(244 days)
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.
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.
This document describes the premarket notification (510(k)) for the Rapid Aid Infant Transport Mattress Warmer with Disc. It's important to note that this device is a medical warming device, not an AI/Software as a Medical Device (SaMD). Therefore, many of the typical acceptance criteria and study designs associated with AI/SaMD (like those involving human readers, ground truth establishment by experts, MRMC studies, or training sets) are not applicable to this physical device.
Based on the provided document, here's an analysis of the acceptance criteria and the study proving the device meets them:
1. A table of acceptance criteria and the reported device performance
The acceptance criteria are primarily focused on the physical and performance characteristics of the warming mattress, demonstrating its substantial equivalence to a predicate device.
| Acceptance Criteria (Characteristic being tested) | Reported Device Performance (Rapid Aid Infant Transport Mattress Warmer with Disc) |
|---|---|
| Temperature Target Range | Achieved temperature range of 101°F to 104°F |
| Dwell Time at Temperature | ≥10 minutes |
| Seal Strength (Pressure Test) | Remained intact when subjected to 500 PSI for 30 seconds (Passed) |
| Seal Width | Measured; Passed |
| Seal Integrity (Visual) | Measured; Passed |
| Weight | Measured; Passed |
| Outer Packaging Thickness | Measured; Passed |
| Shipping Testing | Passed |
| Biocompatibility | Performed Cytotoxicity, Irritation, and Sensitization tests per ISO 10993-1; Passed all applicable requirements |
| Shelf Life (Accelerated Temperature at 40°C) | Passed pressure test and temperature test after 30 weeks (corresponds to 24 months of real-time shelf life) |
2. Sample size used for the test set and the data provenance
The document does not specify the exact sample sizes (number of units tested) for each performance test. It states "all tests were a pass," implying multiple units were tested to demonstrate consistency and meet specifications.
The data provenance is from performance testing conducted by Rapid Aid Corp. The studies are inherently prospective as they are tests performed on manufactured devices to demonstrate compliance with specifications. The location of the testing is not explicitly stated but would likely be internal to the manufacturer or a contracted lab. Given the manufacturer is based in Canada (Mississauga, ON, Canada), the tests would have been performed there or an affiliated laboratory.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
This question is not applicable to this type of medical device. "Ground truth" in the context of AI/SaMD for diagnostic tasks involves expert consensus on medical images or patient records. For a physical warming device, the "ground truth" is measured physical properties like temperature, pressure resistance, and material compatibility, established through validated testing methodologies by engineers and laboratory technicians, not medical experts for diagnostic purposes.
4. Adjudication method for the test set
This question is not applicable. Adjudication methods like 2+1 or 3+1 are used in studies where human readers provide subjective assessments (e.g., categorizing medical images). For physical performance tests, the results are objective measurements against defined specifications. There is no subjective human interpretation requiring adjudication.
5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
This question is not applicable as this is not an AI/SaMD device. MRMC studies are used to evaluate the impact of AI assistance on human reader performance in diagnostic tasks.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
This question is not applicable as this is not an AI/SaMD device. Standalone performance refers to the accuracy of an automated AI algorithm without human intervention in diagnostic or analytical tasks.
7. The type of ground truth used
The "ground truth" for this device's performance is established by objective engineering and laboratory measurements against predefined physical and chemical specifications. This includes:
- Direct temperature readings.
- Timers for dwell time.
- Pressure gauges for seal strength.
- Weight scales for weight.
- Microscopes/visual inspection for seal integrity and material assessment.
- Standardized biocompatibility tests (e.g., ISO 10993-1).
- Accelerated aging tests.
8. The sample size for the training set
This question is not applicable. This is a physical medical device, not a machine learning model, so there is no "training set."
9. How the ground truth for the training set was established
This question is not applicable as there is no training set for a physical device.
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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 (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
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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: 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 DeviceRapid Aid Corp.Infant Transport MattressWarmer with Disc |
|---|---|---|
| Intended Use / Indicationsfor Use Statement | "Provision of warmth duringtransport of infant within thehospital or between hospitals.Recommended for full terminfants." | "The Rapid Aid Infant TransportMattress Warmer with Discprovides warmth during transport ofan infant within the hospital orbetween hospitals. It isrecommended for full-terminfants." |
| Single Use or MultipleUse | 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 wovencloth material on bag | Polyethylene/60 g polyamide(PE/PA) with woven cloth materialon bottom outside of bag |
| Contents of bag | Sodium acetate, water, thickener,activation disc; supersaturatedsolution | Sodium acetate, water, thickener,activation disc; supersaturatedsolution |
| 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 DeviceRapid Aid Corp.Infant Transport MattressWarmer with Disc |
|---|---|---|
| pouch | pouch | pouch |
| Disc Material | Stainless Steel | Stainless Steel |
| Activation | Activating Disc triggers theexothermic reaction | Activating Disc triggers theexothermic reaction |
| Performance Testing -Temperature | Temperature performance testing | Temperature performance testing toachieve temperature range of 101°Fto 104°F and dwell time is ≥10minutes |
| Performance testing forproper seal strength | Unknown | Device shall remain intact whensubjected to 500 PSI for 30 sec. |
| Shipping testing | Passed | Passed |
| Biocompatibility testing | Not performed because not differentfrom predicate | Performed Cytotoxicity, Irritationand 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.
§ 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.