(154 days)
The device is indicated for any area of the body where it is necessary to separate the layers of connective tissue for surgical access. The intended use of the Spacemaker® Surgical Balloon Dissectors is to create a operative space by dissecting layers of connective tissue along natural tissue planes of separation of the extraperitoneal (including preperitoneal), or subcutaneous extremity or thoracic space.
The indications for use include dissection of tissue for the following surgical procedures: endoscopic; laparoscopic; general surgery; plastic and reconstructive surgery, including aesthetic surgery; vascular surgery for the exposure of superficial vessels of the upper and/or lower extremities (no deep structure would be targeted), including the saphenous vein and femoral vessels; thoracoscopic procedures involving exposure and dissection of structures external to the parietal pleura, including nerves, blood vessels and other tissues of the chest wall; procedures in the extraperitoneal space involving dissection of tissue layers allowing exposure of structures including: adrenals, bone, spine, lymph nodes, and kidneys.
Examples of specific surgical procedures the Spacemaker® Surgical Balloon Dissectors may be used to facilitate tissue dissection include: fascial lavers between the skin and peritoneum. hernia repair, varicocele dissection, sympathectomy, lymph node dissection, urethropexy, subfascial perforator vein ligation, access to the saphenous vein and femoral vessels, retroperitoneal access to the anterior spine, access for long bone plating.
The cannula portion of the device is intended to provide access for surgical and diagnostic instruments for the duration of the operative procedure.
The Spacemaker® Surgical Balloon Dissector devices are handheld, manually manipulated surgical balloon dissectors. The devices can be supplied with either a solid center rod or a hollow center rod. The hollow center rod allows for the insertion of an endoscopic visualization accessory, if desired. The devices can be supplied with or without a cannula. The cannula provides access for operative and diagnostic instrumentation for the surgical procedure.
The provided 510(k) summary for K973046 does not contain information about acceptance criteria or a study proving the device meets those criteria in the way typically associated with AI/medical imaging device submissions.
This 510(k) submission is for the "Spacemaker® Surgical Balloon Dissector" and related devices. The basis for substantial equivalence is that the devices have the "same principle of operation as the predicate devices" and that "there are no changes to any of the Spacemaker® devices." Furthermore, the submission explicitly states:
"No functional bench testing was performed for this submission because no tests were necessary to substantiate the safety, performance or substantial equivalence."
Therefore, I cannot populate the requested table or answer most of the questions about acceptance criteria, performance studies, sample sizes, ground truth establishment, or expert adjudication, as this information is not present in the provided document. The device's clearance was based on its established substantial equivalence to predicate devices without new performance testing being deemed necessary.
However, I can provide the following based on the available information:
Summary based on K973046:
The K973046 submission for the Spacemaker® Surgical Balloon Dissector devices was granted clearance based on substantial equivalence to existing predicate devices, rather than through a performance study against specific acceptance criteria. The submission explicitly states that no functional bench testing was performed due to the lack of necessary substantiation for safety, performance, or substantial equivalence. Therefore, there are no reported acceptance criteria or a study proving the device meets acceptance criteria in the context of new performance testing.
1. A table of acceptance criteria and the reported device performance:
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Not applicable. The submission states "No functional bench testing was performed for this submission because no tests were necessary to substantiate the safety, performance or substantial equivalence." Substantial equivalence was based on the devices having the same principle of operation and no changes from predicate devices. | Not applicable. No new performance data was generated or reported as testing was deemed unnecessary. |
2. Sample size used for the test set and the data provenance:
- Not applicable. No test set was used for a performance study.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not applicable. No test set requiring expert-established ground truth was used.
4. Adjudication method for the test set:
- Not applicable. No test set was used.
5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, and the effect size of how much human readers improve with AI vs without AI assistance:
- Not applicable. This device is a surgical instrument and not an AI-powered diagnostic or assistive tool for human readers. No MRMC study was performed.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:
- Not applicable. This device is a surgical instrument, not an algorithm. No standalone performance study was done.
7. The type of ground truth used:
- Not applicable. No performance study requiring ground truth was conducted. Substantial equivalence was based on device design and intended use matching predicate devices.
8. The sample size for the training set:
- Not applicable. This submission does not involve a machine learning model or a training set.
9. How the ground truth for the training set was established:
- Not applicable. No training set or associated ground truth was established for this submission.
§ 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.