(175 days)
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.
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.
The provided document (K98657) is a 510(k) submission for the Allegiance Porta-Warm™ Mattress, a hot therapy pack. The submission focuses on demonstrating substantial equivalence to predicate devices rather than proving performance against specific acceptance criteria in a detailed study format. Therefore, several aspects of your request, such as a formal table of acceptance criteria with reported performance values, specific sample sizes for test sets, expert-established ground truths, and MRMC studies, are not explicitly provided in this type of regulatory document.
However, I can extract the information that is available within the document regarding testing and how equivalence was established.
Here's a breakdown of the available information based on your request:
Acceptance Criteria and Device Performance
Due to the nature of a 510(k) submission for a predicate device, explicit acceptance criteria with numerical performance targets are not detailed. Instead, the document establishes substantial equivalence based on material composition, performance attributes, and intended use.
Table of Acceptance Criteria and Reported Device Performance (as inferred from the document):
| Acceptance Criteria Category (Inferred) | Specific Criteria (Inferred from Predicate Equivalence) | Reported Device Performance / Justification |
|---|---|---|
| Chemical Composition | Must be the same as the predicate devices (Preamendment Porta-Warm™ Mattress and Allegiance Infant Heel™ Warmer). | "the chemical composition is the same" (for both internal heat source and general materials). Active chemical ingredient (Sodium Thiosulfate) meets Food Chemicals Codex, 3rd Ed. (1981), p. 304 specifications (21 CFR 184.1807) and all food grade requirements. |
| Performance Attributes | Must be the same as the predicate devices (Preamendment Porta-Warm™ Mattress and Allegiance Infant Heel™ Warmer for active chemical ingredients; Preamendment Porta-Warm™ Mattress and Prism Technologies, Inc. Transwarmerl™ for overall performance). | "performance attributes of active chemical ingredients are the same." "performance attributes are the same." Physical tests completed include: "temperature performance" and "tensile strength tests." (No specific numerical results for these tests are provided in the summary, implied acceptable.) |
| Method of Activation | Must be the same as the predicate devices (Preamendment Porta-Warm™ Mattress and Allegiance Infant Heel™ Warmer). | "method of activation is the same" (folding to open inner bubble, releasing liquid, creating exothermic reaction). |
| Intended Use | Must be the same as the predicate devices (Preamendment Porta-Warm™ Mattress and Prism Technologies, Inc. Transwarmerl™). | "intended use is the same" (single-use, non-sterile heat therapy pack for medical purposes providing hot therapy for body surfaces). |
| Biocompatibility | Materials must be biologically safe for skin contact, as per ISO Standard 10993 Part 1. Active chemical mixture must be safe for intended usage. | Materials were "identified, evaluated and tested as required in ISO Standard 10993 Part 1." Tests included: "skin sensitization, intracutaneous reactivity and cytotoxicity testing." Active chemical mixture subjected to "primary skin irritation testing." This mixture was "found to be toxicologically acceptable for its intended usage." |
| Compliance | Must comply with established standards where applicable, and be deemed acceptable for its intended use. | "This product is in compliance with established standards, where applicable, and was deemed acceptable for its intended use." (Implied compliance with 21 CFR 820 for GMP, etc., as per FDA letter). Active chemical ingredient meets Food Chemicals Codex specifications. |
Additional Information on Testing and Ground Truth:
-
Sample size used for the test set and the data provenance:
- Test Set Sample Size: Not specified. The document states that various tests (skin sensitization, intracutaneous reactivity, cytotoxicity, temperature performance, tensile strength, primary skin irritation) were performed, but it does not provide the number of samples or units tested for each.
- Data Provenance: The tests were conducted by the manufacturer, Allegiance Healthcare Corporation. The specific country of origin of the raw data/testing is not explicitly stated beyond the manufacturer's address in Moberly, Missouri, USA and McGaw Park, Illinois, USA. The testing appears to be "prospective" in the sense that it was conducted specifically for this submission to demonstrate safety and equivalence.
-
Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not applicable/Not specified. For biocompatibility and physical performance tests, the "ground truth" is typically defined by accepted laboratory standards (e.g., ISO, Food Chemicals Codex) and interpreted by qualified laboratory personnel, not by a panel of medical experts establishing a diagnostic ground truth. The document does not detail the specific experts or their qualifications involved in these lab tests, beyond implicitly assuming adequately qualified personnel.
-
Adjudication method (e.g., 2+1, 3+1, none) for the test set:
- Not applicable. Adjudication methods like 2+1 or 3+1 are typically used in clinical studies where multiple human readers interpret medical images or data. The tests described are laboratory and material science-based, not reliant on human reader interpretation in that context. Results are presumed to be objective measurements against predefined standards.
-
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:
- No MRMC study was conducted or described. This device is a simple, non-AI medical product.
-
If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:
- Not applicable. This device is not an algorithm or AI.
-
The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- The "ground truth" for this submission relies on established scientific and regulatory standards:
- Chemical Composition: Conformance to Food Chemicals Codex specifications (e.g., Sodium Thiosulfate on page 1).
- Biocompatibility: Conformance to ISO Standard 10993 Part 1 (skin sensitization, intracutaneous reactivity, cytotoxicity, primary skin irritation).
- Physical Performance: Conformance to internal specifications for "temperature performance and tensile strength tests" (no numerical details provided).
- Substantial Equivalence: Direct comparison to already legally marketed predicate devices for chemical composition, performance attributes, method of activation, and intended use.
- The "ground truth" for this submission relies on established scientific and regulatory standards:
-
The sample size for the training set:
- Not applicable. This device is a physical product, not an AI, so there is no "training set" in the context of machine learning. The "training" could conceptually be considered the development and refinement of the manufacturing process and material selection.
-
How the ground truth for the training set was established:
- Not applicable, as there is no training set for an AI/algorithm. For the development of the product, the "ground truth" for design and manufacturing would have been established through internal engineering specifications, material science principles, and regulatory requirements (e.g., Good Manufacturing Practices).
{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 medicalpurposes that consists of a sealed plastic bagincorporating 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 |
|---|---|
| --------------- | --------- |
§ 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.