(89 days)
Not Found
No
The description mentions a "defined algorithm" that adjusts generator output based on tissue resistance, which is a standard control mechanism in electrosurgery, not indicative of AI/ML. There are no mentions of AI, ML, deep learning, training data, or image processing.
No.
The device is used for surgical procedures like ligation and division of vessels and tissue, which are not therapeutic processes aimed at treating a disease or condition in itself, but rather a means to achieve a surgical outcome.
No
The device is described as a surgical instrument for ligation, division, and tissue fusion during open surgical procedures, not for diagnosing conditions.
No
The device description clearly states it is a "sterile, single use, hand-held electrosurgical device" that incorporates RF tissue fusion technology and attaches to a generator with a cord and connector. This indicates it is a physical hardware device, not software only.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostic devices are used to examine specimens taken from the human body (like blood, urine, or tissue samples) to provide information about a person's health. This testing is done outside of the body (in vitro).
- BiZact Device Function: The BiZact device is a surgical instrument used during open surgical procedures. It directly interacts with tissue inside the body to ligate and divide vessels and tissue bundles using radio frequency energy. It does not analyze samples taken from the body.
The description clearly indicates its use in surgical procedures for tissue manipulation, which is the function of a surgical device, not an IVD.
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 of the device can be used on vessels (arteries and veins) and lymphatics up to an including 3 mm diameter. The BiZact device is indicated for use in open general surgical procedures.
It's also indicated for adult, children and adolescent ENT procedures (3 years of age and above), including tonsillectorny, for the ligation and division of vessels, tissue bundles 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/Divider is a sterile, single use, hand-held electrosurgical device that incorporates radio frequency (RF) tissue fusion technology for a desired tissue effect when used with the ForceTriad™ Energy Platform (Force Triad), the Valleylab™ LS10 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/Divider attaches to a compatible electrosurgical generator with a 10-foot cord containing a proprietary connector. The generator can identify the BiZact™ Tonsillectomy Device Advanced Bipolar Tissue/Divider via the radiofrequency identification (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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
vessels (arteries and veins), tissue bundles, lymphatics
Indicated Patient Age Range
adult, children and adolescent (3 years of age and above)
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
A prospective, multi-center, single arm clinical study was conducted to demonstrate the safety and effectiveness of the BiZact™ Tonsillectomy Device Advanced Bipolar Tissue/Divider for the use with the pediatric population. Sixty (60) pediatric subjects ranging in age from three (3) to twelve (12) were enrolled in the study and all underwent tonsillectomy with the BiZact™ Tonsillectomy Device Advanced Bipolar Tissue Sealer/Divider. The primary outcome of intra-operative blood loss of the BiZact™ Tonsillectomy Device Advanced Bipolar Tissue Sealer/Divider was significantly less than the benchmark derived from a large meta-analysis, meeting the primary objective.
During the course of the clinical study, adverse events (AEs) were identified and assessed by the Investigators and an Independent External Medical Monitor in terms of severity and relatedness to the device and procedure. The assessment findings were that: a) none (0) of the events were related to use of the BiZact™ Tonsillectomy Device Advanced Bipolar Tissue Sealer/Divider: b) none (0) of the events qualified as serious AEs, and; c) thirteen (13) AEs were related to the tonsillectomy procedure itself. These include fever, vomiting, swollen tongue, throat pain, ear pain, and dehydration. The majority of these tonsillectomy-related AEs were treated at home by caregivers with pain medication. Four (4) subjects with five (5) events of dehydration, received outpatient intervention in the form of IV fluids administered in emergency rooms or a surgery center. None of the subjects were admitted or readmitted to the hospital during this study.
Key Metrics
Intra-operative blood loss: significantly less than the benchmark derived from a large meta-analysis.
Adverse Events: None (0) of the events were related to use of the BiZact™ Tonsillectomy Device Advanced Bipolar Tissue Sealer/Divider; None (0) of the events qualified as serious AEs; Thirteen (13) AEs were related to the tonsillectomy procedure itself (fever, vomiting, swollen tongue, throat pain, ear pain, and dehydration).
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.
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March 2, 2020
Covidien, LLC Juma Hoshino Regulatory Affairs Manager 5920 Longbow Drive Boulder, Colorado 80301
Re: K193356
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: December 3, 2019 Received: December 4, 2019
Dear Juma Hoshino:
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.
1
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/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (OS) 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 https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
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/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). 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 (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely.
for Michael J. Ryan Director DHT1C: Division of ENT, Sleep Disordered Breathing, Respiratory and Anesthesia Devices OHT1: Office of Ophthalmic, Anesthesia, Respiratory, ENT and Dental Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known) K193356
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 of the device can be used on vessels (arteries and veins) and lymphatics up to an including 3 mm diameter. The BiZact device is indicated for use in open general surgical procedures.
It's also indicated for adult, children and adolescent ENT procedures (3 years of age and above), including tonsillectorny, for the ligation and division of vessels, tissue bundles 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) |
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510(k) Summary
Date summary prepared: March 2, 2020
510(k) Submitter/Holder
Covidien Ilc 5920 Longbow Drive Boulder, CO 80301
Contact:
Juma Hoshino Regulatory Affairs Manager Telephone: 303-530-6541 Email: juma.hoshino@medtronic.com
Name of Device
| Trade Name: | BiZact™ Tonsillectomy Device Advanced Bipolar Tissue Sealer/Divide |
|---|---|
| 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: | K182451 (cleared November 6, 2018) |
| Manufacturer: | Covidien llc |
Device Description
The BiZact™ Tonsillectomy Device Advanced Bipolar Tissue/Divider is a sterile, single use, hand-held electrosurgical device that incorporates radio frequency (RF) tissue fusion technology for a desired tissue effect when used with the ForceTriad™ Energy Platform (Force Triad), the Valleylab™ LS10 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/Divider attaches to a compatible electrosurgical generator with a 10-foot cord containing a proprietary connector. The generator can identify the BiZact™ Tonsillectomy Device Advanced Bipolar Tissue/Divider via the radiofrequency identification (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.
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 (ForceTriad) .
- . Valleylab™ LS10 Generator (VLLS10GEN)
- Valleylab™ FT10 Energy Platform (VLFT10GEN) .
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 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, children and adolescent ENT procedures (3 years of age and above), including tonsillectorny, for the ligation of vessels, tissue bundles and lymphatics 2-3 mm away from unintended sensitive structures.
The BiZact device has not been shown to be effective for tubal coagulation for sterilization procedures. Do not use for these procedures.
Patient Contacting Materials
Patient contacting materials in the manufacture of the BiZact™ Tonsillectomy Device Advanced Bipolar Tissue Sealer/Divider include stainless steel. Polyphthalamide, ceramic, ethylene-tetrafluoroethylene, silicone, and PETE lubricants.
Comparison of Technological Characteristics with the Predicate Device
BiZact™ Tonsillectomy Device Advanced Bipolar Tissue Sealer/Divider is unchanged from the predicate device, as cleared under K182451, in terms of intended use, design, performance, and technological characteristics. The only difference is that the indications for use have been updated to include children population (3 years to less than 12 years). Tonsillectomy is a very well characterized surgical risks and adverse events are similar for all age ranges. While there is a change in the indicated patient population, the clinical study has demonstrated that the addition of children patients does not raise new questions of safety or effectiveness. Therefore, the subject device is substantially equivalent to the predicate device.
5
| Characteristic | Proposed Device
BiZact Device | Predicate Device
BiZact Device (K182451) | Comment | | |
|---------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------|---------------------------------------------------------------------------------------------|------|
| Class Regulation | 21 CFR §878.4400 | 21 CFR §878.4400 | Same | | |
| Class | II | II | Same | | |
| Product Code | GEI | GEI | Same | | |
| 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, children
and adolescent ENT procedures (3
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. | 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. | Expansion
to include
children
population. | | |
| | Contraindications | None | | None | Same |
| | Instrument Design | Pistol Grip | | Pistol Grip | Same |
| | Energy Type | Electrical (RF) bipolar energy | | Electrical (RF) bipolar energy | Same |
| | Compatible Energy
Platforms | ForceTriad™ Energy Platform
Valleylab™ LS10 Generator
Valleylab™ FT10 Energy Platform | | ForceTriad™ Energy Platform
Valleylab™ LS10 Generator
Valleylab™ FT10 Energy Platform | Same |
| Energy Activation | Handswitch
• ForceTriad™ Energy Platform
• Valleylab™ LS10 Generator
• Valleylab™ FT10 Energy Platform | Handswitch
• ForceTriad™ Energy Platform
• Valleylab™ LS10 Generator
• Valleylab™ FT10 Energy Platform | Same | | |
| | Footswitch
• ForceTriad™ Energy Platform
• Valleylab™ FT10 Energy Platform | Footswitch
• ForceTriad™ Energy Platform
• Valleylab™ FT10 Energy Platform | Same | | |
| Hand-activated Button
Design | Single Stage | Single Stage | Same | | |
| 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 | Ethylene Oxide | Ethylene Oxide | Same | | |
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Performance Characteristics
No design or specification changes are associated with the expanded indication of the BiZact™ Tonsillectorny Device Advanced Bipolar Tissue Sealer/Divider. Evidence of safety and effectiveness was presented in the previously submitted 510(k)s and includes the following:
- . Testing in accordance with IEC 60601-1, IEC 60601-1-2, IEC 60601-2-2
- Biocompatibility (ISO 10993-1) .
- Device functionality
- Bench burst pressure .
- In vivo acute and chronic animal studies ●
Clinical Studies
A prospective, multi-center, single arm clinical study was conducted to demonstrate the safety and effectiveness of the BiZact™ Tonsillectomy Device Advanced Bipolar Tissue/Divider for the use with the pediation. Sixty (60) pediatric subjects ranging in age from three (3) to twelve (12) were enrolled in the study and all underwent tonsillectomy with the BiZact™ Tonsillectomy Device Advanced Bipolar Tissue Sealer/Divider. The primary outcome of intra-operative blood loss of the BiZact™ Tonsillectomy Device Advanced Bipolar Tissue Sealer/Divider was significantly less than the benchmark derived from a large meta-analysis, meeting the primary objective.
During the course of the clinical study, adverse events (AEs) were identified and assessed by the Investigators and an Independent External Medical Monitor in terms of severity and relatedness to the device and procedure. The assessment findings were that: a) none (0) of the events were related to use of the BiZact™ Tonsillectomy Device Advanced Bipolar Tissue Sealer/Divider: b) none (0) of the events qualified as serious AEs, and; c) thirteen (13) AEs were related to the tonsillectomy procedure itself. These include fever, vomiting, swollen tongue, throat pain, ear pain, and dehydration. The majority of these tonsillectomy-related AEs were treated at home by caregivers with pain medication. Four (4) subjects with five (5) events of dehydration, received outpatient intervention in the form of IV fluids administered in emergency rooms or a surgery center. None of the subjects were admitted or readmitted to the hospital during this study.
Conclusions
The proposed BiZact™ Tonsillectomy Device Advanced Bipolar Tissue Sealer/Divider with indications for use in Children (3 years to less than 12 years) is substantially equivalent to the predicate BiZact™ Tonsillectomy Device Advanced Bipolar Tissue Sealer/Divider with indications for use in adults and adolescents (12 years of age and above). The clinical study conducted with the proposed device has demonstrated that the subject device is substantially equivalent to the predicate device.