BiZact Tonsillectomy Device Advanced Bipolar Tissue Sealer/Divider
Device Facts
| Record ID | K182451 |
|---|---|
| Device Name | BiZact Tonsillectomy Device Advanced Bipolar Tissue Sealer/Divider |
| Applicant | Covidien, LLC |
| Product Code | GEI · General, Plastic Surgery |
| Decision Date | Nov 6, 2018 |
| Decision | SESE |
| Submission Type | Traditional |
| Regulation | 21 CFR 878.4400 |
| Device Class | Class 2 |
| Attributes | Therapeutic |
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 3mm diameter. The BiZact device is indicated for use in open general surgical procedures. It is also indicated for adult and adolescent ENT procedures (12 years of age and above), 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 coagulation for sterilization procedures. Do not use for these procedures.
Device Story
BiZact is a sterile, single-use, hand-held bipolar electrosurgical instrument; used in open general surgery and ENT procedures (tonsillectomy). Device connects to compatible electrosurgical generators (ForceTriad, Valleylab LS10, Valleylab FT10) via 10-foot cord with proprietary connector. Generator identifies device via RFID or barcode. During operation, generator delivers RF energy using a defined algorithm that adjusts output based on real-time tissue electrical resistance; achieves permanent tissue fusion. Surgeon operates device via handswitch or footswitch. Output provides hemostasis and tissue division. Benefits include effective vessel ligation and division in surgical fields. No changes to device design or performance for adolescent indication expansion.
Clinical Evidence
No new clinical trials conducted. Evidence relies on clinical literature review comparing tonsillectomy risk factors and anatomical measurements between adults and adolescents, concluding similarity. Previous bench testing (IEC 60601-1, IEC 60601-1-2, IEC 60601-2-2, ISO 10993-1) and in-vivo studies (acute/chronic hemostasis, thermal spread) from the predicate submission remain applicable.
Technological Characteristics
Bipolar RF electrosurgical device; pistol-grip design with integrated cutting blade. Materials: stainless steel, PPA, ceramic, ETFE, silicone, PTFE lubricants. Connectivity: proprietary connector with RFID/barcode for generator identification. Sterilization: Ethylene Oxide (EO). Energy: RF bipolar. Software: Generator-based algorithm for tissue fusion.
Indications for Use
Indicated for adult and adolescent (12+ years) patients undergoing open general surgical procedures, specifically ENT procedures including tonsillectomy, for ligation and division of vessels, tissue bundles, and lymphatics up to 3mm diameter. Contraindicated for tubal sterilization or tubal coagulation.
Regulatory Classification
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.
Predicate Devices
- BiZact Tonsillectomy Device Advanced Bipolar Tissue Sealer/Divider (K171066)
Submission Summary (Full Text)
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November 6, 2018
Covidien, LLC Rebecca Clark Senior Regulatory Affairs Specialist 5920 Longbow Drive Boulder, CO 80301
Re: K182451
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: September 6, 2018 Received: September 7, 2018
Dear Rebecca Clark:
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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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.
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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 of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see
https://www.fda.gov/CombinationProducts/GuidanceRegulatoryInformation/ucm597488.htm); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
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 comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely.
# Srinivas Nandkumar -S
for Malvina B. Eydelman, M.D. Director Division of Ophthalmic and Ear, Nose, and Throat Devices Office of Device Evaluation Center for Devices and Radiological Health
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## Indications for Use
510(k) Number (if known) K182451
#### Device Name
BiZact Tonsillectomy Device Advanced Bipolar Tissue 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 3mm diameter. The BiZact device is indicated for use in open general surgical procedures.
It is also indicated for adult and adolescent ENT procedures (12 years of age and above), 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 coagulation for sterilization procedures. Do not use for these procedures.
X Prescription Use (Part 21 CFR 801 Subpart D)
Over-The-Counter Use (21 CFR 801 Subpart C)
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#### 510(k) Summary Date summary prepared: October 30, 2018
### 510(k) Submitter/Holder
Covidien 5920 Longbow Drive Boulder, CO 80301
#### Contact
Rebecca Clark Senior Regulatory Affairs Specialist Telephone: 303-581-6427 Fax: 303-516-8316 Email: rebecca.a.clark@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™ Tonsillectomy Device Advanced Bipolar Tissue Sealer/Divider Catalog Number: BZ4212A Common Name: Bipolar Vessel Sealing Device 510(k) Number: K171066 (cleared June 8, 2017) 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 (ForceTriad), the Valleylab™ LS10 LS Series Single Channel Vessel Sealing Generator (VLLS10GEN), or the Valleylab™ FT10 Energy Platform (VLFT10GEN) 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 can identify the BiZact™ device via the RFID tag embedded in the connector (VLLS10GEN and VLFT10GEN) 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 tissue. The combination of the BiZact instrument and the generator algorithm achieve complete and permanent tissue fusion.
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## How provided
The BiZact™ Tonsillectomy Device Advanced Bipolar Tissue Sealer/Divider is provided sterile and is intended for single use. It is disposable and provided prescription only.
Image /page/4/Picture/3 description: The image shows a medical device inside of a clear plastic package. The device is white and gray and has a long, thin needle extending from the front. A blue tube is connected to the device. The device is held in place by a white cardboard cutout.
Provided as viewed in the image below.
#### Compatible Electrosurgical Generators
BZ4212A, BiZact™ Tonsillectomy Device Advanced Bipolar Tissue Sealer/Divider compatible with:
| Code: FORCETRIAD | Code: VLLS10GEN | Code: VLFT10GEN |
|-----------------------------|---------------------------------------------|------------------------------------|
| Force Triad Energy Platform | Valleylab™ LS10 Vessel<br>Sealing Generator | Valleylab™ FT10 Energy<br>Platform |
#### Patient Contacting Materials in BiZact™ Tonsillectomy Device Advanced Bipolar Tissue Sealer/Divider
Patient contacting materials included in the manufacture of the BiZact™ Tonsillectomy Device Advanced Bipolar Tissue Sealer/Divider (BZ4212A) include stainless steel, Polyphthalimide (PPA), ceramic, Ethylene-tetraflouroethylene, silicone, and PFTE lubricants.
#### Comparison of Technological Characteristics with the Predicate Device
BiZact Tonsillectomy Device Advanced Bipolar Tissue Sealer/Divider (BZ4212A) and is unchanged from the predicate device, as cleared under K171066, in terms of intended use, design, performance, and technological characteristics. The only difference is that the Indications for Use has been changed to include an adolescent population (12-21 years of age).
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| K182451 | | | |
|----------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------|
| CHARACTERISTIC | PROPOSED DEVICE | PREDICATE DEVICE | Comment |
| | BiZact (BZ4212A) | BiZact (BZ4212A) | |
| | K182451 | K171066 | |
| Class Regulation | 878.44 | 878.44 | Same |
| Class | II | II | Same |
| Product Code | GEI | GEI | Same |
| Indications for Use | The BiZact device is a<br>bipolar instrument<br>intended for use in<br>open surgical<br>procedures where<br>ligation and division of<br>vessels, tissue bundles,<br>and lymphatics is<br>desired.<br><br>The tissue fusion<br>function of the device<br>can be used on<br>vessels(arteries and<br>veins) and lymphatics<br>up to and including 3<br>mm diameter. The<br>BiZact device is<br>indicated for use in<br>open general surgical<br>procedures.<br><br>It is also indicated for<br>adult and adolescent<br>ENT procedures (12<br>years of age and<br>above), including<br>tonsillectomy, for the<br>ligation and division of<br>vessels, tissue bundles<br>and lymphatics 2-3 mm<br>away from unintended<br>thermally sensitive<br>structures.<br><br>The BiZact device has<br>not been shown to be<br>effective for tubal<br>sterilization or tubal<br>coagulation for<br>sterilization procedures.<br>Do not use for these<br>procedures. | The BiZact device is a<br>bipolar instrument<br>intended for use in<br>open surgical<br>procedures where<br>ligation and division of<br>vessels, tissue bundles,<br>and lymphatics is<br>desired.<br><br>The tissue fusion<br>function of the device<br>can be used on<br>vessels(arteries and<br>veins) and lymphatics<br>up to and including 3<br>mm diameter. The<br>BiZact device is<br>indicated for use in<br>open general surgical<br>procedures.<br><br>It is also indicated for<br>adult ENT procedures,<br>including<br>tonsillectomy, for the<br>ligation and division of<br>vessels, tissue bundles<br>and lymphatics 2-3 mm<br>away from unintended<br>thermally sensitive<br>structures.<br>The BiZact device has<br>not been shown to be<br>effective for tubal<br>sterilization or tubal<br>coagulation for<br>sterilization procedures.<br>Do not use for these<br>procedures. | Expansion to include<br>adolescent in the<br>indication. |
| Contraindications | None | None | Same |
| Instrument Design | Pistol Grip | Pistol Grip | Same |
| K182451 | | | |
| Energy Type | Electrical (RF)bipolar energy | Electrical (RF) bipolar energy | Same |
| CHARACTERISTIC | PROPOSED DEVICE | PREDICATE DEVICE | Comment |
| | BiZact (BZ4212A) | BiZact (BZ4212A) | |
| Compatible Energy<br>Platform(s) and 510(k)s | Valleylab ForceTriad™ | Valleylab ForceTriad™ | Same |
| | (K102913) | (K102913) | |
| | Valleylab FT10 Energy<br>Platform, Valleylab<br>FX8 FX Series Energy<br>Platform(K181389) | Valleylab FT10 Energy<br>Platform, Valleylab<br>FX8 FX Series Energy<br>Platform(K181389) | Same |
| | ValleylabTM LS, LS<br>Series Single Channel<br>Vessel Sealing<br>Generator (K143654) | ValleylabTM LS, LS<br>Series Single Channel<br>Vessel Sealing<br>Generator (K143654) | Same |
| Energy Activation<br>(Generator) | Handswitch (All<br>compatible generators) | Handswitch (All<br>compatible generators) | Same |
| | Footswitch<br>(ForceTriad) (Valleylab<br>VLFT10) | Footswitch<br>(ForceTriad) (Valleylab<br>VLFT10) | Same |
| | | | |
| | | | |
| Hand-activated button<br>design | Single stage | Single Stage | Same |
| | | | |
| Proprietary Connector | Yes | Yes | Same |
| In-Line Activation | Yes | Yes | Same |
| Cutting Mechanism<br>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<br>mm | Up to and including 3<br>mm | Same |
| | | | |
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#### 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 and adolescent ENT procedures (12 years of age and above), 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.
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## Performance Summary
Verification and validation results demonstrate that the BiZact Adolescent Tonsillectomy Device Advanced Bipolar Tissue Sealer/Divider performs as intended. 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 (renal artery and lymph)
- . Performance Testing - In-vivo - acute (hemostasis, thermal spread) and chronic (hemostasis)
No design or specification changes are associated with expanded indication, therefore the previous performance testing listed above remains applicable.
### Clinical Literature Summary
A study of clinical literature for tonsillectomy procedures in adults and adolescents show that treatments in tonsillectomy considering risk factors such as bleeding, and anatomical measurements of the treatment area in adults and adolescents are very similar without creating additional risk concerns for using the BiZact device to perform ENT procedures in both populations.
### Conclusion on Substantial Equivalence
The proposed BiZact Tonsillectomy Device Advanced Bipolar Tissue Sealer/Divider (BZ4212A) for use in adolescents defined as (12-21 years of age in this submission) is substantially equivalent to the predicate BiZact Tonsillectomy Device Advanced Bipolar Tissue Sealer/Divider (BZ4212A) for use in adults defined as (22+ years of age). Supporting clinical literature attached to this submission shows that inclusion of adolescents in the indications for this device do not raise new questions of safety or efficacy.
All performance and design specifications remain the same as for the previously cleared design. The subject device is substantially equivalent to the 510(k) cleared predicate device.
