(23 days)
ValleyLab CUSA® Model 200H Ultrasonic Surgical Aspirator, Spembly Selector® Ultrasonic Surgical Aspirator
Not Found
No
The 510(k) summary describes a traditional ultrasonic surgical system that uses mechanical vibration for tissue fragmentation and aspiration. There is no mention of AI, ML, image processing, or any data-driven decision-making components. The performance studies focus on engineering characteristics, not algorithmic performance.
Yes
The device is indicated for use in the fragmentation and aspiration of soft tissue in various surgical specialties, which describes a therapeutic intervention.
No
The device is an ultrasonic surgical system used for fragmentation and aspiration of soft tissue during surgery. It is a therapeutic device, not a diagnostic one.
No
The device description clearly outlines hardware components including a generator, handpiece with piezoelectric crystals, a titanium tip, and an irrigation/aspiration unit.
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 system used for the fragmentation and aspiration of soft tissue during surgical procedures. This is an in vivo application (within a living organism), not an in vitro application (outside of the body, typically on biological samples).
- Device Description: The description details a system that uses ultrasonic vibration to break down tissue and an irrigation/aspiration unit to remove the fragmented material. This is consistent with a surgical tool, not a diagnostic device that analyzes samples.
- Lack of Diagnostic Elements: There is no mention of analyzing biological samples, detecting biomarkers, or providing diagnostic information. The device's function is purely mechanical tissue removal.
IVD devices are used to examine specimens derived from the human body (like blood, urine, tissue samples) to provide information for diagnosis, monitoring, or screening. The Alliger Ultrasonic Surgical System does not perform this function.
N/A
Intended Use / Indications for Use
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
Product codes
LFL
Device Description
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Soft tissue, Neurosurgery, Gastrointestinal, Affiliated Organ, Urological, Plastic and Reconstructive, General Surgery, Orthopedic, Gynecology, External genitalia (condyloma, benign tumors, malignant primary and metastatic tumors, cystic lesions: Bartholin's cysts, vestibular adenitis, inclusion cysts, sebaceous cysts), Abdominal area (ovary, fallopian tube, uterus, supporting structures of the uterus), Thoracic (pulmonary)
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
Non-Clinical Tests:
Engineering tests were performed to determine that operating characteristics are substantially equivalent to the predicate device.
- 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
Clinical Tests: N/A
Key Metrics
Not Found
Predicate Device(s)
ValleyLab CUSA® Model 200H Ultrasonic Surgical Aspirator, Spembly Selector® Ultrasonic Surgical Aspirator
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
N/A
0
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 System |
| Ultrasonic 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®.
2
-
- 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
3
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.
4
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
5
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)