(244 days)
Not Found
No
The device description and performance studies focus on a simple exothermic reaction for warming, with no mention of AI or ML terms or functionalities.
No.
The device provides warmth for transport but does not treat or diagnose a disease or condition, which are characteristic functions of therapeutic devices.
No
The device's stated purpose is to provide warmth to an infant during transport, not to diagnose any medical condition. It generates heat through an exothermic reaction and its performance studies focus on temperature, seal integrity, and biocompatibility, not diagnostic accuracy.
No
The device description clearly describes a physical, single-use disposable pad with a liquid solution and activator disc, indicating it is a hardware device, not software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is to provide warmth during infant transport. This is a therapeutic or supportive function, not a diagnostic one.
- Device Description: The device description details a physical warming pad with a chemical reaction for heat generation. It does not involve analyzing biological samples or providing diagnostic information.
- Lack of Diagnostic Elements: There is no mention of analyzing blood, urine, tissue, or any other biological sample. There is no mention of detecting markers, measuring substances, or providing any kind of diagnostic result.
- Performance Studies: The performance studies focus on physical properties (seal integrity, weight, temperature, dwell time) and biocompatibility, which are relevant to a medical device providing physical support, not a diagnostic device.
In vitro diagnostics are devices used to examine specimens taken from the human body (like blood, urine, or tissue) to provide information for the diagnosis, monitoring, or treatment of diseases or conditions. This device does not fit that description.
N/A
Intended Use / Indications for 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.
Product codes
IMD
Device Description
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
full-term infants.
Intended User / Care Setting
within the hospital or between hospitals.
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)
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.
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.
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.
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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
1
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 (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" (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 (800) 638-2041 or (301) 796-7100 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
2
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: 703.307.2921 Fax: 703.242.1117 Email: dmh@mandellhorwitzconsulting.com
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
Rapid Aid Corp.
Infant Transport Mattress
Warmer with Disc |
|-------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Intended Use / Indications
for Use Statement | "Provision of warmth during
transport of infant within the
hospital or between hospitals.
Recommended for full term
infants." | "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." |
| Single Use or Multiple
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
cloth material on bag | Polyethylene/60 g polyamide
(PE/PA) with woven cloth material
on bottom outside of bag |
| Contents of bag | Sodium acetate, water, thickener,
activation disc; supersaturated
solution | Sodium acetate, water, thickener,
activation disc; supersaturated
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
Rapid Aid Corp.
Infant Transport Mattress
Warmer with Disc |
|-------------------------------------------------|-------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------|
| pouch | pouch | pouch |
| Disc Material | Stainless Steel | Stainless Steel |
| Activation | Activating Disc triggers the
exothermic reaction | Activating Disc triggers the
exothermic reaction |
| Performance Testing -
Temperature | Temperature performance testing | Temperature performance testing to
achieve temperature range of 101°F
to 104°F and dwell time is ≥10
minutes |
| Performance testing for
proper seal strength | Unknown | Device shall remain intact when
subjected to 500 PSI for 30 sec. |
| Shipping testing | Passed | Passed |
| Biocompatibility testing | Not performed because not different
from predicate | Performed Cytotoxicity, Irritation
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.