(98 days)
The Misonix Inc. FS 1000 RF Ultrasonic Aspirator System is indicated for use in the fragmentation, emulsification 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 Gynecological Surgery Thoracic Surgery Laparoscopic Surgery Thoracoscopic Surgery The system may also be combined with electrosurgery using optional RF Surgery interface components.
The Misonix Inc. FS 1000 RF Ultrasonic Aspirator System is comprised of a generator that feeds a 23 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 system incorporates features that allow it to interface with standard electrosurgery generators (modules). By activating the output of the electrosurgery generators, RF voltage is available at the distal end of the ultrasonic cannula. This feature allows the surgeon to cauterize tissue with or without the simultaneous application of ultrasound energy.
The Misonix Inc. FS 1000 RF Ultrasonic Aspirator System is indicated for use in the fragmentation, emulsification, and aspiration of soft tissue across various surgical specialties including Neurosurgery, Gastrointestinal and Affiliated Organ Surgery, Urological Surgery, Plastic and Reconstructive Surgery, General Surgery, Orthopedic Surgery, Gynecological Surgery, Thoracic Surgery, Laparoscopic Surgery, and Thoracoscopic Surgery. The system may also be combined with electrosurgery using optional RF Surgery interface components.
The device's safety and performance were established by demonstrating substantial equivalence to predicate devices (ValleyLab CUSA® EXCEL Ultrasonic Surgical Aspirator and Misonix Inc. AUSS-5 Ultrasonic Surgical Aspirator) through non-clinical testing performed against recognized voluntary and tested standards.
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Table of acceptance criteria and the reported device performance:
Acceptance Criteria (Voluntary and Tested Standards) Reported Device Performance UL 2601-1 Medical Electrical Equipment, Part 1 Device designed to pass and tested against this standard. EN 60601-1 Medical Electrical Equipment, Part 1 Device designed to pass and tested against this standard. EN 60601-2-2 Medical Electrical Equipment, Part 2 Device designed to pass and tested against this standard. EN 60601-1-2:2001 Electromagnetic Compatibility Device designed to pass and tested against this standard (EMC Requirements). FCC Part 18 EMC Requirements Device designed to pass and tested against this standard (EMI Tests). Software Validation Software has been validated, considering failure and effects analysis. Output Frequency Measurements Performed as part of non-clinical tests. Output Power Measurements (No Load to Maximum Load) Performed as part of non-clinical tests. Tip Displacement Measurements Performed as part of non-clinical tests. Irrigation Flowrate Measurements Performed as part of non-clinical tests. Life Tests Performed as part of non-clinical tests (RF Cautery Life Tests). Vacuum Flowrate and Pressure Measurements Performed as part of non-clinical tests. Input Power Measurements Performed as part of non-clinical tests. Dielectric Tests on Mains Circuits Performed as part of non-clinical tests. Difficult Current Leakage and Patient Sink Current Measurements Performed as part of non-clinical tests. Power Line Ground Leakage Measurements Performed as part of non-clinical tests. Dielectric Tests on Patient Circuits Performed as part of non-clinical tests. Dielectric Tests with RF Cautery Unit Attached Performed as part of non-clinical tests. RF Cautery Unit Output Power Tests Performed as part of non-clinical tests. -
Sample size used for the test set and the data provenance: Not applicable. The device's substantial equivalence was determined through non-clinical laboratory testing and adherence to standards, not through a clinical test set involving patient data.
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Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable, as no clinical test set requiring expert ground truth was performed for this 510(k) submission.
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Adjudication method: Not applicable, as no clinical test set requiring adjudication was performed.
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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: Not applicable. This device is an ultrasonic surgical aspirator and does not involve AI or human readers for diagnostic interpretation.
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If a standalone (i.e. algorithm only without human-in-the loop performance) was done: Not applicable. This device is a surgical instrument, not an algorithm.
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The type of ground truth used: For the non-clinical tests, the "ground truth" was established by the specifications and requirements of the referenced voluntary and tested standards (e.g., UL 2601-1, EN 60601 series, FCC Part 18) and engineering test protocols for performance metrics (e.g., output frequency, power, tip displacement, flow rates, dielectric strength).
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The sample size for the training set: Not applicable. This device is a hardware surgical instrument, and its performance was evaluated through non-clinical testing against standards and direct comparison of operating characteristics to predicate devices, not through machine learning model training.
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How the ground truth for the training set was established: Not applicable. There was no training set for a machine learning model.
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DEC - 9 2003
K032690 (e3 1of 3)
510(k) SUMMARY - Misonix Inc. FS 1000 RF Ultrasonic Aspirator System
This summary of safety and effectiveness information is being submitted in accordance with the requirements of SMDA 1990 and 21CFR 807.92.
1. 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: | July 15, 2003 |
2. Name of Device
4
| Proprietary Name: | Misonix Inc. FS 1000 RF Ultrasonic Surgical AspiratorSystem |
|---|---|
| Common/Usual Name: | Ultrasonic Surgical SystemUltrasonic Surgical Aspirator |
| Classification Name: | Instrument, Ultrasonic Surgical |
3. Predicate Device Information
| Predicate Devices | ValleyLab CUSA® EXCEL Ultrasonic Surgical AspiratorMisonix Inc. AUSS-5 Ultrasonic Surgical Aspirator |
|---|---|
| 4. Device Description | The Misonix Inc. FS 1000 RF Ultrasonic Aspirator Systemis comprised of a generator that feeds a 23 kHz electricalsignal to piezoelectric crystals mounted in a hand-heldHandpiece. The crystals then vibrate at the same frequency.The vibration is amplified by a titanium Tip attached to theHandpiece. Fragmentation of unwanted tissue occurs at theend of the Tip. An Irrigation/Aspiration unit is provided tointroduce irrigation solution and remove fragmentedmaterial and waste liquids. The system incorporatesfeatures that allow it to interface with standardelectrosurgery generators (modules). By activating theoutput of the electrosurgery generators, RF voltage isavailable at the distal end of the ultrasonic cannula. Thisfeature allows the surgeon to cauterize tissue with orwithout the simultaneous application of ultrasound energy. |
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KO32690 leg 2 of 3
510(k) SUMMARY - Misonix Inc. FS 1000 RF Ultrasonic Aspirator System
- The Misonix Inc. FS 1000 RF Ultrasonic Aspirator System ર . Intended Use: is indicated for use in the fragmentation, emulsification 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 Gynecological Surgery Thoracic Surgery
Laparoscopic Surgery Thoracoscopic Surgery
The system may also be combined with electrosurgery using optional RF Surgery interface components.
- The Misonix Inc. FS 1000 RF Ultrasonic Aspirator Q. Comparison to Predicate Device Systemis similar in design, material and operating parameters to the CUSA® EXCEL Ultrasonic Surgical Aspirator. Although the CUSA® has a magneto-strictive transducer and the Misonix Inc. FS 1000 RF Ultrasonic Aspirator System has a piezoelectric transducer, the FDA has determined in past that the piezoelectric handpiece is the substantially equivalent to the magnetostrictive handpiece technology.
- The Misonix Inc. FS 1000 RF has been designed 7. · Safety and Performance Data to pass the following Voluntary and tested 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 60601-2-2 Medical Electrical Equipment, Part 2: Particular Requirements for Safety of High Frequency Surgical Equipment EN 60601-1-2:2001 Electromagnetic Compatibility FCC Part 18 EMC Requirements
- Software Validation 7.
This device contains software. The software has been validated. The validation protocol considered failure and effects analysis.
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510(k) SUMMARY - Misonix Inc. FS 1000 RF Ultrasonic Aspirator System
- Non-Clinical Tests Performed for Determination of Substantial Equivalence are as 8. follows:
Output Frequency Measurements Output Power Measurements (No Load to Maximum Load) Tip Displacement Measurements I Ip 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 Dicient Current Leakage and Patient Sink Current Measurements Power Line Ground Leakage Measurements Dielectric Tests on Patient Circuits RF Cautery Life Tests Dielectric Tests with RF Cautery Unit Attached RF Cautery Unit Ouput Power Tests
Discussions of Clinical Tests Performed 9.
N/A
Conclusions 9.
Based upon an analysis of the operating characteristic specifications, Based upon an anarysis of the operating and Voluntary Consensus Output of Engineering Tests, Hazard I Enc. has concluded that the Misonix Inc. Standard Investigations, Institution System is substantially equivalent to the CUSA EXCEL system.
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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 features a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" around the perimeter. Inside the circle is a stylized symbol resembling three overlapping human figures or abstract shapes, often referred to as the "Human Services Symbol" or "HHS Symbol."
DEC - 9 2003
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Mr. Ronald R. Manna Vice President Regulatory Affairs Misonix, Inc. 1938 New Highway Farmingdale, New York 11735
Re: K032690
R022070
Trade/Device Name: Misonix Inc. FS 1000 RF Ultrasonic Surgical Aspirator System Regulatory Class: Unclassified Product Code: LFL Dated: August 27, 2003 Received: September 11, 2003
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 use stated in the encreases 976, the enactment date of the Medical Device Amendments, or to connices that have been reclassified in accordance with the provisions of the Federal Food, Drug, de nees that have been room 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 I ou may, merenter, mains 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 cither class II (Special Controls) or class III (PMA), it If your device is elashined (overols. Existing major regulations affecting your device can may be subject to such actively a subtions, 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 docs not mean I lease be advised that i Drivination that your device complies with other requirements of the Act that I DA has made a acted regulations administered by other Federal agencies. You must or any I edetar statuted and requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set CFR Part 6077, adoning (Dr OS) regulation (21 CFR Part 820); and if applicable, the electronic fordline the quarty by overse (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 (301) 594-4659. 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 (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html
Sincerely yours,
Miriam C. Provost
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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Indications for Use Statement Exhibit C
510(k) Number (if known): K032690
Device Name: Misonix Inc. FS 1000 RF Ultrasonic Surgical Aspirator System
- Indications For Use: The Misonix Inc. FS 1000 RF Ultrasonic Aspirator System is indicated for use in the fragmentation, emulsification 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 Gynecological Surgery Thoracic Surgery Laparoscopic Surgery Thoracoscopic Surgery
The system may also be combined with electrosurgery using optional RF Surgery interface components.
Prescription Use X (Part 21 CFR 801 Subpart D) AND/OR
Over-The-Counter Use --------(21 CFR 807 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Muriam C. Provost
(Division Sign-Off) Division of General, Restorative and Neurological Devices
Page 1 of 1
510(k) Number K032690
N/A