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.

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.

AI/ML Overview

The Sonokinetics SONOTOME™ System (K990572) is an ultrasonic aspiration device cleared through the 510(k) pathway.

Acceptance Criteria and Device Performance:

The 510(k) submission for the SONOTOME™ System is based on its substantial equivalence to previously cleared predicate devices: SonoKinetics' ACRYL-X™ II System (K930629) and ValleyLabs Inc. CUSA® 200 System (K853143, K864983, K884412, K884413, K894600, K910696).

The acceptance criteria for the SONOTOME™ System are implicitly defined by its technological characteristics being substantially equivalent to the predicate devices. The submission states that the device has not been modified from the ACRYL-X™ II System (K930629), and the current 510(k) is for expanded indications only. Therefore, the device performance is reported as identical to the ACRYL-X™ II System, and within the range of the CUSA® NS-200.

Acceptance Criteria (Predicate Device K930629 / K910696)	Reported Device Performance (SONOTOME™ System)
Intended Use: Removal of thermoplastic cement from bones in revision procedures (K930629) OR Breakup and removal of soft tissues in Neurosurgery, GI and affiliated organ surgery, Urology, General surgery, Plastic and Reconstructive surgery, Orthopedic, GYN, Thoracic (K910696)	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, cooling and aspiration of plastic through tip (K930629) OR Metal tip driven by ultrasound causing tissue fragmentation and aspiration through tip (K910696)	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
Amplitude of vibration of tip: 240 microns, peak to peak (K930629) OR Adjustable up to 355 microns (K910696)	240 microns, peak to peak
Vibration frequency: 20 kHz (K930629) OR 23 kHz (K910696)	20 kHz
Irrigation flow rates: 10-400 ml/min (K930629) OR 1.5-50cc/min (K910696)	10-400ml/min
Aspiration: 5-15 in. Hg. (K930629) OR 0-24 in. Hg (K910696)	5-15 in. Hg.
Disposable components: Surgical Tips, suction trap, irrigation/suction tubing set	Surgical Tips, suction trap, irrigation/suction tubing set
Power requirements: 105-130 v a-c, 60 Hz, 500 watts (K930629) OR 100-120 VAC, 15amps, 50-60 Hz; 200-240 VAC, 10amps, 50-60 Hz (K910696)	105-130 v a-c, 60 Hz, 500 watts

Study Information:

Sample size used for the test set and the data provenance:
- The document explicitly states: "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."
- Therefore, there is no new test set or data provenance for the current 510(k) submission. The performance is based on the previously cleared device, ACRYL-X™ II System (K930629), and its historical data. The original studies for K930629 are not detailed in this submission.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not applicable, as no new performance testing was conducted for this 510(k) submission.
Adjudication method for the test set:
- Not applicable, as no new performance testing was conducted for this 510(k) submission.
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:
- No MRMC study was conducted. This device is a mechanical surgical instrument, not an AI-assisted diagnostic or therapeutic tool for which MRMC studies are typically performed.
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- No standalone performance study was done for an algorithm, as this is a mechanical surgical device.
The type of ground truth used:
- For the original predicate devices, the ground truth would have been established through a combination of engineering specifications, preclinical testing (e.g., tissue ablation rates, aspiration efficiency, temperature control in various tissue types), and potentially clinical experience/observation for surgical outcomes. The current submission relies on the established performance of the predicate device.
The sample size for the training set:
- Not applicable, as this is not an AI/machine learning device that requires a training set.
How the ground truth for the training set was established:
- Not applicable, as this is not an AI/machine learning device.

Summary

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510K Submission

Sonokinetics SONOTOME™ System

K990572

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

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.

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6. Comparison of Technological Characteristics

	CUSA® NS-200Valleylab Inc.	ACRYL-XTM IISYSTEMSonoKinetics	SONOTOMETMSonokinetics
K#	K910696, 894600,K884413, K884412	K930629	K930629
Intended Use	Breakup and removalof soft tissues inNeurosurgery, GI andaffiliated organsurgery, Urology,General surgery, Plasticand Reconstructivesurgery, Orthopedic,GYN, Thoracic	Removal ofthermoplastic cementfrom bones in revisionprocedures	Breakup and removal ofsoft tissues inNeurosurgery, GI andaffiliated organ surgery,Urology, General surgery,Plastic and Reconstructivesurgery, Orthopedic, GYN,Thoracic
Basic operatingprinciple	Metal tip driven byultrasound causingtissue fragmentationand aspiration throughtip	Metal tip driven byultrasound, cooling andaspiration of plasticthrough tip	Metal tip driven byultrasound causing tissuefragmentation andaspiration through tip
System console	Self-contained withultrasonic, irrigation,and aspirationsubsystems	Self-contained withultrasonic, irrigation,and aspirationsubsystems	Self-contained withultrasonic, irrigation andaspiration subsystems
Amplitude ofvibration of tip	Adjustable up to 355microns	240 microns, peak topeak	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.
Disposablecomponents	Surgical Tips, suctiontrap, irrigation/suctiontubing set	Surgical Tips, suctiontrap, irrigation/suctiontubing set	Surgical Tips, suction trap,irrigation/suction tubingset
Power requirements	100-120 VAC, 15amps,50-60 Hz200-240 VAC, 10amps,50-60 Hz	105-130 v a-c, 60 Hz,500 watts	105-130 v a-c, 60 Hz, 500watts

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.

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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.

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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

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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

Regulation Number and Section

N/A