The intended use of VHT 200 wound treatment system is to provide humidified oxygen to open, acute or chronic wounds as an adjunct therapy in wound management and treatment.

The VHT-200 wound treatment system is intended for the following kinds of wounds:

· skin ulcerations due to diabetes, venous stasis, and post-surgical infections, and gangrenous lesions
decubitus ulcers
· amputations/infected stumps
· skin grafts
burns
· frostbite

Device Description

The VHT-200 Wound Treatment System is a prescription medical device. This system is designed for most topical skin injuries that can benefit from the properties of oxygen and moisture therapy treatments. All the benefits of oxygen and moisture modalities are self-contained into one system and applied without the need of switching applications. The VHT-200 is made for clinical office use. The VHT-200 wound treatment system is designed for the medical provider to add oxygen flow rate and frequency of the treatments based on experience and professional assessment of the individual patient's medical need.

AI/ML Overview

This document is a 510(k) summary for the VHT-200 Wound Treatment System. It does not describe a study involving acceptance criteria and device performance in the way a clinical performance study for an AI-powered diagnostic device would. Instead, it focuses on demonstrating substantial equivalence to a predicate device through various types of engineering and safety testing.

Therefore, many of the requested categories are not applicable to the information provided. The document outlines regulatory and engineering tests, not a clinical study involving human readers or AI algorithms.

Here's a breakdown based on the provided text, indicating where information is missing or not applicable:

No clinical performance study with acceptance criteria in the requested format was performed or described in this 510(k) summary. The provided text describes engineering, safety, and performance testing to demonstrate substantial equivalence to a predicate device, not a human-in-the-loop or standalone AI performance study against specific clinical acceptance criteria.

Here's how the information maps to your request:

A table of acceptance criteria and the reported device performance:
This information is not provided in the context of a clinical performance study with specific metrics like sensitivity, specificity, or accuracy. The document states "The VHT-200 has been evaluated in various conditions and determined to be safe and effective" and lists types of engineering and safety tests, but does not provide a table of acceptance criteria and reported performance for clinical outcomes or diagnostic accuracy.
Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective):
Not applicable. This document describes testing for a medical device (topical oxygen chamber), not an AI diagnostic algorithm evaluated on a test set of patient data. The "test set" here refers to conditions for engineering and safety tests.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience):
Not applicable. This document describes testing for a medical device, not a clinical study requiring expert ground truth for diagnostic purposes.
Adjudication method (e.g. 2+1, 3+1, none) for the test set:
Not applicable. This document describes testing for a medical device, not a clinical study requiring adjudication of expert interpretations.
If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:
No. This document does not mention any MRMC study or AI assistance.
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
Not applicable. The VHT-200 is a physical medical device (topical oxygen chamber) and does not involve an AI algorithm with standalone performance.
The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
Not applicable in the context of diagnostic "ground truth." The "ground truth" for the VHT-200 system would relate to its physical performance against engineering standards (e.g., oxygen concentration maintained, biocompatibility, electrical safety).
The sample size for the training set:
Not applicable. This device does not use a training set in the context of AI or machine learning.
How the ground truth for the training set was established:
Not applicable. This device does not use a training set.

Summary of "Performance Testing" from the document:

The 510(k) summary indicates that the VHT-200 Wound Treatment System underwent various tests to demonstrate its safety and effectiveness, and its substantial equivalence to the predicate device. These tests fall under engineering and regulatory compliance, not clinical diagnostic performance.

Tests Performed:
- Software validation
- IEC 60601-1-2 (Medical electrical equipment - Part 1-2: General requirements for basic safety and essential performance - Collateral standard: Electromagnetic disturbances - Requirements and tests)
- IEC 80601-1-2 (Likely a typo and refers to IEC 60601-1-2 or another specific part of the IEC 60601 series)
- IEC 80601-2-69 (Medical electrical equipment - Part 2-69: Particular requirements for the basic safety and essential performance of oxygen concentrators) - This is highly relevant as the device includes an oxygen concentrator.
- Biocompatibility evaluation
- Performance testing (general statement, specific metrics not detailed)
- Cleaning validation
- Distribution testing
Conclusion: Based on these tests, the VHT-200 was concluded to be as safe, as effective, and to perform at least as safely and effectively as the predicate device.

Summary

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March 23, 2023

Vaporox, Inc. % Allyson Mullen Hyman, Phelps, & McNamara, P.C. 700 Thirteenth Street NW. Suite 1200 Washington, District of Columbia 20005

Re: K212121

Trade/Device Name: VHT-200 Wound Treatment System Regulation Number: 21 CFR 878.5650 Regulation Name: Topical Oxygen Chamber For Extremities Regulatory Class: Class II Product Code: KPJ Dated: July 6, 2021 Received: July 7, 2021

Dear Allyson Mullen:

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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to 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.

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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); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.

For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).

Sincerely, Julie A. Morabito -5

Julie Morabito, Ph.D. Assistant Director DHT4B: Division of Infection Control and Plastic Surgery Devices OHT4: Office of Surgical and Infection Control Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health

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Indications for Use

510(k) Number (if known) K212121

Device Name

VHT-200 Wound Treatment System

Indications for Use (Describe)

The intended use of VHT 200 wound treatment system is to provide humidified oxygen to open, acute or chronic wounds as an adjunct therapy in wound management and treatment.

The VHT-200 wound treatment system is intended for the following kinds of wounds:

· skin ulcerations due to diabetes, venous stasis, and post-surgical infections, and gangrenous lesions
decubitus ulcers
· amputations/infected stumps
· skin grafts
burns
· frostbite

Type of Use (Select one or both, as applicable)
-------------------------------------------------	--

X Prescription Use (Part 21 CFR 801 Subpart D)

| Over-The-Counter Use (21 CFR 801 Subpart C)

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510(k) Summary

VHT-200 Wound Treatment System August 20, 2021

Company:	Vaporox, Inc.7012 S. Revere Pkwy, Suite 100Centennial, CO 80112
Company Contact:	Alan Sage CEO, Vaporox(303) 558-5145
Trade Name:	VHT-200 Wound Treatment System
Common Name:	Topical oxygen chamber for extremities
Classification:	Class II
Regulation Number:	21 CFR 878.5650
Product Code:	KPJ
Predicate Device:	Hyper-Box Topical Wound Oxygen System (K080966

Device Description:

Indications for Use:

VHT-200 is intended to provide humidified oxygen to open, acute and chronic wounds as an adjunct therapy in wound management and treatment.

The VHT-200 System is intended for 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

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K212121

Substantial Equivalence:

The subject device is substantially equivalent to the predicate Hyper-Box Topical Wound Oxygen System (K080966). The subject device is similar in indications, technological characteristics, and materials to the predicate device. The subject device includes an integrated oxygen concentrator versus the predicate device's use of an external oxygen supply and uses a treatment chamber bag rather than the predicate's sleeve and boot design for the treatment environment. However, neither of these differences in technology raise different questions of safety or effectiveness and performance testing on the subject device has verified it is appropriate for its intended use.

Performance Testing:

The VHT-200 has been evaluated in various conditions and determined to be safe and effective. Testing included software validation, IEC 60601-1-2, IEC 80601-1-2, IEC 80601-2-69, biocompatibility evaluation, performance testing, cleaning validation, and distribution testing.

Conclusion:

The VHT-200 has equivalent indications for use, similarities in design, and equivalent performance to the predicate device. Therefore, it can be concluded that the subject device is as safe, as effective, and performs at least as safely and effectively as the predicate device.

Regulation Number and Section

§ 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.