Infant Transport Mattress Warmer with Disc

K163295 · Rapid Aid Corp. · IMD · Jul 24, 2017 · Physical Medicine

Device Facts

• Record ID: K163295
• Device Name: Infant Transport Mattress Warmer with Disc
• Applicant: Rapid Aid Corp.
• Product Code: IMD · Physical Medicine
• Decision Date: Jul 24, 2017
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 890.5710
• Device Class: Class 1
• Attributes: Therapeutic, Pediatric

Intended Use

The Rapid Aid Infant Transport Mattress Warmer with Disc provides warmth during transport of an infant within the hospital or between hospitals. It is recommended for full-term infants.

Device Story

Single-use, disposable rectangular pad; provides warmth to full-term infants during transport. Device contains liquid solution and stainless steel activator disc; bending disc triggers exothermic reaction. Warms pad to 101°F–104°F for ≥10 minutes. Used in hospital settings or during inter-hospital transport; operated by clinical staff. Provides passive thermal support to maintain infant temperature during transit.

Clinical Evidence

Bench testing only. Performance testing confirmed seal integrity, seal strength (500 PSI for 30 sec), and temperature performance (101°F–104°F for ≥10 minutes). Biocompatibility testing (cytotoxicity, irritation, sensitization) passed per ISO 10993-1. Accelerated aging studies (40°C for 30 weeks) validated a 24-month shelf life.

Technological Characteristics

Rectangular pad; polyethylene/60g polyamide (PE/PA) pouch with non-woven cloth; stainless steel activator disc. Exothermic chemical reaction (sodium acetate, water, thickener). Dimensions: 15.7 x 9.6 in. Non-sterile. Standalone device.

Indications for Use

Indicated for full-term infants requiring warmth during transport within or between hospitals.

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

• Neo Nest Gel Infant Transport Mattress (K112547)

Submission Summary (Full Text)

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Image /page/0/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 emblem featuring a stylized caduceus-like symbol with three human profiles facing to the right.

Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

July 24, 2017

Rapid Aid Corp. % Diane Horwitz, Ph.D., RAC Regulatory Consultant Mandell Horwitz Consultants 2995 Steven Martin Dr. Fairfax. Virginia 22031

Re: K163295

Trade/Device Name: Infant Transport Mattress Warmer with Disc Regulation Number: 21 CFR 890.5710 Regulation Name: Hot or Cold Disposable Pack Regulatory Class: Class I Product Code: IMD Dated: July 3, 2017 Received: July 3, 2017

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. listing 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 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); medical device reporting (reporting of medical devicerelated adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in

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the quality systems (OS) 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 Industry and Consumer Education at its toll-free number [phone] or [phone] 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" (21 CFR 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 Industry and Consumer Education at its toll-free number [phone] or [phone] or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

# Sincerely, Michael J. Hoffmann -S

for

Carlos L. Peña, PhD, MS Director Division of Neurological and Physical Medicine Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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# Indications for Use

510(k) Number (if known) K163295

Device Name

Rapid Aid Infant Transport Mattress Warmer with Disc

Indications for Use (Describe)

The Rapid Aid Infant Transport Mattress Warmer with Disc provides warmth during transport of an infant within the hospital or between hospitals. It is recommended for full-term infants.

Type of Use (Select one or both, as applicable)

X Prescription Use (Part 21 CFR 801 Subpart D)

| Over-The-Counter Use (21 CFR 801 Subpart C)

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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 composed of the word "RAPID" in blue, with a red plus sign and the word "AID" in red to the right of it. Below the logo is the slogan "Makes it Better!" in blue. The text at the top of the logo says "Treating the World's Bumps & Bruises".

# 510(k) SUMMARY

#### 1. GENERAL INFORMATION

#### Submitter and 510(k) Owner 1.1

Jeff Whitely, CEO Rapid Aid Corp. 4120A Sladeview Crescent Mississauga ON L5L 5Z3 CANADA

#### 1.2 Official Correspondent

Diane Horwitz, Ph.D., RAC, Regulatory Consultant 2995 Steven Martin Dr. Fairfax, VA 22031

Telephone: [phone] Fax: [phone] Email: [e-mail]

#### 1.3 Date of Preparation

June 30, 2017

#### NAME OF THE DEVICE 2.

#### Trade/Proprietary Name 2.1.1

Rapid Aid Infant Transport Mattress Warmer with Disc

#### 2.1.2 Common/Usual Name

Hot or cold disposable pack

#### Classification Information 2.1.3

| Classification Name: | Hot or cold disposable pack |
|----------------------------|-----------------------------|
| Classification Regulation: | 21 CFR 890.5710 |
| Class: | 1 |
| Product Code: | IMD |
| Panel: | Physical Medicine |

#### 3. PREDICATE DEVICE

The predicate device is Neo Nest Gel Infant Transport Mattress (DeNovo Products, K112547).

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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 blue and "AID" in red, with a red plus sign in the upper right corner. The tagline "Makes it Better!" is written in blue below the logo. The logo is simple and eye-catching, and it effectively communicates the company's mission.

#### 4. DESCRIPTION OF THE DEVICE

The Rapid Aid Infant Transport Mattress Warmer with Disc (Infant Transport Mattress) is a rectangular pad that is intended to provide warmth during transport of an infant within a hospital or between hospitals. The single-use disposable device consists of an outer pouch with a liquid solution activated by bending an activator disc; an exothermic reaction warms the Infant Transport Mattress to no higher than 104°F (range 101°F to 104°F) for a dwell time of ≥10 minutes.

#### INTENDED USE 5.

The Intended Use / Indications for Use for the Rapid Aid Infant Transport Mattress Warmer with Disc (Infant Transport Mattress):

"The Rapid Aid Infant Transport Mattress Warmer with Disc provides warmth during transport of an infant within the hospital or between hospitals. It is recommended for full-term infants."

#### 6. SUBSTANTIAL EQUIVALENCE OF THE RAPID AID INFANT TRANSPORT MATTRESS COMPARED TO THE PREDICATE

The Rapid Aid Infant Transport Mattress device and the predicate device have almost identical intended use statements and are planned for identical uses in the clinic. The technological characteristics of the Rapid Aid device and the predicate are also similar.

| Characteristic | Predicate (K112547) | Subject Device<br>Rapid Aid Corp.<br>Infant Transport Mattress<br>Warmer with Disc |
|-------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Intended Use / Indications<br>for Use Statement | "Provision of warmth during<br>transport of infant within the<br>hospital or between hospitals.<br>Recommended for full term<br>infants." | "The Rapid Aid Infant Transport<br>Mattress Warmer with Disc<br>provides warmth during transport of<br>an infant within the hospital or<br>between hospitals. It is<br>recommended for full-term<br>infants." |
| Single Use or Multiple<br>Use | Single Use | Single Use |
| Sterile or Nonsterile | Nonsterile | Nonsterile |
| Bag Size | $16 \times 10$ in. (160 sq. in.) | $15.7 \times 9.6$ in. (151 sq. in.) |
| Bag Material | Unknown material with woven<br>cloth material on bag | Polyethylene/60 g polyamide<br>(PE/PA) with woven cloth material<br>on bottom outside of bag |
| Contents of bag | Sodium acetate, water, thickener,<br>activation disc; supersaturated<br>solution | Sodium acetate, water, thickener,<br>activation disc; supersaturated<br>solution |
| Patient facing material | Non-woven cloth adhered to the | Non-woven cloth adhered to the |

# Table 1. SUBSTANTIAL EQUIVALENCE OF THE RAPID AID INFANT TRANSPORT MATTRESS DEVICE AND THE PREDICATE DEVICE

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Image /page/5/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 blue and "AID" in red, with a plus sign in the upper right corner of the word "AID". The tagline "Makes it Better!" is written in blue below the logo. The text "Treating the World's Bumps & Bruises" is written in blue above the logo.

| Characteristic | Predicate (K112547) | Subject Device<br>Rapid Aid Corp.<br>Infant Transport Mattress<br>Warmer with Disc |
|-------------------------------------------------|-------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------|
| pouch | pouch | pouch |
| Disc Material | Stainless Steel | Stainless Steel |
| Activation | Activating Disc triggers the<br>exothermic reaction | Activating Disc triggers the<br>exothermic reaction |
| Performance Testing -<br>Temperature | Temperature performance testing | Temperature performance testing to<br>achieve temperature range of 101°F<br>to 104°F and dwell time is ≥10<br>minutes |
| Performance testing for<br>proper seal strength | Unknown | Device shall remain intact when<br>subjected to 500 PSI for 30 sec. |
| Shipping testing | Passed | Passed |
| Biocompatibility testing | Not performed because not different<br>from predicate | Performed Cytotoxicity, Irritation<br>and Sensitization; passed |

#### 7. PERFORMANCE TESTING

The 510(k) submission provided performance data to establish the substantial equivalence of the Rapid Aid Infant Transport Mattress with Disc to the predicate device. A summary of these performance tests is provided below.

Performance Testing: The Infant Transport Mattress with Disc was tested for seal width, seal integrity (visual), weight, temperature after activation, dwell time, seal integrity and strength (pressure test), outer packaging thickness were all measured; all tests were a pass.

Biocompatibility Testing: The Infant Transport Mattress with Disc was tested for biocompatibility per ISO 10993-1 and was found to meet all applicable requirements.

Temperature Testing: Infant Transport Mattress with Disc has passed the pressure test and the temperature test after storage for 30 weeks in 40°C accelerated temperature conditions, which corresponds to 24 months of real time shelf life.

#### CONCLUSIONS 8.

This 510(k) submission demonstrates that the Rapid Aid Infant Transport Mattress Warmer with Disc is substantially equivalent to the predicate device.