(51 days)
No
The device description and intended use focus on mechanical surgical tools (trocars, scissors, forceps, dissectors, hook) and their physical properties and sterilization. There is no mention of any software, algorithms, image processing, or terms related to AI/ML.
No
The device is used for surgical procedures to access, visualize, cut, dissect, manipulate, and cauterize tissues, which are actions related to surgical intervention rather than therapy.
No
The device is described as a surgical tool to cut, dissect, manipulate, and/or cauterize tissues, and to provide access and visualization during surgery, not for diagnosing conditions.
No
The device description clearly outlines physical, disposable hardware components (trocars, scissors, forceps, dissectors, hook) made of biocompatible materials and sterilized using ethylene oxide. There is no mention of software as the primary or sole component.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states that the devices are for providing access to and visualization of body cavities, organs, and canals, and for cutting, dissecting, manipulating, and/or cauterizing tissues during surgical procedures. This is a description of a surgical instrument used directly on the patient's body.
- Device Description: The description details surgical tools like trocars, scissors, forceps, dissectors, and a hook, used for physical manipulation and cauterization of tissues.
- Lack of IVD Characteristics: There is no mention of the device being used to examine specimens (like blood, urine, tissue samples) in vitro (outside the body) to provide information about a physiological state, health, disease, or congenital abnormality.
IVD devices are used to perform tests on samples taken from the body to diagnose or monitor conditions. This device is a surgical tool used for intervention and manipulation within the body.
N/A
Intended Use / Indications for Use
The VECTEC Disposable Trocar and Laparoscopic Accessories are single-use, sterile devices intended to provide access to and visualization of body cavities, organs, and canals and to cut, dissect, manipulate, and/or cauterize various tissues during endoscopic/laparoscopic, general, vascular, gynecological and thoracic surgical procedures. Accessories include scissors, forceps, dissectors and a hook.
Product codes
GEI
Device Description
The VECTEC Disposable Trocars and Laparoscopic Accessories can be used in a variety of procedures (general, vascular, gynecological and thoracic surgical procedures) to cut, dissect, manipulate, and/or cauterize various tissues. Trocars are sterile, single-use devices that allow visualization of body cavities and use of the laparoscopic accessories. The accessory devices are disposable, single use, individually packaged devices that are composed of biocompatible materials. Scissors, forceps, and dissectors have a handle attached to an insulated shaft with different tips, which allows the shaft and tip to rotate. They include a male cautery connector when attached to standard monopolar cautery cables and their generators. All devices are sterilized using a traditional, validated ethylene oxide procedure per EN 550:1994 to a SAL of 106 and with acceptable residual EO levels per ISO 0993-7:1995.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
body cavities, organs, and canals
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)
VECTEC laparoscopic accessories met the dielectric withstand testing requirements of ANSI/AAMI HF-18:2001.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
K994066, K062169, K981389, K962119
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 878.4400 Electrosurgical cutting and coagulation device and accessories.
(a)
Identification. An electrosurgical cutting and coagulation device and accessories is a device intended to remove tissue and control bleeding by use of high-frequency electrical current.(b)
Classification. Class II.
0
K 07/976
SUMMARY OF SAFETY AND EFFECTIVENESS
GENERAL INFORMATION 1.
1.1 Submitter and Owner of the 510(k)
Yves Arboy, President VECTEC Bioparc 03270 Hauterive FRANCE Establishment Registration: Pending
Page 1 of 3
SEP - 6 2007
1.2 Official Correspondent
Diane Mandell Horwitz, Ph.D., RAC THE WEINBERG GROUP INC. 1220 19th Street N.W., Suite 300 Washington, D.C. 20036 Telephone: 703.242.0027 Facsimile: 703.242.0027 Electronic mail: dianehorwitz@gmail.com
1.3 Date of Preparation
July 11, 2007
2. NAME OF THE DEVICES
2.1 Trade/Proprietary Names
VECTEC Disposable Trocars and Laparoscopic Accessories
2.2 Classification Information
| Classification Name: | Electrosurgical cutting and coagulation device and
accessories |
|----------------------------|-------------------------------------------------------------------|
| Classification Regulation: | 21 CFR § 878.4400 |
| Class: | II |
| Product Code: | GEI, electrosurgical, cutting and coagulation and
accessories |
| Panel: | General and Plastic Surgery |
1
Page 2 of 3
SUMMARY OF SAFETY AND EFFECTIVENESS (Continued
PREDICATE DEVICES 3.
| Trocars | MTP Disposable Trocars | MTP Medical Technical
Promotion GMBH
(manufactured by VECTEC) | K994066 |
|---------------------------|--------------------------------------------------------------------|---------------------------------------------------------------------|---------|
| Scissors | Applied Laparoscopic Disposable
Monopolar Scissor | Applied Medical Resources
Corporation | K062169 |
| Forceps and
Dissectors | Disposable Re-New Forceps | Microline Pentax, Inc. | K981389 |
| Hook | "Re-New" Laparoscopic Instruments
(includes hook configuration) | Microline Pentax, Inc. | K962119 |
4. DESCRIPTION OF THE DEVICES
The VECTEC Disposable Trocars and Laparoscopic Accessories can be used in a variety of procedures (general, vascular, gynecological and thoracic surgical procedures) to cut, dissect, manipulate, and/or cauterize various tissues. Trocars are sterile, single-use devices that allow visualization of body cavities and use of the laparoscopic accessories. The accessory devices are disposable, single use, individually packaged devices that are composed of biocompatible materials. Scissors, forceps, and dissectors have a handle attached to an insulated shaft with different tips, which allows the shaft and tip to rotate. They include a male cautery connector when attached to standard monopolar cautery cables and their generators. All devices are sterilized using a traditional, validated ethylene oxide procedure per EN 550:1994 to a SAL of 106 and with acceptable residual EO levels per ISO 0993-7:1995.
INDICATIONS FOR USE AND INTENDED USE ട.
The VECTEC Disposable Trocar and Laparoscopic Accessories are single-use, sterile devices intended to provide access to and visualization of body cavities, organs, and canals and to cut, dissect, manipulate, and/or cauterize various tissues during endoscopic/laparoscopic, general, vascular, gynecological and thoracic surgical procedures. Accessories include scissors, forceps, dissectors and a hook.
SUBSTANTIAL EQUIVALENCE 6.
The VECTEC Trocars (the subject of this application) and the predicate trocars (K994066) are both manufactured by VECTEC and are identical; thus, they are substantially equivalent.
Substantial equivalence of the scissors, forceps, dissectors, and hook is demonstrated by the similarity in Intended Use of instruments to their predicate. The devices are similar in characteristics to the predicate devices, and both are composed of biocompatible materials. The energy source that is used with the VECTEC accessories, monopolar electrosurgical energy, is the same as used for the predicate devices. Comparison of
2
K 0.71976
Page 3 of 3
SUMMARY OF SAFETY AND EFFECTIVENESS (Continued)
technological characteristics and bench electrosurgical device performance testing has confirmed that the VECTEC Disposable Trocars and Laparoscopic Accessories are substantially equivalent to the predicate devices.
7. PERFORMANCE TESTING
VECTEC laparoscopic accessories met the dielectric withstand testing requirements of ANSI/AAMI HF-18:2001.
CONCLUSIONS 8.
Based on the technical testing and dimensional information and intended use information provided, the VECTEC Disposable Trocars and Laparoscopic Accessories have been shown to be substantially equivalent to the predicate devices listed above.
3
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
VECTEC
% The Weinberg Group, Inc. Diane Mandell Horwitz, Ph.D., RAC Regulatory Consultant 1220 Nineteenth Street, Northwest Suite 300 Washington, District of Columbia 20036-2400
SEP -6 2007
Re: K071976
Trade/Device Name: VECTEC Disposable Trocar and Laparoscopic Accessories Regulation Number: 21 CFR 878.4400 Regulation Name: Electrosurgical cutting and coagulation device and accessories Regulatory Class: II Product Code: GEI Dated: July 17, 2007 Received: July 17, 2007
Dear Dr. Horwitz:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is 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 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 (PMA), 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 898. In addition, FDA may publish further announcements concerning your device 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 device complies 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 requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set
4
Page 2 - Diane Mandell Horwitz, Ph.D., RAC
forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
This letter will allow you to begin marketing your device as described in your Section 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), please contact the Office of Compliance at (240) 276-0115. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Parl 807.97). You may obtain other general information on your responsibilities under the Act from the Division of Souall 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/industry/support/index.html.
Sincerely yours
Mark N. Melkerson
Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
5
1. STATEMENT OF INDICATIONS FOR USE
510(k) Number (if known): K071976
Device Name: VECTEC Disposable Trocar and Laparoscopic Accessories
Indications for Use:
The VECTEC Disposable Trocar and Laparoscopic Accessories are single-use, sterile devices intended to provide access to and visualization of body cavities, organs, and canals and to cut, dissect, manipulate, and/or cauterize various tissues during endoscopic/laparoscopic, general, vascular, gynecological and thoracic surgical procedures. Accessories include scissors, forceps, dissectors and a hook.
Prescription Use X X (Part 21 CFR 801 Subpart D)
Over-The-Counter Use 21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)
Concurrence of CDRH, Office of Device Evaluation
(Divis on Sign-Off Division of General. Restorative. and Neurological Devices
510(k) Number /4671974