(125 days)
No
The summary describes a reprocessed electrosurgical instrument and its use with an energy platform. There is no mention of AI, ML, or any computational processing that would suggest the use of such technologies. The device's function is based on delivering controlled energy for tissue fusion, which is a standard electrosurgical principle.
Yes
The device is an electrosurgical instrument used to cut and seal vessels and tissues during open surgical procedures, which is a therapeutic intervention.
No
The device is an electrosurgical instrument for cutting, sealing, and dissecting tissue during surgery, not for diagnosing conditions.
No
The device description clearly states it is a hand-held bipolar electrosurgical instrument with a physical handle, jaw, shaft, cord, and connector, indicating it is a hardware device.
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 open surgical procedures for ligation and division of vessels and tissue. This is a surgical intervention performed directly on the patient's body.
- Device Description: The description details a hand-held bipolar electrosurgical instrument used with an energy platform to seal and divide tissue. This is a surgical tool.
- Lack of Diagnostic Purpose: There is no mention of the device being used to examine specimens derived from the human body (like blood, urine, tissue samples, etc.) to provide information for diagnosis, monitoring, or screening.
IVD devices are used to perform tests on samples taken from the body, not to perform procedures on the body itself. This device is a surgical instrument used during a procedure.
N/A
Intended Use / Indications for Use
The reprocessed Medline ReNewal LigaSure Impact LF4318 Curved Large Jaw, Open Sealer/Divider is a dedicated bipolar electrosurgical instrument intended for use in open surgical procedures where ligation and division of vessels is desired. The LF4318 is intended to be used with the ForceTriad energy platform to cut and seal vessels, and to cut, grasp and dissect tissue during surgery.
The indications for use include open procedures (general, urologic, vascular, thoracic, and gynecological) where ligation and division of vessels is performed. These procedures include vaginal hysterectomies, Nissen fundoplication, colectomy, adhesiolysis, oophorectomy, etc. The LigaSure Impact 4318 can be used on vessels (arteries, veins, pulmonary vasculature, and lymph) up to and including 7 mm and tissue bundles.
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.
Product codes (comma separated list FDA assigned to the subject device)
NUJ
Device Description
The reprocessed Medline ReNewal LigaSure Impact, Curved, Large Jaw, Open Sealer/Divider (LF4318) is a sterile, single-use, hand-held bipolar electrosurgical instrument designed exclusively for use with the ForceTriad Energy Platform (cleared under K051644, K070162) to seal and divide vessels (including pulmonary) up to and including 7 mm in diameter, tissue bundles, and lymphatics during open general surgical procedures. The ForceTriad's' tissue-fusion (LigaSure) mode is designed to deliver precise energy to tissue for a controlled time period to achieve complete and permanent tissue fusion.
The device combines the benefits of a long, curved jaw and a shaft-based jaw mechanism for improved access and visibility to critical structures. The pistol-grip-style handle was designed for improved comfort and usability, with an integrated hand switch and cutter for the subsequent sealing and dividing of tissue. Hand controls have been symmetrically placed to facilitate handling by both left- and right-handed users. The LF4318 device connects to the ForceTriad energy platform with a 10-foot cord containing a LigaSure cable connector. This connector functions as a unique product identifier for device -specific recognition by the generator. The 10-foot cord, cable connector, and ForceTriad are not reprocessed by Medline ReNewal.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
vessels (arteries, veins, pulmonary vasculature, and lymph), tissue bundles
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)
The functional characteristics of the proposed devices have been evaluated and found to be equivalent to the predicate devices based on the following tests:
electrical safety and electromagnetic compatibility in accordance with IEC 60601-1 and 60601-1-2; simulated use; device integrity; blade trigger advance/return; shaft knob rotation; device recognition; thermal analysis characterization; handle locking; burst pressure; histopathology; seal quality; tissue sticking; Cleaning: protein, and carbohydrates; Biocompatibility: sensitization, irritation; pyrogenicity, and acute systemic toxicity; performance qualification; sterilization validation; and product stability.
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.
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.
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.
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Image /page/0/Picture/1 description: The image shows the logo for the Department of Health & Human Services - USA. The logo consists of a stylized eagle with three heads facing right, representing the department's commitment to health, human services, and the USA. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the eagle.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
May 2, 2016
Surgical Instrument Service and Savings, Inc. Ms. Brandi J. Panteleon Director, Quality Assurance and Regulatory Affairs 2747 SW 6th St. Redmond, Oregon 97756
Re: K153745
Trade/Device Name: Medline Renewal Reprocessed Ligasure Impact Open Sealer/Divider Regulation Number: 21 CFR 878.4400 Regulation Name: Electrosurgical Cutting And Coagulation Device And Accessories Regulatory Class: Class II Product Code: NUJ Dated: April 7, 2016 Received: April 8, 2016
Dear Ms. Panteleon:
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. 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 801); medical device reporting of medical devicerelated 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.
1
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. 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
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 Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely vours.
Jennifer R. Stevenson -A
For Binita S. Ashar, M.D., M.B.A., F.A.C.S. Director Division of Surgical Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
2
| Device Model | Device Name | Original
Manufacturer |
|--------------|-----------------------------------------------------------|--------------------------|
| LF4318 | LigaSure Impact Curved, Large Jaw, Open
Sealer/Divider | Covidien |
3
Indications for Use
510(k) Number (if known) K153745
Device Name
Medline ReNewal Reprocessed LigaSure Impact Curved, Large Jaw Sealer/Divider (LF4318)
Indications for Use (Describe)
The reprocessed Medline ReNewal LigaSure Impact LF4318 Curved Large Javy, Open Sealer/Divider is a dedicated bipolar electrosurgical instrument intended for use in open surgical procedures where ligation of vessels is desired. The LF4318 is intended to be used with the ForceTriad energy platform to cut and seal vessels, and to cut, grasp and dissect tissue during surgery.
The indications for use include open procedures (general, urologic, vascular, thoracic, and gyneoological) where ligation and division of vessels is performed. These procedures include vaginal hysterectomies, Nissen fundoplication, colectorny, adhesiolysis, oophorectomy, etc. The LigaSure Impact 4318 can be used on vessels (arteries, veins, pulmonary vasculature, and lymph) up to and including 7 mm and tissue bundles.
The LigaSure system has not been shown to be effective for tubal coagulation for sterilization procedures. Do not use the LigaSure system for these procedures.
| Type of Use (Select one or both, as applicable) |
|---|
| X Prescription Use (Part 21 CFR 801 Subpart D) |
| Over-The-Counter Use (21 CFR 801 Subpart C) |
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4
Image /page/4/Picture/0 description: The image shows the Medline Renewal logo. The word "MEDLINE" is in blue, with a star-like symbol to the left. To the right of the Medline logo is the word "Renewal" in green and blue, with the words "Full Circle Reprocessing" in gray below it.
510(k) Summary
| Submitter/Owner | Medline ReNewal
2747 SW 6th St.
Redmond, OR 97756 |
|--------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Contact Name | Brandi Panteleon
Director, Quality Assurance and Regulatory Affairs
P: 541-516-4180
F: 541-923-3375
E: bpanteleon@medline.com |
| Prepared by | Stephanie Boyle Mays
Technical Writer, Product Development
P: 541-516-4205
F: 541-923-3375
E: smays@medline.com |
| Date Prepared | December 23, 2015 |
| Device Names | Proprietary Name: Medline ReNewal Reprocessed LigaSure Impact
Curved, Large Jaw Sealer/Divider (LF4318)
Common Name: Bipolar electrosurgical instrument |
| Classification | Electrosurgical cutting and coagulation device and accessories
Product code: NUJ
Class: Class II, non-exempt
Classification Number: 21 CFR § 878.4400 |
| Predicate Device | K123444 LigaSure Impact Curved, Large Jaw, Open Sealer/Divider LF4318 |
| Device Description | The reprocessed Medline ReNewal LigaSure Impact, Curved, Large Jaw,
Open Sealer/Divider (LF4318) is a sterile, single-use, hand-held bipolar
electrosurgical instrument designed exclusively for use with the ForceTriad
Energy Platform (cleared under K051644, K070162) to seal and divide
vessels (including pulmonary) up to and including 7 mm in diameter, tissue
bundles, and lymphatics during open general surgical procedures. The
ForceTriad's' tissue-fusion (LigaSure) mode is designed to deliver precise
energy to tissue for a controlled time period to achieve complete and
permanent tissue fusion.
The device combines the benefits of a long, curved jaw and a shaft-based
jaw mechanism for improved access and visibility to critical structures. The
pistol-grip-style handle was designed for improved comfort and usability,
with an integrated hand switch and cutter for the subsequent sealing and
dividing of tissue. Hand controls have been symmetrically placed to
facilitate handling by both left- and right-handed users. The LF4318 device
connects to the ForceTriad energy platform with a 10-foot cord containing a
LigaSure cable connector. This connector functions as a unique product
identifier for device -specific recognition by the generator. The 10-foot cord,
cable connector, and ForceTriad are not reprocessed by Medline ReNewal. |
5
Image /page/5/Picture/0 description: The image shows the Medline ReNewal logo. The word "MEDLINE" is in blue, with a blue star to the left of it. To the right of the word "MEDLINE" is a vertical line, followed by the word "ReNewal" in green and blue. Underneath the word "ReNewal" is the phrase "Full Circle Reprocessing".
| Intended Use | The reprocessed Medline ReNewal LigaSure Impact LF4318 Curved Large
Jaw, Open Sealer/Divider is a dedicated bipolar electrosurgical instrument
intended for use in open surgical procedures where ligation and division of
vessels is desired. The LF4318 is intended to be used with the ForceTriad
energy platform to cut and seal vessels, and to cut, grasp and dissect
tissue during surgery.
The indications for use include open procedures (general, urologic,
vascular, thoracic, and gynecological) where ligation and division of vessels
is performed. These procedures include vaginal hysterectomies, Nissen
fundoplication, colectomy, adhesiolysis, oophorectomy, etc. The LigaSure
Impact 4318 can be used on vessels (arteries, veins, pulmonary
vasculature, and lymph) up to and including 7 mm and tissue bundles.
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. |
|----------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Technological
Characteristics | The technological characteristics and the fundamental scientific technology
of the subject devices are identical to the predicate device. The proposed
devices are a reprocessed version of the predicate devices. K123444
LigaSure Impact Curved, Large Jaw, Open Sealer/Divider LF4318 was
used as the primary predicate to support intended use, technological
characteristics, and functional performance specifications. |
| Performance
Testing | The functional characteristics of the proposed devices have been evaluated
and found to be equivalent to the predicate devices based on the following
tests:
electrical safety and electromagnetic compatibility in accordance
with IEC 60601-1 and 60601-1-2; simulated use; device integrity; blade trigger advance/return; shaft knob rotation; device recognition; thermal analysis characterization; handle locking; burst pressure; histopathology; seal quality; tissue sticking; Cleaning: protein, and carbohydrates; Biocompatibility: sensitization, irritation; pyrogenicity, and acute
systemic toxicity; performance qualification; sterilization validation; and product stability. |
| Conclusion | Based on comparisons of the indications for use, intended use,
technological characteristics, and performance data to the predicate
devices, Medline ReNewal reprocessed Medline ReNewal LigaSure Impact,
Curved, Large Jaw, Open Sealer/Divider (LF4318) is substantially
equivalent to the predicate devices. |
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Image /page/6/Picture/0 description: The image contains the Medline Renewal logo. The Medline logo is a blue star-like shape with the word "MEDLINE" in blue letters next to it. To the right of the Medline logo is the word "Renewal" in green and blue letters, with the words "Full Circle Reprocessing" in gray letters below it.
Predicate and Medline ReNewal Reprocessed LigaSure Impact Curved, Large Jaw Sealer/Divider (LF4318) device Table 1: comparison chart.
| Predicate | Proposed | Comparison | |
|---|---|---|---|
| Device | |||
| Characteristics | Covidien LigaSure Impact Curved, Large Jaw | ||
| Sealer/Divider | Medline ReNewal LigaSure Impact Curved, | ||
| Large Jaw Sealer/Divider | Same device; | ||
| different | |||
| manufacturer | |||
| Predicate 510(k) | K123444 | TBD | N/A |
| Model Numbers | LF4318 | LF4318 | N/A |
| Intended | |||
| Use/Indications for | |||
| Usea | The Covidien LigaSure Impact Curved Large Jaw, | ||
| Open Sealer/Divider is a dedicated bipolar | |||
| electrosurgical instrument intended for use in | |||
| open surgical procedures where ligation and | |||
| division of vessels is desired. The LF4318 is | |||
| intended to be used with the ForceTriad energy | |||
| platform to cut and seal vessels, and to cut, grasp | |||
| and dissect tissue during surgery. | |||
| The indications for use include open procedures | |||
| (general, urologic, vascular, thoracic, and | |||
| gynecological) where ligation and division of | |||
| vessels is performed. These procedures include | |||
| vaginal hysterectomies, Nissen fundoplication, | |||
| colectomy, adhesiolysis, oophorectomy, etc. The | |||
| LigaSure Impact 4318 can be used on vessels | |||
| (arteries veins, pulmonary vasculature, and | |||
| lymph) up to and including 7 mm and tissue | |||
| bundles. | The reprocessed Medline ReNewal LigaSure | ||
| Impact Curved Large Jaw, Open Sealer/Divider is | |||
| a dedicated bipolar electrosurgical instrument | |||
| intended for use in open surgical procedures | |||
| where ligation and division of vessels is desired. | |||
| The LF4318 is intended to be used with the | |||
| ForceTriad energy platform to cut and seal | |||
| vessels, and to cut, grasp and dissect tissue | |||
| during surgery. | |||
| The indications for use include open procedures | |||
| (general, urologic, vascular, thoracic, and | |||
| gynecological) where ligation and division of | |||
| vessels is performed. These procedures include | |||
| vaginal hysterectomies, Nissen fundoplication, | |||
| colectomy, adhesiolysis, oophorectomy, etc. The | |||
| LigaSure Impact 4318 can be used on vessels | |||
| (arteries veins, pulmonary vasculature, and | |||
| lymph) up to and including 7 mm and tissue | |||
| bundles. | Same |
7
Image /page/7/Picture/0 description: The image shows the Medline Renewal logo. The word "Renewal" is in large font, with "Re" in green and "newal" in blue. Below "Renewal" is the phrase "Full Circle Reprocessing" in a smaller, blue font. To the left of the text is the Medline logo, which is a blue star-like shape with the word "MEDLINE" in blue letters next to it.
Table 1: Predicate and Medline ReNewal Reprocessed LigaSure Impact Curved, Large Jaw Sealer/Divider (LF4318) device comparison chart (concluded).
| Device
| Characteristics | Predicate | Proposed | Comparison |
|---|---|---|---|
| Covidien LigaSure Impact Curved, Large Jaw | |||
| Sealer/Divider | Medline ReNewal LigaSure Impact Curved, | ||
| Large Jaw Sealer/Divider | Same device; | ||
| different | |||
| manufacturer | |||
| Intended | |||
| Use/Indications for | |||
| Use (concluded)a | 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. | 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. | Same | ||
| Power Platform | ForceTriad Electrosurgical Generator running | ||
| software version 3.50 or higher.b | ForceTriad Electrosurgical Generator running | ||
| software version 3.50 or higher.b | Same | ||
| Technological | |||
| Characteristics | The LigaSure Impact Curved Large Jaw, Open | ||
| Sealer/Divider uses bipolar energy to seal and | |||
| divide vessels up to and including 7 mm in | |||
| diameter. | The LigaSure Impact Curved Large Jaw, Open | ||
| Sealer/Divider uses bipolar energy to seal and | |||
| divide vessels up to and including 7 mm in | |||
| diameter. | Same | ||
| a Intended Use and Indications for Use were the same category in the K123444 predicate. | |||
| b ForceTriad generator was cleared under K070162: It will not be reprocessed, and it is not part of this submission. |