(40 days)
The LigaSure™ Vessel Sealing System includes a bipolar electrosurgical generator and dedicated bipolar electrosurgical instruments intended for use in general, laparoscopic and gynecologic surgical procedures where ligation of vessels, including lymph vessels, is desired. The system creates a vessel ligation (seal) by the application of bipolar electrosurgical RF energy (coagulation) to vessels interposed between the jaws of the device. The generator can also be used with standard bipolar devices where bipolar cutting or coagulation is desired.
The indications for use include general (including urologic, thoracic, plastic and reconstructive), laparoscopic, and gynecological procedures where ligation of vessels is performed, including such procedures as bowel resections, hysterectomies (both vaginal and abdominal), laparoscopic cholesystectomies, laparoscopically assisted vaginal hysterectomies, gall bladder procedures, Nissen fundoplication, adhesiolysis, oophorectomy. etc. The devices can be used on vessels up to 7mm and bundles as large as will fit in the jaws of the instruments.
The LigaSure™ Vessel Sealing 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 LigaSure™ Vessel Sealing System consists of a microprocessor-based radiofrequency (RF) generator and a selection of instruments designed to be used exclusively with the LigaSure™ generator. All of the instruments are capable of sealing vessels up to, and including, 7mm, and tissue bundles as large as can fit in the jaws of each instrument. When a LigaSure™ instrument is applied to a vessel or tissue bundle and RF energy is applied, the collagen and elastin in the tissues are reformed by heat and pressure to fuse vessel walls, thereby forming a permanent seal. The microprocessor in the generator monitors the tissue properties, stops the application of energy, and allows a brief period of cooling before indicating that the seal cycle is complete.
No changes are being made to the design or operation of any of the devices within the current system. The change as proposed in this 510(k) notification is to the intended use as described above and the resulting labeling changes.
This document is a 510(k) premarket notification for the LigaSure™ Vessel Sealing System. The primary purpose of this notification is to advise the FDA of a change in the intended use and resulting labeling for the device, not to introduce a new device or demonstrate a new level of performance. As such, the information you're requesting regarding acceptance criteria and performance studies for a new device or algorithm development is largely not present in this submission.
The document confirms the safety and effectiveness of the device for its expanded indications based on pre-clinical studies and its substantial equivalence to a legally marketed predicate device.
Here's an attempt to answer your questions based on the provided text, highlighting what is explicitly stated and what is not:
1. Table of Acceptance Criteria and Reported Device Performance
No specific numerical acceptance criteria (e.g., target accuracy, sensitivity, specificity) are defined or reported in this document. The document states that pre-clinical studies were conducted.
| Acceptance Criteria (Explicitly Stated) | Reported Device Performance (from Pre-clinical studies) |
|---|---|
| Effectiveness in sealing lymphatic vessels | Produces seals with burst pressures substantially greater than the physiologic pressures in the vessels. |
| Seals vessels up to 7mm and tissue bundles as large as can fit in the jaws of each instrument | Confirmed operation for vessels up to 7mm and bundles as large as will fit in the jaws of the instruments. |
| Substantial Equivalence to Predicate Device (K981916) | The device is considered substantially equivalent to the predicate device for its stated indications for use. |
2. Sample Size Used for the Test Set and Data Provenance
The document mentions "pre-clinical studies" but does not specify the sample size, the type of test set (e.g., animal models, cadaveric tissue), or the data provenance (e.g., country of origin, retrospective/prospective).
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications
This information is not provided. The pre-clinical studies likely involved laboratory measurements and potentially histological analysis by trained personnel, but no details on expert consensus for ground truth are given.
4. Adjudication Method for the Test Set
This information is not provided.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
No MRMC study is mentioned. This is a medical device for surgical procedures, not an AI diagnostic tool, so such a study would not be typically performed in this context.
6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study
This is not applicable as the LigaSure™ Vessel Sealing System is a physical medical device operated by a surgeon, not an AI algorithm.
7. Type of Ground Truth Used
Based on the "pre-clinical studies," the ground truth likely involved:
- Measurement of burst pressures: This is a direct physical measurement.
- Visual and/or histological examination of sealed vessels: To confirm complete and effective sealing.
- Functional tests: To ensure the seals withstand physiological pressures.
8. Sample Size for the Training Set
This information is not provided, nor is it directly relevant in the context of this type of device where "training set" for an algorithm is not applicable. The device's "training" refers to its design and engineering iterations.
9. How the Ground Truth for the Training Set Was Established
This information is not provided, and the concept of a "training set ground truth" in the AI sense does not apply to this device. The design and validation of this medical device would have relied on engineering principles, material science, and pre-clinical testing to establish its performance and safety characteristics.
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JAN - 5 2005
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SUMMARY OF SAFETY AND EFFECTIVENESS INFORMATION
KO43273
LigaSure™ Vessel Sealing System
Submitter Information 1.
Valleylab A Division of Tyco Healthcare Group LP 5920 Lonabow Drive Boulder, CO 80301 Contact: Herbert W. Vinson Senior Requlatory Associate Telephone: 303-530-6469 Fax: 303-530-6313 E-mail: Herb.Vinson@Tycohealthcare.com
Date summary prepared: November 24, 2004
2. Name of Device
Trade or Proprietary Name: LigaSure™ Vessel Sealing System
Common/Classification Name: Electrosurgical Cutting and Coagulation Device and Accessories
3. Predicate Devices
The LigaSure™ Vessel Sealing System is substantially equivalent to the following legally marketed medical devices:
- LigaSure™ Vessel Sealing System (K981916) .
4. Device Description
The LigaSure™ Vessel Sealing System consists of a microprocessor-based radiofrequency (RF) generator and a selection of instruments designed to be used exclusively with the LigaSure™ generator. All of the instruments are capable of sealing vessels up to, and including, 7mm, and tissue bundles as large as can fit in the jaws of each instrument. When a LigaSure™ instrument is applied to a vessel or tissue bundle and RF energy is applied, the collagen and elastin in the tissues are reformed by heat and pressure to fuse vessel walls, thereby forming a permanent seal. The microprocessor in the generator monitors the tissue properties, stops the application of energy, and allows a brief period of cooling before indicating that the seal cycle is complete.
No changes are being made to the design or operation of any of the devices within the current system. The change as proposed in this 510(k) notification is to the intended use as described above and the resulting labeling changes.
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5. Intended Use
The LigaSure™ Vessel Sealing System includes a bipolar electrosurgical generator and dedicated bipolar electrosurgical instruments intended for use in general, laparoscopic and gynecologic surgical procedures where ligation of vessels, including lymph vessels, is desired. The system creates a vessel ligation (seal) by the application of bipolar electrosurgical RF energy (coagulation) to vessels interposed between the jaws of the device. The generator can also be used with standard bipolar devices where bipolar cutting or coagulation is desired.
The indications for use include general (including urologic, thoracic, plastic and reconstructive), laparoscopic, and gynecological procedures where ligation of vessels is performed, including such procedures as bowel resections, hysterectomies (both vaginal and abdominal), laparoscopic cholesystectomies, laparoscopically assisted vaqinal hysterectomies, gall bladder procedures, Nissen fundoplication, adhesiolysis, oophorectomy, etc. The devices can be used on vessels up to 7mm and bundles as large as will fit in the jaws of the instruments.
6. Summary of Technological Characteristics
The technological characteristics of the LigaSure™ Vessel Sealing System have not been modified.
7. Performance and Clinical Data
Pre-clinical studies have shown that the LigaSure™ Vessel Sealing System effectively seals lymphatic vessels, producing seals with burst pressures substantially greater than the physiologic pressures in the vessels.
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Image /page/2/Picture/1 description: The image is a black and white circular seal. The seal contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" in a circular pattern around the edge. In the center of the seal is a stylized image of an eagle.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
JAN - 5 2005
Mr. Herbert W. Vinson Senior Regulatory Associate Valleylab A Division of Tyco Healthcare Group LP 5920 Longbow Drive Boulder, Colorado 80301
Re: K043273
K045275
Trade/Device Name: LigaSure™ Vessel Sealing System Regulation Number: 21 CFR 878.4400 Regulation Name: Electrosurgical cutting and coagulation device and accessories Regulatory Class: II Product Code: GEI Dated: November 24, 2004 Received: November 26, 2004
Dear Mr. Vinson:
We have reviewed your Section 510(k) premarket notification of intent to market the device in indication we nave reviewed your bection 9 re(s) personalially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate for use stated in the encrosule) to regars than to the Medical Device Amendments, or to commerce prior to May 26, 1776, the encordance with the provisions of the Federal Food, Drug, devices that have been recuire in asse approval of a premarket approval application (PMA). allo Cosmetic Act (Act) market the device, subject to the general controls provisions of the Act. The T ou may, therefore, market are act include requirements for annual registration, listing of general controls provisions of the rest lebeling, and prohibitions against misbranding and adulteration.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it If your device is classified (soc above) als. Existing major regulations affecting your device can may be subject to sublements. Ventreiner , Title 21, Parts 800 to 898. In addition, FDA may oc found in the Outs neements concerning your device in the Federal Register.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean Frease of advised that FDF 5 results of the complies with other requirements of the Act that I DA has made a acterimations administered by other Federal agencies. You must or any I catal statutes and regirements, including, but not limited to: registration and listing (21 Comply with an the 70t 5 requirements, and 801); good manufacturing practice requirements as set CFR in tool); idoomig (21 OFF Part 820); and if applicable, the electronic forth in the quality Bysteins (Sections 531-542 of the Act); 21 CFR 1000-1050.
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Page 2 - Mr. Herbert W. Vinson
This letter will allow you to begin marketing your device as described in your Section 510(k) I mis letter will and h your of substantial equivalence of your device to a legally promative noticated on " results in a classification for your device and thus, permits your device to proceed to the market.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please 11 you dome office of Compliance at (240) 276-0115. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the Division of Small other Economic International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html
Sincerely yours,
Miriam C. Provost
Celia M. Witten, Ph.D., M.D. Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known): K043273
Device Name: LigaSure™ Vessel Sealing System
Indications For Use:
The LigaSure™ Vessel Sealing System includes a bipolar electrosurgical generator and dedicated bipolar electrosurgical instruments intended for use in general. Iaparoscopic and gynecologic surgical procedures where ligation of vessels, including lymph vessels, is desired. The system creates a vessel ligation (seal) by the application of bipolar electrosurgical RF energy (coaqulation) to vessels interposed between the jaws of the device. The generator can also be used with standard bipolar devices where bipolar cutting or coagulation is desired.
The indications for use include general (including urologic, thoracic, plastic and reconstructive), laparoscopic, and gynecological procedures where ligation of vessels is performed, including such procedures as bowel resections, hysterectomies (both vaginal and abdominal), laparoscopic cholesystectomies, laparoscopically assisted vaginal hysterectomies, gall bladder procedures, Nissen fundoplication, adhesiolysis, oophorectorny. etc. The devices can be used on vessels up to 7mm and bundles as large as will fit in the jaws of the instruments.
The LigaSure™ Vessel Sealing 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.
Prescription Use (Per 21 CFR 801 Subpart D)
AND/OR
Over-The-Counter Use (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Miriam C. Provost
(Division Sign-Off) Division of General, Restorative, and Neurological Devices
K043273 510(k) Number_
§ 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.