(75 days)
The LSI Suture Placement device and accessories are intended for use in the approximation of soft tissue.
The LSI Suture Placement device and accessories are intended for the approximation of surgical wounds by passing ligature through soft tissue.
This 510(k) premarket notification for the LSI Suture Placement Device and Accessories does not contain specific acceptance criteria or an associated study proving the device meets criteria using performance metrics. This submission relies on substantial equivalence to a predicate device rather than performance testing against defined metrics.
Here's a breakdown of why the requested information cannot be fully provided based on the given text:
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A table of acceptance criteria and the reported device performance:
- No specific acceptance criteria or performance metrics are listed. The submission focuses on comparing the LSI Suture Placement Device and its accessories to a predicate device (AUTO SUTURE* Suture Closure** device and accessories, K954853) based on "design, function, and indicated use."
- The comparison table lists functional aspects (delivering suture materials, approximating soft tissue, biocompatible materials, sterilization method, packaging) and states they are the "same" between the subject and predicate devices. These are not quantitative performance metrics with associated acceptance criteria.
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Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective):
- No test set or performance evaluation data are described. The submission is a premarket notification based on substantial equivalence, not a clinical trial or performance study report.
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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):
- Not applicable. There is no test set or ground truth established for performance evaluation within this document. The "ground truth" for the submission's purpose is the established safety and effectiveness of the predicate device.
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Adjudication method (e.g. 2+1, 3+1, none) for the test set:
- Not applicable. No test set or related adjudication method is mentioned.
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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:
- Not applicable. This device is a manual surgical instrument, not an AI-powered diagnostic or assistive technology. No MRMC study was conducted or is relevant here.
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If a standalone (i.e. algorithm only without human-in-the loop performance) was done:
- Not applicable. This is a hardware surgical device, not an algorithm.
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The type of ground truth used (expert consensus, pathology, outcomes data, etc):
- Not applicable in the context of a performance study. The basis for approval is substantial equivalence to a legally marketed predicate device, implying that the predicate's established safety and effectiveness serve as the "ground truth" for the new device's comparable attributes.
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The sample size for the training set:
- Not applicable. This device does not involve machine learning or a training set.
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How the ground truth for the training set was established:
- Not applicable. This device does not involve machine learning or a training set.
Summary based on the provided text:
The LSI Suture Placement Device and Accessories received 510(k) clearance based on its substantial equivalence to a predicate device (AUTO SUTURE* Suture Closure** device and accessories, K954853). The submission argues that both devices share the same:
- Design
- Function (deliver suture materials, approximate soft tissue)
- Indicated Use (approximation of soft tissue)
- Materials (biocompatible)
- Sterilization method (ethylene oxide, 10-6 lethality)
- Packaging (disposable, thermoformed blister with TYVEK™ cover)
Therefore, no specific performance acceptance criteria or study results are presented within this document because the regulatory pathway chosen (510(k) premarket notification for substantial equivalence) does not typically require novel clinical or performance studies for devices considered substantially equivalent to already marketed devices. The FDA's letter states that the device can be marketed subject to general controls, and assumes compliance with Good Manufacturing Practice (GMP) requirements.
§ 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.