(81 days)
Not Found
No
The description focuses on the physical components and function of a hot/cold therapy blanket, with no mention of AI or ML.
Yes
The device is described as providing "hot/cold therapy," which is a therapeutic intervention for body surfaces.
No
Explanation: The "Intended Use / Indications for Use" states that the device is intended to "provide hot/cold therapy for body surfaces," which is a therapeutic function, not a diagnostic one.
No
The device description explicitly mentions physical components like a connector/tubing, plastic blanket, and securing straps, indicating it is a hardware device for delivering hot/cold therapy.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is to "provide hot/cold therapy for body surfaces." This is a therapeutic application, not a diagnostic one.
- Device Description: The description details a system for circulating water for temperature therapy. There is no mention of analyzing biological samples (blood, urine, tissue, etc.) which is the core function of an IVD.
- Lack of IVD Indicators: The document does not mention any of the typical characteristics of an IVD, such as:
- Analyzing biological samples.
- Detecting or measuring substances in biological samples.
- Providing information for diagnosis, monitoring, or screening.
In summary, the InCare HOT/ICE Cold Therapy Foot/Ankle Blanket is a therapeutic device designed for applying temperature to the body, not for performing in vitro diagnostic tests.
N/A
Intended Use / Indications for Use
The InCare HOT/ICE System Foot/Ankle Blanket is intended to provided hot/cold therapy for body surfaces.
The InCare HOT/ICE Cold Therapy Foot/Ankle Blanket is intended to provide hot/cold therapy for body surfaces.
Product codes (comma separated list FDA assigned to the subject device)
ILO
Device Description
Hollister Incorporated, through its InCare division, currently markets the HOT/ICE System which is intended to provide hot/cold therapy for body surfaces. The HOT/ICE System products operate by pumping heated or chilled water through a plastic blanket.
The proposed devices consist of a connector/tubing that is an integral part of the plastic blanket where warm or cold water is circulated through and is intended to be used for the delivery of hot or cold therapy to the Foot/Ankle surface of the body. Detachable hook and loop securing straps allow for more flexibility in positioning the blanket onto the Foot/Ankle.
The proposed HOT/ICE System Foot/Ankle Blanket can be used with all of the circulating pumps within the InCare HOT/ICE System and is available as a sterile product.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Foot/Ankle surface of the body
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)
Not Found
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 890.5720 Water circulating hot or cold pack.
(a)
Identification. A water circulating hot or cold pack is a device intended for medical purposes that operates by pumping heated or chilled water through a plastic bag and that provides hot or cold therapy for body surfaces.(b)
Classification. Class II (special controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to § 890.9.
0
Image /page/0/Picture/0 description: The image shows the date November 3, 1997. The month is abbreviated to NOV. The day is 3 and the year is 1997. The text is in bold font.
Image /page/0/Picture/1 description: The image shows the Hollister logo. The logo consists of a black geometric shape resembling a stylized cross or asterisk, followed by the word "Hollister" in a serif typeface. The text is positioned to the right of the geometric shape.
Hollister Incorporated 2000 Hollister Drive Libertyville, Illinois 60048-3781
InCare HOT/ICE Cold Therapy Foot/Ankle Blanket
510(k) Summary
KL973023
1. Submitter's name, Address and Contact Person
Submitter Hollister Incorporated 2000 Hollister Drive Libertyville, IL 60048
Contact Person Joseph S. Tokarz Manager, Regulatory Affairs (847)680-2849 Ph (847)918-3860 Fax
Date Summary Prepared - August 12, 1997
2. Name of Device:
InCare HOT/ICE System Foot/Ankle Blankets
3. Name of Predicate Device(s)
InCare HOT/ICE System Foot/Ankle Blankets (K931843)
4. Description of Device
Hollister Incorporated, through its InCare division, currently markets the HOT/ICE System which is intended to provide hot/cold therapy for body surfaces. The HOT/ICE System products operate by pumping heated or chilled water through a plastic blanket.
The proposed devices consist of a connector/tubing that is an integral part of the plastic blanket where warm or cold water is circulated through and is intended to be used for the delivery of hot or cold therapy to the Foot/Ankle surface of the body. Detachable hook and loop securing straps allow for more flexibility in positioning the blanket onto the Foot/Ankle.
The proposed HOT/ICE System Foot/Ankle Blanket can be used with all of the circulating pumps within the InCare HOT/ICE System and is available as a sterile product.
5. Statement of Intended Use
The InCare HOT/ICE System Foot/Ankle Blanket is intended to provided hot/cold therapy for body surfaces.
6. Statement of Technological Characteristics of the Device
The subject device is identical in intended use, size/shape and flow design to the predicate device, with the following exception, the proposed device is available with detachable
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Hollister.
InCare HOT/ICE Cold Therapy Foot/Ankle Blanket
hook and loop securing straps that hold the blanket in place and allow for more flexibility in positioning the blanket.
7. Biocompatibility Assessment
Material Biocompatibility: Issues of biomaterial safety or biocompatibility have been addressed based upon the biomaterial history or in separate in-vitro or in-vivo evaluations using licensed commercial reference laboratories. Each assessment was conducted based on principles and guidelines established by various governmental and standard setting organizations among these are the following:
- -- ISO 10993, International Standards Organization (ISO) Standard
- -- General Program Memorandum #G95-1, United States FDA Office of Device Evaluation
- -- United Stated Pharmacopeia (USP)
The materials used to construct the InCare HOT/ICE Cold Therapy Foot/Ankle Blanket are considered biocompatible and appropriate for their intended use.
8. Conclusion
Based upon the information presented above it is concluded that the proposed InCare HOT/ICE Cold Therapy Foot/Ankle Blanket is safe and effective for it's intended use and is substantially equivalent to the predicate device.
2
Image /page/2/Picture/2 description: The image shows a partial view of the Department of Health & Human Services logo. The logo includes the department's name arranged in a circular fashion around a symbol. The symbol consists of a stylized human figure with three overlapping profiles, representing the department's focus on health and human well-being. The image is in black and white.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
NOV - 3 1997
Mr. Joseph S. Tokarz Manager, Regulatory Affairs Hollister, Inc. 2000 Hollister Drive Libertyville, Illinois 60048-3781
Re : K973023 InCare HOT/ICE Cold Therapy Foot/Ankle Blanket Regulatory Class: II Product Code: ILO Dated: Auqust 11, 1997 August 14, 1997 Received:
Dear Mr. Tokarz:
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 regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 895. ਸੋ 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 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 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.
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Page 2 - Mr. Joseph S. Tokarz
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
premarket notification" (21 CFR 807.97). 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,
[signature]
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
4
InCare HOT/ICE Cold Therapy Foot/Ankle Blanket
b. Statements of Indications for Use
510(k) Number (if Known): Device Name:
InCare HOT/ICE Cold Therapy Foot/Ankle Blanket
Indications For Use:
The InCare HOT/ICE Cold Therapy Foot/Ankle Blanket is intended to provide hot/cold therapy for body surfaces.
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED) Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use _ (Per 21 CFR 801.109) OR
Over-the-Counter-Usé X
(Optional Format 1-2-96)
to coell