RAPID AID INSTANT DISPOSABLE INFANT HEEL WARMER

K040856 · Rapid Aid , Ltd. · MPO · May 3, 2004 · Physical Medicine

Device Facts

• Record ID: K040856
• Device Name: RAPID AID INSTANT DISPOSABLE INFANT HEEL WARMER
• Applicant: Rapid Aid , Ltd.
• Product Code: MPO · Physical Medicine
• Decision Date: May 3, 2004
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 890.5710
• Device Class: Class 1
• Attributes: Therapeutic, Pediatric

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.

Device Story

Rapid Aid Infant Heel Warmer is a single-use, disposable, non-sterile, non-toxic warm pack. Device consists of a flexible poly/nylon outer pouch containing an inner perforated pouch with a liquid solution of food-grade sodium acetate and water, plus minute sodium acetate crystals. Activation occurs by squeezing the inner fluid pouch, exposing the liquid to the crystals; this triggers an exothermic crystallization reaction, heating the unit to approximately 105°F. An integrated adhesive tape secures the warmer to the infant's heel. Used in clinical settings (hospitals, doctor's offices) by healthcare providers to increase local blood circulation, facilitating blood draws for analysis. Benefits include improved blood flow for easier sampling.

Clinical Evidence

Bench testing only. Testing included peak temperature performance, seal integrity, and pressure testing. Materials tested for thickness (ASTM D1203), tensile strength (ASTM D-882), and sensitization. Results demonstrated temperature profiles reaching ~105°F, consistent with predicate devices.

Technological Characteristics

Flexible poly/nylon outer pouch; inner perforated polyethylene/polyester pouch. Chemical contents: food-grade sodium acetate and water. Exothermic crystallization principle. Dimensions/form factor: pouch with adhesive strip. Latex-free. Testing standards: ASTM D1203 (thickness), ASTM D-882 (tensile strength).

Indications for Use

Indicated for use on infants to increase blood circulation to the heel to aid in blood collection for analysis. Used in hospitals, doctor's offices, and healthcare facilities.

Regulatory Classification

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.

Predicate Devices

• Medi-Heat Infant Heel Warmer (K032989)
• Baxter Sodium Acetate Infant Heel Warmer (K936084)
• Warm Gel Infant Heel Warmer by Prism (K912715)

Submission Summary (Full Text)

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K040856

RAPID AID LTD.

4120 A Sladevicw Crescent Mississauga, ON L5L 5Z3 Canada

Phone: [phone] Fax: [phone]

## 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 [phone] Fax [phone] 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.

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## 510 (k) Rapid Aid Infant Heel Warmer

| Description Cont'd | An adhesive tape is attached to the top of the unit.<br>The unit is activated by squeezing firmly on the<br>inner fluid pouch, this will cause the inner<br>perforated pouch to activate. Rapid crystallization<br>occurs when the liquid contents are exposed to the<br>minute crystals of sodium acetate contained within<br>the poly/nylon outer pouch. This exothermic<br>reaction causes the unit to heat up to 105 degrees F.<br>The adhesive tape strip is used to hold the warmer<br>in place on the infant's heel. |
|-------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Intended Use | The Rapid Aid Infant Heel Warmer is a single use,<br>non-toxic, non-sterile, disposable device. It is an<br>instant warm pack intended to be used on an<br>infant's heel to aid in the drawing of blood for<br>analysis. |
| Substantial Equivalence | The Rapid Aid Infant Heel Warmer is substantially<br>equivalent to the Medi-Heat Infant Heel Warmer,<br>Baxter Sodium Acetate Infant Heel Warner, and<br>the Warm Gel Infant Heel Warmer by Prism in that:<br>- intended use is the same<br>- performance attributes are the same<br>- temperature output of the Rapid Aid Infant Heel<br>warmer is within the range of the predicate<br>devices<br>- chemical composition is primarily the same in<br>the predicate devices and the Rapid Aid Infant<br>Heel Warmer; food grade sodium acetate and<br>water<br>- The Rapid Aid Infant Heel Warmer<br>differentiates from the predicate devices in that<br>it does not require a disc for activation, rather<br>the exposure of the saturated sodium acetate<br>solution to the sodium acetate crystals located in<br>the outer pouch are the catalyst for the chemical<br>reaction. |
| Summary of Testing | All materials used in the composition of the<br>formulation are subject to testing at the supplier site<br>and are accepted based on results from a Certificate<br>of Analysis. |

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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.

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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.

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## 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 [phone]. 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 [phone] or [phone] 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

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## 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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