(84 days)
Introducer for Endoscopic/Laparoscopic procedures.
The PMIPIN15 Percutaneous Introducer Needle is a single- use, disposable EO sterilized device made of 304 stainless steel with a luer hub made of polycarbonate. The introducer sheath is 5 Fr and manufactured from low density polyethylene. The device is manually inserted by the physician during endoscopic and/or laparoscopic procedures.
Here's an analysis of the provided text regarding the acceptance criteria and study for the PMIPIN15 Percutaneous Introducer Needle.
The document is a 510(k) summary for a medical device, which primarily focuses on demonstrating substantial equivalence to a predicate device rather than presenting a novel device with extensive new clinical performance data. Therefore, the "acceptance criteria" here are largely derived from the performance and characteristics of the predicate device and relevant international standards.
1. Table of Acceptance Criteria and Reported Device Performance
Given that this is a 510(k) submission, the "acceptance criteria" are essentially demonstrating equivalence to the predicate device and compliance with relevant standards. The "device performance" is presented as meeting these standards and being similar to the predicate.
| Acceptance Criteria Category | Specific Acceptance Criterion (Implicitly derived or explicitly stated) | Reported Device Performance |
|---|---|---|
| Biocompatibility | Compliant with ISO 10993 series for medical devices. | Passed Cytotoxicity Test (ISO10993-5), Dermal Sensitization Guinea Pig Maximization Tests (ISO10993-10), Intracutaneous Test (ISO10993-10). |
| Sterilization | Validated for Ethylene Oxide (EO) sterilization. | Passed Ethylene Oxide Sterilization Validation (ISO 11135:2014). |
| Packaging | Validated for package integrity and shelf-life. | Passed Package Validation (ASTM 2096-11, ASTM F1186/1886M-16, ASTM F88/F88M-15, ASTM D5276-98). |
| Physical/Mechanical Performance | Equivalent to predicate device in design and materials; compliant with ISO 11070:2014(E) for needle and hub strength, force at break, and penetration. | Physical measurements and visual inspection confirmed similarity to predicate. Performance evaluation (strength of union, force at break) met ISO 11070:2014(E). Needle penetration testing met ISO 11070:2014(E). |
| Accelerated Aging/Shelf Life | Validated for shelf life. | Passed Accelerated aging testing per ASTM F1980-16. Device "met its design specifications" for a 2-year shelf life. |
| Design Specifications | Meet established design specifications (e.g., needle gauge, length, introducer diameter, materials). | The device "met its design specifications" and shown to be similar to the predicate for all listed specifications. |
| Indications for Use | Same as predicate. | "Introducer for Endoscopic/Laparoscopic procedures." - Same as predicate. |
| Sterility | Must be sterile. | "Yes" (Sterility) - Same as predicate. |
| Single Use | Must be single use. | "Yes" (Single Use) - Same as predicate. |
| Biocompatible | Must be biocompatible. | "Yes" (Biocompatible) - Same as predicate. |
2. Sample Size Used for the Test Set and the Data Provenance
The document does not provide specific sample sizes for the individual tests (biocompatibility, sterilization, package, mechanical performance). It states "A series of preclinical tests were performed" and refers to ISO and ASTM standards, which would dictate appropriate sample sizes for each test.
- Test Set Sample Size: Not explicitly stated (implied by compliance with standards).
- Data Provenance: The tests are non-clinical (laboratory-based, material-based). There's no human clinical data presented, so country of origin and retrospective/prospective distinctions are not applicable in the typical sense. Physical measurements and performance evaluations were done on samples of the new device and the predicate device. Needle penetration testing was conducted by an "independent lab."
3. Number of Experts Used to Establish the Ground Truth for the Test Set and the Qualifications of Those Experts
Not applicable. This device's evaluation is based on non-clinical engineering and materials testing, not on interpretation by clinical experts. The "ground truth" for these types of tests comes from the established scientific methods and standards (ISO, ASTM).
4. Adjudication Method for the Test Set
Not applicable. As described above, there is no clinical data or expert interpretation requiring adjudication. Performance is assessed against quantitative standards.
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
Not applicable. This is not an AI-powered diagnostic or assistive device. It is a physical percutaneous introducer needle.
6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This is not an algorithm or AI device.
7. The Type of Ground Truth Used
For the non-clinical tests, the "ground truth" is based on:
- International Standards: ISO 10993 (biocompatibility), ISO 11135 (sterilization), ISO 11070 (needles), ASTM standards (packaging, shelf-life). These standards define acceptable methodologies and performance thresholds.
- Predicate Device Characteristics: For comparative aspects (design, materials, indications for use), the characteristics of the legally marketed predicate device (Ranfac Percutaneous Introducer PIN-15, K951090) serve as a de-facto "ground truth" for substantial equivalence.
8. The Sample Size for the Training Set
Not applicable. This is not a machine learning or AI device that requires a training set.
9. How the Ground Truth for the Training Set was Established
Not applicable, as there is no training set for this type of device.
§ 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.