(179 days)
For Treatment of open acute or chronic wounds, e.g.,
- Skin ulcerations due to diabetes, venous stasis, post surgical infections and gangrenous lesions
- Decubitus ulcers
- Amputations/infected stumps
- Skin grafts
- Burns
- Frostbite
The VX-400 Topical Hyperbaric Oxygen Chamber is a small, portable system that provides oxygen, at prescribed pressure for a prescribed duration, to a patient's limb. It is used at home or a clinical setting to help speed wound healing. The system consists of five (5) major components:
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- The Blue/Clear Plastic Chamber
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- The Control Unit
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- The Hand Held Controller
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- The Silicone Sleeve
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- Power Cube (Power Supply)
The VX-400 is a rectangular, yet rounded (10 x 24 x 16) rigid plastic shell constructed of two plastic half-panels, to which epoxy is applied and then heat-sealed together along the edges to form one chamber.
The chamber is a rigid plastic sleeve into which the patient places their limbs. There are two (2) hose barbs on the chamber, one for oxygen tubing that fills the chamber, and one for tubing to a pressure sensor. The controller consists of a plastic box with two (2) pieces of attached clear flexible tubing; these connect to the two (2) barbs on the chamber. The controller has a hose connected from the 50-psi oxygen source, a connector for a "power cube" that plugs into an AC wall outlet, and a cable that connects to the hand controller. The controller also incorporates a flowmeter. The hand-held controller can be programmed by the clinician to the prescribed time and pressure therapy, and then set to allow the patient to only turn the unit on and then off; it has a small 2 line LCD alphanumeric display and several push buttons.
Here's an analysis of the provided text regarding the acceptance criteria and supporting study for the VX-400 Topical Hyperbaric Oxygen Chamber:
Important Note: The provided document is a 510(k) summary for a medical device seeking substantial equivalence to predicate devices, not a clinical study report or a document explicitly detailing acceptance criteria for a new clinical indication. Therefore, information typically found in clinical trials (like specific quantitative clinical acceptance criteria, sample sizes for test sets, expert ground truth establishment, MRMC studies, etc.) is largely absent. The document focuses on demonstrating engineering performance and safety relative to predicate devices.
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria Category | Specific Criteria (from document) | Reported Device Performance (from document) |
|---|---|---|
| Operational Performance | Operations by setting several treatment combinations, checking time and pressure (clock). | "Performance testing to confirm the operations by setting several treatment combinations, and checking time and pressure (clock) was conducted in order to show that the device meets product specifications." |
| Environmental Performance | Operation at +5°C and at +40°C, 90-95% relative humidity. | "Operation at 5 +5°C and at +40°C, 90- 95% relative humidity (to assure that the device operates normally in the environment of use)" - implies successful operation. |
| Storage Resistance | Storage at -20°C and at +60°C, 90-95% relative humidity. | "Storage at -20°C and at +60°C, 90-95% relative humidity (storage resistance)" - implies successful storage. |
| Mechanical Integrity | Sinusoidal vibration. | "Sinusoidal vibration" - implies successful tolerance. |
| Electrical Safety | Leakage current and dielectric withstand of power cube. | "Leakage current and dielectric withstand of power cube (electrical safety)" - implies compliance. |
| Thermal Safety | Thermal Safety. | "Thermal Safety" - implies compliance. |
| Physical Durability | Impact (drop) resistance testing. | "Vascular One, Inc. conducted Impact (drop) resistance testing." - implies successful resistance. |
| Overall Safety/Effectiveness | Meets requirements of the FDA November 1993 Draft "Reviewer Guidance for Premarket Notification Submissions", DCRND. | "None of the testing demonstrated any design characteristics that violated the requirements of the Reviewer Guidance or resulted in any safety hazard. It was the contract testing laboratory and Vascular One, Inc.'s conclusion that the VX-400 device samples(s) tested met all relevant requirements of the aforementioned test." |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size: The document does not specify a numerical sample size for the test set. It refers to "VX-400 device samples(s) tested," implying a limited number of physical units were used for the engineering tests. This is typical for premarket device testing where the focus is on device function and safety, not clinical efficacy in a large patient population.
- Data Provenance: The data is from non-clinical (engineering/bench) testing. The testing was conducted by "A Contract Testing Laboratory" and "Vascular One, Inc." within the United States. It is retrospective in the sense that the results were submitted after the tests were completed.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications
- This information is not applicable and not provided in the document. The "ground truth" for these engineering tests would be the established scientific and engineering principles and the specifications outlined in the FDA's "Reviewer Guidance." The tests were performed to verify the device's adherence to these specifications, not to assess clinical diagnoses or outcomes requiring expert medical consensus.
4. Adjudication Method for the Test Set
- This information is not applicable and not provided in the document. Adjudication methods like 2+1 or 3+1 are used in clinical trials to resolve discrepancies in expert interpretations of medical data. Since this document describes engineering performance tests, such methods are not relevant. The "adjudication" here would be the pass/fail result of each engineering test against its pre-defined criteria.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done
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No, an MRMC comparative effectiveness study was not done. The document explicitly states: "Discussion of Clinical Tests Performed: Not applicable." This device is a Class III device, but its 510(k) submission relies on substantial equivalence to existing predicate devices, which often means extensive new clinical efficacy studies are not required if technological characteristics are similar and safety is demonstrated through non-clinical means.
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Effect Size: Not applicable, as no MRMC study was performed.
6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Was Done
- This concept is not applicable to this device. The VX-400 is a physical medical device (a hyperbaric oxygen chamber), not an algorithm or AI system. Its performance is inherent in its physical function and control system. While it is "software driven," its "standalone" performance would be its ability to maintain pressure and deliver oxygen as programmed, which is covered under the operational performance tests.
7. The Type of Ground Truth Used
- The "ground truth" for the non-clinical tests described in the document is the engineering specifications and safety standards outlined by the manufacturer and the FDA guidance document (FDA November 1993 Draft "Reviewer Guidance for Premarket Notification Submissions", DCRND). The tests were designed to verify that the device performed according to these pre-defined, measurable engineering and safety parameters.
8. The Sample Size for the Training Set
- This information is not applicable and not provided. "Training set" refers to data used to train algorithms or AI models. This device is a physical hyperbaric chamber, not an AI model requiring a training set for performance.
9. How the Ground Truth for the Training Set Was Established
- This information is not applicable and not provided, as there is no training set for this type of device.
§ 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.