K Number
K020220
Device Name
ULTRASONIC STRAIGHT/ULTRASONIC KNIFE/ULTRASONIC RING CURRETTE
Manufacturer
Date Cleared
2002-08-23

(213 days)

Product Code
Regulation Number
N/A
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
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.
More Information

Not Found

Not Found

No
The device description and performance studies focus on the mechanical function of an ultrasonic aspirator tip, with no mention of AI or ML capabilities.

No.

The device is an accessory (tip) for an ultrasonic surgical aspirator system used to fragment, emulsify, and remove tissue during surgery. It is a surgical tool, not a therapeutic device designed to treat a disease or medical condition itself.

No

The device description clearly states it is a surgical tool used for fragmentation, emulsification, and aspiration of tissue during various surgical procedures. It does not perform any diagnostic function.

No

The device description clearly states it is a physical accessory (tips) that attaches to a handpiece and transmits power, indicating it is a hardware component, not software.

Based on the provided text, this device is not an IVD (In Vitro Diagnostic).

Here's why:

  • Intended Use: The intended use clearly describes a surgical device used for fragmenting, emulsifying, and aspirating tissue during surgical procedures. This is a direct intervention on the patient's body.
  • Device Description: The description reinforces that it's a surgical tool that transmits ultrasonic power to remove tissue.
  • Lack of IVD Characteristics: There is no mention of analyzing samples (blood, tissue, etc.) in vitro (outside the body) to diagnose a condition, monitor treatment, or screen for diseases.

IVD devices are used to perform tests on samples taken from the body to provide information about a person's health status. This device is a surgical instrument used for tissue removal during surgery.

N/A

Intended Use / Indications for Use

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

Product codes

LFL

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.

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)

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.

Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)

Not Found

Predicate Device(s)

Not Found

Reference Device(s)

Not Found

Predetermined Change Control Plan (PCCP) - All Relevant Information

Not Found

N/A

0

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 Oster
Director 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 DeviceProposed DeviceSafety & Effectiveness Comparison
CUSA Excel Ultrasonic Surgical
AspiratorSynergetics Sonotome Ultrasonic
Aspirator Tips
Intended UseIndicated for use in surgical
procedures where fragmentation,
emulsification and aspiration of
soft tissue is desirable.Indicated for use in surgical
procedures where fragmentation,
emulsification and aspiration of
soft and hard (e.g.: bone) tissue
is desirable.No difference in intended
use. No safety or
effectiveness issues
identified.
Materials and
Assembly
MethodsTips made of 6AL-4V Titanium.
Tips are drawn and machined
from one solid piece of titanium.Tips made of 6AL-4V Titanium.
Tips are drawn and machined
from one solid piece of titanium.Identical in material and
construction. No safety or
effectiveness issues
identified.
PackagingSupplied non-sterile in packages
of four individual tips. Also
supplied in a procedural kit.Supplied sterile in packages of
three. Individual tips are
supplied in a Tyvek peel pouch.Terminal sterilization of the
proposed device prior to
distribution should provide
greater flexibility for the
surgeon to change tips
during the procedure if
necessary

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

1

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:

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

2

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.

3

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

4

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)

OR

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

for

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

510(k) Number _