(67 days)
Promotes wound healing through lavage of wound tissue (acute and chronic wounds, burns, diseased or necrotic tissue) and maintenance debridement for the removal of debris, exudates, fragments, bacteria and other matter.
The AS1000 Ultrasonic Wound Therapy System promotes wound healing through the ultrasonic lavage of wound tissue (acute and chronic wounds, burns, diseased or necrotic tissue) and cleansing irrigation & maintenance debridement of the removal of debris, exudates, fragments, bacteria, and other matter through the use of low-frequency, low-intensity, nonthermal non-contact ultrasonic energy and oxygenated fluid irrigation. This is accomplished by the non-contact, non-thermal application of a fine oxygenated fluid stream spray to the wound bed whereby ultrasound energy is transmitted via the stream from the applicator tip to the wound tissue. Non-contact ultrasound provides cellular stimulation, increased blood flow, and reduced bioburden with much less pain or thermal-effect than competing direct contact ultrasound devices. The AS1000 uses continuous ultrasonic energy to oxygenate the fluid (typically sterile saline) into a solution stream and couple the delivery of ultrasonic energy via the stream to the treatment site.
The provided 510(k) summary for the AS1000 Ultrasonic Wound Therapy System does not contain specific acceptance criteria or a dedicated study proving the device meets particular numerical performance targets. Instead, it focuses on demonstrating substantial equivalence to predicate devices based on technological characteristics, safety standards compliance, and intended use.
Therefore, many of the requested sections (e.g., specific performance values, sample sizes for test sets, number of experts for ground truth, MRMC study, training set details) cannot be extracted directly from this document. The document describes the basis for equivalence rather than presenting a performance study with detailed acceptance criteria and results against those criteria.
However, I can extract information related to safety and the general approach to demonstrating effectiveness through equivalence.
1. Table of Acceptance Criteria and Reported Device Performance
As mentioned, explicit numerical acceptance criteria for performance are not stated in this 510(k) summary. The "acceptance criteria" are implied to be substantial equivalence to predicate devices in terms of intended use, technological characteristics, and safety.
| Feature/Aspect | Acceptance Criteria (Implied) | Reported Device Performance/Characteristics |
|---|---|---|
| Intended Use | Substantially equivalent to predicate devices for promoting wound healing through lavage and debridement. | "Promotes wound healing through lavage of wound tissue (acute and chronic wounds, burns, diseased or necrotic tissue) and maintenance debridement for the removal of debris, exudates, fragments, bacteria and other matter." This is explicitly stated to be comparable to the predicates. |
| Technological Characteristics | Substantially equivalent to predicate devices (Celleration MIST, Arobella AR1000, DeRoyal JetOx ND, Smith & Nephew VersaJet) in key features like agent, delivery, mechanism, treatment variables, and physical specifications. | AS1000: Low-Intensity Low-Frequency Ultrasound (35kHz), Oxygenated Irrigant (e.g. Saline) & Non-Contact Probe, Ultrasound lavage spray for cleansing, variable intensity (0.1-0.5 W/cm2), continuous or pulsed modes, 5-15mm treatment distance. |
| Compared to predicates: Similar ultrasound frequency, non-contact delivery, similar intensity range, uses oxygenated irrigant (distinguishing it from some predicates but combining features from others), similar treatment distance to Celleration MIST. Explicitly states "substantially equivalent between the AS1000 device and the predicate Celleration MIST device since both have the same size diameter (10mm) oscillating surface generating the ultrasonic energy." | ||
| Safety - Electrical & EMC | Compliance with relevant international and national electrical safety and electromagnetic compatibility standards. | Complies with: IEC 60601-1, UL 60601-1, IEC 60601-1-2, IEC 60601-1-4, FCC Part 18. |
| Safety - Ultrasonic | Compliance with relevant ultrasonic safety standards. | Complies with: 21 CFR 1050.10, IEC 61847. |
| Safety - Biocompatibility | Compliance with biological evaluation standards for medical devices based on patient contact. | Complies with: ISO 10993-1:2003 and relevant annexes. Testing conducted in compliance with 21 CFR, Part 58 (GLP). |
| Reprocessing | Reprocessing instructions are validated and comparable to predicate devices. | Instructions for reprocessing (cleaning and sterilizing) are "identical to the predicate Arobella AR1000 which have already been validated." |
2. Sample Size Used for the Test Set and Data Provenance
- The document does not describe a test set or clinical study with a specified sample size.
- The "data provenance" for performance is based on the substantial equivalence argument to existing, legally marketed predicate devices, and a general reference to clinical literature supporting the use of therapeutic ultrasound for wound healing. It does not refer to new clinical data generated specifically for the AS1000.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
- Not applicable, as no specific test set requiring expert-established ground truth is described.
4. Adjudication Method for the Test Set
- Not applicable, as no specific test set requiring adjudication is described.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was Done
- No, an MRMC comparative effectiveness study is not mentioned or described in this 510(k) summary. The submission focuses on device equivalence, not a comparison of human reader effectiveness with or without AI assistance, as this is not an AI-based diagnostic device.
6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) was Done
- Not applicable, as this is a physical medical device, not a standalone algorithm.
7. The Type of Ground Truth Used
- The "ground truth" implicitly used is the established safety and efficacy profile of the predicate devices and the general scientific understanding of ultrasound therapy for wound healing, as supported by referenced (though not detailed) clinical literature. There is no specific, newly generated ground truth data for the AS1000 in this submission.
8. The Sample Size for the Training Set
- Not applicable, as this is a physical medical device, not an AI/Machine Learning algorithm requiring a training set.
9. How the Ground Truth for the Training Set Was Established
- Not applicable, as this is a physical medical device.
§ 878.4410 Low energy ultrasound wound cleaner.
(a)
Identification. A low energy ultrasound wound cleaner is a device that uses ultrasound energy to vaporize a solution and generate a mist that is used for the cleaning and maintenance debridement of wounds. Low levels of ultrasound energy may be carried to the wound by the saline mist.(b)
Classification. Class II (special controls). The special control is FDA's guidance document entitled “Class II Special Controls Guidance Document: Low Energy Ultrasound Wound Cleaner.” See § 878.1(e) for the availability of this guidance document.