(134 days)
Intended to clear the end of a rigid rod endoscope in order to maintain clear visualization of endoscopic procedures without having to remove the scope from the surgical site.
The device is indicated for use during routine diagnostic procedures and during endoscopic sinus surgery.
The InstaClear Lens Cleaner system is equivalent to the predicate device cleared under K982594. The system includes a reusable AC powered console with pump, a reusable footpedal, and sterile disposable single-use accessories.
The system is used to clear the end of a rigid endoscope in order to maintain clear visualization of endoscopic procedures without having to remove the scope from the surgical site. The device is indicated for use during routine diagnostic procedures and during endoscopic sinus surgery (ESS).
The system accessories include sterile sheaths to fit various sizes of 4mm Olympus and Storz endoscopes, a sterile irrigation tubeset, and a non-sterile footpedal. The console includes software to control irrigation delivery and suction.
This document describes the InstaClear Lens Cleaner device and its performance testing to support its substantial equivalence to a predicate device.
1. Table of Acceptance Criteria and the Reported Device Performance
| Acceptance Criteria Category | Specific Test/Criterion | Reported Device Performance |
|---|---|---|
| Biocompatibility | Cytotoxicity, Sensitization, Irritation (for patient-contacting materials) | Full GLP biocompatibility testing on similar devices containing all patient-contacting materials on file for other Gyrus ACMI marketed devices. |
| Electrical Safety | Compliance with IEC 60601-1 | Device complies. |
| Electromagnetic Compatibility (EMC) | Compliance with IEC 60601-1-2 | Device complies. |
| Sterilization | Sterility Assurance Level (SAL) of 10^-6 for disposable items (sheaths, tubesets) | Sterilized with Ethylene Oxide, cycle validated in accordance with ISO 11135 to provide SAL of 10^-6. |
| Shelf Life | Initial one-year shelf life for disposable items | Supported by analysis of shelf-life stability of materials and packaging, and accelerated aging studies. Real-time aging testing will confirm. |
| Cleaning Performance | Cleaning compatibility (e.g., with blood/mucous analog) | Testing demonstrated cleaning compatibility. |
| Noise Levels | Acceptable noise levels during operation | Testing performed. (Specific acceptable level not provided, but implies met.) |
| Heat Generation | Acceptable heat generation during operation | Testing performed. (Specific acceptable level not provided, but implies met.) |
| Tabletop Stability | Device stability on tabletop | Testing performed. (Implies met.) |
| Burst Pressure | Integrity of components under pressure | Testing performed. (Implies met.) |
| Suction Strength | Effective suction capability | Testing performed. (Implies met.) |
| Hub Strength | Mechanical strength of hubs | Testing performed. (Implies met.) |
| Torque Strength | Mechanical strength under torque | Testing performed. (Implies met.) |
| Leak Testing | Absence of leaks in the system | Testing performed. (Implies met.) |
| Ship Testing | Device integrity after shipping conditions | Representative samples subjected to environmental conditioning and ship testing. (Implies met.) |
| Baseline Performance Testing | General functional performance | Testing performed. (Implies met.) |
| Cleaning Cycle Time (compared to predicate) | Comparable or improved cleaning cycle time post-debris | Device performs as well as or better than the predicate device. |
| Clearing Performance (compared to predicate) | Comparable or improved clearing performance (removal of debris) | Device performs as well as or better than the predicate device. |
| Leak/Drip Occurrence Rate (compared to predicate) | Comparable or improved absence of leaks/drips post-cleaning | Device performs as well as or better than the predicate device. |
| Risk Analysis | Compliance with ISO 14971 | Risk analysis carried out in accordance with established in-house acceptance criteria based on ISO 14971. |
2. Sample Size Used for the Test Set and the Data Provenance
The document does not explicitly state the specific sample sizes used for each performance test. It refers to "representative samples" for stability and environmental testing.
- Data Provenance: The studies were non-clinical (electrical, mechanical, functional) performance testing and preclinical (bench) evaluations and testing. These are laboratory-based tests, not human trials.
- Country of Origin: Not specified, but conducted by Gyrus ACMI, Inc. a US-based company with manufacturing in Bartlett, TN, USA.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and the Qualifications of Those Experts
Not applicable. This device's performance was evaluated through non-clinical and preclinical bench testing against objective criteria and comparison to a predicate device, not through expert-reviewed clinical data or human studies.
4. Adjudication Method for the Test Set
Not applicable. As described above, the testing involved objective performance metrics and comparison to a predicate device, not expert adjudication of human subject results.
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 lens cleaner, not an AI-powered diagnostic or interpretive tool that would involve human readers.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done
Not applicable. This device is a physical medical device, not a software algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
The "ground truth" for the non-clinical and preclinical performance tests was based on:
- Objective Engineering Specifications: For electrical safety, EMC, burst pressure, torque strength, etc.
- Established Sterilization Standards: For sterility assurance level.
- Simulated Use Conditions with Analogs: For cleaning performance (using a blood analog).
- Performance Characteristics of the Predicate Device: For comparative evaluation of features like cleaning cycle time, clearing performance, and leak/drip rate.
8. The Sample Size for the Training Set
Not applicable. This document describes a physical medical device, not a machine learning or AI model that requires a training set.
9. How the Ground Truth for the Training Set Was Established
Not applicable, as there is no training set for this device.
§ 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.