(108 days)
Not Found
No
The summary describes a bipolar electrosurgical instrument for tissue ligation and division, focusing on mechanical and electrical features. There is no mention of AI or ML in the intended use, device description, or performance studies.
No.
Explanation: The device is an electrosurgical instrument used for ligation and division of vessels and tissue during surgical procedures, which is a surgical tool rather than a therapeutic device for long-term health management or treatment.
No
The device is an electrosurgical instrument designed for cutting, sealing, and ligating tissue during surgical procedures, not for diagnosing medical conditions.
No
The device description clearly describes a physical, sterile, single-use bipolar vessel sealer with mechanical components (jaws, cutting blade, shaft, handle) that connects to an electrosurgical generator. It is not solely software.
Based on the provided text, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly describes a surgical instrument used for sealing and dividing tissue and vessels during surgical procedures. This is an in vivo application, meaning it's used within a living organism.
- Device Description: The description details a bipolar electrosurgical instrument that connects to a generator and applies energy to tissue. This is consistent with a surgical tool, not a device that analyzes samples outside the body.
- Lack of IVD Characteristics: The text does not mention any of the typical characteristics of an IVD, such as:
- Analyzing biological samples (blood, urine, tissue samples, etc.)
- Providing diagnostic information about a patient's condition
- Using reagents or assays
IVD devices are used to perform tests on samples taken from the body to diagnose diseases or conditions. This device is a surgical tool used to perform a procedure on the body itself.
N/A
Intended Use / Indications for Use
The LigaSure XP Maryland Jaw Sealer/Divider is a bipolar electrosurgical instrument intended for use in minimally invasive or open surgical procedures where ligation of vessels, thick tissue (tissue (tissue bundles), and lymphatics is desired. The LigaSure XP Maryland Jaw Sealer/Divider can be used on veins) up to and including 7 mm. It is indicated for use in general such surgical specialties as colorectal, bariatric, urologic, vascular, thoracic, and gynecologic. These may include, but are not limited to, such procedures as Nissen fundoplication, colectomy, cholecystectomy, adhesiolysis, hysterectomy, oophorectomy, and so forth.
The LigaSure XP Maryland Jaw Sealer/Divider has not been shown to be effective for tubal sterilization or tubal coagulation for sterilization procedures. Do not use the LigaSure XP Maryland Jaw Sealer/Divider for these procedures.
Product codes (comma separated list FDA assigned to the subject device)
GEI
Device Description
The proposed LigaSure™ XP Maryland Jaw Sealer/Divider is a sterile, single-use bipolar vessel sealer. It is labeled as prescription use only. The device connects to the Valleylab™ FT10 Electrosurgical Platform generator for tissue ligation. Energy is applied to tissue interposed between the nano-coated Maryland-style jaws creating a ligation. The jaws contain an independent cutting blade for division of tissue. A distinctive characteristic is the new continuous rotation capability of the jaws and shaft. The shaft is a common 5 mm diameter available in three lengths (23 cm, 37 cm, 44 cm) for various general surgical procedures in both open and minimally invasive (laparoscopic) approaches. The instrument body is a pistol grip design which can be used by right or left-handed users to access the controls. The new device is offered with two handle body designs, One-Step Sealing (LXMJ23S, LXMJ37S, LXMJ44S) or Latching Handle (LXMJ23L, LXMJ37L, LXMJ44).
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
vessels (arteries and veins), tissue (tissue bundles), lymphatics
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Performance Testing - Bench: The LigaSure™ XP Maryland Jaw Sealer/Divider bench testing studies met the predetermined device requirements (acceptance criteria) for mechanical/functional performance, visual inspection, device reliability, ex vivo vessel sealing/burst and ex vivo lymphatic sealing/burst testing.
Performance Testing - Animal: The LigaSure™ XP Maryland Jaw Sealer/Divider met all predetermined device requirements (acceptance criteria) for in vivo acute hemostasis, acute thermal spread and chronic hemostasis tissue testing.
Performance Testing – Clinical: Clinical literature studies were evaluated to further support the safety and effectiveness use of the proposed LigaSure™ XP Maryland Jaw Sealer/Divider indications for use.
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 & Drug Administration (FDA). The logo consists of two parts: on the left, there is a symbol representing the Department of Health & Human Services, and on the right, there is the text "FDA U.S. FOOD & DRUG ADMINISTRATION" in blue. The text is arranged in two lines, with "FDA" being larger and bolder than the rest of the text.
January 23, 2023
Covidien, Ilc Miranda Miles Regulatory Affairs Specialist 5920 Longbow Dr. Boulder, Colorado 80301
Re: K223158
Trade/Device Name: LigaSure™ XP Maryland Jaw Sealer/Divider Regulation Number: 21 CFR 878.4400 Regulation Name: Electrosurgical Cutting And Coagulation Device And Accessories Regulatory Class: Class II Product Code: GEI Dated: December 21, 2022 Received: December 27, 2022
Dear Miranda Miles:
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. 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 statutes and regulations administered by other Federal agencies. You must comply with all the Act's
1
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/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (OS) 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 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,
Jessica Carr -S
for Long Chen, Ph.D. Assistant Director DHT4A: Division of General Surgery Devices OHT4: Office of Surgical and Infection Control Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known) K223158
Device Name LigaSure™ XP Maryland Jaw Sealer/Divider
Indications for Use (Describe)
The LigaSure XP Maryland Jaw Sealer/Divider is a bipolar electrosurgical instrument intended for use in minimally invasive or open surgical procedures where ligation of vessels, thick tissue (tissue (tissue bundles), and lymphatics is desired. The LigaSure XP Maryland Jaw Sealer/Divider can be used on veins) up to and including 7 mm. It is indicated for use in general such surgical specialties as colorectal, bariatric, urologic, vascular, thoracic, and gynecologic. These may include, but are not limited to, such procedures as Nissen fundoplication, colectomy, cholecystectomy, adhesiolysis, hysterectomy, oophorectomy, and so forth.
The LigaSure XP Maryland Jaw Sealer/Divider has not been shown to be effective for tubal sterilization or tubal coagulation for sterilization procedures. Do not use the LigaSure XP Maryland Jaw Sealer/Divider 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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3
K223158
Image /page/3/Picture/1 description: The image contains the logo for Covidien. The logo consists of a blue square with a white rectangle inside, bisected by a light blue vertical line. To the right of the square is the word "COVIDIEN" in a bold, dark blue font.
510(k) Summary
Date summary prepared: January 19, 2023
510(k) Submitter/Holder
Covidien llc 5920 Longbow Drive Boulder, CO 80301
Contact
Miranda Miles, Regulatory Affairs Specialist Telephone: 303-530-6205 Email: miranda.r.miles@medtronic.com
Proposed Device
| Trade Name: | LigaSure™ XP Maryland Jaw Sealer/Divider |
|---|---|
| Catalog Numbers: | LXMJ23S, LXMJ37S, LXMJ44S, LXMJ23L, LXMJ37L, LXMJ44L |
| Common Name: | Bipolar Vessel Sealing Device |
| Classification Name: | Electrosurgical cutting and coagulation device and accessories |
| (21 CFR 878.4400, Class II, GEI) |
Predicate Devices
The primary predicate device is the LigaSure™ Maryland Jaw Sealer/Divider, One-Step Sealing, Nano-Coated cleared under K170869 and the secondary predicate device is the LigaSure™ Blunt Tip Sealer/Divider, Nano-Coated cleared under K162941.
Primary
| Trade Name: | LigaSure™ Maryland Jaw Sealer/Divider, One-Step Sealing, Nano-Coated |
|---|---|
| Catalog Numbers: | LF1923, LF1937, LF1944 |
| Classification Name: | Electrosurgical cutting and coagulation device and accessories |
| (21 CFR 878.4400, Class II, GEI) | |
| 510(k) Number: | K170869 cleared April 21, 2017 |
Secondary
| Trade Name: | LigaSure™ Blunt Tip Sealer/Divider, Nano-Coated |
|---|---|
| Catalog Numbers: | LF1823, LF1837, LF1844 |
| Classification Name: | Electrosurgical cutting and coagulation device and accessories |
| (21 CFR 878.4400, Class II, GEI) | |
| 510(k) Number: | K162941 cleared November 14, 2016 |
4
K223158
Device Description
The proposed LigaSure™ XP Maryland Jaw Sealer/Divider is a sterile, single-use bipolar vessel sealer. It is labeled as prescription use only. The device connects to the Valleylab™ FT10 Electrosurgical Platform generator for tissue ligation. Energy is applied to tissue interposed between the nano-coated Maryland-style jaws creating a ligation. The jaws contain an independent cutting blade for division of tissue. A distinctive characteristic is the new continuous rotation capability of the jaws and shaft. The shaft is a common 5 mm diameter available in three lengths (23 cm, 37 cm, 44 cm) for various general surgical procedures in both open and minimally invasive (laparoscopic) approaches. The instrument body is a pistol grip design which can be used by right or left-handed users to access the controls. The new device is offered with two handle body designs, One-Step Sealing (LXMJ23S, LXMJ37S, LXMJ44S) or Latching Handle (LXMJ23L, LXMJ37L, LXMJ44).
Indications for Use
The LigaSure XP 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, thick tissue (tissue bundles), and lymphatics is desired. The LigaSure XP Maryland Jaw 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 colorectal, bariatric, urologic, vascular, thoracic, and gynecologic. These may include, but are not limited to, such procedures as Nissen fundoplication, colectomy, cholecystectomy, adhesiolysis, hysterectomy, and so forth.
The LigaSure XP Maryland Jaw Sealer/Divider has not been shown to be effective for tubal sterilization or tubal coagulation for sterilization procedures. Do not use the LigaSure XP Maryland Jaw Sealer/Divider for these procedures.
Comparison of Technological Characteristics with the Predicate Devices
The LigaSure™ XP Maryland Jaw Sealer/Divider has the same intended use compared to the predicates with different indications and some different technological characteristics. A summary comparison is provided in the table below.
| Characteristic | Proposed Device:
LigaSure™ XP
Maryland Jaw,
Sealer/Divider,
Nano-Coated,
One-Step Sealing/
Latching Handle | Primary Predicate
Device:
LigaSure™ Maryland
Jaw Sealer/Divider,
Nano-Coated, One-Step
Sealing
(K170869) | Secondary Predicate
Device:
LigaSure™ Blunt Tip
Sealer/Divider, Nano-
Coated,
(K162941) | Results
(compared to predicates) |
|--------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Indications for Use | The LigaSure XP
Maryland Jaw
Sealer/Divider is a
bipolar electrosurgical
instrument intended for | The LigaSure
Sealer/Divider is a
bipolar electrosurgical
instrument intended for
use in minimally | The LigaSure
Sealer/Divider is a
bipolar electrosurgical
instrument intended for
use in minimally | The proposed
indications for use
statement includes
colorectal and bariatric
specialties, clarifies the |
| | use in minimally
invasive or open
surgical procedures
where ligation and
division of vessels, thick
tissue (tissue bundles),
and lymphatics is
desired. The LigaSure
XP Maryland Jaw
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
colorectal, bariatric,
urologic, vascular,
thoracic, and
gynecologic. These may
include, but are not
limited to, such
procedures as Nissen
fundoplication,
colectomy,
cholecystectomy,
adhesiolysis,
hysterectomy,
oophorectomy, and so
forth.
The LigaSure XP
Maryland Jaw
Sealer/Divider has not
been shown to be
effective for tubal
sterilization or tubal
coagulation for
sterilization procedures.
Do not use the LigaSure
XP Maryland Jaw
Sealer/Divider for these
procedures. | 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. These may
include, but are not
limited to, such
procedures as 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. | 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, such
procedures as 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. | term tissue bundles with
the term thick tissue and
replaced 'etc.' with 'and
so forth'. Differences do
not change the intended
use of the device and do
not affect safety and
effectiveness as
demonstrated through
performance testing. |
| Sterile | Yes | Yes | Yes | Same |
| Product Packaging | Single sterile barrier | Single sterile barrier | Single sterile barrier | Same |
| Instrument Design | Pistol Grip | Pistol Grip | Pistol Grip | Same |
| Lever Latching
Mechanism | LXMJxxS: No
LXMJxxL: Yes | No | Yes | Same; Same
technological
characteristic. |
| Energy Activation
Mechanisms | Button or footswitch | Button or footswitch | Button or footswitch | Same |
| Shaft/Jaws Rotation
Distance | Continuous 360° | 350° | 180° | The proposed device can
rotate continuously 360°
in both directions.
Differences do not affect
the safety and
effectiveness and do not
raise different questions
of safety and
effectiveness as
demonstrated through
performance testing. |
| Jaw Type | Unilateral | Unilateral | Bilateral | Same; Same
technological
characteristic. |
| Jaw Shape | Curved | Curved | Blunt | Same; Same
technological
characteristic. |
| Electrical Characteristics | | | | |
| Energy Type | bipolar electrosurgical | bipolar electrosurgical | bipolar electrosurgical | Same |
| Compatible Energy
Platform | VLFT10GEN
(K191601) | VLFT10GEN
(K191601)
VLLS10GEN
(K143654)
FORCETRIAD
(K110268) | VLFT10GEN
(K191601)
VLLS10GEN
(K143654)
FORCETRIAD
(K110268) | Same; VLFT10GEN is
compatible with the
predicates. |
| Operating Amperage
(Maximum) | VLFT10GEN: 5.5 A | VLFT10GEN: 5.5 A
VLLS10GEN: 6.1 A
FORCETRIAD: 6.1 A | VLFT10GEN: 5.5 A
VLLS10GEN: 6.1 A
FORCETRIAD: 6.1 A | Same; VLFT10GEN is
compatible with the
predicates. |
| Operating Voltage
(Maximum) | VLFT10GEN: 244 Vpk (@ 434
kHz | VLFT10GEN: 244 Vpk (@ 434
kHz
VLLS10GEN: 250 Vpk @ 400
kHz
FORCETRIAD: 288 Vpk (a)
472 kHz | VLFT10GEN: 244 Vpk @ 434
kHz
VLLS10GEN: 250 Vpk @ 400
kHz
FORCETRIAD: 288 Vpk (a)
472 kHz | Same; VLFT10GEN is
compatible with the
predicates. |
| Direct Tissue Contacting Materials | | | | |
| Patient Contacting
Materials
Biocompatible | Yes | Yes | Yes | Same |
| Jaw Coating | Yes | Yes | Yes | Same |
| Shaft Material | Stainless steel | Stainless steel with
black heat shrink wrap | Stainless steel with
black heat shrink wrap | Removal of heat shrink
does not affect the safety
and effectiveness and
does not raise different
questions of safety and
effectiveness as
demonstrated through
performance testing. |
5
6
Performance Testing
The following testing performance data are provided in support of the substantial equivalence determination of the LigaSure™ XP Maryland Jaw Sealer/Divider.
7
K223158
Sterilization and Shelf Life
The LigaSure™ XP Maryland Jaw Sealer/Divider met the acceptance criteria for sterilization by ethylene oxide (EO) in accordance with the applicable validation standards ISO 11135, ISO 11737-1, ISO 11737-2, and ISO 10993-7. In addition, the LigaSure™M XP Maryland Jaw Sealer/Divider packaging and product integrity were found to be acceptable for the five-year shelf life in accordance with the applicable packaging standards ISO 11607-1, ISO 11607-2, ASTM D4169 and ASTM F1980.
Biocompatibility
The LigaSure™ XP Maryland Jaw Sealer/Divider met the requirements of biocompatibility standard ISO 10993-1 for the following endpoints: cytotoxicity, sensitization, intracutaneous reactivity, acute systemic toxicity, and material-mediated pyrogenicity.
Software
The LigaSure™ XP Maryland Jaw Sealer/Divider does not contain software.
Electromagnetic Compatibility and Electrical Safety
The LigaSure™ XP Maryland Jaw Sealer/Divider met the applicable clauses of electromagnetic compatibility and electrical safety verification standards IEC 60601-1-2. IEC 60601-1-2. IEC 60601-2-2, and IEC 60601-2-18.
Performance Testing - Bench
The LigaSure™ XP Maryland Jaw Sealer/Divider bench testing studies met the predetermined device requirements (acceptance criteria) for mechanical/functional performance, visual inspection, device reliability, ex vivo vessel sealing/burst and ex vivo lymphatic sealing/burst testing.
Performance Testing - Animal
The LigaSure™ XP Maryland Jaw Sealer/Divider met all predetermined device requirements (acceptance criteria) for in vivo acute hemostasis, acute thermal spread and chronic hemostasis tissue testing.
Performance Testing – Clinical
Clinical literature studies were evaluated to further support the safety and effectiveness use of the proposed LigaSure™ XP Maryland Jaw Sealer/Divider indications for use.
Conclusion
The proposed LigaSure™ XP Maryland Jaw Sealer/Divider device family is substantially equivalent to the predicate device families LigaSure™ Maryland Jaw Sealer/Divider, One-Step Sealing, Nano-Coated and LigaSure™ Blunt Tip Sealer/Divider, Nano-Coated.