(266 days)
Not Found
No
The summary describes a surgical system using ultrasonic and electrosurgical energy for cutting and coagulating tissue. There is no mention of AI, ML, image processing, or any data-driven decision-making components. The performance studies focus on traditional device metrics like sealing performance, thermal spread, and hemostasis.
No
The device is used for cutting, coagulating, and ligating soft tissue and vessels during surgery, which are surgical procedures, not therapeutic treatments.
No
Explanation: The device is described as a surgical system used for cutting, coagulating, and ligating soft tissue and vessels, which are interventional actions rather than diagnostic ones.
No
The device description explicitly lists multiple hardware components (Ultrasonic Generator, Electrosurgical Generator, THUNDERBEAT, SONICBEAT, Transducer) that are part of the system.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states the system is for "open, laparoscopic (including single-site surgery), and endoscopic surgery to cut (dissect) or coagulate soft tissue or to ligate (seal and cut) vessels." This describes a surgical procedure performed directly on the patient's body.
- Device Description: The description details a system used in surgical procedures, involving generators, transducers, and surgical instruments.
- Lack of IVD Characteristics: There is no mention of the device being used to examine specimens (like blood, urine, tissue samples) in vitro (outside the body) to provide information for diagnosis, monitoring, or screening.
IVD devices are specifically designed to perform tests on samples taken from the human body to provide medical information. This surgical system operates directly on the patient's tissues during a surgical procedure.
N/A
Intended Use / Indications for Use
The Surgical Tissue Management System is intended to be used with the Ultrasonic Generator (USG-400), the Electrosurgical Generator (ESG-400), the THUNDERBEAT Transducer (TD-TB400), the SONICBEAT Transducer (TD-SB400), the THUNDERBEAT, and / or the SONICBEAT for open, laparoscopic (including single-site surgery), and endoscopic surgery to cut (dissect) or coagulate soft tissue or to ligate (seal and cut) vessels.
The Surgical Tissue Management System has three output modes, Seal & Cut (THUNDERBEAT), Seal (THUNDERBEAT) and Ultrasonic (SONICBEAT). The Seal & Cut mode provides combined HF bipolar and ultrasonic energy, the seal mode provides only HF bipolar energy and the Ultrasonic mode provides only ultrasonic energy.
This system has not been shown to be effective for tubal sterilization or tubal coagulation for sterilization procedures, and should not be used for these procedures.
The Ultrasonic Generator (USG-400) is intended to be used with the Electrosurgical Generator (ESG-400), the THUNDERBEAT Transducer (TD-TB400), the SONICBEAT Transducer (TD-SB400), the THUNDERBEAT, and / or the SONICBEAT for open, laparoscopic (including single-site surgery), and endoscopic surgery to cut (dissect) or coagulate soft tissue or to ligate (seal and cut) vessels.
The ESG-400 is an electrosurgical generator intended for tissue cutting and coagulation in open, laparoscopic and endoscopic surgery in conjunction with electrosurgical accessories and ancillary equipment.
The THUNDERBEAT Transducer (TD-TB400) is intended to be used with the Ultrasonic Generator (USG-400), the Electrosurgical Generator (ESG-400), and the THUNDERBEAT for open, laparoscopic (including single-site surgery), and endoscopic surgery to cut (dissect) or coagulate soft tissue or to ligate (seal and cut) vessels.
The THUNDERBEAT hand instruments are 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 hand instruments when used in combination with the Seal & Cut mode are indicated for open, laparoscopic (including single-site surgery) general surgery and gynecological surgery (including urologic, thoracic, plastic and reconstructive, bowel resections, cholecystectomies, Nissen fundoplication, adhesiolysis, oophorectomy, hysterectomies (both vaginal assisted and abdominal) etc) and endoscopic surgery or in any procedure in which cutting, vessel ligation (sealing and cutting), coagulation, grasping, and dissection is performed. These devices have been designed to seal and cut vessels up to and including 7mm in diameter.
Seal mode:
The THUNDERBEAT hand instruments when used in combination with the Seal mode are indicated for open, laparoscopic (including single-site surgery) general surgery and gynecological surgery (including urologic, thoracic, plastic and reconstructive, bowel resections, cholecystectomies, Nissen fundoplication, adhesiolysis, oophorectorny, hysterectomies (both vaginal assisted and abdominal) etc), and endoscopic surgery or in any procedure in which vessel sealing, coagulation, grasping is performed. These devices have been designed to seal vessels up to and including 7mm in diameter.
The THUNDERBEAT hand instruments have not been shown to be effective for tubal sterilization or tubal coagulation for sterilization procedures, and should not be used for these procedures.
The SONICBEAT Transducer (TD-SB400) is intended to be used with the Ultrasonic Generator (USG-400) and the SONICBEAT for open, laparoscopic (including single-site surgery), and endoscopic surgery to cut (dissect) or coagulate soft tissue or to ligate (seal and cut) vessels.
The SONICBEAT is intended to be used with the Ultrasonic Generator (USG-400) and the SONICBEAT Transducer (TD-SB400) for open, laparoscopic (including single-site surgery), and general surgery to cut (dissect), coagulate, or grasp soft tissue or to ligate (seal and cut) vessels in gynecologic, thoracic, urologic, and endoscopic surgical procedures.
These devices have been designed to seal and cut vessels up to and including 5mm in diameter.
The SONICBEAT 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 (comma separated list FDA assigned to the subject device)
GEI, KNS, LFL
Device Description
The Surgical tissue management system has been designed to be used for open, laparoscopic, and endoscopic procedures in surgery. With the Ultrasonic Generator (USG-400) as the main component, the system is composed of the Electrosurgical Generator (ESG-400, K103032), the THUNDERBEAT (TB-0545PC, 0535PC, 0545IC, 0535IC, 0520IC, 0510IC), the SONICBEAT (SB-0545PC, 0535PC, 0545IC, 0535IC, 0520IC, 0510IC), and the Transducer (TD-TB400, TD-SB400).
The Surgical tissue management system has three different output modes.
- Seal & Cut mode (when a THUNDERBEAT.and THUNDERBEAT TRANSDUCER are connected with the system):
Combining and activating the Ultrasonic output and the HF Bipolar output simultaneously enables to seal and cut vessels and to cut and coagulate soft tissue. - Seal mode (when a THUNDERBEAT and THUNDERBEAT TRANSDUCER are connected with the system):
Activating the HF Bipolar output enables vessel sealing and hemostasis. - Ultrasonic mode (when a SONICBEAT and SONICBEAT TRANSDUCER are connected with the system)
Activating the Ultrasonic output enables to seal and cut vessels and to cut and coagulate soft tissue.
Output:
- To use the THUDERBEAT, the handpiece plug of the THUNDERBEAT Transducer which converts drive current into Ultrasonic output is connected to the THUNDERBEAT socket of the USG-400. Then HF Bipolar current and drive current are supplied to the Transducer via a cable, eliminating the need to connect a cord to the ESG-400.
- To use the THUDERBEAT, the centralized control function of the USG-400 controls the HF Bipolar output and the output settings of the ESG-400. In other words, operating the Handswitches mounted on the THUNDERBEAT enables to turn ON/OFF the Seal & Cut mode output and the Seal mode output. Operating the Touch-screen of the USG-400 facilitates changing the output settings.
- To use the SONICBEAT, the handpiece plug of the SONICBEAT Transducer is connected to the SONICBEAT socket of the USG-400. Operating either of the Handswitches of the SONICBEAT enables to ON/OFF the Ultrasonic output.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
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)
Non-Clinical/ Preclinical Performance: Evidence of safety and effectiveness was obtained from two primary areas:
(1) non-clinical (electrical/mechanical/functional/biocompatibility/stability) performance testing
(2) preclinical (bench tissue/animal) evaluations and testing
Non-clinical: Basic safety and performance testing was performed in accordance with IEC 60601- 1, IEC60601-1-1, 6060 1-1-2, and IEC60601-2-2. In addition, verification and comparison studies were conducted to evaluate the mechanical and functional performance. Specifically, test results in the following areas were provided: temperature of the grasping section, less mist production, dissecting performance, wiper jaw technology performance (grasping force).
Biocompatibility: In Vitro Cytotoxicity Test, Skin Sensitization Test, Intracutaneous Reactivity Test, Acute Systemic Toxicity Test.
Stability: Representative samples of devices were subjected to accelerated and real time ageing. The results of the accelerated age testing demonstrates that the device will be stable for the stated shelf-life. In addition, real time age testing will confirm the results of the accelerated age testing. The test devices were evaluated to ensure they continued to meet their specifications.
Preclinical: Evidence obtained from preclinical bench tissue (ex vivo) and animal (in vivo acute and chronic) studies using porcine and canine models (and in a variety of tissue types and conditions) demonstrate that the THUNDERBEAT and SONICBEAT performs substantially equivalent to the predicate devices in relevant aspects associated with sealing and cutting tissue; namely,
Evaluated ex vivo using excised porcine carotid, splenic, renal arteries, mesenterium, and jejunum.
-sealing performance (burst pressure) with isolated vessel
-ligation (sealing) speed with isolated vessel
-cutting speed with mesenterium and jejunum
Evaluated in vivo/acute using porcine models
-overall hemostasis (isolated arteries)
-overall cutting speed (mesenterium and peritoneum)
-lateral thermal spread (measured on sealed isolated vessels)
Evaluated in vivo/chronic using canine models
-ability to maintain hemostasis at application and through survival (isolated arteries) -tissue healing through histological sample -blood testing
The combined energy output has been verified and validated to be equivalent in sealing performance, thermal spread and coagulation (ex vivo burst pressure tests and in vivo animal acute and survival study, hemostasis),when compared to the predicate devices with the same indications. As the performance test results demonstrate equivalent performance, we believe there are no new concerns regarding safety or efficacy as it relates to combining HF bipolar and ultrasonic energy for vessel sealing and cutting.
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.
K050885, K002906, K051644, K070162, K043008, K021962, K031305, K031523, K031710, K990430, K031011, K051036, K081129, K031133
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
§ 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
JAN 2 0 2012
510(k) SUMMARY
Surgical Tissue Management System Ultrasonic surgical system
January 20, 2012
General Information 1 OLYMPUS MEDICAL SYSTEMS CORP. ■ Applicant: 2951 Ishikawa-cho. Hachioji-shi, Tokyo, Japan 192-8507 Establishment Registration No: 8010047 Stacy Abbatiello Kluesner, M.S., RAC I Official Correspondent: Regulatory Affairs & Quality Assurance Olympus America Inc. 3500 Corporate Parkway PO Box 610 Center Valley, PA 18034-0610, USA Phone: 484-896-5405 FAX: 484-896-7128 Email: stacy.kluesner@olympus.com Aomori Olympus Co., Ltd. . Manufacturer: 248-1 Okkonoki 2-chome Kuroishi-shi, Aomori, Japan 036-0367 Establishment Registration No .: 9614641 Device Identification 2 Surgical Tissue Management System I Device Trade Name: I Common Name: Ultrasonic surgical system ■ Regulation Number: 21 CFR 878.4400 21 CFR 876.4300 Unclassified Electrosurgical, cutting & coagulation device and accessories I Regulation Name: Endoscopic electrosurgical unit and accessories Instrument, Ultrasonic surgical . Regulatory Class: I General and Plastic Surgery, Gastroenterology/ Urology 할 Classification Panel: . GEI, KNS, LFL Product Code:
1
3 Predicate Device Information
| Table 12-1 Primary Components & Predicate Devices of the Surgical Tissue Management | ||||
|---|---|---|---|---|
| Svstem |
| System
Subject Device
(Part of this submission) | Predicate Device | PD's
510(k)
No. |
|------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------|
| Ultrasonic Generator USG-400
Electrosurgical Generator ESG-400 | Olympus Ultrasonic Surgical System
Sonosurg
UltraCision Harmonic Scalpel Generator
300 System
Valleylab ForceTriad Eleotrosurgical Generator
Valleylab ForceTriad Eleotrosurgical Generator
EnSeal Vessel Sealing & Hemostasis System (with RF-60 generator/controller) | K050885
K002906
K051644
K070162
K043008 |
| THUNDERBEAT TRANSDUCER
TD-TB400
SONICBEAT TRANSDUCER
TD-SB400 | Olympus Ultrasonic Surgical System
Olympus Ultrasonic Surgical System
Olympus Ultrasonic Sonosurg System
Olympus Ultrasonic Surgical System
Olympus Ultrasonic Surgical System
Sonosurg
Ultrasonic Harmonic Scalpel Hand Piece
UltraCision Harmonic Scalpel Generator 300 System | K021962
K031305
K031523
K031710
K050885
K990430
K002906 |
| THUNDERBEAT
TB-0545PC/ 0535PC/ 0545IC/ 0535IC/
0520IC/ 0510IC
SONICBEAT
SB-0545PC/ 0535PC/ 0545IC/ 0535IC/
0520IC/ 0510IC | Olympus Ultrasonic Surgical System
Olympus Ultrasonic Surgical System
Olympus Ultrasonic Sonosurg System
Olympus Ultrasonic Surgical System
Olympus Ultrasonic Surgical System
Sonosurg
Ligasure 5mm Laparoscopic Sealer-Divider, Model LS1500
Harmonic ACE Curved Shears with Pistol Handle and Hand Control and Harmonic ACE Curved Shears with Scissor Handle and Hand Control
EnSeal PowerTip with EnSeal Universal
EnSeal Vessel Sealing & Hemostasis System | K021962
K031305
K031523
K031710
K050885
K031011
K051036
K081129
K031133 |
4 Device Description
The Surgical tissue management system has been designed to be used for open, laparoscopic, and endoscopic procedures in surgery. With the Ultrasonic Generator (USG-400) as the main component, the system is composed of the Electrosurgical Generator (ESG-400, K103032), the THUNDERBEAT (TB-0545PC, 0535PC, 0545IC, 0535IC, 0520IC, 0510IC), the SONICBEAT (SB-0545PC, 0535PC, 0545IC, 0535IC, 0520IC, 0510IC), and the Transducer (TD-TB400, TD-SB400).
2
Output mode
The Surgical tissue management system has three different output modes.
- Seal & Cut mode (when a THUNDERBEAT.and THUNDERBEAT TRANSDUCER are connected with the system):
Combining and activating the Ultrasonic output and the HF Bipolar output simultaneously enables to seal and cut vessels and to cut and coagulate soft tissue.
- Seal mode (when a THUNDERBEAT and THUNDERBEAT TRANSDUCER are connected with the system):
Activating the HF Bipolar output enables vessel sealing and hemostasis.
mode (when a SONICBEAT and SONICBEAT TRANSDUCER are - Ultrasonic connected with the system)
Activating the Ultrasonic output enables to seal and cut vessels and to cut and coagulate soft tissue.
Output
-
To use the THUDERBEAT, the handpiece plug of the THUNDERBEAT Transducer which converts drive current into Ultrasonic output is connected to the THUNDERBEAT socket of the USG-400. Then HF Bipolar current and drive current are supplied to the Transducer via a cable, eliminating the need to connect a cord to the ESG-400.
-
To use the THUDERBEAT, the centralized control function of the USG-400 controls the HF Bipolar output and the output settings of the ESG-400. In other words, operating the Handswitches mounted on the THUNDERBEAT enables to turn ON/OFF the Seal & Cut mode output and the Seal mode output. Operating the Touch-screen of the USG-400 facilitates changing the output settings.
-
To use the SONICBEAT, the handpiece plug of the SONICBEAT Transducer is connected to the SONICBEAT socket of the USG-400. Operating either of the Handswitches of the SONICBEAT enables to ON/OFF the Ultrasonic output.
5 Indications for Use
Surgical Tissue Management System
The Surgical Tissue Management System is intended to be used with the Ultrasonic Generator (USG-400), the Electrosurgical Generator (ESG-400), the THUNDERBEAT Transducer (TD-TB400), the SONICBEAT Transducer (TD-SB400), the THUNDERBEAT, and / or the SONICBEAT for open, laparoscopic (including single-site surgery), and endoscopic surgery to cut (dissect) or coagulate soft tissue or to ligate (seal and cut) vessels.
The Surgical Tissue Management System has three output modes, Seal & Cut (THUNDERBEAT), Seal (THUNDERBEAT) and Ultrasonic (SONICBEAT). The Seal & Cut mode provides combined HF bipolar and ultrasonic energy, the seal mode provides only HF bipolar energy and the Ultrasonic mode provides only ultrasonic energy.
This system has not been shown to be effective for tubal sterilization or tubal coagulation for sterilization procedures, and should not be used for these procedures.
3
Ultrasonic Generator (USG-400)
The Ultrasonic Generator (USG-400) is intended to be used with the Electrosurgical Generator (ESG-400), the THUNDERBEAT Transducer (TD-TB400), the SONICBEAT Transducer (TD-SB400), the THUNDERBEAT, and / or the SONICBEAT for open, laparoscopic (including single-site surgery), and endoscopic surgery to cut (dissect) or coagulate soft tissue or to ligate (seal and cut) vessels.
Electrosurgical Generator (ESG-400 K103032)
The ESG-400 is an electrosurgical generator intended for tissue cutting and coagulation in open, laparoscopic and endoscopic surgery in conjunction with electrosurgical accessories and ancillary equipment.
THUNDERBEAT Transducer (TD-TB400)
The THUNDERBEAT Transducer (TD-TB400) is intended to be used with the Ultrasonic Generator (USG-400), the Electrosurgical Generator (ESG-400), and the THUNDERBEAT for open, laparoscopic (including single-site surgery), and endoscopic surgery to cut (dissect) or coagulate soft tissue or to ligate (seal and cut) vessels.
THUNDERBEAT (TB-0545PC, 0535PC, 0545IC, 0535IC, 0520IC, 0510IC)
The THUNDERBEAT hand instruments are 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 hand instruments when used in combination with the Seal & Cut mode are indicated for open, laparoscopic (including single-site surgery) general surgery and gynecological surgery (including urologic, thoracic, plastic and reconstructive, bowel resections, cholecystectomies, Nissen fundoplication, adhesiolysis, oophorectomy, hysterectomies (both vaginal assisted and abdominal) etc) and endoscopic surgery or in any procedure in which cutting, vessel ligation (sealing and cutting), coagulation, grasping, and dissection is performed. These devices have been designed to seal and cut vessels up to and including 7mm in diameter.
Seal mode:
The THUNDERBEAT hand instruments when used in combination with the Seal mode are indicated for open, laparoscopic (including single-site surgery) general surgery and gynecological surgery (including urologic, thoracic, plastic and reconstructive, bowel resections, cholecystectomies, Nissen fundoplication, adhesiolysis, oophorectorny, hysterectomies (both vaginal assisted and abdominal) etc), and endoscopic surgery or in any procedure in which vessel sealing, coagulation, grasping is performed. These devices have been designed to seal vessels up to and including 7mm in diameter.
The THUNDERBEAT hand instruments have not been shown to be effective for tubal sterilization or tubal coagulation for sterilization procedures, and should not be used for
4
these procedures.
SONICBEAT Transducer (TD-SB400)
The SONICBEAT Transducer (TD-SB400) is intended to be used with the Ultrasonic Generator (USG-400) and the SONICBEAT for open, laparoscopic (including single-site surgery), and endoscopic surgery to cut (dissect) or coagulate soft tissue or to ligate (seal and cut) vessels.
SONICBEAT (SB-0545PC, 0535PC, 0545IC, 0535IC, 0520IC, 0510IC)
The SONICBEAT is intended to be used with the Ultrasonic Generator (USG-400) and the SONICBEAT Transducer (TD-SB400) for open, laparoscopic (including single-site surgery), and general surgery to cut (dissect), coagulate, or grasp soft tissue or to ligate (seal and cut) vessels in gynecologic, thoracic, urologic, and endoscopic surgical procedures.
These devices have been designed to seal and cut vessels up to and including 5mm in diameter.
The SONICBEAT has not been shown to be effective for tubal sterilization or tubal coagulation for sterilization procedures, and should not be used for these procedures.
Comparison of Technological Characteristics ರಿ
The Surgical Tissue Management System is basically identical to the predicate device in intended use, and similar in specifications.
Generator:
When compared to the predicate electrical surgical generators, the subject device has the similar technological features such as the number of instruments sockets, footswitch options, output, output levels and waveforms. There are differences in the input current, RF bipolar frequency, RF bipolar constant voltage and maximum wattage, however these differences are considered minor and do not impact the performance of the device as demonstrated in performance testing.
When compared to the predicate ultrasonic generators, the subject device has the similar technological features such as the footswitch options, output, frequency output, output levels and waveforms. The Input current, ultrasonic output voltage and ultrasonic output current are different, however these differences are considered minor and do not impact the performance of the device as demonstrated in performance testing.
Instruments:
When compared to the predicate electrical surgical instruments (K031011 and K081129), the subject device THUNDERBEAT instruments has similar technological features such as the shaft length, shaft rotation, shaft diameter and vessel seal claim. The only difference is that the subject device does not require a mechanical blade for cutting.
5
When compared to the predicate ultrasonic instruments (K050885 and K051036), the subject device has similar technological features such as the shaft length, shaft rotation, shaft diameter, cutting mechanism and vessel seal claim.
Substantially Equivalent Discussion 7
The Surgical Tissue Management System subject device is a modification to an Ultrasonic Generator to allow for independent or synchronistic use with a previously cleared Electrosurgical Unit (ESG400, K103032). The indications for use, principles of operation and fundamental technology of the Surgical Tissue Management System are similar to the predicate devices. The indicated patient population and procedures are also similar or identical to the predicate devices.
The main difference between the predicate devices and the Surgical Tissue Management System is that in the THUNDERBEAT Seal & Cut mode, ultrasonic and HF bipolar energy are combined to seal and cut tissue. The predicate devices use either HF bipolar or ultrasonic energy to seal and/or cut vessels. The combined energy output has been verified and validated to be equivalent in sealing performance, thermal spread and coagulation (ex vivo burst pressure tests and in vivo animal acute and survival study, hemostasis),when compared to the predicate devices with the same indications. As the performance test results demonstrate equivalent performance, we believe there are no new concerns regarding safety or efficacy as it relates to combining HF bipolar and ultrasonic energy for vessel sealing and cutting.
The THUNDERBEAT and SONICBEAT handpiece series are similar in method of operation and design as the predicate devices. In addition, similar or identical materials are used and biocompatibility results were provided.
రు Summary of Non-Clinical Testing
The following non-clinical test, preclinical test, and usability studies were performed:
Non-Clinical/ Preclinical Performance
Evidence of safety and effectiveness was obtained from two primary areas:
(1) non-clinical (electrical/mechanical/functional/biocompatibility/stability) performance testing
(2) preclinical (bench tissue/animal) evaluations and testing
Non-clinical: Basic safety and performance testing was performed in accordance with IEC 60601- 1, IEC60601-1-1, 6060 1-1-2, and IEC60601-2-2. in addition, verification and comparison studies were conducted to evaluate the mechanical and functional performance. Specifically, test results in the following areas were provided: temperature of the grasping
6
section, less mist production, dissecting performance, wiper jaw technology performance(grasping force).
Biocompatibility
In Vitro Cytotoxicity Test Skin Sensitization Test Intracutaneous Reactivity Test Acute Systemic Toxicity Test
Stability
Representative samples of devices were subjected to accelerated and real time ageing. The results of the accelerated age testing demonstrates that the device will be stable for the stated shelf-life. In addition, real time age testing will confirm the results of the accelerated age testing. The test devices were evaluated to ensure they continued to meet their specifications.
Preclinical: Evidence obtained from preclinical bench tissue (ex vivo) and animal (in vivo acute and chronic) studies using porcine and canine models (and in a variety of tissue types and conditions) demonstrate that the THUNDERBEAT and SONICBEAT performs substantially equivalent to the predicate devices in relevant aspects associated with sealing and cutting tissue; namely,
Evaluated ex vivo using excised porcine carotid, splenic, renal arteries, mesenterium, and jejunum.
-sealing performance (burst pressure) with isolated vessel
-ligation (sealing) speed with isolated vessel
- -cutting speed with mesenterium and iejunum
Evaluated in vivo/acute using porcine models
-overall hemostasis (isolated arteries)
- -overall cutting speed (mesenterium and peritoneum)
- -lateral thermal spread (measured on sealed isolated vessels)
Evaluated in vivo/chronic using canine models
-ability to maintain hemostasis at application and through survival (isolated arteries) -tissue healing through histological sample -blood testing
3) Use of Standards
The following standards were used during the design and validation of the subject devices:
- a) IEC 60601-1:1988+A1:1991+A2:1995
- b) IEC60601-1-1:2000
- c) IEC60601-2-2:2006
- d) IEC 60601-1-2:2001+A1:2004
- e) ISO10993-1:2003
- ISO 10993-5:2009 f)
- g) ISO10993-10:2002
7
- h) ISO10993-11:2006
- AAMI/ANSI/ISO17665-1.2006 i)
- AAMI/ANSI/ISO11135:2007 j)
- k) ASTM F1980-07
- ISO14971:2007 ()
The risk analysis was carried out in accordance with established in-house acceptance criteria based on ISO 14971:2007. The design verifications tests and their acceptance criteria were identified and performed as a result of this risk analysis assessment.
9 Conclusion
When compared to the predicate device, the Surgical Tissue Management System does not incorporate any significant changes in intended use, method of operation, material, or design that could affect the safety or effectiveness of the device.
8
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/8/Picture/1 description: The image shows the logo for the Department of Health & Human Services, USA. The logo features a stylized eagle with three wing-like shapes, oriented diagonally from the upper right to the lower left. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES. USA" is arranged in a circular fashion around the eagle symbol.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room-WO66-G609 Silver Spring, MD 20993-0002
Olympus Medical Systems Corporation Olympas Icy A. Kluesner, M.S., RAC % Ms. Stacy Fr. irs and Quality Assurance 3500 Corporate Parkway 3500 Corporato Pannsylvania 18034-0610
JAN 2 0 2012
Re: K111202 K 1 1 1202
Trade/Device Name: Surgical Tissue Management System
Trade/Device Name 24 Surgical Tissue 878 1400 Trade/Dovios imber: 21 CFR 878.4400 Regulation Number: 21 CFR 870. 1700 device and accessories Regulatory Class: Class II Product Code: GEI, KNS, LFL Dated: October 26, 2011 Received: October 31, 2011
Dear Ms. Kluesner:
Dear not one one of the mined the device is substantially equivalent (for the indication We have reviewed your Section 510(k) premarket notification in the market in the indications
referenced above and have detemined the device is substantially equivale we are for use stated in the enclosure) to legally marketed producal Device Amendments, or to
commerce prior to May 18, 1976, the enactment date of the Medical Device Amend Frood Dr commerce prior to May 28, 1976, the enactment date of the Federal Food, Drug, commerce proved to not require approval of a provisions of the 7 only 1 only 1 only 1 only 1 only 1 only 1 only 1 only 1 only.
and Cosmetic Act (Act) and the dayson swhiert t and Cosmetic Act (Act) that do not require approval of a previsions of the Act. and Controls, market the device, subject to the general connols provins for annual registration, listing of
general controls provisions of the Act include requirements misb remeral controls provisions of the Act include requirenteliis for almour to manufacturing and
devices, good manufacturing practice, labeling, and prohibitions against liabili getter on the mainter CDRH does not evaluate information related to contract liability
adulteration. Please not evaluate information related to contract labeling must be tru de note; food more: CDRH does not evaluate information realed to comment of the official of the official of the subjection.
warranties. We remind you; however, that device
Warmines in assified (see above) into either class II (Special Controls) or class III (PMA), it
is a many and this and any attake - Existing major regulations affecting your If your device is classified (see above) into either class it (Spiculations) er on be
may be subject to additional controls. Existing major regulations affective your device 11 your at to additional controls. Existing major regulations antocing -
may be subject to additional controls. Title 21, Parts 800 to 898. In addition, FDA may
found in found in the Code of Federal Regulations, Thic 21, Full 80 Febral Register.
publish further announcements concerning your device in the Federal Register.
publish turnities and the substantial equivalence determination does not mean Please be advised that FDA's issuance of a substantial equity with other requirements of the Act
that FDA has made a determination that your device complies with on the r rouse a determination that your acvice comines with once on its. You must
or any Federal statutes and regulations administered by other Federal and listing that 1 Dr. has and regulations administered by other Federal agential - Free
omply with all the Act's requirements, including, but not limited to: registration and listing (2
9
Page 2 - Ms. Stacy A. Kluesner
CFR Part 807); labeling (21 CFR Part 801); medical device reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. 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 Small Manufacturers, International and Consumer Assistance 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.
Sincerely yours.
Sincerely yours,
Mark N. Melkerson
Director Division of Surgical, Orthopedic and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
10
510(k) Number (if known): K | | | 20 J
Device Name: Surgical Tissue Management System
The Surgical Tissue Management System is intended to be used with the Ultrasonic Generator (USG-400), the Electrosurgical Generator (ESG-400), the THUNDERBEAT Transducer (TD-TB400), the SONICBEAT Transducer (TD-SB400), the THUNDERBEAT, and / or the SONICBEAT for open, laparoscopic (including single-site surgery), and endoscopic surgery to cut (dissect) or coagulate soft tissue or to ligate (seal and cut) vessels.
The Surgical Tissue Management System has three output modes, Seal & Cut (THUNDERBEAT), Seal (THUNDERBEAT) and Ultrasonic (SONICBEAT). The Seal & Cut mode provides combined HF bipolar and ultrasonic energy, the seal mode provides only HF bipolar energy and the Ultrasonic mode provides only ultrasonic energy.
This system has not been shown to be effective for tubal sterilization or tubal coagulation for sterilization procedures, and should not be used for these procedures.
Netreldel formatn
(Division Sign-Off) Division of Surgical, Orthopedic, and Restorative Devices
510(k) Number K111202
Prescription Use (Part 21 CFR 801 Subpart D) AND/OR
Over-The-Counter Use (21 CFR 807 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
11
510(k) Number (if known): K /// 20 J
Device Name: Ultrasonic Generator (USG-400)
The Ultrasonic Generator (USG-400) is intended to be used with the Electrosurgical Generator (ESG-400), the THUNDERBEAT Transducer (TD-TB400), the SONICBEAT Transducer (TD-SB400), the THUNDERBEAT, and / or the SONICBEAT for open, laparoscopic (including single-site surgery), and endoscopic surgery to cut (dissect) or coagulate soft tissue or to ligate (seal and cut) vessels.
Milred Sybren forman
(Division Sign-Off) Division of Surgical, Orthopedic, and Restorative Devices
510(k) Number K111202
Prescription Use (Part 21 CFR 801 Subpart D)
AND/OR
Over-The-Counter Use_ (21 CFR 807 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
12
510(k) Number (if known): K | | 2 6 2
Device Name:
Electrosurgical Generator (ESG-400 K103032)
The ESG-400 is an electrosurgical generator intended for tissue cutting and coagulation in open, laparoscopic and endoscopic surgery in conjunction with electrosurgical accessories and ancillary equipment.
uklR D. de forma
(Division Sign-Off) Division of Surgical, Orthopedic, and Restorative Devices
510(k) Number K111202
Prescription Use_ (Part 21 CFR 801 Subpart D) AND/OR
Over-The-Counter Use_ (21 CFR 807 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
13
510(k) Number (if known): (
Device Name: THUNDERBEAT Transducer (TD-TB400)
The THUNDERBEAT Transducer (TD-TB400) is intended to be used with the Ultrasonic Generator (USG-400), the Electrosurgical Generator (ESG-400), and the THUNDERBEAT for open, laparoscopic (including single-site surgery), and endoscopic surgery to cut (dissect) or coagulate soft tissue or to ligate (seal and cut) vessels.
Device Name: THUNDERBEAT (TB-0545PC, 0535PC, 0545IC, 0535IC, 0520IC, 0510IC)
The THUNDERBEAT hand instruments are 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 hand instruments when used in combination with the Seal & Cut mode are indicated for open, laparoscopic (including single-site surgery) general surgery and gynecological surgery (including urologic, thoracic, plastic and reconstructive, bowel resections, cholecystectomies. Nissen fundoplication, adhesiolysis, oophorectorny, hysterectomies (both vaginal assisted and abdominal) etc) and endoscopic surgery or in any procedure in which cutting, vessel ligation (sealing and cutting), coagulation, grasping, and dissection is performed. These devices have been designed to seal and cut vessels up to and including 7mm in diameter.
Seal mode:
The THUNDERBEAT hand instruments when used in combination with the Seal mode are indicated for open, laparoscopic (including single-site surgery) general surgery and gynecological surgery (including urologic, thoracic, plastic and reconstructive, bowel resections, cholecystectomies, Nissen fundoplication, adhesiolysis, oophorectorny, hysterectomies (both vaginal assisted and abdominal) etc), and endoscopic surgery or in any procedure in which vessel sealing, coagulation, grasping is performed. These devices have been designed to seal vessels up to and including 7mm in diameter.
The THUNDERBEAT hand instruments have not been shown to be effective for tubal sterilization or tubal coagulation for sterilization procedures, and should not be used for these procedures.
Prescription Use _____________________________________________________________________________________________________________________________________________________________ (Part 21 CFR 801 Subpart D) AND/OR
Over-The-Counter Use (21 CFR 807 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
et resolution format
(Division Sign-Off) Concurrence of CDRH, Office of Device Evaluation (ODE) Division of Surgical, Orthopedic, and Restorative Devices
510(k) Number K111202
Page 4 of 5
14
510(k) Number (if known):
Device Name: SONICBEAT Transducer (TD-SB400)
The SONICBEAT Transducer (TD-SB400) is intended to be used with the Ultrasonic Generator (USG-400) and the SONICBEAT for open, laparoscopic (including single-site surgery), and endoscopic surgery to cut (dissect) or coagulate soft tissue or to ligate (seal and cut) vessels.
Device Name: SONICBEAT (SB-0545PC, 0535PC, 0545IC, 0535IC, 0520IC, 0510IC)
The SONICBEAT is intended to be used with the Ultrasonic Generator (USG-400) and the SONICBEAT Transducer (TD-SB400) for open, laparoscopic (including single-site surgery), and general surgery to cut (dissect), coagulate, or grasp soft tissue or to ligate (seal and cut) vessels in gynecologic, thoracic, urologic, and endoscopic surgical procedures.
These devices have been designed to seal and cut vessels up to and including 5mm in diameter.
The SONICBEAT has not been shown to be effective for tubal sterilization or tubal coagulation for sterilization procedures, and should not be used for these procedures.
Netklo de forman
(Division Sign-Off)
Division of Surgical, Orthopedic, and Restorative Devices
510(k) Number K111202
Prescription Use (Part 21 CFR 801 Subpart D) AND/OR
Over-The-Counter Use (21 CFR 807 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)