(26 days)
The reusable FloShield 10mm Endoscopic Cannula and Conical Blunt Obturator is an access device indicated for use with a disposable 8.5 - 13mm Cannula Seal manufactured by Applied Medical to provide a passageway for the introduction of endoscopic instruments in general laparoscopic procedures. The access device is compatible with the da Vinci Si Surgical System.
The FloShield 10mm Endoscopic Conical Blunt Obturator is a re-usable stainless steel endoscopic instrument delivered non-sterile with the FloShield 10mm Endoscopic Cannula to the hospital where it is cleaned, sterilized (steam / moist heat), and assembled prior to surgery. The FloShield 10mm stainless steel Cannula mates with a disposable Applied Medical 8.5 -13mm Cannula Seal manufactured and supplied sterile by Applied Medical. The stainless steel Cannula has the ability to connect to a standard male luer fitting, via the female luer that is present on the Cannula. The device will accommodate a standard 8.5mm to 10mm endoscopic instrument (outside diameter). The stainless steel Obturator has a conical blunt style tip which facilitates the insertion of the cannula through an incision site.
This document describes a 510(k) premarket notification for the FloShield 10mm Endoscopic Cannula and Conical Blunt Obturator. The acceptance criteria and supporting study details are heavily focused on demonstrating equivalence to a predicate device rather than establishing new performance benchmarks for a standalone AI system.
Here's an analysis of the provided text in relation to your request:
1. Table of Acceptance Criteria and Reported Device Performance
The submission is for a medical device (endoscopic cannula and obturator), not an AI algorithm. Therefore, the "acceptance criteria" are related to mechanical and functional performance, as well as biological compatibility and sterilization, rather than diagnostic accuracy or AI model metrics.
| Acceptance Criteria Category | Specific Criteria/Tests Performed | Reported Device Performance |
|---|---|---|
| Functional Performance | Ability to create and maintain a port of entry during simulated laparoscopic surgery | Demonstrated |
| Ability to maintain pneumoperitoneum during surgery | Demonstrated | |
| Leak Resistance | Comparable to predicate device | |
| Insufflating Flow Rates | Comparable to predicate device | |
| Insertion and Removal Force | Comparable to predicate device | |
| Snap Retention | Comparable to predicate device | |
| Sterilization Validation | Compliance with ISO 17665:2006 (Moist Heat) | Successfully performed |
| Compliance with ANSI/AAMI ST81:2004 (R2010) | Successfully performed | |
| Biocompatibility | Not explicitly detailed in this summary, but required for medical devices. | Assumed to be compliant based on predicate equivalence and materials. |
| Material Equivalence | Stainless steel construction, dimensions for cannula, and compatibility with specific cannula seal. | Same design, materials, and intended use as predicate. Obturator is functionally identical with a different tip style. |
2. Sample Size for the Test Set and Data Provenance
The document does not specify a "test set" in the context of an AI algorithm evaluating data. The performance testing described is for a physical medical device.
- Sample Size for Test Set: Not applicable in the context of an AI test set. The number of physical devices tested for performance (e.g., leak resistance, insertion force) is not specified.
- Data Provenance: Not applicable in the context of an AI algorithm. The performance testing would be conducted in a laboratory or simulated environment, not on patient data from a specific country.
- Retrospective or Prospective: Not applicable for device performance testing.
3. Number of Experts Used to Establish Ground Truth and Qualifications
This is not applicable as the device is a physical instrument, not an AI diagnostic tool. Ground truth in this context would be defined by engineering specifications, validated test methods, and regulatory standards, not by expert consensus on patient data.
4. Adjudication Method
Not applicable for a physical device's performance testing.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
Not applicable. This device is not an AI system. The comparison is between the new device and its predicate, primarily on functional and material equivalence, not human reader performance with or without AI assistance.
6. Standalone (i.e., algorithm only without human-in-the-loop performance) Study
Not applicable. This is a physical medical device.
7. Type of Ground Truth Used
The "ground truth" for this medical device's performance is based on:
- Engineering specifications and design requirements: For functional metrics like leak resistance, flow rates, insertion/removal force, and snap retention.
- Established industry standards: For sterilization (ISO 17665, ANSI/AAMI ST81) and for biocompatibility.
- Predicate device characteristics: The new device must demonstrate comparable characteristics to the legally marketed predicate.
8. Sample Size for the Training Set
Not applicable. There is no AI model or training set involved.
9. How the Ground Truth for the Training Set Was Established
Not applicable. There is no AI model or training set involved.
Summary for the FloShield 10mm Endoscopic Cannula and Conical Blunt Obturator:
This submission is for a physical medical device, not an AI algorithm. Therefore, many of the requested categories related to AI performance metrics (like test set size, data provenance, expert ground truth, MRMC studies, training sets) are not applicable.
The study presented in the 510(k) summary primarily focuses on demonstrating substantial equivalence to a predicate device (FloShield 10mm Endoscopic Cannula and Blunt Obturator - K141272) through:
- Comparison of technological characteristics: Verifying similar design, materials (stainless steel), and intended use. The only noted difference is the tip style of the obturator (conical blunt vs. full blunt).
- Performance and functional testing: To ensure the device fulfills its intended mechanical functions during simulated laparoscopic surgery. This included tests for creating/maintaining port of entry, maintaining pneumoperitoneum, leak resistance, insufflating flow rates, insertion/removal force, and snap retention, all of which were found to be "comparable to the predicates."
- Sterilization validation: Conforming to relevant ISO and ANSI/AAMI standards for reusable devices.
The "acceptance criteria" are met by demonstrating that the new device performs equivalently to the predicate and complies with relevant safety and performance standards for medical devices.
§ 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.