K050156 · Iyia Technologies, Inc. · KPJ · Jun 17, 2005 · General, Plastic Surgery
Device Facts
Record ID
K050156
Device Name
WHS-1000 WOUND HEALING SYSTEM
Applicant
Iyia Technologies, Inc.
Product Code
KPJ · General, Plastic Surgery
Decision Date
Jun 17, 2005
Decision
SESE
Submission Type
Traditional
Regulation
21 CFR 878.5650
Device Class
Class 2
Attributes
Therapeutic
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.
Device Story
WHS-1000 Wound Treatment System (Misty™) is a rigid plastic chamber for extremity wound treatment. Device delivers humidified hyperbaric oxygen, heat, massage, moisture, and infrared/ultraviolet light to open, chronic wounds. System includes oxygen tubing, pressure sensor, mist delivery, and water transfer fittings; controlled via external plastic panel with switches and timer. Operated by physician or podiatrist in clinical setting. Provides adjunct therapy to promote wound management; output effects clinical decision-making by facilitating wound healing through localized hyperbaric environment and therapeutic modalities.
Clinical Evidence
No clinical data.
Technological Characteristics
Rigid plastic shell chamber for extremities. Features oxygen, pressure, mist, and water transfer ports. Includes control panel with switches and timer. Powered by AC outlet. Materials tested to ASTM specifications and ISO biocompatibility standards. Non-software based control system.
Indications for Use
Indicated for patients with open, chronic wounds including diabetic skin ulcerations, venous stasis ulcers, post-surgical infections, gangrenous lesions, decubitus ulcers, amputations/infected stumps, skin grafts, burns, and frostbite. Restricted to use by or on the order of a physician or podiatrist.
Regulatory Classification
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.
Special Controls
*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.
Predicate Devices
VX-400 Topical Hyperbaric Oxygen Chamber, Vascular One, Inc. (K022028)
Submission Summary (Full Text)
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# 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. .
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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 --
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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.
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# 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
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# INDICATIONS FOR USE STATEMENT
(As required by ODE for all 510(k)'s received after 1/2/96.)
510(k) Number:
K050156
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
Two short videos show you everything — or skip straight to the written tutorial if you'd rather read. You can reopen this any time from the Tutorial button in the top bar.
Part 1 — Search, results, and everyday workflows 16 min
Part 2 — Embeddings: the galaxy map 3 min
1. Search: exact and fuzzy
Type a phrase like "coronary artery calcification" into the search box. You get two kinds of results. Exact results match the literal phrase — prefix searches work ("coronary artery calcificati") but suffix searches do not. Fuzzy results match on the meaning and intent of your phrase rather than the exact words, and are sorted by relevance score. Hover over the Exact or Fuzzy badge on any row to see exactly why it matched.
Use the checkboxes above the results to narrow: SaMD keeps only software-only devices, AI / ML keeps only devices with AI.
Exact vs. fuzzy search: what's the difference?
Exact matches on the literal phrase (prefix search works, suffix does not). Fuzzy matches on the meaning and intent of the phrase rather than the exact words. Hover over the badge on any row to see why it matched.
You search "coronary artery calcification" and want only software devices with AI. What two filters do you apply?
Narrow by SaMD (software-only devices), then narrow by AI/ML (devices with AI).
2. The results table
Scroll right in the results table. The intended use is extracted for you — no need to open the PDF. The device story gives a high-level snapshot of what the device does and how it's used. The AI Performance sub-table shows each output name, acceptance criteria, observed values, and development/test dataset descriptions — the same format Innolitics uses for regulatory strategy outputs, and the fastest high-level fingerprint of an AI device. It is AI-generated but has been very reliable in practice.
Where do you find a device's intended use without opening the PDF?
Scroll right in the search results table. The intended use column is extracted for you; no need to dig into the 510(k) summary PDF.
What does the AI Performance sub-table show, and why is it useful?
Output name, acceptance criteria, observed values, development dataset description, and test dataset description. It's the same format we use for regulatory strategy output and Fast 510(k) input, and the fastest high-level fingerprint of an AI device. AI-generated but reliable in practice.
3. Judging fuzzy relevance
Fuzzy results trail off in relevance as you scroll. Use three signals to decide how far down to go: the fuzzy badge explanations, the intended use column, and whether your target output (e.g., Cobb angle) still appears in the AI Performance sub-table. Once it stops appearing, you're past the relevant zone. A top hit with a low score (~0.4) and a stretched explanation is a hint the closest predicates are far away — the project may be headed for De Novo. Note the fuzzy search is a pattern match: it doesn't handle negation ("not") well, and hardware devices can appear — filter by SaMD/AI ML to cut them.
How do you judge how far down fuzzy search results to go?
Use the relevancy signals: the fuzzy badge explanations, the intended use column, and whether the target output (e.g., Cobb angle) still appears in the AI Performance sub-table. Once it stops appearing, results are trailing off in relevancy.
4. Device detail page: chat and citations
Click a device name to open its detail page: device facts on the left, a chat window on the right. Ask something like "Describe the training data". The answer carries little citation bubbles — click one to jump to the highlighted passage in the source PDF, so you can verify every AI answer against the document. There's also a Download PDF button for sharing.
How do you verify an AI chat answer on the device detail page?
Click the citation bubbles to jump to the relevant highlight in the source document.
Reading rule for every project: how many summaries do you read in full?
At least the three most relevant 510(k) or De Novo summaries, in full. After that, use targeted chat questions to confirm your memory quickly. The tool supports this professional habit — it doesn't replace it.
5. Side-by-side comparison
Select multiple rows in the results table (aim for under ~10), then open the PDF Viewer tab. Ask one question — it goes to all selected devices in parallel, each with citations. This is the fastest way to compare and contrast devices: training data, PCCP scope, how they handled adding new scanners, and so on.
What does the side-by-side PDF viewer mode do?
Select multiple devices, open the PDF viewer tab, and ask one question (e.g., "Describe the training data"). It queries all selected devices simultaneously with citations, so you can compare and contrast quickly.
6. Collections
With rows selected, go to the Collections tab and create a labeled collection (e.g., "Cobb Angle Project"). Reload that selection any time — before a client call, pull up the collection and ask questions across all of its devices at once.
How do you save a set of selected devices for later use?
Select the rows, go to the Collections tab, and create a labeled collection (e.g., "Cobb Angle Project"). You can reload the selection anytime and carry it into the PDF viewer and other tabs that support selections.
7. Product codes and the regulations tree
Click a product code in the results to jump to it in the regulations tree — identification text, sibling product codes, and devices you can open in a PDF viewer on the right. Click a regulation number to see its identification, special controls, and related product codes. You can also search by product code or regulation number at the top of the tree. Always read the special controls if any exist for your device — it broadens your search and sharpens pre-kickoff research.
What can you do from the regulations tree view?
Browse product codes and regulation numbers, read the identification text and special controls, browse sibling product codes, open device PDFs on the right, and search by product code or regulation number at the top of the tree.
8. Chart view
Click Show Chart and segment by regulation number (or product code) to see which regulations dominate your result set. Clicking a regulation takes you into the regulations tree. Great for spotting that most matches are, say, hardware laparoscopic devices — a cue to go back and filter.
How do you see which regulations dominate a search result set?
Click "Show Chart" and segment by Regulation Number. Clicking a regulation takes you to the regulations tree.
9. The predicate graph
Open the Predicates tab for a family-tree view of predicate relationships. Click a node to trace its parents and children; selections from search carry over pre-selected. Commonly predicated devices are worth reading — a lot of people predicated them for a reason. The visual lineage is also handy on client calls, e.g. to show how a predicate family evolved and justify why your predicate still holds.
In the predicate graph, why are commonly predicated devices worth reading?
A lot of people predicated them for a reason. Clicking a node traces parents and children, and selections from search carry over pre-selected.
10. Embeddings: the galaxy map
The Embeddings tab plots every matching document in a 2-D "galaxy map" where semantically similar devices cluster together. Hover or click clusters to explore, and let AI label the clusters for you. Embeddings beat product codes for grouping: two devices can carry different product codes (LLZ vs. QIH) yet do the same thing — the embedding captures the meaning of the intended use and device story. This is also exactly how retrieval-augmented generation (RAG) works under the hood, and it makes a great visual on client calls.
Try it yourself
Head to the search page and work through a few of these AI/ML fuzzy searches to build intuition: perivascular fat on CT · aortic valve calcification opportunistic screening on noncontrast CT · breast cancer prediction on digital pathology slides · autism detection · gestational age prediction · a hearing aid that can also detect a pulse · foundation model based analysis of ECG · large language models · penetration test. Watch how the relevance scores, intended use, and AI Performance tables tell you when results stop being meaningful.
