest and the bottom profile being the smallest. The profiles are all connected by a single line that runs from the top of the head to the bottom of the chin. The image is surrounded by a circular border with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" written around it.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
FEB 2 6 1998
Ms. Camille Matlock Regulatory Affairs DeRoyal Industries, Inc. 200 DeBusk Lane Powell, Tennessee 37849
K980509 Re: Trade Name: DeRoyal Industries, Inc. Infant Transport Mattress Requlatory Class: I Product Code: IMD February 9, 1998 Dated: Received: February 10, 1998
Dear Ms. Matlock:
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 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 (Premarket Approval), 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 895. ਜੋ substantially equivalent determination assumes compliance with the current Good Manufacturing Practice requirement, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic (QS) 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 Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.
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Page 2 - Ms. Camille Matlock
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) 594-4659. 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,
Celia M. Witten, Ph.D., M.D. Director Division of General and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure --------------------------------------------------------------------------------------------------------------------------------------------------------------------
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| 510(k) Number (if known): | |
|---|---|
| Device Name: | DeRoyal Industries Inc. Infant Transport Mattress |
Indications for Use:
:
:
)
The DeRoyal Industries Inc. Infant Transport Mattress is to be used to assist in maintaining infant body temperature.
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
| Sign-Off of General Restorative Devices Number | K980509 |
| Prescription Use (Per 21 CFR § 801.109) | OR | Over-The-Counter Use ______ |
|---|---|---|
| ---------------------------------------------------------------------------------- | ---- | ----------------------------- |