(29 days)
AUSS-4, NS-100
Not Found
No
The device description and performance studies focus on the mechanical and electrical aspects of an ultrasonic surgical system, with no mention of AI or ML technologies.
Yes.
The device is used for surgical fragmentation and aspiration of tissues, which is a therapeutic intervention.
No
The device description and intended use indicate it is an ultrasonic surgical system designed for tissue fragmentation and aspiration, which are therapeutic procedures, not diagnostic ones.
No
The device description clearly outlines hardware components including a generator, handpiece with piezoelectric crystals and titanium tip, and an irrigation/aspiration unit.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly describes a surgical system used for the fragmentation and aspiration of tissue within the body during various surgical procedures. This is an in vivo application, not an in vitro (outside the body) diagnostic test.
- Device Description: The description details a system that uses ultrasonic vibrations to break down tissue and an irrigation/aspiration unit to remove it. This is a surgical tool, not a device designed to analyze samples of bodily fluids or tissues for diagnostic purposes.
- Lack of Diagnostic Elements: There is no mention of analyzing samples, detecting biomarkers, or providing diagnostic information based on the analysis of biological specimens.
IVD devices are specifically designed to perform tests on samples taken from the human body (like blood, urine, tissue biopsies) to provide information for diagnosis, monitoring, or screening. The Alliger Ultrasonic Surgical System is a therapeutic and surgical tool used directly on the patient's tissue during surgery.
N/A
Intended Use / Indications for Use
The Alliger Ultrasonic Surgical System is 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 resection such as segmetectomies, nonanatomical subsegmentectomies, and metastatectomies
Product codes
LFL
Device Description
The Alliger 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 / aspiration unit is provided to introduce irrigation solution and remove fragmented material and waste liquids from the area.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Soft and hard (e.g.: bone) tissue in the following surgical specialties: Neurosurgery, Gastrointestinal and Affiliated Organ, Urological, Plastic and Reconstructive, General, Orthopedic, Gynecology (External genitalia, Abdominal area), Thoracic.
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)
Non-Clinical Tests Performed: Output Frequency Measurements, Output Power Measurements (No Load to Maximum Load), Tip Displacement Measurements, Irrigation Flowrate Measurements (Ultrasound On and Flush Mode), 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.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Alliger Ultrasonic Surgical System model AUSS-4, CUSA Model NS-100 Ultrasonic Surgical Aspirator
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
N/A
0
510K SUMMARY – Alliger Ultrasonic Surgical System Model AUSS-5
0/2028
This summary of 510(k)-safety and effectiveness information is being submitted in accordance with the requirements of SMSA 1990 and 21CFR 807.92.
Submitter's Identification 1.
| Name: | MISONIX, INC. | |
|---|---|---|
| Address: | 1938 New Highway, Farmingdale, NY 11735 | |
| Telephone Number: | (631) 694-9555 | |
| Contact Person: | Albert F. Clancy Jr. | |
| Date Prepared: | 22 June 2001 | |
| 2. | Name of Device | |
| Proprietary Name: | Alliger Ultrasonic Surgical System Model AUSS-5 | |
| Common / Usual Name: | Ultrasonic Surgical System | |
| Ultrasonic Surgical Aspirator | ||
| Classification Name: | Instrument, Ultrasonic Surgical | |
| 3. | Predicate Device Information | |
| Predicate Devices | Alliger Ultrasonic Surgical System model AUSS-4 and the Cavitron | |
| Ultrasonic Surgical Aspirator (CUSA) Model NS-100 Ultrasonic | ||
| Surgical Aspirator | ||
| 4. | Device Description | The Alliger 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 / aspiration unit is provided to introduce | ||
| irrigation solution and remove fragmented material and waste liquids | ||
| from the area. | ||
| 5. | Intended Use: | The Alliger Ultrasonic Surgical System is 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) |
-
and the following cystic lesions:
- Bartholin's cysts -
- Vestibular adenitis u
- Inclusion cysts -
- Sebaceous cysts -
1
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 resection such as segmetectomies, nonanatomical subsegmentectomies, and metastatectomies
- Comparison to Predicate Device:
The Alliger Ultrasonic Surgical Systems are similar in design, material and operating parameters to the CUSA NS-100 Ultrasonic Surgical Aspirator. Although the CUSA NS-100 has a magneto-strictive transducer and the Alliger Ultrasonic Surgical Systems have a piezoelectric transducer, and has been previously determined by the FDA to be substantially equivalent.
- Discussions of 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 (Ultrasound On and Flush Mode) 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.
- Discussions of Clinical Tests Performed
N/A
- Conclusions
Based upon an analysis of the operating characteristic specifications, Output of Engineering Tests, Hazard Analysis, and Voluntary Consensus Standard Investigations, Misonix, Inc. has concluded that the Alliger Ultrasonic System Model AUSS-5 is substantially equivalent to both the AUSS-4, and the CUSA Model NS-100 system.
2
Image /page/2/Picture/2 description: The image shows a partial view of the Department of Health & Human Services logo. The text "DEPARTMENT OF HEALTH &" is visible along the left side, oriented vertically. To the right of the text is the symbol of the department, which features a stylized caduceus.
JUL 27 2001
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Mr. Albert F. Clancy, Jr. Manager, Quality Assurance/Regulatory Affairs Misonix, Inc. 1938 New Highway Farmingdale, New York 11735
Re: K012028
Trade/Device Name: Alliger Ultrasonic Surgical System (Model AUSS-5) Regulation Number: 878.4400 Regulatory Class: II Product Code: LFL Dated: June 22, 2001 Received: June 28, 2001
Dear Mr. Clancy:
We have reviewed your Section 510(k) notification of intent to market the device referenced wo have review four bothed the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce beared in the 228, 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). You may, therefore, market the device, subject to the general controls Southers of the Act. The general controls provisions of the Act include requirements for annual provisions of the Prea. The Press, 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 (Premarket Approval), 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 895. A substantially equivalent determination assumes compliance with the Current Good Manufacturing Practice requirements, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic QS inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.
3
Page 2 - Mr. Albert F. Clancy, Jr.
This letter will allow you to begin marketing your device as described in your 510(k) premarket This lotter will and in your of substantial equivalence of your device to a legally marketed nouticate 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 and 11 you decline specially an in vitro diagnostic devices), please contact the Office of Compliance at additionally 60911 o ditionally, for questions on the promotion and advertising of your device, (Jease contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its internet address "http://www.fda.gov/cdrh/dsma/dsmamain.html".
Sincerely yours,
Celia M. Witten, Ph.D., M.D. Director
Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
PREMARKET NOTIFICATION
INDICATIONS FOR USE
510k Number: K012028
Device Name: Alliger Ultrasonic Surgical System (Model AUSS-5)
The Alliger Ultrasonic Surgical System is indicated for use in the fragmentation and aspiration of both soft and hard (c.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 turnors (lipomas, fibromas, and . lciomyomas)
- . malignant primary and metastatic tumors of all types and the following cystic lesions:
- A Bartholin's cysts
- A Vestibular adenitis
- A Inclusion cysts
- A 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 resection such as segmetectomies, nonanatomical subsegmentectomics, and metastatectomies
Ro. Mark N. Millbern
(Division Sign-Off) (Division of General, Restorative Division ological Devices
510(k) Number -