(255 days)
Not Found
No
The document describes a reprocessed electrosurgical instrument for vessel sealing and cutting using RF energy. There is no mention of AI or ML in the intended use, device description, or performance studies.
No
The device is a bipolar electrosurgical instrument used for sealing and dividing tissue during surgical procedures, not for therapeutic treatment. Its purpose is to perform surgical actions (ligation and division), which are interventions, not therapies.
No
Explanation: The device is an electrosurgical instrument designed for sealing and dividing vessels and tissue during surgical procedures, not for diagnostic purposes. Its intended use is to perform therapeutic actions, not to identify or characterize diseases or conditions.
No
The device description clearly states it is a "handle-held bipolar vessel sealing device" and describes physical components like jaws and an activation button, indicating it is a hardware device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostic devices are used to examine specimens (like blood, urine, or tissue) taken from the human body to provide information about a person's health. This testing is performed outside of the body (in vitro).
- Device Function: The Medline ReNewal Reprocessed LigaSure Sealer/Divider is a surgical instrument used during surgical procedures on the patient's body. It uses electrosurgical energy to seal and divide vessels and tissues.
- Intended Use: The intended use clearly describes its application in open surgical procedures for ligation and division of vessels and tissues within the body.
The device's function and intended use are entirely focused on surgical intervention within the body, not on analyzing samples taken from the body.
N/A
Intended Use / Indications for Use
The Medline ReNewal Reprocessed LigaSure Sealer/Divider is a bipolar electrosurgical instrument intended for use in open surqical procedures where ligation of vessels, tissue bundles, and lymphatics is desired. The LigaSure Sealer/Divider can be used on vessels (arteries and veins) up to and including 7 mm. It is indicated for use in general surgery and in such surgical specialties as urologic, thoracic, plastic, and reconstructive. Procedures may include, but are not limited to, bowel resections, gall bladder procedures, Nissen fundoplication, and adhesiolysis. The instrument is also indicated for open ENT procedures in adults (thyroidectomy, radical neck dissection, parotidectorny, and tonsillectomy) for ligation and division of vessels. Ivmphatics and tissue bundles 2-3 mm away from unintended thermally-sensitive structures such as nerves and parathyroid glands.
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, GEI
Device Description
The Medline ReNewal Remanufactured LigaSure Exact Dissector, Nano-coated (LF2019) device is a sterile, single-use, handle-held bipolar vessel sealing device designed for use with compatible Covidien electrosurgical generators that include vessel sealing capabilities to ligate (seal) and divide (cut) vessels, tissue bundles, and lymphatics clamped between the jaws, grasp tissue, and perform blunt dissection during general surgical procedures (as indicated) using radio frequency (RF) energy. A hemostat style body allows the user to open or close the instrument jaws during vessel sealing and cutting, with a single activation button incorporated into the body of the device.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
vessels, tissue bundles, lymphatics, bowel, gall bladder, ENT (thyroidectomy, radical neck dissection, parotidectomy, tonsillectomy)
Indicated Patient Age Range
Adults (for ENT procedures)
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 subject device have been evaluated and found to be substantially equivalent to the predicate device based on the following tests:
Functional performance: simulated use and artificial soiling; visual inspection; device functionality; in vivo acute and chronic animal studies Electrical Safety Cleaning Validation: Biocompatibility: Sterilization Validation Packaging and shelf life validation; bioburden testing; and ethylene oxide and ethylene chlorohydrin residuals testing 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.
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
Image /page/0/Picture/0 description: The image shows the logo for the U.S. Food and Drug Administration (FDA). On the left is the Department of Health and Human Services logo. To the right of that is the FDA logo, with the letters "FDA" in a blue box. Underneath that is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
April 29, 2024
Surgical Instrument Service and Savings Inc. Stephanie Boyle Mays Senior Regulatory Affaiirs Specialst, QA/RA (dba Medline ReNewal) 1500 NE Hemlock Ave. Redmond, Oregon 97756
Re: K232511
Trade/Device Name: Medline ReNewal Reprocessed LigaSure Exact Dissector, Nano-coated (LF2019) Regulation Number: 21 CFR 878.4400 Regulation Name: Electrosurgical Cutting And Coagulation Device And Accessories Regulatory Class: Class II Product Code: NUJ, GEI Dated: August 17, 2023 Received: August 18, 2023
Dear Stephanie Boyle Mays:
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 (the 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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database available at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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.
Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device"
1
(https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download).
Your device is also subject to, among other requirements, the Quality System (QS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30. Design controls; 21 CFR 820.90. Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review, the OS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181).
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 device-related adverse events) (21 CFR Part 803) for devices or postmarketing safety reporting (21 CFR Part 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely. Digitally signed by Mark Mark Trumbore -S Trumbore -S Date: 2024.04.29 Mark Trumbore, Ph.D. Assistant Director, THT4A1: Robotically-Assisted Surgical Devices Team DHT4A: Division of General Surgery Devices OHT4: Office of Surgical and Infection Control Devices Office of Product Evaluation and Quality
2
Center for Devices and Radiological Health
Enclosure
3
Indications for Use
Submission Number (if known)
232511
Device Name
Medline ReNewal Remanufactured LigaSure Exact Dissector, without Nano-coating (LF2019)
Indications for Use (Describe)
The Medline ReNewal Reprocessed LigaSure Sealer/Divider is a bipolar electrosurgical instrument intended for use in open surqical procedures where ligation of vessels, tissue bundles, and lymphatics is desired. The LigaSure Sealer/Divider can be used on vessels (arteries and veins) up to and including 7 mm. It is indicated for use in general surgery and in such surgical specialties as urologic, thoracic, plastic, and reconstructive. Procedures may include, but are not limited to, bowel resections, gall bladder procedures, Nissen fundoplication, and adhesiolysis. The instrument is also indicated for open ENT procedures in adults (thyroidectomy, radical neck dissection, parotidectorny, and tonsillectomy) for ligation and division of vessels. Ivmphatics and tissue bundles 2-3 mm away from unintended thermally-sensitive structures such as nerves and parathyroid glands.
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.
Type of Use (Select one or both, as applicable)
Prescription Use (Part 21 CFR 801 Subpart D)
Over-The-Counter Use (21 CFR 801 Subpart C)
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Image /page/4/Picture/0 description: The image shows the Medline Renewal logo. On the left is the Medline logo, which is a blue square with a white cross inside. To the right of the Medline logo is the word "Renewal" in large, green and blue letters. Below the word "Renewal" is the phrase "Full Circle Reprocessing" in smaller, blue letters.
510(k) 232511 Summary
This 510(k) summary of safety and effectiveness information is prepared in accordance with 21 CFR § 807.92.
| Submitter/
Owner | Surgical Instrument Service and Savings (dba Medline ReNewal)
1500 NE Hemlock Ave., Redmond, OR 97756 | | |
|--------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------|--|
| Contact/
Prepared by | Stephanie Boyle Mays
Senior Regulatory Affairs Specialist, Quality Assurance/Regulatory Affairs
P: 541-516-4205 • F: 541-923-3375 • smays@medline.com | | |
| Date Prepared | August 17, 2023 | | |
| Device Name
and
Classification | Proprietary/Trade
Name: | Medline ReNewal Remanufactured LigaSure Exact
Dissector, without Nano-coating | |
| | Common or Usual
Name | Bipolar sealing device | |
| | Regulatory
Name/Reference | Electrosurgical, cutting & coagulation & accessories
21 CFR § 878.4400 | |
| | Regulatory Class | 2 | |
| | Product Code | GEI | |
| | Panel | General & Plastic Surgery | |
| | 510(k) Number | K202917 | |
| Predicate
Device | Proprietary or
Trade Name | LigaSure Exact Dissector, Nano-coated | |
| | Common or Usual
Name | Bipolar sealing device | |
| | Regulatory
Name/Reference | Electrosurgical, cutting & coagulation & accessories
21 CFR § 878.4400 | |
| | Regulatory Class | 2 | |
| | Product Code | GEI | |
| | Panel | General & Plastic Surgery | |
| | Manufacturer | Covidien LLC, 5920 Longbow Dr., Boulder, CO 80301 | |
| Device
Description | The Medline ReNewal Remanufactured LigaSure Exact Dissector, Nano-
coated (LF2019) device is a sterile, single-use, handle-held bipolar vessel
sealing device designed for use with compatible Covidien electrosurgical
generators that include vessel sealing capabilities to ligate (seal) and divide
(cut) vessels, tissue bundles, and lymphatics clamped between the jaws,
grasp tissue, and perform blunt dissection during general surgical
procedures (as indicated) using radio frequency (RF) energy.
A hemostat style body allows the user to open or close the instrument jaws
during vessel sealing and cutting, with a single activation button
incorporated into the body of the device. | | |
| Technological
Characteristics | The technological characteristics, materials, and the fundamental scientific
technology of the subject device is equivalent to the predicate device. The
proposed device is a reprocessed version of the predicate device. K202917
LigaSure Exact Dissector, Nano-coated was used as the primary predicate
to support intended use, technological characteristics, and functional
performance specifications. | | |
| | The original equipment manufacturer of the LigaSure Exact Dissector,
Nano-coated applied a nano-coating to the device jaws to reduce tissue
sticking. Medline ReNewal does not replace the coating on the device jaws
in its process of decontamination, inspections, packaging and sterilization. | | |
| Non-clinical
Testing
Summary | The functional characteristics of the subject device have been evaluated
and found to be substantially equivalent to the predicate device based on
the following tests:
Functional performance: simulated use and artificial soiling; visual inspection; device functionality; in vivo acute and chronic animal studies Electrical Safety Cleaning Validation: Biocompatibility: Sterilization Validation Packaging and shelf life validation; bioburden testing; and ethylene oxide and ethylene chlorohydrin residuals testing Product stability | | |
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Image /page/5/Picture/0 description: The image contains the logo for Medline Renewal Full Circle Reprocessing. The Medline logo is on the left and consists of a blue square with a white cross inside and the word "MEDLINE" below the cross. To the right of the Medline logo is the word "Renewal" in large, bold, green and blue letters. Below "Renewal" is the phrase "Full Circle Reprocessing" in smaller, black letters.
Product stability
Summary Table: Predicate and Medline ReNewal Reprocessed LigaSure Exact Dissector, Nano-coated comparison chart.
| Predicate | Proposed | Comparison | |
|---|---|---|---|
| View | Covidien LigaSure Exact | ||
| Dissector, Nano-coated | Medline ReNewal | ||
| Remanufactured LigaSure | |||
| Exact Dissector, without | |||
| Nano-coating | As Stated | ||
| 510(k) | K202917 | K232511 | N/A |
| Model Number | LF2019 | LF2019 | As stated |
| Common Name | Bipolar sealing device | Bipolar sealing device, | Same |
| Regulation No. | 21 CFR § 878.4400 | 21 CFR § 878.4400 | Same |
| Regulatory | |||
| Class | 2 | 2 | Same |
| Product Code | GEI | GEI | Same |
| Indications for | |||
| Use | LigaSure Sealer/Divider is a | ||
| bipolar electrosurgical | |||
| instrument intended for use in | |||
| open surgical procedures | |||
| where ligation and division of | |||
| vessels, tissue bundles, and | |||
| lymphatics is desired. The | |||
| LigaSure Sealer/ Divider can | |||
| be used on vessels (arteries | |||
| and veins) up to and including | |||
| 7 mm. It is indicated for use in | |||
| general surgery and in such | |||
| surgical specialties as | |||
| urologic, thoracic, plastic, and | |||
| reconstructive. Procedures | |||
| may include, but are not | |||
| limited to, bowel resections, | |||
| gall bladder procedures, | |||
| Nissen fundoplication, breast | |||
| procedures, and adhesiolysis. | |||
| The instrument is also | |||
| indicated for open ENT | |||
| procedures in adults | |||
| (thyroidectomy, radical neck | |||
| dissection, parotidectomy, and | |||
| tonsillectomy) for ligation and | |||
| division of vessels, lymphatics | |||
| and tissue bundles 2-3 mm | |||
| away from unintended | |||
| thermally-sensitive structures | |||
| such as nerves and | |||
| parathyroid glands. | |||
| 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 Medline ReNewal | ||
| Remanufactured LigaSure | |||
| Sealer/Divider is a bipolar | |||
| electrosurgical instrument | |||
| intended for use in open | |||
| surgical procedures where | |||
| ligation and division of | |||
| vessels, tissue bundles, and | |||
| lymphatics is desired. The | |||
| LigaSure Sealer/ Divider can | |||
| be used on vessels (arteries | |||
| and veins) up to and including | |||
| 7 mm. It is indicated for use in | |||
| general surgery and in such | |||
| surgical specialties as | |||
| urologic, thoracic, plastic, and | |||
| reconstructive. Procedures | |||
| may include, but are not | |||
| limited to, bowel resections, | |||
| gall bladder procedures, | |||
| Nissen fundoplication, and | |||
| adhesiolysis. | |||
| The instrument is also | |||
| indicated for open ENT | |||
| procedures in adults | |||
| (thyroidectomy, radical neck | |||
| dissection, parotidectomy, and | |||
| tonsillectomy) for ligation and | |||
| division of vessels, lymphatics | |||
| and tissue bundles 2-3 mm | |||
| away from unintended | |||
| thermally-sensitive structures | |||
| such as nerves and | |||
| parathyroid glands. | |||
| 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 | ||
| Technological | |||
| Characteristics | To operate, the device is | ||
| connected to a compatible | |||
| generator and is operated by | |||
| either a hand or a food switch. | To operate, the device is | ||
| connected to a compatible | |||
| generator and is operated by | |||
| either a hand or a food switch. | Same |
6
Image /page/6/Picture/0 description: The image contains two logos. The first logo is a blue square with a white star-like shape in the center and the word "MEDLINE" written in white below the shape. The second logo is the word "ReNewal" in green and blue, with the words "Full Circle Reprocessing" written in smaller font below it.
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Image /page/7/Picture/0 description: The image shows the logo for "ReNewal Full Circle Reprocessing". The word "ReNewal" is in a large font, with "Re" in green and "Newal" in blue. Below that is the phrase "Full Circle Reprocessing" in a smaller font. To the left of the text is the Medline logo, which consists of the word "MEDLINE" in blue, next to a blue symbol that looks like a stylized star or compass.
| a Neither K202917 nor the current submission included the generators as part of their
| respective submissions. Only device LF2019 is included in the project scope. | |
|---|---|
| Conclusion | The predicate and proposed devices in this application have the same |
| indications for use and technological characteristics. Based on this and the | |
| non-clinical testing data presented in this 510(k) submission, the Medline | |
| ReNewal Remanufactured LigaSure Exact Dissector, without Nano-coating | |
| device model LF2019 is substantially equivalent to the predicate device. |