AUSS-6 ULTRASONIC SURGICAL ASPIRATOR SYSTEM

K050776 · Misonix, Inc. · LFL · Jun 6, 2005 · SU

Device Facts

• Record ID: K050776
• Device Name: AUSS-6 ULTRASONIC SURGICAL ASPIRATOR SYSTEM
• Applicant: Misonix, Inc.
• Product Code: LFL · SU
• Decision Date: Jun 6, 2005
• Decision: SESE
• Submission Type: Traditional
• Device Class: Class U
• Attributes: Therapeutic

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.

Device Story

AUSS-6 is an ultrasonic surgical aspirator system consisting of a generator, handpiece, and irrigation/aspiration components. The generator delivers a 22.5 kHz electrical signal to piezoelectric crystals in the handpiece, causing vibration. A titanium tip amplifies this vibration to fragment tissue. An integrated irrigation system delivers solution to the site, while an aspirator removes fragmented tissue and waste liquids. Used in OR settings by surgeons for tissue ablation and wound debridement. The device allows for precise tissue removal, potentially reducing trauma to surrounding healthy tissue compared to traditional sharp debridement. Healthcare providers operate the handpiece directly to perform procedures; output is the physical fragmentation and removal of target tissue.

Clinical Evidence

No new clinical trials were conducted for soft and hard tissue ablation as these indications are well-established for ultrasonic aspirators. Clinical evidence for wound debridement was provided via literature review and clinical test results (Exhibit L), supporting the safety and efficacy of the device for debriding burns, ulcers, and septic wounds.

Technological Characteristics

System includes generator, handpiece with piezoelectric crystals, and titanium tip. Operates at 22.5 kHz. Includes irrigation and aspiration pumps. Complies with UL 2601-1, EN 60601-1, EN 60601-1-2:2001, and FCC Part 18. No software component.

Indications for Use

Indicated for fragmentation and aspiration of soft and hard (bone) tissue in neurosurgery, GI, urological, plastic/reconstructive, general, orthopedic, and gynecological surgery. Specific applications include benign/malignant tumors, cystic lesions (Bartholin's, vestibular, inclusion, sebaceous), abdominal growths, and limited pulmonary resections. Also indicated for wound debridement (burns, diabetic ulcers, bedsores, vaginal ulcers) and surgical site cleansing where sharp debridement is required.

Predicate Devices

• CUSA NS-100 Ultrasonic Surgical Aspirator System (K801623)
• Alliger Ultrasonic Surgical System AUSS-5 (K012028)

Submission Summary (Full Text)

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# 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<br>System and Accessories |
|----------------------|-----------------------------------------------------------------------------|
| Common/Usual Name: | Ultrasonic Surgical System<br>Ultrasonic Surgical Aspirator |
| Classification Name: | Instrument, Ultrasonic Surgical |

#### 3. Predicate Device Information

| Predicate Devices | CUSA NS-100 Ultrasonic Surgical Aspirator<br>System K801623<br>Alliger Ultrasonic Surgical System AUSS-5<br>K012028 |
|-----------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| 4. Device Description | The AUSS-6 Ultrasonic Surgical System is<br>comprised of a generator, which feeds a 22.5 kHz<br>electrical signal to a piezoelectric crystals mounted<br>in a hand-held handpiece; the crystals then vibrate<br>at the same frequency. The titanium tip attached to<br>the handpiece amplifies the vibration. An irrigation<br>unit is provided to introduce irrigation solution to<br>the operative site. An aspirator system removes<br>fragmented material and waste liquids from the<br>area. Accessories include probe tips, wrenches,<br>sterile and non sterile tube sets and sterile Surgical<br>Procedure bags. |

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| 5. | Intended Use: | The AUSS-6 Ultrasonic Surgical Aspiration<br>System and Accessories are indicated for the<br>fragmentation and aspiration of soft and<br>hard (i.e. bone) tissues in various General<br>and Specialty surgery applications. It is also<br>indicated for use in the debridement of<br>wounds (such as, but not limited to, burn<br>wounds, diabetic ulcers, bedsores and<br>vaginal ulcers), soft tissue debridement and<br>cleansing of the surgical site in applications<br>in which, in the physician's judgment would<br>require the use of an ultrasonic aspirator<br>with sharp debridement. |
|----|--------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| 6. | Comparison to Predicate Device | AUSS-6 Ultrasonic Surgical Aspirator<br>System and Accessories are similar in<br>design, material and operating parameters to<br>the Misonix Inc. AUSS-5 Ultrasonic<br>Surgical Aspirator, the CUSA NS-100<br>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:

.

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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.

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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.

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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 [phone] . 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 [phone] or [phone] 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

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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

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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

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