(222 days)
The intended use of the Spacemaker® Serial Surgical Balloon Dissector is the same as the predicate devices (K944418, K951878). The intended use of the Spacemaker® Serial Surgical Balloon Dissector and the predicate devices is to dissect layers of connective tissue along natural planes of separation. The cannula portion of the device is intended to provide access for operative and diagnostic instruments for the duration of the operative procedure.
Indications: Any area of the body where it is necessary to separate the layers of connective tissue for surgical access.
Examples where surgical dissection of natural tissue planes can provide surgical access: General, laparoscopic, endoscopic, plastic and reconstructive, including aesthetic surgery and vascular use for the exposure of superficial veins of the upper and/or lower extremities; no arterial nor deep nor non-extremity structure would be targeted.
The Spacemaker® Serial Surgical Balloon Dissector device is a disposable, handheld, manually manipulated surgical balloon dissection device consists of a balloon, center rod, handle, and suction/fill assembly. The device can be supplied either with a solid center rod or with a hollow center rod. The hollow center rod allows for the insertion of an endoscopic visualization accessory, if desired. Both versions can be inflated and deflated multiple times during a procedure.
The device can be supplied with or without a cannula. The cannula provides access for operative and diagnostic instrumentation for the duration of the surgical procedure.
This submission seeks clearance for the Spacemaker® Serial Surgical Balloon Dissector to be supplied in four configurations as follows:
Spacemaker® Serial Surgical Balloon Dissector, Class II
Spacemaker® Serial Surgical Balloon Dissector with Cannula, Class II
Spacemaker® Serial Surgical Balloon Dissector with Visualization, Class II
Spacemaker® Serial Surgical Balloon Dissector with Visualization and Cannula, Class II
This document describes the Spacemaker® Serial Surgical Balloon Dissector, a manual surgical device, and its comparison to predicate devices for its 510(k) submission.
Based on the provided text, the device itself is a physical surgical tool and not an AI/ML powered device. Therefore, many of the requested categories related to AI performance, ground truth, and expert evaluation are not applicable. The information focuses on bench testing for safety and efficacy in relation to material and function changes.
Here's a breakdown of the available information:
1. A table of acceptance criteria and the reported device performance
The document does not explicitly state acceptance criteria in a quantitative manner for specific performance metrics of the device itself (e.g., dissection time, precision of dissection). Instead, the performance verification is centered around demonstrating that modifications do not affect the safety or efficacy compared to predicate devices. The key "performance" aspect highlighted is the ability for multiple balloon inflations per procedure (a new feature) and the biocompatibility of new materials.
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| Safety & Efficacy | Modifications do not affect safety or efficacy compared to predicate devices. |
| Material Biocompatibility | New material (silicone) meets biocompatibility test requirements as defined in ANSI/AAMI 10993-1 (ISO 10993-1). |
| Balloon Inflations | Designed for and capable of multiple inflations per procedure (a change from single inflation in predicate devices). |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
The document mentions "performance bench tests." It does not specify the sample size for these bench tests, nor does it provide information on the data provenance (e.g., country of origin, retrospective/prospective).
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
This section is not applicable as the device is a manual surgical tool and the tests described are bench tests, not clinical evaluations requiring expert ground truth for interpretation of outcomes.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
This is not applicable as there is no human interpretation or adjudication described for the bench tests.
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
This is not applicable as the device is not an AI/ML powered tool and therefore no MRMC study would be relevant.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
This is not applicable as the device is a manual surgical tool, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
For the biocompatibility testing, the "ground truth" is defined by the ANSI/AAMI 10993-1 (ISO 10993-1) standard. For the overall safety and efficacy, the "ground truth" is the performance of the predicate devices. The testing aims to show non-inferiority based on bench test results.
8. The sample size for the training set
This is not applicable as the device is a manual surgical tool and does not employ AI/ML that would require a training set.
9. How the ground truth for the training set was established
This is not applicable for the same reasons as point 8.
§ 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.