LogoFDA 510(k) Search
K Number
K103549
Device Name
DENOVO TEDDY GEL INFANT HEEL WARMER
Manufacturer
DENOVO PRODUCTS LLC
Date Cleared
2011-04-08

(126 days)

Product Code
MPO
Regulation Number
890.5710
Type
Traditional
Panel
PM
Reference & Predicate Devices
N/A
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
Intended 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.

Device Description

Not Found

AI/ML Overview

This document is a 510(k) clearance letter for a medical device called the "DeNovo Teddy Gel Infant Heel Warmer." It is not a study report and therefore does not contain information about acceptance criteria or a study proving device performance as requested in the prompt.

The document primarily states that the FDA has reviewed the premarket notification and determined the device is substantially equivalent to legally marketed predicate devices. It lists the device name, regulation number, regulatory class, and product code. It also includes an "Indications for Use Form" which specifies the intended use of the device.

Since the input document does not provide the requested information, I cannot fill out the table or answer the specific questions about acceptance criteria, study details, sample sizes, ground truth, or expert qualifications.

Here's what I can extract from the provided text, noting that the core request for study data cannot be fulfilled:

1. Table of Acceptance Criteria and Reported Device Performance:

  • Not applicable. This document is a clearance letter, not a study report. It does not contain acceptance criteria or reported device performance metrics.

2. Sample size used for the test set and the data provenance:

  • Not applicable. No study details are provided.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

  • Not applicable. No study details are provided.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:

  • Not applicable. No study details are provided.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:

  • Not applicable. This is a non-AI medical device (a heel warmer). No MRMC study or AI component is mentioned.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:

  • Not applicable. This is a non-AI medical device.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc):

  • Not applicable. No study details are provided.

8. The sample size for the training set:

  • Not applicable. No study details are provided.

9. How the ground truth for the training set was established:

  • Not applicable. No study details are provided.

§ 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.