(72 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, pediatric, 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™ 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 length. The lengths are 13 cm, 26 cm, 39 cm (cleared through K101797), and 48 cm; corresponding with catalog numbers SCD13, SCD26, SCD391/6, and SCD48, respectively.
The provided text describes a 510(k) premarket notification for the "Sonicision™ Cordless Ultrasonic Dissection Device" (K141371). This submission aims to demonstrate substantial equivalence to a predicate device, not to prove that the device meets specific acceptance criteria through a standalone study with clinical outcomes.
Therefore, much of the requested information regarding acceptance criteria, device performance, ground truth, and study design elements like MRMC studies, sample sizes for test/training sets, and expert qualifications/adjudication methods typically associated with clinical performance studies validating a new AI/diagnostic device, cannot be found in this document.
This document focuses on bench testing and preclinical testing to demonstrate that the proposed device, despite having different shaft lengths, maintains the same safety and performance characteristics as its predicate device.
However, I can extract information related to the types of tests performed and what was demonstrated, which implicitly serve as a form of "acceptance criteria" for demonstrating substantial equivalence in this context.
Here's a summary based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
Note: The document does not provide specific numerical acceptance criteria or performance values in a table format. Instead, it states that "All aspects were found to be identical" to the predicate device, implying that the performance of the new device (SCD13, SCD26, SCD48) matched that of the predicate (SCD391, SCD396) for the tested characteristics. The list below represents the areas of performance that were evaluated.
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| Bench Testing - Electrical/Mechanical Characteristics: | |
| Basic safety and essential performance (AAMI ES60601-1:2005) | Conformance demonstrated (implicitly "identical" to predicate) |
| Electromagnetic compatibility (IEC 60601-1-2:2007) | Conformance demonstrated (implicitly "identical" to predicate) |
| Active blade displacement | Evaluated, found to be "identical" to predicate |
| Active blade frequency | Evaluated, found to be "identical" to predicate |
| Shaft deflection | Evaluated, found to be "identical" to predicate |
| Jaw clamping force | Evaluated, found to be "identical" to predicate |
| Packaging performance | Evaluated, found to be "identical" to predicate |
| System compatibility | Evaluated, found to be "identical" to predicate |
| Bench Testing - Performance Characteristics (excised porcine tissue): | |
| Burst pressures/hemostasis of isolated vessel up to 5mm diameter | Evaluated, found to be "identical" to predicate |
| Coagulation/Dissection speed | Evaluated, found to be "identical" to predicate |
| Temperature of the active blade and shaft | Evaluated, found to be "identical" to predicate |
| Preclinical Testing (device and human factors on tissue bundles and isolated vessels up to 5mm in diameter using porcine): | |
| Acute hemostasis | Evaluated, found to be "identical" to predicate |
| Thermal spread | Evaluated, found to be "identical" to predicate |
| Chronic hemostasis | Evaluated, found to be "identical" to predicate |
| Human factors and usability | Evaluated, found to be "identical" to predicate |
Key statement from the document: "All aspects were found to be identical, with the exception of the shaft length and measurement marks." And "The shaft-length differences were found to not affect safety or performance through design verification and validation testing..."
2. Sample size used for the test set and the data provenance
- Sample Size for Test Set: Not specified in terms of numerical count for tissues or animals. The text mentions "excised porcine tissue" and "porcine" for preclinical testing, indicating animal tissue was used. No human data or specific number of tissue samples is provided.
- Data Provenance: Porcine (animal) tissue. The testing was described as "Bench testing" and "Preclinical testing." Given the context of a 510(k) submission, this would be prospective testing conducted by the manufacturer.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
Not applicable to this type of submission. This document does not concern an AI/diagnostic device requiring expert consensus for ground truth. The "ground truth" for the performance evaluations would be objective measurements from the bench and preclinical tests (e.g., actual burst pressure, measured temperature, observed hemostasis).
4. Adjudication method for the test set
Not applicable. There's no indication of human expert adjudication for the performance results. The evaluations would rely on direct measurements and observations during testing.
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
No. This device is a surgical dissection device, not an imaging/diagnostic device that would involve human "readers" or an AI component in that capacity.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This is a medical device (surgical instrument), not an algorithm or AI.
7. The type of ground truth used
The ground truth for the performance characteristics was derived from objective measurements during bench testing (e.g., active blade displacement, frequency, force, temperature, burst pressures) and observed physiological responses during preclinical testing on porcine tissue (e.g., hemostasis, thermal spread).
8. The sample size for the training set
Not applicable. The device is not an AI/ML model that requires a training set.
9. How the ground truth for the training set was established
Not applicable. No training set was used.
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Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
August 7, 2014
Covidien Mr. David M. Horton Manager, Regulatory Affairs 5920 Longbow Drive Boulder, Colorado 80301
Re: K141371
Trade/Device Name: Sonicision™Cordless Ultrasonic Dissection Device Regulatory Class: Unclassified Product Code: LFL Dated: July 17, 2014 Received: July 18, 2014
Dear Mr. Horton:
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 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 (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
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If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm. Also, please note the regulation entitled. "Misbranding by reference to premarket notification" (21CFR 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.
You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely yours,
David Krause -S
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)
Device Name
Sonicision™ Cordless Ultrasonic Dissection Device
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 ioint 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.
Type of Use (Select one or both, as applicable)
2 Prescription Use (Part 21 CFR 801 Subpart D)
_ Over-The-Counter Use (21 CFR 801 Subpart C)
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FOR FDA USE ONLY
Concurrence of Center for Devices and Radiological Health (CDRH) (Signature)
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510(k) Summary
Date summary prepared: 5/23/2014
510(k) Submitter/Holder
Covidien 5920 Longbow Drive Boulder, CO 80301
Contact
David Horton Manager, Regulatory Affairs Telephone: 303-530-6391 Fax: 303-530-6313 Email: david.m.horton@covidien.com
Name of Device
| Trade Name: | Sonicision™ Cordless Ultrasonic Dissector |
|---|---|
| Catalog Numbers: | SCD13, SCD26, SCD48 |
| Common Name: | Instrument, Ultrasonic Surgical |
| Classification Name: | Unclassified (product code LFL) |
Predicate Device
| Trade Name: | Sonicision™ Cordless Ultrasonic Dissector |
|---|---|
| Common Name: | Instrument, Ultrasonic Surgical |
| Catalog Number: | SCD391, SCD396 |
| 510(k) Number: | K101797 (cleared 2/24/2011) |
| Manufacturer: | Covidien |
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 length. The lengths are 13 cm, 26 cm, 39 cm (cleared through K101797), and 48 cm; corresponding with catalog numbers SCD13, SCD26, SCD391/6, and SCD48, respectively.
Intended 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
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adjunct to or substitute for electrosurgery, lasers, and steel scalpels in general, plastic, pediatric, 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.
Technological and Performance Characteristics
Qualitative and quantitative data were obtained and used to compare the three proposed Sonicision dissectors to the predicate dissector. All aspects were found to be identical, with the exception of the shaft length and measurement marks.
The shaft-length differences were found to not affect safety or performance through design verification and validation testing; specifically, through conformance to applicable technical design specifications and performance requirements, industry safety and performance standards, and other nonclinical testing.
Bench testing to evaluate electrical/mechanical characteristics:
- Basic safety and essential performance in accordance with AAMI ES60601-1:2005 0
- Electromagnetic compatibility in accordance with IEC 60601-1-2:2007 ●
- Active blade displacement
- Active blade frequency
- Shaft deflection
- Jaw clamping force
- Packaging performance ●
- . System compatibility
Bench testing to evaluate performance characteristics using excised porcine tissue:
- Burst pressures/hemostasis of isolated vessel up to 5mm in diameter
- Coagulation/Dissection speed ●
- . Temperature of the active blade and shaft
Preclinical testing to evaluate (device and human factors) performance on tissue bundles and isolated vessels up to 5mm in diameter using porcine:
- . Acute hemostasis
- Thermal spread ●
- . Chronic hemostasis
- Human factors and usability ●
This premarket submission did not rely on the assessment of clinical performance data to demonstrate substantial equivalence.
Through the comparison of technological and performance characteristics, the proposed Sonicision™ dissectors (SCD13, SCD26, SCD48) were found to be substantially equivalent to the predicate device.
N/A