(67 days)
Not Found
No
The description focuses on the physical mechanism of ultrasonic energy and fluid irrigation for wound treatment. There is no mention of AI, ML, image processing, or data analysis that would suggest the use of such technologies.
Yes
The device is intended to promote wound healing, which is a therapeutic outcome.
No
The device description indicates that the AS1000 promotes wound healing through ultrasonic lavage and debridement, which are therapeutic actions, not diagnostic ones. It focuses on treating wounds by removing debris and stimulating healing, rather than identifying or characterizing a disease or condition.
No
The device description clearly describes a physical system ("AS1000 Ultrasonic Wound Therapy System") that applies ultrasonic energy and fluid irrigation via an "applicator tip" and "fluid stream spray" to wound tissue. This involves hardware components beyond just software.
Based on the provided information, this device is not an In Vitro Diagnostic (IVD).
Here's why:
- IVDs are used to examine specimens from the human body. The intended use and device description clearly state that this device is used for treating wound tissue directly on the patient's body through lavage and debridement. It does not involve analyzing samples taken from the body.
- The mechanism of action is physical. The device uses ultrasonic energy and fluid irrigation to clean and stimulate wound tissue. This is a physical intervention applied to the body, not a test performed on a sample.
- There is no mention of analyzing biological samples. The description focuses on the application of energy and fluid to the wound bed.
Therefore, the AS1000 Ultrasonic Wound Therapy System is a therapeutic device used for wound treatment, not an IVD.
N/A
Intended Use / Indications for Use
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.
Product codes (comma separated list FDA assigned to the subject device)
NRB, FQH
Device Description
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 AS1000 system consists of an ultrasonic power supply (hereto after referred to as a generator), an ultrasonic converter hand piece (or just converter), an applicator & tip, a saline supply reservoir & conduit tubing, a oxygen supply reservoir & conduit tubing, and, optionally, a waste chamber for material removed by aspiration.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Wound tissue (acute and chronic wounds, burns, diseased or necrotic tissue)
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Hospital, clinic, in-home, or Intraoperative settings. The entire system is compact in size such that in can be used at a primary care provider's office (on an out-patient basis), clinic, specialized treatment center (i.e. burn center), or hospital.
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)
Not Found
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
K050129, K062544, Exempt, K060782
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 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.
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510(k) Summary
The following 510(k) summary has been prepared pursuant to requirements specified in 21CFR 807.92(a).
807.92(a)(1)
Submitter Information
JUN 19 2009
I
Eliaz Babaev 5929 Baker Road, Suite 470 Minnetonka, MN 55345
Phone: (952) 345-6846 Fax: (952) 345-6841
Contact Person: Eliaz Babaev
Date: April 1, 2009
807.92(a)(2)
| Trade Name: | AS1000 Ultrasonic Wound Therapy System |
|---|---|
| Common Name: | Ultrasonic Wound Therapy System |
| Classification Name(s): | Wound Cleaner, |
| Ultrasound | |
| Classification Number: | NRB |
807.92(a)(3)
Predicate Device(s)
| Celleration | Celleration Mist Therapy System | K050129 |
|---|---|---|
| Arobella Medical, LLC | AR1000 Ultrasonic Wound Therapy System | K062544 |
| DeRoyal | Jetox-ND | Class I |
| Smith & Nephew | VersaJet Hydrosurgery System | K060782 |
807.92(a)(4)
Device Description
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.
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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 level of airborne ultrasound energy generated by the device, its spatial characteristics, and the potential exposure to unwanted acoustic energy is 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 transmitted thru their respective streams. In addition, since both the AS1000 device and the predicate Celleration i MIST device are intended to treat tissue at the same distance and same pattern, the level of ultrasound energy transmitted to the patient and the effects of the applicator from the wound is substantially equivalent. As the AS1000 device and the predicates (Celleration MIST device and Arobella AR1000 device) are all derived from classic Langevin transducer designs, the variability in the field from device is expected to be substantially equivalent, and all AS1000 devices are tested and verified to perform within the reported parameters to maintain safety and efficacy
The converter has a transducer horn that is made from titanium alloy (TI-6AL-4V). The applicator and tip are made from titanium alloy (TI-6AL-4V), like the probes for Celleration MIST and Arobella AR1000 predicated devices, and the other indirect patient-contact materials are stainless steel (both AIS) Type 300 & 17-4PH series), anodized aluminum alloy (6061), nylon, polyurethane, and silicone tubing. No latex is used in this device, including any potential patientcontact areas, and testing has revealed no negative reactions to the materials used in this device.
Specifications:
Generator Power Source
115VAC. 2.5A. 50/60Hz
Converter Power Output
Amplitude
Frequency
Weight
Generator: ~16.5 Ibs