(132 days)
No
The document describes a standard electrosurgical vessel sealing device that uses RF energy. There is no mention of AI, ML, image processing, or any other technology typically associated with AI/ML in medical devices. The performance studies focus on traditional benchtop, ex-vivo, and in-vivo testing, not AI/ML model validation.
Yes
The device is intended for the "ligation and division of tissue bundles, lymphatics, and vessels" within the human body, specifically used in various surgical procedures, which constitutes a therapeutic action.
No
Explanation: The device is a vessel sealer used for ligation and division of tissues and vessels, which are surgical functions, not diagnostic ones.
No
The device description explicitly states it is a "sterile, single use bipolar vessel sealing hand piece" and creates a seal by applying "radio frequency (RF) electrosurgical energy," 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 diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections.
- Device Function: The CONMED CleanSeal Vessel Sealer is a surgical instrument used during surgical procedures to seal and divide tissue and vessels within the body. It uses radio frequency energy to create a seal.
- Intended Use: The intended use clearly describes surgical procedures performed on patients, not laboratory testing of samples.
The device is an electrosurgical instrument used for therapeutic purposes during surgery, not for diagnostic testing of samples outside the body.
N/A
Intended Use / Indications for Use
CONMED CleanSeal Vessel Sealers are intended to be used in open and mimimally invasive procedures for the ligation and division of tissue bundles, lymphatics, and vessels up to and including 6 mm vessels (arteries, veins, pulmonary arteries, pulmonary veins). The handpiece is indicated for use in gynecological and general surgical procedures, including urologic, thoracic, and vascular. These procedures include, but are not limited to, hysterectomies, colectomies, Nissen fundoplication, and adhesiolysis. CleanSeal vessel sealer has not been shown to be effective for ubal sterilization or tubal coagulation for sterilization procedures. Do not use CleanSeal vessel sealer for these procedures.
Product codes (comma separated list FDA assigned to the subject device)
GEI
Device Description
CleanSeal Advanced Bipolar Vessel Sealer Maryland is designed to be used, with a compatible MEP-1 electrosurqical generator, in open and minimally invasive procedures for the ligation and division of tissue bundles, lymphatics, and vessels up to and including 6 mm arteries and veins. They are sterile, single use bipolar vessel sealing hand pieces featuring double action non-stick coated jaws, three shaft length options, a one-hand controlled handle with latchable lever. The instrument creates a seal by application of radio frequency (RF) electrosurgical energy to vascular structures or tissue bundles interposed between the jaws.
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)
CleanSeal Advanced Bipolar Vessel Sealers Maryland have been tested according to the applicable requirements listed in FDA guidance "Premarket Notification (510(k)) Submissions for Electrosurgical Devices for General Surgery" and "Premarket Notification (510(k)) Submissions for Bipolar Electrosurgical Vessel Sealers for General Surgery". Benchtop and ex-vivo comparison testing, in-vivo simulated use testing, and chronic animal studies support that the CleanSeal Maryland is substantially equivalent to the Ligasure Maryland Jaw nano-coated (primary predicate), Ligasure Maryland Jaw thoracic nano-coated (secondary predicate) and the CleanSeal Vessel Sealer 5mm (reference device) in intended use, technology, and system performance.
Mechanical and electrical verification activities demonstrate the CleanSeal Advanced Bipolar Vessel Sealers Maryland complies with the applicable sections of AAMI/ANSI ES60601-1, IEC 60601-2-2 and 60601-2-18 . Risk management activities in accordance with ISO 14971 demonstrate the risks associated with the use of CleanSeal Maryland is mitigated to an acceptable level. Analyses of these activities conclude the benefits associated with the use of the CleanSeal Maryland outweigh the residual risks.
Biocompatibility Test - The CleanSeal Advanced Bipolar Vessel Sealer Marylance with 2020 FDA Guidance of Use of International Standard ISO 10993-1, "Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process". The biological test results support that the CleanSeal Maryland met acceptance criteria for all biocompatibility test endpoints.
A chronic animal study was conducted according to FDA guidance, "Premarket Notification (510(k)) Submissions for Bipolar Electrosurgical Vessel Sealers for General Surgery" Guidance for Industry and Food and Drug Administration Staff, issued on August 15, 2016; and "Premarket Notification (510(k)) Submissions for Electrosurgical Devices for General Surgery" Guidance for Industry and Food and Drug Administration Staff, issued on March 9, 2020. The first test evaluated, in a porcine model, the performance of the CleanSeal Maryland with MEP-1 (Test system) in comparison to the LigaSure Maryland with Nanocoating and Valleylab FT10 ESU. (Primary predicate). After 21 days in the porcine model, the treatment of vascular structures (i.e., arteries, veins, and arterio-venous [AV] bundles) with the test system was determined to result in the effective sealing of treated vessels. The second test evaluated, in a canine model, the performance of the CleanSeal Maryland with MEP-1 (Test system) in comparison to the LigaSure Maryland thoracic with Nanocoating and Valleylab FT10 ESU, (Secondary predicate). After 21 days in the canine model, the treatment of vascular structures in the thoracic cavity (i.e., Pulmonary arteries, veins, and arterio-venous [A/V] bundles) with the test system was determined to result in the effective sealing of treated vessels.
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.
0
Image /page/0/Picture/0 description: The image contains two logos. On the left is the Department of Health & Human Services logo. On the right is the FDA logo, which includes the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue text.
October 23, 2023
Comed Corporation Ali Abusaleh Senior Regulatory Affairs Specialist 525 French Road Utica, New York 13502
Re: K231732
Trade/Device Name: CleanSeal Advanced Bipolar Vessel Sealer Maryland Regulation Number: 21 CFR 878.4400 Regulation Name: Electrosurgical Cutting And Coagulation Device And Accessories Regulatory Class: Class II Product Code: GEI Dated: September 18, 2023 Received: September 18, 2023
Dear Ali Abusaleh:
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 mediation-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.
Mark
Digitally signed by
Mark Trumbore -S
Trumbore -S Date: 2023.10.23
11:57:16-04'00'
Mark Trumbore, Ph.D. Assistant Director DHT4A: Division of General Surgery Devices OHT4: Office of Surgical and Infection Control Devices
2
Office of Product Evaluation and Quality Center for Devices and Radiological Health
3
Indications for Use
510(k) Number (if known)
Device Name
CleanSeal Advanced Bipolar Vessel Sealer Maryland
Indications for Use (Describe)
CONMED CleanSeal Vessel Sealers are intended to be used in open and mimimally invasive procedures for the ligation and division of tissue bundles, lymphatics, and vessels up to and including 6 mm vessels (arteries, veins, pulmonary arteries, pulmonary veins). The handpiece is indicated for use in gynecological and general surgical procedures, including urologic, thoracic, and vascular. These procedures include, but are not limited to, hysterectomies, colectomies, Nissen fundoplication, and adhesiolysis. CleanSeal vessel sealer has not been shown to be effective for ubal sterilization or tubal coagulation for sterilization procedures. Do not use CleanSeal vessel sealer 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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4
Section 6 - 510(k) Summary of Safety and Effectiveness
CONMED CleanSeal Advanced Bipolar Vessel Sealer Maryland
In accordance with the requirements of the Safe Medical Device Act of 1990 and 21CFR 807.92, ConMed Corporation is hereby submitting the 510(k) Summary of Safety and Effectiveness
A. Submitter
ConMed Corporation 525 French Road Utica, NY 13502
B. Company Contact
Ali AbuSaleh Senior Regulatory Affairs Specialist (708) 407-4324 Aliabusaleh@conmed.com Date prepared: 06/13/2023
C. Device Name
| Proprietary Name: | CleanSeal Advanced Bipolar Vessel Sealer Maryland |
|---|---|
| Catalog Numbers: | CS-M5-23, CS-M5-37, CS-M5-44 |
| Common Name: | Bipolar Vessel Sealing Device |
| Classification Name: | Electrosurgical cutting & coagulation device and accessories |
| Regulation Number: | 878.4400 |
| Product Code: | GEI |
| Regulatory Class: | II |
| Panel: | General and Plastic Surgery |
D. Predicate Device
| Primary Predicate | |
|---|---|
| Device Name: | LigaSure Maryland Jaw Sealer/Divider One-step Sealing, Nano-coated |
| Company Name: | Covidien LLC |
| 510(k): | K170869 |
Secondary Predicate
LigaSure Maryland Jaw Thoracic Sealer/Divider, One-step sealing Nano-coated Device Name: Covidien LLC Company Name: 510(k): K181085
Reference Device
| Device Name: | CleanSeal Vessel Sealer 5mm |
|---|---|
| Company Name: | CONMED |
| 510(k): | K213354 |
5
E. Device Description
CleanSeal Advanced Bipolar Vessel Sealer Maryland is designed to be used, with a compatible MEP-1 electrosurqical generator, in open and minimally invasive procedures for the ligation and division of tissue bundles, lymphatics, and vessels up to and including 6 mm arteries and veins. They are sterile, single use bipolar vessel sealing hand pieces featuring double action non-stick coated jaws, three shaft length options, a one-hand controlled handle with latchable lever. The instrument creates a seal by application of radio frequency (RF) electrosurgical energy to vascular structures or tissue bundles interposed between the jaws.
F. Intended Use/ Indications for Use
CONMED CleanSeal Vessel Sealers are intended to be used in open and minimally invasive procedures for the ligation and division of tissue bundles, and vessels up to and including 6 mm vessels (arteries, veins, pulmonary arteries, pulmonary veins). The handpiece is indicated for use in gynecological and general surqical procedures, including urologic, thoracic, and vascular. These procedures include, but are not limited to, hysterectomies, colectomies, Nissen fundoplication, and adhesiolysis. CleanSeal vessel sealer has not been shown to be effective for tubal sterilization or tubal coagulation for sterilization procedures. Do not use CleanSeal vessel sealer for these procedures.
G. Technological Characteristics
CleanSeal Advanced Bipolar Vessel Sealers Maryland (23cm, 37cm and 44cm) connect to the CleanSeal/Bipolar Resection port on MEP-1 via a three-prong ESU plug with a smart chip containing unique parameters specific to the handpiece model. A hand actuated lever allows the user to open or close the instrument jaws during vessel sealing and cutting. An activation button is incorporated into the body of the handle. When connected to MEP-1 and the jaws are shut, the activation button can be pressed to allow the ESU to deliver energy to the CleanSeal Maryland vessel sealer. The cut trigger allows for the transection of tissue, when the jaws are shut, through the deployment of a stainless-steel knife. A rotator knob on the handle allows for 360° rotation of the shaft to position the jaw accurately on the targeted tissue or vessel. The CleanSeal Maryland comes in three shaft lengths (23 cm, 37 cm, and 44 cm). The device is single use.
H. Performance Testing
CleanSeal Advanced Bipolar Vessel Sealers Maryland have been tested according to the applicable requirements listed in FDA guidance "Premarket Notification (510(k)) Submissions for Electrosurgical Devices for General Surgery" and "Premarket Notification (510(k)) Submissions for Bipolar Electrosurgical Vessel Sealers for General Surgery". Benchtop and ex-vivo comparison testing, in-vivo simulated use testing, and chronic animal studies support that the CleanSeal Maryland is substantially equivalent to the Ligasure Maryland Jaw nano-coated (primary predicate), Ligasure Maryland Jaw thoracic nano-coated (secondary predicate) and the CleanSeal Vessel Sealer 5mm (reference device) in intended use, technology, and system performance.
Mechanical and electrical verification activities demonstrate the CleanSeal Advanced Bipolar Vessel Sealers Maryland complies with the applicable sections of AAMI/ANSI ES60601-1, IEC 60601-2-2 and 60601-2-18 . Risk management activities in accordance with ISO 14971 demonstrate the risks associated with the use of CleanSeal Maryland is mitigated to an acceptable level. Analyses of these activities conclude the benefits associated with the use of the CleanSeal Maryland outweigh the residual risks.
6
Biocompatibility Test -
The CleanSeal Advanced Bipolar Vessel Sealer Marylance with 2020 FDA Guidance of Use of International Standard ISO 10993-1, "Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process". The biological test results support that the CleanSeal Maryland met acceptance criteria for all biocompatibility test endpoints.
J. Chronic Animal Study
A chronic animal study was conducted according to FDA guidance, "Premarket Notification (510(k)) Submissions for Bipolar Electrosurgical Vessel Sealers for General Surgery" Guidance for Industry and Food and Drug Administration Staff, issued on August 15, 2016; and "Premarket Notification (510(k)) Submissions for Electrosurgical Devices for General Surgery" Guidance for Industry and Food and Drug Administration Staff, issued on March 9, 2020. The first test evaluated, in a porcine model, the performance of the CleanSeal Maryland with MEP-1 (Test system) in comparison to the LigaSure Maryland with Nanocoating and Valleylab FT10 ESU. (Primary predicate). After 21 days in the porcine model, the treatment of vascular structures (i.e., arteries, veins, and arterio-venous [AV] bundles) with the test system was determined to result in the effective sealing of treated vessels. The second test evaluated, in a canine model, the performance of the CleanSeal Maryland with MEP-1 (Test system) in comparison to the LigaSure Maryland thoracic with Nanocoating and Valleylab FT10 ESU, (Secondary predicate). After 21 days in the canine model, the treatment of vascular structures in the thoracic cavity (i.e., Pulmonary arteries, veins, and arterio-venous [A/V] bundles) with the test system was determined to result in the effective sealing of treated vessels.
K. Shelf Life
CleanSeal Advanced Bipolar Vessel Sealer Maryland has a one-year shelf-life based on results of an accelerated aging study. The shelf-life study evaluated the device specifications and package integrity/sterile barrier. The device met all acceptance criteria to support a shelf-life of one year.
L. Substantial Equivalence
The differences between the predicate devices and the proposed device do not raise any new risks of safety or efficacy. Supporting information per this premarket submission confirms that the CleanSeal Advanced Bipolar Vessel Sealer Maryland is safe and effective for its intended use and is substantially equivalent in design, intended use, principals of operation, and technical characteristics to the LigaSure Maryland Jaw Sealer/Divider One-step Sealing, Nano-coated, LigaSure Maryland Jaw Thoracic Sealer/Divider, One-step sealing Nano-coated and CleanSeal 5mm Vessel Sealer.
7
| Features | Subject Device: CleanSeal
Advanced Bipolar Vessel Sealer
Maryland | Reference Device: CleanSeal
Vessel Sealer 5mm | Predicate Device:
LigaSure
Maryland Jaw Open
sealer/Divider, One-step sealing
Nano-coated
LF1923, LF1937 and LF1944 | Secondary Predicate:
LigaSure
Maryland Jaw Thoracic
Sealer/Divider, One-step sealing
Nano-coated
LF1930T | Comparison/
Discussion | |
|--------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------|---------------------------|
| Model
Numbers
510(k)
Intended
Use/
Indications
for Use | CS-M5-23, CS-M5-37 and CS-
M5-44
CONMED CleanSeal Vessel
Sealers are intended to be used
in open and minimally invasive
procedures for the ligation and
division of tissue bundles,
lymphatics, and vessels up to and
including 6 mm vessels (arteries,
veins, pulmonary arteries,
pulmonary veins). The handpiece
is indicated for use in
gynecological and general
surgical procedures, including
urologic, thoracic, and vascular.
These procedures include, but
are not limited to, hysterectomies,
oophorectomies, colectomies,
Nissen fundoplication, and
adhesiolysis. CleanSeal vessel
sealer has not been shown to be
effective for tubal sterilization or
tubal coagulation for sterilization
procedures. Do not use
CleanSeal vessel sealer for these
procedures. | CS-M5-23, CS-M5-37 and CS-
M5-44
CONMED CleanSeal Vessel
Sealers are intended to be used in
open and minimally invasive
procedures for the ligation and
division of tissue bundles,
lymphatics, and vessels up to and
including 7 mm vessels (arteries
and veins). The handpiece is
indicated for use in gynecological
and general surgical procedures,
including urologic, thoracic, and
vascular. These procedures
include, but are not limited to,
hysterectomies, oophorectomies,
colectomies, Nissen
fundoplication, and adhesiolysis.
CleanSeal VS has not been
shown to be effective for tubal
sterilization or tubal coagulation
for sterilization procedures. Do not
use CleanSeal VS for these
procedures. | K170869
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. | K181085
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, veins,
pulmonary arteries, pulmonary 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. | Similar | |
| | Polarity | Bipolar | Bipolar | Bipolar | Bipolar | |
| | Features | Subject Device: CleanSeal
Advanced Bipolar Vessel Sealer
Maryland | Reference Device: CleanSeal
Vessel Sealer 5mm | Predicate Device:
LigaSure
Maryland Jaw Open
sealer/Divider, One-step sealing
Nano-coated | Secondary Predicate:
LigaSure
Maryland Jaw Thoracic
Sealer/Divider, One-step sealing
Nano-coated | Comparison/
Discussion |
| | Model
Numbers | CS-M5-23, CS-M5-37 and CS-
M5-44 | CS-M5-23, CS-M5-37 and CS-
M5-44 | LF1923, LF1937 and LF1944 | LF1930T | |
| 510(k) | K231732 | K213354 | K170869 | K181085 | | |
| Dimensional
Design | Jaw size: 5mm
Length of shaft: 23cm, 37cm and
44cm
Tip Shape: Curve similar to
Maryland curve; | Jaw size: 5mm
Length of shaft: 23cm, 37cm and
44cm
Tip Shape: Curve similar to
Maryland curve; | Jaw size: 5mm
Length of shaft: 23cm, 37cm and
44cm
Tip Shape: Curve similar to
Maryland curve; | Jaw size: 5mm
Length of shaft: 37 cm
Tip Shape: Curve similar to Maryland
curve; | Similar | |
| | Rated
Voltage | 350Vpk | 350Vpk | 288Vpk | 288Vpk | Similar |
| Shelf-life | 1 years | 1 year | 3 years | 3 years | Similar | |
| Sterilization
Method | Ethylene oxide, SAL of 10-6 | Ethylene oxide, SAL of 10-6 | Ethylene oxide, SAL of 10-6 | Ethylene oxide, SAL of 10-6 | Identical | |
| Disposable
device | Single patient use device | Single patient use device | Single patient use device | Single patient use device | Identical | |
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