(41 days)
No
The description focuses on electrosurgical energy delivery and mechanical actions (jaw opening/closing, knife activation) and does not mention any AI/ML components or functions. The performance studies listed are standard tests for electrosurgical devices and do not indicate AI/ML evaluation.
Yes
Explanation: The device is used in surgical procedures to ligate (seal) and divide (cut) vessels, tissue bundles, and lymphatics, which are therapeutic interventions.
No
The device is described as a bipolar electrosurgical instrument designed for sealing and dividing vessels, tissue bundles, and lymphatics during surgical procedures. Its function is to perform a surgical action (ligation and division), not to diagnose a condition.
No
The device description clearly states it is a "hand-held bipolar electrosurgical instrument" with physical components like jaws, controls, and a knife, 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 surgical procedures to ligate and divide vessels, tissue bundles, and lymphatics. This is a surgical intervention, not a diagnostic test performed in vitro (outside the body).
- Device Description: The description details a hand-held electrosurgical instrument that uses RF energy to seal and cut tissue during surgery. This aligns with a surgical tool, not a diagnostic device.
- Lack of Diagnostic Function: There is no mention of the device being used to analyze samples (blood, tissue, etc.) or provide diagnostic information about a patient's condition.
IVD devices are used to examine specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes. This device performs a surgical function on the body.
N/A
Intended Use / Indications for Use
The Medline ReNewal Reprocessed LigaSure Maryland Jaw Sealer/Divider is a bipolar electrosurgical instrument intended for use in minimally invasive or open surgical procedures where ligation of vessels, tissue bundles, and lymphatics is desired. The LigaSure Sealer/Divider can be used on vessels (atteries and veins) up to and including 7 mm. It is indicated for use in general surgery and such surgical specialties as urologic, vascular, thoracic, and gynecologic. Procedures may include, but are not limited to, Nissen fundoplication, colectomy, adhesiolysis, hysterectomy, oophorectomy, etc.
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.
Product codes (comma separated list FDA assigned to the subject device)
NUJ
Device Description
The Medline ReNewal Reprocessed LigaSure Maryland Jaw Sealer/Dividers (models LF1723, LF1737 and LF1744) are sterile, single-use, hand-held bipolar electrosurgical instruments designed for use with the Covidien electrosurgical generators to ligate (seal) and divide (cut) vessels, tissue bundles and lymphatics during open and minimally invasive general surgical procedures using radio frequency (RF) energy. A hand actuated mechanism allows the user to open and close the instrument jaws. When the instrument jaws are correctly placed over tissue or vessel to be sealed, the user operates a second control to initiate delivery of bipolar energy, which seals the tissue. When the sealing cycle is complete, the user operates a separate control to activate a knife, which divides the tissue along the seal line.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
vessels, tissue bundles, lymphatics
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Minimally invasive or open surgical procedures, general surgery, urologic, vascular, thoracic, and gynecologic surgical specialties.
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 60601-2-2 and 60601-1-2; simulated use; device integrity; blade trigger advance/return; activation button device recognition; thermal analysis characterization; tissue sticking; burst pressure; histopathology; seal quality; Cleaning: protein, and carbohydrates; Biocompatibility: cytotoxicity 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/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: a symbol on the left and the FDA acronym with the agency's name on the right. The symbol on the left is a stylized representation of the Department of Health & Human Services seal. To the right of the seal is the acronym "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue text.
October 31, 2018
Surgical Instrument Service and Savings Inc (dba Medline ReNewal) Ms. Stephanie Boyle Mays Senior Regulatory Specialist. Quality Assurance and Regulatory Affairs 1500 NE Hemlock Ave. Redmond, Oregon 97756
Re: K182588
Trade/Device Name: Medline ReNewal Reprocessed LigaSure Maryland Jaw Sealer/Dividers (Model # LF1723, LF 1737, and LF1744) Regulation Number: 21 CFR 878.4400 Regulation Name: Electrosurgical Cutting and Coagulation Device and Accessories Regulatory Class: Class II Product Code: NUJ Dated: September 18, 2018 Received: September 20, 2018
Dear Ms. Mays:
We have reviewed vour 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. 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 located 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.
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
1
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 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/CombinationProducts/GuidanceRegulatoryInformation/ucm597488.html; 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 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
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 comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). 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 (http://www.fda.gov/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 Long H. Chen Lona H. Chen=S -2 Date: 2018.10.31 17:43:50 -04'00' 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
Indications for Use
510(k) Number (if known) K182588
Device Name
Medline ReNewal Reprocessed LigaSure Maryland Jaw Sealer/Dividers (LF1723, LF1737, LF1744)
Indications for Use (Describe)
The Medline ReNewal Reprocessed LigaSure Maryland Jaw Sealer/Divider is a bipolar electrosurgical instrument intended for use in minimally invasive or open surgical procedures where ligation of vessels, tissue bundles, and lymphatics is desired. The LigaSure Sealer/Divider can be used on vessels (atteries and veins) up to and including 7 mm. It is indicated for use in general surgery and such surgical specialties as urologic, vascular, thoracic, and gynecologic. Procedures may include, but are not limited to, Nissen fundoplication, colectomy, adhesiolysis, hysterectomy, oophorectomy, etc.
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)
| ☑ Prescription Use (Part 21 CFR 801 Subpart D) |
|---|
| □ Over-The-Counter Use (21 CFR 801 Subpart C) |
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3
| Device Model | Device Name | Original
Manufacturer |
|--------------|------------------------------------------------------------------------------------|--------------------------|
| LF1723 | Maryland Jaw Sealer Divider
(13-mm jaw and 5-mm diameter x 23-cm
long shaft) | Covidien |
| LF1737 | Maryland Jaw Sealer Divider
(13-mm jaw and 5-mm diameter x 37-cm
long shaft) | Covidien |
| LF1744 | Maryland Jaw Sealer Divider
(13-mm jaw and 5-mm diameter x 44-cm
long shaft) | Covidien |
Reprocessed Single-Use Device Model Included in Submission:
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Image /page/4/Picture/1 description: The image shows the logo for Medline Renewal Full Circle Reprocessing. The Medline logo is on the left side of the image and consists of a blue square with a white cross and the word "MEDLINE" in white letters. To the right of the Medline logo is the word "Renewal" in green letters, and below that is the phrase "Full Circle Reprocessing" in smaller, blue letters.
K182588 510(k) 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 • E: smays@medline.com | |
| Date Prepared | October 29 2018 | |
| Device Name
and
Classification | Proprietary/Trade Name: | Medline ReNewal Reprocessed LigaSure Maryland
Jaw Sealer/Dividers models LF1723, LF1737, and
LF1744 |
| | Common or Usual Name | Bipolar electrosurgical instrument |
| | Regulatory Name/Reference | Electrosurgical cutting and coagulation device and
accessories reprocessed, 21 CFR § 878.4400 |
| | Regulatory Class | Class II |
| | Product Code | NUJ |
| | Panel | General & Plastic Surgery |
| | 510(k) Number | K141153 |
| Predicate
Device | Proprietary or Trade Name | LigaSure Maryland Jaw One Step Sealer/Dividers
models LF1723, LF1737, and LF1744 |
| | Common or Usual Name | Bipolar electrosurgical instrument |
| | Regulatory Name/Reference | Electrosurgical cutting and coagulation device and
accessories reprocessed, 21 CFR § 878.4400 |
| | Regulatory Class | Class II |
| | Product Code | GEI |
| | Panel | General & Plastic Surgery |
| | Manufacturer | Covidien
5920 Longbow Dr., Boulder, CO 80301 |
| Device
Description | The Medline ReNewal Reprocessed LigaSure Maryland Jaw
Sealer/Dividers (models LF1723, LF1737 and LF1744) are sterile, single-
use, hand-held bipolar electrosurgical instruments designed for use with the
Covidien electrosurgical generators to ligate (seal) and divide (cut) vessels,
tissue bundles and lymphatics during open and minimally invasive general
surgical procedures using radio frequency (RF) energy. A hand actuated
mechanism allows the user to open and close the instrument jaws. When
the instrument jaws are correctly placed over tissue or vessel to be sealed,
the user operates a second control to initiate delivery of bipolar energy,
which seals the tissue. When the sealing cycle is complete, the user
operates a separate control to activate a knife, which divides the tissue
along the seal line. | |
| Indications for
use | The Medline ReNewal Reprocessed LigaSure Maryland Jaw Sealer/Divider
is a bipolar electrosurgical instrument intended for use in minimally invasive
or 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 such surgical specialties as
urologic, vascular, thoracic, and gynecologic. Procedures may include, but
are not limited to, Nissen fundoplication, colectomy, cholecystectomy,
adhesiolysis, hysterectomy, oophorectomy, etc.
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. K141153
LigaSure Maryland Jaw Sealer/Divider 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 60601-2-2 and 60601-1-2; simulated use; device integrity; blade trigger advance/return; activation button device recognition; thermal analysis characterization; tissue sticking; burst pressure; histopathology; seal quality; Cleaning: protein, and carbohydrates; Biocompatibility: cytotoxicity sensitization, irritation; pyrogenicity, and acute systemic toxicity; performance qualification; sterilization validation; and product stability | |
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Image /page/5/Picture/1 description: The image shows the Medline Renewal logo. The Medline logo is on the left side of the image and is a blue square with a white cross and the word "MEDLINE" in white letters. To the right of the Medline logo is the word "Renewal" in green and blue letters. Below the word "Renewal" is the phrase "Full Circle Reprocessing" in blue letters.
The generators are not reprocessed by Medline ReNewal.
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Image /page/6/Picture/0 description: The image contains the Medline Renewal Full Circle Reprocessing logo. The Medline logo is on the left, followed by the word Renewal in green and blue. Below that is the phrase "Full Circle Reprocessing" in a smaller font.
| Predicate | Proposed | Comparison | |
|---|---|---|---|
| Device | |||
| Characteristics | Covidien LigaSure Maryland | ||
| Jaw One Step Sealer/Divider | Medline ReNewal LigaSure | ||
| Maryland Jaw Sealer/Divider | As Stated | ||
| 510(k) | K141153 | TBD | N/A |
| Model Numbers | LF1723, LF1737, and LF1744 | LF1723, LF1737, and LF1744 | Same |
| Common Name | Bipolar electrosurgical | ||
| instrument | Bipolar electrosurgical | ||
| instrument | Same | ||
| Regulation No. | 21 CFR § 878.4400 | 21 CFR § 878.4400 | Same |
| Regulatory Class | Class II | Class II | Same |
| Product Code | GEI | NUJ | As stated |
| Indications for | |||
| Use | The LigaSure Sealer/Divider is | ||
| a bipolar electrosurgical | |||
| instrument intended for use in | |||
| minimally invasive or 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 such | |||
| surgical specialties as | |||
| urologic, vascular, thoracic, | |||
| and gynecologic. Procedures | |||
| may include, but are not | |||
| limited to, Nissen | |||
| fundoplication, colectomy, | |||
| cholecystectomy, | |||
| adhesiolysis, hysterectomy, | |||
| oophorectomy, etc. | |||
| 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 | ||
| Reprocessed LigaSure | |||
| Maryland Jaw Sealer/Divider | |||
| is a bipolar electrosurgical | |||
| instrument intended for use in | |||
| minimally invasive or 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 such | |||
| surgical specialties as | |||
| urologic, vascular, thoracic, | |||
| and gynecologic. Procedures | |||
| may include, but are not | |||
| limited to, Nissen | |||
| fundoplication, colectomy, | |||
| cholecystectomy, | |||
| adhesiolysis, hysterectomy, | |||
| oophorectomy, etc. | |||
| 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 | ||
| Predicate | Proposed | Comparison | |
| Device | |||
| Characteristics | Covidien LigaSure | ||
| Maryland Jaw One Step | |||
| Sealer/Divider | Medline ReNewal LigaSure | ||
| Maryland Jaw | |||
| Sealer/Divider | As stated | ||
| Power Platforma | • LF1723 = ForceTriad SW | ||
| v3.6 or higher. | |||
| • LF1737 = VL FT10 GEN | |||
| SW v1.0 or higher | |||
| • LF1744 = VL LS10 GEN | |||
| SW v1.0 or higher | • LF1723 = ForceTriad SW | ||
| v3.6 or higher.b | |||
| • LF1737 = VLFT10GEN SW | |||
| v1.0 or higher | |||
| • LF1744 = VLLS10GEN SW | |||
| v1.0 or higher | Same | ||
| Technological | |||
| Characteristics | The LigaSure Maryland Jaw | ||
| One Step Sealer/Divider uses | |||
| bipolar RF energy to seal and | |||
| divide vessels up to and | |||
| including 7 mm in diameter. | The LigaSure Maryland Jaw | ||
| One Step Sealer/Divider uses | |||
| bipolar RF energy to seal and | |||
| divide vessels up to and | |||
| including 7 mm in diameter. | Same | ||
| aForceTriad generator was cleared under K070162; VL FT10 generator was cleared under | |||
| K151649; and the VL LS10 generator was cleared under K143654. None of the generators | |||
| will be reprocessed by Medline ReNewal. They are not a part of this submission. | |||
| Conclusion | Based on comparisons of the indications for use, intended use, technological | ||
| characteristics, and performance data to the predicate devices, Medline | |||
| ReNewal Reprocessed LigaSure Maryland Jaw Sealer/Divider models | |||
| LF1723, LF1737, and LF1744 are substantially equivalent to the predicate | |||
| devices. |
Summary Table: Predicate and Medline ReNewal Reprocessed LigaSure Maryland Jaw Open Sealer/Divider device comparison chart.
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Image /page/7/Picture/0 description: The image shows the Medline Renewal logo. The Medline logo is on the left side of the image and consists of a blue square with a white star and the word "MEDLINE" in white letters. The Renewal logo is on the right side of the image and consists of the word "Renewal" in green and blue letters, with the words "Full Circle Reprocessing" in smaller blue letters below it. The Renewal logo also has a trademark symbol.
K182588 Medline ReNewal