(76 days)
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Not Found
No
The summary does not mention AI, ML, image processing, or any other indicators of AI/ML technology. The device description and intended use are consistent with a non-AI/ML hydrotherapy system.
Yes
Explanation: The intended use of the device is to "Relieve pain and itching," which falls under therapeutic purposes.
No
The intended use is hydrotherapy to relieve pain and itching, which describes a therapeutic function, not a diagnostic one. There is no indication that it identifies or characterizes a disease or condition.
No
The device description "Hydrotone-Thermal Capsule System" strongly suggests a physical hardware component (a capsule system) is involved, not just software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is "Hydrotherapy; Relieve pain and itching." This describes a therapeutic or physical treatment, not a diagnostic test performed on samples taken from the body.
- Device Description: The device is described as a "Hydrotone-Thermal Capsule System." This suggests a physical apparatus for hydrotherapy, not a laboratory instrument or reagent for analyzing biological samples.
- Lack of IVD Characteristics: The description lacks any mention of:
- Analyzing biological samples (blood, urine, tissue, etc.)
- Detecting or measuring substances in biological samples
- Providing information for diagnosis, monitoring, or screening of diseases or conditions
IVDs are specifically designed to be used in vitro (outside the body) to examine specimens from the human body to provide information for clinical purposes. This device's description and intended use clearly fall outside of that definition.
N/A
Intended Use / Indications for Use
Hydrotherapy; Relieve pain and itching.
Product codes
ILJ
Device Description
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Mentions image processing
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Mentions AI, DNN, or ML
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Input Imaging Modality
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Anatomical Site
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Indicated Patient Age Range
Not for children, elderly or handicapped unless supervised. Pregnant women should consult a medical doctor before using this system.
Intended User / Care Setting
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Description of the training set, sample size, data source, and annotation protocol
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Description of the test set, sample size, data source, and annotation protocol
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Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Not Found
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
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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.
Not Found
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.
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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).
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§ 890.5100 Immersion hydrobath.
(a)
Identification. An immersion hydrobath is a device intended for medical purposes that consists of water agitators and that may include a tub to be filled with water. The water temperature may be measured by a gauge. It is used in hydrotherapy to relieve pain and itching and as an aid in the healing process of inflamed and traumatized tissue, and it serves as a setting for removal of contaminated tissue.(b)
Classification. Class II (special controls). The device, when it is a hydromassage bath or a powered sitz bath, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 890.9.
0
Image /page/0/Picture/1 description: The image shows the seal of the Department of Health & Human Services - USA. The seal is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an image of an eagle with its wings spread.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
JUN 2 3 1999
Mr. Richard C. Lanzillotto Agent for HydroCo North American Technical Services Corporation 30 Northport Road Sound Beach, New York 11789-1734
Re: K991184 Hydrotone-Thermal Capsule System Trade Name: Regulatory Class: II Product Code: ILJ Dated: May 5, 1999 Received: May 7, 1999
Dear Mr. Lanzillotto:
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 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. 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 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. Richard C. Lanzillotto
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,
Cella 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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Page 5
INDICATIONS FOR USE
510(k) Number (if known):
Hydrotone-Thermal Capsule System Device Name: Indications for Use: Hydrotherapy;
Relieve pain and itching.
Contraindications:
- Not for children, elderly or handicapped unless supervised.
- Prolonged immersion in hot water may induce hyperthermia. -
- -Do not use following strenuous exercise.
- Pregnant women should consult a medical doctor before using this system.
- -Consult with a medical doctor if using medication prior to using this system.
- Do not use with alcohol or drugs. The combination could result in fatal hyperthermia.
(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 Use
Teedle
(Division Sign-Off)
Division of General Restorative Devices K991184
510(k) Number.