(59 days)
No
The document describes a standard electrosurgical instrument for vessel sealing and division, with no mention of AI or ML capabilities in its operation or control. The "smart" connector identifies the instrument type, which is a simple identification mechanism, not indicative of AI/ML.
Yes
The device is described as an electrosurgical instrument for sealing and dividing vessels during surgical procedures, which is a therapeutic action.
No
The device is an electrosurgical instrument for sealing and dividing vessels, not for diagnosing conditions. Its function is interventional (ligation and division), not diagnostic.
No
The device description clearly details a physical electrosurgical instrument with a shaft, jaws, blade, handle, and cable, which connects to a generator. This is a hardware device, not software only.
Based on the provided text, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states the device is for use in surgical procedures to ligate and divide vessels. This is an in vivo application (within a living organism), not an in vitro application (outside of a living organism, typically on biological samples).
- Device Description: The description details a surgical instrument with jaws, a blade, and connections to an electrosurgical generator. This aligns with a surgical tool, not a diagnostic device that analyzes samples.
- Lack of Diagnostic Language: The text does not mention any diagnostic purpose, analysis of biological samples, or measurement of biomarkers.
IVD devices are used to examine specimens derived from the human body (like blood, urine, or tissue) to provide information for diagnostic, monitoring, or screening purposes. This device operates directly on tissue within the body during surgery.
N/A
Intended Use / Indications for Use
The LigaSure™ 5mm Vessel Sealer-Divider is a bipolar electrosurgical instrument intended for use with the LigaSure Generator in general and gynecologic laparoscopic surgical procedures where ligation and division of vessels is desired. The instrument creates a seal by the application of RF electrosurgical energy to vascular structures (vessels) interposed between the jaws of the instrument. A blade within the instrument is surgeon-actuated to divide tissue.
Indications for use include general laparoscopic procedures including urologic, vascular, thoracic and thoracoscopic, and gynecologic laparoscopic procedures where ligation and division of vessels is performed. These procedures include: laparoscopically assisted vaginal hysterectomy, Nissen fundoplication, colectomy, adhesiolysis, oophorectomy, etc. 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 5mm Vessel Sealer-Divider can be used on vessels up to and including 7mm diameter, and tissue bundles as large as will fit in the jaws of the instrument.
Product codes
GEI
Device Description
The LigaSure 5mm Laparoscopic Sealer-Divider is a multi-functional electrosurgical instrument for use with the LigaSure Vessel Sealing Generator (K981916) when performing laparoscopic surgery. The instrument is capable of sealing vessels, dividing vessels and tissue clamped between its jaws, grasping tissue, and blunt dissection. The outer diameter of the instrument shaft is 5mm, with a working length of 37 cm. Controls are located on the instrument handle. All controls can be operated with either the right or left hand.
The instrument attaches to the generator with a "smart" connector that identifies the instrument type to the LigaSure generator, and a ten (10) foot cable. The instrument is supplied sterile for single-use.
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)
Performance testing and pre-clinical studies were performed to ensure that the LigaSure™ 5mm Laparoscopic Sealer-Divider functions as intended, and meets design specifications. Sufficient data were obtained to show that the device is substantially equivalent to the predicate devices, and meets safety and effectiveness criteria.
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
KO31011
SUMMARY OF SAFETY AND EFFECTIVENESS INFORMATION
Valleylab LigaSure™ 5mm Laparoscopic Sealer-Divider
Submitter Information 1.
Valleylab, Inc. 5920 Longbow Drive Boulder, CO 80301 Contact: Herbert Vinson Telephone: 303-530-6469
Date summary prepared: March 11, 2003
2. Name of Device
Trade or Proprietary Name: LigaSure™ 5mm Laparoscopic Sealer-Divider
Common Name: Bipolar Laparoscopic Electrosurgical Instrument
Classification Name:
- Electrosurqical Cutting and Coagulation Device and Accessories, and ●
- Gynecologic Electrocautery and Accessories .
3. Predicate Devices
The Valleylab LigaSure™ 5mm Laparoscopic Sealer-Divider is substantially equivalent to the Vallevlab LS1000 LigaSure™ LAP Laparoscopic Instrument (K981916), and the Valleylab LS1100 LigaSure ATLAS™ Laparoscopic Sealer-Divider Instrument (K010013). All three of these devices are used in laparoscopic surgery to seal vessels by the application of RF enerqy to the vessels and tissues interposed between the jaws of the instrument. The LigaSure™ 5mm Laparoscopic Sealer-Divider and the LS1100 LigaSure ATLAS™ Laparoscopic Sealer-Divider Instrument divide tissue using a surgeonactuated blade.
4. Device Description
The LigaSure 5mm Laparoscopic Sealer-Divider is a multi-functional electrosurgical instrument for use with the LigaSure Vessel Sealing Generator (K981916) when performing laparoscopic surgery. The instrument is capable of sealing vessels, dividing vessels and tissue clamped between its jaws, grasping tissue, and blunt dissection. The outer diameter of the instrument shaft is 5mm,
1
with a working length of 37 cm. Controls are located on the instrument handle. All controls can be operated with either the right or left hand.
The instrument attaches to the generator with a "smart" connector that identifies the instrument type to the LigaSure generator, and a ten (10) foot cable. The instrument is supplied sterile for single-use.
5. Intended Use
The LigaSure™ 5mm Vessel Sealer-Divider is a bipolar electrosurgical instrument intended for use with the LigaSure Generator in general and gynecologic laparoscopic surgical procedures where ligation and division of vessels is desired. The instrument creates a seal by the application of RF electrosurgical energy to vascular structures (vessels) interposed between the jaws of the instrument. A blade within the instrument is actuated to divide tissue.
Indications for use include general laparoscopic surgical procedures including urologic, vascular, thoracic and thoracoscopic, and gynecologic laparoscopic procedures where ligation and division of vessels is performed. These procedures include: laparoscopically assisted vaginal hysterectomy, Nissen fundoplication, colectorny, adhesiolysis, oophorectomy, etc. The LigaSure 5mm Vessel Sealer-Divider 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 5mm Vessel Sealer-Divider can be used on vessels up to and including 7mm diameter, and tissue bundles as large as will fit in the jaws of the instrument.
6. Summary of Technological Characteristics
The LigaSure™ 5mm Laparoscopic Sealer-Divider has the same basic technological characteristics as the predicate devices noted above.
7. Performance Data
Performance testing and pre-clinical studies were performed to ensure that the LigaSure™ 5mm Laparoscopic Sealer-Divider functions as intended, and meets design specifications. Sufficient data were obtained to show that the device is substantially equivalent to the predicate devices, and meets safety and effectiveness criteria.
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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" arranged around the perimeter. Inside the circle is a stylized symbol that resembles an abstract caduceus or a representation of human figures.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
MAY 2 9 2003
Mr. Herbert Vinson Senior Regulatory Associate Valleylab. Inc. 5920 Longbow Drive Boulder, Colorado 80301
Re: K031011
Trade/Device Name: LigaSure™ 5mm Laparoscopic Sealer-Divider Regulation Number: 21 CFR 878.4400 Regulation Name: Electrosurgical cutting and coagulation device and accessories Regulatory Class: II Product Code: GEI Dated: March 11, 2003 Received: March 31, 2003
Dear Mr. Vinson:
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. 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 (PMA), 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 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
3
Page 2 - Mr. Herbert Vinson
This letter will allow you to begin marketing your device as described in your Section 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), please contact the Office of Compliance at (301) 594-4659. 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" (21CFR Part 807.97) you may obtain. Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers, 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.
Muriam 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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Page 1 of 1
510(k) Number (if known): KO31011
Device Name: LigaSure™ 5mm Laparoscopic Sealer-Divider
Indications For Use:
The LigaSure™ 5mm Vessel Sealer-Divider is a bipolar electrosurgical instrument intended for use with the LigaSure Generator in general and gynecologic laparoscopic surgical procedures where ligation and division of vessels is desired. The instrument creates a seal by application of RF electrosurgical energy to vascular structures (vessels) interposed between the jaws of the instrument. A blade within the instrument is surgeonactuated to divide tissue.
Indications for use include general laparoscopic procedures including urologic, vascular, thoracic and thoracoscopic, and gynecologic laparoscopic procedures where ligation and division of vessels is performed. These procedures include: laparoscopically assisted vaginal hysterectorny, Nissen fundoplication, colectomy, adhesiolysis, oophorectomy, etc. The LigaSure Vessel Sealing System has not been shown to be effective for tubal sterilization or tubal coaqulation for sterilization procedures, and should not be used for these procedures.
The LigaSure 5mm Vessel Sealer-Divider can be used on vessels up to and including 7mm diameter, and tissue bundles as large as will fit in the jaws of the instrument.
PLEASE DO NOT WRITE BELOW THIS LINE CONTINUE ON ANOTHER PAGE IF NEEDED
Concurrence of CDRH, Office of Device Evaluation (ODE)
Musiam C. Provost
(Division Sign-Off) Division of General, Restorative and Neurological Devices
Prescription Use \ (Per 21 CFR 801.109)
510(k) Number K03/011
OR
Over-The-Counter Use
(Optional Format 1-2-96)