(115 days)
Not Found
No
The document describes a mechanical ultrasonic dissection device and its components. There is no mention of AI or ML in the intended use, device description, or performance studies.
Yes
The device is described as forming incisions, dissecting tissue, and coagulating vessels, all of which are actions to treat or modify body function, classifying it as a therapeutic device.
No.
The device is described as an ultrasonic dissection device used for surgical procedures, specifically for cutting and coagulating tissue and vessels, not for diagnosing conditions.
No
The device description clearly outlines hardware components (dissector, generator, battery) that are assembled to form the functional device. It is a physical, hand-held surgical instrument.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostic devices are used to examine specimens taken from the human body (like blood, urine, tissue samples) to provide information about a person's health. This testing is done outside of the body (in vitro).
- Sonicision™ Device Function: The Sonicision™ device is a surgical tool used directly on tissue within the body during surgical procedures. It performs dissection and coagulation of tissue and vessels.
The description clearly indicates its use in surgical settings for cutting and sealing tissue, which is a therapeutic and surgical function, not an in vitro diagnostic function.
N/A
Intended Use / Indications for Use
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
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.
Product codes (comma separated list FDA assigned to the subject device)
LFL
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 |
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
soft tissue, vessels, otorhinolaryngologic (ENT)
Indicated Patient Age Range
Not Found
Intended User / Care Setting
surgeon, user facility/operating room
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
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.
- 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.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
N/A
0
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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
1
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
2
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
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.
| 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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3
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 was |
| identified 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. |
4
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 |
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.
Indications for Use (SCD7AXX and SCG7AX)
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.
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)
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.
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
5
- . 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.
6
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 Device
SonicisionTM 7 Dissection
Device (SCD7AXX, SCG7AX, SCBA) | Primary Predicate Device
SonicisionTM Dissection
Device (K180149) | Secondary Predicate Device
Harmonic Ace +7
(K132612) | Comment |
|-------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------|
| Class | None Established | None Established | None Established | Identical |
| Product Code | LFL | LFL | LFL | Identical |
| Intended Use | Vessel coagulation using
ultrasonic energy | Vessel coagulation using
ultrasonic energy | Vessel coagulation
using ultrasonic
energy | Identical |
| Maximum Vessel
Diameter
Coagulation | 7 mm | 5 mm | 7 mm | The performance
testing demonstrated
the proposed device
is able to coagulate
vessels up to and
including 7 mm |
| Characteristic | Proposed Device
Sonicision™ 7 Dissection
Device (SCD7AXX,
SCG7AX, SCBA) | Primary Predicate
Device
Sonicision™ Dissection
Device (K180149) | Secondary
Predicate Device
Harmonic Ace +7
(K132612) | Comment |
| Operating
principle | 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. The user can
also apply pressure with
the passive jaw to
achieve specific tissue
effects (e.g., coagulating
a vessel) | 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. The user can
also apply pressure with
the passive jaw to
achieve specific tissue
effects (e.g., coagulating
a vessel) | 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. The user can
also apply pressure
with the passive jaw
to achieve specific
tissue effects (e.g.,
coagulating a vessel) | Identical |
| Cordless | Yes | Yes | No | Identical to primary
predicate |
| Assembly
required prior to
use? | Yes | Yes | Yes | Identical |
| Instrument form
factor | Shaft-based design | Shaft-based design | Shaft-based design | Identical |
| Power source type | Lithium-ion battery | Lithium-ion battery | Generator | Identical to primary
predicate |
| Power settings | The Sonicision device
has two power levels:
minimum and maximum. | The Sonicision device
has two power levels:
minimum and maximum. | The Harmonic Ace
+7 has three power
levels: minimum,
maximum, and
advanced hemostasis. | Identical to primary
predicate |
| Power output
algorithm | Power varied according
to load in order to
achieve constant
displacement. | Power varied according
to load in order to
achieve constant
displacement. | Power varied
according to load in
order to achieve
constant
displacement. | Identical |
| Software | Software modified to
allow for 7 mm
coagulation using
minimum mode. | Software allows for 5
mm coagulation. | Software allows for 7
mm coagulation. | The performance
testing demonstrated
the proposed device
is able to coagulate
vessels up to and
including 7 mm. |
| LED | Change in LED driver
and component
manufacturer | Current LED driver and
component manufacturer | N/A | Part is equivalent to
primary predicate. |
| Jaw leg taper | Taper added to jaw leg | No jaw leg taper | N/A | The performance
testing demonstrated
the proposed device
is able to coagulate
vessels up to and
including 7 mm. |
Table 1: Comparison of the Proposed and Predicate Devices
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