(175 days)
Not Found
No
The device description and performance studies focus on a chemical exothermic reaction for heat generation, with no mention of AI or ML technologies.
Yes.
The device's intended use is to provide hot therapy for body surfaces, which is a therapeutic function.
No
The device description indicates it provides hot therapy for body surfaces through an exothermic reaction, which is a therapeutic function, not a diagnostic one.
No
The device description clearly outlines a physical product (a sealed plastic bag with chemicals) that undergoes a physical exothermic reaction to produce heat. There is no mention of software components or functionality.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is "Hot disposable pack intended for medical purposes that consists of a sealed plastic bag incorporating chemicals that, upon activation, provides hot therapy for body surfaces." This describes a device used for therapeutic purposes (applying heat to the body), not for examining specimens derived from the human body to provide information for diagnosis, monitoring, or compatibility testing.
- Device Description: The description details a chemical reaction that produces heat for external application. It does not involve the analysis of biological samples.
- Lack of IVD Indicators: There is no mention of analyzing blood, urine, tissue, or any other biological specimen. The device's function is purely physical (heat generation).
Therefore, this device falls under the category of a therapeutic medical device, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
The Allegiance Porta-Warm™ Mattress is a singleuse, non-sterile heat therapy pack intended for medical purposes that consists of a sealed plastic bag incorporating chemicals that, upon activation, provides hot therapy for body surfaces.
Hot disposable pack intended for medical purposes that consists of a sealed plastic bag incorporating chemicals that, upon activation, provides hot therapy for body surfaces.
Product codes
IMD
Device Description
The. Porta-Warm™ Mattress consists of a heat source housed in a plastic pouch. The heat source pouch consists of a supercooled solution of sodium thiosulfate, dextrose and water. The sodium thiosulfate, dextrose and water "bubble" is housed in a separate plastic pouch inside the outer pouch. Activation of the heat source occurs by folding the unit to open the inner bubble which releases the liquid, thus creating a physical exothermic reaction.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
body surfaces
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
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
All materials used in the composition of this hot pack were identified, evaluated and tested as required in ISO Standard 10993 Part 1. The materials were subiected to skin sensitization. intracutaneous reactivity and cytotoxicity testing. Physical tests completed include: temperature performance and tensile strength tests. The active chemical mixture was subjected to primary skin irritation testing. This mixture was found to be toxicologically acceptable for its intended usage. The active chemical ingredient was tested as identified in the specifications of the Food Chemicals Codex. 3rd Ed. (1981), p. 304, which is incorporated by reference in the Code of Federal Requlations, 21 CFR 184.1807. Sodium Thiosulfate meets all food grade requirements. This product is in compliance with established standards, where applicable, and was deemed acceptable for its intended use.
Key Metrics
Not Found
Predicate Device(s)
Preamendment (K950860) (K934631)
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.
0
JAN 2 1 1999
K98657
Image /page/0/Picture/2 description: The image shows the word "Allegiance" in a bold, italicized font. To the left of the word is a graphic of a cluster of small squares arranged in a grid-like pattern. The word and graphic are both in black against a white background.
FAX: 847.785.2461
Allegiance Healthcare Corporation 1500 Waukegan Road McGaw Park, IL 60085 847.473.1500
ATTACHMENT F
SUMMARY OF SAFETY AND EFFECTIVENESS
Manufacturer:
Allegiance Healthcare Corporation Thermal Business Unit 808 Highway 24 West Moberly, Missouri 65270
Regulatory Affairs Contact Patricia Sharpe-Gregg 1500 Waukegan Road McGaw Park, Illinois 60085
Telephone:
Date Summary Prepared:
Product Trade Name:
Common Name:
Classification:
Predicate Device: Preamendment (K950860) (K934631)
Description:
(847) 578-3636
April 28, 1998
Allegiance Porta-Warm™ Mattress
Hot Pack
Cold and Hot Disposable Pack
Allegiance Porta-Warm™ ™ Mattress Allegiance Infant Heel™ Warmer Prism Technologies, Inc. Transwarmer™
The. Porta-Warm™ Mattress consists of a heat source housed in a plastic pouch. The heat source pouch consists of a supercooled solution of sodium thiosulfate, dextrose and water. The sodium thiosulfate, dextrose and water "bubble" is housed in a separate plastic pouch inside the outer pouch. Activation of the heat source occurs by folding the unit to open the inner bubble which releases the liquid, thus creating a physical exothermic reaction.
1
Image /page/1/Picture/0 description: The image shows the word "Allegiance" in a stylized, bold, sans-serif font. To the left of the word is a symbol resembling a plus sign or cross, formed by a grid of small dots. The overall impression is of a logo or brand name.
Allegiance Healthcare Corporation
ATTACHMENT F Page 2 of 2
1500 Waukegan Road McGaw Park, IL 60085 847.473.1500 FAX: 847.785.2461
Intended Use:
The Allegiance Porta-Warm™ Mattress is a singleuse, non-sterile heat therapy pack intended for medical purposes that consists of a sealed plastic bag incorporating chemicals that, upon activation, provides hot therapy for body surfaces.
The Allegiance Porta-Warm™ Mattress is substantially equivalent to the preamendment Porta-Warm™ Mattress and the Allegiance Infant Heel™ Warmer in that the:
- chemical composition is the same
- performance attributes of active chemical ingredients are the same.
- method of activation is the same
The Allegiance Porta-Warm™ Mattress is substantially equivalent to the preamendment Porta-Warm™ Mattress and Prism Technologies, Inc. Transwarmerl™ in that the:
- intended use is the same
- performance attributes are the same
All materials used in the composition of this hot pack were identified, evaluated and tested as required in ISO Standard 10993 Part 1. The materials were subiected to skin sensitization. intracutaneous reactivity and cytotoxicity testing. Physical tests completed include: temperature performance and tensile strength tests. The active chemical mixture was subjected to primary skin irritation testing. This mixture was found to be toxicologically acceptable for its intended usage. The active chemical ingredient was tested as identified in the specifications of the Food Chemicals Codex. 3rd Ed. (1981), p. 304, which is incorporated by reference in the Code of Federal Requlations, 21 CFR 184.1807. Sodium Thiosulfate meets all food grade requirements. This product is in compliance with established standards, where applicable, and was deemed acceptable for its intended use.
Substantial Equivalence:
Summary of Testing:
2
Image /page/2/Picture/1 description: The image is a black and white seal for the Department of Health & Human Services - USA. The seal is circular with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the top half of the circle. In the center of the seal is an abstract image of an eagle.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
JAN 2 1 1999
Patricia Sharpe-Gregg, R.N., B.S.N. Manager, Regulatory Affairs Allegiance Healthcare Corporation 1500 Waukegan Road, Building MP-WM McGaw Park, Illinois 60085
Re: K982652 Allegiance Porta-Warm™ Mattress Trade Name: Regulatory Class: I Product Code: IMD Dated: November 19, 1998 December 2, 1998 Received:
Dear Ms. Sharpe-Gregg:
We have reviewed your Section 510(k) notification of intent to market the device referenced above and we 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). 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.
If your device is classified (see above) into either class II (Special Controls) or class III (Premarket Approval), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Requlations, Title 21, Parts 800 to 895. ਕੇ substantially equivalent determination assumes compliance with the Current Good Manufacturing Practice requirements, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic QS inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory In addition, FDA may publish further announcements action. concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531
3
Page 2 - Ms. Sharpe-Gregg
through 542 of the Act for devices under the Electronic Chrough 542 OF the notrol provisions, or other Federal laws or regulations.
This letter will allow you to begin marketing your device as Inis recei will as on the motification. The FDA described in your sio\n privalence of your device to a legally I inding of subbeancial ogeresults in a classification for your marketed predication of mits your device to proceed to the market.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801 and additionally 809.10 for in regulacion (ic devices), please contact the Office of Compliance at (301) 594-4692. Additionally, for questions on the promotion and advertising of your device, please contact Also, please note the Office of Compliance at (301) 594-4639. the regulation entitled, "Misbranding by reference to ene regaracontification" (21CFR 807.97). " Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance oblained from cho momber (800) 638-2041 or (301) 443-6597 or at its internet address
"http://www.fda.gov/cdrh/dsma/dsmamain.html".
Sincerely yours,
Timothy A. Ulatowski
Director
Division of Dental, Infection Control, and General Hospital Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
Image /page/4/Picture/0 description: The image shows the word "Allegiance" in a bold, sans-serif font. To the left of the word is a symbol that looks like a plus sign made up of small dots. The word is in black and the background is white.
Allegiance Healthcare Corporation 1500 Waukegan Road McGaw Park, Manois 60085 USA 847-473-1500 FAX: 847-785-2461
510(k) Notification Porta-Warm™ Mattress Thermal Business Unit Page 1 of 1
| 510(k) Number (if known): | Unknown |
|---|---|
| Device Name: | Allegiance Porta-Warm™ Mattress |
| Indications For Use: | Hot disposable pack intended for medical |
| purposes that consists of a sealed plastic bag | |
| incorporating chemicals that, upon activation, | |
| provides hot therapy for body surfaces. |
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use . (Per 21 CFR 801.109) or
Over-The Counter Use سَرِ حَ
| (Division Sign-Off). | B. Ballee |
|---|---|
| ---------------------- | ----------- |
Division of Dental, Infection Control,
and General Hospital Devices
| 510(k) Number | K982652 |
|---|---|
| --------------- | --------- |