(28 days)
Not Found
No
The device description focuses on mechanical and electrical functions (grasping, coagulating, transecting with a blade, rotation wheel, electrical current). There is no mention of AI, ML, image processing, or data analysis that would indicate the use of such technologies. The performance studies mentioned are standard verification tests for functionality and compliance with electrical safety standards.
Yes
The device is intended for use in open and laparoscopic surgery for grasping, coagulating, and transecting tissue, which are therapeutic actions.
No
Explanation: The device is described as a surgical instrument used for grasping, coagulating, and transecting during open and laparoscopic surgery, not for diagnosing conditions or diseases.
No
The device description clearly details a physical surgical instrument with mechanical and electrical components, including a handle, jaws, blade, rotation wheel, and connectors. It is a hardware device.
Based on the provided information, the LiNA PowerBlade Plus™ HC is not an IVD (In Vitro Diagnostic) device.
Here's why:
- Intended Use: The intended use is for "grasping, coagulating and transecting" during surgical procedures. This is a direct surgical intervention on the patient's body.
- Device Description: The device is a surgical instrument that uses electrical current and a mechanical blade to perform these surgical actions.
- Lack of Diagnostic Function: There is no mention of the device being used to examine specimens (like blood, tissue, or urine) in vitro (outside the body) to provide information for diagnosis, monitoring, or screening.
IVD devices are specifically designed to perform tests on samples taken from the human body to provide diagnostic information. The LiNA PowerBlade Plus™ HC is a surgical tool used on the body during a procedure.
N/A
Intended Use / Indications for Use
The LiNA PowerBlade Plus™ HC is intended for use in open and laparoscopic surgery where grasping, coagulating and transecting is indicated.
Product codes
GEI
Device Description
The PowerBlade Plus HC is a sterile 5 mm single use instrument available in one 330mm length version with a 10mm jaw opening. The proposed device is a bipolar forceps device that grasps and coagulates utilizing electrical current. Transecting is done with a mechanical sharp blade. The LiNA PowerBlade Plus HC includes a rotation wheel on the handle that rotates the grasper jaws at the tip to improve positioning and ergonomics during the surgical procedure. The device is single use ethylene oxide sterilized and is compatible with most standard electrosurgical generators that provide a bipolar outlet. Two types of connectors are provided: the two pin connector is for use with most standard electrosurgical generators with a bipolar outlet, and a 3-pin connector that is attached to the cable of the LiNA PowerBlade Plus HC for use with ValleyLab™ generators with a LigaSure™ outlet. When the 3-pin connector is used, the control button on the hand piece can be used to activate the coagulation. When using the 2pin connector the coagulation function of the PowerBlade Plus HC is foot pedal controlled.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
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
Non-Clinical Performance Data: Verification testing was performed as part of design controls to verify functionality of the proposed device and compliance with the same recognized standards as the predicate (IEC60601-1, and IEC60601-2-2).
Key Metrics
Not Found
Predicate Device(s)
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
Image /page/0/Picture/1 description: The image shows the seal of the U.S. Department of Health and Human Services. The seal features a stylized caduceus, a symbol often associated with medicine and healthcare, with three intertwined snakes and a staff. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular pattern around the caduceus. The seal is presented in black and white.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
October 23, 2014
LINA Medical ApS % Ms. Christine E. Nichols RAC Boston Biomedical Associates 100 Crowley Drive, Suite 216 Marlborough, Massachusetts 01752
Re: K142757
Trade/Device Name: LiNA PowerBlade Plus™ HC Regulation Number: 21 CFR 878.4400 Regulation Name: Electrosurgical cutting and coagulation device and accessories Regulatory Class: Class II Product Code: GEI Dated: September 24, 2014 Received: September 25, 2014
Dear Ms. Nichols:
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 CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical
1
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 contact the Division of Industry and Consumer Education 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. 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 Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely yours,
David Krause -S
- Binita S. Ashar, M.D., M.B.A., F.A.C.S. for Director Division of Surgical Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known) K142757
Device Name LiNA PowerBlade Plus™ HC
Indications for Use (Describe)
The LiNA PowerBlade Plus™ HC is intended for use in open and laparoscopic surgery where grasping, coagulating and transecting is indicated
Type of Use (Select one or both, as applicable)
X Prescription Use (Part 21 CFR 801 Subpart D)
| Over-The-Counter Use (21 CFR 801 Subpart C)
CONTINUE ON A SEPARATE PAGE IF NEEDED.
This section applies only to requirements of the Paperwork Reduction Act of 1995.
DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.
The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:
Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff@fda.hhs.gov
"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."
3
5 510(k) Summary
1. Submission Sponsor
LINA Medical ApS Formervangen 5 2600 Glostrup Denmark Phone: +45 43 29 66 66 Fax: -45 43 29 66 99 Contact: Louisa Memborg, Regulatory Affairs Officer
Submission Correspondent
Christine E. Nichols RAC Boston Biomedical Associates 100 Crowley Dr., Suite 216 Marlborough, MA 01752
Date Prepared
September 24, 2014
2. Device Identification
Trade/Proprietary Name: Common/Usual Name:
Classification Name:
Classification Regulation:
Product Code: Device Class: Classification Panel:
3. Predicate Device
LiNA PowerBlade Plus™ K132837
4. Device Description
The PowerBlade Plus HC is a sterile 5 mm single use instrument available in one 330mm length version with a 10mm jaw opening. The proposed device is a bipolar forceps device that grasps and coagulates utilizing electrical current. Transecting is done with a mechanical sharp
LiNA PowerBlade Plus™ HC
electrosurgical, cutting & coagulation & accessories Electrosurgical cutting and coagulation device and accessories 21 CFR 878.4400
GEI Class II General & Plastic Surgery
4
blade. The LiNA PowerBlade Plus HC includes a rotation wheel on the handle that rotates the grasper jaws at the tip to improve positioning and ergonomics during the surgical procedure. The device is single use ethylene oxide sterilized and is compatible with most standard electrosurgical generators that provide a bipolar outlet. Two types of connectors are provided: the two pin connector is for use with most standard electrosurgical generators with a bipolar outlet, and a 3-pin connector that is attached to the cable of the LiNA PowerBlade Plus HC for use with ValleyLab™ generators with a LigaSure™ outlet. When the 3-pin connector is used, the control button on the hand piece can be used to activate the coagulation. When using the 2pin connector the coagulation function of the PowerBlade Plus HC is foot pedal controlled.
5. Intended Use
The LiNA PowerBlade Plus HC is intended for use in open and laparoscopic surgery where grasping, coagulating and transecting is indicated.
6. Comparison of Technological Characteristics
This special 510(k) is a modification to the LiNA PowerBlade Plus previously cleared by the FDA via 510(k) K132837. No changes were made to the intended use, indications for use, energy type, materials, sterilization method or fundamental scientific technology. The LiNA PowerBlade Plus HC has the following differences from the predicate: Added hand control activation button for coagulation when device is used with the ValleyLab Generators with a LigaSure outlet, and the addition of a 3 pin connector adapter to allow connection with the ValleyLab Generators that have the LigaSure outlet. The three pin connector adapter can be easily removed from the cable so that the cable is compatible with most ESUs.
Non-Clinical Performance Data
Verification testing was performed as part of design controls to verify functionality of the proposed device and compliance with the same recognized standards as the predicate (IEC60601-1, and IEC60601-2-2).
Clinical Testing
There was no clinical testing required to support the medical device as the indications for use is equivalent to the predicate device. The descriptive information detailed in this submission supports the substantial equivalence of the device.
7. Conclusion Statement of Substantial Equivalence
The differences between the LiNA PowerBlade Plus HC and the predicate LiNA PowerBlade Plus do not raise any new questions regarding its safety and effectiveness. Verification testing and compliance with voluntary recognized standards, demonstrate that the LiNA PowerBlade Plus is substantially equivalent to the predicate device LiNA PowerBlade Plus in terms of design, components, principals of operation, sterilization, performance characteristics, and intended use. The LiNA PowerBlade Plus, as designed is determined to be substantially equivalent to the referenced predicate device.