(66 days)
The Sonicision™ Curved Jaw Cordless Ultrasonic Dissection Device is indicated for soft tissue incisions when bleeding control and minimal thermal injury are desired. The Device can be used as an adjunct to or substitute for electrosurgery, lasers, and steel scalpels in general, plastic, gynecologic, urologic, exposure to orthopedic structures (such as spine and joint space), and other open and endoscopic procedures. The Sonicision™ Cordless Ultrasonic Dissection Device can be used to coagulate isolated vessels up to and including 5 mm in diameter.
The Sonicision 13 cm device is also indicated for use in otorhinolaryngologic (ENT) procedures.
This is a bundled 510(k) that includes multiple individual component devices, as indicated in the table below.
A functional Sonicision™ Curved Jaw Cordless Ultrasonic Dissection device is assembled by the user within the operating room. The functional device is assembled from the following three components: (1) a sterile, single-use dissector (SCDAxx), (2) a user cleaned and sterilized reusable generator (SCGAA), and (3), a user cleaned and disinfected reusable battery (SCBA). There are four different lengths of sterile single-use dissectors to allow surgeons a range of options to meet the needs of each specific surgical case.
The assembled functional device is a hand-held, battery-powered device used to dissect through tissues and to coagulate vessels up to and including 5 mm in diameter. The clinical intended use is achieved by the surgeon when pressure is applied to tissue placed between the clamping jaw and the exposed portion of the probe while activating ultrasonic energy by pressing a button on the handpiece.
The 510(k) submission includes two accessories. The first is the Battery Insertion Guide (SCBIGA), a reusable, user-sterilized device that facilitates the assembly process.
The second accessory is a custom battery charger (CBCA). The charger is able to charge up to four SCBA batteries at a time. It provides the user with an indication of the charging progress. It also monitors battery health and the number of surgical uses the battery has gone through. It disables batteries that have reached end of life or that are out of specification.
This document is a 510(k) Premarket Notification for a medical device and therefore describes a device comparison study rather than a study aimed at proving a new AI/software-as-a-medical-device (SaMD) meets acceptance criteria. The purpose of a 510(k) submission is to demonstrate that a new device is "substantially equivalent" to a legally marketed predicate device, not necessarily to define and meet new performance acceptance criteria in the same way an AI/SaMD might.
However, based on the provided text, we can extract information regarding performance testing conducted to support the claim of substantial equivalence. I will frame the response by identifying what would traditionally be acceptance criteria for a new device and then describe the performance testing done in this 510(k) to demonstrate comparable performance to the predicate device.
Device: Sonicision™ Curved Jaw Cordless Ultrasonic Dissection Device
Study Purpose: To demonstrate substantial equivalence to the predicate device (Sonicision™ Cordless Ultrasonic Dissection Device family and accessories) by showing comparable performance.
The document does not explicitly state "acceptance criteria" in the traditional sense for a new device's performance benchmarks. Instead, the study aims to show that the proposed device performs comparably to the predicate device. The "acceptance criteria" can be inferred as performance that is not statistically or clinically meaningfully worse than the predicate device for key characteristics.
Here's how the information aligns with your requested format, interpreting "acceptance criteria" as "comparable performance to the predicate":
1. Table of Acceptance Criteria (Inferred as Demonstrating Comparability to Predicate) and Reported Device Performance
| Characteristic (Inferred Acceptance Criteria: Performance Comparable to Predicate) | Predicate Device Performance / Characteristic | Proposed Device (Sonicision Curved Jaw) Performance / Characteristic | Comment / Performance Result |
|---|---|---|---|
| Vessel Coagulation Diameter | Coagulate isolated vessels up to 5 mm in diameter. | Coagulate isolated vessels up to and including 5 mm in diameter. | Minor difference; "up to and including" 5mm. Supported by bench and pre-clinical testing. |
| Ex Vivo Burst Strength | (No explicit predicate value, but implicitly, the performance achieved by the predicate.) | Blood vessels coagulated by the Sonicision Curved Jaw device had comparable burst strength to the same type of blood vessels coagulated by predicate Sonicision device. | Comparable performance. |
| Ex Vivo Tissue Temperature (Max Blade/Shaft Temp) | (No explicit predicate value, but implicitly, the performance achieved by the predicate.) | Maximum temperature of the Sonicision Curved Jaw active blade and shaft were comparable to the maximum temperatures of the predicate Sonicision active blade and shaft after multiple activations on mesentery. | Comparable performance. |
| Acute In Vivo Hemostasis Rate | (No explicit predicate value, but implicitly, the performance achieved by the predicate.) | Achieved comparable rates of hemostasis to the predicate Sonicision device family. | Comparable performance. |
| Acute In Vivo Lateral Thermal Spread | (No explicit predicate value, but implicitly, the performance achieved by the predicate.) | Achieved comparable lateral thermal spread to the predicate Sonicision device family. | Comparable performance. |
| Chronic In Vivo Hemostasis Duration | (No explicit predicate value). | Vessels (up and including 5 mm) coagulated by the Sonicision Curved Jaw device family maintain hemostasis for at least 21 days. Surgical sites showed an expected healing response. | Meets user needs. |
| Human Factors/Usability | (No explicit predicate value, but implicitly, acceptable usability). | User interfaces and cleaning/sterilization instructions are suitable for intended user populations: OR staff (circulating nurses, surgical scrub nurses/technicians), surgeons (multiple specialties), and central processing technicians. | Validation demonstrated. |
2. Sample Size Used for the Test Set and Data Provenance
The document does not specify exact sample sizes for each test (e.g., number of vessels tested, number of mesentery activations). It broadly refers to "several bench and animal tests."
- Test Set Sample Size: Not specified quantitatively.
- Data Provenance: The tests are described as "ex vivo burst testing," "ex vivo tissue testing," "acute in vivo testing," and "chronic in vivo testing." This indicates the use of biological tissues (likely from animal models or perhaps excised human tissues, though species not specified) and live animal subjects for the in vivo studies. The country of origin of the data is not specified in the provided text. The studies would be considered prospective as they were conducted specifically for this submission.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications
The concept of "experts establishing ground truth" as typically seen in AI/SaMD studies (e.g., radiologists labeling images) is not directly applicable here. This is a medical device performance study.
- For Human Factors and Usability validation, the text mentions "Extensive human factors evaluation with operating room nurses and surgical technicians, surgeons, and central processing." While these are experts in their fields, their role is to evaluate usability rather than to establish a 'ground truth' in the diagnostic sense. The number of such participants is not specified.
4. Adjudication Method for the Test Set
Adjudication methods (e.g., 2+1 consensus) are typically used for establishing ground truth in diagnostic studies (like image interpretation by multiple readers). This type of adjudication is not relevant to the performance tests conducted for this ultrasonic dissection device (e.g., burst strength, temperature measurement, hemostasis rates).
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
No, an MRMC comparative effectiveness study was not done. This type of study is primarily relevant for AI applications where multiple human readers interpret patient cases, often with and without AI assistance, to measure diagnostic performance change. This document describes performance testing of a surgical device, not a diagnostic AI tool.
6. Standalone (Algorithm Only Without Human-in-the-Loop Performance)
Not applicable. This device is a surgical instrument operated by a human, not an AI algorithm performing a task without human intervention. The performance tests ("ex vivo," "in vivo") are of the device's physical performance in the hands of users or under simulated conditions, not a standalone algorithm.
7. Type of Ground Truth Used
The "ground truth" for this type of device performance study is established through highly controlled experimental measurements and observations:
- Quantitative Measurements: Burst strength, temperature, hemostasis rates, lateral thermal spread. These are direct physical measurements and observable outcomes from the bench and animal studies.
- Qualitative Observations: Healing responses in chronic in vivo testing, user feedback on usability. These are assessed based on established biological and usability criteria.
- The comparison is primarily against the performance of the predicate device.
8. The Sample Size for the Training Set
Not applicable. This is a medical device performance study, not an AI/Machine Learning study involving training data sets.
9. How the Ground Truth for the Training Set Was Established
Not applicable, as there is no training set mentioned or implied in this 510(k) submission.
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Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
March 26, 2018
Covidien, LLC Ms. Nancy Sauer Manager, Regulatory Affairs 5920 Longbow Drive Boulder, Colorado 80301
Re: K180149
Trade/Device Name: Sonicision Reusable Generator, Sonicision Reusable Battery Pack, Sonicision Curved Jaw Dissectors (multiple lengths), Sonicision Battery Charger, Sonicision Battery Insertion Guide Regulatory Class: Unclassified Product Code: LFL
Dated: January 18, 2018 Received: January 19, 2018
Dear Ms. Sauer:
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, 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 of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820);
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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 the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
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.
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
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Indications for Use
510(k) Number (if known) K180149
Device Name
Sonicision Curved Jaw Cordless Ultrasonic Dissection Device
Indications for Use (Describe)
The Sonicision™ Curved Jaw Cordless Ultrasonic Dissection Device is indicated for soft tissue incisions when bleeding control and minimal thermal injury are desired. The Device can be used as an adjunct to or substitute for electrosurgery, lasers, and steel scalpels in general, plastic, gynecologic, urologic, exposure to orthopedic structures (such as spine and joint space), and other open and endoscopic procedures. The Sonicision™ Cordless Ultrasonic Dissection Device can be used to coagulate isolated vessels up to and including 5 mm in diameter.
The Sonicision 13 cm device is also indicated for use in otorhinolaryngologic (ENT) procedures.
| Type of Use (Select one or both, as applicable) | |
|---|---|
| ------------------------------------------------- | -- |
X Prescription Use (Part 21 CFR 801 Subpart D)
Over-The-Counter Use (21 CFR 801 Subpart C)
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Page 1 of 7
Summary of Safety and Effectiveness
510(k) Number:
Date summary prepared: 01/13/2018
510(k) Submitter/Holder
Covidien 5920 Longbow Drive Boulder, CO 80301
Contact
Nancy Sauer Regulatory Affairs Manager Telephone: 303-581-6791 Fax: 303-530-6313 Email: nancy.k.sauer@medtronic.com
Name of Device
| Trade Name: | Sonicision™ Curved Jaw Cordless Ultrasonic Dissection Device and Accessories |
|---|---|
| Common Name: | Ultrasonic Dissection Device |
| Classification Name: | None established |
Predicate Device
The primary predicate device for this submission™ Cordless Ultrasonic Dissection Device family and accessories. The following table identifies the products included in the predicate device family and the most recent 510(k) for each of these products.
| Component Description (Catalog Number) | Applicable 510(k)s |
|---|---|
| Sonicision Reusable Generator (SCG) | K101797 |
| K153371 | |
| Sonicision Reusable Battery (SCB) | K101797 |
| K153371 | |
| 39 cm Single use Dissector (SCD39x) | K101797 |
| 13 cm Single use Dissector (SCD13) | K141371 |
| K153371 | |
| 26 cm Single use Dissector (SCD26) | K141371 |
| 48 cm Single use Dissector (SCD48) | K141371 |
| Sonicision Battery Charger (CBC) | K101797 |
| Sonicision Torque Wrench (SCT12) | K101797 |
The i-Drive Powered Stapler (K071708, K073001) is a reference device with regard to the device assembly process.
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Device Description
This is a bundled 510(k) that includes multiple individual component devices, as indicated in the table below.
| Trade Name | Catalog Number |
|---|---|
| Sonicision™ Reusable Generator | SCGAA |
| Sonicision™ Reusable Battery Pack | SCBA |
| Sonicision™ Curved Jaw Cordless Ultrasonic Dissector5 mm – 13 cm | SCDA13 |
| Sonicision™ Curved Jaw Cordless Ultrasonic Dissector5 mm - 26 cm | SCDA26 |
| Sonicision™ Curved Jaw Cordless Ultrasonic Dissector5 mm - 39 cm | SCDA39 |
| Sonicision™ Curved Jaw Cordless Ultrasonic Dissector5 mm – 48 cm | SCDA48 |
| Sonicision™ Reusable Battery Insertion Guide | SCBIGA |
| Sonicision™ Battery Charger | CBCA |
A functional Sonicision™ Curved Jaw Cordless Ultrasonic Dissection device is assembled by the user within the operating room. The functional device is assembled from the following three components: (1) a sterile, single-use dissector (SCDAxx), (2) a user cleaned and sterilized reusable generator (SCGAA), and (3), a user cleaned and disinfected reusable battery (SCBA). There are four different lengths of sterile single-use dissectors to allow surgeons a range of options to meet the needs of each specific surgical case.
The assembled functional device is a hand-held, battery-powered device used to dissect through tissues and to coagulate vessels up to and including 5 mm in diameter. The clinical intended use is achieved by the surgeon when pressure is applied to tissue placed between the clamping jaw and the exposed portion of the probe while activating ultrasonic energy by pressing a button on the handpiece.
The 510(k) submission includes two accessories. The first is the Battery Insertion Guide (SCBIGA), a reusable, user-sterilized device that facilitates the assembly process.
The second accessory is a custom battery charger (CBCA). The charger is able to charge up to four SCBA batteries at a time. It provides the user with an indication of the charging progress. It also monitors battery health and the number of surgical uses the battery has gone through. It disables batteries that have reached end of life or that are out of specification.
Indications for Use
The Sonicision Cordless Ultrasonic Dissection Device is indicated for soft tissue incisions when bleeding control and minimal thermal injury are desired. The device can be used as an adjunct to or substitute for electrosurgery, lasers, and steel scalpels in general, plastic, gynecologic, urologic, exposure to orthopedic structures (such as spine and joint space) and other open and endoscopic procedures. The Sonicision Cordless Ultrasonic Dissection Device can be used to coagulate isolated vessels up to and including 5 mm in diameter.
The Sonicision 13 cm device is also indicated for use in otorhinolaryngologic (ENT) procedures.
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Technological Characteristics
Sonicision dissectors
These are sterile single-use devices that include the following features:
- . Active blade that vibrates at ultrasonic frequency and delivers the energy that provides the tissue effect
- . Clamping jaw that the surgeon uses to provide pressure to vessels, tissues, or vascular bundles as needed to deliver the desired tissue effect
- Controls for activating the delivery of ultrasonic energy, positioning the jaws, and for opening ● and closing the clamping jaw
- . A speaker to deliver audio signals
Sonicision Reusable Generator
This is a re-usable device that is cleaned and sterilized by the user facility. It has the following features
- Transducer that converts electrical energy into ultrasonic energy (resonant frequency of approximately 56.0 kHz)
- . Indicator LED that notifies the user of the state of the assembled device
- . Control software
Sonicision Reusable Batterv Pack
This is a reusable device that is cleaned and disinfected by the user facility. It has the following features
- . Li-ion chemistry
- 7.2 V ●
- . Multiple internal safety protections
Sonicision Reusable Battery Insertion Guide
This is a reusable device that is cleaned and sterilized by the user facility. It is a molded plastic component that is designed to interface with the battery compartment of the single-use dissectors. It has the following features
- Keying features to assist with the assembly process ●
- Printed graphic showing the correct placement orientation .
Sonicision Battery Charger
This is a custom battery charger that is compatible only with the SCBA battery. It has the following features
- . Charging bays that are keyed to facilitate correct orientation of the SCBA batteries
- A user interface that indicates charging progress, if there is a problem with a battery, and if there . is a problem with a charger bay.
- Monitors battery health and usage; disables batteries that have problems or are at end of life ●
Comparison to the Predicate Device
The table below compares the main device characteristics and performance of the Sonicision™ Curved Jaw Cordless Ultrasonic Dissection Device to the device characteristics and performance of the legally marketed Sonicision™ Cordless Ultrasonic Dissection Device.
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Page 4 of 7
| Characteristic | Sonicision Curved Jaw(Proposed Device) | Currently marketedSonicision (PredicateDevice) | Comment |
|---|---|---|---|
| Indications for Use | The Sonicision™ Curved JawCordless UltrasonicDissection Device is indicatedfor soft tissue incisions whenbleeding control and minimalthermal injury are desired.The device can be used asan adjunct to or substitute forelectrosurgery, lasers, andsteel scalpels in general,plastic, pediatric,gynecologic, urologic,exposure to orthopedicstructures (such as spine andjoint space) and other openand endoscopic procedures.The Sonicision CordlessUltrasonic Dissection Devicecan be used to coagulateisolated vessels up to andincluding 5 mm in diameter.The Sonicision 13 cm deviceis also indicated for use in | The Sonicision™ CordlessUltrasonic Dissection Deviceis indicated for soft tissueincisions when bleedingcontrol and minimal thermalinjury are desired. TheDevice can be used as anadjunct to or substitute forelectrosurgery, lasers, andsteel scalpels in general,plastic, pediatric,gynecologic, urologic,exposure to orthopedicstructures (such as spine andjoint space), and other openand endoscopic procedures.The Sonicision™ CordlessUltrasonic Dissection Devicecan be used to coagulateisolated vessels up to 5 mmin diameter.The Sonicision 13 cm deviceis also indicated for use in | The only difference is thatthe indicated vessel size isbeing changed from "up to 5mm" to "up to and including5mm."This minor difference invessel size range does notcreate a new intended use orraise new kinds of safety oreffectiveness questions. Theability of the SonicisionCurved Jaw device tocoagulate vessels that are 5mm in diameter is supportedby both bench testing andpre-clinical testing includedwithin this submission. |
| otorhinolaryngologic (ENT)procedures. | otorhinolaryngologic (ENT)procedures. | ||
| Contraindications | The device is not indicatedfor incising bone.The device is not intended forcontraceptive tubal occlusion. | The device is not indicatedfor incising bone.The device is not intended forcontraceptive tubal occlusion. | Same |
| Operating Principle | Waveguide (also referred toas blade) vibrates atultrasonic frequencies. Themotion of the waveguidecreates thermal andmechanical effects thatdisrupt cells and tissue. Theuser can also apply pressurewith the passive jaw toachieve specific tissue effects(e.g., coagulating a vessel) | Waveguide (also referred toas blade) vibrates atultrasonic frequencies. Themotion of the waveguidecreates thermal andmechanical effects thatdisrupt cells and tissue. Theuser can also apply pressurewith the passive jaw toachieve specific tissue effects(e.g., coagulating a vessel) | Same |
| Characteristic | Sonicision Curved Jaw(Proposed Device) | Currently marketedSonicision (PredicateDevice) | Comment |
| Resonant frequency ofoperation | 56.0 kHz | 55.5 kHz | This is a very minor shift inresonant frequencyassociated with designchanges in the proposedcurved jaw device. |
| Cordless | Yes | Yes | Same |
| Assembly Required prior touse? | Yes | Yes | Some differences in theassembly process. |
| Power source type | Lithium-ion battery | Lithium-ion battery | Same |
| Instrument form factor | Shaft-based design, pistolgrip | Shaft-based design, pistolgrip | Same |
| Active blade length | 14.5 mm | 14.5 mm | Same |
| Jaw and active blade shape | Curved | Straight | The curve is an alternatedesign, which is a commonfeature of many surgicalinstruments. Testing showedequivalent performance to thepredicate device. |
| Power Settings | Two power levels: minimumand maximum. | Two power levels: minimumand maximum. | Same |
| Audio Indicators - functional | Audio tones from the handsetprovide feedback that energyhas been activated. The pitchof the tone correlates withminimum or maximumsetting. | Audio tones from the handsetprovide feedback that energyhas been activated. The pitchof the tone correlates withminimum or maximumsetting. | Same |
| Audio indicators - errors | Audio tones with distinctpatterns also indicateassembly errors, devicemalfunction, and low batteryconditions. | Audio tones with distinctpatterns also indicateassembly errors, devicemalfunction, and low batteryconditions. | Same set of indications. |
| Visual Indicators | Visual indicators (LEDs) ontop of device identify the stateof the assembled device,battery, and generator. | Visual indicators (LEDs) ontop of device identify the stateof the assembled device,battery, and generator. | All of the original indicatorsare present, plus a new visualindicator related to generatorstatus. |
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The impact of these differences was evaluated through
(1) Comparative studies described below showing equivalent performance of the Sonicision Curved Jaw device and predicate Sonicision device.
(2) Comparison to a reference device, the i-Drive powered stapling device for aspects related to device assembly.
(3) Validation of cleaning, disinfection, and sterilization processes in accordance with FDA guidance.
(4) Extensive human factors evaluation with operating room nurses and surgical technicians, surgeons, and central processing.
Standards Compliance
The devices that make up the Sonicision™ Curved Jaw Ultrasonic Dissection Device and the accessories included in this 510(k) submission have been shown to meet the medical device standards listed below, as applicable.
- . ISO 10993-1: 2009, Biological evaluation of medical devices – Part 1: Evaluation and testing within a risk management process - Fourth Edition
- IEC 60601-1: 2005 + A1 2012, Medical electrical equipment = Part 1: General reguirements for . basic safety and essential performance - Edition 3.1
- IEC 60601-1-2: 2014, Medical electrical equipment Part 1-2: General Requirements for Safety . - Collateral Standard: Electromagnetic compatibility - Requirements and tests, 4th edition
- IEC 62133: 2012, Secondary cells and batteries containing alkaline or other non-acid ● electrolytes-Safety requirements for portable sealed secondary cells, and for batteries made from them, for use in portable applications
- IEC 62281: 2012, Safety of primary and secondary lithium cells and batteries during transport
- UN Manual of Tests and Criteria, 6th Edition, "Recommendations on the Transport of Dangerous . Goods. Section 38.3 - Lithium Batteries"
The software development process was evaluated by a third party and found to meet the requirements of IEC 62304: 2006 (Medical device software - Software life cycle processes, 1* edition).
The human factors and usability engineering process was evaluated by a third party and found to meet the requirements of IEC 62366-1: 2015 (Medical devices. Application of usability engineering to medical devices).
Performance
The performance of the Sonicision™ Curved Jaw Cordless Ultrasonic Dissection Device was compared to the performance of the primary predicate device in several bench and animal tests, as described below. The results of this testing show comparable performance between the two device families.
- . Ex vivo burst testing showed that blood vessels coagulated by the Sonicision Curved Jaw device had comparable burst strength to the same type of blood vessels coagulated by predicate Sonicision device.
- Ex vivo tissue testing showed that the maximum temperature of the Sonicision Curved Jaw active ● blade and shaft were comparable to the maximum temperatures of the predicate Sonicision active blade and shaft after multiple activations on mesentery.
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-
. Acute in vivo testing showed that the Sonicision Curved Jaw device family and the predicate Sonicision device family achieved comparable rates of hemostasis and comparable lateral thermal spread.
Other tests demonstrated that the Sonicision Curved Jaw Cordless Ultrasonic Dissection Device family meets user needs and FDA expectations. -
. Chronic in vivo testing showed that vessels (up and including 5 mm in diameter) coagulated by the Sonicision Curved Jaw device family maintain hemostasis for at least 21 days. Surgical sites showed an expected healing response.
-
. Human Factors and Usability validation demonstrated that the user interfaces and cleaning/sterilization instructions for the various devices included in this 510(k) are suitable for the intended user populations: OR staff (circulating nurses and surgical scrub nurses and technicians, surgeons from multiple surgical specialties, and central processing technicians.
Conclusion
The Sonicision™ Curved Jaw Cordless Ultrasonic Dissection Device family and accessories are substantially equivalent to the predicate Sonicision™ Cordless Ultrasonic Dissection Device family and accessories.
N/A