(394 days)
The AFS MEDICAL's Sterile Single-Use Access Port System for surgery is a manual device designed to access the peritoneal cavity during laparoscopic surgery minimally invasive surgery. Examples of procedures where the device may be used include colorectal, urological, and general surgery to access the surgical site
The AFS MEDICAL's Sterile Single-Use Access Port System for surgery is a manual device designed to access the peritoneal cavity during laparoscopic surgery. The modular system can be used in a number of configurations as desired by the user. The system is named, JACK . System options include integrated LED lighting to provide additional intrabdominal illumination if desired, insufflation ports, and multiple cap/port options. Other device variants include retractor diameter, height, number of ports and port size configurations, number of LEDs, power line length, with disposable or external/rechargeable battery (to power light source). The device includes a receiving ring that allows for 360° rotation of the port during use.. The device includes blue light indicators on the port head to inform the user that the port head is correctly attached and sealed. The system includes Smart Tubing that contains LED lighting for additional illumination and holes connected to tubing for introduction of CO2 and removal of surgical smoke
The provided text describes a 510(k) premarket notification for the AFS Medical Sterile Single-Use Access Port System. The document focuses on demonstrating substantial equivalence to predicate devices through non-clinical performance testing and biocompatibility testing, rather than a clinical study evaluating diagnostic performance of an AI-powered device. Therefore, many of the requested categories in your prompt are not applicable to this submission.
However, I can extract the relevant information regarding acceptance criteria and testing results:
1. Table of Acceptance Criteria and Reported Device Performance
| Test Name | Acceptance Criteria | Reported Device Performance |
|---|---|---|
| Non-Clinical Performance Tests | ||
| Leak, Instrument Insertion/Withdrawal, and Insufflation | Insertion, withdrawal, leak, and insufflation performance must be acceptable and equivalent to the reference device. Insufflation port performance must be confirmed at 20 LPM. | Insertion, withdrawal, leak, and insufflation performance were acceptable; Pass. |
| Smoke Evacuation | Acceptable smoke evacuation performance under simulated use conditions. | Smoke evacuation performance was acceptable; Pass. |
| Power Line Connection Force | Force to disconnect power line from the controller unit must be >30N. | Power line connection force was >30 N; Pass. |
| LED Intensity and Holding Time | Illumination must be >30,000 lux and maintain holding time for at least one hour. | Illumination and holding time met the acceptance criteria; Pass. |
| Electrical Safety Testing | Must meet relevant clauses of IEC 60601-1. | All requirements were met; Pass. |
| Electromagnetic Compatibility | Must meet relevant clauses of IEC 60601-1-2. | All requirements were met; Pass. |
| Biocompatibility Testing | ||
| Cytotoxicity | Noncytotoxic according to predetermined acceptance criteria. | Noncytotoxic according to the predetermined acceptance criteria; Pass. |
| Intracutaneous Irritation | Test requirements for intracutaneous reactivity must be met according to predetermined acceptance criteria. | Test requirements for intracutaneous reactivity were met according to the predetermined acceptance criteria; Pass. |
| Sensitization | Must not elicit a sensitization response according to predetermined acceptance criteria. | Did not elicit a sensitization response according to the predetermined acceptance criteria; Pass. |
| Clinical Testing (Qualitative) | No adverse events related to the device and assessed performance of all key attributes as acceptable. | No adverse events related to the device and assessed performance of all key attributes as acceptable. |
2. Sample size used for the test set and the data provenance
- Non-Clinical Performance Tests: Sample sizes are not explicitly stated for individual tests. The data provenance is internal testing performed by the manufacturer, likely in a laboratory setting.
- Clinical Testing: "Real-world data was collected from two independent clinical sites in Austria." The number of procedures or patients is not specified. This is prospective data collection.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
- Non-Clinical Performance Tests: Not applicable, as these are objective engineering and material tests, not reliant on expert interpretation for "ground truth."
- Clinical Testing: The text mentions "multiple clinicians reported no adverse events related to the device and assessed performance of all key attributes as acceptable." The exact number or qualifications of these clinicians are not specified beyond their role in performing procedures at clinical sites.
4. Adjudication method for the test set
- Non-Clinical Performance Tests: Not applicable as these are objective tests.
- Clinical Testing: Not specified, beyond the general statement that "multiple clinicians" assessed performance. There is no mention of a formal adjudication process (e.g., 2+1, 3+1).
5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done
No, an MRMC comparative effectiveness study was not done. This submission is for a surgical access port system, not a diagnostic AI device that would utilize such a study design.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done
Not applicable. This device is a manual surgical tool, not an algorithm or an AI-powered system designed for standalone performance.
7. The type of ground truth used
- Non-Clinical Performance Tests: Objective measurements against engineering and materials standards (e.g., force measurements, light intensity, leakage rates, compliance with IEC standards).
- Biocompatibility Testing: Laboratory results from standardized biological tests (ISO 10993 series).
- Clinical Testing: Clinician assessment of device performance and adverse event reporting based on real-world use during surgical procedures.
8. The sample size for the training set
Not applicable. This is not an AI/machine learning device, so there is no "training set."
9. How the ground truth for the training set was established
Not applicable. There is no training set for this 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.