The Sonicision™ 7 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, and other open and endoscopic procedures. The device can be used to coagulate isolated vessels up to and including 7 mm in diameter, using the minimum mode. The device can be used to coagulate isolated vessels up to and including 5 mm in diameter, using the maximum mode.

The Sonicision™ 7 13 cm device is also indicated for use in otorhinolaryngologic (ENT) procedures.

The Sonicision™ reusable battery pack is a non-sterile, rechargeable, lithium-ion battery that provides power to compatible surgical devices. For full device indications for use, reference the indications for use statements of the compatible devices.

Device Description

A functional Sonicision™ 7 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, (2) a user cleaned and sterilized reusable generator, and (3) a user cleaned and disinfected reusable battery. 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 tissue and to coagulate vessels up to and including 7 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.

AI/ML Overview

The provided FDA 510(k) summary for the Sonicision™ 7 Curved Jaw Cordless Ultrasonic Dissection Device does not contain information about acceptance criteria for AI/ML performance, nor does it describe a study specifically proving the device meets AI/ML acceptance criteria. This document describes a medical device, not an AI/ML algorithm.

However, I can extract the performance data and comparisons that were provided for this medical device to demonstrate its substantial equivalence to predicate devices. This will address the general request for acceptance criteria and the study that proves the device meets them, but it will be in the context of a medical device, not an AI/ML algorithm.

Acceptance Criteria and Device Performance for Sonicision™ 7 Curved Jaw Cordless Ultrasonic Dissection Device

The submission demonstrates substantial equivalence to predicate devices through various performance tests. The "acceptance criteria" here are implied by achieving comparable performance to the predicate devices or meeting recognized standards.

1. Table of Acceptance Criteria and Reported Device Performance

Performance Characteristic	Implied Acceptance Criterion (Comparable to Predicates / Standard Met)	Reported Device Performance (Sonicision™ 7)
Biocompatibility	No new materials introduced compared to the primary predicate (K180149), thus demonstrating similar biocompatibility.	Evidence presented in previously submitted primary predicate 510(k) [K180149]. The proposed device did not introduce any new materials, therefore, by inference, it met this criteria.
Software	Compliance with "Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices" (May 11, 2005) and IEC 62304:2015.	Software tested in accordance with the specified guidance. The software development process met the requirements of IEC 62304:2015. (Note: Software was modified to allow 7 mm coagulation using minimum mode, compared to the primary predicate's 5 mm coagulation. This implies the software changes met the safety and effectiveness criteria for the expanded capability.)
Electromagnetic Compatibility (EMC)	Meeting applicable requirements of IEC 60601-1-2, 4th edition.	The assembled device met the applicable requirements of IEC 60601-1-2, 4th edition.
Electrical Safety	Meeting applicable requirements of IEC 60601-1:2005/A1:2012, Edition 3.1.	The device met all applicable requirements of IEC 60601-1:2005/A1:2012, Edition 3.1.
Ex-vivo Burst Strength (Vessel Coagulation)	Comparable burst strength to the same type of blood vessels coagulated by predicate devices. This criterion is crucial for demonstrating effective hemostasis.	Ex-vivo burst testing showed that blood vessels coagulated by the Sonicision™ 7 Curved Jaw Cordless Ultrasonic Dissection Device had comparable burst strength to the same type of blood vessels coagulated by the predicates. (Specifically, the device is able to coagulate vessels up to and including 7 mm, an improvement over the primary predicate's 5 mm).
Ex-vivo Tissue Testing (Thermal Effects)	Maximum temperatures and cool down times of the active blade and shaft comparable to predicate devices after multiple activations on mesentery, implying acceptable thermal injury control.	Ex-vivo tissue testing showed that the maximum temperatures and cool down times of the Sonicision™ 7 Curved Jaw Cordless Ultrasonic Dissection Device's active blade and shaft were comparable to the maximum temperatures and cool down times of the predicate's active blade and shaft after multiple activations on mesentery.
Acute In-vivo Testing (Hemostasis & Lateral Thermal Spread)	Comparable rates of hemostasis and comparable lateral thermal spread to predicate devices, indicating equivalent immediate surgical performance.	Acute in-vivo testing showed that the Sonicision™ 7 Curved Jaw Cordless Ultrasonic Dissection Device and the predicates achieved comparable rates of hemostasis and comparable lateral thermal spread.
Chronic In-vivo Testing (Sustained Hemostasis)	Maintenance of hemostasis for at least 21 days for vessels up to and including 7 mm in diameter. This confirms long-term efficacy of vessel sealing.	Chronic in-vivo testing showed that vessels (up to and including 7 mm in diameter) coagulated by the Sonicision™ 7 Curved Jaw Cordless Ultrasonic Dissection Device maintain hemostasis for at least 21 days.
Human Factors	Meeting user needs and demonstrated ability for intended users to use the device safely and effectively in intended use environments.	Human factors activities demonstrated that the Sonicision™ 7 Curved Jaw Cordless Ultrasonic Dissection Device meets user needs and is able to be used for the intended users, intended use, and use environments.

2. Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective)

The document does not explicitly state the numerical sample sizes for each of the performance tests (e.g., how many vessels were tested in ex-vivo burst testing, how many animals in acute/chronic in-vivo studies). It only mentions "several bench and animal tests."

The data provenance (country of origin, retrospective/prospective) is not specified in this summary. These types of tests are typically prospective studies conducted by the device manufacturer or contracted labs.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g., radiologist with 10 years of experience)

This device is a surgical instrument, not an AI/ML diagnostic tool requiring expert interpretation of images for ground truth. Therefore, the concept of "experts establishing ground truth" in the diagnostic AI sense does not apply here. The "ground truth" or reference standards are established through direct measurements (e.g., burst pressure), histological analysis, and observed clinical outcomes in animal models. The experts involved would be qualified biomedical engineers, veterinarians, and possibly surgeons overseeing the animal studies, but their specific number and qualifications are not detailed.

4. Adjudication method (e.g., 2+1, 3+1, none) for the test set

Not applicable. This is a medical device performance study, not an AI/ML algorithm evaluation with human readers.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

Not applicable. This is a medical device performance study, not an AI/ML algorithm evaluation with human readers.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

Not applicable. This is a medical device performance study, not an AI/ML algorithm evaluation. While the device has "control software," its performance is evaluated in conjunction with the mechanical and ultrasonic components, as a complete system operated by a human surgeon.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

The "ground truth" for the device's performance is established through:

Direct physical measurements: Ex-vivo burst pressure, temperature measurements.
Biological observations: Visual assessment of hemostasis, measurement of lateral thermal spread.
Pathology/Histology: Although not explicitly stated, chronic in-vivo studies often involve histological examination of tissue to confirm vessel sealing and assess tissue damage.
Outcomes data: For the chronic in-vivo study, "maintaining hemostasis for at least 21 days" refers to an outcome measurement.

8. The sample size for the training set

Not applicable. This is a medical device and not an AI/ML algorithm. There is no "training set" in the context of machine learning. The device development involved engineering design, prototyping, and iterative testing, but not machine learning training.

9. How the ground truth for the training set was established

Not applicable. As there is no AI/ML training set, there is no ground truth established for it.

Summary

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November 15, 2021

Covidien, LLC Celso Duran Principal Regulatory Affairs Specialist 5920 Longbow Dr. Boulder, Colorado 80301

Re: K212301

Trade/Device Name: Sonicision 7 Curved Jaw Cordless Ultrasonic Dissection Device Regulatory Class: Unclassified Product Code: LFL Dated: October 13, 2021 Received: October 14, 2021

Dear Celso Duran:

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/cfpm/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.

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

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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 (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 https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.

For comprehensive regulatory information about mediation-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/cdrl-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,

Long Chen, Ph.D. Assistant Director DHT4A: Division of General Surgery Devices OHT4: Office of Surgical and Infection Control Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known) K212301

Device Name

Sonicision™ 7 Curved Jaw Cordless Ultrasonic Dissector, Sonicision™ Generator; and Sonicision™ Reusable Battery

Indications for Use (Describe)

Sonicision™ 7 Curved Jaw Cordless Ultrasonic Dissector and Sonicision™ 7 Reusable Ultrasonic Generator The Sonicision™ 7 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, and other open and endoscopic procedures. The device can be used to coagulate isolated vessels up to and including 7 mm in diameter, using the minimum mode. The device can be used to coagulate isolated vessels up to and including 5 mm in diameter, using the maximum mode.

The Sonicision™ 7 13 cm device is also indicated for use in otorhinolaryngologic (ENT) procedures.

Sonicision™ Reusable Battery

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: November 11, 2021

510(k) Submitter/Holder

Covidien llc 5920 Longbow Drive Boulder, CO 80301

Contact:

Celso Duran Principal Regulatory Affairs Specialist Telephone: (303) 530 - 6445 Email: celso.duran@medtronic.com

Name of Device

Trade Name:	Sonicision™ 7 Curved Jaw Cordless Ultrasonic Dissection Device
Catalog Number:	SCD7A13, SCD7A26, SCD7A39, SCD7A48, SCG7AA, SCG7AB, SCBA
Common Name:	Ultrasonic Dissection Device
Classification Name:	None Established (unclassified, product code LFL)

Predicate Devices

Primary
Trade Name:	Sonicision™ Curved Jaw Cordless Ultrasonic Dissection Device
Catalog Number:	SCDA13, SCDA26, SCDA39, SCDA48, SCGAA, SCBA
Common Name:	Ultrasonic Dissection Device
Classification Name:	None Established (unclassified, product code LFL)
510(k) Number:	K180149 (cleared March 26, 2018)
Manufacturer:	Covidien llc
Recalls:	This predicate was the subject to a recall. The root cause of this recall wasidentified and corrected in the subject device.

Secondary

Trade Name:	Harmonic Ace +7
Catalog Number:	HARH23, HARH36, HARH45
Common Name:	Ultrasonic Dissection Device
Classification Name:	None Established (unclassified, product code LFL)
510(k) Number:	K132612 (cleared October 17, 2013)
Manufacturer:	Ethicon
Recalls:	This predicate has not been subject to a design-related recall.

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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™ 7 Curved Jaw Cordless Ultrasonic Dissector 5 mm – 13 cm	SCD7A13
Sonicision™ 7 Curved Jaw Cordless Ultrasonic Dissector 5 mm – 26 cm	SCD7A26
Sonicision™ 7 Curved Jaw Cordless Ultrasonic Dissector 5 mm – 39 cm	SCD7A39
Sonicision™ 7 Curved Jaw Cordless Ultrasonic Dissector 5 mm – 48 cm	SCD7A48
Sonicision™ 7 Reusable Ultrasonic Generator	SCG7AA, SCG7AB
Sonicision™ Reusable Battery Pack	SCBA

Indications for Use (SCD7AXX and SCG7AX)

The Sonicision™ 7 13 cm device is also indicated for use in otorhinolaryngologic (ENT) procedures.

Contraindications (SCD7AXX and SCG7AX)

The device is not indicated for incising bone.
. The device is not to be used for contraceptive tubal occlusion.

Indications for Use (SCBA)

Contraindications (SCBA)

None known.

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

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. Features that interface with the Sonicision generator and the Sonicision battery.

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 Battery 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

Patient Contacting Materials

Patient contacting materials included in the manufacture of the Sonicision™ 7 Curved Jaw Ultrasonic Dissection Device include stainless steel, titanium, Teflon (PTFE), polycarbonate (PC), and silicone rubber.

Comparison of Technological Characteristics with the Predicate Devices

The operating principle for the proposed and predicate devices is the waveguide (also referred to as blade) vibrates at ultrasonic frequencies. The motion of the waveguide creates thermal and mechanical effects that disrupt cells and tissue. At a high level, the proposed and predicate devices are based on the following technological elements:

Intended use .
Contraindications
Clamping jaws actuated using a lever ●
Modes of operation: a minimum power mode that is used for vessel coagulation and a maximum power mode that is used for dissection

The following technological differences exist between the proposed and predicate devices:

Dissectors ●
- 0 Jaw leg taper
Generator
- Software updates o
- LED updates O
. Battery (SCBA)
- O Labeling

A more detailed comparison to the predicate is provided at the end of this summary (Table 1).

Performance Data

The performance of the Sonicision™ 7 Curved Jaw Cordless Ultrasonic Dissection Device was compared to the performance of the predicate devices in several bench and animal tests, as described below. The following performance data were provided in support of the substantial equivalence determination:

Biocompatibility Evidence was presented in the previously submitted primary predicate 510(k) . [K180149]. The proposed device did not introduce any new materials when compared to the primary predicate.
. Software - The software of the proposed device was tested in accordance to "Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices," issued May 11, 2005. The software development process used to develop the SCG7AX software met the requirements of the FDArecognized standard IEC 62304: 2015.

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K212301

. Electromagnetic compatibility - The assembled device was found to meet the applicable requirements of IEC 60601-1-2, 4th edition, Medical electrical equipment - Part 1-2: General Requirements for Safety – Collateral Standard: Electromagnetic compatibility – Requirements and tests.
Electrical safety The device was found to meet all applicable requirements of IEC 60601-1: 2005/ ● A1: 2012, Medical electrical equipment - Part 1: General requirements for basic safety and essential performance - Edition 3.1.
. Ex-vivo burst testing showed that blood vessels coagulated by the Sonicision™ 7 Curved Jaw Cordless Ultrasonic Dissection Device had comparable burst strength to the same type of blood vessels coagulated by the predicates.
. Ex-vivo tissue testing showed that the maximum temperatures and cool down times of the Sonicision™ 7 Curved Jaw Cordless Ultrasonic Dissection Device's active blade and shaft were comparable to the maximum temperatures and cool down times of the predicate's active blade and shaft after multiple activations on mesentery.
. Acute in-vivo testing showed that the Sonicision™ 7 Curved Jaw Cordless Ultrasonic Dissection Device and the predicates achieved comparable rates of hemostasis and comparable lateral thermal spread.
. Chronic in-vivo testing showed that vessels (up to and including 7 mm in diameter) coagulated by the Sonicision™ 7 Curved Jaw Cordless Ultrasonic Dissection Device maintain hemostasis for at least 21 days.
. Human factors activities demonstrate that the Sonicision™ 7 Curved Jaw Cordless Ultrasonic Dissection Device meets user needs and is able to be used for the intended users, intended use, and use environments.

Conclusions

The proposed Sonicision™ 7 Curved Jaw Cordless Ultrasonic Dissection Device is substantially equivalent to the predicate devices.

Characteristic	Proposed DeviceSonicisionTM 7 DissectionDevice (SCD7AXX, SCG7AX, SCBA)	Primary Predicate DeviceSonicisionTM DissectionDevice (K180149)	Secondary Predicate DeviceHarmonic Ace +7(K132612)	Comment
Class	None Established	None Established	None Established	Identical
Product Code	LFL	LFL	LFL	Identical
Intended Use	Vessel coagulation usingultrasonic energy	Vessel coagulation usingultrasonic energy	Vessel coagulationusing ultrasonicenergy	Identical
Maximum VesselDiameterCoagulation	7 mm	5 mm	7 mm	The performancetesting demonstratedthe proposed deviceis able to coagulatevessels up to andincluding 7 mm
Characteristic	Proposed DeviceSonicision™ 7 DissectionDevice (SCD7AXX,SCG7AX, SCBA)	Primary PredicateDeviceSonicision™ DissectionDevice (K180149)	SecondaryPredicate DeviceHarmonic Ace +7(K132612)	Comment
Operatingprinciple	Waveguide (also referredto as blade) vibrates atultrasonic frequencies.The motion of thewaveguide createsthermal and mechanicaleffects that disrupt cellsand tissue. The user canalso apply pressure withthe passive jaw toachieve specific tissueeffects (e.g., coagulatinga vessel)	Waveguide (also referredto as blade) vibrates atultrasonic frequencies.The motion of thewaveguide createsthermal and mechanicaleffects that disrupt cellsand tissue. The user canalso apply pressure withthe passive jaw toachieve specific tissueeffects (e.g., coagulatinga vessel)	Waveguide (alsoreferred to as blade)vibrates at ultrasonicfrequencies. Themotion of thewaveguide createsthermal andmechanical effectsthat disrupt cells andtissue. The user canalso apply pressurewith the passive jawto achieve specifictissue effects (e.g.,coagulating a vessel)	Identical
Cordless	Yes	Yes	No	Identical to primarypredicate
Assemblyrequired prior touse?	Yes	Yes	Yes	Identical
Instrument formfactor	Shaft-based design	Shaft-based design	Shaft-based design	Identical
Power source type	Lithium-ion battery	Lithium-ion battery	Generator	Identical to primarypredicate
Power settings	The Sonicision devicehas two power levels:minimum and maximum.	The Sonicision devicehas two power levels:minimum and maximum.	The Harmonic Ace+7 has three powerlevels: minimum,maximum, andadvanced hemostasis.	Identical to primarypredicate
Power outputalgorithm	Power varied accordingto load in order toachieve constantdisplacement.	Power varied accordingto load in order toachieve constantdisplacement.	Power variedaccording to load inorder to achieveconstantdisplacement.	Identical
Software	Software modified toallow for 7 mmcoagulation usingminimum mode.	Software allows for 5mm coagulation.	Software allows for 7mm coagulation.	The performancetesting demonstratedthe proposed deviceis able to coagulatevessels up to andincluding 7 mm.
LED	Change in LED driverand componentmanufacturer	Current LED driver andcomponent manufacturer	N/A	Part is equivalent toprimary predicate.
Jaw leg taper	Taper added to jaw leg	No jaw leg taper	N/A	The performancetesting demonstratedthe proposed deviceis able to coagulatevessels up to andincluding 7 mm.

Table 1: Comparison of the Proposed and Predicate Devices

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Regulation Number and Section

N/A