(280 days)
Not Found
No
The summary describes a surgical hand instrument with different modes for cutting, sealing, coagulation, grasping, and dissection. There is no mention of AI, ML, image processing, or any other technology that would typically indicate the presence of AI/ML. The performance studies are bench and animal testing focused on the physical performance of the device (burst pressure, temperature, seal maintenance, thermal spread).
Yes
The device directly performs actions like cutting, sealing, and coagulating vessels and tissues to treat conditions during surgery.
No
The device is described as a surgical instrument used for cutting, sealing, coagulating, grasping, and dissecting tissues and vessels. Its functions are therapeutic/interventional, not diagnostic.
No
The device description clearly states it is a "hand instrument" and a "functional device capable of vessel sealing & cutting, tissue coagulating & cutting, grasping, and dissecting," indicating it is a physical hardware device used in surgery.
Based on the provided text, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In vitro diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections.
- Device Function: The THUNDERBEAT Open Fine Jaw Type X hand instrument is a surgical tool used during open surgery to physically cut, seal, coagulate, grasp, and dissect tissue and vessels. It operates directly on the patient's body.
- Intended Use: The intended use clearly describes surgical procedures and actions performed on the patient, not analysis of samples outside the body.
- Device Description: The description reinforces that it's a functional surgical device for direct use in surgery.
- Lack of IVD Indicators: There is no mention of analyzing samples, detecting biomarkers, or any other activities associated with in vitro diagnostics.
Therefore, the THUNDERBEAT Open Fine Jaw Type X hand instrument is a surgical device, not an IVD.
N/A
Intended Use / Indications for Use
The THUNDERBEAT Open Fine Jaw Type X hand instrument is intended to be used for open surgery to cut, seal, coagulate, grasp, and dissect.
Seal & Cut mode:
The THUNDERBEAT Open Fine Jaw Type X hand instrument when used in combination with the Seal & Cut mode is indicated for open, general surgery (including plastic and reconstructive, etc.) or in any procedure in which cutting, vessel ligation (sealing and cutting), coagulation, grasping, and dissection is performed. The device has been designed to seal and cut vessels (up to and including 7 mm in diameter), tissue bundles, and lymphatics.
This mode is also indicated for open ENT procedure in adults (thyroidectomy, parathyroidectomy, parotidectomy, radical neck dissection, and tonsillectomy) for only ligation (sealing and cutting) of vessels, lymphatics and tissue bundles greater than 3 mm away from unintended thermally sensitive structures such as nerves and parathyroid glands.
Seal mode:
The THUNDERBEAT Open Fine Jaw Type X hand instrument when used in combination with the Seal mode is indicated for open, general surgery (including plastic and reconstructive, etc.) or in any procedure in which vessel sealing, coagulation, grasping is performed. The device has been designed to seal vessels (up to and including 7 mm in diameter), tissue bundles, and lymphatics.
This mode is also indicated for open ENT procedure in adults (thyroidectomy, parathyroidectomy, parotidectomy, radical neck dissection, and tonsillectomy) for sealing of vessels, lymphatics and tissue bundles greater than 3 mm away from unintended thermally sensitive structures such as nerves and parathyroid glands.
The THUNDERBEAT Open Fine Jaw Type X hand instrument has not been shown to be effective for tubal sterilization or tubal coagulation for sterilization procedures, and should not be used for these procedures.
Product codes
GEI, LFL
Device Description
THUNDERBEAT Open Fine Jaw Type X hand instrument is intended to be used for open surgery to cut, seal, coagulate, grasp, and dissect.
The THUNDERBEAT Open Fine Jaw Type X hand instrument is provided as a sterile, single use device. The subject device is functional device capable of vessel sealing & cutting, tissue coagulating & cutting, grasping, and dissecting. This device has been designed to seal and cut vessels up to and including 7 mm in diameter, tissue bundles, and lymphatics. This device also has been designed for open ENT procedures in adults.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
vessels, tissue bundles, lymphatics, nerves, parathyroid glands
Indicated Patient Age Range
adults
Intended User / Care Setting
open surgery, general surgery (including plastic and reconstructive, etc.), ENT procedure
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)
-
Bench Testing
Test Code: OFJX-001, Item: Ex-vivo Vessel Burst Pressure, Contents: Ex-vivo burst pressure testing of porcine blood vessels was conducted on both the subject and predicate devices to demonstrate vessel sealing performance.
Test Code: OFJX-020, Item: Ex Vivo Testing for Temperature-time History, Contents: Ex Vivo Testing for Temperature-time History was conducted on both the subject and predicate devices compare the spatio-temporal temperature distribution and thermal damage. -
Animal Test
Test Code: OFJX-012, OFJX-014, OFJX-015, Item: Chronic Animal Study, Contents: Chronic animal study of porcine/ Beagle Dogs was conducted on both the subject and predicate devices to demonstrate seal performance (ex. seal maintenance rates include vessels up to 7.0mm in diameter and lymphatics and tissue bundles, thermal spread, degree of healing progression ).
Test Code: OFJX-011-a, OFJX-013, OFJX-018b, OFJX-016, Item: Acute Animal Study, Contents: Acute animal study of porcine/ Beagle Dogs was conducted on both the subject and predicate devices to demonstrate seal performance and safety (ex. seal maintenance rates include vessels up to 7.0mm in diameter and lymphatics and tissue bundles, thermal spread, degree of degeneration). -
Clinical Testing
Clinical testing was not performed.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 878.4400 Electrosurgical cutting and coagulation device and accessories.
(a)
Identification. An electrosurgical cutting and coagulation device and accessories is a device intended to remove tissue and control bleeding by use of high-frequency electrical current.(b)
Classification. Class II.
0
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May 11, 2020
Olympus Medical Systems Corp. Christina Flores Manager, Regulatory Affairs Gyrus ACMI inc. 136 Turnpike Road Southborough, Massachusetts 01772
Re: K192103
Trade/Device Name: Thunderbeat Open Fine Jaw Type X Hand Instrument Regulation Number: 21 CFR 878.4400 Regulation Name: Electrosurgical cutting and coagulation device and accessories Regulatory Class: Class II Product Code: GEI, LFL Dated: May 6, 2020 Received: May 7, 2020
Dear Christina Flores:
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 requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part
1
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 (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 medical devices and radiation-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,
for Michael J. Ryan Director DHT1C: Division of ENT, Sleep Disordered Breathing, Respiratory and Anesthesia Devices OHT1: Office of Ophthalmic, Anesthesia, Respiratory, ENT and Dental Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known) K192103
Device Name
THUNDERBEAT Open Fine Jaw Type X hand instrument
Indications for Use (Describe)
The THUNDERBEAT Open Fine Jaw Type X hand instrument is intended to be used for open surgery to cut, seal, coagulate, grasp, and dissect.
Seal & Cut mode:
The THUNDERBEAT Open Fine Jaw Type X hand instrument when used in combination with the Seal & Cut mode is indicated for open, general surgery (including plastic and reconstructive, etc.) or in any procedure in which cutting, vessel ligation (sealing and cutting), coagulation, grasping, and dissection is performed. The device has been designed to seal and cut vessels (up to and including 7 mm in diameter), tissue bundles, and lymphatics.
This mode is also indicated for open ENT procedure in adults (thyroidectomy, parotidectomy, partical neck dissection, and tonsillectory) for only ligation (sealing and cutting) of vessels, lymphatics and tissue bundles greater than 3 mm away from unintended thermally sensitive structures such as nerves and parathyroid glands.
Seal mode:
The THUNDERBEAT Open Fine Jaw Type X hand instrument when used in combination with the Seal mode is indicated for open, general surgery (including plastic and reconstructive, etc.) or in any procedure in which vessel sealing, coagulation, grasping is performed. The device has been designed to seal vessels (up to and including 7 mm in diameter), tissue bundles, and lymphatics.
This mode is also indicated for open ENT procedure in adults (thyroidectomy, parotidectomy, radical neck dissection, and tonsillectomy) for sealing of vessels, lymphatics and tissue bundles greater than 3 mm away from unintended thermally sensitive structures such as nerves and parathyroid glands.
The THUNDERBEAT Open Fine Jaw Type X hand instrument has not been shown to be effective for tubal sterilization or tubal coagulation for sterilization procedures, and should not be used for these procedures.
| 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) | Prescription Use (Part 21 CFR 801 Subpart D) | Over-The-Counter Use (21 CFR 801 Subpart C) |
| Prescription Use (Part 21 CFR 801 Subpart D) | ||
| Over-The-Counter Use (21 CFR 801 Subpart C) |
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3
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510(k) Summary Gyrus ACMI, Inc. THUNDERBEAT Open Fine Jaw Type X hand instrument
General Information
| Applicant: | OLYMPUS MEDICAL SYSTEMS
CORP.
2951 Ishikawa-cho, Hachioji-shi, Tokyo,
Japan 192-8507
Phone: (+81) 42-642-2694
Fax: (+81) 42-642-2307 |
|------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------|
| Establishment Registration Number: | 8010047 |
| Manufacturer: | Aomori Olympus
2-248-1 okkonoki
kuroishi-shi aomori, Japan 036-0357
Phone: (+81) 172-52-8543
Fax: (+81) 172-52-8515 |
| Establishment Registration Number: | 9614641 |
| 510(k) Submitter: | Gyrus ACMI, Inc.
136 Turnpike Rd.
Southborough, MA 01772-2104 |
| Establishment Registration Number: | 3003790304 |
| Contact Person: | Christina Flores, RAC
Manager, Regulatory Affairs |
| Date Prepared: | May 10, 2020 |
Device Description
Classification Name: Electrosurgical cutting and coagulation device and accessories Regulation Number: 21 CFR 878.4400 Regulatory Class: Class II, Product Codes: GEI, LFL Review Panel: General & Plastic Surgery
4
Image /page/4/Picture/0 description: The image shows the word "OLYMPUS" in large, bold, blue letters. The font is sans-serif and the letters are evenly spaced. A registered trademark symbol is located to the right of the letter "S".
Trade Name:
THUNDERBEAT Open Fine Jaw Type
| X hand instrument | ||
|---|---|---|
| Model Name | Device Name | |
| TB-0009OFX | THUNDERBEAT Open Fine Jaw Type X hand instrument | |
| Generic/Common Name: | Ultrasonic and electrosurgical devices |
Ultrasonic and electrosurgical devices
Primary Predicate Device
| Device name | 510(k) Submitter | 510(k) No. |
|---|---|---|
| THUNDERBEAT Open Fine Jaw | ||
| (TB-0009OF) | OLYMPUS MEDICAL | |
| SYSTEMS CORP. | K151743 |
Secondary Predicate Device
| Device name | 510(k) Submitter | 510(k) No. |
|---|---|---|
| LigaSure Curved, Small Jaw, Open | ||
| Sealer/Divider | COVIDIEN | K113572 |
Product Description
THUNDERBEAT Open Fine Jaw Type X hand instrument is intended to be used for open surgery to cut, seal, coagulate, grasp, and dissect.
The THUNDERBEAT Open Fine Jaw Type X hand instrument is provided as a sterile, single use device. The subject device is functional device capable of vessel sealing & cutting, tissue coagulating & cutting, grasping, and dissecting. This device has been designed to seal and cut vessels up to and including 7 mm in diameter, tissue bundles, and lymphatics. This device also has been designed for open ENT procedures in adults.
Comparison of Technological Characteristics
The basic principle and operational characteristics of the subject device are identical to the predicate device. The proposed THUNDERBEAT Open Fine Jaw Type X Hand Instrument is equivalent to the predicate device in that each device is connected to Surgical Tissue Management System, specifically the ESG-400 Electrosurgical Generator, USG-400 Ultrasonic Generator and THUNDERBEAT Transducer (TD-TB400). Like the predicate device, the subject device activates combined HF Bipolar (FineCoag) output and Ultrasonic output [Seal & Cut mode] simultaneously or only the HF Bipolar output (Seal mode) while grasping vessels, tissue bundles and lymphatics between the Probe and the H electrode in the Grasping section.
5
In terms of the design concept of the subject device, the differences from the predicate device are as follows:
- Addition of the Radical Neck Dissection indication
- Removal of generator specific information from indications for use
- Adding resin cover (PEEK) on the H electrode
- Changing a material of H electrode in the grasping section and Sheath cover
A side by side comparison of the subject device and the predicate device is provided below.
| Item | Subject Device | Primary Predicate
Device (PD) K151743 | Secondary
Predicate Device
(PD2)
K113572 | Discussion |
|--------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| | TB-0009OFX | TB-0009OF | LigaSure Curved,
Small Jaw, Open
Sealer/Divider | |
| Indicatio
ns for
Use | The THUNDERBEAT
Open Fine Jaw Type X
hand instrument is
intended to be used for
open surgery to cut,
seal, coagulate, grasp,
and dissect.
Seal & Cut mode:
The THUNDERBEAT
Open Fine Jaw Type X
hand instrument when
used in combination
with the Seal & Cut
mode is indicated for
open, general surgery
(including plastic and
reconstructive, etc.) or
in any procedure in
which cutting, vessel
ligation (sealing and
cutting), coagulation,
grasping, and
dissection is
performed. The device
has been designed to
seal and cut vessels (up
to and including 7 mm
in diameter), tissue
bundles, and
lymphatics.
This mode is also
indicated for open
ENT procedure in
adults (thyroidectomy | The THUNDERBEAT
Open Fine Jaw hand
instrument is intended
to be used with the
Ultrasonic Generator
(USG-400), the
Electrosurgical
Generator (ESG-400),
and the
THUNDERBEAT
Transducer, (TD-
TB400).
Seal & Cut mode:
The THUNDERBEAT
Open Fine Jaw hand
instrument when used
in combination with
the Seal & Cut mode is
indicated for open,
general surgery
(including plastic and
reconstructive, etc) or
in any procedure in
which cutting, vessel
ligation (sealing and
cutting), coagulation,
grasping, and
dissection is
performed. The device
has been designed to
seal and cut vessels (up
to and including 7 mm
in diameter), tissue
bundles, and
lymphatics. | The LigaSure™
Curved, Small Jaw,
Open Sealer /
Divider is a bipolar
electrosurgical
instrument
intended to be used
with the
ForceTriad™
energy platform.
The instrument is
indicated for use in
open general
surgical procedures
where ligation and
division of vessels
(up to 7 mm in
diameter), tissue
bundles, and
lymphatics is
performed, such as
urologic, thoracic,
plastic, and
reconstructive, and
including such
procedures as
bowel resections,
gall bladder
procedures, Nissen
fundoplication,
adhesiolysis, etc.
The device is also
indicated for open
ENT procedures in
adults | The
differences
between SD
and PD are the
removal of the
specific
generator
information
and the
addition of the
Radical Neck
Dissection
indication.
The Radical
Neck
Dissection
indication is
carried by the
PD2. |
| Item | Subject Device | Primary Predicate
Device (PD) K151743 | Secondary
Predicate Device
(PD2)
K113572 | Discussion |
| | TB-0009OFX
parathyroidectomy,
parotidectomy, radical
neck dissection, and
tonsillectomy) for only
ligation (sealing and
cutting) of vessels,
lymphatics and tissue
bundles greater than
3mm away from
unintended thermally
sensitive structures
such as nerves and
parathyroid glands.
Seal mode:
The THUNDERBEAT
Open Fine Jaw Type X
hand instrument when
used in combination
with the Seal mode is
indicated for open,
general surgery
(including plastic and
reconstructive, etc.) or
in any procedure in
which vessel sealing,
coagulation, grasping
is performed. The
device has been
designed to seal
vessels (up to and
including 7 mm in
diameter), tissue
bundles, and
lymphatics.
This mode is also
indicated for open
ENT procedure in
adults (thyroidectomy,
parathyroidectomy,
parotidectomy, radical
neck dissection, and
tonsillectomy) for
sealing of vessels,
lymphatics and tissue
bundles greater than
3mm away from | TB-0009OF
This mode is also
indicated for open
ENT procedure in
adults (thyroidectomy,
parathyroidectomy,
parotidectomy, and
tonsillectomy) for only
ligation (sealing and
cutting) of vessels,
lymphatics and tissue
bundles 2-3 mm1
away from unintended
thermally sensitive
structures such as
nerves and parathyroid
glands.
Seal mode:
The THUNDERBEAT
Open Fine Jaw hand
instrument when used
in combination with
the Seal mode is
indicated for open,
general surgery
(including plastic and
reconstructive, etc.) or
in any procedure in
which vessel sealing,
coagulation, grasping
is performed. The
device has been
designed to seal
vessels (up to and
including 7 mm in
diameter), tissue
bundles, and
lymphatics.
This mode is also
indicated for open
ENT procedure in
adults (thyroidectomy,
parathyroidectomy,
parotidectomy, and
tonsillectomy) for
sealing of vessels, | LigaSure Curved,
Small Jaw, Open
Sealer/Divider
(thyroidectomy,
radical neck
dissection,
parotidectomy, and
tonsillectomy) for
ligation and
division of vessels,
lymphatics and
tissue bundles 2-3
mm away from
unintended
thermally sensitive
structures such as
nerves and
parathyroid glands.
The LigaSure
system has not
been shown to be
effective for tubal
sterilization or
tubal
coagulation for
sterilization
procedures. Do not
use the LigaSure
system for these
procedures. | |
| Item | Subject Device | Primary Predicate Device (PD) K151743 | Secondary Predicate Device (PD2) K113572 | Discussion |
| | TB-00090FX
unintended thermally
sensitive structures
such as nerves and
parathyroid glands.
The THUNDERBEAT
Open Fine Jaw Type X
hand instrument has
not been shown to be
effective for tubal
sterilization or tubal
coagulation for
sterilization
procedures, and should
not be used for these
procedures. | TB-0009OF
lymphatics and tissue
bundles 2-3mm1
away from unintended
thermally sensitive
structures such as
nerves and parathyroid
glands.
The THUNDERBEAT
Open Fine Jaw hand
instrument has not
been shown to be
effective for tubal
sterilization or tubal
coagulation for
sterilization
procedures, and should
not be used for these
procedures.
*1 It should be
extended appropriately
depending on the
operation situation. | LigaSure Curved,
Small Jaw, Open
Sealer/Divider | |
| Regulati
on
Number | 878.4400 | 878.4400 | 878.4400 | Same as PD |
| Regulati
on Name | Electrosurgical, cutting
& coagulation &
accessories | Electrosurgical, cutting
& coagulation &
accessories | Electrosurgical,
cutting &
coagulation &
accessories | |
| Regulato
ry Class | II | II | II | |
| Product
Code | GEI, LFL | GEI, LFL | GEI | |
| Classific
ation
Panel | General & Plastic
Surgery | General & Plastic
Surgery | General & Plastic
Surgery | |
| Basic
principle | Seal and Cut mode:
Activating the
Ultrasonic output
(generated by the
USG-400, Ultrasonic
Generator) and the HF
Bipolar output
(generated by the
ESG-400) | Seal and Cut mode:
Activating the
Ultrasonic output
(generated by the
USG-400, Ultrasonic
Generator) and the HF
Bipolar output
(generated by the
ESG-400) | High-frequency
current generated
by Covidien's
Electrosurgical
Generators (such
as Force Triad) is
delivered to the
jaw (electrodes),
and coagulate
(seal) vessels, | Same as PD |
| Item | Subject Device
TB-0009OFX | Primary Predicate
Device (PD) K151743
TB-0009OF | Secondary
Predicate Device
(PD2)
K113572
LigaSure Curved, Small Jaw, Open
Sealer/Divider | Discussion |
| | sealing and cutting of
vessels, tissue bundles,
and lymphatics and
cutting and coagulation
soft tissue.
Seal mode: Uses only
the HF Bipolar (ESG-
400) energy output
which enables vessel,
tissue bundle and
lymphatic sealing and | sealing and cutting of
vessels, tissue bundles,
and lymphatics and
cutting and coagulation
soft tissue.
Seal mode: Uses only
the HF Bipolar (ESG-
400) energy output
which enables vessel,
tissue bundle and
lymphatic sealing and | tissue bundles,
lymphatics
clamped by the
jaw. The internal
mechanical blade
in the jaw makes
the soft tissues
divided | |
| Handle
shape | hemostasis.
hemostat-style body | hemostasis.
hemostat-style body | hemostat-style
body | Same as PD |
| Tip
shape | Probe and H electrode | Probe and H electrode | Jaw | Same as PD |
| Resin
cover on
the tip of
grasping
section | Equipped | N/A | Unknown | The resin
cover is added
on the H
electrode. |
| Grasping
section | PTFE/SUS630 | PTFE/Aluminum alloy | SUS | The material
of the H
electrode was
changed from
aluminum
alloy to
SUS63. |
| Device
performa
nce | Performance testing including Bench and Animal testing was conducted in support of the
substantial equivalence determination. | | | |
| Reproce
ssing | Sterile, for single use | Sterile, for single use | Sterile, for single
use | Same as PD |
| Shelf
Life | 3years | 3years | Unknown | Same as PD |
| Item | Subject Device | Primary Predicate Device (PD) K151743 | Secondary Predicate Device (PD2) K113572 | Discussion |
| | TB-0009OFX | TB-0009OF | LigaSure Curved, Small Jaw, Open Sealer/Divider | |
| Patient Contacting
Materials | Poly-carbonate,
ADC12, PEEK, PTFE,
SUS630, PTFE
composite nickel
plating, SUS304,
SUS303, Ti-6Al-4V | Poly-carbonate,
ADC12, Zircon oxide,
PFA, PTFE,
Aluminum alloy
(A7075-T6), PTFE,
composite nickel
plating, Parylene HT
(tetrafluoro-di- para-
xylylene), Aluminum
alloy (ADC12), Zircon
oxide (inside),
SUS303, Ti-6Al-4V | SUS
Other materials are
unknown. | Biological
safety of the
material was
tested in
accordance
with
ISO10993. |
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7
Image /page/7/Picture/0 description: The image shows the word "OLYMPUS" in large, bold, blue letters. The font is sans-serif and the letters are closely spaced. There is a registered trademark symbol to the right of the word.
8
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9
Material
Full biocompatibility testing on all patient contacting surfaces has been performed in compliance to the relevant requirements of ISO-10993 series.
Indications for use
The THUNDERBEAT Open Fine Jaw Type X hand instrument is intended to be used for open surgery to cut, seal, coagulate, grasp, and dissect.
Seal & Cut mode:
The THUNDERBEAT Open Fine Jaw Type X hand instrument when used in combination with the Seal & Cut mode is indicated for open, general surgery (including plastic and reconstructive, etc.) or in any procedure in which cutting, vessel ligation (sealing and cutting), coagulation, grasping, and dissection is performed. The device has been designed to seal and cut vessels (up to and including 7 mm in diameter), tissue bundles, and lymphatics.
This mode is also indicated for open ENT procedure in adults (thyroidectomy, parathyroidectomy, parotidectomy, radical neck dissection, and tonsillectomy) for only ligation (sealing and cutting) of vessels, lymphatics and tissue bundles greater than 3mm away from unintended thermally sensitive structures such as nerves and parathyroid glands.
Seal mode:
The THUNDERBEAT Open Fine Jaw Type X hand instrument when used in combination with the Seal mode is indicated for open, general surgery (including plastic and reconstructive, etc.) or in any procedure in which vessel sealing,
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coagulation, grasping is performed. The device has been designed to seal vessels (up to and including 7 mm in diameter), tissue bundles, and lymphatics. This mode is also indicated for open ENT procedure in adults (thyroidectomy, parathyroidectomy, parotidectomy, radical neck dissection, and tonsillectomy) for sealing of vessels, lymphatics and tissue bundles greater than 3mm away from unintended thermally sensitive structures such as nerves and parathyroid glands.
The THUNDERBEAT Open Fine Jaw Type X hand instrument has not been shown to be effective for tubal sterilization or tubal coagulation for sterilization procedures, and should not be used for these procedures.
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Compliance to Voluntary Standards
The design of the THUNDERBEAT Open Fine Jaw Hand Instrument complies with the following standards:
ANSI AAMI ES60601-1:2005/(R)2012 and A1:2012 IEC60601-1-2: 2014 IEC60601-2-2:2017 ISO10993-1:2009 ISO10993-5: 2009 ISO10993-10: 2010 ISO10993-11: 2006 ISO11135:2014 ISO10993-7: 2008 ISO11607-1: 2006/Amd 1:2014 ISO11607-2: 2006/Amd 1:2014 ASTM F1980-16 ISO14971:2007
Device-specific guidance
- Premarket Notification (510(k)) Submissions for Bipolar Electrosurgical Vessel Sealers for General Surgery - Guidance for Industry and Food and Drug Administration Staff, 08/15/2016
- Premarket Notification (510(k)) Submissions for Electrosurgical Devices for General Surgery - Guidance for Industry and Food and Drug Administration Staff, 08/15/2016
Summary of Sterilization and Shelf Life Discussion
Sterilization testing for the THUNDERBEAT Open Fine Jaw Type X hand instrument was conducted in accordance with the FDA's Guidance for Industry and Food and Drug Administration Staff, "Submission and Review of Sterility Information in Premarket Notification (510(k)) Submissions for Devices Labeled as Sterile". Stability evaluation for the sterile packaging and for product performance supports the three year shelf life. Accelerated aging test was conducted in accordance with ASTM F1980-16, the standard guide for accelerated aging of sterile barrier systems for medical devices.
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Summary of Performance Testing
The following performance testing was conducted in support of the substantial equivalence determination.
| 1. Bench Testing | ||
|---|---|---|
| Test Code | Item | Contents |
| OFJX-001 | Ex-vivo Vessel | |
| Burst Pressure | Ex-vivo burst pressure testing of porcine blood | |
| vessels was conducted on both the subject and | ||
| predicate devices to demonstrate vessel sealing | ||
| performance. | ||
| OFJX-020 | Ex Vivo Testing | |
| for Temperature- | ||
| time History | Ex Vivo Testing for Temperature-time History | |
| was conducted on both the subject and predicate | ||
| devices compare the spatio-temporal | ||
| temperature distribution and thermal damage. |
2. Animal Test
| Test Code | Item | Contents |
|---|---|---|
| OFJX-012 | ||
| OFJX-014 | ||
| OFJX-015 | Chronic Animal | |
| Study | Chronic animal study of porcine/ Beagle Dogs | |
| was conducted on both the subject and predicate | ||
| devices to demonstrate seal performance (ex. | ||
| seal maintenance rates include vessels up to | ||
| 7.0mm in diameter and lymphatics and tissue | ||
| bundles, thermal spread, degree of healing | ||
| progression ). | ||
| OFJX-011-a | ||
| OFJX-013 | ||
| OFJX-018b | ||
| OFJX-016 | Acute Animal | |
| Study | Acute animal study of porcine/ Beagle Dogs | |
| was conducted on both the subject and predicate | ||
| devices to demonstrate seal performance and | ||
| safety (ex. seal maintenance rates include | ||
| vessels up to 7.0mm in diameter and lymphatics | ||
| and tissue bundles, thermal spread, degree of | ||
| degeneration). |
- Clinical Testing
Clinical testing was not performed.
Substantial Equivalence
The subject and predicate device have the same fundamental technology. Compared with the primary predicate device (K151743), the subject device proposes the expanded indication of Radical Neck Dissection; the removal of generator specific information from indications for use; a design modification that includes a resin cover (PEEK) addition on the electrode; and the material change of H electrode and Sheath cover. The secondary predicate device (K113572) is being used for the expanded indication of Radical Neck Dissection. To support the proposed modifications, the performance tests summarized above were conducted.
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Conclusion
In summary, the THUNDERBEAT Open Fine Jaw Type X hand instrument is substantially equivalent to the predicate device and presents no new questions of safety or effectiveness.