(42 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. Also used as a heat therapy pack with an absorbent perineal pad; for use post delivery to absorb lochea while relieving edema and inflammation associated with an an episiotomy.
The Allegiance Kwik Heat™ Perineal Warm Pack is comprised of an outer pouch which is secured to a perineal pad and then wrapped in a polyester material. 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. The perineal pad is made of a non-woven wrapped cellulose wood pulp fiber. Activation of the heat source occurs by folding the unit to open the inner bubble which releases the liquid, and kneading the unit, thus creating a physical exothermic reaction.
The document describes the Allegiance Kwik Heat™ Perineal Warm Pack, a hot therapy pack intended for medical purposes, including post-delivery use to absorb lochia and provide therapeutic heat to relieve pain associated with an episiotomy incision.
Here's an analysis of the acceptance criteria and study information:
1. Table of Acceptance Criteria and Reported Device Performance:
| Acceptance Criteria Category | Specific Criteria | Reported Device Performance |
|---|---|---|
| Biocompatibility | Skin sensitization | "materials were subjected to skin sensitization...testing." |
| Intracutaneous reactivity | "materials were subjected to...intracutaneous reactivity...testing." | |
| Cytotoxicity | "materials were subjected to...cytotoxicity testing." | |
| Primary Skin Irritation | "The active chemical mixture was subjected to primary skin irritation testing." | |
| Material Safety | Toxicological Acceptability | "This mixture was found to be toxicologically acceptable for its intended usage." |
| Food Grade Requirements | "Sodium Thiosulfate meets all food grade requirements." (Referencing Food Chemicals Codex, 3rd Ed. (1981), p. 304, incorporated by reference in 21 CFR 184.1807) | |
| Physical Performance | Temperature Performance | "Physical tests completed include: temperature performance testing." |
| General Standards Compliance | Established Standards | "This product is in compliance with established standards, where applicable, and was deemed acceptable for its intended use." |
2. Sample Size Used for the Test Set and Data Provenance:
The document does not specify sample sizes for the test sets related to the biological and physical testing. It only states that "All materials used in the composition of this hot pack were identified, evaluated and tested."
The data provenance is also not specified. Given the context of a 510(k) submission in 1997, it's highly likely that testing was done by or for the manufacturer (Allegiance Healthcare Corporation) and would be considered prospective data for the purpose of demonstrating device safety and effectiveness. There is no information about country of origin of the data.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Their Qualifications:
The document does not provide any information regarding the number of experts, their qualifications, or how ground truth was established for the test data. The types of tests (biocompatibility, chemical composition, temperature performance) would typically rely on standardized laboratory protocols and measurements rather than expert consensus on a 'ground truth' in the way it's understood for diagnostic AI.
4. Adjudication Method for the Test Set:
The document does not describe any adjudication method. This is not relevant for the type of safety and performance testing described (e.g., cytotoxicity, temperature measurement) which relies on objective laboratory results rather than subjective assessments requiring adjudication.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done:
No, an MRMC comparative effectiveness study was not done. This type of study is relevant for diagnostic devices that involve human interpretation, often aided by AI. The Allegiance Kwik Heat™ Perineal Warm Pack is a physical medical device (a hot pack), not a diagnostic tool, and therefore, an MRMC study is not applicable.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Study Was Done:
No, a standalone study (in the context of an algorithm) was not done. The device itself is a physical product and does not involve any algorithms or artificial intelligence. Therefore, this question is not applicable.
7. The Type of Ground Truth Used:
The "ground truth" for the device's safety and performance was established through a combination of:
- Standardized laboratory testing results: For biocompatibility (skin sensitization, intracutaneous reactivity, cytotoxicity, primary skin irritation) and physical temperature performance.
- Compliance with established specifications and standards: For the chemical composition (e.g., Food Chemicals Codex for Sodium Thiosulfate) and general safety standards (ISO Standard 10993 Part 1).
- Toxicological assessment: Determining that the chemical mixture was "toxicologically acceptable."
8. The Sample Size for the Training Set:
The concept of a "training set" is applicable to machine learning and AI algorithms. Since this device is a physical product and does not involve AI, there is no training set in this context.
9. How the Ground Truth for the Training Set Was Established:
As there is no training set for an AI algorithm, this question is not applicable.
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Allegiance Healthcare Corporation 510(k) Notification Allegiance Kwik Heat™ Perineal Warm Pack Thermal Business Unit
NOV 1 3 1997
ATTACHMENT F
SUMMARY OF SAFETY & EFFECTIVENESS
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Image /page/1/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 resembles a plus sign, but it is made up of many small squares. The word "Allegiance" is the main focus of the image.
Allegiance Healthcare Corporation
1500 Waukegan Road McGaw Park, IL 60085 847.473.1500 FAX: 847.785.2461
Kg73770
ATTACHMENT F
SUMMARY OF SAFETY AND EFFECTIVENESS
Manufacturer:
Regulatory Affairs Contact
Telephone:
Date Summary Prepared:
Product Trade Name:
Common Name:
Classification:
Predicate Device: (K970399) Preamendment
Description:
Allegiance Healthcare Corporation Thermal Business Unit 808 Highway 24 West Moberly, Missouri 65270
Patricia Sharpe-Gregg 1500 Waukegan Road McGaw Park, Illinois 60085
(847) 578-3636
September 26, 1997
Allegiance Kwik Heat™ Perineal Warm Pack
Perineal Hot Pack
Cold and Hot Disposable Pack
Allegiance Kwik Kold™ Peri Cold Pack Large Adult Hot Pack
The Allegiance Kwik Heat™ Perineal Warm Pack is comprised of an outer pouch which is secured to a perineal pad and then wrapped in a polyester material. 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. The perineal pad is made of a non-woven wrapped cellulose wood pulp fiber. Activation of the heat source occurs by folding the unit to open the inner bubble which releases the liquid, and kneading the unit, thus creating a physical exothermic reaction.
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Image /page/2/Picture/0 description: The image shows the word "Allegiance" in a stylized font. To the left of the word is a plus sign made up of small dots. The word is in black and the plus sign is also in black.
Allegiance Healthcare Corporation
・。
| 1500 Waukegan RoadMcGaw Park, IL 60085847.473.1500FAX: 847.785.2461 | Page 2 of 2 |
|---|---|
| Intended Use: | The Allegiance Kwik Heat™ Perineal Warm Packis an Over-The-Counter, single-use, non-steriledevice. It is a heat therapy pack intended toprovide heat therapy for body surfaces.Additionally, this pack can be used post delivery toabsorb postpartum lochia and provide therapeuticheat to relieve pain associated with an episiotomyincision. |
| Substantial Equivalence: | The Allegiance Kwik Heat™ Perineal Warm Packis substantially equivalent to the Allegiance KwikKold™ Peri Cold Pack, the Jack Frost Perineal Pad(Warm), and the H.M.S. ™ Peri Warm™ PerinealPack in that the:- intended use is the same- performance attributes are the same- method of activation is the sameThe Allegiance Kwik Heat™ Perineal Warm Packis substantially equivalent to the AllegiancePreamendment Small Hot Pack in that the:- chemical composition is the same- performance attributes of activechemical ingredients are the same. |
| Summary of Testing: | All materials used in the composition of this hotpack were identified, evaluated and tested asrequired in ISO Standard 10993 Part 1. Thematerials were subjected to skin sensitization,intracutaneous reactivity and cytotoxicity testing.Physical tests completed include: temperatureperformance testing. The active chemical mixturewas subjected to primary skin irritation testing.This mixture was found to be toxicologicallyacceptable for its intended usage. The activechemical ingredient was tested as identified in thespecifications of the Food Chemicals Codex, 3rdEd. (1981), p. 304, which is incorporated byreference in the Code of Federal Regulations, 21CFR 184.1807. Sodium Thiosulfate meets all foodgrade requirements. This product is in compliancewith established standards, where applicable, andwas deemed acceptable for its intended use. |
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Image /page/3/Picture/2 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized graphic element resembling an abstract human form, positioned to the right of the text "DEPARTMENT OF HEALTH & HUMAN SERVICES · USA". The text is arranged in a circular fashion around the graphic, emphasizing the department's name and its association with the United States of America.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
NOV 1 3 1997
Ms. Patricia Sharpe-Gregg Manager, Regulatory Affairs Alleqiance Healthcare Corporation 1500 Waukegan Road McGaw Park, Illinois 60085
Re: K973770 Allegiance Kwik Heat™ Perineal Warm Pack Regulátory Class: I Product Code: IMD Dated: October 1, 1997 Received: October 2, 1997
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 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 The general controls provisions of the Act 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 requlations affecting your device can be found in the Code of Federal Requlations, Title 21, Parts 800 to 895. A substantially equivalent determination assumes compliance with the current Good Manufacturing Practice requirement, 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 action. In addition, FDA may publish further announcements 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 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or requlations.
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Page 2 - Ms. Patricia Sharpe-Gregg
This letter will allow you to begin marketing your device as described in your 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 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4659. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to ene rogalacion Chororos) 211655 and .97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its internet address "http://www.fda.gov/cdrh/dsmamain.html".
Sincerely yours,
Celia M. Witten, Ph.D., M.D. Director Division of General and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Image /page/5/Picture/0 description: The image shows the word "Allegiance" in a bold, italicized font. To the left of the word is a symbol that resembles a plus sign, but it is made up of many small dots. The word "Allegiance" is the main focus of the image and is prominently displayed.
Allegiance Healthcare Corporation
1500 Waukegan Road
McGaw Park, Minois 60085 USA
847-473-1500
FAX: 847-785-2460
510(k) Notification Kwik Heat™Warm Perineal Pack Thermal Business Unit Page 1 of 1
| 510(k) Number (if known): | Unknown |
|---|---|
| --------------------------- | --------- |
Device Name:
Indications For Use:
Allegiance Kwik Heat™ Warm Perineal Pack
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. Also used as a heat therapy pack with an absorbent perineal pad; for use post delivery to absorb lochea while relieving edema and inflammation associated with an episiotomy.
(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) | |
|---|---|
| Over-The Counter Use X |
(Division Sign-Off)
sion of General Restorat
| 510(k) Number | K973770 |
|---|---|
| --------------- | --------- |
§ 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.