(15 days)
The Respironics Heel Snuggler infant heel warmer is intended for use whenever circulation needs to be stimulated in the infant heel in order for blood sampling to occur.
The Heel Snuggler is a butterfly shaped packet that is filled with a non-toxic solution and a catalyst disk. Two straps with adhesive ends are attached to one side of the packet for securing the heel warmer to the infant's foot. Immediately following activation of the user rests the bottom of the infant's foot on the larger portion of the packet and holds the smaller portion of the packet to the ankle. The straps with adhesive tape on the end are then fitted across the infant's foot and ankle and secured to the opposite side of the packet. The adhesive portion of the strap is affixed to the packet only, not the infant's skin. This forms a boot shape around the infant's foot. The heel warmer are perforated, which enables the user to easily tear the straps and remove the heel warmer from the infant's foot after use.
When the catalyst disk inside the packet is flexed by the catalyst reachs with the solution a ri initiates a chemical exothermic reaction, which produces warmth.
The Heel Snuggler Infant Heel Warmer is a Class I device, and the provided documentation is a 510(k) summary for its clearance. Medical devices in Class I, especially those cleared via a 510(k), are generally considered low risk and do not require the rigorous clinical efficacy studies that higher-risk devices or software as a medical device (SaMD) might.
From the provided text, there is no information about an AI/ML powered device, acceptance criteria or a study that proves a device meets acceptance criteria in the context of an AI/ML device. The document describes a traditional medical device (an infant heel warmer) and its 510(k) clearance process.
Therefore, I cannot provide the requested table and information about acceptance criteria and studies related to an AI/ML device. The document specifically states:
- "Design verification tests were performed on the Heel Snuggler as a result of the risk analysis and product requirements. All tests were verified to meet the required acceptance criteria." This indicates that the device underwent engineering and design verification testing to ensure it met pre-defined product requirements and safety standards, which is typical for a non-AI/ML medical device.
- The comparison is made to a predicate device (DeRoyal Industries, Inc. Infant Heel Warmer (K954716)) to establish substantial equivalence, which is the standard pathway for 510(k) clearance for traditional medical devices.
The information you are requesting (AI/ML relevant details) is not present in this document because the device described is not an AI/ML product.
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JAN 2 7 2004
Image /page/0/Picture/2 description: The image shows a handwritten text that appears to be a combination of letters and numbers. The text includes 'K040044' prominently displayed at the top, with the number '1072' written below it. The handwriting is somewhat stylized, with the numbers and letters varying in size and thickness, giving the text a unique, informal appearance.
Image /page/0/Picture/3 description: The image shows a logo for Respironics. The logo consists of the word "RESPIRONICS" in a bold, sans-serif font, with the website address "www.respironics.com" underneath. Above the word "RESPIRONICS" is a triangular shape containing a stylized image that resembles a flower or a three-leaf clover. The background of the image is a grainy, textured pattern.
SECTION 9
510(K) SUMMARY
| Date of Submission | December 15, 2003 |
|---|---|
| Official Contact / Addressof Manufacturing facility | Zita A. YurkoManager, Regulatory AffairsRespironics, Inc.1001 Murry Ridge LaneMurrysville, PA 15668Phone: 724-387-4120Fax: 724-387-4216 |
| Proprietary Name | Heel Snuggler |
| Common/Usual Name | Infant Heel Warmer (Chemical Heat Pack) |
| Classification Reference | 21 CFR 890.5710 |
| Classification | Class I |
| Appropriate Classification Panel | Physical Medicine |
| Product Code | MPO |
| Predicate Device | DeRoyal Industries Infant Heel Warmer (K954716) |
| Reason for submission | Acquisition of Children's Medical Ventures resulted in 510(k) filing |
. .
Intended Use/Indications for Use
The Respironics Hecl Snuggler infant heel warmer is intended for use whenever circulation needs to be stimulated in the infant heel in order for blood sampling to occur.
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K040044
20F2
Image /page/1/Picture/2 description: The image shows a logo with the word "RESPIRONICS" in a sans-serif font. Above the word is a triangular shape containing a stylized figure. Below the word "RESPIRONICS" is the text "www.respironics.com".
Patient Population/Environment of Use
The Heel Snuggler is disposable and for single patient use only.
Substantial Equivalence
This traditional 510(k) submittal demonstrates that the Heel Snuggier is substantially equivalent to : • DeRoyal Industries, Inc. Infant Heel Warmer (K954716).
Design verification tests were performed on the Heel Snuggier as a result of the risk analysis and II :: product requirements. All tests were verified to meet the required acceptance criteria. Respironics has determined that the differences between the Heel Snuggler infant heel warmer and the predicate infant heel warmer have no impact on the safety and effectiveness of the Heel Snuggler and that al hazards were successfully mitigated.
Device Description
The Heel Snuggler is a butterfly shaped packet that is filled with a non-toxic solution and a catalyst disk. Two straps with adhesive ends are attached to one side of the packet for securing the heel warmer to the infant's foot. Immediately following activation of the user rests the bottom of the infant's foot on the larger portion of the packet and holds the smaller portion of the packet to the ankle. The straps with adhesive tape on the end are then fitted across the infant's foot and ankle and secured to the opposite side of the packet. The adhesive portion of the strap is affixed to the packet only, not the infant's skin. This forms a boot shape around the infant's foot. The heel warmer are perforated, which enables the user to easily tear the straps and remove the heel warmer from the infant's foot after use.
When the catalyst disk inside the packet is flexed by the catalyst reachs with the solution a ri initiates a chemical exothermic reaction, which produces warmth.
End of Section.
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Image /page/2/Picture/1 description: The image shows the seal of the Department of Health and Human Services (HHS) of the United States. The seal features a circular design with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" arranged around the perimeter. Inside the circle is an emblem depicting a stylized eagle with three wings, symbolizing health, services, and humanity.
Public Health Service
JAN 2 7 2004
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Respironics, Inc. C/o Mr. Ned Devine Entela, Inc 3033 Madison Avenue SE Grand Rapids, Michigan 49548
Re: K040044
Trade/Device Name: Heel Snuggler Infant Hecl Warmer Regulation Number: 21 CFR 890.5710 Regulation Name: Hot or cold disposable pack Regulatory Class: I Product Code: MPO Dated: January 12, 2004 Received: January 12, 2004
Dear Mr. Devine:
We have reviewed your Scetion 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. Iisling of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.
If your device is classified (see above) into either 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 - Mr. Ned Devine
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) 594-1308. 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 vours.
sincerely yours.
Mark M. Mulhearn
Celia M. Witten, PhD, MD Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known): _K040044
Device Name: Heel Snuggler Infant Hecl Warmer___________________________________________________________________________________________________________________________
Indications for Use:
Intended Use/Indications for Use
The Respironics Heel Snuggler infant heel warmer is intended for use whenever circulation needs to be stimulated in the infant heel in order for blood sampling to occur.
Patient Population/Environment of Use
The Heel Snuggler is disposable and for single patient use only.
Mark N. Mulkerson
Prescription Use __ X (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 OF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
§ 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.