(31 days)
The Dissecting Balloon System is indicated for patients undergoing laparoscopic surgery requiring tissue separation of the extraperitoneal space.
Applied Medical's Dissecting Balloon System consists of a rigid cannula with an inflatable balloon attached at the distal end that achieves separation of tissue planes during laparoscopic surgery. The system is provided sterile. The system includes three main components: An introducer that facilitates insertion of the balloon through an abdominal incision. A dissecting cannula with attached balloon, which is compatible with a 10mm endoscope to allow for visualization during tissue separation. Two balloon configurations will be offered (oval and round). An inflation bulb that is used to manually inflate the balloon
This document is a 510(k) Premarket Notification for the Applied Medical Resources Corp. Dissecting Balloon System. As such, it focuses on demonstrating substantial equivalence to a predicate device rather than providing a detailed study proving the device meets specific performance criteria in a clinical setting. The "performance testing" section describes bench-top functional assessments and biocompatibility, which are primarily aimed at showing that the new device functions similarly and is as safe as the predicate, not necessarily that it achieves a specific clinical outcome with a quantifiable performance metric.
Therefore, many of the requested elements regarding clinical performance studies, such as sample sizes for test and training sets, expert qualifications, adjudication methods, and MRMC studies, are not applicable in the context of this 510(k) submission.
Here's a breakdown of the information that can be extracted or deduced from the provided document:
1. Table of Acceptance Criteria and Reported Device Performance:
This document does not provide a table of explicit, quantifiable acceptance criteria with corresponding device performance metrics in a clinical context. The "performance testing" section describes functional equivalence testing.
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| Biocompatibility: Device materials are not cytotoxic, irritating, sensitizing, or acutely systemically toxic when in contact with tissue for less than 24 hours. | All materials were found to be biocompatible for cytotoxicity, intracutaneous irritation, sensitization, and acute systemic toxicity, in accordance with ISO 10993-1. |
| Functional Performance (Bench-top): | |
| Device insertion is comparable to the predicate. | Side-by-side bench-top testing demonstrated comparable device insertion to the predicate device. |
| Tissue separation is comparable to the predicate. | Side-by-side bench-top testing demonstrated comparable tissue separation to the predicate device. |
| Surgical site visualization is comparable to the predicate. | Side-by-side bench-top testing demonstrated comparable surgical site visualization to the predicate device. |
| Balloon deflation and device removal are comparable to the predicate. | Side-by-side bench-top testing demonstrated comparable balloon deflation and device removal to the predicate device. |
2. Sample Size Used for the Test Set and Data Provenance:
- Sample Size: Not specified for the functional performance bench testing.
- Data Provenance: The document describes "side-by-side bench top testing," which implies laboratory-based, prospective testing conducted by the manufacturer. No information on country of origin for clinical data is applicable as it's not a clinical study.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications of Those Experts:
- Number of Experts: Not applicable. The "ground truth" for functional performance was likely established by engineers or technicians assessing the physical properties and operation of the devices in a bench-top setting, not clinical experts.
- Qualifications of Experts: Not specified or applicable in the human reader / clinical context.
4. Adjudication Method for the Test Set:
- Not applicable. The bench-top testing would have involved objective measurements or direct observation of device function, not an adjudication process by human readers or clinical experts.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:
- No, an MRMC comparative effectiveness study was not done. This 510(k) submission focuses on demonstrating substantial equivalence through bench-top testing and biocompatibility, not clinical effectiveness studies involving human readers or AI.
6. Standalone Performance (Algorithm Only Without Human-in-the-Loop Performance):
- Not applicable. This device is a mechanical surgical tool (dissecting balloon system), not an AI algorithm. Therefore, there is no "algorithm only" performance to evaluate.
7. Type of Ground Truth Used:
- Functional Performance: The ground truth for functional performance was based on direct observation and measurement of the device's physical operation and its ability to perform its intended mechanical functions (insertion, tissue separation, visualization, deflation, removal) in a bench-top setting, compared to the predicate device. It is not clinical ground truth like pathology or outcome data.
- Biocompatibility: The ground truth was established through adherence to the FDA's guidance document and international standard ISO 10993-1, with results based on laboratory tests for cytotoxicity, irritation, sensitization, and systemic toxicity.
8. Sample Size for the Training Set:
- Not applicable. This is a physical medical device, not an AI model requiring a training set.
9. How the Ground Truth for the Training Set Was Established:
- Not applicable. As there's no AI model or training set, this information is not relevant.
§ 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.