(26 days)
The Syntec, Inc. Disposable Bare End Fiber is used to illuminate with visible spectrum light the intraocular portion of the eye for improved visualization during vitreo-retinal surgery.
The Bare End Fiber is comprised of five basic components: the handpiece tube, the fiberoptic cable, the fiber optic cable sheath and the connector.
This K971338 submission is for a medical device called "Syntec, Inc. Disposable Bare End Fiber," an ophthalmic endoilluminator used for vitreo-retinal surgery to illuminate the intraocular portion of the eye. It is a 510(k) submission, meaning it aims to demonstrate substantial equivalence to a predicate device rather than proving novel safety and effectiveness.
Based on the provided text, a formal study to establish acceptance criteria and prove its meeting is not described. The submission focuses on demonstrating substantial equivalence to a predicate device (Grieshaber Disposable Monofilament) through material and design similarities, and identical functionality.
Here's an analysis of the provided information in the context of your request:
1. A table of acceptance criteria and the reported device performance
The document does not explicitly state acceptance criteria in terms of performance metrics (e.g., sensitivity, specificity, accuracy) for the device's intended use (illumination during surgery). Instead, it focuses on demonstrating substantial equivalence to a predicate device.
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| Intended Use Equivalence: To illuminate with visible spectrum light the intraocular portion of the eye for improved visualization during vitreo-retinal surgery. | The Syntec, Inc. Disposable Bare End Fiber is used for the "same clinical purpose" as the predicate: to illuminate with visible spectrum light the intraocular portion of the eye for improved visualization during vitreo-retinal surgery. |
| Design and Material Equivalence: Similar design and exact same materials as the predicate device. | Both devices "are of a similar design and are made using the exact same materials." |
- Handpiece tube: Surgical grade stainless steel.
- Fiberoptic cable: Polystyrene core and polymethylmethacrylate cladding.
- Fiber optic cable sheath: PVC tubing.
- Connector: 6063 aluminum. |
| Biocompatibility: Biocompatible with body tissue and fluids. | "The device is biocompatible with the body tissue and fluids that it comes in contact with as it is made of the same materials as the predicate device. These materials meet US Pharmacopoeia Class VI criteria and are widely used in many other medical products." |
| Sterilization Efficacy: Device is sterile. | "The device is sterilized using ethylene oxide gas which is then validated by the overkill method." (This implies a successful validation, meeting sterility requirements.) |
| Functional Equivalence (Light Output): Light output intensity and spot size are the same as the predicate device. | "The light output intensity and spot size is the same as the predicate device." |
| Differences only Cosmetic: Any differences between the devices are cosmetic and do not impact safety or effectiveness. | "The only device differences are cosmetic." |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Not applicable / Not provided. The summary does not describe a clinical study or a test set of data to evaluate the device's performance against specific acceptance criteria. Instead, it relies on demonstrating substantial equivalence to a predicate device.
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)
- Not applicable / Not provided. This document is not performing a diagnostic or interpretative function that would require "ground truth" establishment by experts in a test set.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not applicable / Not provided. See point 3.
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
- No. This is a medical device for illumination, not an AI-powered diagnostic tool. Therefore, an MRMC study comparing human readers with and without AI assistance is irrelevant and not mentioned.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- No. This is a physical medical device (an endoilluminator), not an algorithm. Standalone performance for an algorithm is not applicable.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- Not applicable / Not provided. "Ground truth" in the sense of a diagnostic reference standard is not relevant for this type of device submission, which focuses on substantial equivalence for illumination.
8. The sample size for the training set
- Not applicable / Not provided. This is not an AI/machine learning device that requires a training set.
9. How the ground truth for the training set was established
- Not applicable / Not provided. See point 8.
In summary:
This 510(k) submission for the Syntec, Inc. Disposable Bare End Fiber seeks to establish substantial equivalence to a predicate device. It defines the "performance" of the device by asserting that its materials, design, intended use, biocompatibility, sterilization method, and crucial functional aspects (light output intensity and spot size) are either identical to or "substantially equivalent" to an already cleared device. There is no mention of a clinical study, test set, expert involvement for ground truth, or AI-related metrics because the regulatory pathway chosen (510(k) for substantial equivalence) does not typically require such detailed clinical performance data if substantial equivalence can be demonstrated through other means.
§ 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.