(23 days)
The Alliger Ultrasonic Surgical System is indicated for use in the fragmentation and aspiration of soft 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 and 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 segmentectomies, nonanatomical subsegmentectomies, and metastatectomies
The Alliger Ultrasonic Surgical System is comprised of a generator which feeds a 40 kHz electrical signal to piezoelectric crystals mounted in a hand-held Handpiece: the crystals then vibrate at the same frequency. The vibration is amplified by a titanium Tip attached to the Handpiece. Fragmentation of unwanted tissue occurs at the end of the Tip. An Irrigation/Aspiration unit is provided to introduce irrigation solution and remove fragmented material and waste liquids.
The provided 510(k) summary for the Alliger Ultrasonic Surgical System Model AUSS-4 focuses on establishing substantial equivalence to predicate devices based on non-clinical engineering tests, rather than clinical performance acceptance criteria. Therefore, many of the requested items (e.g., sample size, expert qualifications, adjudication methods, MRMC studies, standalone performance, training set details) are not applicable or not provided in this regulatory submission as it pertains to a pre-market notification for a Class II device.
Here's a breakdown of the available information:
1. Table of Acceptance Criteria and Reported Device Performance
The submission does not present specific acceptance criteria in terms of clinical performance metrics (e.g., sensitivity, specificity, accuracy) because it's a device for surgical fragmentation and aspiration, not a diagnostic or imaging device. Instead, the acceptance criteria were based on demonstrating that its operating characteristics are "substantially equivalent" to predicate devices through engineering tests.
| Acceptance Criteria (Demonstration of Substantial Equivalence via Engineering Tests) | Reported Device Performance (Implied by equivalence claim) |
|---|---|
| Output Frequency Measurements within appropriate range | System operates at 40 kHz, similar to predicate's operating frequency. |
| Output Power Measurements (No Load to Maximum Load) similar to predicate | Power output is comparable to predicate, ensuring effective tissue fragmentation. |
| Tip Displacement Measurements similar to predicate | Titanium tip vibrates effectively for tissue fragmentation. |
| Irrigation Flowrate Measurements (Ultrasound On and Flush Mode) similar to predicate | Effective irrigation and aspiration for clear surgical field and waste removal. |
| Life Tests demonstrating durability | Device maintains functionality over expected operational lifespan. |
| Vacuum Flowrate and Pressure Measurements similar to predicate | Efficient aspiration of fragmented tissue and liquids. |
| Input Power Measurements within specifications | Device operates safely and efficiently with standard power input. |
| EMI Tests demonstrating electromagnetic compatibility | Device does not cause or succumb to electromagnetic interference. |
| Dielectric Tests on Mains Circuits demonstrating electrical safety | Electrical insulation meets safety standards for mains circuits. |
| Patient Current Leakage and Patient Sink Current Measurements within safety limits | Minimal current leakage to ensure patient safety. |
| Power Line Ground Leakage Measurements within safety limits | Safe grounding to prevent electrical hazards. |
| Dielectric Tests on Patient Circuits demonstrating electrical safety | Electrical insulation meets safety standards for patient-contacting circuits. |
2. Sample size used for the test set and the data provenance
- Sample size: Not applicable. The study involved non-clinical engineering tests, not a "test set" of patients or data in the traditional sense for evaluating diagnostic or predictive performance.
- Data provenance: Not applicable. These were engineering measurements conducted by the manufacturer, Misonix Inc., likely in their laboratory or a contracted testing facility.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
- Not applicable. Ground truth for engineering tests is established by physical measurement standards and engineering specifications, not expert consensus as would be used for clinical interpretations.
4. Adjudication method for the test set
- Not applicable. There was no clinical test set requiring adjudication.
5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
- No. This device is an ultrasonic surgical system, not an AI-powered diagnostic or interpretive tool that would involve human readers.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Not applicable. This is not an algorithmic or AI-driven device. Its performance is inherent to its mechanical and electrical operation.
7. The type of ground truth used
- The "ground truth" for the engineering tests would be measured physical parameters and compliance with established engineering and safety standards (e.g., electrical safety standards, mechanical performance benchmarks, frequency and power specifications). The predicate devices (ValleyLab CUSA® Model 200H and Spembly Selector®) served as benchmarks for demonstrating substantial equivalence of these parameters.
8. The sample size for the training set
- Not applicable. There was no training set, as this is not a machine learning or AI device.
9. How the ground truth for the training set was established
- Not applicable.
Summary of the Study Proving Device Meets Acceptance Criteria:
The study proving the Alliger Ultrasonic Surgical System Model AUSS-4 meets its acceptance criteria (i.e., is substantially equivalent to predicate devices) was a non-clinical engineering study.
- Objective: To determine that the operating characteristics of the Alliger Ultrasonic Surgical System Model AUSS-4 are substantially equivalent to the predicate devices (ValleyLab CUSA® Model 200H and Spembly Selector® Ultrasonic Surgical Aspirator).
- Methodology: A series of engineering tests were performed, including:
- 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
- Comparison: The results of these tests were compared to the known operating parameters and safety profiles of the predicate devices. The submission also highlights that while the CUSA 200H uses a magnetostrictive transducer, the Spembly Selector, which was previously deemed substantially equivalent to the CUSA 200H, uses a similar piezoelectric transducer as the Alliger system, strengthening the basis for comparison.
- Conclusion: Based on the analysis of these engineering tests, hazard analysis, and voluntary consensus standard investigations, Misonix Inc. concluded that the Alliger Ultrasonic Surgical System Model AUSS-4 is substantially equivalent to its predicate devices. The FDA concurred with this determination, allowing the device to be marketed.
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K 982841
l
4 1998 SEP
510(k) SUMMARY - Alliger Ultrasonic Surgical System Model AUSS-4
This summary of 510(k) safety and effectiveness information is being submitted in accordance with the requirements of SMDA 1990 and 21 CFR 807.92.
The assigned 510(k) number is:
- Submitter's Identification 1.
| Name: | MISONIX INCORPORATED |
|---|---|
| Address: | 1938 New Highway, Farmingdale, NY 11735 |
| Telephone Number: | 516-694-9555 |
| Contact Person: | Ronald Manna |
| Date Prepared: | 6/16/98 |
- Name of Device 2.
| Proprietary Name: | Alliger Ultrasonic Surgical System Model AUSS-4 |
|---|---|
| Common/Usual Name: | Ultrasonic Surgical SystemUltrasonic Surgical Aspirator |
| Classification Name: | Instrument, Ultrasonic Surgical |
3. Predicate Device Information
ValleyLab CUSA® Model 200H Ultrasonic Surgical Predicate Device: Aspirator Spembly Selector® Ultrasonic Surgical Aspirator
- The Alliger Ultrasonic Surgical System is comprised of a Device Description: 4. generator which feeds a 40 kHz electrical signal to piezoelectric crystals mounted in a hand-held Handpiece: the crystals then vibrate at the same frequency. The vibration is amplified by a titanium Tip attached to the Handpiece. Fragmentation of unwanted tissue occurs at the end of the Tip. An Irrigation/Aspiration unit is provided to introduce irrigation solution and remove fragmented material and waste liquids.
- ર્ . Intended Use: The Alliger Ultrasonic Surgical System is indicated for use in the fragmentation and aspiration of soft tissue in the following surgical specialties:
{1}------------------------------------------------
-
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 and 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 segmentectomies, nonanatomical subsegmentectomies, and metastatectomies
-
The Alliger Ultrasonic Surgical System is similar in Comparison to Predicate Device: 6. design, material and operating parameters to the Ultrasonic Surgical Aspirator. CUSA 200H® Although the CUSA 200H® has a magneto-strictive transducer and the Alliger Ultrasonic Surgical System has a piezoelectric transducer, the Spembly Selector®, which also contains a piezoelectric transducer, has been previously determined by FDA to be substantially equivalent to the CUSA 200H®.
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-
- Discussion of Non-Clinical Tests Performed for Determination of Substantial Equivalence are as follows:
The following engineering tests were performed to determine that operating characteristics are substantially equivalent to the predicate device.
- Discussion of Non-Clinical Tests Performed for Determination of Substantial Equivalence are as follows:
ﺯﻥ
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
-
- Discussion of Clinical Tests Performed
N/A
- Discussion of Clinical Tests Performed
-
- 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 Surgical System Model AUSS-4 is substantially equivalent to the CUSA Model 200H and the Spembly Selector Ultrasonic Surgical System.
- Conclusions
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Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized symbol featuring three abstract human figures or forms, possibly representing people or services provided by the department.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
SEP 4 1998
Misonix, Inc. c/o MDI Consultants, Inc. Ms. Susan D. Goldstein-Falk Official Correspondent for Misonix, Inc. 55 Northern Blvd., Suite 200 Great Neck. New York 11021
K982841 Re:
Trade Name: Modification to Alliger Ultrasonic Surgical System Model AUSS-4 Regulatory Class: Unclassified Product Code: LFL Dated: August 10, 1998 Received: August 12, 1998
Dear Ms. Goldstein-Falk:
We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to devices marketed in interstate commerce prior to May 28, 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 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 (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 requirement, 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 - Ms. Susan D. Goldstein-Falk
This letter will allow you to begin marketing your device as described in your 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 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4595. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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/dsmamain.html".
Sincerely yours,
Celia M. Witten, Ph.D., M.D.
Celia M. Witten, Ph.D., M.D. Director Division of General and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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510(k) Number (if known):
Alliger Ultrasonic Aspirator Model AUSS-4
Device Name
Indications For Use
The Alliger Ultrasonic Surgical System is indicated for use in The Alliger Ulcration and aspiration of soft tissue in the following surgical specialities:
Neurosurgery Gastrointestinal and Affiliated Organ Surgery Urological Surgery Plastic and Reconstructive Surgery General Surgery Orthopedic Surgery Gynecology External genitalia - contlyloma
- benign tumors (lipomea, fibromas and leiomyomas)
- malignant primary and metastatic tumors of all types and the following cystic lesions: Bartholin's cysts, vestibular adenitis, inclusion cysts and 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 segmentectomies, nonanatomical subsegmentectetomies and metastatectomies
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
(Division Sign-Off)
Division of General Restorative Devices [K982841](https://510k.innolitics.com/search/K982841)
510(k) Number
Prescription Use OR Over-The-Counter Use
(Per 21 CFR 801.109)
OR
(Optional Formal 1-2-96)
N/A