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).

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.

AI/ML Overview

The provided document is a 510(k) summary for the Alliger Ultrasonic Surgical System Model AUSS-5. This type of submission is for demonstrating substantial equivalence to a legally marketed predicate device, rather than proving safety and efficacy through extensive clinical trials with pre-defined acceptance criteria for device performance. Therefore, many of the requested categories of information related to clinical studies and acceptance criteria are not applicable or not detailed in this document.

Here's a breakdown based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

Not Applicable. The 510(k) summary does not include an explicit table of acceptance criteria or reported device performance in the way a clinical study report would. Instead, it demonstrates substantial equivalence by comparing the design, materials, and operating parameters of the AUSS-5 to its predicate devices (AUSS-4 and CUSA Model NS-100). The "acceptance criteria" in this context are implicitly that the AUSS-5 performs comparably or better than the predicate devices and meets relevant engineering and safety standards.

The document lists "Non-Clinical Tests Performed" which include:

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.

The conclusion states that based on an analysis of operating characteristics, output of engineering tests, hazard analysis, and voluntary consensus standard investigations, the device is substantially equivalent. However, specific values or ranges for these tests are not provided in this summary.

2. Sample Size Used for the Test Set and Data Provenance

Not Applicable. This submission is based on non-clinical testing and comparison to predicate devices, not a clinical study with a "test set" of patient data. The non-clinical tests involved physical device measurements and performance evaluations.

3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications

Not Applicable. No clinical study with a "test set" and associated ground truth established by experts is described in this 510(k) summary.

4. Adjudication Method for the Test Set

Not Applicable. No clinical study with a "test set" requiring adjudication is described.

5. Multi Reader Multi Case (MRMC) Comparative Effectiveness Study

No. The document explicitly states "Discussions of Clinical Tests Performed: N/A". Therefore, no MRMC study was conducted or reported in this summary.

6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study

No. The Alliger Ultrasonic Surgical System is a physical surgical device, not an algorithm, and the submission clarifies that no clinical tests were performed.

7. Type of Ground Truth Used

Not Applicable. No clinical study requiring "ground truth" (e.g., pathology, outcomes data) is described. The basis for the submission is non-clinical engineering and performance testing, and comparison to legally marketed predicate devices.

8. Sample Size for the Training Set

Not Applicable. As no clinical study was performed, there is no "training set" of data as described in the context of an algorithm or AI.

9. How the Ground Truth for the Training Set Was Established

Not Applicable. Since there was no training set, there was no ground truth to establish for it.

Summary

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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:	(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 SystemUltrasonic Surgical Aspirator
	Classification Name:	Instrument, Ultrasonic Surgical
3.	Predicate Device Information
	Predicate Devices	Alliger Ultrasonic Surgical System model AUSS-4 and the CavitronUltrasonic Surgical Aspirator (CUSA) Model NS-100 UltrasonicSurgical 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 crystalsmounted in a hand-held handpiece; the crystals then vibrate at the samefrequency. The titanium tip attached to the handpiece amplifies thevibration. An irrigation / aspiration unit is provided to introduceirrigation solution and remove fragmented material and waste liquidsfrom the area.
5.	Intended Use:	The Alliger Ultrasonic Surgical System is indicated for use in thefragmentation and aspiration of both soft and hard (e.g.: bone) tissue inthe following surgical specialties:NeurosurgeryGastrointestinal and Affiliated Organ SurgeryUrological SurgeryPlastic and Reconstructive SurgeryGeneral SurgeryOrthopedic SurgeryGynecologyExternal genitalia- condyloma- 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

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.

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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.

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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 (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

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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 -

Regulation Number and Section

N/A