(181 days)
Not Found
No
The summary describes a mechanical and electrical surgical instrument with no mention of AI or ML capabilities.
No.
The device is used for surgical procedures (coagulation and manipulation of tissue) which are not therapeutic in nature but are rather a surgical tool.
No
Explanation: The device description and intended use clearly state that the device is used for "manipulation and coagulation of tissue" and "electrosurgical cauterization." These are therapeutic or surgical functions, not diagnostic ones. Diagnostic devices are used to identify or detect medical conditions.
No
The device description clearly details a physical, disposable surgical instrument made of stainless steel with a needle/cannula shaft and retractable grasper, designed for electrosurgical cauterization. This is a hardware device, not software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use describes the device for "manipulation and coagulation of tissue" during surgical procedures. This is a direct intervention on the patient's body.
- Device Description: The description details a surgical instrument used for percutaneous access and electrosurgical cauterization. This is a tool used during a surgical procedure, not for testing samples outside the body.
- Lack of IVD Characteristics: There is no mention of the device being used to test samples (like blood, urine, tissue) in vitro (in a lab setting). The device interacts directly with the patient's tissue in vivo.
IVD devices are used to examine specimens derived from the human body to provide information for diagnosis, monitoring, or screening. This device does not fit that description.
N/A
Intended Use / Indications for Use
The MiniLap Technologies family of BiPolar instruments with bipolar cautery have applications in a variety of general, thoracic, gynecologic (except for use in female sterilization), urologic, laparoscopic and endoscopic procedures for manipulation and coagulation of tissue.
Product codes (comma separated list FDA assigned to the subject device)
KOG, FBQ, GEI
Device Description
The MiniLap Bipolar Electrocautery devices are a family of disposable bipolar electrosurgical graspers that directly penetrate soft tissue to access certain areas of the human anatomy without the need for a traditional insertion conduit. These disposable instruments are used for electrosurgical cauterization during general laparoscopic procedures.
Fabricated from a stainless steel alloy, MiniLap Bipolar instruments consist of an integrated 2.4mm (+/- .1mm) insulated needle/cannula shaft that houses a retractable grasper instrument. The shaft can be introduced percutaneously to the surgical site, after which the working portion of the instrument can be deployed to approximate and cauterize soft tissue. Each BiPolar instrument has a male connection provided as an integral part of the instrument that may be utilized for the bipolar connection when attached to standard two plug bipolar cables and their generators. The bipolar connection is compatible with manufacturers of standard dual female bipolar plug cables.
The instruments come in multiple lengths from 150mm to 300mm.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
soft tissue, certain areas of the human anatomy
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)
The subject device has been subjected to and passed a variety of mechanical and electrical tests and evaluations. Additionally, the device is composed of biocompatible materials with a history of usage in the medical device industry.
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.
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
§ 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
510(k) Summary
JUN - 3 2012
Date Prepared [21 CFR 807.92(a)(1)] November 1, 2011, Updated May 31, 2012
Submitter's Information [21 CFR 807.92(a)(1)]
Regulatory Contact Allan Alward 88 Ashford Avenue Dobbs Ferry, NY 10522
Sponsor/Manufacturer Mini Lap Technologies, Inc. 88 Ashford Avenue Dobbs Ferry, NY 10522 Contact: Dr. S. Ravikumar Tel: 914 591 8400
FDA Establishment Registration Number is 3007123990
Trade Name, Common Name, Classification [21 CFR 807.92(a)(2)|
Trade Names
- MINI LAP Bipolar Electrocautery Devices ◆
Device Common, Usual or Classification Names
Laparoscopic Instruments, Graspers, Cannula, Trocar, Manual Surgical Instruments, Bipolar Instruments
Classification Panel
Classification of this device would fall under the responsibility of the General & Plastic Surgery panel.
Class
Class 2 device under the following product codes/regulations:
- KOG, 21 CFR 876.1500, Endoscope Accessories
- 트 FBQ, 21 CFR 878.5090, Trocar
- . GEI, 21 CFR 878.4400, Electrosurgical cutting and coagulation accessories
1
Predicate Device [21 CFR 807.92(a)(3)]
The following devices have been identified as predicate devices:
Description of the Device [21 CFR 807.92(a)(4)]
The MiniLap Bipolar Electrocautery devices are a family of disposable bipolar electrosurgical graspers that directly penetrate soft tissue to access certain areas of the human anatomy without the need for a traditional insertion conduit. These disposable instruments are used for electrosurgical cauterization during general laparoscopic procedures.
Fabricated from a stainless steel alloy, MiniLap Bipolar instruments consist of an integrated 2.4mm (+/- .1mm) insulated needle/cannula shaft that houses a retractable grasper instrument. The shaft can be introduced percutaneously to the surgical site, after which the working portion of the instrument can be deployed to approximate and cauterize soft tissue. Each BiPolar instrument has a male connection provided as an integral part of the instrument that may be utilized for the bipolar connection when attached to standard two plug bipolar cables and their generators. The bipolar connection is compatible with manufacturers of standard dual female bipolar plug cables.
The instruments come in multiple lengths from 150mm to 300mm.
Intended Use [21 CFR 807.92(a)(5)]
The MiniLap Technologies family of BiPolar instruments with bipolar cautery have applications in a variety of general, thoracic, gynecologic (except for use in female sterilization), urologic, laparoscopic and endoscopic procedures for manipulation and coagulation of tissue.
Technological Characteristics [21 CFR 807.92(a)(6)]
We believe the MINI LAP Bipolar Electrocautery Devices are substantially equivalent to the predicate devices. see chart
2
| Characteristic | Mini Lap Technologies | Richard Wolf Medical
Instruments Corp. | Mini Lap Technologies |
|----------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| | BiPolar Electrocautery Devices | | MINI LAP Instruments |
| | | Bipolar Forceps | |
| | | | |
| 510(k) | K113597 | K023813 | K070686 |
| Indications for Use | The MiniLap Technologies family
of BiPolar instruments with
bipolar cautery have applications
in a variety of general, thoracic,
gynecologic (except for use in
female sterilization), urologic,
laparoscopic and endoscopic
procedures for manipulation and
coagulation of tissue. | For use in open and laparoscopic
surgery where grasping,
coagulating, and transecting
tissue is indicated. | Penetrate soft tissue to access
certain areas of the human
anatomy. The devices are used to
grasp, hold and manipulate other
soft internal tissues as well as
items such as hernia mesh. |
| Needle diameter | 2.4mm ± .1mm | 3.5 mm, 5 mm | 2.4 mm |
| Device length | 150-300 mm | 320 mm, 450 mm | 150-300 mm |
| Material Composition | Medical Grade Stainless Steel
17-7 SS, 300 SS | Medical Grade Stainless Steel | Medical Grade Stainless Steel
470 SS, 300 SS |
| Sterilization | Sterile, single use | Non sterile, reusable | Sterile, single use |
| Power Source | Bipolar Electrosurgical Generator | Bipolar Electrosurgical Generator | N/A |
| Power Ranges | 70 watts maximum, 20-35 watts
normal operating range | 50 watts maximum, 20-35 watts
normal operating range | |
| Safety | Safety Interlock | Safety Interlock is not applicable | Safety Interlock |
| | Insulated shaft and jaws | Insulated jaws | |
| | Compliant to applicable IEC
electrical safety standards | Compliant to applicable IEC
electrical safety standards | |
| Rotation | 175 degree shaft rotation, each
direction | | 360 degree shaft rotation |
Technological Characteristics Comparison Chart
Performance Data [21 CFR 807.92(b)(1)]
The subject device has been subjected to and passed a variety of mechanical and electrical tests and evaluations. Additionally, the device is composed of biocompatible materials with a history of usage in the medical device industry.
Conclusion [21 CFR 807.92(b)(3)]
We believe the changes are minimal and conclude that the subject device is as safe and effective as the predicate device.
3
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/3/Picture/1 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo features a stylized eagle with three wing-like shapes, symbolizing health and human services. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the eagle.
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002
MiniLap Technologies % Mr. Allan Alward Vice President Research and Development 88 Ashford Ave. Dobbs Ferry. NY 10522
JUN. - 3 2012
Re: K113597
Trade/Device Name: Mini-Lan Bipolar Electrocautery Devices Regulation Number: 21 CFR 878.4400 Regulation Name: Electrosurgical Cutting And Coagulation Device And Accessories Regulatory Class: Class II Product Code: GEI Dated: May 15, 2012 Received: May 16, 2012
Dear Mr. Alward:
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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to 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
4
Page 2 - Mr. Allan Alward
CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set 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.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to
http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
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 (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.
Sincerely yours,
Sincerely yours,
Mark N. Melkerson
Director Division of Surgical, Orthopedic & Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
5
Indications for Use
510(k) Number (if known): K113597
Device Name: Mini-Lap Bipolar Electrocautery Devices
Indications for Use:
The MiniLap Technologies family of BiPolar instruments with bipolar cautery have applications in a variety of general, thoracic, gynecologic (except for use in female sterilization), urologic, laparoscopic and endoscopic procedures for manipulation and coagulation of tissue.
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 OF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Sign-Off
(Division Sign-Off) (Division Sign-Off)
Division of Surgical, Orthopedic.
Division of Surgical, Orthopedic. Division of Surgices and Restorative Devices
510(k) Number