(42 days)
Not Found
No
The device description and performance studies focus on a chemical exothermic reaction for heat generation and material safety testing. There is no mention of AI or ML in the intended use, device description, or performance summaries.
Yes
The device is described as providing "hot therapy for body surfaces" and "relieving edema and inflammation associated with an episiotomy," which are therapeutic benefits.
No
This device is a therapeutic device that provides heat therapy and absorbs fluid; it does not diagnose any conditions or provide diagnostic information.
No
The device description clearly outlines a physical product consisting of a sealed plastic bag, chemicals, a perineal pad, and polyester material. It describes a physical exothermic reaction for activation, indicating a hardware-based device, not software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for providing hot therapy to body surfaces and specifically as a heat therapy pack with an absorbent perineal pad for post-delivery use. This is a therapeutic application, not a diagnostic one.
- Device Description: The device description details a physical process (exothermic reaction) for generating heat and an absorbent pad. There is no mention of analyzing biological samples (blood, urine, tissue, etc.) or providing information about a patient's health status based on such analysis.
- Lack of IVD Characteristics: The description does not include any elements typically associated with IVDs, such as reagents, assays, or methods for detecting or measuring substances in biological specimens.
The device is clearly intended for external therapeutic use to provide heat and absorb fluids, which falls outside the scope of In Vitro Diagnostics.
N/A
Intended Use / Indications for Use
The Allegiance Kwik Heat™ Perineal Warm Pack is an Over-The-Counter, single-use, non-sterile device. It is a heat therapy pack intended to provide heat therapy for body surfaces. Additionally, this pack can be used post delivery to absorb postpartum lochia and provide therapeutic heat to relieve pain associated with an episiotomy incision.
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.
Product codes
IMD
Device Description
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
body surfaces, perineal
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 (study type, sample size, AUC, MRMC, standalone performance, key results)
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 subjected to skin sensitization, intracutaneous reactivity and cytotoxicity testing. Physical tests completed include: temperature performance testing. 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 Regulations, 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 (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
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
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
1
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.
2
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 Road
McGaw Park, IL 60085
847.473.1500
| FAX: 847.785.2461 | Page 2 of 2 |
|---|---|
| Intended Use: | The Allegiance Kwik Heat™ Perineal Warm Pack |
| is an Over-The-Counter, single-use, non-sterile | |
| device. It is a heat therapy pack intended to | |
| provide heat therapy for body surfaces. | |
| Additionally, this pack can be used post delivery to | |
| absorb postpartum lochia and provide therapeutic | |
| heat to relieve pain associated with an episiotomy | |
| incision. | |
| Substantial Equivalence: | The Allegiance Kwik Heat™ Perineal Warm Pack |
| is substantially equivalent to the Allegiance Kwik | |
| Kold™ Peri Cold Pack, the Jack Frost Perineal Pad | |
| (Warm), and the H.M.S. ™ Peri Warm™ Perineal | |
| Pack in that the: |
- intended use is the same
- performance attributes are the same
- method of activation is the same
The Allegiance Kwik Heat™ Perineal Warm Pack
is substantially equivalent to the Allegiance
Preamendment Small Hot Pack in that the: - chemical composition is the same
- performance attributes of active
chemical ingredients are the same. |
| Summary of Testing: | 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 subjected to skin sensitization,
intracutaneous reactivity and cytotoxicity testing.
Physical tests completed include: temperature
performance testing. 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 Regulations, 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. |
3
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.
4
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
5
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 |
|---|---|
| --------------- | --------- |