(65 days)
Not Found
No
The device description and performance studies focus on mechanical components and surgical manipulation, with no mention of AI or ML capabilities. The testing described is traditional usability and functional testing, not AI/ML model validation.
No.
The device is a surgical system used for tissue manipulation during laparoscopic surgery, not for treating a disease or condition.
No.
The device is indicated for manipulating tissue during laparoscopic surgery, which is a therapeutic rather than a diagnostic function.
No
The device description clearly outlines multiple physical components (Handle, Shaft, End Effectors, Seal Bridge) and the performance studies detail bench testing and functional verification of these hardware components.
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 to "penetrate soft tissue to access certain areas of the human abdomen and used to grasp, hold and manipulate tissue during laparoscopic surgery." This describes a surgical instrument used in vivo (within the living body) for direct surgical intervention.
- Device Description: The description details components like a Handle, Shaft, End Effectors (scissors, graspers, dissector), and a Seal Bridge. These are all tools designed for physical manipulation of tissue during surgery.
- Lack of IVD Characteristics: An IVD device is used to examine specimens derived from the human body (like blood, urine, tissue samples) in vitro (outside the body) to provide information for diagnosis, monitoring, or screening. This device does not perform any such analysis of biological specimens.
Therefore, the Percuvance® Percutaneous Surgical System is a surgical device, not an IVD.
N/A
Intended Use / Indications for Use
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.
Product codes (comma separated list FDA assigned to the subject device)
GCJ
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
human abdomen
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
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.
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.
Not Found
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
§ 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.
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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
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Indications for Use
510(k) Number (if known) Unknown K143299
Device Name
Percuvance® Percutaneous Surgical System
Indications for Use (Describe)
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.
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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FOR FDA USE ONLY
Concurrence of Center for Devices and Radiological Health (CDRH) (Signature)
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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
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.
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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
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.
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.
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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.
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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.