(70 days)
No
The device description focuses on the mechanical and electrical components of an ultrasonic surgical aspiration system. There is no mention of AI, ML, image processing, or data-driven decision-making within the provided text. The performance studies listed are standard electrical and mechanical tests, not AI/ML model validation.
Yes
Explanation: The device is indicated for various surgical applications and for the debridement of wounds, which are therapeutic interventions.
No
The AUSS-6 Ultrasonic Surgical Aspiration System is indicated for the fragmentation and aspiration of tissues and debridement of wounds, which are therapeutic functions, not diagnostic ones.
No
The device description explicitly details hardware components including a generator, handpiece with piezoelectric crystals, titanium tip, irrigation unit, and aspirator system.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices used to perform tests on samples taken from the human body, such as blood, urine, or tissue, to provide information for diagnosis, monitoring, or screening.
- Device Function: The AUSS-6 Ultrasonic Surgical Aspiration System is a surgical tool used for the fragmentation and aspiration of tissues during surgical procedures and wound debridement. It operates directly on the patient's body.
- Intended Use: The intended use clearly describes surgical procedures and wound care, not laboratory testing of samples.
- Device Description: The description details a surgical system with a generator, handpiece, tips, irrigation, and aspiration, all designed for use during surgery.
Therefore, the AUSS-6 Ultrasonic Surgical Aspiration System falls under the category of a surgical device, not an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The Alliger AUSS-6 Ultrasonic Surgical System and Accessories are indicated for use in the fragmentation and aspiration of both soft and hard (e.g.: bone) tissue in the following surgical specialties:
- Neurosurgery Gastrointestinal and Affiliated Organ Surgery Urological Surgery Plastic and Reconstructive Surgery General Surgery Orthopedic Surgery Gynecology External genitalia
- condyloma
- benign tumors (lipomas, fibromas, and leiomyomas)
- malignant primary and metastatic tumors of all types and the following cystic lesions:
- Bartholin's cysts
- Vestibular adenitis
- Inclusion cysts
- Sebaceous cysts
Abdominal area
any abnormal growth, cystic or solid, benign or malignant, involving the ovary, fallopian tube, uterus, or the supporting structures of the uterus.
Thoracic Surgery
Limited pulmonary reception such as segmetectomies, nonanatomical subsegmentectomies and metastatectomies.
Wound Care
The Misonix Inc. AUSS-6 Utrasonic Surgical Aspirator is also indicated for use in the debridement of wounds, such as, but not limited to, burn wounds, diabetic ulcers, bedsores and vaginal ulcers, soft tissue debridement and cleansing of the surgical site in applications in which, in the physician's judgement would require the use of an ultrasonic aspirator with sharp debridement.
Product codes
LFL
Device Description
The AUSS-6 Ultrasonic Surgical System is comprised of a generator, which feeds a 22.5 kHz electrical signal to a piezoelectric crystals mounted in a hand-held handpiece; the crystals then vibrate at the same frequency. The titanium tip attached to the handpiece amplifies the vibration. An irrigation unit is provided to introduce irrigation solution to the operative site. An aspirator system removes fragmented material and waste liquids from the area. Accessories include probe tips, wrenches, sterile and non sterile tube sets and sterile Surgical Procedure bags.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
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)
The Misonix Inc. AUSS-6 Ultrasonic Surgical Aspirator System and Accessories have been designed and tested to pass the following Voluntary Standards:
UL 2601-1 Medical Electrical Equipment, Part 1: General Requirements for Safety EN 60601-1 Medical Electrical Equipment, Part 1: General Requirements for Safety EN 60601-1-2:2001 Electromagnetic Compatibility FCC Part 18 EMC Requirements
Non-Clinical Tests Performed for Determination of Substantial Equivalence are as follows:
Output Frequency Measurements Output Power Measurements (No Load to Maximum Load) Tip Displacement Measurements Irrigation Flowrate Measurements Life Tests Vacuum Flowrate and Pressure Measurements Input Power Measurements EMI Tests Dielectric Tests on Mains Circuits Patient Current Leakage and Patient Sink Current Measurements Power Line Ground Leakage Measurements Dielectric Tests on Patient Circuits.
No clinicals were conducted for existing indications for use. Clinical tests for Wound Debridement were performed, results included in Exhibit L.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
N/A
0
JUN 6 - 2005
K050776
510(k) SUMMARY - Misonix Inc. AUSS-6 Ultrasonic Surgical Exhibit E Aspirator System and Accessories
This summary of safety and effectiveness information is being submitted in accordance with the requirements of SMDA 1990 and 21CFR 807.92.
!. Submitter's Identification
| Submitter's Name: | MISONIX INCORPORATED |
|---|---|
| Address: | 1938 New Highway, Farmingdale, NY 11735 |
| Telephone Number: | 516-694-9555 |
| Contact Person: | Ronald R. Manna |
| Date Prepared: | February 5, 2005 |
Name of Device 2.
:
| Proprietary Name: | Misonix Inc. AUSS-6 Ultrasonic Surgical Aspirator
System and Accessories |
|----------------------|-----------------------------------------------------------------------------|
| Common/Usual Name: | Ultrasonic Surgical System
Ultrasonic Surgical Aspirator |
| Classification Name: | Instrument, Ultrasonic Surgical |
3. Predicate Device Information
| Predicate Devices | CUSA NS-100 Ultrasonic Surgical Aspirator
System K801623
Alliger Ultrasonic Surgical System AUSS-5
K012028 |
|-----------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| 4. Device Description | The AUSS-6 Ultrasonic Surgical System is
comprised of a generator, which feeds a 22.5 kHz
electrical signal to a piezoelectric crystals mounted
in a hand-held handpiece; the crystals then vibrate
at the same frequency. The titanium tip attached to
the handpiece amplifies the vibration. An irrigation
unit is provided to introduce irrigation solution to
the operative site. An aspirator system removes
fragmented material and waste liquids from the
area. Accessories include probe tips, wrenches,
sterile and non sterile tube sets and sterile Surgical
Procedure bags. |
1
| 5. | Intended Use: | The AUSS-6 Ultrasonic Surgical Aspiration
System and Accessories are indicated for the
fragmentation and aspiration of soft and
hard (i.e. bone) tissues in various General
and Specialty surgery applications. It is also
indicated for use in the debridement of
wounds (such as, but not limited to, burn
wounds, diabetic ulcers, bedsores and
vaginal ulcers), soft tissue debridement and
cleansing of the surgical site in applications
in which, in the physician's judgment would
require the use of an ultrasonic aspirator
with sharp debridement. |
|----|--------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| 6. | Comparison to Predicate Device | AUSS-6 Ultrasonic Surgical Aspirator
System and Accessories are similar in
design, material and operating parameters to
the Misonix Inc. AUSS-5 Ultrasonic
Surgical Aspirator, the CUSA NS-100
Ultrasonic Surgical Aspirator. |
7. Safety and Performance Data
The Misonix Inc. AUSS-6 Ultrasonic Surgical Aspirator System and Accessories have been designed and tested to pass the following Voluntary Standards:
UL 2601-1 Medical Electrical Equipment, Part 1: General Requirements for Safety EN 60601-1 Medical Electrical Equipment, Part 1: General Requirements for Safety EN 60601-1-2:2001 Electromagnetic Compatibility FCC Part 18 EMC Requirements
| 7. Software Validation | This device does not contain software. |
|---|---|
| 8. Sterilization Validations | Validation statements are contained in Exhibit J |
9. Non-Clinical Tests Performed for Determination of Substantial Equivalence are as follows:
.
2
Output Frequency Measurements Output Power Measurements (No Load to Maximum Load) Tip Displacement Measurements Irrigation Flowrate Measurements Life Tests Vacuum Flowrate and Pressure Measurements Input Power Measurements EMI Tests Dielectric Tests on Mains Circuits Patient Current Leakage and Patient Sink Current Measurements Power Line Ground Leakage Measurements Dielectric Tests on Patient Circuits
9. Discussions of Clinical Tests Performed
The FDA has cleared all indications for use in the predicates since the early 1980's, with the exception of the express indication of Wound Debridement. Ultrasonic Surgical Aspirators have been employed for use in soft and hard tissue ablation for the past 30 years and are well documented in the public domain. Therefore, no clinicals were conducted in anticipation of this submission for those indications.
The use of an Ultrasonic Surgical System for debriding and cleansing of burns, ulcers or septic wounds has been investigated for decades. Several papers have discussed the use of the product in such applications and tabulated the results in Exhibit L. The AUSS-6 has also been the subject of clinical tests for Wound Debridment. The results of these tests are included in Exhibit L as well.
10. Conclusions
Based upon a review of the published literature Misonix Inc. can state that the use of an Ultrasonic Surgical Aspirator for Wound Debridement is safe and efficacious. We can also state that the AUSS-6 is substantially equivalent in this regard to the CUSA NS-100, the Misonix Inc. AUSS-5 in soft and hard tissue ablation. The AUSS-6 is also substantially equivalent to sharps debridment of wounds caused by various mechanisms such as burns, radiation and diabetes. Based upon the clinical experiences outlined herein. the Misonix Inc. AUSS-6 Ultrasonic Surgical System and Accessories pose no new issues of safety or efficacy when used for wound debridement.
3
Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a stylized eagle-like symbol with three curved lines representing the body and wings. The symbol is enclosed within a circle, and the text "DEPARTMENT OF HEALTH AND HUMAN SERVICES, USA" is written around the circumference of the circle.
JUN & - 2005
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Mr. Ronald R. Manna Vice President Regulatory Affairs Misonix Incorporated 1938 New Highway Farmingdale, New York 11735
Re: K050776
Trade/Device Name: AUSS-6 Ultrasonic Surgical Aspirator Systems and Accessories Regulatory Class: Unclassified Product Code: LFL Dated: March 23, 2005 Received: March 28, 2005
Dear Mr. Manna:
We have reviewed your Section 510(k) premarket notification of intent to market the device we nave roviewed your becamed the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate for associated in the encrease to 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 your 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 Orth 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.
4
Page 2 - Mr. Ronald R. Manna
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/cdrh/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
5
510(k) Number (if known): K050776
Device Name: AUSS-6 Ultrasonic Surgical Aspirator System and Accessories
Indications for Use:
The Alliger AUSS-6 Ultrasonic Surgical System and Accessories are indicated for use in the fragmentation and aspiration of both soft and hard (e.g.: bone) tissue in the following surgical specialties:
- Neurosurgery Gastrointestinal and Affiliated Organ Surgery Urological Surgery Plastic and Reconstructive Surgery General Surgery Orthopedic Surgery Gynecology External genitalia
- condyloma ت
- benign tumors (lipomas, fibromas, and leiomyomas)
- ﺪ malignant primary and metastatic tumors of all types and the following cystic lesions:
- Bartholin's cysts -
- Vestibular adenitis -
- Inclusion cysts -
- Sebaceous cysts «
Prescription Use (Part 21 CFR 801 Subpart D)
AND/OR
Over-The-Counter Use (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
General, Restorative
Dental Devices
Page 1 of 2
6
510(k) Number (if known): K050776
Device Name: AUSS-6 Ultrasonic Surgical Aspirator System and Accessories
Indications for Use: (continued)
Abdominal area
any abnormal growth, cystic or solid, benign or malignant, involving the ovary, fallopian tube, uterus, or the supporting structures of the uterus.
Thoracic Surgery
Limited pulmonary reception such as segmetectomies, nonanatomical subsegmentectomies and metastatectomies.
Wound Care
The Misonix Inc. AUSS-6 Utrasonic Surgical Aspirator is also indicated for use in the debridement of wounds, such as, but not limited to, burn wounds, diabetic ulcers, bedsores and vaginal ulcers, soft tissue debridement and cleansing of the surgical site in applications in which, in the physician's judgement would require the use of an ultrasonic aspirator with sharp debridement.
Prescription Use X (Part 21 CFR 801 Subpart D)
AND/OR
Over-The-Counter Use (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Rüben
050776
Page 2of 2