(28 days)
No
The device description details a simple chemical reaction for heating and does not mention any computational or learning components.
No.
A therapeutic device is one that treats a disease or health condition. This device facilitates a diagnostic procedure (blood sampling) by warming the heel to increase blood flow, but it does not treat a condition itself.
No
Explanation: The device is used to warm an infant's heel to increase blood circulation for easier blood sampling. It does not provide any diagnostic information or interpret any physiological parameters. Its function is solely to facilitate a medical procedure.
No
The device description clearly outlines a physical, self-contained unit comprised of a bag, ingredients, an activator disk, and adhesive tape. This is a hardware device, not software.
Based on the provided information, the MediHEAT Infant Heel Warmer is not an In Vitro Diagnostic (IVD) device.
Here's why:
- IVD Definition: IVD devices are used to examine specimens (like blood, urine, or tissue) taken from the human body to provide information about a person's health, such as diagnosing a disease or monitoring a condition.
- MediHEAT's Function: The MediHEAT Infant Heel Warmer's intended use is to warm the infant's heel to increase blood circulation before blood sampling. It does not analyze or test the blood itself. Its function is purely physical – applying heat to the skin.
- Lack of Diagnostic Purpose: The device does not provide any diagnostic information or results about the infant's health. It is a tool to facilitate a procedure (blood sampling), not a diagnostic test.
Therefore, the MediHEAT Infant Heel Warmer falls under the category of a general medical device, not an IVD.
N/A
Intended Use / Indications for Use
The MediHEAT Infant Heel Warmer is a single-use, non-toxic, non-sterile device. The MediHEAT Infant Heel Warmer is intended to be used on an Infant's heel to facilitate drawing blood for analyses.
- MediHEAT Infant Heel Warmer is primarily used in hospitals, Doctor's offices, and other healthcare facilities.
- Normally, Medical Practitioners squeeze the heels of Infants to increase blood circulation in the area before drawing blood for analyses.
- The Infant Heel Warmer is used to warm the heel of an Infant to increase blood circulation to the area to facilitate blood sampling.
Product codes
MPO
Device Description
The MediHeat Infant Heel Warmer is a self-contained unit comprised of a flexible Nylon/Polyethylene bag containing the ingredients: a) Food grade sodium acetate, b) Water and c) Activator disk. When the disk is clicked, it activates the sodium acetate solution causing it to pass from the liquid phase to a solid phase (crystallization), making it exothermic. d) An adhesive tape to hold the warmer in place. It heats up to a maximum temperature of up to 105°F and gradually diminishes.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Infant's heel
Indicated Patient Age Range
Infant
Intended User / Care Setting
hospitals, Doctor's offices, and other healthcare facilities. Medical Practitioners
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
MediHEAT Infant Heel Warmer is tested against Predicate devices, bought in open market, in our lab for their temperature characteristics. They all performed very similarly, i.e. the maximum temperature is up to 105°F. They lasted about 30 minutes and the temperature diminished gradually. The comparison graphs are given in Attachment F.
Key Metrics
Not Found
Predicate Device(s)
K912715, K936084, K961154, K954716, K951383
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
OCT 2 2 2003
MediHEAT, Inc.
505 Hill Road Dalton, GA 30722-2527 Phone: (706) 226-1800 Fax:
510(k) Summary (As required by 807.92(c))
| Submitter of 510(k) | MediHeat, Inc
505 Hill Road
Dalton GA 30722 |
|----------------------------|---------------------------------------------------------|
| Telephone | (706) 226-1800 |
| Fax | (706) 226-2195 |
| Regulatory Affairs Contact | Uma Ramachandran
Director of Requlatory Affairs & QA |
| Date Summary prepared | September 2003 |
| Product Trade Name | MediHEAT Infant Heel Warmer |
| Common or Usual Name | Infant Heel warmer |
| Classification Name | Pack, Hot or Cold Disposable
21 CFR 890-5710 |
| Predicate Devices | [807.92(a)(3)] |
| Device Name | 510(k) Number |
|---|---|
| Instant Warm Gel Pack by Prism | K912715 |
| Omni Warm Gel Pack | K936084 |
| Baxter Sodium Acetate Infant Heel Warmer | K961154 |
| DeRoyal Infant Heel Warmer | K954716 |
| Tempra Heat Pack | K951383 |
1
510(k) MediHEAT Infant Heel Warmer
| Description of the device
[807.92(a)(4)] | The MediHeat Infant Heel Warmer is a
self-contained unit comprised of a
flexible Nylon/Polyethylene bag containing
the ingredients:
a) Food grade sodium acetate,
b) Water and
c) Activator disk.
When the disk is clicked, it activates the
sodium acetate solution causing it to
pass from the liquid phase to a solid
phase (crystallization), making it
exothermic.
d) An adhesive tape to hold the warmer in place.
It heats up to a maximum temperature
of up to 105°F and gradually diminishes. |
|---------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Intended Use [807.92(a)(5)] | The MediHEAT Infant Heel Warmer is a
single-use, non-toxic, non-sterile device.
The MediHEAT Infant Heel Warmer is intended
to be used on an Infant's heel to facilitate
drawing blood for analyses. |
| Substantial Equivalence: | The chemical reaction involved in releasing
the heat in MediHEAT Infant Heel warmer is
substantially equivalent to
PRISM Infant Heel warmer,
Omni warm gel pack,
Baxter sodium acetate infant heel warmer,
DeRoyal infant heel warmer and
Tempra heat pack in their intended use and
performance characteristics.
The temperature output of MediHEAT
Infant Heel Warmer is well within the range
of the predicate devices. |
:
Summary of studies and Technological Characteristics
| Performance Characteristics: | MediHEAT Infant Heel Warmer is tested against Predicate devices, bought in open market, in our lab for their temperature characteristics. |
|---|---|
| ------------------------------ | ------------------------------------------------------------------------------------------------------------------------------------------- |
2
510(k) MediHEAT Infant Heel Warmer
Performance Characteristics (cont'd):
They all performed very similarly, i.e. the maximum temperature is up to 105°F. They lasted about 30 minutes and the temperature diminished gradually. The comparison graphs are given in Attachment F.
Conclusions drawn from studies:
The data from the studies conducted demonstrate that the performance of MediHEAT Infant Heel warmer is similar and substantially equivalent to that of other commercially available Infant Heel Warmers.
3
Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" around the perimeter. Inside the circle is a stylized image of three human profiles facing right, with flowing lines above them that resemble a bird in flight.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
OCT 2 2 2003
Ms. Uma Ramachandran Director of Regulatory Affairs and Quality Assurance MediHeat Inc. 505 Hill Road Dalton, Georgia 30722
Re: K032989
Trade/Device Name: MediHEAT Infant Heel Warmer Regulation Number: 21 CFR 890.5710 Regulation Name: Hot or cold disposable pack Regulatory Class: I Product Code: MPO Dated: September 22, 2003 Received: September 24, 2003
Dear Ms. Ramachandran:
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.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), 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 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); 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.
4
Page 2 - Ms. Uma Ramachandran
This letter will allow you to begin marketing your device as described in your Section 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), please contact the Office of Compliance at (301) 594-1308. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). 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) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html
Sincerely yours,
fo Mark A. Mellema
Celia M. Witten, PhD, MD Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
5
Page 1 of 1
032999 510(k) Number (if known)
Device Name MediHEAT Infant Heel Warmer
Indications For Use:
-
- MediHEAT Infant Heel Warmer is primarily used in hospitals, Doctor's offices, and other healthcare facilities.
-
- Normally, Medical Practitioners squeeze the heels of Infants to increase blood circulation in the area before drawing blood for analyses.
-
- The Infant Heel Warmer is used to warm the heel of an Infant to increase blood circulation to the area to facilitate blood sampling.
(PLEASE DO NOT WRITE BELOW THIS LINE- CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
(Optional Format 3-10-98)
for Mark N. Milliman
eneral, Restorative eurological Device
9(k) Number K032984