ULTRASONIC STRAIGHT/ULTRASONIC KNIFE/ULTRASONIC RING CURRETTE by SYNERGETICS, INC.

Synergetics Sonotome™ Ultrasonic Aspirator Tips are intended for use in surgical procedures where fragmentation, emulsification and aspiration of soft and hard (e.g.: bone) tissue is desirable, including: Neurosurgery, Gastrointestinal and Affiliated Organ Surgery, Urological Surgery, Plastic and Reconstructive Surgery, General Surgery, Orthopedic Surgery, Gynecological Surgery, Thoracic Surgery, Laparoscopic Surgery, Thoracoscopic Surgery.

Device Description

Synergetics Sonotome™ Ultrasonic Aspirator Tips are accessories that are attached to the handpiece of an ultrasonic surgical aspirator system manufactured by another company. The tip, which simply transmits power from the system handpiece, is an ultrasonically vibrating surgical device which, in combination with irrigation and aspiration, fragments, emulsifies and removes unwanted tissue. It allows the selective dissection of target tissues while preserving vessels, ducts and other delicate structures. The main features on the Synergetics Sonotome™ Ultrasonic Aspirator Tips are: A variety of tip diameters, shapes and lengths are available for specific surgical applications. Curved tips are bent so as to provide clear visualization of the surgical site, unobstructed by the handpiece. Individually packaged, sterile tips can be replaced without the need for resterilization of the handpiece. Preaspiration holes in the tips minimize clogging and keep the tip clear of debris.

AI/ML Overview

This document is a 510(k) Premarket Notification summary for the Synergetics Sonotome™ Ultrasonic Aspirator Tips. It specifies the device's intended use, materials, and a comparison to a predicate device.

However, it does not contain any information about acceptance criteria or a study proving the device meets acceptance criteria.

The document states: "Validation and verification of the Ultrasonic Aspirator Tips will be accomplished through a combination of analysis and testing. This process will include a Risk Analysis and a mechanical performance test on prototype units."

This indicates that a mechanical performance test was planned or conducted, but no details about the acceptance criteria, the results of the test, or the study methodology are provided in the extracted text.

Therefore, I cannot fulfill your request for:

A table of acceptance criteria and reported device performance.
Sample size used for the test set or data provenance.
Number of experts used to establish ground truth or their qualifications.
Adjudication method for the test set.
Information about an MRMC comparative effectiveness study or its effect size.
Information about a standalone performance study.
Type of ground truth used.
Sample size for the training set.
How ground truth for the training set was established.

Summary

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AUG 2 3 2002

Image /page/0/Picture/1 description: The image shows a sequence of characters and numbers written in black ink on a white background. The sequence starts with the letter 'K', followed by the number '0', and then the numbers '20220'. The handwriting appears somewhat rough and uneven.

synergetics, inc.

PREMARKET NOTIFICATION 510(k) SUMMARY [As required by 21 CFR 807.92(c)]

Prepared by:	Sue OsterDirector of Quality Assurance and Regulatory Affairs
Contact Person:	Same
Preparation Date:	January 2, 2002
Device Name:	Aspirator tips for ultrasonic surgical instrument systems
Proprietary/Trade Name:	Synergetics, Inc. Sonotome™ Ultrasonic Aspirator Tips
Common/Usual Name:	Ultrasonic aspirator tips
Classification Name:	Instrument, Ultrasonic Surgical

The following table provides a summary of the safety and effectiveness comparison between the predicate device and the proposed device:

Name:	Predicate Device	Proposed Device	Safety & Effectiveness Comparison
	CUSA Excel Ultrasonic SurgicalAspirator	Synergetics Sonotome UltrasonicAspirator Tips
Intended Use	Indicated for use in surgicalprocedures where fragmentation,emulsification and aspiration ofsoft tissue is desirable.	Indicated for use in surgicalprocedures where fragmentation,emulsification and aspiration ofsoft and hard (e.g.: bone) tissueis desirable.	No difference in intendeduse. No safety oreffectiveness issuesidentified.
Materials andAssemblyMethods	Tips made of 6AL-4V Titanium.Tips are drawn and machinedfrom one solid piece of titanium.	Tips made of 6AL-4V Titanium.Tips are drawn and machinedfrom one solid piece of titanium.	Identical in material andconstruction. No safety oreffectiveness issuesidentified.
Packaging	Supplied non-sterile in packagesof four individual tips. Alsosupplied in a procedural kit.	Supplied sterile in packages ofthree. Individual tips aresupplied in a Tyvek peel pouch.	Terminal sterilization of theproposed device prior todistribution should providegreater flexibility for thesurgeon to change tipsduring the procedure ifnecessary

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tissues while preserving vessels, ducts and other delicate structures. The main features on the Synergetics Sonotome™ Ultrasonic Aspirator Tips are:

. A variety of tip diameters, shapes and lengths are available for specific surgical applications.
Curved tips are bent so as to provide clear visualization of the surgical site, . unobstructed by the handpiece.
Individually packaged, sterile tips can be replaced without the need for ● resterilization of the handpiece.
Preaspiration holes in the tips minimize clogging and keep the tip clear of ● debris.

Validation and verification of the Ultrasonic Aspirator Tips will be accomplished through a combination of analysis and testing. This process will include a Risk Analysis and a mechanical performance test on prototype units.

The biological safety of the Ultrasonic Aspirating Tips has been assured through the selection of materials that demonstrate appropriate levels of biocompatibility. The material used (6AL-4V titanium, AMS4928) is the same as the material that is used in the predicate device and in other similar existing systems that are commercially available in the United States.

Intended Use:

. Neurosurgery
Gastrointestinal and Affiliated Organ Surgery .
Urological Surgery ●
. Plastic and Reconstructive Surgery
General Surgery ●
. Orthopedic Surgery
. Gynecological Surgery
. Thoracic Surgery
. Laparoscopic Surgery
. Thoracoscopic Surgery

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Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle with three stripes forming its body and head. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the eagle.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Synergetics, Inc. Sue Oster Director, Quality/Regulatory Affairs 88 Hubble Drive St. Charles, Missouri 63304

Re: K020220

Trade/Device Name: Synergetics Sonotome™ Ultrasonic Aspirator Tips Regulation Number: 878.4400 Regulation Name: Ultrasonic surgical instrument Regulatory Class: Class II Product Code: LFL Dated: April 26, 2002 Received: August 1, 2002

Dear Ms. Oster:

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.

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Page 2 - Ms. Sue Oster

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 vou desire specific advice for your device on our labeling regulation (21 CFR Part 801 and additionally 21 CFR Part 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4659. 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 Part 807.97), Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html

Sincerely yours,

Colin M. Wittwer, Ph.D., M.D.

Celia M. Witten, Ph.D., M.D. Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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K 020220/A'

page 1 of 1

510(k) NUMBER (IF KNOWN): K020220
DEVICE NAME: Ultrasonic/Stright, knife, ring curvette
INDICATIONS FOR USE:

Indications for Use:

Synergetics Sonotome™ Ultrasonic Aspirator Tips are intended for use in surgical procedures where fragmentation, emulsification and aspiration of so and Hard (e.g .: bone) tissue is desirable, including:

Neurosurgery
Gastrointestinal and Affiliated Organ Surgery
Urological Surgery
Plastic and Reconstructive Surgery
General Surgery
Orthopedic Surgery
Gynecological Surgery
Thoracic Surgery
Laparoscopic Surgery
Thoracoscopic 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)

Over-The-Counter-Use
(Optional Format 1-2-9)

for

(Division Sign-Off)
Division of General, Restorative
and Neurological Devices

510(k) Number _

Regulation Number and Section

N/A