(18 days)
GIMMI ALPHA Sinuscopes and Bronchoscopes are intended for use by qualified physicians to perform endoscopic diagnostic and therapeutic surgical procedures of the sinus and larynx/tracheobronchial tree respectively.
GIMMI ALPHA® Bronchoscopes are intended to provide qualified physicians with a means for performing endoscopic diagnostic and therapeutic surgical procedures of the larynx and tracheobronchial tree.
GIMMI ALPHA® Sinuscopes are intended to provide qualified physicians with a means for performing endoscopic diagnostic and therapeutic sinus surgical procedures.
GIMMI ALPHA Sinuscopes and Bronchoscopes are reusable, hand-held instruments designed for performing diagnostic and therapeutic sinus and bronchial procedures. The devices have the same operating principles and intended uses as many of the competitive sinuscopes and bronchoscopes already in commercial distribution.
The devices are comprised of rigid, panoramic telescopes using rod lens technology. The body contact portions are composed of surgical grade stainless steel, which is commonly used in medical devices for a wide range of applications and has a long history of biocompatibility for human use.
The provided document is a 510(k) summary for the GIMMI ALPHA Sinuscopes and Bronchoscopes. Based on the information presented, a traditional clinical performance study with acceptance criteria and a detailed study design to prove the device meets those criteria was not conducted. Instead, the submission relies on demonstrating substantial equivalence to predicate devices.
Here's an breakdown based on your requested information, highlighting what was done according to this document:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Same intended use as predicate devices | "The GIMMI ALPHA Sinuscopes and Bronchoscopes have the same intended use as predicate devices." |
| Made of the same material as predicate devices | "They are made of the same material..." |
| Produced to the same international and FDA-recognized standards as predicate devices | "...and are produced to the same international and FDA-recognized standards." GIMMI "certifies compliance with relevant ISO/EN/ASTM/AAMI/ANS// IEC and other device-related standards." |
| Slight modifications in design do not adversely affect safety and effectiveness | "Slight modifications in design do not adversely affect the safety and effectiveness of these devices." |
| Equivalence in design and materials to predicate devices | "Based on the equivalence in design and materials to predicate devices, performance testing was not warranted." |
| Meet the same criteria of safety and effectiveness as SE devices (predicate) | "The devices will meet the same criteria of safety and effectiveness as SE devices." |
| Identical and/or substantially equivalent intended use, performance attributes, materials, and basic design to predicate devices | "In summary, the intended use, performance attributes, materials, and basic design are identical and/or substantially equivalent to SE devices." |
| Design validation raises no new issues of safety and effectiveness | "The results of design validation raise no new issues of safety and effectiveness." |
2. Sample size used for the test set and the data provenance
- No specific "test set" in the context of a clinical performance study was used. The submission relies on a comparison to predicate devices rather than a direct study on the GIMMI ALPHA devices in a clinical setting.
- Data provenance is therefore not applicable in the traditional sense, as no new clinical data was generated for this submission.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
- Not applicable. No new clinical performance study was conducted that would require experts to establish ground truth for a test set. The assessment relied on regulatory evaluation of equivalence to existing predicate devices.
4. Adjudication method for the test set
- Not applicable. No clinical performance study was conducted.
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 submission for an endoscopic device, not an AI-assisted diagnostic tool. Therefore, an MRMC study or AI-related effectiveness assessment was not performed.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Not applicable. This is a physical medical device, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
- The "ground truth" for the acceptance of this device implicitly relies on the proven safety and effectiveness of the identified predicate devices in clinical use. The assessment is based on the substantial equivalence of the GIMMI ALPHA devices to these predicates in terms of intended use, materials, operating principles, and compliance with recognized standards. No new ground truth specific to the GIMMI ALPHA devices was established through a clinical trial or expert review.
8. The sample size for the training set
- Not applicable. No training set was used, as this is not a machine learning or AI device.
9. How the ground truth for the training set was established
- Not applicable.
In summary: The 510(k) submission for GIMMI ALPHA Sinuscopes and Bronchoscopes does not include a new clinical study with acceptance criteria and device performance evaluation in the typical sense. Instead, it demonstrates the device's safety and effectiveness by asserting substantial equivalence to legally marketed predicate devices, based on similarities in intended use, materials, design, and adherence to established industry standards. The FDA's clearance (K013731) indicates their agreement with this claim of substantial equivalence.
§ 874.4680 Bronchoscope (flexible or rigid) and accessories.
(a)
Identification. A bronchoscope (flexible or rigid) and accessories is a tubular endoscopic device with any of a group of accessory devices which attach to the bronchoscope and is intended to examine or treat the larynx and tracheobronchial tree. It is typically used with a fiberoptic light source and carrier to provide illumination. The device is made of materials such as stainless steel or flexible plastic. This generic type of device includes the rigid ventilating bronchoscope, rigid nonventilating bronchoscope, nonrigid bronchoscope, laryngeal-bronchial telescope, flexible foreign body claw, bronchoscope tubing, flexible biopsy forceps, rigid biopsy curette, flexible biopsy brush, rigid biopsy forceps, flexible biopsy curette, and rigid bronchoscope aspirating tube, but excludes the fiberoptic light source and carrier.(b)
Classification. Class II.