The Percutaneous Surgical System with 5mm attachments is indicated for the means to penetrate soft tissue to access certain areas of the abdomen. The system is used to grasp, manipulate, cut, cauterize and deliver Hem-o-lok® ligating clips to soft tissue during laparoscopic surgery.

Device Description

Teleflex Medical's Percuvance™ Percutaneous Surgical System is a micro-laparoscopic platform that comprises fourteen (14) unique components, which are combined in various configurations to create a multifunctional set of instruments for laparoscopic procedures. In accordance with IEC 60601-1:2005 (A1:2012), the Percuvance™ system is classified as a BF active accessory with a rated accessory voltage of 1000VPeak. System components include two reusable Handles (Ratcheted and Non-Ratcheted), which are manipulated by the surgeon and connect to a Shaft, which is available in two lengths (29 cm and 36 cm), affords various Tool Tips (or End Effectors) to be attached in order to perform basic surgical manipulations. The Percuvance™ Handles, Shafts, and Tool Tips are not compatible or interchangeable with components from other percutaneous systems. Initial access to the surqical site is achieved with the Introducer Tool Tip attached to the Shaft. Once inside the patient, the Introducer Tool Tip is extracorporealized through a pre-inserted, central trocar and is then exchanged for one of the other Tool Tips, which include Scissors, Gripper Grasper, Johans Grasper, Maryland Dissector, Hook Cautery, Spatula Cautery and Clip Applier. No ligating clips are provided with the Percuyance™ Percutaneous Surgical System: however, the Clip Applier Tool Tip is compatible with Teleflex M/L Hem-o-lok® ligating clip (SKU 544230). Finally, the Seal Bridge, which is available in two sizes (5 mm and 12 mm), is used to protect the trocar seal and to aid in maintaining insufflation when it used in conjunction with a trocar to facilitate the extracorporeal exchange of Tool Tips.

AI/ML Overview

This FDA 510(k) summary describes a medical device, the Percuvance™ Percutaneous Surgical System, and its substantial equivalence to a previously cleared predicate device. It does not contain information about the acceptance criteria or results from a study that typically involves human readers or AI.

Here's a breakdown of the information provided and what is missing in relation to your request:

1. A table of acceptance criteria and the reported device performance

Not provided. The document states "Comprehensive bench testing was completed on the modifications identified below to ensure the system performed equivalently (or better) to the predicate system." However, specific quantitative acceptance criteria or detailed performance results in a table format are not present. The "Comparative Characteristics" table (pages 7-8) compares the proposed device to the predicate in terms of features and intended use, but not measured performance against pre-defined criteria.

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

Not provided. The document mentions "bench testing" and "stability testing" but does not specify sample sizes for these tests or details about data provenance.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

Not applicable. This information is relevant for studies involving human interpretation or image analysis where ground truth is established by experts. This document describes a surgical instrument and its functional testing, not a diagnostic or interpretive device.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

Not applicable. See point 3.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

No. This is not an AI-based diagnostic or interpretive device. Therefore, no MRMC study or AI-related effectiveness is discussed.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

No. This is not an AI-based device.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

Not explicitly described in terms of "ground truth" for clinical outcomes. The document refers to "bench testing" and "stability testing" to ensure the device performs "equivalently (or better) to the predicate system." The "ground truth" for these types of tests would be established engineering standards, material properties, and functional performance measurements against design specifications and predicate device performance. For biocompatibility, the ground truth is adherence to ISO standards.

8. The sample size for the training set

Not applicable. This is not a machine learning or AI-driven device.

9. How the ground truth for the training set was established

Not applicable. This is not a machine learning or AI-driven device.

Summary of the Study and Device Performance (based on the provided text):

The document describes the Percuvance™ Percutaneous Surgical System, a micro-laparoscopic platform for grasping, manipulating, cutting, cauterizing, and delivering ligating clips during laparoscopic surgery.

The study to support its 510(k) clearance (K181852) was a substantial equivalence review against a predicate device (K153063 for the system, and K133202 for the clip applier technology and ligating clips).

Device Performance Information (extracted from the text):

The document states:

"Comprehensive bench testing was completed on the modifications identified below to ensure the system performed equivalently (or better) to the predicate system."
"Existing design, usability validations and packaging (ship) testing, performed on the predicate device still adequately covers the proposed device."
"Stability testing was repeated on the sterile components and their packaging to support the legacy extended 3 year shelf life according to aging methods and test methods previously submitted in the predicate 510(k) in support of the initial 1 year shelf life."
"Though the majority of the electrosurgical safety testing submitted for the system is still valid, certain electrosurgical safety tests were repeated at a third party test house to support the Shaft metal lock tube change."
"Biocompatibility data submitted for the Percuvance system still adequately represents the proposed system, as no new patient contacting materials were introduced. However, as a result of Shaft's green ink band modification, which is pad printed on the Shaft's proximal knob, a full biocompatibility panel was completed. Additionally, cytotoxicity testing was performed on the Shaft metal lock tube change."

Conclusion from the document:
"Based upon the testing presented throughout the submission and in this 510(k) Summary, Teleflex Medical's Percuvance™ Percutaneous Surgical System is substantially equivalent in to the predicate device cleared to market via 510(k) K153063. The modifications to the proposed Percuvance™ Percutaneous Surgical System do not introduce any new issues of safety and effectiveness."

This submission relies on demonstrating that the modified device performs as well as the predicate device through various engineering and material tests, rather than a clinical study with specific acceptance criteria on diagnostic accuracy or reader performance typically seen with AI/imaging devices.

Summary

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October 12, 2018

Teleflex Medical, Inc. Kim Campbell Regulatory Affairs Specialist 3015 Carrington Mill Blvd Morrisville, North Carolina 27560

Re: K181852

Trade/Device Name: Percuvance Percutaneous Surgical System Regulation Number: 21 CFR 878.4400 Regulation Name: Electrosurgical Cutting and Coagulation Device and Accessories Regulatory Class: Class II Product Code: GEI, GCJ, GDO Dated: September 19, 2018 Received: September 21, 2018

Dear Kim Campbell:

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 requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part

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801); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/CombinationProducts/GuidanceRegulatoryInformation/ucm597488.htm); 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 http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm.

For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn

(http://www.fda.gov/Training/CDRHLearn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).

Sincerely,

Long H. Chen -S 2018.10.12 10:32:25 -04'00'

for

Binita S. Ashar, M.D., M.B.A., F.A.C.S. Director Division of Surgical Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known)

K181852

Device Name

Percuvance(TM) Percutaneous Surgical System

Indications for Use (Describe)

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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510(k) SUMMARY

Percuvance™ Percutaneous Surgical System

A. Name, Address, Phone, and Fax Number of Applicant

Teleflex Medical, Incorporated 3015 Carrington Mill Boulevard Morrisville, NC 27560 USA Phone:919-433-4918 Fax: 919-433-4996

B. Contact Person

Kim Campbell Regulatory Affairs Specialist

C. Date Prepared

September 19th, 2018

D. Device Name

Trade Name

Percuvance™ Percutaneous Surgical System

Common Name

Primary:	Electrosurgical, Cutting and Coagulation and Accessories
Secondary:	Laparoscope, General and Plastic SurgeryApplier, Surgical, Clip

Classification Regulation

Primary:	21 CFR 878.4400
Secondary:	21 CFR 876.150021 CFR 878.4800

Product Code

Primary:	GEI
Secondary:	GCJ, GDC

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Classification Name

Primary:	Electrosurgical Cutting and Coagulation Device and Accessories
Secondary:	Endoscope and AccessoriesManual Surgical Instrument for General Use

Classification

Class II

Panel

General & Plastic Surgery

E. Device Description

System components include two reusable Handles (Ratcheted and Non-Ratcheted), which are manipulated by the surgeon and connect to a Shaft, which is available in two lengths (29 cm and 36 cm), affords various Tool Tips (or End Effectors) to be attached in order to perform basic surgical manipulations. The Percuvance™ Handles, Shafts, and Tool Tips are not compatible or interchangeable with components from other percutaneous systems.

Initial access to the surqical site is achieved with the Introducer Tool Tip attached to the Shaft. Once inside the patient, the Introducer Tool Tip is extracorporealized through a pre-inserted, central trocar and is then exchanged for one of the other Tool Tips, which include Scissors, Gripper Grasper, Johans Grasper, Maryland Dissector, Hook Cautery, Spatula Cautery and Clip Applier. No ligating clips are provided with the Percuyance™ Percutaneous Surgical System: however, the Clip Applier Tool Tip is compatible with Teleflex M/L Hem-o-lok® ligating clip (SKU 544230).

Finally, the Seal Bridge, which is available in two sizes (5 mm and 12 mm), is used to protect the trocar seal and to aid in maintaining insufflation when it used in conjunction with a trocar to facilitate the extracorporeal exchange of Tool Tips.

Model Number	ComponentDescription	ReusabilityStatus	Sterility Status	Intended toApply MonopolarEnergy?
PCVINT3	Introducer Tool Tip	Single-Patient-Use	Provided Sterile -Gamma Irradiated	No
PCVSC5	Scissors Tool Tip	Single-Patient-Use	Provided Sterile -Gamma Irradiated	Yes

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Model Number	ComponentDescription	ReusabilityStatus	Sterility Status	Intended toApply MonopolarEnergy?
PCVGG5	Traumatic GripperGrasper Tool Tip	Single-Patient-Use	Provided Sterile -Gamma Irradiated	Yes
PCVJG5	Atraumatic JohansGrasper Tool Tip	Single-Patient-Use	Provided Sterile -Gamma Irradiated	Yes
PCVMD5	Maryland DissectorTool Tip	Single-Patient-Use	Provided Sterile -Gamma Irradiated	Yes
PCVHK5	Hook Cautery Tool Tip	Single-Patient-Use	Provided Sterile -Gamma Irradiated	Yes
PCVSPT5	Spatula Cautery ToolTip	Single-Patient-Use	Provided Sterile -Gamma Irradiated	Yes
PCVHCA5	Clip Applier Tool Tip	Single-Patient-Use	Provided Sterile -Gamma Irradiated	No
PCVSH3	29 cm Shaft	Single-Patient-Use	Provided Sterile -Gamma Irradiated	Yes
PCVSHL3	36 cm Shaft	Single-Patient-Use	Provided Sterile -Gamma Irradiated	Yes
PCVNRH	Non-Ratcheted Handle	Reusable	Provided Non-Sterile -Intended to be SteamSterilized by Hospital	Yes
PCVRH	Ratcheted Handle	Reusable	Provided Non-Sterile -Intended to be SteamSterilized by Hospital	Yes
PCVSB5	5 mm Seal Bridge	Single-Patient-Use	Provided Sterile -Gamma Irradiated	N/A - Notconnected to theHandle and Shaftconfiguration
PCVSB12	12 mm Seal Bridge	Single-Patient-Use	Provided Sterile -Gamma Irradiated	N/A – Notconnected to theHandle and Shaftconfiguration

Indications for Use F.

Contraindications G.

The following are contraindications of the Percuvance™ Percutaneous Surgical System:

. The monopolar active Tool Tips are not intended for contraceptive coagulation of fallopian tissue, but may be used to achieve hemostasis following transection of the fallopian tube.

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Do not resterilize single patient use components. These components are provided sterile and are intended for use in a single procedure. Discard after use.
The device is not intended for use when endoscopic techniques are generally contraindicated.

The following are contraindications of the M/L Hem-o-lok® ligating clip (SKU 544230), which is an accessory to the Percuvance™ system:

Hem-o-lok® ligating clips are not intended for use as a fallopian contraceptive tubal occlusion device.
. Hem-o-lok® ligating clips are contraindicated for use in ligating the renal artery during laparoscopic donor nephrectomies.

Substantial Equivalence H.

The Percuvance™ Percutaneous Surgical System is substantially equivalent to the following predicate system.

Predicate Device	Manufacturer	510(k) No.	Date Cleared
Percuvance ™ PercutaneousSurgical System	Teleflex Medical, Inc.	K153063	April 8th, 2016

Additionally, the technology of Teleflex Medical's Percuvance™ Clip Applier Tool Tip is substantially equivalent to that of the M/L Hem-o-lok® manual, endoscopic clip appliers cleared in 510(k) K133202. Like the M/L Hem-o-lok® manual, endoscopic clip appliers, the Percuvance™ Clip Applier Tool Tip is compatible with Teleflex Medical's M/L Hem-o-lok® ligating clip (SKU 544230), which was also cleared in 510(k) K133202.

Reference (Accessory) Device	Manufacturer	510(k) No.	Date Cleared
Hem-o-lok® Ligating Clip System	Teleflex Medical, Inc.	K133202	December 3, 2013

l. Comparison to Predicate Device

The proposed Percuvance™ Percutaneous Surgical System is substantially equivalent to the predicate system with respect to technology, intended use, indications for use and functional characteristics. The proposed modifications to Percuvance™ Percutaneous System does not introduce any new issues of safety and effectiveness.

J. Materials

All patient contacting materials are equivalent to the predicate Percuvance™ Percutaneous Surgical System and have been evaluated in accordance with ISO 10993-1:2009 (C2010) and FDA Guidance: Use of International Standard ISO 10993 (published June 16, 2016), according to their nature and duration of contact.

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K. Technological Characteristics

A comparison of the technological characteristics of the proposed Percuvance™ Percutaneous Surgical System and the predicate system has been performed. The results of this comparison demonstrate that the proposed system utilizes substantially equivalent technology as the predicate system.

ComparativeCharacteristics	Predicate Device (K153063)	Proposed DevicePercuvance™
	Percuvance™ Percutaneous Surgical System	PercutaneousSurgical System
Indications for Use	The Percutaneous Surgical System with 5mmattachments is indicated for the means topenetrate soft tissue to access certain areas of theabdomen. The system is used to grasp,manipulate, cut, cauterize and deliver Hem-o-lok®ligating clips to soft tissue during laparoscopicsurgery.	Equivalent
Intended Use	The Percutaneous Surgical System is a platformconsisting of a percutaneous surgical set andaccessories used as a means to penetrate softtissue to access certain areas of the abdomen.The devices' Tool Tips or attachments areprovided separately from the percutaneous Shaftand are introduced to the site via a traditionalconduit such as a trocar once they are attachedextracorporeally to the Shaft tip. A Seal Bridge isused in conjunction with the trocar to maintaininsufflation during extracorporeally exchange.Once inside the abdomen, the surgical set is usedto grasp, manipulate, cut, cauterize, and deliverHem-o-lok® ligating clips to soft tissues duringlaparoscopic surgery.	Equivalent
Contraindications	The monopolar active Tool Tips are not intendedfor contraceptive coagulation of fallopian tissue,but may be used to achieve hemostasis followingtransection of the fallopian tube. (systemcontraindication)Do not resterilize single patient use components.These components are provided sterile and areintended for use in a single procedure. Discardafter use. (system contraindication)The device is not intended for use whenendoscopic techniques are generallycontraindicated. (system contraindication)	Equivalent
ComparativeCharacteristics	Predicate Device (K153063)Percuvance™ Percutaneous Surgical System	Proposed DevicePercuvance™PercutaneousSurgical System
	Hem-o-lok® ligating clips are not intended for useas a fallopian contraceptive tubal occlusion device.(accessory ligating clip contraindication)
	Hem-o-lok® ligating clips are contraindicated foruse in ligating the renal artery during laparoscopicdonor nephrectomies. (accessory ligating clipcontraindication)
Intended Procedure	Laparoscopic	Equivalent
Reusability Status	Handles are reusable; All other components aresingle patient use and disposable	Equivalent
Sterility Status	Handles are provided non-sterile and are intendedto be sterilized by end user prior to use; All othercomponents are provided sterile	Equivalent
Sterilization Method	Non-sterile (reusable) components to be steamsterilized by end user; Sterile componentssterilized by gamma irradiation using methodVDmax	Equivalent
Energy	Monopolar	Equivalent
Rated AccessoryVoltage	1000 VPeak	Equivalent
Connector Type	Handle Post	Equivalent
ElectrosurgicalTesting	CB Scheme (in compliance with IEC 60601-1series 2nd and 3.1 Editions)	Equivalent
Handle	Yes	Equivalent
Shaft	Yes (2.9 mm)	Equivalent
Introducer Tip	Yes	Equivalent
Tool Tips	Yes (5 mm)	Equivalent
Graspers	Yes	Equivalent
MarylandDissectors	Yes	Equivalent
Scissors	Yes	Equivalent
Cautery Tips	Yes (Spatula and Hook)	Equivalent
Clip Applier	Yes	Equivalent
Seal Bridges	Yes	Equivalent
ExchangeTechnology	Exchanged extracorporeally	Equivalent

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L. Performance Data

Comprehensive bench testing was completed on the modifications identified below to ensure the system performed equivalently (or better) to the predicate system. Existing design, usability validations and packaging (ship) testing, performed on the predicate device still adequately covers the proposed device. Stability testing was repeated on the sterile components and their packaging to support the legacy extended 3 year shelf life according to aging methods and test methods previously submitted in the predicate 510(k) in support of the initial 1 year shelf life. Though the majority of the electrosurgical safety testing submitted for the system is still valid, certain electrosurgical safety tests were repeated at a third party test house to support the Shaft metal lock tube change.

Biocompatibility data submitted for the Percuvance system still adequately represents the proposed system, as no new patient contacting materials were introduced. However, as a result of Shaft's green ink band modification, which is pad printed on the Shaft's proximal knob, a full biocompatibility panel was completed. Additionally, cytotoxicity testing was performed on the Shaft metal lock tube change. The additional biocompatibility and cytotoxicity tests were performed as a conservative measure, as both modifications impacted parts of the device that are not intended to have any patient contact.

M. Conclusion

Based upon the testing presented throughout the submission and in this 510(k) Summary, Teleflex Medical's Percuvance™ Percutaneous Surgical System is substantially equivalent in to the predicate device cleared to market via 510(k) K153063. The modifications to the proposed Percuvance™ Percutaneous Surgical System do not introduce any new issues of safety and effectiveness.

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.