Predicate Devices

Reference Devices

K141153 LigaSure; Curved Small Jaw Sealer/Divider, 5mm Blunt Tip Sealer/Divider, Maryland Jaw One Step Sealer/Divider, curved

AI/ML (Artificial Intelligence / Machine Learning)

No
The device description explicitly states that the proposed devices do not include software, and there are no mentions of AI, DNN, or ML in the summary.

Therapeutic

No
The Medline ReNewal Reprocessed LigaSure Sealer/Divider is a surgical instrument used to ligate and divide vessels and tissues during procedures. While it assists in surgical intervention which can be therapeutic, its primary function is not to directly treat or alleviate a disease or condition, but rather to facilitate the surgical process itself.

Diagnostic

No

The device is described as a surgical instrument for ligating and dividing vessels, not for diagnosing conditions.

SaMD (Software as a Medical Device)

No

The device description explicitly states "The proposed devices do not include software."

IVD (In Vitro Diagnostic)

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 (like blood, urine, or tissue) to detect diseases, conditions, or infections.
Device Function: The description clearly states the device is a "bipolar electrosurgical instrument" used for "ligation and division of vessels, tissue bundles, and lymphatics" during surgical procedures. It uses radio frequency (RF) energy to seal and cut tissue within the body.
Lack of Sample Analysis: There is no mention of the device analyzing samples taken from the body. Its function is to directly interact with and modify tissue during surgery.

Therefore, the Medline ReNewal Reprocessed LigaSure Sealer/Divider is a surgical device, not an In Vitro Diagnostic.

PCCP (Predetermined Change Control Plan) Authorized

N/A

Overview

Intended Use / Indications for Use

The Medline ReNewal Reprocessed 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 specialities 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.

Product codes (comma separated list FDA assigned to the subject device)

NUJ

Device Description

The Medline ReNewal Reprocessed LigaSure Blunt Tip Sealer/Divider (LF1623, LF1637) devices are sterile single-use, hand-held bipolar vessel sealing devices designed for use with Covidien electrosurgical generators that include vessel sealing capabilities to ligate (seal) and divide (cut) vessels, tissue bundles and lymphatics clamped between the jaws, grasping tissue and blunt dissection during open and minimally invasive general surgical procedures (as indicated) using radio frequency (RF) energy. A hand-actuated lever allows the user to open or close the instrument jaws, and includes a latching mechanism that holds the jaws in the closed position during vessel sealing and cutting. The proposed devices do not include software.

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)

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 60601-1, IEC 60601-2-2, and IEC 60601-1-2; simulated use; device integrity; blade trigger advance/return; shaft knob rotation; device recognition; thermal analysis characterization; handle locking; burst pressure; histopathology; seal quality; tissue sticking; cleaning; protein and carbohydrates; biocompatibility; 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.

K142929 LigaSure Blunt Tip Sealer/Divider

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.

K141153 LigaSure; Curved Small Jaw Sealer/Divider, 5mm Blunt Tip Sealer/Divider, Maryland Jaw One Step Sealer/Divider, curved

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

Regulation Number and Section

§ 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.

Summary

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Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized caduceus symbol, which is a staff with two snakes coiled around it. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the symbol.

Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

July 20, 2016

Surgical Instrument Service And Savings Inc. Ms. Brandi Panteleon Director, Quality Assurance and Regulatory Affairs 2747 SW 6th St. Redmond, Oregon 97756

Re: K160333

Trade/Device Name: Medline ReNewal Reprocessed LigaSure Blunt Tip Open Sealer/Divider Regulation Number: 21 CFR 878.4400 Regulation Name: Electrosurgical Cutting And Coagulation Device And Accessories Regulatory Class: Class II Product Code: NUJ Dated: June 17, 2016 Received: June 20, 2016

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 (reporting of medical devicerelated adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in

1

the quality systems (OS) 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 yours,

Christopher J. Ronk -A

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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Page 3 - Ms. Brandi Panteleon

Reprocessed Single-Use Device Models Included in Clearance:

| Device Model | Device Name | Original
Manufacturer |
|--------------|------------------------------------------------------------------|--------------------------|
| LF1623 | LigaSure Blunt Tip Open Sealer/Divider
(5 mm x 23 cm) | Covidien |
| LF1637 | LigaSure Blunt Tip Laparoscopic Sealer/Divider
(5 mm x 37 cm) | Covidien |

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Indications for Use

510(k) Number (if known) K160333

Device Name

Medline ReNewal Reprocessed LigaSure Blunt Tip Sealer/Divider

Indications for Use (Describe)

The Medline ReNewal Reprocessed LigaSure Sealer/Divider is a bipolar electrosurgical instrument intended for use in minimally invasive or open surgical procedures where ligation of vesses, tissue bundles, and lymphatics is desired. The LigaSure Sealer/Divider can be used on veins) up to and including 7 mm. It is indicated for use in general surgery and such specialities 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)

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:

Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov

"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."

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Reprocessed Single-Use Device Models Included in Clearance:

| Device Model | Device Name | Original
Manufacturer |
|--------------|------------------------------------------------------------------|--------------------------|
| LF1623 | LigaSure Blunt Tip Open Sealer/Divider
(5 mm x 23 cm) | Covidien |
| LF1637 | LigaSure Blunt Tip Laparoscopic Sealer/Divider
(5 mm x 37 cm) | Covidien |

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Image /page/5/Picture/0 description: The image contains the Medline Renewal logo. The word "Medline" is in blue, with a blue star to the right of it. To the right of the Medline logo is the word "Renewal", with "Re" in green and "Newal" in blue. Underneath the word "Renewal" is the phrase "Full Circle Reprocessing" in blue.

Summary K160333

| Submitter/
Owner | Medline ReNewal
2747 SW 6th St.
Redmond, OR 97756 |
|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Contact Name | Brandi Panteleon
Director, Quality Assurance and Regulatory Affairs
P: 541-923-3310
F: 541-923-3375
E: bpanteleon@medline.com |
| Prepared by | Stephanie Boyle Mays
Regulatory Affairs Specialist, Regulatory Affairs
P: 541-516-4205
F: 541-516-4180
E: smays@medline.com |
| Date Prepared | February 3, 2015 |
| Device Names | Proprietary Name: Medline ReNewal Reprocessed LigaSure Blunt Tip
Sealer/Divider
Common Name: Bipolar electrosurgical instrument |
| Classification | Electrosurgical cutting and coagulation device and accessories
Product code: NUJ
Class: Class II, non-exempt |
| Predicate
Device | K142929 LigaSure Blunt Tip Sealer/Divider |
| Reference
Device | K141153 LigaSure; Curved Small Jaw Sealer/Divider, 5mm Blunt Tip
Sealer/Divider, Maryland Jaw One Step Sealer/Divider, curved |
| Device Models | LF1623 and LF1637 |
| Device
Description | The Medline ReNewal Reprocessed LigaSure Blunt Tip Sealer/Divider
(LF1623, LF1637) devices are sterile single-use, hand-held bipolar vessel
sealing devices designed for use with Covidien electrosurgical generators
that include vessel sealing capabilities to ligate (seal) and divide (cut)
vessels, tissue bundles and lymphatics clamped between the jaws,
grasping tissue and blunt dissection during open and minimally invasive
general surgical procedures (as indicated) using radio frequency (RF)
energy. A hand-actuated lever allows the user to open or close the
instrument jaws, and includes a latching mechanism that holds the jaws in
the closed position during vessel sealing and cutting. The proposed devices
do not include software. |
| Intended Use | The Medline ReNewal Reprocessed 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 specialities 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 and reference devices.
The proposed devices are reprocessed versions of the predicate and
reference devices. |
| 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 60601-1, IEC 60601-2-2, and IEC 60601-1-2; simulated use; device integrity; blade trigger advance/return; shaft knob rotation; device recognition; thermal analysis characterization; handle locking; burst pressure; histopathology; seal quality; tissue sticking;. cleaning; protein and carbohydrates; biocompatibility; sensitization, irritation; pyrogenicity, and acute systemic
toxicity; performance qualification; sterilization validation; and product stability. |
| Conclusion | Based on comparisons of the indications for use, intended use,
technological characteristics, and performance data to the predicate and
reference devices, Medline ReNewal Reprocessed LigaSure Blunt Tip
Sealer/Dividers (LF1623 and LF1637) are substantially equivalent to the
predicate. |

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Image /page/6/Picture/0 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 in green and blue, and the words "Full Circle Reprocessing" are below the Renewal logo.

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Image /page/7/Picture/0 description: The image shows the Medline Renewal logo. The word "Renewal" is in a large, bold font, with "Re" in green and "newal" in blue. Below "Renewal" is the phrase "Full Circle Reprocessing" in a smaller, gray font. To the left of the text is the Medline logo, which is a blue star-like shape with the word "MEDLINE" written next to it.

| Device

Characteristics	Predicate	Proposed	Reference Device	Comparison
	Covidien LigaSure
Blunt Tip Sealer/Divider	Medline ReNewal LigaSure
Blunt Tip Sealer/Divider	Covidien LigaSure
5-mm Blunt Tip
Laparoscopic
Sealer/Dividera	Same devices;
different
manufacturer
Predicate 510(k)	K142929	K160333	K141153	N/Ab
Model Numbers	LF1623	LF1623, LF1637	LF1637	N/A
Device
Description	The Covidien LigaSure Blunt Tip
Sealer/Divider (LF1623, LF1644)
devices are sterile single-use,
hand-held bipolar vessel sealing
devices designed for use with
Covidien electrosurgical
generators that include vessel
sealing capabilities to ligate (seal)
and divide (cut) vessels, tissue
bundels and lymphatics clamped
between the jaws, grasping tissue
and blunt dissection during open
and minimally invasive general
surgical procedures (as indicated)
using radio frequency (RF) energy
A hand-actuated lever allows the
user to open or close the
instrument jaws, and includes a
latching mechanism that holds the
jaws in the closed	The Medline ReNewal
Reprocessed LigaSure Blunt Tip
Sealer/Divider (LF1623, LF1637)
devices are sterile single-use,
hand-held bipolar vessel sealing
device is designed for use with
Covidien electrosurgical
generators that include vessel
sealing capabilities to ligate (seal)
and divide (cut) vessels, tissue
bundles and lymphatics clamped
between the jaws, grasping tissue
and blunt dissection during open
and minimally invasive general
surgical procedures (as indicate)
using radio frequency (RF) energy.
A hand-actuated lever allows the
user to open or close the
instrument jaws, and includes a
latching mechanism that holds the
jaws in the closed position	Same as predicate	• K142929
(predicate) and
proposed devices
include open and
laparoscopic blunt
tip sealer/dividers.
• K141153
(reference) and
proposed devices
specify use of the
ForceTriad energy
system. The
ForceTriad system
is a Covidien
electrosurgical
generator that is
included in the
K142929
description.

Table 1: Predicate and Medline ReNewal Reprocessed LigaSure Blunt Tip Sealer/Divider comparison chart.

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Image /page/8/Picture/0 description: The image shows the Medline Renewal logo. The word "Renewal" is in a large, bold font, with "Re" in green and "newal" in blue. Below "Renewal" is the phrase "Full Circle Reprocessing" in a smaller, gray font. To the left of the text is the Medline logo, which is a blue star-like shape with the word "MEDLINE" written next to it.

| Device

Characteristics	Predicate	Proposed
	Covidien LigaSure
Blunt Tip Sealer/Divider	Medline ReNewal LigaSure Blunt
Tip Sealer/Divider	Covidien LigaSure
5-mm Blunt Tip
Laparoscopic Sealer/Divider	Same devices;
different
manufacturer
Device
Description
(concluded)	position during vessel sealing and
cutting.
The proposed devices do not
include software.	during vessel sealing and cutting.
The proposed devices do not
include software.	(as stated previously)	· All devices are
LigaSure blunt-tip
sealer/dividers
Indications for
Use (IFU)	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 surgery specialties as
urologic, vascular, thoracic and
gynecologic. Procedures may
include, but are not limited to,
Nissen fundoplication, colectomy,
cholecystectomy, adhesiolysis,
hysterectomy, oophorectomy, etc.	The Medline ReNewal
Reprocessed 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 specialities as
urologic, vascular, thoracic and
gynecologic. Procedures may
include, but are not limited to,
Nissen fundoplication, colectomy,
cholecystectomy, adhesiolysis,
hysterectomy, oophorectomy, etc.	Same as predicate	Indications for use for
the K142929
predicate LigaSure
Sealer/Divider and
the proposed devices
are the same. The
IFU for K142929
includes both the
LF1623 and LF1637
in the instructions that
accompany the
devices.

Table 1: Predicate and Medline ReNewal Reprocessed LigaSure Blunt Tip Sealer/Divider comparison chart (continued).

(continued)

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Image /page/9/Picture/0 description: The image is a logo for Medline Renewal Full Circle Reprocessing. The logo features the Medline logo on the left, which is a blue stylized star. To the right of the Medline logo is the word "Renewal" in green and blue. Below the word "Renewal" is the phrase "Full Circle Reprocessing" in a smaller, blue font.

Predicate and Medline ReNewal Reprocessed LigaSure Blunt Tip Sealer/Divider comparison chart (concluded). Table 1:

| Device

Characteristics	Predicate	Proposed
	Covidien LigaSure
Blunt Tip Sealer/Divider	Medline ReNewal LigaSure Blunt
Tip Sealer/Divider	Covidien LigaSure
5-mm Blunt Tip
Laparoscopic Sealer/Divider	Same devices;
different
manufacturer
Indications for
Use (concluded)	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
procedure.	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.	(as stated previously)	(as stated previously)
Power Platform	ForceTriad SW v.3.60 or higher
for LF1623
ForceTriad SW v. 3.50 or higher
for LF1637°	ForceTriad SW v.3.60 or higher for
LF1623
ForceTriad SW v. 3.50 or higher
for LF 1637	ForceTriad SW v. 3.50 or
higher for LF1637	Same
Technological
Characteristics	The only differences between the
predicate and subject devices are
the length of the shaft.
Note: predicate device for
K142929 is reference device
K141153	The technological characteristics
and the fundamental scientific
technology of the subject devices
are identical to the predicate and
reference devices. The proposed
devices are a reprocessed version
of the predicate and reference
devices.	Same as predicate.	Same
a Only the LigaSure 5 mm Blunt Tip Sealer/Divider is included in this submission from reference device K141153. Medline ReNewal is not

including the LigaSure Curved Small Jaw Sealer/Divider of the Maryland Jaw One Step Sealer/Dividers in this submission. b

N/A = not applicable. C

ForceTriad generator was cleared under K070162: It will not be reprocessed, and it is not part of this submission.