(77 days)
Not Found
No
The device description details a chemical reaction for heat generation and does not mention any computational or data-driven processes indicative of AI/ML. The "Mentions AI, DNN, or ML" section explicitly states "Not Found".
No
The device aids in blood drawing by increasing blood flow, but it does not treat or cure any disease or medical condition.
No
The device is a warmer for an infant's heel designed to increase blood circulation to aid in the drawing of blood for analysis. It does not perform any diagnostic function itself.
No
The device description clearly outlines physical components (poly/nylon pouch, metal disc, liquid solution, crystals, adhesive tape) and a chemical reaction that generates heat, indicating it is a hardware device, not software-only.
Based on the provided information, the Rapid Aid Infant Heel Warmer is not an IVD (In Vitro Diagnostic) device.
Here's why:
- IVD devices are used to examine specimens taken from the human body. The intended use of the Rapid Aid Infant Heel Warmer is to warm an infant's heel on the body to facilitate blood drawing. It does not analyze or test any biological sample.
- The device description and performance studies focus on the physical properties of the warmer (temperature, dwell time) and its function in increasing blood circulation, not on any diagnostic analysis of a sample.
- There is no mention of any reagents, calibrators, or controls which are typical components or requirements for IVD devices.
The device is a therapeutic or procedural aid used in conjunction with a diagnostic procedure (blood drawing for analysis), but it is not the diagnostic device itself.
N/A
Intended Use / Indications for Use
Rapid Aid Infant Heel Warmer is primarily used in hospitals, doctor's offices, and other healthcare facilities. It is an instant warm pack intended to be used on an infant's heel to increase blood circulation to the area to aid in the drawing of blood for analysis. It is a single use, non-toxic, non-sterile, disposable warmer.
Product codes
MPO
Device Description
The Rapid Aid Infant Heel Warmer is a self contained unit comprised of a flexible, poly/nylon outer pouch containing:
- a) A metal disc that can be flexed during activation,
- b) Liquid solution of food grade sodium acetate and water,
- c) Minute crystals of sodium acetate.
An adhesive tape is attached to the top of the unit is activated by squeezing firmly on the inner fluid pouch, this will cause the inner perforated pouch to activate. Rapid crystallization occurs when the liquid contents are exposed to the minute crystals of sodium acetate contained within the poly/nylon outer pouch. This exothermnic reaction causes the unit to heat up to 104ºF. The adhesive tape strip is used to hold the warmer in place if desired.
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
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
The Infant Heel Warmer with Disc was tested against the predicate device to ensure conformance with temperature characteristics (maximum temperature and dwell time requirements). The average maximum temperature achieved was 102.6 ± 0.2 °F (new device) and 102.2 ± 0.4 °F (predicate) and the average dwell time that the unit was between 101 °F and 104 °F was 8.5 ± 1.0 min (new device) and 8.5 ± 0.8 min (predicate). The predicate and the new devices were both within the specified range for this device.
The materials that contact the skin have not changed:
- The outer poly/nylon pouch material has been tested following ASTM standards and is latex free and non-sensitizing.
- The finished packing material is tested for: thickness following ASTM D1203, tensile strength following ASTM D-882 and seal width. Pouch packaging material is subject to incoming inspection for width/length, seal integrity and burst strength.
- The chemical mixture claims are based on the results of testing the sodium acetate, which is a nontoxic, food grade chemical and has been found to be toxicologically acceptable for it's intended use.
- Finished product is subject to testing for peak temperature, seal integrity and pressure testing.
Key Metrics
Average maximum temperature: 102.6 ± 0.2 °F (new device)
Average maximum temperature: 102.2 ± 0.4 °F (predicate)
Average dwell time between 101 °F and 104 °F: 8.5 ± 1.0 min (new device)
Average dwell time between 101 °F and 104 °F: 8.5 ± 0.8 min (predicate)
Predicate Device(s)
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.
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Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo features a stylized depiction of an eagle with three human profiles incorporated into its design. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the eagle emblem.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
May 27, 2015
Rapid Aid Corporation c/o Mandell Horwitz Consultants, LLC Diane Horwitz, Ph.D., RAC 2995 Steven Martin Drive Fairfax, VA 22031
Re: K150627
Trade Name: Rapid Aid Instant Disposable Infant Heel Warmer Regulation Number: 21 CFR 890.5710 Regulation Name: Hot or cold disposable pack Regulatory Class: Class I Product Code: MPO Dated: April 27, 2015 Received: April 27, 2015
Dear Dr. Horwitz:
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. Isting 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 27f 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); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set
1
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 contact the Division of Small Manufacturers, International and Consumer Assistance at its tollfree number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. 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,
Felipe Aquel - S
Carlos L. Peña. PhD. MS for Director Division of Neurological and Physical Medicine Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known) K150627
Device Name
Rapid Aid Instant Disposable Infant Heel Warmer
Indications for Use (Describe)
Rapid Aid Infant Heel Warmer is primarily used in hospitals, doctor's offices, and other healthcare facilities. It is an instant warm pack intended to be used on an infant's heel to increase blood circulation to the area to aid in the drawing of blood for analysis. It is a single use, non-toxic, non-sterile, disposable warmer.
Type of Use (Select one or both, as applicable)
- Prescription Use (Part 21 CFR 801 Subpart D)
Over-The-Counter Use (21 CFR 801 Subpart C)
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Concurrence of Center for Devices and Radiological Health (CDRH) (Signature)
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3
Image /page/3/Picture/0 description: The image is a logo for Rapid Aid, a company that specializes in treating bumps and bruises. The logo is made up of the words "RAPID" in blue and "AID" in red, with a plus sign between them. The tagline "Makes it Better!" is below the logo. The text "Treating the World's Bumps & Bruises" is above the logo.
510(k) Summary of Safety and Effectiveness
Manufacturer and Submitter
| Company Name: | Rapid Aid Corp. |
|---|---|
| Company Address: | 4120A Sladeview Crescent |
| MISSISSAUGA ON L5L 5Z3 CANADA | |
| Telephone: (905) 820-4788 | |
| Fax: (905) 820-1649 | |
| Contact Person: | Rose Ren, QA/Regulatory Affairs Manager |
| Date Summary Prepared: | March 1, 2015 |
Device
| Trade/Device Name: | Rapid Aid Instant Disposable Infant Heel Warmer - Disc |
|---|---|
| Common/Usual Name: | Infant Heel Warmer |
| Classification Name: | Infant Heel Warmer (Chemical Heat Pack) |
| Regulation Number: | 21 CFR 890.5710 |
| Product Code: | MPO |
| Classification Panel: | Physical Medicine |
| Classification: | Class I |
Substantial Equivalence
The Rapid Aid Instant Disposable Infant Heel Warmer with Disc is substantially equivalent to the Rapid Aid Instant Disposable Infant Heel Warmer (K040856).
Device Description
The Rapid Aid Infant Heel Warmer is a self contained unit comprised of a flexible, poly/nylon outer pouch containing:
- a) A metal disc that can be flexed during activation,
- b) Liquid solution of food grade sodium acetate and water,
- c) Minute crystals of sodium acetate.
An adhesive tape is attached to the top of the unit is activated by squeezing firmly on the inner fluid pouch, this will cause the inner perforated pouch to activate. Rapid crystallization occurs when the liquid contents are exposed to the minute crystals of sodium acetate contained within the poly/nylon outer pouch. This exothermnic reaction causes the unit to heat up to 104ºF. The adhesive tape strip is used to hold the warmer in place if desired.
Intended Use/Indications for Use
Rapid Aid Infant Heel Warmer is primarily used in hospitals, doctor's offices, and other healthcare facilities. It is an instant warm pack intended to be used on an infant's heel to increase blood circulation to the area to aid in the drawing of blood for analysis. It is a single use, nontoxic, non-sterile, disposable warmer.
Substantial Equivalence Analysis
The Infant Heel Warmer with Disc has the identical Intended Use and Indications for use as the predicate device. The basic technological characteristics remain the same, with the exception of the replacing an inner pouch for activation with a metal disc, to start the exothermic reaction.
4
Image /page/4/Picture/0 description: The image is a logo for Rapid Aid, a company that specializes in treating bumps and bruises. The logo features the words "RAPID" in large, blue letters, followed by "AID" in red letters. A red cross is incorporated into the design of the word "AID". The tagline "Makes it Better!" is written in blue below the logo.
Several other currently marketed Infant Heel Warmer products cleared by FDA use this method of activation. The modified device has been tested and it has been verified that product specifications are met. It is therefore concluded that the Infant Heel Warmer with Disc is substantially equivalent to the predicate device.
Performance - Bench Testing
The Infant Heel Warmer with Disc was tested against the predicate device to ensure conformance with temperature characteristics (maximum temperature and dwell time requirements). The average maximum temperature achieved was 102.6 ± 0.2 °F (new device) and 102.2 ± 0.4 °F (predicate) and the average dwell time that the unit was between 101 °F and 104 °F was 8.5 ± 1.0 min (new device) and 8.5 ± 0.8 min (predicate). The predicate and the new devices were both within the specified range for this device.
The materials that contact the skin have not changed:
- The outer poly/nylon pouch material has been tested following ASTM standards and is latex free and non-sensitizing.
- . The finished packing material is tested for: thickness following ASTM D1203, tensile strength following ASTM D-882 and seal width. Pouch packaging material is subject to incoming inspection for width/length, seal integrity and burst strength.
- . The chemical mixture claims are based on the results of testing the sodium acetate, which is a nontoxic, food grade chemical and has been found to be toxicologically acceptable for it's intended use.
- . Finished product is subject to testing for peak temperature, seal integrity and pressure testing.
Date Summary Prepared: March 1, 2015