(100 days)
Not Found
No
The description focuses on the mechanical and electrical functions of a surgical instrument, with no mention of AI or ML.
Yes
The device is described as a bipolar forceps that grasps, coagulates, and transects tissue using electrical current, which are therapeutic actions performed during surgery.
No
The device is described as a surgical instrument for grasping, coagulating, and transecting tissue, not for diagnosing conditions.
No
The device description clearly indicates it is a physical surgical instrument (bipolar forceps with a blade) and mentions hardware components like a rotation wheel and compatibility with electrosurgical generators. It is not solely software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for "grasping, coagulating and transecting" during open and laparoscopic surgery. This describes a surgical instrument used directly on tissue within the body.
- Device Description: The description details a bipolar forceps device with a cutting blade, designed for surgical procedures. It utilizes electrical current for coagulation and a physical blade for cutting.
- Lack of IVD Characteristics: An IVD device is used to examine specimens (like blood, urine, or tissue) in vitro (outside the body) to provide information about a patient's health. The LiNA PowerBlade Plus does not perform any such analysis of specimens.
The device is clearly a surgical instrument used for therapeutic and procedural purposes, not for diagnostic testing of samples.
N/A
Intended Use / Indications for Use
The LiNA PowerBlade Plus is intended for use in open and laparoscopic surgery where grasping, coagulating and transecting is indicated.
Product codes
GEI
Device Description
The LiNA PowerBlade Plus is a 5 mm single use instrument available in one 330mm length version with a 10mm jaw opening. The LiNA PowerBlade Plus is a bipolar forceps device that grasps and coagulates utilizing electrical current. Transecting is done with a sharp blade. LiNA PowerBlade Plus 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.
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 (study type, sample size, AUC, MRMC, standalone performance, key results)
Testing was performed to demonstrate that the LiNA PowerBlade Plus complies with the same testing requirements as the predicate device which includes compliance to IEC60601-1:2006, IEC60601-2-18, and IEC60601-2-2, as well as Biocompatibility and sterilization requirements as shown by compliance to ISO10993-1, ISO1135-1, and ISO10993-7.
In addition, comparative functionality testing was performed which demonstrated that the grasping, cutting and coagulation performance of the proposed device was comparable to the predicate device.
The LiNA PowerBlade Plus testing demonstrates that the proposed and predicate devices are substantially equivalent.
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
§ 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 6.
-
- Submission Sponsor
LiNA Medical ApS
- Submission Sponsor
Formervangen 5
2600 Glostrup
Denmark
Phone: +45 4329 6666
Fax: +45 4329 6699
Contact: Louisa Memborg, Regulatory Affairs Officer
2. Submission Correspondent
Christine Nichols RAC Boston Biomedical Associates 386West Main Street Suite 7 Northborough. MA 01532 Phone: 508-351-8632 Ext 252 cnichols@boston-biomedical.com
3. Date Prepared
September 9, 2013
4. Device Identification
Trade/Proprietary Name: LiNA PowerBlade Plus
Bipolar forceps Common/Usual Name:
Electrosurgical, Cutting and Coagulation device and accessories. Classification Name:
| Class. Regulation: | 21 CFR 878.4400 |
|---|---|
| Product Code: | GEI |
| Device Class: | Class II |
| Classification Panel: | General & Plastic Surgery |
REV A
DEC 1 9 2013
1
Traditional 510(k) Premarket Notification Submission: LiNA Medical ApS PowerBlade Plus
5. Predicate Device
LiNA PowerBlade (K063025)
Device Description 6.
The LiNA PowerBlade Plus is a 5 mm single use instrument available in one 330mm length version with a 10mm jaw opening. The LiNA PowerBlade Plus is a bipolar forceps device that grasps and coagulates utilizing electrical current. Transecting is done with a sharp blade. LiNA PowerBlade Plus 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.
7. Intended Use
The LiNA PowerBlade Plus is intended for use in open and laparoscopic surgery where grasping. coagulating and transecting is indicated.
8. Comparison of Technological Characteristics
The LiNA PowerBlade Plus is substantially equivalent to the predicate device with respect to technological characteristics. The devices have similar materials and principal of use, dimensions, as well as the same energy type, performance specifications and fundamental scientific technology.
9. Non-Clinical Performance Data
Testing was performed to demonstrate that the LiNA PowerBlade Plus complies with the same testing requirements as the predicate device which includes compliance to IEC60601-1:2006, IEC60601-2-18, and IEC60601-2-2, as well as Biocompatibility and sterilization requirements as shown by compliance to ISO10993-1, ISO1135-1, and ISO10993-7.
In addition, comparative functionality testing was performed which demonstrated that the grasping, cutting and coagulation performance of the proposed device was comparable to the predicate device.
The LiNA PowerBlade Plus testing demonstrates that the proposed and predicate devices are substantially equivalent.
2
Traditional 510(k) Premarket Notification Submission: LiNA Medical ApS PowerBlade Plus
10. Clinical Testing
There was no clinical testing required to support the medical device as the indications for use is equivalent to the predicate device. These types of devices, including the predicate devices, have been on the market for many years with a proven safety and efficacy for the use of the device. The non-clinical testing detailed in this submission supports the substantial equivalence of the device.
11. Statement of Substantial Equivalence
Performance testing and compliance with voluntary standards, demonstrate that the LiNA PowerBlade Plus is substantially equivalent to the relevant aspects of the predicate device in terms of design, components, materials, principals of operation, sterilization, biocompatibility, performance characteristics, and intended use. The LiNA PowerBlade Plus, as designed and manufactured, is be substantially equivalent to the referenced predicate device.
3
Image /page/3/Picture/0 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" around the perimeter. Inside the circle is a stylized symbol that resembles an abstract human figure with outstretched arms, possibly representing care or support.
DEPARTMENT OF HEALTH & HUMAN SERVICES
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
LiNA Medical ApS % Ms. Christine E. Nichols Boston Biomedical Associates 386 West Main Street, Suite 7 Northborough, Massachusetts 01532 December 19, 2013
Re: K132837
Trade/Device Name: LiNA PowerBlade Plus Regulation Number: 21 CFR 878.4400 Regulation Name: Electrosurgical cutting and coagulation device and accessories Regulatory Class: Class II Product Code: GEI Dated: November 20, 2013 Received: November 21, 2013
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 device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set
4
Page 2 - Ms. Christine E. Nichols
forth in the quality systems (OS) 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 Small Manufacturers, International and Consumer Assistance at its tollfree number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/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 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/ResourcesforYou/Industry/default.htm.
Sincerely yours,
Radiological Health
Joshua C. Nipper -S
Binita S. Ashar, M.D., M.B.A., F.A.C.S. Acting Director For Division of Surgical Devices Office of Device Evaluation Center for Devices and
Enclosure
5
Traditional S10(k) Premarket Notification Submission: LiNA Medical ApS PowerBlade Plus
5. Indications for Use Statement
510(k) Number (if known): K132837
Device Name: LiNA PowerBlade Plus
Indications for Use:
The LiNA PowerBlade Plus is intended for use in open and laparoscopic surgery where grasping, coagulating and transecting is indicated.
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)
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0.9.2342.19200300.100.1.1 = 1.300369050
Date: 2013.12.1 9 1 1 1 1 4 17 -05T00 Chen -A for BSA
(Division Sign-off) Division of Surgical Devices 510 (k) Number: K132837