The Percutaneous Surgical System with 5 mm attachments is indicated for the means to penetrate soft tissue to access certain areas of the human abdomen and used to grasp, hold and manipulate tissue during laparoscopic surgery.

Device Description

Teleflex Medical's proposed Percuvance® Percutaneous Surgical System is a microlaparoscopic platform that comprises 9 unique components, which are combined in various configurations to create a multifunctional set of instruments for laparoscopic procedures. While this system is to be branded as Percuvance®, the specific portfolio name for this proposed platform is Teleflex Percutaneous Solutions. System components include a reusable Handle, which is manipulated by the surgeon and connects to a Shaft. The Shaft affords various End Effectors to be attached in order to perform basic surgical manipulation. Initial access to the surgical site is achieved with the Introducer End Effector attached to the Shaft. Once inside the patient, the Introducer End Effector is extracorporealized through a pre-inserted, central trocar and is then exchanged for one of the other End Effectors, which include Metzenbaum Scissors, Gripper Grasper, Johans Grasper and Maryland Dissector. 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 End Effectors.

AI/ML Overview

This document describes a 510(k) premarket notification for the "Percuvance® Percutaneous Surgical System" by Teleflex Medical Incorporated. It claims substantial equivalence to a predicate device.

Here's the breakdown of the acceptance criteria and study information:

1. Table of Acceptance Criteria and Reported Device Performance

The FDA clearance letter and 510(k) summary do not provide a table with specific, quantifiable acceptance criteria (e.g., "grip strength must be > X Newtons") alongside reported performance values. Instead, they state that various tests were "successfully completed" and "acceptable."

Acceptance Criteria (Implied)	Reported Device Performance
Functional Verification	"Successfully completed"
Dimensional Verification	"Successfully completed"
Force Verification	"Successfully completed"
Handle Durability	"Exposed to repeated actuations, as well as durability studies," results "acceptable."
Shaft Durability & Strength	"Underwent durability and strength testing," results "acceptable."
End Effector Grip Strength & Tissue Retention	"Evaluated for grip strength and tissue retention," results "acceptable."
Seal Bridge Insufflation Leak Prevention	"Exposed to insufflation leak prevention testing," results "acceptable."
System Compatibility	"Evaluated for system compatibility," results "acceptable."
Usability/Performance in Surgical Procedures	"All design and usability validation testing results were acceptable." (Based on surgeon feedback)
Biocompatibility (Patient-Contacting Materials)	"Evaluated in accordance with ISO 10993-1:2009, FDA Bluebook Memorandum G95-1 and FDA Draft Guidance: Use of International Standard ISO 10993." (Implied acceptance if reviewed and found compliant)

2. Sample Size Used for the Test Set and Data Provenance

Bench Testing (Functional, Dimensional, Force Verification): The document does not explicitly state the sample size (number of devices/components tested) for the bench testing. It refers to "The Hands," "The Shafts," "The End Effectors," and "The Seal Bridges" implying multiple units were tested without giving a specific count.
Usability / Validation Testing: 14 surgeons participated.
Data Provenance: The studies were internal "comprehensive bench testing" and "design and usability validation testing" conducted by Teleflex Medical Incorporated. The location of these studies is not specified, but the company is located in Research Triangle Park, North Carolina, USA. It is implied to be prospective as these tests were conducted as part of the device development and submission process.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of those Experts

Usability / Validation Testing: 14 surgeons were used to evaluate the device in a porcine model. Their specific qualifications (e.g., years of experience, specialty) are not detailed beyond "surgeons." For a medical device, it is standard to assume these are practicing surgeons qualified in laparoscopic procedures.
Bench Testing: For the bench tests, the "ground truth" would be engineering specifications and standards, verified by internal testing personnel, not external experts in the same way as clinical or usability tests.

4. Adjudication Method for the Test Set

Usability / Validation Testing: Surgeons completed a "device usability questionnaire to evaluate the performance of the system." The document states, "All design and usability validation testing results were acceptable." This implies that the feedback from the 14 surgeons was aggregated and determined to be satisfactory, but no specific adjudication method (e.g., 2+1, majority vote) is mentioned for resolving conflicting opinions if any arose. The "study director" guided the surgeons "without interference."
Bench Testing: Not applicable, as this involves objective measurements against predefined criteria.

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 MRMC comparative effectiveness study was done. This device is a surgical instrument, not an AI or imaging device that would typically involve a "multi reader multi case" study or AI assistance. The comparison made is for substantial equivalence to a predicate device, not an enhancement of human performance with AI.

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

Not applicable. This device is a manual surgical instrument, not an algorithm or AI system.

7. The Type of Ground Truth Used

Bench Testing: The ground truth for these tests (functional, dimensional, force, durability, strength) was defined by engineering specifications, design requirements, and applicable performance standards for surgical instruments.
Usability / Validation Testing: The ground truth was based on the expert opinion/feedback of 14 surgeons regarding the device's performance and usability during simulated laparoscopic procedures in a porcine model, assessed via a questionnaire.
Biocompatibility: The ground truth was established by international standards (ISO 10993) and FDA guidance for material safety.

8. The Sample Size for the Training Set

Not applicable. This device is a physical surgical instrument, not a machine learning model, so there is no concept of a "training set" in the context of this submission. The "training" for the device would be the R&D and design iterations by Teleflex.

9. How the Ground Truth for the Training Set Was Established

Not applicable. See point 8.

Summary

{0}------------------------------------------------

Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is an abstract symbol resembling a stylized caduceus, featuring three human profiles facing right, suggesting a sense of community and well-being.

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

January 21, 2015

Teleflex Medical Incorporated Ms. Holly Hallock Regulatory Affairs Specialist 2917 Weck Drive Research Triangle Park, North Carolina 27709

Re: K143299

Trade/Device Name: Percuvance® Percutaneous Surgical System Regulation Number: 21 CFR 876.1500 Regulation Name: Endoscope and accessories Regulatory Class: Class II Product Code: GCJ Dated: January 7, 2015 Received: January 8, 2015

Dear Ms. Hallock:

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

{1}------------------------------------------------

device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in 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/Resourcesfor You/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR 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.

for

Sincerely yours,

David Krause -S

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

{2}------------------------------------------------

Indications for Use

510(k) Number (if known) Unknown K143299

Device Name

Percuvance® 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)

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."

{3}------------------------------------------------

510(k) SUMMARY

Percuvance® Percutaneous Surgical System

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

Teleflex Medical, Incorporated 2917 Weck Drive Research Triangle Park, NC 27709 USA 919-433-4918 Phone: 919-433-4996 Fax:

B. Contact Person

Holly Hallock Regulatory Affairs Specialist

C. Date Prepared

January 16th, 2015

D. Device Name

Trade Name:	Percuvance® Percutaneous Surgical System
Common Name:	Laparoscope
Classification Regulation:	CFR 876.1500
Classification:	Class II
Panel:	General & Plastic Surgery
Product Code:	GCJ
Classification Name:	Endoscope and Accessories

E. Device Description

{4}------------------------------------------------

System components include a reusable Handle, which is manipulated by the surgeon and connects to a Shaft. The Shaft affords various End Effectors to be attached in order to perform basic surgical manipulation.

Initial access to the surgical site is achieved with the Introducer End Effector attached to the Shaft. Once inside the patient, the Introducer End Effector is extracorporealized through a pre-inserted, central trocar and is then exchanged for one of the other End Effectors, which include Metzenbaum Scissors, Gripper Grasper, Johans Grasper and Maryland Dissector. 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 End Effectors.

F. Indications for Use

G. Contraindications

There are currently no known contraindications.

H. Substantial Equivalence

Teleflex Medical's proposed Percuvance® Percutaneous Surgical System is substantially equivalent to the predicate Sovereign® Mini Laparoscopic Surgical System:

Predicate Device	Manufacturer	510(k) No.	Date Cleared
Sovereign® Mini	Aesculap, Inc.	K123102	01/03/2013

I. Comparison to Predicate Devices

Teleflex Medical's proposed Percuvance® Percutaneous Surgical System is substantially equivalent to the predicate system with regards to technology, intended use and functional characteristics.

Both systems offer alternatives to traditional laparoscopic procedures, resulting in smaller incision sites. Like the predicate, the Percuvance® Percutaneous Surgical System includes a reusable Handle that connectors to a variety of interchangeable instrument tips, including graspers, scissors and dissectors, which are used for the manipulation of soft tissue.

{5}------------------------------------------------

J. Materials

Patient contacting materials of the Percuvance® Percutaneous Surgical System have been evaluated in accordance with ISO 10993-1:2009, FDA Bluebook Memorandum G95-1 and FDA Draft Guidance: Use of International Standard ISO 10993.

K. Technological Characteristics

A comparison of the technological characteristics of Teleflex Medical's 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.

Like the predicate device, the Percuvance® Percutaneous Surgical System is intended to manipulate tissue and includes components that introduce a variety of instrument configurations into the abdominal cavity with a smaller incision site than traditional laparoscopic surgery requires. Both systems offer reusable Handles that are compatible with interchangeable instrument tips, which include graspers, scissors and dissectors. However, unlike the predicate, the Percuvance® Percutaneous Surgical System affords a percutaneous incision into the patient without the use of a trocar.

L. Performance Data

Comprehensive bench testing, including functional verification, dimensional verification and force verification, has been successfully completed on Teleflex's Medical proposed Percuvance® Percutaneous Surgical System. Resulting data supports that Teleflex Medical's proposed Percuvance® Percutaneous Surgical System performed equivalent to the predicate system.

Design verification testing for the Percuvance® Percutaneous Surgical System consisted of functional testing on the Handle. Shaft, End Effectors and Seal Bridges. The Handles were exposed to repeated actuations, as well as durability studies. The Shafts underwent durability and strength testing, while the End Effectors were evaluated for grip strength and tissue retention. The Seal Bridges were exposed to insufflation leak prevention testing, and all components were evaluated for system compatibility. All design verification testing results were acceptable.

Design and usability validation testing of the Percuvance® Percutaneous Surgical System consisted of 14 surgeons assembling the device, performing laparoscopic procedure steps and disassembling the system in a porcine model. The surgeons were guided without interference by a study director. Surgeons then completed a device usability questionnaire to evaluate the performance of the system. All design and usability validation testing results were acceptable.

{6}------------------------------------------------

M. Conclusion

Based upon the testing and research presented throughout the submission and in this 510(k) Summary, Teleflex Medical's proposed Percuvance® Percutaneous Surgical System is substantially equivalent in to the predicate device cleared to market via 510(k) K123102. The new design of the Percuvance® Percutaneous Surgical System does not introduce any new issues of safety and effectiveness.

Regulation Number and Section

§ 876.1500 Endoscope and accessories.

(a)
Identification. An endoscope and accessories is a device used to provide access, illumination, and allow observation or manipulation of body cavities, hollow organs, and canals. The device consists of various rigid or flexible instruments that are inserted into body spaces and may include an optical system for conveying an image to the user's eye and their accessories may assist in gaining access or increase the versatility and augment the capabilities of the devices. Examples of devices that are within this generic type of device include cleaning accessories for endoscopes, photographic accessories for endoscopes, nonpowered anoscopes, binolcular attachments for endoscopes, pocket battery boxes, flexible or rigid choledochoscopes, colonoscopes, diagnostic cystoscopes, cystourethroscopes, enteroscopes, esophagogastroduodenoscopes, rigid esophagoscopes, fiberoptic illuminators for endoscopes, incandescent endoscope lamps, biliary pancreatoscopes, proctoscopes, resectoscopes, nephroscopes, sigmoidoscopes, ureteroscopes, urethroscopes, endomagnetic retrievers, cytology brushes for endoscopes, and lubricating jelly for transurethral surgical instruments. This section does not apply to endoscopes that have specialized uses in other medical specialty areas and that are covered by classification regulations in other parts of the device classification regulations.(b)
Classification —(1)Class II (special controls). The device, when it is an endoscope disinfectant basin, which consists solely of a container that holds disinfectant and endoscopes and accessories; an endoscopic magnetic retriever intended for single use; sterile scissors for cystoscope intended for single use; a disposable, non-powered endoscopic grasping/cutting instrument intended for single use; a diagnostic incandescent light source; a fiberoptic photographic light source; a routine fiberoptic light source; an endoscopic sponge carrier; a xenon arc endoscope light source; an endoscope transformer; an LED light source; or a gastroenterology-urology endoscopic guidewire, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 876.9.(2) Class I for the photographic accessories for endoscope, miscellaneous bulb adapter for endoscope, binocular attachment for endoscope, eyepiece attachment for prescription lens, teaching attachment, inflation bulb, measuring device for panendoscope, photographic equipment for physiologic function monitor, special lens instrument for endoscope, smoke removal tube, rechargeable battery box, pocket battery box, bite block for endoscope, and cleaning brush for endoscope. The devices subject to this paragraph (b)(2) are exempt from the premarket notification procedures in subpart E of part 807of this chapter, subject to the limitations in § 876.9.