(144 days)
Not Found
No
The summary describes a physical device with controls for oxygen, pressure, mist, heat, massage, and light therapy. There is no mention of any software, algorithms, or data processing that would indicate the use of AI or ML. The "Mentions AI, DNN, or ML" field is explicitly marked as "Not Found".
Yes
The device is described as providing "humidified hyperbaric oxygen" and other therapies "to open, chronic wounds as an adjunct therapy in wound management and treatment," and its intended use is for the management and treatment of various types of wounds, indicating a therapeutic purpose.
No
The intended use describes the device as providing "humidified hyperbaric oxygen" and other therapies for "wound management and treatment," which are therapeutic actions, not diagnostic ones. There is no mention of the device identifying or characterizing a medical condition.
No
The device description clearly outlines physical hardware components including a rigid plastic shell, fittings, a front panel control with switches and indicators, and a power cable. This is not a software-only device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In vitro diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections.
- Device Function: The Misty™ Wound Treatment System is a device that applies humidified hyperbaric oxygen, heat, massage, moisture, and light therapy directly to the patient's wound. It is a therapeutic device, not a diagnostic one.
- Intended Use: The intended use clearly states it is for the "treatment of the following kinds of wounds," listing various wound types. This is a therapeutic purpose.
- Device Description: The description details a chamber that accommodates a body part (foot) and applies physical therapies. There is no mention of analyzing biological samples.
Therefore, the Misty™ Wound Treatment System is a therapeutic medical device, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
The Misty™ Wound Treatment System provides humidified hyperbaric oxygen to open, chronic wounds as an adjunct therapy in wound management and treatment. In addition, the device can also provide heat, gentle massage, moisture, and infrared and ultraviolet light therapy.
The device is intended for the treatment of the following kinds of wounds:
- skin ulcerations due to diabetes, venous stasis, and post surgical infections
- gangrenous lesions. .
- decubitus ulcers
- amputations/infected stumps
- skin grafts
- burns
- frostbite
Product codes
KPJ
Device Description
The Wound Treatment System is composed of a rectangular, rigid plastic shell that is of sufficient size to accommodate the patient's foot. There are four fittings on the chamber: one for oxygen tubing that fills the chamber, one for a pressure sensor, one to allow the mist to enter the chamber and one for water transfer. The front panel control consists of a plastic panel with switches, indicators and timer controls; these connect to the Wound Treatment System via a cable. The system plugs into an AC wall outlet.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
patient's foot
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Physician or podiatrist
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)
Nonclinical Testing: The physical properties of the materials used to manufacture the IYIA Wound Treatment System are tested by the suppliers to ensure they meet the specifications for the finished device. The testing standards are established by ASTM. The materials that come in contact with the body are also tested using ISO methods for biocompatibility. All of the materials meet the specifications for the device, as certified by the supplier of the materials to IYIA Technologies, Inc.
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
§ 878.5650 Topical oxygen chamber for extremities.
(a)
Identification. A topical oxygen chamber for extremities is a device that is intended to surround a patient's limb and apply humidified oxygen topically at a pressure slightly greater than atmospheric pressure to aid healing of chronic skin ulcers such as bedsores.(b)
Classification. Class II (special controls). The special control for this device is FDA's “Class II Special Controls Guidance: Topical Oxygen Chamber for Extremities.” See § 878.1(e) for the availability of this guidance document.
0
XVI. PREMARKET NOTIFICATION [510(K)] SUMMARY - K050156
Applicant name:
IYIA Technologies, Inc. 870 Rancheros Drive San Marcos, CA 92069 (760) 432-8285 (760) 432-8286 (fax)
Contact Person: Mr. Adrian Pelkus, President Date Summary Prepared: May 27, 2005
Device Name:
| Trade Name: | WHS-1000 Wound Treatment System |
|---|---|
| Common Name: | Misty™ |
| Classification Name: | Hyperbaric Oxygen Chamber for Extremities |
| Classification No .: | 878.5650 |
Claiming Substantial Equivalence To:
VX-400 Topical Hyperbaric Oxygen Chamber, Vascular One, Inc., K022028.
Device Description
The Wound Treatment System is composed of a rectangular, rigid plastic shell that is of sufficient size to accommodate the patient's foot. There are four fittings on the chamber: one for oxygen tubing that fills the chamber, one for a pressure sensor, one to allow the mist to enter the chamber and one for water transfer. The front panel control consists of a plastic panel with switches, indicators and timer controls; these connect to the Wound Treatment System via a cable. The system plugs into an AC wall outlet.
The Product and Its Intended Use
The Misty™ Wound Treatment System provides humidified hyperbaric oxygen to open, chronic wounds as an adjunct therapy in wound management and treatment. In addition, the device can also provide heat, gentle massage, moisture, and infrared and ultraviolet light therapy.
The device is intended for the treatment of the following kinds of wounds:
- skin ulcerations due to diabetes, venous stasis, and post surgical infections
- gangrenous lesions. .
1
K05°156 P²/₁
- decubitus ulcers ●
- amputations/infected stumps .
- skin grafts .
- burns
- frostbite .
Caution: Federal law restricts this device to use by or on the order of a physician or podiatrist.
Summary of Technological Characteristics
The Misty™ Wound Treatment System WHS-1000 has the same technological characteristics as its predicate devices.
Nonclinical Testing: The physical properties of the materials used to manufacture the IYIA Wound Treatment System are tested by the suppliers to ensure they meet the specifications for the finished device. The testing standards are established by ASTM. The materials that come in contact with the body are also tested using ISO methods for biocompatibility. All of the materials meet the specifications for the device, as certified by the supplier of the materials to IYIA Technologies, Inc.
Performance Data: N/A
Clinical Data: N/A
-- END OF 510(k) SUMMARY --
2
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/2/Picture/1 description: The image shows the seal of the Department of Health & Human Services (HHS) of the United States of America. The seal features a stylized caduceus, a symbol often associated with medicine and healthcare, with three lines forming the snake and staff. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" is arranged in a circular pattern around the caduceus.
Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
JUN 17 2005
IYIA Technologies Incorporated C/o Mr. Alan Donald, MS, MBA, RAC Matrix Medical Consulting Incorporated 11440 West Bernardo Court, Suite 380 San Diego, California 92127-1644
Re: K050156
Trade/Device Name: WHS-1000 Wound Treatment System Regulation Number: 21 CFR 878.5650 Regulation Name: Topical oxygen chamber for extremities Regulatory Class: III Product Code: KPJ Dated: April 26, 2005 Received: April 27, 2005
Dear Mr. Donald:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and 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) that do not require approval of a premarket approval application (PMA). 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 vour device is classified (see above) into either class II (Special Controls) or class III (PMA), 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 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
3
Page 2 – Mr. Alan Donald, MS, MBA, RAC
This letter will allow you to begin marketing your device as described in your Section 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), please contact the Office of Compliance at (240) 276-0115 . Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrb/industry/support/index.html.
Sincerely yours,
Signature
Miriam C. Provost, Ph.D. Acting Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
INDICATIONS FOR USE STATEMENT
(As required by ODE for all 510(k)'s received after 1/2/96.)
510(k) Number:
Misty™ Wound Treatment System Device Name:
Indications for Use:
The Misty™ Wound Treatment System provides humidified hyperbaric oxygen to open, chronic wounds as an adjunct therapy in wound management and treatment. In addition, the device can also provide heat, gentle massage, moisture, and infrared and ultraviolet light therapy.
The device is intended for the treatment of the following kinds of wounds:
- skin ulcerations due to diabetes, venous stasis, and post surgical infections ◆
- gangrenous lesions, ●
- decubitus ulcers .
- amputations/infected stumps .
- . skin grafts
- . burns
- frostbite ♥
Caution: Federal law restricts this device to use by or on the order of a physician or podiatrist.
Prescription Use (Per 21 CFR 801.109)
OR
Over the Counter Use
Concurrence of CDRH, Office of Device Evaluation (ODE)
ision
General, Restorative
Neurological Devices
K050151