(140 days)
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 5 mm in diameter.
The Sonicision™ 13 cm device is also indicated for use in otorhinolaryngologic (ENT) procedures.
The Sonicision™ Cordless Ultrasonic Dissector is a component of the Sonicision™ Cordless Ultrasonic Dissection Device, which is a hand-held surgical device consisting of three interdependent components that. when assembled, enable ultra-high-frequency mechanical motion (ultrasonic energy) to transect, dissect, and coagulate tissue.
The dissector is a sterile, single-use component to which the Sonicision reusable generators and battery packs attach. This component contains features essential to the control and performance of the assembled device; such as the clamping jaw, active blade, speaker, two-stage energy button, rotation wheel, and jaw lever.
Four configurations are available, differing principally by shaft lengths are 13 cm, 26 cm, 39 cm, and 48 cm; corresponding with catalog numbers SCD13, SCD26, SCD396, and SCD48, respectively. The only difference between SCD391 and SCD396 is the packaging configuration. There is no difference in the design of the device.
The provided text describes a 510(k) premarket notification for the Sonicision™ Cordless Ultrasonic Dissector, a surgical device. While it details performance testing, it does not explicitly state specific "acceptance criteria" numerical values that the device had to meet. Instead, the performance studies aim to demonstrate comparability or non-inferiority to the predicate device.
Therefore, I cannot populate a table with explicit acceptance criteria and corresponding reported performance numerical values as they are not presented in that format in the document. The document describes the type of performance tests conducted and the finding of comparability.
However, I can extract and present the information related to the studies in the requested format, interpreting "acceptance criteria" as the goal of the test (e.g., comparable burst strength) and "reported device performance" as the outcome in relation to the predicate.
Here's the breakdown of the information based on the provided text:
Acceptance Criteria and Device Performance
As explicit numerical acceptance criteria are not provided, the "acceptance criteria" are inferred as demonstrating comparability or non-inferiority to the predicate device for various performance aspects.
| Acceptance Criteria (Inferred Goal) | Reported Device Performance (Study Outcome) |
|---|---|
| Ex-vivo burst strength of coagulated blood vessels comparable to predicate. | Blood vessels coagulated by the Sonicision™ Cordless Ultrasonic Dissector had comparable burst strength to the same type of blood vessels coagulated by the predicate. |
| Maximum temperatures and cool-down times of active blade and shaft comparable to predicate after multiple activations on mesentery. | The device's maximum temperatures and cool down times of the active blade and shaft were comparable to the predicate's active blade and shaft after multiple activations on mesentery. |
| Rates of hemostasis and lateral thermal spread comparable to predicate in acute in-vivo testing. | The Sonicision™ Cordless Ultrasonic Dissector and the predicate achieved comparable rates of hemostasis and comparable lateral thermal spread in acute in-vivo testing. |
| Vessel hemostasis retention (up to 5 mm) for at least 21 days for coagulated vessels. | Vessels (up to 5 mm in diameter) coagulated by the Sonicision™ Cordless Ultrasonic Dissector maintain hemostasis for at least 21 days (demonstrated in chronic in-vivo testing). |
| Meets user needs and FDA expectations (Human Factors Validation). | Human factors validation in a porcine model and a human cadaver model demonstrated that the Sonicision™ Cordless Ultrasonic Dissector meets user needs and FDA expectations. (This implies successful completion of simulated use tasks without critical errors). |
Study Details
-
Sample sizes used for the test set and the data provenance:
- Ex-vivo Burst Testing: Specific sample size not provided, but performed on "blood vessels."
- Ex-vivo Tissue Testing: Specific sample size not provided, but performed on "mesentery."
- Acute In-vivo Testing: Specific sample size not provided.
- Chronic In-vivo Testing: Specific sample size not provided.
- Human Factors Validation: Performed in a "porcine model and a human cadaver model." Specific number of participants/cadavers not provided.
- Data Provenance: The studies are described as "bench and animal tests" and human cadaver models, implying controlled laboratory or clinical simulation environments. The country of origin is not specified but is presumably where Covidien (Boulder, Colorado) conducts its R&D or contracted research. The studies are prospective in nature, designed specifically to test the device.
-
Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- The document does not specify the number or qualifications of experts involved in establishing ground truth for any of these performance tests. For animal and cadaver studies, typically veterinarians, pathologists, and surgeons/anatomists would be involved, but this information is not provided.
-
Adjudication method for the test set:
- The document does not describe any specific adjudication method (e.g., 2+1, 3+1) for the outcomes of these performance tests. The results seem to be presented as direct measurements or observations.
-
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:
- No, an MRMC comparative effectiveness study involving human "readers" or AI assistance was not done. This device is a surgical instrument, not an imaging diagnostic device that would typically involve human "readers" or AI for image interpretation. The human factors validation is about user interaction with the device, not diagnostic interpretation.
-
If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:
- This is not applicable as the device is a physical surgical instrument and does not involve an AI algorithm with standalone performance. Its performance is always integrated with human use.
-
The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- Burst Strength: Likely measured mechanically (physics-based ground truth).
- Temperatures/Cool Down Times: Measured using temperature sensors (physics-based ground truth).
- Hemostasis/Lateral Thermal Spread: Likely assessed visually, histologically (pathology-based), or through direct measurement during animal studies (outcomes/observational ground truth).
- Hemostasis Retention: Assessed through long-term observation in chronic animal studies (outcomes data).
- Human Factors Validation: Established by objective task completion metrics (e.g., successful dissection, coagulation, no user errors) and subjective user feedback, compared against pre-defined user needs and FDA expectations for usability.
-
The sample size for the training set:
- This concept (training set) is not applicable as the device is a physical surgical instrument, not a machine learning/AI model. Therefore, there is no "training set" in the conventional sense. The development of the device would involve engineering, design, and iterative testing, but not data-driven "training" like an AI.
-
How the ground truth for the training set was established:
- As there is no "training set" for an AI model, this question is not applicable to this device submission.
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Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health & Human Services logo on the left and the FDA text logo on the right. The text logo has the FDA acronym in a blue square, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue.
July 10, 2020
Covidien, LLC Celso Duran Principal Regulatory Affairs Specialist 5920 Longbow Dr. Boulder, Colorado 80301
Re: K200427
Trade/Device Name: Sonicision Cordless Ultrasonic Dissector Regulation Number: 21 CFR Regulation Name: Instrument, Ultrasonic Surgical Regulatory Class: Class II Product Code: LFL Dated: June 16, 2020 Received: June 17, 2020
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/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.
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
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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 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/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,
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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Form Approved: OMB No. 0910-0120
Expiration Date: 06/30/2020
See PRA Statement below.
DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration
Indications for Use
510(k) Number (if known) K200427
Device Name
Sonicision™ Cordless Ultrasonic Dissector
Indications for Use (Describe)
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 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 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)
CONTINUE ON A SEPARATE PAGE IF NEEDED.
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510(k) Summary
Date summary prepared: February 19, 2020
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™ Cordless Ultrasonic Dissector |
|---|---|
| Catalog Number: | SCD13, SCD26, SCD391, SCD396, SCD48 |
| Common Name: | Ultrasonic Dissector |
| Classification Name: | None Established (unclassified, product code LFL) |
Predicate Device
| Trade Name: | Sonicision™ Cordless Ultrasonic Dissector |
|---|---|
| Catalog Number: | SCD13, SCD26, SCD391, SCD396, SCD48 |
| Common Name: | Ultrasonic Dissector |
| Classification Name: | None Established (unclassified, product code LFL) |
| 510(k) Number: | K153371 (cleared March 28, 2016) - SCD13K141371 (cleared August 7, 2014) - SCD13, SCD26, SCD48K101797 (cleared February 24, 2011) - SCD391, SCD396 |
| Manufacturer: | Covidien llc |
| Recalls: | This predicate has not been subject to a design-related recall. |
CD13 dissector. K141371 and K101797 are referenced in the table above as those submissions cumulatively provided clearance for all lengths of dissectors.
Reference Device
| Trade Name: | Sonicision™ Curved Jaw Cordless Ultrasonic Dissector |
|---|---|
| Catalog Number: | SCDA13, SCDA26, SCDA39, SCDA48 |
| Common Name: | Ultrasonic Dissector |
| Classification Name: | None Established (unclassified, product code LFL) |
| 510(k) Number: | K180149 (cleared March 26, 2018) |
| Manufacturer: | Covidien llc |
The reference device supports the use of well-established methods in this submission. The methods used in the reference device were found acceptable through K180149. Covidien is the manufacturer of both the reference and predicate device.
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Device Description
The Sonicision™ Cordless Ultrasonic Dissector is a component of the Sonicision™ Cordless Ultrasonic Dissection Device, which is a hand-held surgical device consisting of three interdependent components that. when assembled, enable ultra-high-frequency mechanical motion (ultrasonic energy) to transect, dissect, and coagulate tissue.
The dissector is a sterile, single-use component to which the Sonicision reusable generators and battery packs attach. This component contains features essential to the control and performance of the assembled device; such as the clamping jaw, active blade, speaker, two-stage energy button, rotation wheel, and jaw lever.
Four configurations are available, differing principally by shaft lengths are 13 cm, 26 cm, 39 cm, and 48 cm; corresponding with catalog numbers SCD13, SCD26, SCD396, and SCD48, respectively. The only difference between SCD391 and SCD396 is the packaging configuration. There is no difference in the design of the device.
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, 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 5 mm in diameter.
The Sonicision™ 13 cm device is also indicated for use in otorhinolaryngologic (ENT) procedures.
Technological Characteristics
The Sonicision™ Cordless Ultrasonic Dissector is a sterile single-use device that includes 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 and closing the clamping jaw.
- Features that interface with the Sonicision generator and the Sonicision battery. ●
Patient Contacting Materials
Patient contacting materials in the manufacture of the Sonicision™ Ultrasonic Dissector include stainless steel, titanium, polycarbonate, thermoplastic elastomer, acrylonitrile butadiene styrene (ABS), and silicone.
Comparison of Technological Characteristics with the Predicate Device
The operating principle for both the subject and predicate devices is the same. 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 subject and predicate devices are based on the following technological elements:
- Intended and indicated for the same types of surgeries ●
- Contraindications .
- Resonant frequency, approx. 55.5 kHz ●
- 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 subject and predicate devices:
- Jaw force
- Force to fully close the jaw lever
- Tactile feedback during lever actuation
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Performance Data
The performance of the Sonicision™ Cordless Ultrasonic Dissector was compared to the performance of the predicate device in several bench and animal tests, as described below. The following performance data were provided in support of the substantial equivalence determination:
- . Ex-vivo burst testing showed that blood vessels coagulated by the Sonicision™ Cordless Ultrasonic Dissector had comparable burst strength to the same type of blood vessels coagulated by the predicate.
- Ex-vivo tissue testing showed that the maximum temperatures and cool down times of the Sonicision™ . Cordless Ultrasonic Dissector'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™ Cordless Ultrasonic Dissector and the predicate . achieved comparable rates of hemostasis and comparable lateral thermal spread.
- . Chronic in-vivo testing showed that vessels (up to 5 mm in diameter) coagulated by the Sonicision™ Cordless Ultrasonic Dissector maintain hemostasis for at least 21 days.
- . Human factors validation in a porcine model and a human cadaver model demonstrated that the Sonicision™ Cordless Ultrasonic Dissector meets user needs and FDA expectations.
Conclusions
The proposed Sonicision™ Cordless Ultrasonic Dissector is substantially equivalent to the predicate Sonicision™ Cordless Ultrasonic Dissector.
N/A