(87 days)
Not Found
No
The device description focuses on the mechanical and ultrasonic aspects of tissue removal, with no mention of AI or ML capabilities. The "Mentions AI, DNN, or ML" field is explicitly marked as "Not Found".
Yes
The device is used for the "breakup and removal of soft tissues" in various surgical indications, directly treating a medical condition.
No
The device is described as an ultrasonic surgical system intended for the "Breakup and removal of soft tissues," indicating a therapeutic rather than a diagnostic function.
No
The device description clearly outlines hardware components including a handpiece, probe, ultrasonic power generator, foot pedal, and vacuum canister, indicating it is a physical medical device system, not software-only.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly describes the device's function as breaking up and removing soft tissues during surgical procedures. This is an in vivo application (within a living organism), not an in vitro application (outside of a living organism, typically on biological samples).
- Device Description: The description details a surgical system that uses ultrasonic energy, irrigation, and aspiration to remove tissue directly from the patient during surgery. This aligns with a surgical device, 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 diagnostic tests, or providing diagnostic information.
Therefore, the SONOTOME System is a surgical device, not an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The SONOTOME System is intended for the following indications: Breakup and removal of soft tissues in Neurosurgery, GI and affiliated organ surgery, Urology, General surgery, Plastic and Reconstructive surgery, Orthopedic, GYN, Thoracic Surgery.
Product codes
LFL
Device Description
The SONOTOMETM System contains three subsystems: ultrasonic energy, irrigation and aspiration. The SONOTOME™ System uses a hollow titanium tip PROBE mounted to a reusable handpiece. The ultrasonic power generator provides energy to the handle which converts it into ultrasonic energy at the tip. The irrigation and the ultrasonic energy are activated by depressing the foot pedal. The vibrating probe mounted on the hand piece is then applied to the tissue desired to be removed. The application of ultrasonic energy through the tip breaks down the tissue through a cavitation action. The resultant debris is aspirated through the probe tip and into a disposable trap between the handpiece and the vacuum canister. The flow of saline is maintained to reduce the temperature of the probe and to provide for a means of irrigation to the surgical site.
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)
Since this 510K is for expanded indications only, and the device has not been modified from that cleared under K930629, no further performance testing was performed.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
K930629, K853143, K864983, K884412, K884413, K894600, K910696
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
N/A
0
510K Submission
Sonokinetics SONOTOME™ System
510K Summary Sonokinetics
Sponsor Name 1. Sonokinetics 14 Equestrian Drive North Reading, MA 01864 Debbie Iampietro Contact Individual:
QRC Consulting Associates 7 Tiffany Trail Hopkinton.MA 01748 (508)-435-9893
-
Device Name 2.
Proprietary Name: SONOTOME™ System Common/Usual Name: Ultrasonic Aspiration Device Classification Name: LFL -
Identification of Predicate or Legally Marketed Device 3. The Sonokinetics SONOTOME™ System is a mechanical ultrasonic surgical aspirator which is substantially equivalent to the following predicate devices: SonoKinetics' ACRYL-X™ II System (K930629) and ValleyLabs Inc. CUSA® 200 System (K853143, K864983, K884412, K884413, K894600, K910696).
4. Device Description
The SONOTOMETM System contains three subsystems: ultrasonic energy, irrigation and aspiration. The SONOTOME™ System uses a hollow titanium tip PROBE mounted to a reusable handpiece. The ultrasonic power generator provides energy to the handle which converts it into ultrasonic energy at the tip. The irrigation and the ultrasonic energy are activated by depressing the foot pedal. The vibrating probe mounted on the hand piece is then applied to the tissue desired to be removed. The application of ultrasonic energy through the tip breaks down the tissue through a cavitation action. The resultant debris is aspirated through the probe tip and into a disposable trap between the handpiece and the vacuum canister. The flow of saline is maintained to reduce the temperature of the probe and to provide for a means of irrigation to the surgical site.
- ડ. Intended Use
The SONOTOME System is intended for the following indications: Breakup and removal of soft tissues in Neurosurgery, GI and affiliated organ surgery, Urology, General surgery, Plastic and Reconstructive surgery, Orthopedic, GYN, Thoracic.
1
6. Comparison of Technological Characteristics
| | CUSA® NS-200
Valleylab Inc. | ACRYL-XTM II
SYSTEM
SonoKinetics | SONOTOMETM
Sonokinetics |
|----------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| K# | K910696, 894600,
K884413, K884412 | K930629 | K930629 |
| Intended Use | Breakup and removal
of soft tissues in
Neurosurgery, GI and
affiliated organ
surgery, Urology,
General surgery, Plastic
and Reconstructive
surgery, Orthopedic,
GYN, Thoracic | Removal of
thermoplastic cement
from bones in revision
procedures | Breakup and removal of
soft tissues in
Neurosurgery, GI and
affiliated organ surgery,
Urology, General surgery,
Plastic and Reconstructive
surgery, Orthopedic, GYN,
Thoracic |
| Basic operating
principle | Metal tip driven by
ultrasound causing
tissue fragmentation
and aspiration through
tip | Metal tip driven by
ultrasound, cooling and
aspiration of plastic
through tip | Metal tip driven by
ultrasound causing tissue
fragmentation and
aspiration through tip |
| System console | Self-contained with
ultrasonic, irrigation,
and aspiration
subsystems | Self-contained with
ultrasonic, irrigation,
and aspiration
subsystems | Self-contained with
ultrasonic, irrigation and
aspiration subsystems |
| Amplitude of
vibration of tip | Adjustable up to 355
microns | 240 microns, peak to
peak | 240 microns, peak to peak |
| Vibration frequency | 23 kHz | 20 kHz | 20 kHz |
| Irrigation flow rates | 1.5-50cc/min | 10-400 ml/min | 10-400ml/min |
| Aspiration | 0-24 in. Hg | 5-15 in. Hg. | 5-15 in. Hg. |
| Disposable
components | Surgical Tips, suction
trap, irrigation/suction
tubing set | Surgical Tips, suction
trap, irrigation/suction
tubing set | Surgical Tips, suction trap,
irrigation/suction tubing
set |
| Power requirements | 100-120 VAC, 15amps,
50-60 Hz
200-240 VAC, 10amps,
50-60 Hz | 105-130 v a-c, 60 Hz,
500 watts | 105-130 v a-c, 60 Hz, 500
watts |
7 Performance Testing
Since this 510K is for expanded indications only, and the device has not been modified from that cleared under K930629, no further performance testing was performed.
2
Public Health Service
Image /page/2/Picture/2 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" arranged around the perimeter. Inside the circle is a stylized symbol that resembles a human figure with three flowing lines representing the body and head.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
MAY 2 1 1999
Sonokinetics, Inc. c/o Ms. Debbie Iampietro ORC Consulting Associates 7 Tiffany Trail Hopkinton, Massachusetts 01748
Re: K990572 Trade Name: SONOTOME™ System Regulatory Class: Unclassified Product Code: LFL Dated: February 22, 1999 Received: February 23, 1999
Dear Ms. Iampietro :
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 (OS) 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.
3
Page 2 - Ms. Debbie Iampietro
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.
Director
Division of General and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
510(k) Number (if known): __ K99 05 72
SONOTOME™ System Device Name:
. . . . .
Indications For Use: The SONOTOME System is intended for the following indications: Breakup and removal of soft tissues in Neurosurgery, GI and
affiliated organ surgery, Urology, General surgery, Plastic and Reconstructive surgery, Orthopedic, GYN, Thoracic Surgery.
(PLEASE DO NOT WRITE BELOW THIS LINE. CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use (Per 21 CFR 801.109)
OR Over-The-Counter Use
Division Sign-Off
(Division Sign-Off)
Division of General Restorative Devices
510(k) Number K960572
000000