VANGUARD REPROCESSED HAND-ACTIVATED ULTRASONIC SCALPEL

K043315 · Vanguard Medical Concepts, Inc. · NLQ · Mar 22, 2005 · SU

Device Facts

• Record ID: K043315
• Device Name: VANGUARD REPROCESSED HAND-ACTIVATED ULTRASONIC SCALPEL
• Applicant: Vanguard Medical Concepts, Inc.
• Product Code: NLQ · SU
• Decision Date: Mar 22, 2005
• Decision: SESE
• Submission Type: Traditional
• Device Class: Class U
• Attributes: Therapeutic

Intended Use

The Reprocessed Hand-Activated Ultrasonic Scalpel is intended for use during minimally invasive laparoscopic and open surgical procedures where coagulation and incision of soft tissue is required.

Device Story

Reprocessed ultrasonic surgical instrument; used for soft tissue coagulation and incision in laparoscopic/open surgery. Device consists of 5mm diameter, 36cm length shaft with curved active blade and pistol-type grip handle. Integrated push buttons on handle allow user control of ultrasonic power levels (min/max). Device connects to compatible ultrasonic handpiece and microprocessor controller; controller electrical output converted to mechanical vibrations via transducer in handpiece; vibrations transmitted through shaft to distal blade. Operated by surgeons in OR. Reprocessing involves cleaning, inspection, testing, packaging, labeling, and sterilization of previously used OEM devices. Benefits include providing functional equivalent to original device for surgical tissue management.

Clinical Evidence

Bench testing only. Validation data provided for cleaning, sterilization, packaging, and performance testing to demonstrate reprocessed devices are equivalent to OEM predicates.

Technological Characteristics

5mm diameter, 36cm length ultrasonic surgical instrument. Features pistol-grip handle with 360-degree rotation and integrated power control buttons. Operates via ultrasonic transducer conversion of electrical energy to mechanical vibration. Materials and specifications identical to OEM predicate. Sterilization validated for reprocessed single-use devices.

Indications for Use

Indicated for use in minimally invasive laparoscopic and open surgical procedures requiring soft tissue coagulation and incision. Contraindicated for contraceptive tubal ligation or bone excision.

Regulatory Classification

Identification

Single-use reprocessed versions of the ultrasonic devices used in surgical procedures either for fragmentation, emulsification and aspiration of soft tissue and hard tissue or for ligation of vessels (under product code “LFL”). Reprocessing validation data for this device type must be included in a 510(k) submission.. (70 FR 56911, available at https://www.govinfo.gov/content/pkg/FR-2005-09-29/pdf/05-19510.pdf).

Predicate Devices

• Ethicon Endo-Surgery UltraCision Harmonic Scalpel (K925699)
• Ethicon Endo-Surgery, Inc., UltraCision LaparoSonic Coagulating Shears LCS-5 (K980099)
• Ethicon Endo-Surgery, Inc., UltraCision Harmonic Scalpel LCS and CS Curved Shears (K993054)

Submission Summary (Full Text)

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K0433/5

# 510(k) Summary of Safety & Effectiveness

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| Submitter | Vanguard Medical Concepts, Inc.<br>5307 Great Oak Drive<br>Lakeland, FL 33815 |
|------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Contact | Heather Crawford, RAC<br>Director of Regulatory Affairs<br>863-683-8680 [voice]<br>863-683-8703 [facsimile]<br><a href="mailto:[e-mail]">[e-mail]</a> [email] |
| Date | November 24, 2004 |
| Device | <ul><li>Trade Name: Vanguard Reprocessed Hand-Activated Ultrasonic Scalpel</li><li>Common Name: Ultrasonic Surgical Instrument</li><li>21 CFR Section: Unclassified</li><li>Reprocessed - Class II</li><li>Product Code: NLQ</li></ul> |
| Predicate<br>Devices | <ul><li>Trade Names: <ul><li>Ethicon Endo-Surgery UltraCision^® Harmonic Scalpel^®</li></ul></li><li>510(k) numbers: <ul><li>K925699: Ultracision, Inc., Harmonic Scalpel Laparosonic Clamp Coagulator</li><li>K980099: Ethicon Endo-Surgery, Inc., UltraCision LaparoSonic Coagulating Shears LCS-5</li><li>K993054: Ethicon Endo-Surgery, Inc., UltraCision Harmonic Scalpel LCS and CS Curved Shears</li></ul></li></ul> |
| Indications for<br>Use | The Reprocessed Hand-Activated Ultrasonic Scalpel is intended for use during minimally invasive laparoscopic and open surgical procedures where coagulation and incision of soft tissue is required. |
| Contra-<br>indications | This instrument is not intended for contraceptive tubal ligation or for bone excision. |
| | Continued on next page |

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## 510(k) Summary of Safety & Effectiveness, Continued

The Reprocessed Hand-Activated Ultrasonic Scalpels are hand held Device instruments which may be used to cut and coagulate tissue when connected Description to a compatible ultrasonic handpiece and generator. Scalpels are 5mm in diameter with a functional length of 36cm. The instrument jaws are opened and closed using proximal ring handles, styled in a pistol-type grip. The instrument tip and shaft can be rotated 360° in either direction using a knob on the handle. The Scalpel has a curved active blade. The proximal handle is designed for attachment to a compatible handpiece and microprocessor controller. Electrical outputs from the controller are converted by an ultrasonic transducer within the handpiece to mechanical vibrations that are transmitted through the instrument shaft to the distal scalpel blade. The proximal handle of the Hand-Activated Ultrasonic Scalpel has two integrated push buttons that allow hand control of the ultrasonic power level (minimum or maximum power level). Vanguard receives previously used Ultrasonic Scalpels from healthcare facilities; cleans, inspects, tests, packages, labels, and sterilizes the devices; and returns them to a healthcare facility for subsequent use. The Vanguard Reprocessed Hand-Activated Ultrasonic Scalpels are Technological essentially identical to the currently marketed Original Equipment Characteristics Manufacturer (OEM) devices. Device materials, specifications, and technological characteristics are equivalent. Cleaning, sterilization, and packaging validations, and performance and Test Data biocompatibility testing demonstrate that the reprocessed devices perform as intended and are safe and effective.

Based upon the information provided herein and the 510(k) "Substantial Conclusion Equivalence" Decision Making Process Chart, we conclude that Vanguard Reprocessed Ultrasonic Scalpels are substantially equivalent to their predicate devices under the Federal Food, Drug and Cosmetic Act.

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/2/Picture/1 description: The image is a black and white logo for the U.S. Department of Health and Human Services. The logo features a stylized symbol resembling a person embracing another, or a bird-like shape. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" is arranged in a circular fashion around the symbol.

NOV 2 7 2006

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Public Health Service

Ascent Healthcare Solutions % Ms. Moira Barton Regulatory Affairs Manager 10232 South 51st Street Phoenix, Arizona 85044

Re: K043315 - Supplemental Validation Submission Trade/Device Name: See Enclosed List Regulation Name: Ultrasonic Surgical Instrument Regulatory Class: Unclassified Product Code: NLQ Dated: February 24, 2005 Received: February 25, 2005

Dear Ms. Barton:

This letter corrects our substantially equivalent letter of March 22, 2005. The above-referenced premarket notification (510(k)) was cleared by the Office of Device Evaluation (ODE) on March 22, 2005. We have received your supplemental validation data as required for reprocessed singleuse devices by the Medical Device User Fee and Modernization Act of 2002. After reviewing your supplemental validation data, we have determined the device listed in the enclosure accompanying this letter are 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 these devices, 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 devices are classified (see above) into either class II (Special Controls) or class III (PMA) they 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 devices 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 devices comply 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 applicable 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

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Page 2 - Ms. Moira Barton

The FDA finding of substantial equivalence of your devices to legally marketed predicate devices results in classification for your devices and thus, permits you to legally market the devices. This letter will allow you to continue marketing the devices listed in the enclosure accompanying this letter.

If you desire specific advice for your devices on our labeling regulation (21 CFR Part 801), please contact the Office of Compliance at 240-276-0115. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number [phone] or [phone] or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html.

Sincerely yours

Ron Paulson

Mark N. Melkerson Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Page 3 - Ms. Moira Barton

#### Indications for Use

510(k) Number (if known) : K043315

Vanguard Reprocessed Hand-Activated Ultrasonic Device Name: Scalpel

Indications For Use:

Reprocessed Hand-Activated Ultrasonic Scalpel is intended for use during minimally invasive laparoscopic and open surgical procedures where coagulation and incision of soft tissue is required.

Prescription Use AND/OR Over-The-Counter Use X (Part 21 CFR 801 Subpart D) (21 CFR 807 Subpart C)

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Pele

Division of General, Restorative, and Neurological Devices

Page 1 of

510(k) Number K643315

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A 1998 - 1998 - 1999

#### List of Models:

Ethicon LCSB5HA 5mm Coagulating Shears, Pistol Grip with Integrated Push Buttons, 36mm, Curved Active Blade ,

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