ALLIGER ULTRASONIC SURGICAL SYSTEM MODEL AUSS-5

K012028 · Misonix, Inc. · LFL · Jul 27, 2001 · SU

Device Facts

• Record ID: K012028
• Device Name: ALLIGER ULTRASONIC SURGICAL SYSTEM MODEL AUSS-5
• Applicant: Misonix, Inc.
• Product Code: LFL · SU
• Decision Date: Jul 27, 2001
• Decision: SESE
• Submission Type: Special
• Device Class: Class U
• Attributes: Therapeutic

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 - Inclusion cysts - Sebaceous cysts Abdominal area any abnormal growth, cystic or solid, benign or malignant, involving the ovary, fallopathic tube, uterus, or the supporting structures of the uterus. Thoracic Surgery Limited pulmonary resection such as segmetectomies, nonanatomical subsegmentectomies, and metastatectomies

Device Story

Ultrasonic surgical system for tissue fragmentation and aspiration. Generator feeds 22.5 kHz electrical signal to handpiece piezoelectric crystals; crystals vibrate at frequency; titanium tip amplifies vibration for tissue fragmentation. Integrated irrigation/aspiration unit introduces solution and removes fragmented material/waste. Used by surgeons in OR settings across multiple specialties (neurosurgery, GI, urology, plastic, general, orthopedic, gynecology, thoracic). Output allows precise tissue removal; benefits include controlled fragmentation of soft and hard tissues.

Clinical Evidence

No clinical data. Substantial equivalence determined via bench testing and engineering analysis.

Technological Characteristics

System includes generator, handpiece with piezoelectric transducer, and titanium tip. Operates at 22.5 kHz. Includes irrigation/aspiration pump. Bench testing performed: output frequency/power, tip displacement, flow rates, vacuum pressure, EMI, dielectric, and patient leakage current.

Indications for Use

Indicated for fragmentation and aspiration of soft and hard (bone) tissue in patients undergoing neurosurgery, GI, urological, plastic/reconstructive, general, orthopedic, gynecological, and thoracic surgeries. Includes treatment of benign/malignant tumors, cystic lesions, and pulmonary resections.

Predicate Devices

• Alliger Ultrasonic Surgical System model AUSS-4
• Cavitron Ultrasonic Surgical Aspirator (CUSA) Model NS-100 (K012028)

Submission Summary (Full Text)

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# 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: | [phone] |
| | 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<br>Ultrasonic Surgical Aspirator |
| | Classification Name: | Instrument, Ultrasonic Surgical |
| 3. | Predicate Device Information | |
| | Predicate Devices | Alliger Ultrasonic Surgical System model AUSS-4 and the Cavitron<br>Ultrasonic Surgical Aspirator (CUSA) Model NS-100 Ultrasonic<br>Surgical Aspirator |
| 4. | Device Description | The Alliger Ultrasonic Surgical System is comprised of a generator,<br>which feeds a 22.5 kHz electrical signal to a piezoelectric crystals<br>mounted in a hand-held handpiece; the crystals then vibrate at the same<br>frequency. The titanium tip attached to the handpiece amplifies the<br>vibration. An irrigation / aspiration unit is provided to introduce<br>irrigation solution and remove fragmented material and waste liquids<br>from the area. |
| 5. | Intended Use: | The Alliger Ultrasonic Surgical System is indicated for use in the<br>fragmentation and aspiration of both soft and hard (e.g.: bone) tissue in<br>the following surgical specialties:<br><br>Neurosurgery<br>Gastrointestinal and Affiliated Organ Surgery<br>Urological Surgery<br>Plastic and Reconstructive Surgery<br>General Surgery<br>Orthopedic Surgery<br>Gynecology<br>External genitalia<br>- condyloma<br>- benign tumors (lipomas, fibromas, and leiomyomas) |

- and the following cystic lesions:
- Bartholin's cysts -
- Vestibular adenitis u
- Inclusion cysts -
- Sebaceous cysts -

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#### 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

6. 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.

7. 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.

8. Discussions of Clinical Tests Performed

N/A

9. 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.

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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.

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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 [phone]. 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 [phone] or [phone] 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

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# 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 -