K Number

Device Name

Manufacturer

OMNISONICS MEDICAL TECHNOLOGIES

Date Cleared

1999-12-15

(49 days)

Product Code

LFL

Regulation Number

N/A

Type

Traditional

Panel

General & Plastic Surgery

Reference & Predicate Devices

K990572,K853143,K864983,K884412,K884413,K894600,K910696,K981262

Predicate For

N/A

Intended Use

The intended use of the OmniSonics Ultrasonic Probes is the breakup and removal of soft tissues in Neurosurgery, GI and affiliated organ surgery, Urology, General surgery, Plastic and Reconstructive surgery, Orthopedic, GYN, Thoracic. The OmniSonics Ultrasonic Probes are used in conjunction with the OmniSonics Ultrasonic Surgical System.

The OmniSonics Ultrasonic Probes are designed to be introduced through natural body cavities or surgical incisions through introducers, needles or trocars, catheters, sheaths or other devices with lumens having an inside diameter larger than the outside diameter of the probe.

Device Description

The OmniSonics Ultrasonic probes work in conjunction with the OmniSonics Ultrasonic Generator. The generator creates a specific electrical signal that is directed into the OmniSoncs ultrasonic handle. The signal is converted into an ultrasonic motion within the handle and this motion is transferred to the ultrasonic probe.

The ultrasonic energy in contact with the probe causes a specifically defined motion to occur on the probe shaft. The motion of the probe in contact with the tissue causes a localized cavitation, and immediate destruction of the tissue in contact with the probe. Cavitation is caused by the motion of the probe within water and in contact with tissue.

The motion of the probe causes the formation of microbubbles to be formed. The upstoke of the probe causes the formation of the bubble behind the probe, the downstroke causes the collapse of the bubble and a small localized shock wave. This focused wave formed at the tip of the probe causes a localized and focused shock wave to be formed which impinges upon the tissue and breaks off the most least tightly bound tissue layer. The action is limited to a specific contact area of the probe upon the tissue, and does not travel beyond these contact points.

The OmniSonics Ultrasonic Probes are constructed of titanium and are all specifically designed for use and operation with the OmniSonics Ultrasonic Surgical System.

The specifications of the proposed OmniSonics Ultrasonic Probes are the following:

Diameter Exterior: 1 mm - 10 mm
Diameter Interior: .5 mm - 8 mm
Length: 10 mm - 30 mm

AI/ML Overview

The provided text is a 510(k) summary for the OmniSonics Ultrasonic Probes. This document focuses on demonstrating substantial equivalence to existing devices rather than presenting detailed performance studies against specific acceptance criteria for a novel device or AI algorithm.

Due to the nature of a 510(k) submission for a non-AI/software device from 1999, the information typically requested in your prompt regarding AI/software performance studies (like sample sizes for test/training sets, expert ground truth, MRMC studies, standalone performance, and effect sizes) is not applicable and not present in this document.

The document does mention performance testing in a general sense, but not in the detailed, quantitative manner you're looking for an AI/software product.

Here's a breakdown of what information can be extracted and what cannot:

1. A table of acceptance criteria and the reported device performance

The document does not explicitly state quantitative "acceptance criteria" and "reported device performance" in the way one would for an AI/software device. Instead, it aims to demonstrate substantial equivalence to predicate devices. The "performance testing" section is very brief and general.

Criteria (Implied from 510(k))	OmniSonics Ultrasonic Probes Performance (as stated in document)
Biocompatibility	Materials used are biocompatible.
Sterilization	Sterilized to an SAL of 10⁻⁶ in accordance with AAMI guidelines for ETO sterilization.
Electrical Safety	Tested in compliance with IEC 60601.
Technological Characteristics
Principle of Operation	Localized cavitation and immediate tissue destruction via ultrasonic motion similar to predicates.
Materials	Titanium, similar to predicate devices (metal alloy).
Configuration	Various configurations, lengths, diameters, similar to predicate devices.
Energy Source	Uses an external ultrasonic handpiece, similar to predicate devices.
Intended Use	Breakup and removal of soft tissues in Neurosurgery, GI, Urology, General, Plastic, Orthopedic, GYN, Thoracic surgery, similar to predicate devices.

2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

Not applicable / Not provided. This 510(k) summary does not describe a clinical study with a test set of data as would be used for an AI/software device. The "performance testing" mentioned refers to non-clinical testing (biocompatibility, sterilization, electrical safety).

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

Not applicable / Not provided. No clinical "test set" requiring expert ground truth is described.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

Not applicable / Not provided. No clinical "test set" and thus no adjudication method is described.

5. 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

Not applicable / Not provided. This is a hardware device, not an AI or software product. No MRMC study was conducted or reported.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

Not applicable / Not provided. This is a hardware device.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)

Not applicable / Not provided. No clinical ground truth is discussed in relation to "performance" in the context of an AI/software test. The "performance testing" refers to compliance with standards (IEC 60601) and material properties (biocompatibility, sterilization), which have their own established methods of verification, rather than clinical ground truth as you'd define it for an AI.

8. The sample size for the training set

Not applicable / Not provided. This is a hardware device, not an AI/software product, so there is no "training set."

9. How the ground truth for the training set was established

Not applicable / Not provided. No training set exists for this hardware device.

Summary of Device-Specific Information from the Text:

Device Name: OmniSonics Ultrasonic Probes
Manufacturer: OmniSonics Medical Technologies, Inc.
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. Used in conjunction with the OmniSonics Ultrasonic Surgical System.
Predicate Devices: Sonokinetics SONOTOME System (K990572) and Valleylabs Inc. CUSA® 200 System (K853143, K864983, K884412, K884413, K894600, K910696) and CUSA EXCEL System (K981262).
Principle of Operation: Converts electrical signal to ultrasonic motion via the handle, transferred to the probe. The motion causes localized cavitation and immediate tissue destruction due to microbubble formation, collapse, and localized shockwaves.
Materials: Titanium.
Specifications:
- Diameter Exterior: 1 mm - 10 mm
- Diameter Interior: 0.5 mm - 8 mm
- Length: 10 mm - 30 mm
Regulatory Class: II
Product Code: LFL
Date of Submission: October 23, 1999
FDA Clearance Date: December 15, 1999 (K993628)

Conclusion:

This 510(k) submission for the OmniSonics Ultrasonic Probes is for a physical medical device (ultrasonic probes) and demonstrates "substantial equivalence" to existing, legally marketed predicate devices. It does not contain information related to AI/software performance studies, test sets, training sets, ground truth establishment, or expert reviews as these concepts are not relevant to this type of device and submission. The "performance testing" refers to standard compliance for safety and material properties.

Summary

{0}------------------------------------------------

OmniSonics Medical Technologies, Inc

Robert A Rabiner President

K993628

DEC I 1 2 1999

510K Summary OmniSonics Ultrasonic Probes

Sponsor Name 1. OmniSonics Medical Technologies 14 Equestrian Drive North Reading, MA 01864 Debbie Iampietro Contact Individual: ORC Consulting Associates 7 Tiffany Trail Hopkinton,MA 01748

2. Device Name

Proprietary Name: OmniSonics Ultrasonic Probes Common/Usual Name: Ultrasonic Aspiration Device Classification Name: Ultrasonic Aspiration Device

Identification of Predicate or Legally Marketed Device 3.
The OmniSonics Ultrasonic probes are substantially equivalent to the following predicate devices: Sonokinetics SONOTOME System (K99XXXX) and Valleylabs Inc. CUSA® 200 System (K853143, K864983, K884412, K884413, K894600, K910696) and CUSA EXCEL System (K981262).
1. Device Description

Principle of Operation

14 Equestrian Drive North Reading, MA 01864 978 664 8440 978 664 4248 rrabiner@worldnet.att.net

{1}------------------------------------------------

OmniSonics Medical Technologies, Inc

Robert A Rabiner President

The ultrasonic energy in contact with the probe causes a specifically defined motion to occur on the probe shaft. The motion of the probe in contact with the tissue causes a localized cavitation, and immediate destruction of the tissue in contact with the probe. Cavitation is caused by the motion of the probe within water and in contact with tissue.

Device Configuration and Materials

The OmniSonics Ultrasonic Probes are constructed of titanium and are all specifically designed for use and operation with the OmniSonics Ultrasonic Surgical System.

The specifications of the proposed OmniSonics Ultrasonic Probes are the following:

Diameter Exterior	1 mm - 10 mm
Diameter Interior	.5 mm - 8 mm
Length	10 mm - 30 mm

న్. Intended Use

The OmniSonics Ultrasonic Probes are used in conjunction with the OmniSonics Ultrasonic Surgical System to utilize ultrasonic energy for the removal of tissue. The intended use of the device is the breakup and removal of soft tissues in Neurosurgery, GI and affiliated organ surgery, Urology, General surgery, Plastic and Reconstructive surgery, Orthopedic, GYN, Thoracic.

14 Equestrian Drive North Reading, MA 01864 978 664 8440 978 664 4248 rrabiner(@worldnet.att.net

000055

{2}------------------------------------------------

Robert A Rabiner President

Comparison of Technological Characteristics 6.

The OmniSonics Ultrasonic probes are substantially equivalent to the following predicate devices: Sonokinetics SONOTOME System (K990572) and Valleylabs Inc. CUSA® 200 System (K853143, K864983, K884412, K884413, K894600, K910696) and CUSA EXCEL System (K981262).

Ultrasonic aspiration of tissue through hollow titanium needles has been a part of the U.S. medical landscape since the 1960s. As such, the predicate devices to which the OmniSonics Ultrasonic Probes is substantially equivalent in intended use are based on a well developed technology.

The intended use of the OmniSonics Ultrasonic Probes are the same as that of other manufactures of ultrasonic probes in that they are intended for the breakup and removal of soft tissues in Neurosurgery, GI and affiliated organ surgery, Urology, General surgery, Plastic and Reconstructive surgery, Orthopedic, GYN, Thoracic.

The OmniSonics Ultrasonic Probes have similar technological characteristics to and similar applications as the predicates Sonokinetics SONOTOME System and CUSA® 200 System, in that they are all metal alloy instruments that are attached to an ultrasonic handle providing the ultrasonic energy and motion to the probe to cause a destruction of contacted tissues. All of the devices on the market offer various configurations, lengths, diameters, use an external ultrasonic handpiece as the source of energy and are made of either titanium, stainless steel. The OmniSonics tip does not raise new questions of safety and effectiveness.

7 Performance Testing
The OmniSonics Ultrasonic Probes are tested in compliance with IEC 60601.

The materials used in the manufacture of the OmniSonics Ultrasonic Probes are biocompatable.

The OmniSonics Ultrasonic Probes are sterilized to an SAL of 10° in accordance with AAMI guidelines for ETO sterilization.

000056

14 Equestrian Drive North Reading, MA 01864 978 664 8440 978 664 4248 rrabiner@worldnet.att.net

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Image /page/3/Picture/1 description: The image shows the seal of the U.S. Department of Health & Human Services. The seal is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an abstract image of an eagle with three stripes representing the department's mission to protect the health of all Americans and provide essential human services.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

DEC 1 5 1999

OmniSonics Medical Technologies, Inc. c/o Ms. Debbie Iampietro QRC Consulting 7 Tiffany Trail Hopkinton, Massachusetts 01748

Re: K993628 Trade Name: OmniSonics Ultrasonic Probes Regulatory Class: II Product Code: LFL Dated: October 23, 1999 Received: October 27, 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 (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. 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,

L. Stytz Ruvcles

James E. Dillard III Acting 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): _ _ K 9 9 3 6 & &

Device Name: OmniSoncis Ultrasonic Probes

Indications For Use:

(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)	X
------------------------------------------	---

Over-The-Counter Use
----------------------	--

St. K. Rhodes
(Division Sign-Off)

Division of General Restorative Devices K993628 510(k) Number.

000010

Regulation Number and Section

N/A