(88 days)
Not Found
No
The description focuses on electrosurgical energy application and microprocessor control, with no mention of AI or ML.
Yes
The device is described as a "Vessel Sealing System" intended for "ligation of vessels" and as an "alternative to mechanical claming (clips or staples) or suturing" in various medical procedures, which aligns with the definition of a therapeutic device.
No
Explanation: The device is described as a surgical tool used for vessel ligation, delivering electrosurgical RF energy to seal vessels. Its intended use is therapeutic, not diagnostic.
No
The device description clearly outlines hardware components including a generator, reusable forceps, disposable electrodes, and a laparoscopic instrument. The system relies on the application of bipolar electrosurgical RF energy through these hardware components.
Based on the provided text, the LigaSure™ Vessel Sealing System is not an IVD (In Vitro Diagnostic) device.
Here's why:
- Intended Use: The intended use clearly describes a surgical device used in vivo (within the body) for sealing vessels during various surgical procedures. IVD devices are used in vitro (outside the body) to examine specimens like blood, urine, or tissue to diagnose diseases or conditions.
- Device Description: The description details an electrosurgical generator and instruments designed to apply energy directly to tissue within the body. This is consistent with a surgical device, not an IVD.
- Lack of IVD Characteristics: The text does not mention any of the typical characteristics of an IVD, such as:
- Analyzing biological specimens.
- Providing diagnostic information based on laboratory tests.
- Using reagents or assays.
Therefore, the LigaSure™ Vessel Sealing System is a surgical device, not an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The LigaSure™ Vessel Sealing System is intended for use in general, laparoscopic, and gynecologic procedures where ligation of vessels is desired and as an alternative to mechanical claming (clips or staples) or suturing. The generator can also be used with standard bipolar devices where bipolar cutting or coagulation is desired.
Indications for use for this type of ligation include general, laparoscopic and gynecological procedures such as urological, thoracic, plastic and reconstructive, bowel resections, hysterectomies (LAVH and abdominal) cholesystectomics, gall bladder procedures, Nissen fundoplication, adhesiolysis, oophorectomies, etc. The devices can be used on vessels up to 7 mm. and bundles as large as will fit in the jaws of the instruments.
Product codes
GEI
Device Description
The LigaSure™ Vessel Sealing Generator is an isolated, microprocessor based, bipolar only electrosurgical generator which incorporates three bipolar modes; standard, macro and vessel sealing. The generator will accept standard bipolar devices. In addition, the generator will also accept dedicated LigaSure™ Open and Laparoscopic Instruments for use in vessel sealing.
The LigaSure™ Open instruments are reusable forceps type devices with "snap-in" single use, disposable electrodes which are placed in the jaws of the devices. The LigaSure™ laparoscopic instrument is a sterile, single use device for use in grasping and vessel sealing in laparoscopic procedures. The device outer diameter is 5 mm and the working length is approximately 32 cms.
The system creates vessel ligation by the application of bipolar electrosurgical RF energy (coagulation/desiccation) to vessel tissue or vascular bundles interposed between the electrodes of the device.
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)
Preclinical laboratory (acute and chronic studies) and performance testing were performed to ensure the devices functioned as intended and met design specification. Sufficient data was obtained to show the LigaSure™ Vessel Sealing system was equivalent to or better than the predicate devices and meet safety and effectiveness criteria.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
K944602, K953195, K946177, K932293, K946109, K96009
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
AUG 28 1998
SUMMARY OF SAFETY AND EFFECTIVENESS INFORMATION VALLEYLAB LIGASURE™ VESSEL SEALING SYSTEM
Submitter Information I.
Valleylab Inc a division of United States Surgical Corporation 5920 Longbow Drive Boulder, Colorado 80301 Contact: Charles M. Copperberg Telephone No. : 303-530-6343
Date Summary Prepared: 08/27/98
II. Name of Device
Proprietary Name: LigaSure™ Vessel Sealing System including the LigaSure™ Vessel Sealing Generator and LigaSure™ Open and Laparoscopic Instruments
Common or Usual Name: Bipolar Electrosurgical Generator with bipolar electrosurgical open and laparoscopic instruments
Classification Name: CFR 878.4400, Electrosurgical Cutting and Coagulation Device and Accessories and 21 CFR 884.4120 Gynecologic Electrocautery and Accessories
ш. Predicate Devices
The LigaSure™ Vessel Sealing Generator is a bipolar generator which is substantially equivalent to the following Valleylab electrosurgical generators: Force FX (K944602), Force 300 (K953195) and NS2000 (K946177).
The LigaSure™ Open and Laparoscopic Instruments are substantially equivalent to the Cabot Seitzinger Tripolar Forceps, the Cabot Bipolar Cutting Forceps (K932293 and K946109) and the Storz Bipolar Forceps (K96009). All of these devices perform the coagulation of tissue via bipolar RF energy applied through the electrodes of the devices.
IV. Device Description
The LigaSure™ Vessel Sealing Generator is an isolated, microprocessor based, bipolar only electrosurgical generator which incorporates three bipolar modes; standard, macro and vessel sealing. The generator will accept standard bipolar devices. In addition, the generator will also accept dedicated LigaSure™ Open and Laparoscopic Instruments for use in vessel sealing.
The LigaSure™ Open instruments are reusable forceps type devices with "snap-in" single use, disposable electrodes which are placed in the jaws of the devices. The LigaSure™ laparoscopic
1
instrument is a sterile, single use device for use in grasping and vessel sealing in laparoscopic procedures. The device outer diameter is 5 mm and the working length is approximately 32 cms.
The system creates vessel ligation by the application of bipolar electrosurgical RF energy (coagulation/desiccation) to vessel tissue or vascular bundles interposed between the electrodes of the device.
V. Intended Use
The LigaSure™ Vessel Sealing System is intended for use in general, laparoscopic, and gynecologic procedures where ligation of vessels is desired and as an alternative to mechanical claming (clips or staples) or suturing. The generator can also be used with standard bipolar devices where bipolar cutting or coagulation is desired.
Indications for use for this type of ligation include general, laparoscopic and gynecological procedures such as urological, thoracic, plastic and reconstructive, bowel resections, hysterectomies (LAVH and abdominal) cholesystectomics, gall bladder procedures, Nissen fundoplication, adhesiolysis, oophorectomies, etc. The devices can be used on vessels up to 7 mm. and bundles as large as will fit in the jaws of the instruments.
VI. Summary of Technological Characteristics
The LigaSure™ Vessel Sealing generator and instruments have the same basic technological characteristics as the predicate devices noted above. The LigaSure™ generator provides bipolar RF energy to bipolar devices for coagulation/desiccation of vessels.
VII. Performance Data
Preclinical laboratory (acute and chronic studies) and performance testing were performed to ensure the devices functioned as intended and met design specification. Sufficient data was obtained to show the LigaSure™ Vessel Sealing system was equivalent to or better than the predicate devices and meet safety and effectiveness criteria.
2
Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" around the perimeter. Inside the circle is a stylized symbol featuring three human profiles merging into a wing-like shape.
Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
AUG 28 1998
Mr. Charles Copperberg Senior Regulatory Affairs Associate ValleyLab.Inc. 5920 Longbow Drive Boulder, Colorado 80301
Re: K981916
Trade Name: Ligasure Vessel Sealing System Regulatory Class: II Product Code: GEI Dated: May 29, 1998 Received: June 1, 1998
Dear Mr. Cooperberg:
We have reviewed your Section 510(k) notification of intent to market the device referenced above and we 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). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.
If your device is classified (see above) into either class II (Special Controls) or class III (Premarket Approval), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations. Title 21, Parts 800 to 895. A substantially equivalent determination assumes compliance with the Current Good Manufacturing Practice requirements, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic QS inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.
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Page 2 - Mr. Charles Copperberg
This letter will allow you to begin marketing your device as described in your 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device 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 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4595. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification"(21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers 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,
Celia M. Witten, Ph.D., M.D.
Director Division of General and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health
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Page 1 of 1
510(k) Number (if known): K981916
Device Name:
Valleylab 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, laparoscopic and gynecologic procedures where ligation of 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 7 mm. and bundles as large as will fit in the jaws of the instruments.
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
| Prescription Use (Per 2.1 CFR 801.109) | X | OR | Over-The-Counter Use |
|---|---|---|---|
| ---------------------------------------- | ---------------------------------------------------------------- | ---- | ---------------------- |
(Division Sign-Off)
Division of General Restorative Devices
| 510(k) Number | K981916 Page 21 of 21 |
|---|---|
| --------------- | ----------------------- |
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