(31 days)
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.
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.
This 510(k) summary does not contain sufficient detail to fully answer all aspects of the request, particularly regarding specific numerical acceptance criteria and a detailed study design for device performance. However, based on the provided text, here's an analysis of the acceptance criteria and the study conducted for the Rapid Aid Infant Heel Warmer:
The primary "acceptance criterion" for this device, as presented in the 510(k), is substantial equivalence to predicate devices, specifically concerning temperature characteristics and intended use. The study focuses on demonstrating that the Rapid Aid Infant Heel Warmer performs "very similarly" to and is "substantially equivalent" to predicate infant heel warmers.
1. Table of Acceptance Criteria and Reported Device Performance
Note: The document does not explicitly state numerical acceptance criteria for temperature output beyond "within the range of the predicate devices" and "reaching a maximum temperature around 105 F."
| Acceptance Criteria Category | Specific Criteria (Implicit/Explicit) | Reported Device Performance |
|---|---|---|
| Intended Use | Same as predicate devices (aid in drawing blood from infant heel) | "intended use is the same" |
| Performance Attributes | Same as predicate devices | "performance attributes are the same" |
| Temperature Output | Within the range of predicate devices; reach max ~105°F | "temperature output... is within the range of the predicate devices"; "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." |
| Chemical Composition | Primarily food-grade sodium acetate and water, same as predicate | "chemical composition is primarily the same... food grade sodium acetate and water" |
| Material Safety | Latex-free, non-sensitizing, non-toxic, food-grade chemicals | "outer poly/nylon pouch material... is latex free and non-sensitizing"; "sodium acetate... is a nontoxic, food grade chemical and has been found to be toxicologically acceptable for it's intended use." |
| Physical Properties | Meets ASTM thickness, tensile strength, seal width, seal/burst integrity | "tested for: thickness following ASTM D1203, tensile strength following ASTM D-882 and seal width"; "subject to incoming inspection for width/length, scal integrity and burst strength." |
| Peak Temperature | Consistent with production batch results and predicate performance | "Summary of peak temperature from batch production results is attached [not provided in extract]"; performs "very similarly" to predicates reaching ~105°F. |
2. Sample Size Used for the Test Set and Data Provenance
The document does not explicitly state the sample size used for the performance testing against predicate devices. It refers to "batch production results" for peak temperature but does not specify how many units or batches were tested.
- Sample Size: Not specified.
- Data Provenance: Not explicitly stated, but assumed to be internal testing by Rapid Aid Ltd. There is no mention of country of origin for data or whether it was retrospective or prospective, although performance testing is generally prospective.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications
This type of device (a simple warming pack) does not typically require expert-established ground truth in the way diagnostic or prognostic AI devices do. The "truth" here is objective physical measurements of temperature and material properties. Therefore:
- Number of Experts: Not applicable/not specified for ground truth establishment.
- Qualifications of Experts: N/A. The "ground truth" is based on instrumental measurements and adherence to ASTM standards.
4. Adjudication Method for the Test Set
Not applicable. This device does not involve subjective interpretations requiring adjudication (e.g., medical image reading). Performance is evaluated through objective measurements and comparisons to predicate device characteristics.
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
Not applicable. This is a physical medical device (an infant heel warmer), not an AI diagnostic or prognostic tool. Therefore, MRMC studies and "human reader improvement with AI" are not relevant.
6. If a Standalone (i.e. algorithm only without human-in-the loop performance) was done
Not applicable. This is a physical medical device, not an algorithm.
7. The Type of Ground Truth Used
The ground truth for this device's performance is based on:
- Objective Physical Measurements: Temperature (peak and duration), material properties (thickness, tensile strength, seal integrity, burst strength), and chemical composition analysis.
- Predicate Device Performance: The primary "ground truth" for comparison is the established performance characteristics and safety profile of the legally marketed predicate infant heel warmers.
8. The Sample Size for the Training Set
Not applicable. This is not an AI/machine learning device that requires a "training set." The device's function is based on a chemical reaction, not a learned algorithm.
9. How the Ground Truth for the Training Set Was Established
Not applicable, as there is no training set for this type of device.
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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.
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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.The unit is activated by squeezing firmly on theinner fluid pouch, this will cause the innerperforated pouch to activate. Rapid crystallizationoccurs when the liquid contents are exposed to theminute crystals of sodium acetate contained withinthe poly/nylon outer pouch. This exothermicreaction causes the unit to heat up to 105 degrees F.The adhesive tape strip is used to hold the warmerin 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 aninstant warm pack intended to be used on aninfant's heel to aid in the drawing of blood foranalysis. |
| Substantial Equivalence | The Rapid Aid Infant Heel Warmer is substantiallyequivalent to the Medi-Heat Infant Heel Warmer,Baxter Sodium Acetate Infant Heel Warner, andthe 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 Heelwarmer is within the range of the predicatedevices- chemical composition is primarily the same inthe predicate devices and the Rapid Aid InfantHeel Warmer; food grade sodium acetate andwater- The Rapid Aid Infant Heel Warmerdifferentiates from the predicate devices in thatit does not require a disc for activation, ratherthe exposure of the saturated sodium acetatesolution to the sodium acetate crystals located inthe outer pouch are the catalyst for the chemicalreaction. |
| Summary of Testing | All materials used in the composition of theformulation are subject to testing at the supplier siteand are accepted based on results from a Certificateof 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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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.
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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 (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
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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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§ 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.