(59 days)
No
The device description mentions a "defined algorithm that adjusts the generator output as a function of the electrical resistance," which is a standard control mechanism for electrosurgical devices and does not indicate the use of AI or ML. There is no mention of AI, ML, or related concepts in the document.
Yes
The device is described as a bipolar instrument for use in open surgical procedures for the ligation and division of vessels, tissue bundles, and lymphatics, which directly relates to treating a medical condition.
No
The BiZact™ device is an electrosurgical device intended for ligation and division of vessels and tissue, not for diagnostic purposes. It is used in open surgical procedures to achieve tissue fusion.
No
The device is a hand-held electrosurgical device that incorporates RF tissue fusion technology and is used with external generators. It is a physical medical device, not software only.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly describes a device used during surgical procedures to ligate and divide vessels and tissue. This is an in vivo application (within a living organism), not an in vitro application (outside of a living organism, typically on biological samples).
- Device Description: The description details an electrosurgical device that applies energy to tissue in situ for fusion and division. This is consistent with a surgical tool, not a diagnostic device that analyzes samples.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue samples, etc.), detecting specific analytes, or providing diagnostic information based on laboratory testing.
Therefore, the BiZact™ device is a surgical instrument used for therapeutic purposes during open procedures, not an in vitro diagnostic device.
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™ Tonsillectomy Device Advanced Bipolar Tissue Sealer/Divider is a sterile, single use, hand-held electrosurgical device that incorporates RF tissue fusion technology for a desired tissue effect when used with the ForceTriad Energy Platform (K051644, K070162, K102913, and K110268), the Valleylab™ LS10 LS Series Single Channel Vessel Sealing Generator (K143654), or the Valleylab FT10 Energy Platform (K151649, K170170) for ligation and division of vessels, tissue bundles, and lymphatics during open general surgical procedures.
The BiZact™ Tonsillectomy Device Advanced Bipolar Tissue Sealer/Divider attaches to a compatible electrosurgical generator with a 10 foot cord containing a proprietary connector. The generator is able to identify the BiZact™ device via the RFID tag embedded in the connector (Valleylab LS10 LS Series single Channel Vessel Sealing Generator and Valleylab FT10 Electrosurgical Platform) or with a barcode on the connector (ForceTriad). The generator delivers energy to the device using a defined algorithm that adjusts the generator output as a function of the electrical resistance of the combination of the BiZact instrument and the generator algorithm achieve complete and permanent tissue fusion.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
vessels, tissue bundles, lymphatics
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)
Performance Data:
Verification and validation results demonstrate that the BiZact Tonsillectomy Device Advanced Bipolar Tissue Sealer/Divider performs as intended and is substantially equivalent to its predicate, BZ4112. The following summarizes testing conducted to establish safety and substantial equivalence:
Sterilization/Shelf life
BiZact Tonsillectomy Device Advanced Bipolar Tissue Sealer/Divider (BZ4212A) underwent sterilization using a validated ethylene oxide cvcle in accordance with ISO 11135: 2014 "Sterilization of health care products - Ethylene oxide - Requirements for development, validation and routine control of a sterilization process for medical devices.
Both packaging and product stability testing (time-based/ambient storage conditions and at higher temperatures for accelerated testing) were conducted to determine the shelf life for the BiZact Tonsillectomy Device Advanced Bipolar Tissue Sealer/Divider (BZ4212A)
Basic Electrical Safety and Electromagnetic Compatibility (EMC)
Electrical safety testing and EMC were conducted on the BiZact Tonsillectomy Device Advanced Bipolar Tissue Sealer/Divider (BZ4212A). The system complies with the relevant portions of IEC 60601-1 (Basic Safety), IEC 60601-2-2 (HF Equipment & Accessories) and IEC 60601-2-2 (EMC)
ISO 10993-1 Biocompatibility
The biocompatibility evaluation of the BiZact Tonsillectomy Device Advanced Bipolar Tissue Sealer/Divider (BZ4212A) was conducted in accordance with ISO 10993-1, "Biological Evaluation of Medical Devices - Part 1: Evaluation and Testing Within a Risk Management Process." The BZ4212A is categorized as an External Communicating device; blood path, indirect with limited exposure (
§ 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/2 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" arranged around the perimeter. Inside the circle is a stylized image of three human profiles facing to the right, stacked on top of each other, forming a single, abstract shape.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
June 8, 2017
Covidien Ms. Sharon McDermott Senior Specialist Regulatory Affairs 5920 Longbow Drive Boulder, Colorado 80301
Re: K171066
Trade/Device Name: BiZact Tonsillectomy Device Advanced Bipolar Tissue 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: April 7, 2017 Received: April 10, 2017
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, 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
1
Part 807); labeling (21 CFR Part 801); medical device reporting of medical devicerelated adverse events) (21 CFR 803); good manufacturing practice requirements as set 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 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. Jennifer R. Stevenson -S3
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) K171066
Device Name
BiZact™ Tonsillectomy Device Advanced Bipolar Tissue Sealer/Divide
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/1 description: The image contains the logo for Covidien. The logo consists of a blue square with a white cross in the center, followed by the word "COVIDIEN" in blue, sans-serif font. The logo is simple and modern, and the colors are clean and professional.
510(k) Summary
Date summary prepared: May 17, 2017
510(k) Submitter/Holder
Covidien 5920 Longbow Drive Boulder, CO 80301
Contact
Sharon McDermott Senior Specialist, Regulatory Affairs Telephone: 303-581-6789 Fax: 303-530-6313 Email: sharon.l.mcdermott@medtronic.com
Name of Device
| Trade Name: | BiZact™ Tonsillectomy Device Advanced Bipolar Tissue Sealer/Divider |
|---|---|
| Catalog Number: | BZ4212A |
| Common Name: | Bipolar Vessel Sealing Device |
| Classification Name: | Electrosurgical cutting and coagulation device and accessories (21 CFR |
| 878.4400, Class II, GEI) |
Predicate Device
| Trade Name: | BiZact™ Open Sealer/Divider |
|---|---|
| Catalog Numbers: | BZ4112 |
| Common Name: | Bipolar Vessel Sealing Device |
| 510(k) Number: | K160539 (cleared 6/15/16) |
| Manufacturer: | Covidien |
Device Description
The BiZact™ Tonsillectomy Device Advanced Bipolar Tissue Sealer/Divider is a sterile, single use, hand-held electrosurgical device that incorporates RF tissue fusion technology for a desired tissue effect when used with the ForceTriad Energy Platform (K051644, K070162, K102913, and K110268), the Valleylab™ LS10 LS Series Single Channel Vessel Sealing Generator (K143654), or the Valleylab FT10 Energy Platform (K151649, K170170) for ligation and division of vessels, tissue bundles, and lymphatics during open general surgical procedures.
The BiZact™ Tonsillectomy Device Advanced Bipolar Tissue Sealer/Divider attaches to a compatible electrosurgical generator with a 10 foot cord containing a proprietary connector. The generator is able to identify the BiZact™ device via the RFID tag embedded in the connector (Valleylab LS10 LS Series single Channel Vessel Sealing Generator and Valleylab FT10 Electrosurgical Platform) or with a barcode on the connector (ForceTriad). The generator delivers energy to the device using a defined algorithm that adjusts the generator output as a function of the electrical resistance of the combination of the BiZact instrument and the generator algorithm achieve complete and permanent tissue fusion.
How Provided
The BiZact™ Tonsillectomy Device Advanced Bipolar Tissue Sealer/Divider is provided sterile and is intended for single use.
4
Compatible Electrosurgical Generators:
- ForceTriad Energy Platform (K051644, K070162, K102913, and K110268) ●
- . Valleylab™ LS10 LS Series Single Channel Vessel Sealing Generator (K143654)
- . Valleylab FT10 Energy Platform (K151649, K170170)
Patient Contacting Materials
Patient contacting materials in the manufacture of the BiZact™ Tonsillectomy Device Advanced Bipolar Tissue Sealer/Divider (BZ4212A) include stainless steel, Polyphthalamide (PPA), ceramic, Ethylene-tetrafluoroethylene, silicone and PFTE lubricants.
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 general open 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.
Comparison of Technological Characteristics with the Predicate Device
BiZact™ Tonsillectomy Device Advanced Bipolar Tissue Sealer/Divider (BZ4212A) and its predicate BiZact™ Open Sealer/Divider, BZ4112, share the same fundamental technology and indications for use. The BZ4212A uses the same vessel fusion technology as the predicate BZ4112 device to achieve its intended use. Both devices apply this technology to surgications using an instrument connected to an electrically (AC) powered generator to manipulate and control bipolar RF energy. In addition, both instruments rely on the combination of a generator-controlled power output, mechanical force/pressure applied to tissue through the use of the jaw mechanism, and proper gap between electrode surfaces to achieve effective sealing of tissue.
| CHARACTERISTIC | PROPOSED DEVICE
BiZact (BZ4212A) | PREDICATE DEVICE
BiZact (BZ4112) | Comment |
|----------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Class Regulation | 878.44 | 878.44 | Same |
| Class | II | II | Same |
| Product Code | GEI | GEI | Same |
| CHARACTERISTIC | PROPOSED DEVICE
BiZact (BZ4212A) | PREDICATE DEVICE
BiZact (BZ4112) | Comment |
| 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. | 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. | Same |
| Contraindications | None | None | Same |
| Instrument Design | Pistol Grip | Pistol Grip | Same |
| Energy Type | Electrical (RF) bipolar energy | Electrical (RF) bipolar energy | Same |
| Compatible Energy
Platform(s) and 510(k)s | Valleylab LS10 Vessel Sealing
Generator (K143654) | Valleylab LS10 Vessel Sealing
Generator (K143654) | Same |
| | Valleylab Force Triad
Electrosurgical Generator
(K051644, K070162, K102913) | No | Single-generator
compatibility considered
sufficient for initial release
of BZ4112. |
| | Valleylab FT10 Electrosurgical
Platform (K151649, K170170) | No | Compatibility with a single
generator was considered
sufficient for initial release
of the predicate BZ4112. |
| Energy Activation
(Generator) | Handswitch | Handswitch | Predicate BZ4112 is only
compatible with the LS10
generator. Neither the
predicate BZ4112 nor
subject BZ4212A can be
footswitch- activated on the |
| | Footswitch
(ForceTriad)
(Valleylab VLFT10) | No | Valleylab LS10.
Activation by hand or foot
does not lead to any
difference in energy output,
therefore does not affect
performance. |
| Hand-activated button
design | Single stage | Single stage | Same |
| CHARACTERISTIC | PROPOSED DEVICE
BiZact (BZ4212A) | PREDICATE DEVICE
BiZact (BZ4112) | Comment |
| Proprietary Connector | Yes | Yes | Same |
| In-Line Activation | Yes | Yes | Same |
| Cutting Mechanism
Design | Integrated cutting blade | Integrated cutting blade | Same |
| Single Use | Yes | Yes | Same |
| Sterile | Yes | Yes | Same |
| Sterilization Method | EO | EO | Same |
| Vessel Size Range | Up to and including 3 mm | Up to and including 3 mm | Same |
5
6
Performance Data:
Verification and validation results demonstrate that the BiZact Tonsillectomy Device Advanced Bipolar Tissue Sealer/Divider performs as intended and is substantially equivalent to its predicate, BZ4112. The following summarizes testing conducted to establish safety and substantial equivalence:
Sterilization/Shelf life
BiZact Tonsillectomy Device Advanced Bipolar Tissue Sealer/Divider (BZ4212A) underwent sterilization using a validated ethylene oxide cvcle in accordance with ISO 11135: 2014 "Sterilization of health care products - Ethylene oxide - Requirements for development, validation and routine control of a sterilization process for medical devices.
Both packaging and product stability testing (time-based/ambient storage conditions and at higher temperatures for accelerated testing) were conducted to determine the shelf life for the BiZact Tonsillectomy Device Advanced Bipolar Tissue Sealer/Divider (BZ4212A)
Basic Electrical Safety and Electromagnetic Compatibility (EMC)
Electrical safety testing and EMC were conducted on the BiZact Tonsillectomy Device Advanced Bipolar Tissue Sealer/Divider (BZ4212A). The system complies with the relevant portions of IEC 60601-1 (Basic Safety), IEC 60601-2-2 (HF Equipment & Accessories) and IEC 60601-2-2 (EMC)
ISO 10993-1 Biocompatibility
The biocompatibility evaluation of the BiZact Tonsillectomy Device Advanced Bipolar Tissue Sealer/Divider (BZ4212A) was conducted in accordance with ISO 10993-1, "Biological Evaluation of Medical Devices - Part 1: Evaluation and Testing Within a Risk Management Process." The BZ4212A is categorized as an External Communicating device; blood path, indirect with limited exposure (