UAS ULTRASONIC ASPIRATOR SYSTEM

• K Number: K971580
• Device Name: UAS ULTRASONIC ASPIRATOR SYSTEM
• Manufacturer: WELLS JOHNSON CO.
• Date Cleared: 1997-12-09 ( 223 days)
• Product Code: LFL
• Regulation Number: N/A

Intended Use

The UAS is designed for use in the fragmentation, emilsification and aspiration of soft tissue in the following surgical specialties: Neurosurgery, Gastrointestinal and affiliated Organ Surgery, Urological Surgery, Plastic and Reconstructive Surgery, General Surgery, Gynecology, Orthopedic Surgery.

Device Description

Not Found

Predicate Devices

Not Found

Reference Devices

Not Found

AI/ML (Artificial Intelligence / Machine Learning)

No
The provided text describes a surgical device for tissue fragmentation and aspiration and contains no mention of AI, ML, image processing, or any related concepts.

Therapeutic

Yes
The device is intended for surgical procedures involving the fragmentation, emulsification, and aspiration of soft tissue, which are therapeutic interventions.

Diagnostic

No
The device is used for fragmentation, emulsification, and aspiration of soft tissue during surgery, which are therapeutic actions rather than diagnostic ones.

SaMD (Software as a Medical Device)

No

The 510(k) summary describes a device for the fragmentation, emulsification, and aspiration of soft tissue, which are physical actions requiring hardware. The description of the device is not found, but the intended use clearly indicates a physical device, not software.

IVD (In Vitro Diagnostic)

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

Here's why:

• Intended Use: The intended use clearly states the device is for "fragmentation, emulsification and aspiration of soft tissue in the following surgical specialties...". This describes a surgical procedure performed on the patient's body, not a test performed on a sample taken from the body.
• Lack of IVD Characteristics: The description does not mention any of the typical characteristics of an IVD, such as:
  • Analyzing biological samples (blood, urine, tissue samples, etc.)
  • Detecting or measuring substances in samples
  • Providing diagnostic information based on sample analysis

The device described is a surgical tool used for tissue manipulation during surgery.

PCCP (Predetermined Change Control Plan) Authorized

N/A

Overview

Intended Use / Indications for Use

The UAS is designed for use in the fragmentation, emulsification and aspiration of soft tissue where the preservation of vascular and neural structures is important.

Indications for Use include surgery of the:

• Neurosurgery
• Gastrointestinal and affiliated Organ Surgery
• Urological Surgery
• Plastic and Reconstructive Surgery
• General Surgery
• Gynecology
• Orthopedic Surgery.

Product codes

LFL

Device Description

Not Found

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)

Not Found

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

Regulation Number and Section

N/A

Summary

0

Image /page/0/Picture/1 description: The image shows the logo for the United States Department of Health and 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 image of an eagle with three overlapping profiles, suggesting a sense of community and collaboration.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Ms. Brenda Hunt Ouality Assurance/Regulatory Affairs Wells Johnson Company 8000 S. Kolb Road-85706 P.O. Box 18230 Tucson, Arizona 85731-8230

DEC - 9 1997

Re: K971580

Trade Name: UAS Ultrasonic Aspirator System Regulatory Class: II Product Code: LFL Dated: October 28, 1997 Received: November 5, 1997

Dear Ms. Hunt:

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 requirements , 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

1

Page 2 - Ms. Hunt

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.

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 [phone]. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at [phone]. 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 [phone] or [phone] or at its internet address "http://www.fda.gov/cdrh/dsmamain.html".

Sincerely yours,

t.c. Olles

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

2

Image /page/2/Picture/1 description: The image is a black and white logo for the Department of Health & Human Services - USA. The logo consists of a circular border with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the circumference. Inside the circle is a stylized symbol that resembles an abstract eagle or bird in flight, composed of three curved lines.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Ms. Brenda Hunt Ouality Assurance/Regulatory Affairs Wells Johnson Company 8000 S. Kolb Road-85706 P.O. Box 18230 Tucson, Arizona 85731-8230

DEC - 9 1997

Re: K971580

Trade Name: UAS Ultrasonic Aspirator System Regulatory Class: II Product Code: LFL Dated: October 28, 1997 Received: November 5, 1997

Dear Ms. Hunt:

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 requirements , 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

3

Page 2 - Ms. Hunt

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.

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 [phone]. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at [phone]. 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 [phone] or [phone] or at its internet address "http://www.fda.gov/cdrh/dsmamain.html".

Sincerely yours,

t.c. Olles

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): K971580

Device Name: UAS ULTRASONIC ASPIRATOR SYSTEM

Indications For Use:

The UAS is designed for use in the fragmentation, emilsification
and is a Ine ons is debigned 200

• 米 Neurosurgery
• Gastrointestinal and affiliated Organ Surgery ★
• Urological Surgery *
• Plastic and Reconstructive Surgery ★
• General Surgery ★
• Gynecology *
• Orthopedic Surgery. ★

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)
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(Division Sign-Off)

Division of General Restorative Devices
510(k) Number	K971580

Prescription Use (Per 21 CFR 801.1199)

OR

Over-The-Counter Use _________________________________________________________________________________________________________________________________________________________

(Optional Format 1-2-96)

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