(28 days)
- 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.
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.
Here is the detailed breakdown of the acceptance criteria and the study that proves the device meets them, based on the provided text:
Acceptance Criteria and Device Performance Study
The MediHEAT Infant Heel Warmer is a simple device designed to warm an infant's heel to facilitate blood drawing. The acceptance criteria and supporting study primarily focus on its temperature characteristics and equivalence to predicate devices.
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Maximum Temperature | Up to 105°F |
| Duration of Heat | Approximately 30 minutes |
| Gradual Diminishment of Temperature | Temperature diminished gradually |
| Equivalence to Predicate Devices (chemical reaction) | Substantially equivalent to listed predicate devices (PRISM, Omni Warm, Baxter, DeRoyal, Tempra) |
| Equivalence to Predicate Devices (temperature output) | Temperature output is well within the range of the predicate devices. |
Conclusion from Studies: The performance of MediHEAT Infant Heel Warmer is similar and substantially equivalent to that of other commercially available Infant Heel Warmers.
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size: Not explicitly stated, but the study compared the MediHEAT Infant Heel Warmer against "Predicate devices, bought in open market." This implies testing was done on at least one unit of each predicate device and at least one unit of the MediHEAT device.
- Data Provenance: The testing was conducted "in our lab" (referring to MediHeat, Inc.'s lab) which suggests internal testing. The country of origin for the data is therefore likely the USA (Dalton, GA). The study appears to be prospective as it involved testing new devices for their performance characteristics.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications
- None. For this type of device (a heat pack), the "ground truth" is objective physical measurements (temperature, duration) rather than expert interpretation. Experts are not mentioned as being involved in establishing the ground truth for this device's performance study.
4. Adjudication Method for the Test Set
- None. Adjudication methods like 2+1 or 3+1 are typically used for studies involving subjective human interpretation of data (e.g., medical images). This study involves direct physical measurements of temperature over time, which do not require interpretive adjudication.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done
- No. An MRMC study is not applicable here. This device warms a physical object (an infant's heel) and its performance is measured by objective temperature readings, not by human reader interpretation of complex data.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done
- Yes, effectively. The "study" described is a standalone performance test of the device itself. There is no algorithm or human-in-the-loop component for the function of a heel warmer; it's a direct physical-chemical reaction. The performance characteristics (temperature, duration) were measured directly from the device.
7. The Type of Ground Truth Used
- Objective Physical Measurements: The ground truth was established through direct measurement of temperature and duration of heat from the devices.
8. The Sample Size for the Training Set
- Not Applicable. This device is a physical product, not an AI or machine learning algorithm. Therefore, there is no "training set" in the computational sense. The device's performance is inherent to its design and chemical composition, not learned from data.
9. How the Ground Truth for the Training Set was Established
- Not Applicable (as there is no training set for this type of device).
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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, Inc505 Hill RoadDalton GA 30722 |
|---|---|
| Telephone | (706) 226-1800 |
| Fax | (706) 226-2195 |
| Regulatory Affairs Contact | Uma RamachandranDirector 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 Disposable21 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 |
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510(k) MediHEAT Infant Heel Warmer
| Description of the device[807.92(a)(4)] | The MediHeat Infant Heel Warmer is aself-contained unit comprised of aflexible Nylon/Polyethylene bag containingthe ingredients:a) Food grade sodium acetate,b) Water andc) Activator disk.When the disk is clicked, it activates thesodium acetate solution causing it topass from the liquid phase to a solidphase (crystallization), making itexothermic.d) An adhesive tape to hold the warmer in place.It heats up to a maximum temperatureof up to 105°F and gradually diminishes. |
|---|---|
| Intended Use [807.92(a)(5)] | The MediHEAT Infant Heel Warmer is asingle-use, non-toxic, non-sterile device.The MediHEAT Infant Heel Warmer is intendedto be used on an Infant's heel to facilitatedrawing blood for analyses. |
| Substantial Equivalence: | The chemical reaction involved in releasingthe heat in MediHEAT Infant Heel warmer issubstantially equivalent toPRISM Infant Heel warmer,Omni warm gel pack,Baxter sodium acetate infant heel warmer,DeRoyal infant heel warmer andTempra heat pack in their intended use andperformance characteristics.The temperature output of MediHEATInfant Heel Warmer is well within the rangeof 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. |
|---|---|
| ------------------------------ | ------------------------------------------------------------------------------------------------------------------------------------------- |
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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.
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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.
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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
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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
§ 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.