(99 days)
No
The device description focuses on the mechanical and electrical aspects of ultrasonic tissue fragmentation and aspiration, with no mention of AI or ML technologies.
Yes.
The device is used for fragmentation and aspiration of tissue, debridement of wounds, and cleansing of surgical sites, which are all therapeutic interventions for medical conditions.
No
This device is described as an "Alliger Ultrasonic Surgical System" used for fragmentation and aspiration of tissues, debridement of wounds, and cleansing surgical sites, all of which are therapeutic or surgical procedures, not diagnostic ones.
No
The device description explicitly states it is comprised of hardware components including a generator, handpiece with piezoelectric crystals, and a titanium tip. It also mentions irrigation and aspiration capabilities, which are hardware-dependent functions.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In vitro diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections. They are used to provide information for diagnosis, monitoring, or screening.
- Device Function: The Alliger Ultrasonic System is a surgical device used for the fragmentation and aspiration of tissue during surgical procedures. It physically breaks down and removes tissue from the body.
- Intended Use: The intended use clearly describes surgical applications across various specialties, focusing on the physical manipulation and removal of tissue.
- Device Description: The description details the mechanical and electrical components that enable the ultrasonic fragmentation and aspiration of tissue.
There is no indication in the provided text that this device is used to analyze samples taken from the body to provide diagnostic information. It is a therapeutic and surgical tool used directly on the patient's tissue.
N/A
Intended Use / Indications for Use
The AUSS-7 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
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 reception such as segmetectomies, nonanatomical subsegmentectomies and metastatectomies.
Wound Care
The Misonix Inc. AUSS-7 Utrasonic Surgical Aspirator is also indicated for use in the debridement of wounds, such as, but not limited to, burn wounds, diabetic ulcers, bedsores and vaginal ulcers, soft tissue debridement and cleansing of the surgical site in applications in which, in the physician's judgement would require the use of an ultrasonic aspirator with sharp debridement.
Product codes
LFL
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. Both irrigation / aspiration can be provided to introduce irrigation solution and remove fragmented material and waste liquids from the area.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
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, Abdominal area), Thoracic Surgery, and Wounds (burn wounds, diabetic ulcers, bedsores and vaginal ulcers).
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, 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, Software Validations.
N/A for Clinical Tests.
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
Exhibit E
K070313
510K SUMMARY - Alliger Ultrasonic Surgical System Model AUSS-7
This summary of 510(k)-safety and effectiveness information is being submitted in accordance with the requirements of SMSA 1990 and 21CFR 807.92.
1. Submitter's Identification
| Name: | MISONIX, INC. |
|---|---|
| Address: | 1938 New Highway, Farmingdale, NY 11735 |
| Telephone Number: | (631) 694-9555 |
| Contact Person: | Ronald R. Manna, Vice President Regulatory Affairs |
| Date Prepared: | January 23, 2007 |
Name of Device 2.
| Proprietary Name: | Alliger Ultrasonic Surgical System Model AUSS- | |
|---|---|---|
| Common / Usual Name: | Ultrasonic Surgical System | |
| Ultrasonic Surgical Aspirator |
3. Predicate Device Information
Classification Name:
| Original Device: | Misonix Inc. Ultrasonic Surgical Aspirator AUS-6, K050776 | |
|---|---|---|
| ------------------ | -- | ----------------------------------------------------------- |
Instrument, Ultrasonic Surgical
-
- 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. Both irrigation / aspiration can be provided to introduce irrigation solution and remove fragmented material and waste liquids from the area.
The AUSS-7 Ultrasonic Surgical System is indicated for use in the 5. Intended Use: fragmentation and aspiration of both soft and hard (e.g.: bone) tissue in the following surgical specialties:
- 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. Both irrigation / aspiration can be provided to introduce irrigation solution and remove fragmented material and waste liquids from the area.
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
1
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 reception such as segmetectomies, nonanatomical subsegmentectomies and metastatectomies.
Wound Care
The Misonix Inc. AUSS-7 Utrasonic Surgical Aspirator is also indicated for use in the debridement of wounds, such as, but not limited to, burn wounds, diabetic ulcers, bedsores and vaginal ulcers, soft tissue debridement and cleansing of the surgical site in applications in which, in the physician's judgement would require the use of an ultrasonic aspirator with sharp debridement.
-
- Comparison to Original Device: The AUSS-7 is identical in its mode of operation and Indications for Use. The main difference is the controls, displays and alarms are microprocessor controlled and displayed on an LCD screen. The outer housing is also different for cosmetic purposes.
-
- 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. Software Validations
-
- Discussions of Clinical Tests Performed
N/A
- Discussions of Clinical Tests Performed
-
- Conclusions
Based upon an analysis of the operating characteristic specifications. Output of Engineering Tests, Risk Analysis, and Voluntary Consensus Standard Investigations, Misonix, Inc. has concluded that the Alliger Ultrasonic System Model AUSS-7 is substantially equivalent to the AUSS-6 and introduces no new safety or efficacy concerns.
- Conclusions
2
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
MAY 1 2007
Misonix Inc. % Mr. Ronald Manna Vice President, Regulatory Affairs 1938 New Highway Farmingdale, New York 11735
Re: K070313
Trade/Device Name: Misonix Inc. AUSS-7 Ultrasonic Surgical Aspirator System Regulatory Class: Unclassified Product Code: LFL Dated: April 16, 2007 Received: April 18, 2007
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 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.
3
Page 2 - Mr. Ronald 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 (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 yours,
For
Mark N. Melkerson
Director
Division of General, Restorative
DEP
DIRECTOR
Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
EXHIBIT C
K070313 Indications for Use
Device Name: Misonix Inc. AUSS-7 Ultrasonic Surgical Aspirator System
The Alliger Ultrasonic 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.
| Prescription Use | X | AND/OR | Over-The-Counter Use |
|---|---|---|---|
| (Part 21 CFR 801 Subpart D) | (21 CFR 801 Subpart C) |
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)
(Division Sign-Off)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Division of General, Restorative, and Neurological Devices
| 510(k) Number | L070313 |
|---|---|
| --------------- | --------- |
5
14070313
Indications for Use (con't)
Thoracic Surgery
Limited pulmonary reception such as segmetectomies, nonanatomical subsegmentectomies and metastatectomies.
Wound Care
The Misonix Inc. AUSS-7 Ultrasonic Surgical Aspirator is also indicated for use in the debridement of wounds, such as, but not limited to, burn wounds, diabetic ulcers, bedsores and vaginal ulcers, soft tissue debridement and cleansing of the surgical site in applications in which, in the physician's judgment would require the use of an ultrasonic aspirator with sharp debridement.