(90 days)
The Recover® Infant Heel Warmer is intended to be used for warming the heel site of an infant prior to a heel stick procedure. The warmth enhances vasodilation and increases blood flow in an infant's heel to ensure adequate blood for sampling.
Non Toxic, Food Grade Sodium Acetate and water with a stainless steel catalytic disc sealed in a nylon /polyethylene laminate bag. Provides heat to 105°F.
This 510(k) summary describes a medical device, the Recover® Infant Heel Warmer, and compares it to a predicate device. However, it does not contain any information about acceptance criteria or a study proving the device meets those criteria, nor does it provide details about clinical performance, ground truth, or expert involvement as requested in your prompt.
Therefore, I cannot fulfill your request for:
- A table of acceptance criteria and the reported device performance
- Sample size used for the test set and the data provenance
- Number of experts used to establish the ground truth for the test set and their qualifications
- Adjudication method for the test set
- If a multi-reader multi-case (MRMC) comparative effectiveness study was done
- If a standalone (algorithm only) performance study was done
- The type of ground truth used
- The sample size for the training set
- How the ground truth for the training set was established
The document provided focuses on the physical description, contents, temperature, and intended use of the device, along with its classification and predicate device. It's a pre-market notification (510(k)) summary from 1997, which might predate the regulatory requirements for the types of detailed performance studies you are asking about, especially those related to AI/algorithm performance.
{0}------------------------------------------------
K964523
510(K) SUMMARY
FEB 1 0 1997
(as required by 807.92(c))
Regulatory & Marketing Services, Inc. (RMS) Submitter of 510(k): 40178 U.S. 19 North Tarpon Springs, FL 34689
Phone: 813-942-3908 Fax: 813-942-3828
Patrick J. Lamb or Edward H. Ransom
Contact Person:
Date of Summary:
Trade Name: Recover® Infant Heel Warmer
Classification Name: Pack, Hot, Disposable
Predicate Device: Florida Medical Industries, Recover® Infant Heel Warmer Pre 1976 Device
October 18 , 1996
Device Description/ Comparison:
Non Toxic, Food Grade Sodium Acetate and water with a stainless steel catalytic disc sealed in a nylon /polyethylene laminate bag. Provides heat to 105°F.
| Proposed Device | Marketed Device | |
|---|---|---|
| Florida MedicalIndustries | Florida MedicalIndustries | |
| Contents | Food-grade sodiumacetate and water.Disc: Stainless SteelCatalytic disc. | Magnesium Sulphate(Kieserite); Colloidal Clay; water. |
| Temp. | 105° | 105° |
Intended Use:
The Recover® Infant Heel Warmer is intended to be used for warming the heel site of an infant prior to a heel stick procedure. The warmth enhances vasodilation and increases blood flow in an infant's heel to ensure adequate blood for sampling.
§ 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.