(187 days)
Not Found
Not Found
No
The summary does not mention AI, ML, image processing, or any other technology typically associated with AI/ML in medical devices. The device description and intended use point to a simple warming mattress.
No
The device provides warmth for transport, which is a supportive function, but it does not treat or cure a disease or condition.
No
The device provides warmth, which is a therapeutic function, not a diagnostic one. It does not identify or analyze a condition.
No
The device description explicitly states "Neo Nest Infant Transport Mattress," indicating a physical hardware component (a mattress) is the primary device, 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 "Provision of warmth during transport of infant within the hospital or between hospitals." This describes a physical intervention (providing warmth) for a patient (an infant) in a clinical setting.
- Device Description: The device is a "Neo Nest Infant Transport Mattress." This is a physical object used for patient care.
- Lack of IVD Characteristics: The description does not mention any of the typical characteristics of an IVD, such as:
- Analyzing samples (blood, urine, tissue, etc.)
- Providing diagnostic information
- Using reagents or assays
- Performing tests outside of the body (in vitro)
IVDs are devices used to examine specimens derived from the human body to provide information for the diagnosis, prevention, monitoring, treatment, or alleviation of disease. The Neo Nest Infant Transport Mattress does not fit this description.
N/A
Intended Use / Indications for Use
Provision of warmth during transport of infant within the hospital or between hospitals. Recommended for full term infants.
Product codes
IMD
Device Description
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Mentions image processing
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Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
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Anatomical Site
Not Found
Indicated Patient Age Range
full term infants
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)
Not Found
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
DEPARTMENT OF HEALTH & HUMAN SERVICES
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 an eagle or bird with three lines forming its head and body. The logo is surrounded by the text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" in a circular arrangement.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002
MAR - 6 2012
DeNovo Products, LLC % Mr. Dale Walters 17051 Alico Commerce Court #3 Fort Myers, Florida 33967
Re: K112547
Trade/Device Name: DeNovo Products Neo Nest Gel Infant Transport Mattress Regulation Number: 21 CFR 890.5710 Regulation Name: Hot or cold disposable pack Regulatory Class: Class II Product Code: IMD Dated: February 28, 2012 Received: February 28, 2012
Dear Mr. Walters:
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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to 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 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); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); 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.
1
Page 2 - Mr. Dale Walters
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please 11 you active operilio adv/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for go to mtp., www.radiological Health's (CDRH's) Office of Compliance. Also, please the Concertify BotTects and Andress of the may by reference to premarket notification" (21CFR Part note the regulation onlined, "Interesting of adverse events under the MDR regulation (21 CFR Part 803), please go to
http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
You may obtain other general information on your responsibilities under the Act from the Tou may obtain other generers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.
Sincerely yours,
for Doth
Oscar Dr.
Mark N. Melkerson Director Division of Surgical, Orthopedic, and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known): K 112547
Neo Nest Infant Transport Mattress Device Name:
Indications For Use:
Provision of warmth during transport of infant within the hospital or between hospitals. Recommended for full term infants.
X Prescription Use (Part 21 CFR 801 Subpart D)
AND/OR
Over-The-Counter Use (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Vance W. Lary
(Division Sign-Off) Division of Surgical, Orthopedic, and Restorative Devices
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510(k) Number K112547