(169 days)
No
The description focuses on mechanical and electrical components and does not mention any AI/ML capabilities or data processing related to learning or decision-making.
No
The device is described as a surgical system used to penetrate soft tissue, grasp, manipulate, cut, cauterize, and deliver ligating clips during laparoscopic surgery. While these actions are part of medical treatment, the device itself is an instrument for performing surgery, focusing on mechanical and electrical actions on tissue, rather than providing therapy that directly treats or cures a disease or condition through non-surgical means. It is a tool for a surgeon to perform surgical procedures.
No
The device is a surgical system used for grasping, manipulating, cutting, cauterizing, and delivering ligating clips during laparoscopic surgery, not for diagnosing medical conditions.
No
The device description clearly outlines multiple physical components including handles, shafts, and various tool tips, indicating it is a hardware-based surgical system.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states the device is used for "penetrate soft tissue to access certain areas of the abdomen" and to "grasp, manipulate, cut, cauterize and deliver Hem-o-lok ligating clips to soft tissue during laparoscopic surgery." This describes a surgical instrument used in vivo (within the body) during a surgical procedure.
- Device Description: The description details a surgical system with components like handles, shafts, and various tool tips (scissors, graspers, dissectors, cautery tools, clip applier) designed for direct interaction with tissues during surgery.
- Lack of IVD Characteristics: There is no mention of the device being used to examine specimens (like blood, urine, tissue samples) in vitro (outside the body) to provide information about a physiological state, health, or disease.
IVD devices are specifically designed for testing biological samples outside the body to aid in diagnosis, monitoring, or screening. This device is a surgical tool used directly on the patient during a procedure.
N/A
Intended Use / Indications for Use
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.
Product codes (comma separated list FDA assigned to the subject device)
GEI, GCJ, GDO
Device Description
Teleflex Medical’s next generation 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 to be performed in a hospital setting. In accordance with IEC 60601-1:2005 (A1:2012), this next generation Percuvance™ system is classified as an active accessory with a rated accessory voltage of 1000V peak.
System components include two reusable Handles (Ratcheted and Non-Ratcheted), which are manipulated by the surgeon and connect to a Shaft. The 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 manipulation. The next generation Percuvance™ Handles, Shafts, and Tool Tips are not compatible or interchangeable with components from other percutaneous systems, including those of the existing Percuvance™ Percutaneous Surgical System, which was cleared under 510(k) K143299.
Initial access to the surgical 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 Percuvance™ Percutaneous Surgical System; however, the Clip Applier Tool Tip is compatible with Teleflex Medical’s 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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Abdomen
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Hospital setting
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)
Comprehensive bench testing has been successfully completed on Teleflex’s Medical next generation Percuvance™ Percutaneous Surgical System. Similar to the predicate devices, the next generation Percuvance™ System was subjected to a variety of tests, including biocompatibility evaluation, functional verification, dimensional verification and force verification. Resulting data found that Teleflex Medical’s next generation Percuvance™ Percutaneous Surgical System performed equivalently or better than the predicate systems.
Like the predicate Percuvance™ Percutaneous Surgical System (K143299), Teleflex Medical’s next generation Percuvance™ Percutaneous Surgical System was evaluated for biocompatibility according to ISO 10993-1:2009, FDA Bluebook Memorandum G95-1 and FDA Draft Guidance: Use of International Standard ISO 10993. The following tests were performed on both the predicate Percuvance™ Percutaneous Surgical System (K143299) and the next generation Percuvance™ Percutaneous Surgical System: Cytotoxicity, Intracutaneous, Sensitization, Systemic Toxicity. All tests were successful.
Design verification testing for the next generation Percuvance™ Percutaneous Surgical System consisted of functional testing on the Handle, Shaft, Tool Tips and Seal Bridges. The Handles were exposed to repeated actuations, as well as durability studies. The Shafts underwent durability and strength testing, while the Tool Tips were evaluated for grip strength and tissue retention. The Clip Applier Tool Tip was tested for compatibility with the accessory ligating clip, and the Cautery Tool Tips were exposed to a variety of electrosurgical performance tests. Additionally, the Seal Bridges were exposed to insufflation leak prevention testing, and the entire system was evaluated for compatibility. All design verification testing results were acceptable.
Additional testing was conducted to compare the next generation Percuvance™ Percutaneous Surgical System’s functionality to that of the predicate devices. Side-by-side bench testing compared the Clip Applier Tool Tip (SKU PCVHCA5) to the existing Hem-o-lok® Manual Endoscopic Clip Applier (SKU 544965, K133202). Tests evaluated trocar compatibility, clip formation and clip retention. The results of these tests demonstrate that trocar compatibility is equivalent and that there is not an increased incidence in poorly formed clips or poor clip retention when compared to the reference Clip Appliers.
Side-by-side testing was also conducted to compare the thermal effects of the next generation Percuvance™ Percutaneous Surgical System to that of the predicate devices in accordance with FDA Draft Guidance: Submissions for Electrosurgical Devices for General Surgery. This testing compared the thermal effects of the Maryland Dissector Tool Tip (SKU PCVMD5) to the thermal effects of the existing Pilling® Marvland Dissector (SKU 728014, K040855). Additionally, the Spatula Cautery Tool Tip (SKU PCVSPT5) and the Hook Cautery Tool Tip (SKU PCVHK5) were evaluated against the predicate MiniLap® MiniPolar Straight Spatula (SKU ECMS300, K083754) and L-Hook Probe (SKU ECMH300, K083754), respectively. As part of this testing, thermal effects were evaluated in three ex vivo soft tissue samples (chicken breast, beef liver and beef kidney) at minimum, default and maximum intensity settings for each type of activation (cut and coagulation). Thermal effects were measured and the dimensions (length, width and depth) of each thermal effect were compared to evaluate the thermal effects of each Tool Tip. Results of this testing concluded that the thermal effects of the next generation Percuvance™ Percutaneous Surgical System are equivalent to, or better than, the thermal effects of existing electrosurgical devices.
Design and usability validation testing of the next generation Percuvance™ Percutaneous Surgical System consisted of surgeons assembling the system, performing laparoscopic procedure steps in a porcine model and disassembling the system. 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.
During the porcine usability study, the surgeons also used both the Clip Applier Tool Tip (SKU PCVHCA5) and the existing Hem-o-lok® Manual Endoscopic Clip Applier (SKU 544965, K133202) to apply ligation in the porcine model. After ligation was applied, surgeons used a quantifiable score system to compare the compatibility with the trocar, clip security in the instrument during deployment, clip security in the instrument during tissue manipulation, feedback on closure, and lack of trauma during tissue manipulation and deployment. Results of this comparison conclude that the Clip Applier Tool Tip performs as well as the reference Hem-o-lok® Manual Endoscopic Clip Applier.
Like the predicate MiniLap® MiniPolar Electrocautery Instruments (K083754), the next generation Percuvance™ Percutaneous Surgical System is classified as an active accessory, in accordance with AAMI/ANSI ES60601-1-:2005 (A1:2012). Based on this classification, the Percuvance™ System has been evaluated by a third party test house for electrosurgical safety and usability in accordance with the following applicable collateral and particular standards:
- AAMI/ANSI ES60601-1:2005 (A1:2012) Medical Electrical Equipment Part 1: General Requirements For Basic Safety And Essential Performance (200 edition and 3.1 edition)
- AAMI/ANSI/IEC 60601-1-2:2014 Medical Electrical Equipment -- Part 1-2: General Requirements For Basic Safety And Essential Performance --Collateral Standard: Electromagnetic Disturbances -- Requirements And Tests
- IEC 60601-1-6:2010 (A1:2013) Medical Electrical Equipment -- Part 1-6: General Requirements For Basic Safety And Essential Performance --Collaterial Standard: Usability
- AAMI/ANSI/IEC 60601-2-2:2009 Medical Electrical Equipment Part 2-2: Particular Requirements For The Basic Safety And Essential Performance Of High Frequency Surgery Equipment And High Frequency Surgical Accessories
- IEC 60601-2-18:2009 Medical Electrical Equipment Part 2-18: Particular Requirements For The Basic Safety And Essential Performance Of Endoscopic Equipment
- ISO 8600-1:2013 Optics And Photonics -- Medical Endoscopes And Endotherapy Devices -- Part 1: General Requirements
- ISO 8600-3:1997 (A1:2003) Optics And Optical Instruments Medical Endoscopes And Endoscopic Accessories - Part 3: Determination Of Field Of View And Direction Of View Of Endoscopes With Optics
- ISO 8600-4:2014 Optics And Optical Instruments -- Medical Endoscopes And Certain Accessories -- Part 4: Determination Of Maximum Width Of Insertion Portion
- IEC 62366:2007 (A1:2014) Medical devices Application of usability engineering to medical devices - Edition 1.0
All electrical safety and usability testing results were acceptable.
Based on its intended use and active accessory classification, the next generation Percuvance™ System has been tested for high frequency dielectric strength and mains frequency dielectric strength. Additionally, the following electromagnetic compatibility (EMC) testing was conducted on the next generation Percuvance™ System: Emissions Testing (CISPR 11, Radiated Emissions (Class A), CISPR 11, Conducted Emissions (Class A)) and Immunity Testing (IEC 61000-4-3, Radiated Immunity, IEC 61000-4-6, Conducted Immunity). All results for emissions and immunity testing were compliant.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 878.4400 Electrosurgical cutting and coagulation device and accessories.
(a)
Identification. An electrosurgical cutting and coagulation device and accessories is a device intended to remove tissue and control bleeding by use of high-frequency electrical current.(b)
Classification. Class II.
0
Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized image of three human profiles facing right, stacked on top of each other. The profiles are black and have a flowing, abstract design. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the image.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
April 8, 2016
Teleflex Medical, Inc. Ms. Holly Hallock Senior Regulatory Affairs Specialist 3015 Carrington Mill Blvd Morrisville, North Carolina 27560
Re: K153063
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: March 4, 2016 Received: March 7, 2016
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 of medical devicerelated 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.
1
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,
Jennifer R. Stevenson -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
2
Indications for Use
510(k) Number (if known) K153063
Device Name
Percuvance(TM) Percutaneous Surgical System
Indications for Use (Describe)
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.
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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3
510(k) SUMMARY - K153063
Percuvance™ Percutaneous Surgical System
A. Name, Address, Phone, and Fax Number of Applicant
Teleflex Medical, Incorporated 3015 Carrington Mill Boulevard Morrisville, NC 27560 USA 919-433-4918 Phone: Fax: 919-433-4996
B. Contact Person
Holly Hallock Senior Regulatory Affairs Specialist
C. Date Prepared
April 7th, 2016
D. Device Name
Trade Name
Percuvance™ Percutaneous Surgical System
Common Name
| Primary: | Electrosurgical, Cutting and Coagulation and Accessories |
|---|
Secondary: Laparoscope, General and Plastic Surgery Applier, Surgical, Clip
Classification Regulation
| Primary: | 21 CFR 878.4400 |
|---|---|
| ---------- | ----------------- |
| Secondary: | 21 CFR 876.1500 |
|---|---|
| 21 CFR 878.4800 |
Product Code
Primary: GEI
4
Secondary: GCJ GDO
Classification Name
| Primary: | Electrosurgical Cutting and Coagulation Device and Accessories |
|---|---|
| Secondary: | Endoscope and Accessories |
| Manual Surgical Instrument for General Use | |
| Classification: | Class II |
Panel
General & Plastic Surgery
E. Device Description
Teleflex Medical's next generation 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 to be performed in a hospital setting. In accordance with IEC 60601-1:2005 (A1:2012), this next generation Percuvance™ system is classified as an active accessory with a rated accessory voltage of 1000V peak-
System components include two reusable Handles (Ratcheted and Non-Ratcheted), which are manipulated by the surgeon and connect to a Shaft. The 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 manipulation. The next generation Percuvance™ Handles, Shafts, and Tool Tips are not compatible or interchangeable with components from other percutaneous systems, including those of the existing Percuvance™ Percutaneous Surgical System, which was cleared under 510(k) K143299.
Initial access to the surgical 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 Percuvance™ Percutaneous Surgical System; however, the Clip Applier Tool Tip is compatible with Teleflex Medical's M/L Hem-o-lok® ligating clip (SKU 544230).
5
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 | Component
Description | Reusability
Status | Sterility Status | Intended to
Apply
Monopolar
Energy? |
|--------------|---------------------------------------|------------------------|---------------------------------------------------------------------------------|------------------------------------------------------------------------|
| PCVINT3 | Introducer Tool Tip | Single-
Patient-Use | Provided Sterile -
Gamma Irradiated | No |
| PCVSC5 | Scissors Tool Tip | Single-
Patient-Use | Provided Sterile -
Gamma Irradiated | Yes |
| PCVGG5 | Traumatic Gripper
Grasper Tool Tip | Single-
Patient-Use | Provided Sterile -
Gamma Irradiated | Yes |
| PCVJG5 | Atraumatic Johans
Grasper Tool Tip | Single-
Patient-Use | Provided Sterile -
Gamma Irradiated | Yes |
| PCVMD5 | Maryland Dissector
Tool 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
Tool Tip | 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 Steam
Sterilized by
Hospital | Yes |
| PCVRH | Ratcheted Handle | Reusable | Provided Non-
Sterile - Intended
to be Steam
Sterilized by
Hospital | Yes |
| PCVSB5 | 5 mm Seal Bridge | Single-
Patient-Use | Provided Sterile -
Gamma Irradiated | N/A – Not
connected to
the Handle and
Shaft |
| | | | | configuration |
| PCVSB12 | 12 mm Seal Bridge | Single-
Patient-Use | Provided Sterile –
Gamma Irradiated | N/A – Not
connected to
the Handle and
Shaft
configuration |
All model numbers and associated descriptions of components included in the next generation Percuvance™ Percutaneous Surgical System are identified below.
6
F. Indications for Use
The following are indications for use of the next generation Percuvance™ Percutaneous Surgical System:
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-olok ligating clips to soft tissue during laparoscopic surgery.
These indications for use were primarily generated from identical indications for use identified from the predicate Percuvance™ Percutaneous Surgical System (K143299):
The Percutaneous Surgical System with 5mm 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.
The only differences in these indications for use statements are that the next generation Percuvance™ Percutaneous Surgical System introduces the abilities to "cut, cauterize" and "deliver Hem-o-lok® ligating clips," which were generated from the predicate MiniLap® MiniPolar Electrocautery Instruments and the reference Hem-o-lok® Ligating Clip System, respectively.
The following are indications for use of the predicate MiniLap® MiniPolar Electrocautery Instruments (K083754):
The MiniPolar Instruments are used to cut and cauterize soft tissue.
The following are indications for use of the reference Hem-o-lok® Ligating Clip System:
Weck Hem-o-lok® Endoscopic Ligating Clip Appliers are indicated for use as delivery devices for Hem-o-lok® Ligating Clips.
7
These additions to the next generation Percuvance™ Percutaneous Surgical System's indications for use are not critical, as they were generated from predicate and reference devices that have already been cleared by the FDA.
G. Contraindications
The following are contraindications of the next generation 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.
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™M 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.
H. Substantial Equivalence
Teleflex Medical's next generation Percuvance™ Percutaneous Surgical System is substantially equivalent to the following predicate systems.
| Predicate Device | Manufacturer | 510(k) No. | Date Cleared |
|---|---|---|---|
| Percuvance™ Percutaneous | |||
| Surgical System | Teleflex Medical, | ||
| Inc. | K143299 | January 21, 2015 | |
| MiniLap® MiniPolar | |||
| Electrocautery Instruments | Teleflex Medical, | ||
| Inc. | K083754 | November 20, 2009 |
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.
8
| Reference (Accessory) Device | Manufacturer | 510(k) No. | Date Cleared |
|---|---|---|---|
| Hem-o-lok® Ligating Clip | |||
| System | Teleflex Medical, Inc. | K133202 | December 3, 2013 |
I. Comparison to Predicate Devices
Teleflex Medical's next generation Percuvance™ Percutaneous Surgical System is substantially equivalent to the predicate systems with regards to technology, intended use, indications for use and functional characteristics.
One predicate system is Teleflex Medical's existing Percuvance™ Percutaneous Surgical System, which is legally marketed under 510(k) K143299. Like the next generation Percuvance™ system, the existing Percuvance™ system is a microlaparoscopic system comprised of a multifunctional set of instruments that reduces the need for ports during laparoscopic procedures. Both systems are indicated for the penetration of soft tissue to access certain areas of the abdomen and used to grasp, hold and manipulate tissue.
Like this predicate system, the next generation Percuvance™ system utilizes an Introducer Tool Tip, Shaft and Handle to percutaneously introduce the system into the patient's surgical site. After introduction, both systems are capable of exchanging the Introducer Tool Tip for a variety of other Tool Tips in order to perform the surgical steps of the laparoscopic procedure. Each Percuvance™ system also includes a Seal Bridge, which is used to protect the trocar seal and to aid in maintaining insufflation when used in conjunction with a trocar to facilitate the extracorporeal exchange of Tool Tips.
The next generation Percuvance™ Percutaneous Surgical System combines the features of the existing Percuvance™ System with the electrosurgical features of Teleflex Medical's MiniLap® MiniPolar Electrocautery Instruments, which are legally marketed under 510(k) K083754. The MiniLap® system, which is also a predicate device, is a percutaneous system that allows surgeons to apply RF energy through a variety of monopolar instruments. Like the predicate MiniLap® system, the next generation Percuvance™ system includes a Hook Cautery Tool Tip and a Spatula Cautery Tool Tip for the application of monopolar RF energy.
A manual Clip Applier Tool Tip has also been added to the next generation Percuvance™ system to afford users the ability to ligate. While ligation clips are not provided with the next generation Percuvance™ system, the manual Clip Applier Tool Tip is compatible with M/L Hem-o-lok® ligating clip (SKU 544230), currently marketed by Teleflex Medical under 510(k) K133202.
The similarities and differences of the next generation Percuvance™ system compared to the predicate devices are presented in the following table.
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| Comparative
Characteristics | Next
Generation
Percuvance™
System | Percuvance™M
System | MiniLap®
MiniPolar
Electrocautery
Instruments | Hem-o-lok®
Ligating
Clip System | Explanation
of
Differences |
|--------------------------------|------------------------------------------------|------------------------------------|---------------------------------------------------------------------------------------------------------------|---------------------------------------|-----------------------------------------|
| | K153063 | Predicate -
K143299 | Predicate -
K083754 | Reference -
K133202 | |
| Handle | Yes | Yes | Yes, thumb grip
Handle pre-
assembled to
Shaft and
Instrument Tip
as one finished
component | N/A | Equivalent to
K143299 and
K083754 |
| Shaft | Yes (2.9mm) | Yes (3mm) | Yes (2.4mm) | N/A | Equivalent to
K143299 and
K083754 |
| Introducer Tip | Yes | Yes | Yes, pre-
assembled to
Shaft and
Instrument Tip
as one finished
component | N/A | Equivalent to
K143299 and
K083754 |
| Tool Tips | Yes (5mm) | Yes (5mm) | Yes, but not
exchangeable;
Tips pre-
assembled to
Shaft | N/A | Equivalent to
K143299 and
K083754 |
| Tool Tip
Attachment | Snap
connection to
Shaft over
detents | Threaded to
Shaft | Pre-assembled | N/A | Equivalent to
K143299 |
| Graspers | Yes | Yes | No | N/A | Equivalent to
K143299 |
| Maryland
Dissectors | Yes | Yes | No | N/A | Equivalent to
K143299 |
| Scissors | Yes | Yes | No | N/A | Equivalent to
K143299 |
| Cautery Tips | Yes (Spatula
and Hook) | No | Yes (Spatula,
Hook, and
Conical) | N/A | Equivalent to
K083754 |
| Clip Applier | Yes | No | No | Yes | Equivalent to
K133202 |
| Seal Bridges | Yes | Yes | No | N/A | Equivalent to
K143299 |
| Energy | Monopolar | No | Monopolar | N/A | Equivalent to
K083754 |
| Exchange
Technology | Exchanged
extra-
corporeally | Exchanged
extra-
corporeally | Instrument Tips
are pre-
assembled to
Shaft and not
exchangeable | N/A | Equivalent to
K143299 |
10
J. Materials
Patient contacting materials of the next generation 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.
| Model
Number | Component
Description | Materials | Type of Contact |
|-----------------|-----------------------------------|---------------------------------------------------|------------------------------------------------------------------------------|
| PCVINT3 | Introducer Tool
Tip | Stainless Steel | External Communicating Device
with Tissue Contact for Limited
Duration |
| PCVSC5 | Scissors Tool
Tip | Stainless Steel
PEEK
White Ink
Lubricant | External Communicating Device
with Tissue Contact for Limited
Duration |
| PCVGG5 | Gripper Grasper
Tool Tip | Stainless Steel
PEEK
White Ink | External Communicating Device
with Tissue Contact for Limited
Duration |
| PCVJG5 | Johans Grasper
Tool Tip | Stainless Steel
PEEK
White Ink | External Communicating Device
with Tissue Contact for Limited
Duration |
| PCVMD5 | Maryland
Dissector Tool
Tip | Stainless Steel
PEEK
White Ink | External Communicating Device
with Tissue Contact for Limited
Duration |
| PVCHK5 | Hook Cautery
Tool Tip | Stainless Steel
PEEK
White Ink | External Communicating Device
with Tissue Contact for Limited
Duration |
| PCVSPT5 | Spatula Cautery
Tool Tip | Stainless Steel
PEEK
White Ink | External Communicating Device
with Tissue Contact for Limited
Duration |
| PCVHCA5 | Clip Applier
Tool Tip | Stainless Steel
PEEK
White Ink | External Communicating Device
with Tissue Contact for Limited
Duration |
| PCVSH3 | 29cm Shaft | Stainless Steel
PEEK
PET
PC | External Communicating Device
with Tissue Contact for Limited
Duration |
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| Green Ink | |||
|---|---|---|---|
| PCVSHL3 | 36cm Shaft | Stainless Steel | |
| PEEK | |||
| PET | |||
| PC | |||
| Green Ink | External Communicating Device | ||
| with Tissue Contact for Limited | |||
| Duration | |||
| PCVNRH | Non-Ratcheted | ||
| Handle | Stainless Steel | ||
| PEEK | |||
| Nylon | |||
| Medical Grade Epoxy | Surface Device with Skin Contact | ||
| for Limited Duration | |||
| PCVRH | Ratcheted | ||
| Handle | Stainless Steel | ||
| PEEK | |||
| Nylon | |||
| Medical Grade Epoxy | Surface Device with Skin Contact | ||
| for Limited Duration | |||
| PCVSB5 | 5mm Seal | ||
| Bridge | Silicone | ||
| Cyrolite | External Communicating Device | ||
| with Tissue Contact for Limited | |||
| Duration | |||
| PCVSB12 | 12mm Seal | ||
| Bridge | Silicone | ||
| Cyrolite | External Communicating Device | ||
| with Tissue Contact for Limited | |||
| Duration |
K. Technological Characteristics
A comparison of the technological characteristics of Teleflex Medical's next generation Percuvance™ Percutaneous Surgical System and the predicate systems has been performed. The results of this comparison demonstrate that the proposed system utilizes substantially equivalent technology as the predicate systems.
Both predicate systems and the next generation Percuvance™ Percutaneous Surgical System offer alternatives to traditional laparoscopic procedures, resulting in smaller incision sites to the abdomen. Like the existing Percuvance™ predicate system (K143299), the next generation 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. Like the MiniLap® MiniPolar predicate system (K083754), the next generation Percuvance™ Percutaneous Surgical System includes Hook Cautery and Spatula Cautery instrument tips to apply monopolar RF energy.
The next generation Percuvance™ Percutaneous Surgical System also includes a Clip Applier Tool Tip, which utilizes technology equivalent to that of the M/L Hem-olok® manual, endoscopic clip applier cleared in 510(k) K133202. Like the M/L Hemo-lok® manual, endoscopic clip appliers, the Percuvance™ Clip Applier Tool Tip is
12
compatible with Teleflex Medical's M/L Hem-o-lok® ligating clip (SKU 544230). which was also cleared in 510(k) K133202.
L. Performance Data
Comprehensive bench testing has been successfully completed on Teleflex's Medical next generation Percuvance™ Percutaneous Surgical System. Similar to the predicate devices, the next generation Percuvance™ System was subjected to a variety of tests, including biocompatibility evaluation, functional verification, dimensional verification and force verification. Resulting data found that Teleflex Medical's next generation Percuvance™ Percutaneous Surgical System performed equivalently or better than the predicate systems.
Like the predicate Percuvance™ Percutaneous Surgical System (K143299), Teleflex Medical's next generation Percuvance™ Percutaneous Surgical System was evaluated for biocompatibility according to ISO 10993-1:2009, FDA Bluebook Memorandum G95-1 and FDA Draft Guidance: Use of International Standard ISO 10993. The following tests were performed on both the predicate Percuvance™ Percutaneous Surgical System (K143299) and the next generation Percuvance™ Percutaneous Surgical System. All tests were successful.
| Model
Number | Component
Description | Type of Contact | Tests Conducted | Results |
|-----------------|-----------------------------------|---------------------------------------------------------------------------------|----------------------------------------------------------------------|---------|
| PCVINT3 | Introducer Tool
Tip | External
Communicating Device
with Tissue Contact for
Limited Duration | Cytotoxicity
Intracutaneous
Sensitization
Systemic Toxicity | Pass |
| PCVSC5 | Scissors Tool
Tip | External
Communicating Device
with Tissue Contact for
Limited Duration | Cytotoxicity
Intracutaneous
Sensitization
Systemic Toxicity | Pass |
| PCVGG5 | Gripper Grasper
Tool Tip | External
Communicating Device
with Tissue Contact for
Limited Duration | Cytotoxicity
Intracutaneous
Sensitization
Systemic Toxicity | Pass |
| PCVJG5 | Johans Grasper
Tool Tip | External
Communicating Device
with Tissue Contact for
Limited Duration | Cytotoxicity
Intracutaneous
Sensitization
Systemic Toxicity | Pass |
| PCVMD5 | Maryland
Dissector Tool
Tip | External
Communicating Device
with Tissue Contact for
Limited Duration | Cytotoxicity
Intracutaneous
Sensitization
Systemic Toxicity | Pass |
| PVCHK5 | Hook Cautery
Tool Tip | External
Communicating Device
with Tissue Contact for | Cytotoxicity
Intracutaneous
Sensitization | Pass |
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| Limited Duration | Systemic Toxicity | |||
|---|---|---|---|---|
| PCVSPT5 | Spatula Cautery | |||
| Tool Tip | External | |||
| Communicating Device | ||||
| with Tissue Contact for | ||||
| Limited Duration | Cytotoxicity | |||
| Intracutaneous | ||||
| Sensitization | ||||
| Systemic Toxicity | Pass | |||
| PCVHCA5 | Clip Applier | |||
| Tool Tip | External | |||
| Communicating Device | ||||
| with Tissue Contact for | ||||
| Limited Duration | Cytotoxicity | |||
| Intracutaneous | ||||
| Sensitization | ||||
| Systemic Toxicity | Pass | |||
| PCVSH3 | 29cm Shaft | External | ||
| Communicating Device | ||||
| with Tissue Contact for | ||||
| Limited Duration | Cytotoxicity | |||
| Intracutaneous | ||||
| Sensitization | ||||
| Systemic Toxicity | Pass | |||
| PCVSHL3 | 36cm Shaft | External | ||
| Communicating Device | ||||
| with Tissue Contact for | ||||
| Limited Duration | Cytotoxicity | |||
| Intracutaneous | ||||
| Sensitization | ||||
| Systemic Toxicity | Pass | |||
| PCVNRH | Non-Ratcheted | |||
| Handle | Surface Device with | |||
| Skin Contact for | ||||
| Limited Duration | Cytotoxicity | |||
| Intracutaneous | ||||
| Sensitization | Pass | |||
| PCVRH | Ratcheted | |||
| Handle | Surface Device with | |||
| Skin Contact for | ||||
| Limited Duration | Cytotoxicity | |||
| Intracutaneous | ||||
| Sensitization | Pass | |||
| PCVSB5 | 5mm Seal | |||
| Bridge | External | |||
| Communicating Device | ||||
| with Tissue Contact for | ||||
| Limited Duration | Cytotoxicity | |||
| Intracutaneous | ||||
| Sensitization | ||||
| Systemic Toxicity | Pass | |||
| PCVSB12 | 12mm Seal | |||
| Bridge | External | |||
| Communicating Device | ||||
| with Tissue Contact for | ||||
| Limited Duration | Cytotoxicity | |||
| Intracutaneous | ||||
| Sensitization | ||||
| Systemic Toxicity | Pass |
Design verification testing for the next generation Percuvance™ Percutaneous Surgical System consisted of functional testing on the Handle, Shaft, Tool Tips and Seal Bridges. The Handles were exposed to repeated actuations, as well as durability studies. The Shafts underwent durability and strength testing, while the Tool Tips were evaluated for grip strength and tissue retention. The Clip Applier Tool Tip was tested for compatibility with the accessory ligating clip, and the Cautery Tool Tips were exposed to a variety of electrosurgical performance tests. Additionally, the Seal Bridges were exposed to insufflation leak prevention testing, and the entire system was evaluated for compatibility. All design verification testing results were acceptable.
14
Additional testing was conducted to compare the next generation Percuvance™ Percutaneous Surgical System's functionality to that of the predicate devices. Sideby-side bench testing compared the Clip Applier Tool Tip (SKU PCVHCA5) to the existing Hem-o-lok® Manual Endoscopic Clip Applier (SKU 544965, K133202). Tests evaluated trocar compatibility, clip formation and clip retention. The results of these tests demonstrate that trocar compatibility is equivalent and that there is not an increased incidence in poorly formed clips or poor clip retention when compared to the reference Clip Appliers.
Side-by-side testing was also conducted to compare the thermal effects of the next generation Percuvance™ Percutaneous Surgical System to that of the predicate devices in accordance with FDA Draft Guidance: Submissions for Electrosurgical Devices for General Surgery. This testing compared the thermal effects of the Maryland Dissector Tool Tip (SKU PCVMD5) to the thermal effects of the existing Pilling® Marvland Dissector (SKU 728014. K040855). Additionally, the Spatula Cautery Tool Tip (SKU PCVSPT5) and the Hook Cautery Tool Tip (SKU PCVHK5) were evaluated against the predicate MiniLap® MiniPolar Straight Spatula (SKU ECMS300, K083754) and L-Hook Probe (SKU ECMH300, K083754), respectively. As part of this testing, thermal effects were evaluated in three ex vivo soft tissue samples (chicken breast, beef liver and beef kidney) at minimum, default and maximum intensity settings for each type of activation (cut and coagulation). Thermal effects were measured and the dimensions (length, width and depth) of each thermal effect were compared to evaluate the thermal effects of each Tool Tip. Results of this testing concluded that the thermal effects of the next generation Percuvance™ Percutaneous Surgical System are equivalent to, or better than, the thermal effects of existing electrosurgical devices.
Design and usability validation testing of the next generation Percuvance™ Percutaneous Surgical System consisted of surgeons assembling the system, performing laparoscopic procedure steps in a porcine model and disassembling the system. 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.
During the porcine usability study, the surgeons also used both the Clip Applier Tool Tip (SKU PCVHCA5) and the existing Hem-o-lok® Manual Endoscopic Clip Applier (SKU 544965, K133202) to apply ligation in the porcine model. After ligation was applied, surgeons used a quantifiable score system to compare the compatibility with the trocar, clip security in the instrument during deployment, clip security in the instrument during tissue manipulation. feedback on closure, and lack of trauma during tissue manipulation and deployment. Results of this comparison conclude that the Clip Applier Tool Tip performs as well as the reference Hem-olok® Manual Endoscopic Clip Applier.
Like the predicate MiniLap® MiniPolar Electrocautery Instruments (K083754), the next generation Percuvance™ Percutaneous Surgical System is classified as an active
15
accessory, in accordance with AAMI/ANSI ES60601-1-:2005 (A1:2012). Based on this classification, the Percuvance™ System has been evaluated by a third party test house for electrosurgical safety and usability in accordance with the following applicable collateral and particular standards. All electrical safety and usability testing results were acceptable.
- AAMI/ANSI ES60601-1:2005 (A1:2012) Medical Electrical Equipment Part 1: General Requirements For Basic Safety And Essential Performance (200 edition and 3.1 edition)
- AAMI/ANSI/IEC 60601-1-2:2014 Medical Electrical Equipment -- Part 1-2: General Requirements For Basic Safety And Essential Performance --Collateral Standard: Electromagnetic Disturbances -- Requirements And Tests
- IEC 60601-1-6:2010 (A1:2013) Medical Electrical Equipment -- Part 1-6: General Requirements For Basic Safety And Essential Performance --Collaterial Standard: Usability
- AAMI/ANSI/IEC 60601-2-2:2009 Medical Electrical Equipment Part 2-2: Particular Requirements For The Basic Safety And Essential Performance Of High Frequency Surgery Equipment And High Frequency Surgical Accessories
- IEC 60601-2-18:2009 Medical Electrical Equipment Part 2-18: Particular Requirements For The Basic Safety And Essential Performance Of Endoscopic Equipment
- ISO 8600-1:2013 Optics And Photonics -- Medical Endoscopes And Endotherapy Devices -- Part 1: General Requirements
- ISO 8600-3:1997 (A1:2003) Optics And Optical Instruments Medical Endoscopes And Endoscopic Accessories - Part 3: Determination Of Field Of View And Direction Of View Of Endoscopes With Optics
- ISO 8600-4:2014 Optics And Optical Instruments -- Medical Endoscopes And Certain Accessories -- Part 4: Determination Of Maximum Width Of Insertion Portion
- IEC 62366:2007 (A1:2014) Medical devices Application of usability engineering to medical devices - Edition 1.0
Based on its intended use and active accessory classification, the next generation Percuvance™ System has been tested for high frequency dielectric strength and mains frequency dielectric strength. Additionally, the following electromagnetic
16
| Emissions Testing (IEC 60601-1-2:2014) | |
|---|---|
| Standard and Test Description | Results |
| CISPR 11, Radiated Emissions (Class A) | Compliant |
| CISPR 11, Conducted Emissions (Class A) | Compliant |
| Immunity Testing (IEC 60601-1-2:2014) | |
| Standard and Test Description | Results |
| IEC 61000-4-3, Radiated Immunity | Compliant |
| IEC 61000-4-6, Conducted Immunity | Compliant |
compatibility (EMC) testing was conducted on the next generation Percuvance™ System.
M. Conclusion
Based upon the testing and research presented throughout the submission and in this 510(k) Summary, Teleflex Medical's next generation Percuvance™ Percutaneous Surgical System is substantially equivalent in to the predicate devices cleared to market via 510(k) K143299 and K083754. The new design of the Percuvance™ Percutaneous Surgical System does not introduce any new issues of safety and effectiveness.