(110 days)
Not Found
No
The description mentions "tissue sensing circuitry to constantly measure the electrical resistance of the tissue and instantaneously adjust the generator output," which is a form of feedback control based on real-time measurements, not AI/ML. There is no mention of AI, ML, or related concepts like training data or complex algorithms.
No
The device is used for surgical procedures like ligation and division of vessels and tissue, which is a surgical intervention rather than a therapeutic treatment in itself. Its purpose is to facilitate surgery, not to treat a disease or condition therapeutically.
No
The BiZact device is described as a surgical instrument used for ligation and division of vessels and tissue during open surgical procedures, which is a therapeutic function, not a diagnostic one. Its operation involves RF tissue fusion and tissue sensing to achieve a controlled tissue response, consistent with a surgical tool for treatment.
No
The device description clearly states it is a "hand-held electrosurgical device" that incorporates "RF tissue fusion technology" and attaches to a "Valleylab™ LS10 Vessel Sealing Generator" with a cord. This indicates a physical hardware component is the primary medical device, not software.
Based on the provided information, the BiZact device is not an In Vitro Diagnostic (IVD).
Here's why:
- Intended Use: The intended use clearly states the device is for use in "open surgical procedures where ligation and division of vessels, tissue bundles, and lymphatics is desired." This describes a surgical tool used directly on living tissue within the body.
- Device Description: The description details an "electrosurgical device that incorporates RF tissue fusion technology" and is used with a "Vessel Sealing Generator." This further reinforces its function as a surgical instrument for tissue manipulation.
- Lack of IVD Characteristics: IVDs are typically used to examine specimens (like blood, urine, or tissue samples) outside the body to provide information about a patient's health status, diagnose conditions, or monitor treatment. The BiZact device does not perform any such analysis of specimens.
The BiZact device is a surgical instrument used in vivo (within the body) during surgical procedures.
N/A
Intended Use / Indications for Use
The BiZact device is a bipolar instrument intended for use in open surgical procedures where ligation of vessels, tissue bundles, and lymphatics is desired.
The tissue fusion function of the device can be used on veins) and lymphatics up to and including 3 mm diameter. The BiZact device is indicated for use in open general surgical procedures.
It is also indicated for adult ENT procedures, including tonsillectomy, for the ligation of vessels, tissue bundles and lymphatics 2-3 mm away from unintended thermally sensitive structures.
The BiZact device has not been shown to be effective for tubal coagulation for sterilization procedures. Do not use for these procedures.
Product codes
GEI
Device Description
The BiZact Open Sealer/Divider is sterile, single use, hand-held electrosurgical device that incorporates RF tissue fusion technology for a desired tissue effect when used with the Valleylab™ LS10 Vessel Sealing Generator for ligation of vessels, tissue bundles, and lymphatics during open general surgical procedures.
The BiZact attaches to the Valleylab LS10 Vessel Sealing Generator with a 10 foot cord containing a connector. The generator is able to identify the BiZact device via the RFID tag embedded in the connector. The generator delivers precise energy through the device to tissue for a controlled tissue response to achieve complete and permanent tissue fusion by incorporating tissue sensing circuitry to constantly measure the electrical resistance of the tissue and instantaneously adjust the generator output to maintain the desired power.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
vessels, tissue bundles, lymphatics, ENT procedures (including tonsillectomy)
Indicated Patient Age Range
adult
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)
Verification and validation results demonstrate that the BiZact Open Sealer/Divider performs as intended and is substantially equivalent to its predicate, LF1212A. The following summarizes testing conducted to establish safety and substantial equivalence:
- IEC 60601-1 Basic Electrical Safety ●
- IEC 60601-1-2 Electromagnetic Compatibility ●
- IEC 60601-2-2 Basic Safety for HF Equipment and HF Accessories ●
- ISO 10993-1 Biocompatibility ●
- Performance Testing - Device Functionality
- Performance Testing Bench Tissue burst testing ●
- Performance Testing In-vivo acute (hemostasis, thermal spread, lymphatic burst pressure,) ● and chronic (hemostasis)
- Usability - Design Validation - Summative testing in simulated use environment
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
Image /page/0/Picture/1 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 image of three human profiles facing to the right, stacked on top of each other.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
June 15, 2016
Covidien Ms. Sharon McDermott Senior Product Specialist Regulatory Affairs 5920 Longbow Drive Boulder, Colorado 80301
Re: K160539
Trade/Device Name: Bizact Open Sealer/divider Regulation Number: 21 CFR 878.4400 Regulation Name: Electrosurgical cutting and coagulation device and accessories Regulatory Class: Class II Product Code: GEI Dated: May 24, 2016 Received: May 25, 2016
Dear Ms. McDermott:
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. Isting 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 devicerelated 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.
1
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/ResourcesforYou/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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,
Jennifer R. Stevenson -A
For Binita S. Ashar, M.D., M.B.A., F.A.C.S. 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) K160539
Device Name BiZact Open Sealer/Divider
Indications for Use (Describe)
The BiZact device is a bipolar instrument intended for use in open surgical procedures where ligation of vessels, tissue bundles, and lymphatics is desired.
The tissue fusion function of the device can be used on veins) and lymphatics up to and including 3 mm diameter. The BiZact device is indicated for use in open general surgical procedures.
It is also indicated for adult ENT procedures, including tonsillectomy, for the ligation of vessels, tissue bundles and lymphatics 2-3 mm away from unintended thermally sensitive structures.
The BiZact device has not been shown to be effective for tubal coagulation for sterilization procedures. Do not use for these procedures.
Type of Use (Select one or both, as applicable)
| ☑ 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
Image /page/3/Picture/0 description: The image contains the Covidien logo. The logo consists of a blue square with a white square in the center and a blue vertical line running through the center. To the right of the square is the word "COVIDIEN" in blue, sans-serif font. The logo is simple and modern.
510(k) Summary
Date summary prepared: June 10, 2016
510(k) Submitter/Holder
Covidien, llc 5920 Longbow Drive Boulder, CO 80301
Contact
Sharon McDermott Senior Product Specialist, Regulatory Affairs Telephone: 303-581-6789 Fax: 303-516-6313 Email: sharon.1.mcdermott@medtronic.com
Name of Device
Trade Name: BiZact™ Open Sealer/Divider Common Name: Bipolar electrosurgical instrument Classification Name: Electrosurgical cutting and coagulation device and accessories (21 CFR § 878.4400, class II. GEI).
Predicate Devices
The BiZact, Open Sealer/Divider was compared and found to be substantially equivalent to the following products of comparable type in commercial distribution:
| Device Common Name: | Bipolar electrosurgical instrument |
|---|---|
| Trade Name: | LigaSure™ Small Jaw, Open Sealer/Divider |
| Catalog Number: | LF1212A |
| 510(k) Number: | K152286 |
| Manufacturer: | Covidien, llc |
Device Description
The BiZact Open Sealer/Divider is sterile, single use, hand-held electrosurgical device that incorporates RF tissue fusion technology for a desired tissue effect when used with the Valleylab™ LS10 Vessel Sealing Generator for ligation of vessels, tissue bundles, and lymphatics during open general surgical procedures.
The BiZact attaches to the Valleylab LS10 Vessel Sealing Generator with a 10 foot cord containing a connector. The generator is able to identify the BiZact device via the RFID tag embedded in the connector. The generator delivers precise energy through the device to tissue for a controlled tissue response to achieve complete and permanent tissue fusion by incorporating tissue sensing circuitry to constantly measure the electrical resistance of the tissue and instantaneously adjust the generator output to maintain the desired power.
4
Indications for Use
The BiZact device is a bipolar instrument intended for use in open surgical procedures where ligation and division of vessels, tissue bundles, and lymphatics is desired.
The tissue fusion function of the device can be used on vessels (arteries and veins) and lymphatics up to and including 3 mm diameter. The BiZact device is indicated for use in open general surgical procedures.
It is also indicated for adult ENT procedures, including tonsillectomy, for the ligation and division of vessels, tissue bundles and lymphatics 2-3 mm away from unintended thermally sensitive structures.
The BiZact device has not been shown to be effective for tubal sterilization or tubal coagulation for sterilization procedures. Do not use for these procedures.
Testing Summary:
Verification and validation results demonstrate that the BiZact Open Sealer/Divider performs as intended and is substantially equivalent to its predicate, LF1212A. The following summarizes testing conducted to establish safety and substantial equivalence:
- IEC 60601-1 Basic Electrical Safety ●
- IEC 60601-1-2 Electromagnetic Compatibility ●
- IEC 60601-2-2 Basic Safety for HF Equipment and HF Accessories ●
- ISO 10993-1 Biocompatibility ●
- Performance Testing - Device Functionality
- Performance Testing Bench Tissue burst testing ●
- Performance Testing In-vivo acute (hemostasis, thermal spread, lymphatic burst pressure,) ● and chronic (hemostasis)
- Usability - Design Validation - Summative testing in simulated use environment
Conclusion on Substantial Equivalence
The proposed BiZact Open Sealer/Divider is substantially equivalent to the predicate LigaSure Small Jaw Open Sealer/Divider. Both devices have the same intended use and fundamental technology. The proposed device has some intentional design and indications differences that enable it to be well suited for its indicated uses. Testing demonstrated that these differences do not raise any new questions of safety or effectiveness.