(103 days)
The Indications for this device use is for medical practitioner needing visualization of soft tissue, either through a natural orifice or incision.
'Use for visualization inside the human body to view surgical procedure(s), by physician. '
The design of SOLOS ENDOSCOPY made/marketed endoscope K983538 is identical in every way as the scope approved for intended uses that are listed in this document. The physical characteristics, except for miniaturization, are identical as the approved device and this predicate device has been accepted with respect to: performance specifications, composition, intended use, technology employed, biocompatibility, manufacturing, QC, physical testing, etc.
The provided text is related to a 510(k) premarket notification for a medical device, the Miniature Endo/Laparoscope, submitted by DOFI Communications. The core of this submission is to establish Substantial Equivalence to an already legally marketed predicate device (Solos Endoscopy's K983538).
Crucially, a 510(k) submission for substantial equivalence does not typically involve a new clinical study to prove the device meets specific acceptance criteria in the same way a novel device might via a de novo or PMA pathway. Instead, it demonstrates that the new device is as safe and effective as a predicate device. Therefore, the requested information about "acceptance criteria and the study that proves the device meets the acceptance criteria" in terms of performance metrics (like sensitivity, specificity, etc.), sample sizes, ground truth, and human-in-the-loop studies is not present in this document because it's not relevant to a substantial equivalence claim based on identicality.
The document explicitly states that the DOFI Communications device is "IDENTICAL in every way" to the Solos Endoscopy device (K983538). This means it is assumed to share the same performance characteristics, safety profile, and efficacy as the predicate device.
However, I can extract the information relevant to how the substantial equivalence was claimed, which acts as the "proof" in this context.
Here's a breakdown based on the provided text, addressing the points where information is available or noting its absence due to the nature of the 510(k) claim:
Acceptance Criteria and Study Proving Device Meets Criteria
The fundamental "acceptance criterion" for this 510(k) submission is demonstrating Substantial Equivalence to a legally marketed predicate device. The "study" proving this is the comparison report provided by DOFI Communications, asserting the device's identicality to the predicate.
1. Table of Acceptance Criteria and Reported Device Performance
Given the claim of "identicality" to a predicate device, specific performance metrics for the DOFI device are not reported independently. The "acceptance criteria" are not quantitative performance thresholds for a novel study, but rather a qualitative assessment of identicality/similarity to the predicate.
| Acceptance Criterion (for Substantial Equivalence) | Reported Device "Performance" / Justification |
|---|---|
| Physical Characteristics | "IDENTICAL in every way" to predicate K983538 (except for miniaturization, which is deemed to have "no impact on the safe use and/or effectiveness") |
| Performance Specifications | Deemed identical to predicate K983538 |
| Composition | Deemed identical to predicate K983538 |
| Intended Use | "IDENTICAL" to predicate K983538 and other similar devices; "Use for visualization inside the human body to view surgical procedure(s), by physician." |
| Technology Employed | Deemed identical to predicate K983538 |
| Biocompatibility | Deemed identical to predicate K983538 |
| Manufacturing | Deemed by DOFI to be identical in process to predicate K983538 |
| Quality Control (QC) | Deemed by DOFI to be identical in process to predicate K983538 |
| Physical Testing | Deemed by DOFI to be identical in process to predicate K983538 |
| Safety and Effectiveness | Minor changes (miniaturization) have "no impact on the safe use and/or effectiveness of the device." Wide, general use of similar devices demonstrates safe use. |
2. Sample Size Used for the Test Set and Data Provenance
- Not applicable. This submission is based on a claim of identicality to a predicate device, not on a new clinical study with a test set of data. The "test set" here is the design and specifications of the DOFI device being compared to the existing specifications of the predicate device (Solos Endoscopy K983538).
- The provenance of underlying data for the predicate device's approval (K983538) is not detailed in this document.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications
- Not applicable. No new "ground truth" establishment for a test set was required for this substantial equivalence claim. The "ground truth" is effectively the established safety and efficacy of the predicate device as determined by its original approval.
4. Adjudication Method for the Test Set
- Not applicable. No test set requiring expert adjudication was used. The substantial equivalence was assessed by the FDA against the provided documentation from DOFI Communications confirming the identicality to the predicate.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done
- No. An MRMC study was not conducted as this is a substantial equivalence claim based on physical and functional identicality, not a new assessment of AI or reader performance.
6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) Was Done
- No. This is not an AI device, and no standalone performance study in this context was performed or required.
7. The Type of Ground Truth Used
- Implicitly, the ground truth is the established safety and effectiveness profile of the predicate device (Solos Endoscopy K983538) and other similar legally marketed endoscopes. The DOFI device is deemed safe and effective because it is "identical" to these already-approved devices.
8. The Sample Size for the Training Set
- Not applicable. This is not an AI or machine learning device; therefore, there is no "training set" in the context of an algorithm.
9. How the Ground Truth for the Training Set Was Established
- Not applicable. As above, there is no training set for an algorithm in this context.
§ 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.