(31 days)
Not Found
No
The device description details a simple chemical reaction for heating and does not mention any computational or data-driven components.
No.
The device increases blood circulation to aid in drawing blood, which is a diagnostic procedure, not a therapeutic treatment for a medical condition.
No
The device is a warmer intended to increase blood circulation to aid in the drawing of blood for analysis, not to diagnose a condition or disease.
No
The device description clearly outlines a physical product composed of pouches, liquid solutions, and crystals, activated by a physical action (squeezing). There is no mention of software as a component or the primary function of the device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In vitro diagnostics are tests performed on samples taken from the human body, such as blood or tissue, to detect diseases, conditions, or infections. They are used outside of the body (in vitro) to analyze these samples.
- Device Function: The Rapid Aid Infant Heel Warmer is a physical device applied to the body (in vivo) to facilitate a procedure (blood drawing). It does not analyze any biological samples. Its purpose is to increase blood flow in the infant's heel to make blood collection easier.
Therefore, while it aids in a process that leads to an in vitro diagnostic test (blood analysis), the device itself is not an IVD.
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 flexible, perforated, polyethylene/polyester inner pouch that holds the liquid solution.
- b) Liquid solution of food grade sodium acetate and water contained in a).
- c) Minute crystals of sodium acetate.
An adhesive tape is attached to the top of the unit. 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 exothermic reaction causes the unit to heat up to 105 degrees F. The adhesive tape strip is used to hold the warmer in place on the infant's heel.
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 (study type, sample size, AUC, MRMC, standalone performance, key results)
All materials used in the composition of the formulation are subject to testing at the supplier site and are accepted based on results from a Certificate of Analysis. 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, scal 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, scal integrity and pressure testing. Summary of peak temperature from batch production results is attached. The Rapid Aid Infant Heel Warmer was tested against predicate devices for temperature characteristics. They performed very similarly with temperatures within the same ranges, reaching a maximum temperature around 105 F within the first minutes and then steadily decreasing in temperature.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
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.
0
RAPID AID LTD.
4120 A Sladevicw Crescent Mississauga, ON L5L 5Z3 Canada
Phone: (905) 820-4788 Fax: (905) 820-1649
510(k) Summarv [As required by 807.92(c)] Submitter of 510(k) Rapid Aid Ltd. 4120 A Sladeview Crescent Mississauga, Ontario L5L 5Z3 Tclephone (905) 820-4788 Fax (905) 820-1649 Regulatory Contact Anna Olasz Q.A. & Regulatory Manager Date Summary Prepared March 2004 Product Trade Name Rapid Aid Instant Disposable Infant Heel Warmer Infant Heel Warmer Common or Usual Name Classification Name Pack, Hot or Cold Disposable Class I, 21 CFR 890-5710 Panel: Physical Medicine Product Code: MPO Predicate Devices [870.92(a)(3)]
| Device Name | 510(k) Number |
|---|---|
| Medi-Heat Infant Heel Warmer | K032989 |
| Baxter Sodium Acetate Infant Heel Warmer | K936084 |
| Warm Gel Infant Heel Warmer by Prism | K912715 |
Description of the device
The Rapid Aid Infant Heel Warmer is a self contained unit comprised of a flexible, poly/nylon outer pouch containing:
- a) A flexible, perforated, polyethylene/polyester inner pouch that holds the liquid solution.
- b) Liquid solution of food grade sodium acetate and water contained in a).
- c) Minute crystals of sodium acetate.
1
510 (k) Rapid Aid Infant Heel Warmer
| Description Cont'd | An adhesive tape is attached to the top of the unit.
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 exothermic
reaction causes the unit to heat up to 105 degrees F.
The adhesive tape strip is used to hold the warmer
in place on the infant's heel. |
|-------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Intended Use | The Rapid Aid Infant Heel Warmer is a single use,
non-toxic, non-sterile, disposable device. It is an
instant warm pack intended to be used on an
infant's heel to aid in the drawing of blood for
analysis. |
| Substantial Equivalence | The Rapid Aid Infant Heel Warmer is substantially
equivalent to the Medi-Heat Infant Heel Warmer,
Baxter Sodium Acetate Infant Heel Warner, and
the Warm Gel Infant Heel Warmer by Prism in that:
- intended use is the same
- performance attributes are the same
- temperature output of the Rapid Aid Infant Heel
warmer is within the range of the predicate
devices - chemical composition is primarily the same in
the predicate devices and the Rapid Aid Infant
Heel Warmer; food grade sodium acetate and
water - The Rapid Aid Infant Heel Warmer
differentiates from the predicate devices in that
it does not require a disc for activation, rather
the exposure of the saturated sodium acetate
solution to the sodium acetate crystals located in
the outer pouch are the catalyst for the chemical
reaction. |
| Summary of Testing | All materials used in the composition of the
formulation are subject to testing at the supplier site
and are accepted based on results from a Certificate
of Analysis. |
2
510 (k) Rapid Aid Infant Hecl Warmer
The outer poly/nylon pouch material has been tested Summary of Testing Cont'd 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, scal 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, scal integrity and pressure testing. Summary of peak temperature from batch production results is attached. The Rapid Aid Infant Heel Warmer was tested Performance Data against predicate devices for temperature characteristics. They performed very similarly with temperatures within the same ranges, reaching a maximum temperature around 105 F within the first minutes and then steadily decreasing in temperature.
Conclusions drawn from testing:
The data from testing demonstrates that the performance of the Rapid Aid Infant Heel Warmer is very similar to and substantially cquivalent 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 an abstract symbol resembling an eagle or bird with three stylized wing or feather shapes.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
MAY - 3 2004
Ms. Anna Olasz Quality Assurance and Regulatory Affairs Manger Rapid Aid Ltd. 4120 A Sladeview Crescent Mississauga. Ontario Canada L5L 5Z3
Re: K040856
Trade/Device Name: Rapid Aid Infant Heel Warmer Regulation Number: 21 CFR 890.5710 Regulation Name: Hot or cold disposable pack Regulatory Class: I Product Code: MPO Dated: March 26, 2004 Received: April 5, 2004
Dear Ms. Olasz:
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 prohibit.ons against misbranding and adulteration.
If your device is classified (see above) into ether 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. Anna Olasz
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) 594-4659. 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,
Sincerely yours,
Mark N Milliken
Celia M. Witten, Ph.D., M.D. Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
5
RAPID AID INFANT HEEL WARMER 510(k) Notification Indications for Use
510(k) Number (if known):_040856
Device Name: Rapid Aid Infant Heel Warmer
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.
Prescription Use (Part 21 CFR 801 Subpart D) AND/OR
Over-The-Counter Use (21 CFR 807 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
(Division Sign-Off)
Division of General, Restorative,
and Neurological Devices
510(k) Number K040856
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