(65 days)
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.
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.
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.
§ 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.