K Number
K043225
Device Name
VANGUARD REPROCESSED ULTRASONIC SCALPEL
Date Cleared
2005-03-22

(120 days)

Product Code
Regulation Number
N/A
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
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 Description
The Reprocessed Ultrasonic Scalpels are hand held instruments which may be used to cut and coagulate tissue when connected to a compatible ultrasonic handpiece and generator. Scalpels are 5mm in diameter with functional lengths of 14 to 36cm. The instrument jaws are opened and closed using proximal ring handles, available with a pistol or scissor grip style. The instrument tip and shaft can be rotated 360° in either direction using a knob on the handle. Scalpels are available with various blade configurations: curved, blunt, and knife down. 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. 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.
More Information

Not Found

No
The description focuses on the mechanical and ultrasonic function of the device and the reprocessing process. There is no mention of AI or ML in the intended use, device description, or performance studies.

No.
A therapeutic device is one that treats or heals a disease or medical condition. This device is used for cutting and coagulating tissue during surgery and does not treat or heal a condition itself.

No

The device is described as an ultrasonic scalpel used for cutting and coagulating soft tissue during surgical procedures, which is a therapeutic function, not a diagnostic one.

No

The device description clearly outlines a physical, hand-held surgical instrument with mechanical components (jaws, shaft, blade) and a connection to an ultrasonic handpiece and generator. It is a hardware device that is reprocessed.

No, this device is not an IVD (In Vitro Diagnostic).

Here's why:

  • IVD Definition: In Vitro Diagnostic devices are used to examine specimens taken from the human body (like blood, urine, or tissue) to provide information about a person's health. This testing is done outside of the body (in vitro).
  • Device Function: The Reprocessed Ultrasonic Scalpel is a surgical instrument used during surgical procedures to cut and coagulate soft tissue within the body. It directly interacts with the patient's tissue.
  • Intended Use: The intended use clearly states "during minimally invasive laparoscopic and open surgical procedures where coagulation and incision of soft tissue is required." This describes a surgical intervention, not a diagnostic test on a specimen.

The device description and intended use clearly indicate that this is a surgical tool used for treatment and manipulation of tissue in vivo, not for diagnostic testing of samples in vitro.

N/A

Intended Use / Indications for 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.

Product codes (comma separated list FDA assigned to the subject device)

NLQ

Device Description

The Reprocessed Ultrasonic Scalpels are hand held instruments which may be used to cut and coagulate tissue when connected to a compatible ultrasonic handpiece and generator. Scalpels are 5mm in diameter with functional lengths of 14 to 36cm. The instrument jaws are opened and closed using proximal ring handles, available with a pistol or scissor grip style. The instrument tip and shaft can be rotated 360° in either direction using a knob on the handle. Scalpels are available with various blade configurations: curved, blunt, and knife down.

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.

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.

Mentions image processing

Not Found

Mentions AI, DNN, or ML

Not Found

Input Imaging Modality

Not Found

Anatomical Site

soft tissue

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)

Cleaning, sterilization, and packaging validations, and performance and biocompatibility testing demonstrate that the reprocessed devices perform as intended and are safe and effective.

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

Not Found

Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.

K925699, K980099, K993054

Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.

Not Found

Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).

Not Found

N/A

0

510(k) Summary of Safety & Effectiveness

KO43215

| Submitter | Vanguard Medical Concepts, Inc.
5307 Great Oak Drive
Lakeland, FL 33815 |
|------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Contact | Heather Crawford, RAC
Director of Regulatory Affairs
863-683-8680 [voice]
863-683-8703 [facsimile]
hcrawford@safe-reuse.com [email] |
| Date | November 20, 2004 |
| Device | Trade Name: Vanguard Reprocessed Ultrasonic ScalpelCommon Name: Ultrasonic Surgical Instrument21 CFR Section: UnclassifiedProduct Code: NLQ - Scalpel, Ultrasonic, Reprocessed - Class II |
| Predicate
Devices | Trade Names: Ethicon Endo-Surgery UltraCision® Harmonic Scalpel®510(k) numbers: K925699: Ultracision, Inc., Harmonic Scalpel Laparosonic Clamp CoagulatorK980099: Ethicon Endo-Surgery, Inc., UltraCision LaparoSonic Coagulating Shears LCS-5K993054: Ethicon Endo-Surgery, Inc., UltraCision Harmonic Scalpel LCS and CS Curved Shears |
| Indications for
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-
indications | This instrument is not intended for contraceptive tubal ligation or for bone excision. |
| | Continued on next page |

1

510(k) Summary of Safety & Effectiveness, Continued

| Device
Description | The Reprocessed Ultrasonic Scalpels are hand held instruments which may
be used to cut and coagulate tissue when connected to a compatible
ultrasonic handpiece and generator. Scalpels are 5mm in diameter with
functional lengths of 14 to 36cm. The instrument jaws are opened and closed
using proximal ring handles, available with a pistol or scissor grip style. The
instrument tip and shaft can be rotated 360° in either direction using a knob
on the handle. Scalpels are available with various blade configurations:
curved, blunt, and knife down. |
|----------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| | 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. |
| | 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. |
| Technological
Characteristics | The Vanguard Reprocessed Ultrasonic Scalpels are essentially identical to the
currently marketed Original Equipment Manufacturer (OEM) devices. No
changes are made to the device materials or specifications and the reprocessed
Ultrasonic Scalpels possess identical technological characteristics. |
| Test Data | Cleaning, sterilization, and packaging validations, and performance and
biocompatibility testing demonstrate that the reprocessed devices perform as
intended and are safe and effective. |
| Conclusion | Based upon the information provided herein and the 510(k) "Substantial
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. |

2

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.

3

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 (240) 276-0115. 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 (800) 638-2041 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

4

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)

gn-Off)
General, Restcrative
ological Devices
mber. K043225

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