(213 days)
K152286 LigaSure Curved, Small Jaw, Open Sealer/Divider LF1212A
No
The description focuses on electrosurgical energy delivery and mechanical action (sealing and cutting) without mentioning any computational analysis or learning algorithms. The "Mentions AI, DNN, or ML" section also explicitly states "Not Found".
Yes
Explanation: The device is used in open surgical procedures to ligate and divide vessels, tissue, and lymphatics, which are therapeutic actions to treat medical conditions.
No.
The device is an electrosurgical instrument used for sealing and dividing vessels and tissues during surgical procedures, not for diagnosing conditions.
No
The device is a hand-held bipolar electrosurgical instrument with physical components (jaws, blade, cord, cable connector) designed for use in open surgical procedures. It is a hardware device that utilizes electrical energy.
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 done outside the body (in vitro).
- Device Function: The Medline ReNewal Reprocessed LigaSure Curved Small Jaw, Open Sealer/Divide LF1212A is an electrosurgical instrument used during open surgical procedures. It directly interacts with tissues and vessels within the body to seal and divide them.
- Intended Use: The intended use clearly describes its application in surgical procedures for ligation and division of vessels and tissues. It does not mention any analysis of specimens taken from the body.
Therefore, the device's function and intended use place it firmly in the category of a surgical instrument used in vivo (within the body), not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
The Medline ReNewal Reprocessed LigaSure Curved Small Jaw, Open Sealer/Divide LF1212A 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 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, parotidectory, and tonsillectorny) for ligation and division of vessels, lymphatiss 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 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 Curved, Small Jaw, Open Sealer/Divider LF1212A is a sterile, single-use, hand-held bipolar electrosurgical instrument designed for use with compatible Covidien generators that include vessel sealing capabilities to ligate (seal) and divide (cut) vessels, tissue bundles and lymphatics during open general surgical procedures. Covidien electrosurgical generators that include vessel sealing capabilities deliver precise energy through the device to tissue for a controlled tissue response to achieve complete and permanent tissue fusion while producing minimal sticking, charring, and thermal spread to adjacent tissue.
The surgeon first grasps the vessel or tissue with the jaws of the instrument. Once the surgeon is confident that the instrument is placed correctly, he or she initiates a seal by pressing a hand switch or footswitch. The instrument creates a seal by application of RF electrosurgical energy to vascular structures (vessels and lymph) or tissue bundles interposed between the jaws of the instrument. Once the seal cycle is complete, the surgeon actuates a blade within the instrument to divide tissue along the seal line.
The 10-foot cord, cable connector, and generator are not reprocessed by Medline ReNewal.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
vessels, tissue bundles, lymphatics, nerves, parathyroid glands
Indicated Patient Age Range
adults
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
The functional characteristics of the proposed devices have been evaluated and found to be equivalent to the predicate devices based on the following tests:
electrical safety and electromagnetic compatibility in accordance with IEC 60601-2-2 and 60601-1-2; simulated use; device integrity; blade trigger advance/return; activation button device recognition; thermal analysis characterization; tissue sticking; blade sharpness; transient cooling analysis burst pressure; histopathology; seal quality; Cleaning: protein, carbohydrates, and endotoxin; 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.
K152286 LigaSure Curved, Small Jaw, Open Sealer/Divider LF1212A
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 878.4400 Electrosurgical cutting and coagulation device and accessories.
(a)
Identification. An electrosurgical cutting and coagulation device and accessories is a device intended to remove tissue and control bleeding by use of high-frequency electrical current.(b)
Classification. Class II.
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Image /page/0/Picture/1 description: The image shows the seal of the U.S. Department of Health and Human Services. The seal features a stylized caduceus-like symbol with three intertwined figures, representing health and well-being. The symbol is encircled by the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA". The seal is black and white.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
May 1, 2017
Surgical Instrument Services and Savings, Inc. Ms. Brandi Panteleon Director, Quality Assurance and Regulatory Affairs 2747 SW 6th St. Redmond, Oregon 97756
Re: K162751
Trade/Device Name: Medline ReNewal Reprocessed LigaSure Curved, Small Jaw Open Sealer/Divider LF1212A Regulation Number: 21 CFR 878.4400 Regulation Name: Electrosurgical Cutting and Coagulation Device and Accessories Regulatory Class: Class II
Product Code: NUJ Dated: April 19, 2017 Received: April 21, 2017
Dear Ms. Panteleon:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food. Drug. and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA), You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting of medical devicerelated adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in
1
the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to
http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely, Jennifer R. Stevenson -S 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
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Reprocessed Single-Use Device Models Subject to Clearance:
| Model
| Number | Device Name/Description | Original Manufacturer |
|---|---|---|
| LF1212A | LigaSure Curved, Small Jaw, Open Sealer/Divider | Covidien |
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Indications for Use
510(k) Number (if known) K162751
Device Name
Medline ReNewal Reprocessed LigaSure Curved, Small Jaw Open Sealer/Divider LF1212A
Indications for Use (Describe)
The Medline ReNewal Reprocessed LigaSure Curved Small Jaw, Open Sealer/Divide LF1212A 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 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, parotidectory, and tonsillectorny) for ligation and division of vessels, lymphatiss 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 coagulation for sterilization procedures. Do not use the LigaSure system for these procedures.
Type of Use (Select one or both, as applicable)
2 Prescription Use (Part 21 CFR 801 Subpart D)
Over-The-Counter Use (21 CFR 801 Subpart C)
PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON A SEPARATE PAGE IF NEEDED.
FOR FDA USE ONLY
Concurrence of Center for Devices and Radiological Health (CDRH) (Signature)
This section applies only to requirements of the Paperwork Reduction Act of 1995.
DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.
The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:
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Form Approved: OMB No. 0910-0120 Expiration Date: January 31, 2017 See PRA Statement below.
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Image /page/4/Picture/2 description: The image shows the Medline Renewal logo. The word "MEDLINE" is in blue, with a blue star-like symbol to the right. To the right of that is a vertical line, followed by the word "Renewal" in green and blue. Underneath "Renewal" is the phrase "Full Circle Reprocessing" in a smaller font.
K162751 Summary
| Submitter/
Owner | Medline ReNewal
2747 SW 6th St.
Redmond, OR 97756 |
|----------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Contact Name | Brandi Panteleon
Director, Regulatory Affairs
P: 541-516-4180
F: 541-923-3375
E: bpanteleon@medline.com |
| Prepared by | Stephanie Boyle Mays
Requlatory Affairs Specialist, Requlatory Affairs
P: 541-516-4205
F: 541-923-3375
E: smays@medline.com |
| Date Prepared | September 29, 2016 |
| Device Names | Proprietary Name: Medline ReNewal Reprocessed LigaSure Curved, Small
Jaw Open Sealer/Divider LF1212A
Common Name: Bipolar electrosurgical instrument |
| Classification | Electrosurgical cutting and coagulation device and accessories
reprocessed
Product code: NUJ
Class: Class II, non-exempt |
| Predicate
Device | K152286 LigaSure Curved, Small Jaw, Open Sealer/Divider LF1212A |
| Device
Description | The Medline ReNewal Reprocessed LigaSure Curved, Small Jaw, Open
Sealer/Divider LF1212A is a sterile, single-use, hand-held bipolar
electrosurgical instrument designed for use with compatible Covidien
generators that include vessel sealing capabilities to ligate (seal) and divide
(cut) vessels, tissue bundles and lymphatics during open general surgical
procedures. Covidien electrosurgical generators that include vessel sealing
capabilities deliver precise energy through the device to tissue for a
controlled tissue response to achieve complete and permanent tissue
fusion while producing minimal sticking, charring, and thermal spread to
adjacent tissue.
The surgeon first grasps the vessel or tissue with the jaws of the
instrument. Once the surgeon is confident that the instrument is placed
correctly, he or she initiates a seal by pressing a hand switch or footswitch.
The instrument creates a seal by application of RF electrosurgical energy to
vascular structures (vessels and lymph) or tissue bundles interposed
between the jaws of the instrument. Once the seal cycle is complete, the
surgeon actuates a blade within the instrument to divide tissue along the
seal line.
The 10-foot cord, cable connector, and generator are not reprocessed by
Medline ReNewal. |
| Intended Use | The Medline ReNewal Reprocessed LigaSure Curved Small Jaw, Open
Sealer/Divide LF1212A 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. |
| 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. K152286
LigaSure Curved, Small Jaw, Open Sealer/Divider LF1212A 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; blade sharpness; transient cooling analysis burst pressure; histopathology; seal quality; Cleaning: protein, carbohydrates, and endotoxin; Biocompatibility: cytotoxicity sensitization, irritation; pyrogenicity, and acute systemic toxicity; performance qualification. |
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Image /page/5/Picture/2 description: The image contains the Medline Renewal logo. The Medline logo is on the left, and the Renewal logo is on the right. The Renewal logo is green and blue, and the text "Full Circle Reprocessing" is below the Renewal logo.
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Image /page/6/Picture/2 description: The image shows the Medline Renewal logo. The Medline logo is on the left, and the Renewal logo is on the right. The Renewal logo is green and blue, and the words "Full Circle Reprocessing" are below it.
sterilization validation; and ● ● product stability. Based on comparisons of the indications for use, intended use, technological characteristics, and performance data to the predicate Conclusion devices, Medline ReNewal reprocessed Medline ReNewal LigaSure Impact, Curved, Large Jaw, Open Sealer/Divider (LF1212A) is substantially equivalent to the predicate devices.
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Image /page/7/Picture/2 description: The image features the word "ReNewal" in a vertically stacked format, with the "Re" in green and the "Newal" in blue. To the right of "ReNewal" is the phrase "Full Circle Reprocessing" in a smaller, vertically stacked font. Below "ReNewal" is the word "MEDLINE" in blue, accompanied by a stylized logo. The logo consists of a blue star-like shape with an arrow pointing to the right, suggesting a sense of direction or progress.
Predicate and Medline ReNewal Reprocessed LigaSure Curved, Small Jaw Open Sealer/Divider (LF1212A) device
comparison chart. Table 1:
| Device
| Characteristics | Predicate | Proposed | Comparison |
|---|---|---|---|
| Predicate 510(k) | K152286 | K162751 | N/A |
| Model Numbers | LF1212A | LF1212A | N/A |
| Intended | |||
| Use/Indications for | |||
| Usea | The Covidien LigaSure Curved Small Jaw, Open | ||
| Sealer/Divide model LF1212A 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 Medline ReNewal Reprocessed LigaSure | ||
| Curved Small Jaw, Open Sealer/Divide model | |||
| LF1212A 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. | Same device; | ||
| different | |||
| manufacturer | |||
| Device | |||
| Characteristics | Predicate | ||
| Covidien LigaSure Impact Curved, Large Jaw | |||
| Sealer/Divider | Proposed | ||
| Medline ReNewal Reprocessed LigaSure | |||
| Impact Curved, Large Jaw Sealer/Divider | Comparison | ||
| Intended | |||
| Use/Indications for | |||
| Use (concluded)a | The LigaSure system has not been shown to be | ||
| effective for tubal sterilization or tubal | |||
| coagulation for sterilization procedures. Do not | |||
| use the LigaSure system for these procedures. | The LigaSure system has not been shown to be | ||
| effective for tubal sterilization or tubal | |||
| coagulation for sterilization procedures. Do not | |||
| use the LigaSure system for these procedures. | |||
| parathyroid glands. | Same device; | ||
| different | |||
| manufacturer | |||
| Power Platform | ForceTriad Electrosurgical Generator running | ||
| software version 3.40 or higher.b | ForceTriad Electrosurgical Generator running | ||
| software version 3.40 or higher.b | Same | ||
| Technological | |||
| Characteristics | The LigaSure Impact Curved Large Jaw, Open | ||
| Sealer/Divider uses bipolar energy to seal and | |||
| divide vessels up to and including 7 mm in | |||
| diameter. | The LigaSure Impact Curved Large Jaw, Open | ||
| Sealer/Divider uses bipolar energy to seal and | |||
| divide vessels up to and including 7 mm in | |||
| diameter. | Same | ||
| a Intended Use and Indications for Use were the same category in the K1522864 predicate. | |||
| b Force Triad generator was cleared under K070162: It will not be reprocessed and it is not part of this submission |
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Image /page/8/Picture/2 description: The image shows the Medline Renewal logo. The word "Renewal" is written vertically in a combination of green and blue colors. Below the word "Renewal" is the phrase "Full Circle Reprocessing" in a smaller, blue font. To the left of the word "Renewal" is the Medline logo.
- Predicate and: Medline ReNewal Reprocessed LigaSure Impact Curved, Large Jaw Sealer/Divider (LF1212A) device compariso
chart (concluded). Table 1: