VANGUARD REPROCESSED ULTRASONIC SCALPEL

K043225 · Vanguard Medical Concepts, Inc. · NLQ · Mar 22, 2005 · SU

Device Facts

• Record ID: K043225
• Device Name: VANGUARD REPROCESSED 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 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

Vanguard Reprocessed Ultrasonic Scalpel is a reprocessed, hand-held surgical instrument used for soft tissue coagulation and incision. Device connects to a compatible ultrasonic handpiece and generator. Input: electrical signals from a microprocessor controller; transformed by an ultrasonic transducer into mechanical vibrations transmitted through the shaft to the distal blade. Features 5mm diameter, 14-36cm length, 360-degree rotation, and various blade configurations (curved, blunt, knife down). Used in laparoscopic and open surgical procedures by surgeons. Reprocessing involves cleaning, inspection, testing, packaging, labeling, and sterilization of previously used OEM devices. Benefits include providing a functional, reprocessed alternative for surgical tissue management.

Clinical Evidence

No clinical data. Bench testing, including cleaning, sterilization, and packaging validations, as well as performance and biocompatibility testing, was conducted to demonstrate safety and effectiveness.

Technological Characteristics

Hand-held ultrasonic surgical instrument; 5mm diameter; 14-36cm length; 360-degree rotation; pistol or scissor grip handles. Operates via connection to compatible ultrasonic handpiece and generator. Materials and specifications are identical to OEM predicates. Sterilization is performed as part of the reprocessing cycle.

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

Submission Summary (Full Text)

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## 510(k) Summary of Safety & Effectiveness

KO43215

| 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>[e-mail] [email] |
| Date | November 20, 2004 |
| Device | <ul><li>Trade Name: Vanguard Reprocessed Ultrasonic Scalpel</li><li>Common Name: Ultrasonic Surgical Instrument</li><li>21 CFR Section: Unclassified</li><li>Product Code: NLQ - Scalpel, Ultrasonic, Reprocessed - Class II</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 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

| Device<br>Description | The Reprocessed Ultrasonic Scalpels are hand held instruments which may<br>be used to cut and coagulate tissue when connected to a compatible<br>ultrasonic handpiece and generator. Scalpels are 5mm in diameter with<br>functional lengths of 14 to 36cm. The instrument jaws are opened and closed<br>using proximal ring handles, available with a pistol or scissor grip style. The<br>instrument tip and shaft can be rotated 360° in either direction using a knob<br>on the handle. Scalpels are available with various blade configurations:<br>curved, blunt, and knife down. |
|----------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| | The proximal handle is designed for attachment to a compatible handpiece<br>and microprocessor controller. Electrical outputs from the controller are<br>converted by an ultrasonic transducer within the handpiece to mechanical<br>vibrations that are transmitted through the instrument shaft to the distal<br>scalpel blade. |
| | Vanguard receives previously used Ultrasonic Scalpels from healthcare<br>facilities; cleans, inspects, tests, packages, labels, and sterilizes the devices;<br>and returns them to a healthcare facility for subsequent use. |
| Technological<br>Characteristics | The Vanguard Reprocessed Ultrasonic Scalpels are essentially identical to the<br>currently marketed Original Equipment Manufacturer (OEM) devices. No<br>changes are made to the device materials or specifications and the reprocessed<br>Ultrasonic Scalpels possess identical technological characteristics. |
| Test Data | Cleaning, sterilization, and packaging validations, and performance and<br>biocompatibility testing demonstrate that the reprocessed devices perform as<br>intended and are safe and effective. |
| Conclusion | Based upon the information provided herein and the 510(k) "Substantial<br>Equivalence" Decision Making Process Chart, we conclude that Vanguard<br>Reprocessed Ultrasonic Scalpels are substantially equivalent to their predicate<br>devices under the Federal Food, Drug and Cosmetic Act. |

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### DEPARTMENT OF HEALTH & HUMAN SERVICES

Public Health Service

Image /page/2/Picture/2 description: The image shows the seal of the Department of Health & Human Services (HHS) of the United States. The seal features a circular design with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" arranged around the perimeter. Inside the circle is a stylized representation of an eagle, which is a common symbol of the United States.

#### MAR 2 2 2005

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Ms. Heather Crawford, RAC Director of Regulatory Affairs Vanguard Medical Concepts, Inc. 5307 Great Oak Drive Lakeland, Florida 33815

Re: K043225

K043223
Trade/Device Name: Vanguard Reprocessed Ultrasonic Scalpel Regulatory Class: Unclassified Product Code: NLQ Dated: February 17, 2005 Received: February 18, 2005

Dear Ms. Crawford:

We have reviewed your Section 510(k) premarket notification of intent to market the device We have reviewed your Section 910(x) premainter institution (for the included in interests a referenced above and nave decemblied the arrest of predicate devices marketed in interstate for use stated in the enclosure to regary manated to the Medical Device Amendments, or to commerce prior to May 28, 1976, the enatified in accordance with Federal Food. Drug.
devices that have been reclassified in accordance with the provision (UMA) devices that have been reclassified in acceraarses whiles approval application (PMA).
and Cosmetic Act (Act) that do not require approval of a previsions of the Act - The and Cosment Act (Act) that do not require approvid controls provisions of the Act. The
You may, therefore, market the device, subject to the general controls provisions of You may, merefore, market me dovres, basjer to the one of the general controls provisions of the Fiel 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 c If your device is classified (see above) the existing major regulations affecting your device can
may be subject to such additional controls. Existing major may be subject to such additional controllor "Entrolo" of the 800 to 898. In addition, FDA may be found in the Ood of Pourse concerning your device in the Federal Register.

Please be advised that FDA's issuance of a substantial equivalence determination docs not mean Please be advised that FDA s issualles of a statually with other requirements of the Act
that FDA has made a determination that your device complies with other requirements o that 117A has made a dolorimiation administered by other Federal agencies. You must of any Federal Statutes and regulations and miting, but not limited to: registration and listing (21 comply with an the Act 3 requirements, meteaning, .
CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set CFK Part 807), labeling (21 CFR Part 807). good manart 820); and if applicable, the clectronic
forth in the quality systems (QS) regulation (21 CFR Part 820); 1489-1950 form in the quality systems (Sections 531-542 of the Act); 21 CFR 1000-1050.

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Page 2 - Ms. Heather Crawford, RAC

This letter will allow you to begin marketing your device as described in your Section 510(k) This letter will allow you to begin hankeling your article equivalence of your device to a legally
premarket notification. The FDA finding of substantial end this permits vo premarket notification. The PDA inding of succlainted by:
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), please
s and the may be and 15 and be and any and one more the regulation entitled If you desire specific advice ior your ac vice on our same note the regulation entitled.
contact the Office of Compliance at [phone]. Also, please note the regulation contact the Office of Compliance at (210) 276 - 107 (21CFR Patt 807.97). You may obtain "Misbranding by reference to premation non heat the Act from the Division of Small
other general information on your responsibilities under the Act from worther (800) 633-20) other general information on your responsionnes and its toll-fire number [phone] or Manufacturers, Internet and Consulter Assistance at to courted to to courters index.html.

Sincerely yours,

Z. Zohrab

Miriam C. Provost, Ph.D. Acting Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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### Indications for Use

510(k) Number (if known):

Device Name: Vanguard Reprocessed Ultrasonic Scalpel

Indications for Use:

Reprocessed Ultrasonic Scalpel is intended for use during minimally invasive Reprocessed Ontrasonic Ocalper is intentional for see bagulation and incision of soft tissue is required.

Prescription Use_ X (Part 21 CFR 801 Subpart D)

AND/OR

Over-The-Counter Use__________________________________________________________________________________________________________________________________________________________ (21 CFR 801 Subpart C)

(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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