(43 days)
The KSEA Miniature Endoscope is indicated for use in visualization of sinus anatomy and pathology.
The KSEA Miniature Endoscope is a manually operated, reusable surgical device that is provided to the end-user in a non-sterile condition. The device is a flexible fiber optic telescope which utilizes fiber-optic technology to perform the intended use.
This K070752 510(k) submission for the Karl Storz Miniature Endoscope (KSEA Miniature Endoscope) does not contain a study that demonstrates the device meets specific acceptance criteria in terms of performance metrics like sensitivity, specificity, or accuracy. Instead, this submission focuses on demonstrating substantial equivalence to predicate devices. This means the manufacturer is asserting that their new device is as safe and effective as devices already legally marketed, without needing to prove new performance claims through extensive clinical trials.
Therefore, the requested information elements (1, 2, 3, 4, 5, 6, 7, 8, 9) regarding acceptance criteria and performance studies are not applicable in the context of this 510(k) submission, as it relies on substantial equivalence rather than novel performance claims.
Here's a breakdown based on the provided document:
1. Table of acceptance criteria and reported device performance:
- Not Applicable. The submission does not provide acceptance criteria in terms of performance metrics (e.g., accuracy, sensitivity, specificity) for the device's clinical function. Its acceptance by the FDA is based on demonstrating substantial equivalence to predicate devices, meaning it has similar technological characteristics and intended use, and does not raise new questions of safety or effectiveness.
2. Sample size used for the test set and the data provenance:
- Not Applicable. There is no "test set" in the context of a performance study for this 510(k) submission. Substantial equivalence relies on comparing the device's design and intended use to existing predicate devices, not on new clinical performance data from a sample set.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not Applicable. As there is no test set for a performance study, there are no experts establishing ground truth in this context.
4. Adjudication method for the test set:
- Not Applicable. No test set was used to assess performance.
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:
- Not Applicable. This device is a flexible fiber optic endoscope, not an AI-powered diagnostic tool. Therefore, an MRMC study and AI assistance are not relevant to this submission.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Not Applicable. This is a medical device, not an algorithm.
7. The type of ground truth used:
- Not Applicable. No clinical performance study requiring ground truth was conducted for this 510(k) submission.
8. The sample size for the training set:
- Not Applicable. This is a hardware medical device, not a machine learning algorithm requiring a training set.
9. How the ground truth for the training set was established:
- Not Applicable. This is a hardware medical device, not a machine learning algorithm.
Summary of the 510(k) Filing for K070752 (Karl Storz Miniature Endoscope):
The K070752 510(k) submission is for the Karl Storz Miniature Endoscope. The core of the submission is to demonstrate substantial equivalence to already legally marketed predicate devices.
The key information provided relates to this substantial equivalence:
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Predicate Devices:
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Intended Use: The KSEA Miniature Endoscope is indicated for use in visualization of sinus anatomy and pathology. This intended use is comparable to the visualization purposes of the predicate devices in different anatomical areas (coronary vessels, nasal cavity/larynx/pharynx, salivary gland).
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Technological Characteristics Comparison (as per Substantial Equivalence Chart):
- Shaft Diameter: 0.5 mm (matches Olympus Angioscope)
- Working Length: 100 cm (falls within the range of predicates: 30 cm - 130 cm)
- Viewing Angle: 0° (matches all predicates)
- Field of View: 70° (similar to predicates: 75° for Olympus devices, 70° for KSEA Sialoendoscope)
- Optics: Fiber optic (matches all predicates)
Conclusion from the 510(k) Summary:
The submission states that "The KSEA Miniature Endoscope is substantially equivalent to the predicate devices since the basic features, design, and intended uses are similar. The minor differences between the KSEA Miniature Endoscope and the predicate devices raise no new issues of safety and effectiveness, as these design differences have no affect on the performance, function, or intended use of the devices."
The FDA's letter (Page 2) confirms this, stating, "We have reviewed your Section 510(k) premarket notification... and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices..."
Therefore, the "proof" that this device meets acceptance criteria is the successful demonstration of substantial equivalence to predicate devices, as accepted by the FDA. No specific performance study with numerical criteria was required or provided in this particular 510(k) submission.
§ 874.4760 Nasopharyngoscope (flexible or rigid) and accessories.
(a)
Identification. A nasopharyngoscope (flexible or rigid) and accessories is a tubular endoscopic device with any of a group of accessory devices which attach to the nasopharyngoscope and is intended to examine or treat the nasal cavity and nasal pharynx. It is typically used with a fiberoptic light source and carrier to provide illumination. The device is made of materials such as stainless steel and flexible plastic. This generic type of device includes the antroscope, nasopharyngolaryngoscope, nasosinuscope, nasoscope, postrhinoscope, rhinoscope, salpingoscope, flexible foreign body claw, flexible biopsy forceps, rigid biopsy curette, flexible biospy brush, rigid biopsy forceps and flexible biopsy curette, but excludes the fiberoptic light source and carrier.(b)
Classification. Class II.