(111 days)
Not Found
No
The description focuses on the mechanical and ultrasonic aspects of the device and reprocessing procedures, with no mention of AI or ML.
No.
The device is used for cutting and coagulating soft tissue during surgical procedures, which is an operative function, not a therapeutic one.
No
The device description clearly states its purpose is for "coagulation and incision of soft tissue," indicating a therapeutic function rather than a diagnostic one. It is a surgical tool used to cut and coagulate tissue.
No
The device description clearly outlines a physical, hand-held surgical instrument with mechanical components (jaws, shaft, blade) and electrical connections to a handpiece and generator. It is a hardware device that is reprocessed.
Based on the provided text, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states the device is for "coagulation and incision of soft tissue during minimally invasive laparoscopic and open surgical procedures." This describes a surgical tool used directly on the patient's body.
- Device Description: The description details a hand-held instrument with a scalpel blade, designed to cut and coagulate tissue using ultrasonic vibrations. This is consistent with a surgical device, not a device used to test samples outside the body.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue samples, etc.) or providing diagnostic information based on such analysis. The device's function is purely therapeutic/surgical.
IVD devices are used to examine specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes. This device does not fit that description.
N/A
Intended Use / Indications for 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.
Product codes
NLQ
Device Description
The Reprocessed Hand-Activated Ultrasonic Scalpels are hand held Device 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 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.
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 Test Data 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)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
N/A
0
K0433/5
510(k) Summary of Safety & Effectiveness
.
| 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 24, 2004 |
| Device | Trade Name: Vanguard Reprocessed Hand-Activated Ultrasonic ScalpelCommon Name: Ultrasonic Surgical Instrument21 CFR Section: UnclassifiedReprocessed - Class IIProduct Code: NLQ |
| 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 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-
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
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.
2
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
3
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 (800) 638-2041 or (240) 276-3150 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
4
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
5
Page 4 – Ms. Moira Barton
:
11
. . . . . .
A 1998 - 1998 - 1999
List of Models:
Ethicon LCSB5HA 5mm Coagulating Shears, Pistol Grip with Integrated Push Buttons, 36mm, Curved Active Blade ,
: .
: :
- 11:40
the submit and the submit of the sub-
: