(173 days)
Laparoscopes are used by surgeons in diagnostic and therapeutic procedures. Laparoscopic minimally invasive procedures are performed in the abdominal cavity by means of small skin punctures that allow the insertion of the laparoscope and laparoscopic instruments.
The PMC Laparoscopic instruments are intended to scrape, cut, grasp, hold, remove, and manipulate tissue, organs or bowel during laparoscopic surgery. The secondary function is to provide monopolar electrocautery capability to dissect and coagulate soft tissue.
PMC Laparoscopes provide illumination and visualization in diagnostic procedures and in conjunction with laparoscopic instruments (accessories) operative laparoscopic procedures as:
-unexplained pelvic pain (acute, chronic)
-infertility work-up
-tubal sterilization
-diagnosis and/or treatment of ectopic pregnancy
-evaluation, diagnosis and/or treatment of pelvic tumors, incl. myomata (less than 16 weeks gestational size)
-Retrieval of foreign bodies
-determination of the presence and extent of pelvic endometriosis
-determination of the presence and extent of pelvic inflammatory disease (if not in acute stage)
-access to abdomen for surgical procedures such as LAVH
-visualization, diagnosis and/or treatment of perforate abdominal organs
The PMC Laparoscopic instruments contain different components such as scissors, forceps, connections, handles, sheaths, laparoscopes, light adapters, trocars, electrode, and inserts. The instruments are made out of martensitic stainless steel, a standard material for medical devices, and insulation material.
The provided text is a 510(k) Summary for the PMC Laparoscopic instruments. This document is a premarket notification to the FDA to demonstrate that the device is at least as safe and effective as a legally marketed predicate device and does not raise new questions of safety and effectiveness.
Based on the nature of a 510(k) summary for conventional surgical instruments, the "acceptance criteria" and "study" described are focused on substantially equivalent performance to predicate devices rather than a clinical trial measuring diagnostic accuracy or treatment efficacy in the same way an AI/ML device would be evaluated.
Here's an analysis of the provided information in the context of your questions:
Description of Acceptance Criteria and the Study Demonstrating Device Performance:
The primary acceptance criterion for the PMC Laparoscopic instruments, as stated in the 510(k) summary, is substantial equivalence to existing legally marketed predicate devices (GIMMI ALPHA® Instruments & Accessories K012660 and MicroFrance Laparoscopic Manual Surgical Instruments K080257). This means demonstrating that the new device is as safe and effective as the predicates, and performs as well as or better than them, without raising new questions regarding safety and effectiveness.
The study proving the device meets this criterion is primarily a non-clinical performance evaluation consisting of:
- Bench testing: Performed on the PMC Laparoscopic instruments to demonstrate substantial equivalence to the predicate devices.
- Compliance with relevant standards: PMC certifies adherence to ISO/IEC/EN and other device-related standards.
- Biocompatibility testing:
- Electromagnetic compatibility (EMC) testing:
- Functionality testing:
- Safety testing:
These tests collectively aim to show that the PMC Laparoscopic instruments have similar design, technical characteristics, intended use, indications for use, sterilization methods, and material composition compared to the predicate devices. The summary explicitly states: "The presented data that was conducted on the PMC Laparoscopic instruments shows in its results and in comparison to the predicate devices that the product is safe, as effective, and performs as well as or better than the legally marketed device, therefore do not raise any questions regarding safety and effectiveness."
Specific Information as Requested:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (Implicit for Substantial Equivalence) | Reported Device Performance (Summary of Study Findings) |
|---|---|
| Safety: Device presents no new safety risks compared to predicates. | Bench testing, biocompatibility, EMC, functionality, and safety testing confirm the product components are safe. |
| Effectiveness: Device performs its intended functions effectively. | Bench testing and functionality testing confirm the device performs as well as or better than predicate devices for scraping, cutting, grasping, holding, removing, manipulating tissue, and providing monopolar electrocautery. The device is "as effective" as the legally marketed device. |
| Functional Equivalence: Similar design, materials, and technical characteristics. | Detailed comparison table (page 2) shows similar dimensions (diameter, lengths), materials (stainless steel, carbon-fibre, insulation material), and components (scissors, forceps, connections, handles, sheaths, laparoscopes, light adapters, trocars, electrode, inserts) to the predicate devices. The document states they are "identical to the predicate devices" for the laparoscope and respective instruments. |
| Intended Use/Indications for Use Equivalence: Same clinical applications. | Explicitly stated that intended use and indications for use are similar to predicate devices. |
| Compliance with Standards: Adherence to established medical device standards. | PMC certifies compliance with relevant ISO/IEC/EN and other device-related standards. |
| Absence of New Questions of Safety and Effectiveness: No unanswered concerns arise. | The summary concludes that the data "do not raise any questions regarding safety and effectiveness." |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size: Not explicitly stated. For non-clinical bench testing of surgical instruments, sample sizes are typically determined by engineering V&V protocols based on statistical significance for mechanical properties, material integrity, and functionality tests, rather than patient numbers or imaging data sets.
- Data Provenance: Not explicitly stated, but given the applicant and correspondent are German companies, it's highly probable the testing was conducted in Germany in a laboratory setting. This is retrospective in the sense that the device was fully developed and then tested against the defined criteria.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
- Number of Experts: Not applicable. For this type of device (conventional surgical instruments), ground truth is established by engineering specifications, material standards, and functional performance benchmarks rather than expert consensus on clinical data. The "ground truth" is the established performance of the predicate devices and relevant engineering standards.
- Qualifications of Experts: Not applicable in the context of clinical interpretation. The expertise would lie in engineering, materials science, and quality assurance professionals who designed and executed the bench tests and validated compliance with standards.
4. Adjudication Method for the Test Set
- Adjudication Method: Not applicable. This document does not describe a process involving human adjudicators for "ground truth" establishment in a clinical context. The evaluation is based on objective measurements and compliance with predetermined technical specifications and standards.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done
- MRMC Study: No. This is not an AI/ML device or a diagnostic imaging device that would typically undergo such a study. The comparison is between the new device's physical and functional attributes and those of its predicate devices.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
- Standalone Performance: Not applicable. This is a conventional manual surgical instrument, not an algorithm or AI system.
7. The Type of Ground Truth Used
- Type of Ground Truth: The ground truth used implicitly for substantial equivalence is primarily engineering specifications, material properties, functional performance benchmarks documented for the predicate devices, and international/national standards (ISO/IEC/EN) for medical devices (e.g., biocompatibility standards, electrical safety standards for electrocautery).
8. The Sample Size for the Training Set
- Sample Size for Training Set: Not applicable. This device does not use a training set as it is not an AI/ML algorithm.
9. How the Ground Truth for the Training Set Was Established
- Ground Truth for Training Set Establishment: Not applicable. This device does not use a training set.
§ 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.