(63 days)
Not Found
No
The description focuses on the mechanical and electrical aspects of an ultrasonic aspirator system, with no mention of AI or ML capabilities.
Yes
The device is described as a surgical aspirator system used for fragmentation, emulsification, and aspiration of tissue during various surgical procedures, which are therapeutic interventions.
No
This device is an ultrasonic aspirator system used for fragmentation, emulsification, and aspiration of tissue during surgery, which are therapeutic functions, not diagnostic ones.
No
The device description clearly outlines hardware components such as a generator, handpiece with piezoelectric crystals and titanium tip, irrigation unit, aspirator system, and various accessories. This is not a software-only device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly describes a surgical device used for the fragmentation, emulsification, and aspiration of tissue during surgical procedures. This is an in vivo application (within a living organism), not an in vitro application (testing biological samples outside the body).
- Device Description: The description details a system that physically interacts with tissue using ultrasonic vibrations and aspiration. This is consistent with a surgical tool, not a diagnostic device that analyzes samples.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue samples, etc.), performing tests on these samples, or providing diagnostic information based on such analysis.
Therefore, the Misonix Inc. FS 1000 RF Ultrasonic Aspirator System is a surgical device, not an IVD.
N/A
Intended Use / Indications for Use
The Misonix Inc. FS 1000 RF Ultrasonic Aspirator System is indicated for use in the fragmentation, emulsification and aspiration of both soft and hard (i.e. bone) 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.
Product codes
LFL, GEI
Device Description
The FS 1000 RF Ultrasonic Surgical Aspirator System is comprised of a generator, which feeds a 23 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 unit is provided to introduce irrigation solution to the operative site. An aspirator system removes fragmented material and waste liquids from the area. Accessories include various probe tips. wrenches, tube sets and cleaning brushes.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
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
Acoustic Output Test
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
RF Cautery Life Tests
Dielectric Tests with RF Cautery Unit Attached
RF Cautery Unit Output Power Tests
Discussions of Clinical Tests Performed: Since the FDA has cleared the use of ultrasonic energy to ablate hard tissue in numerous 510(k) grants, no clinical tests were conducted in anticipation of this submission.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
N/A
0
K 062471
510(k) SUMMARY - Misonix Inc. AUSS-6 Ultrasonic Surgical Exhibit E Aspirator System and Accessories
OCT 2 6 2006
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: | August 18, 2006 |
Name of Device 2.
| Proprietary Name: | Misonix Inc. FS 1000 RF Ultrasonic Surgical
Aspirator System and Accessories |
|----------------------|---------------------------------------------------------------------------------|
| Common/Usual Name: | Ultrasonic Surgical System
Ultrasonic Surgical Aspirator |
| Classification Name: | Instrument, Ultrasonic Surgical |
3. Predicate Device Information
Misonix Inc. AUSS-6 Ultrasonic Surgical Aspirator, K050776 Misonix Inc. AUSS-5 Ultrasonic Surgical Aspirator, K012028 Radionics CUSA EXCEL Ultrasonic Surgical Aspirator System with Bone Tip, K051947
Device Description: 4.
The FS 1000 RF Ultrasonic Surgical Aspirator System is comprised of a generator, which feeds a 23 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 unit is provided to introduce irrigation solution to the operative site. An aspirator
1
system removes fragmented material and waste liquids from the area. Accessories include various probe tips. wrenches, tube sets and cleaning brushes.
-
- The Misonix Inc. FS 1000 RF Ultrasonic Aspirator System Intended Use: is indicated for use in the fragmentation, emulsification and aspiration of both soft and hard (i.e. bone) 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 Misonix Inc. FS 1000 RF Ultrasonic Aspirator System Intended Use: is indicated for use in the fragmentation, emulsification and aspiration of both soft and hard (i.e. bone) tissue in the following surgical specialties:
The system may also be combined with electrosurgery using optional RF Surgery interface components.
Comparison to Predicate Device 6. The FS 1000 RF System and Accessories are similar in design, material and operating parameters to the Misonix Inc. AUSS-5 Ultrasonic Surgical Aspirator, the CUSA EXCEL Ultrasonic Surgical Aspirator and the Misonix AUSS-6 Ultrasonic Surgical Aspirator Systems.
Safety and Performance Data
The Misonix Inc. FS-1000 RF 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 60601-2-2 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 Requirement
2
-
- The software included with this device is not Software Validation: affected by the change of indication for use. All software validations were reviewed and cleared under 510(k) K032690.
-
- Sterilization Validations: Validation statements are contained in Exhibit J.
- Non-Clinical Tests Performed for Determination of Substantial 9. 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 Acoustic Output Test 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 RF Cautery Life Tests Dielectric Tests with RF Cautery Unit Attached RF Cautery Unit Output Power Tests
- ರ. Discussions of Clinical Tests Performed: Since the FDA has cleared the use of ultrasonic energy to ablate hard tissue in numerous 510(k) grants, no clinical tests were conducted in anticipation of this submission.
Conclusions: Based upon a review of the published literature Misonix 10. 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.
3
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 circular seal with the text "DEPARTMENT OF HEALTH AND HUMAN SERVICES . USA" around the perimeter. Inside the circle is a stylized symbol of three human profiles facing to the right, stacked on top of each other.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
OCT 2 6 2006
Misonix, Inc. % Mr. Ronald R Manna Vice President Regulatory Affairs 1938 New Highway Farmingdale, NY 11735
Re: K062471
Trade/Device Name: Misonix Inc. FS 1000 RF Ultrasonic Surgical Aspirator System Regulatory Class: Unclassified Product Code: LFL Dated: August 18, 2006 Received: August 24, 2006
Trade/Device Name: Misonix Inc. FS 1000 RF Ultrasonic Surgical Aspirator System Regulation Number: 21 CFR 878.4400 Regulation Name: Electrosurgical cutting and coagulation device and accessories Regulatory Class: II Product Code: GEI Dated: August 18, 2006 Received: August 24, 2006
Dear Mr. Manna:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent for the indications for use stated in the enclosure) to legally marketed predicate 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) 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
4
Page 2 - Mr. Ronald R Manna
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 forth 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.
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 (240) 276-0115. 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 (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely vour
Rafa Nadal
Mark N. Melkerson Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
5
Exhibit C
Indications for Use
K ob2471
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 both soft and hard (i.e. bone) tissue in the fotlowing 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
| (Part 21 CFR 801 Subpart D) | X |
|---|---|
| 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)
PO
(Division Sign-C Division of General, Restor ative, and Neurological Devices
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510(k) Number L062471