(126 days)
Not Found
Not Found
No
The summary describes a device for warming infant heels and contains no mention of AI, ML, image processing, or data analysis that would suggest the use of such technologies.
No
The device warms infant's heels for blood drawing, which is a preparatory step for diagnostic analysis, not a treatment or therapy to a disease or condition.
No
The device is used for warming an infant's heels prior to drawing blood for sampling or general analysis, which is a preparation step for a diagnostic procedure, but the device itself does not perform any diagnostic function (e.g., analyzing samples, producing diagnostic images, or interpreting data).
No
The intended use and description clearly indicate a physical device for warming infant's heels, not a software application.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is to warm an infant's heels prior to drawing blood. This is a preparatory step for a diagnostic procedure (blood sampling and analysis), but the device itself is not used to perform the diagnostic test or analyze the sample.
- Device Description: While the description is "Not Found," the intended use clearly describes a physical action (warming) applied to the patient's body, not a process involving a sample in vitro (outside the body).
- Anatomical Site: The device is applied to the infant's heels, which is part of the patient's body. IVDs typically interact with biological samples (blood, urine, tissue, etc.) that have been removed from the body.
IVDs are devices used to examine specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes. This device's function is to facilitate the collection of a sample, not to analyze the sample itself.
N/A
Intended Use / Indications for Use
For use by hospital, Ambulatory Surgery staff, Outpatient Clinics for warming of Infant's Heels prior to drawing blood for sampling or general analysis.
This device is intended for Rx use only.
This device is single use, non-sterile, and disposable.
Product codes
MPO
Device Description
Not Found
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Infant's Heels
Indicated Patient Age Range
Infant
Intended User / Care Setting
hospital, Ambulatory Surgery staff, Outpatient Clinics
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-like figure with outstretched wings. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" is arranged in a circular pattern around the bird symbol.
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring. MD 20993-0002
DeNovo Products LLC % Mr. Dale Walters 17051 Alico Commerce Court, Unit 3 Fort Myers, Florida 33967
Re: K103549
Trade/Device Name: DeNovo Teddy Gel Infant Heel Warmer Regulation Number: 21 CFR 890.5710 Regulation Name: Hot or cold disposable pack Regulatory Class: Class I Product Code: MPO Dated: March 22, 2011 Received: March 22, 2011
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 11 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
APR - 8 2011
1
Page 2 - Mr. Dale Walters
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. If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting 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 Division of Small Manufacturers, 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/ResourcesforYou/Industry/default.htm.
Sincerely yours,
y yours,
For Mr. D. Ruis
Malkerson
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 Form
510(k) Number (if known): _ K103549
Device Name: DeNovo Products Teddy Gel Infant Heel Warmer
Indications for Use:
l
For use by hospital, Ambulatory Surgery staff, Outpatient Clinics for warming of Infant's Heels prior to drawing blood for sampling or general analysis.
This device is intended for Rx use only.
This device is single use, non-sterile, and disposable.
Prescription Use x (Part 21 CFR 801 Subpart D)
AND/OR
Over-The-Counter Use (21 CFR 801 Subpart C)
(Division Sign
Division of Surgical, Orthopedie and Restorative Devices
510(k) Number K103549