(28 days)
The aspirators and pointers are accessories of the previously cleared InstaTrak 3000 System, (K983529) and therefore have the same intended use.
The InstaTrak 3000 System is intended as an aid to the surgeon for precisely locating anatomical structures anywhere on the human body during either open or percutaneous procedures. It is indicated for any medical condition that may benefit from the use of stereotactic surgery and which provides a reference to rigid anatomical structures such as sinus, skull, cranial, a long bone or vertebra, visible on medical images such as CT or MR.
The aspirators and pointers described above are aspiration and/or localization devices supplied as accessories with the InstaTrak 3000 System. The aspirators and pointers have the same principle of operation, as those accessories described in the predicates, K960330, K981998, K982994, and K983529. Other than the non-sterile reusable labeling and a color change to a non-patient contact portion of the instrument the devices are the same as the predicate.
Here's an analysis of the provided text regarding the acceptance criteria and supporting study for the K990919 device submission:
Based on the provided K990919 submission for "Straight Aspirator, 45 Degree Aspirator, 90 Degree Aspirator, 7 French Aspirator, Extended Straight Aspirator, 13.9 cm Straight Pointer, and 4.7 cm Straight Pointer" (accessories for the InstaTrak 3000 System), the information regarding performance criteria and studies is very limited and primarily focuses on equivalence to predicate devices, rather than detailed performance metrics. This is typical for 510(k) submissions for accessories that are substantially equivalent, where rigorous clinical trials with quantifiable performance metrics are often not required if the new device doesn't introduce new risks or fundamental changes in technology.
1. Table of Acceptance Criteria and Reported Device Performance
Given the nature of the submission (accessories with asserted substantial equivalence), the "acceptance criteria" are not reported as numerical performance targets (e.g., accuracy, sensitivity, specificity). Instead, the acceptance criteria are implicitly tied to maintaining the same functional and safety characteristics as the predicate devices. The "performance data" provided confirms these characteristics.
| Acceptance Criteria Category | Specific Criteria | Reported Device Performance |
|---|---|---|
| Functional Equivalence | Same principle of operation as predicate devices | The aspirators and pointers have the same principle of operation as those accessories described in the predicates. |
| Design & Materials | Incorporate the same design and materials as predicate devices | The aspirators and pointers incorporate the same design and materials as the predicate devices. |
| Sterilization Compatibility | Allow for sterilization (multiple reuse cycles) | Testing was performed on the aspirators and pointers to demonstrate their ability to be cleaned and sterilized, and to confirm functionality after multiple reuse cycles. |
| Intended Use | Same intended use as predicate accessories | The aspirators and pointers have the same intended use as the accessories in the InstaTrak 3000, K983529. |
| Technological Characteristics | Identical technological characteristics to predicate devices | The technological characteristics of the aspirators and pointers are identical to those of the predicate devices. |
2. Sample Size Used for the Test Set and Data Provenance
The document does not specify a sample size for any clinical test set in the conventional sense (e.g., number of patients, cases, or image data). The testing mentioned is solely "testing... to demonstrate their ability to be cleaned and sterilized and to confirm functionality after multiple reuse cycles." This suggests bench testing rather than a study involving human subjects or medical data.
Therefore:
- Sample size for test set: Not applicable/not specified for clinical performance. The testing was likely on a sample of the manufactured devices for cleaning/sterilization validation.
- Data provenance: Not applicable. The "testing" refers to internal validation activities by the manufacturer (Visualization Technology, Inc.), likely in a lab setting, to confirm physical and functional integrity.
3. Number of Experts Used to Establish Ground Truth and Qualifications
This information is not provided and is not applicable to the type of testing described. The "ground truth" for chemical (cleaning/sterilization) and mechanical (functionality after reuse) testing is typically established by established laboratory protocols and standards, not by expert medical review.
4. Adjudication Method for the Test Set
This information is not provided and is not applicable. Since no clinical test set or expert review for diagnostic/treatment performance is described, there's no need for an adjudication method.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done
No, an MRMC comparative effectiveness study was not done.
The submission focuses on establishing substantial equivalence of accessories based on design, materials, and functional testing (cleaning/sterilization/reuse), not on the comparative clinical performance with or without AI assistance. The InstaTrak 3000 system itself is a surgical navigation system, and the accessories are tools used with it; their primary "performance" is mechanical integrity and compatibility, not diagnostic accuracy or interpretation improvement.
6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Was Done
This question is not applicable as the device (aspirators and pointers) is not an algorithm or an AI-powered device. It is a set of physical surgical accessories. The InstaTrak 3000 itself is a computer-aided system, but the submission is for its accessories.
7. The Type of Ground Truth Used
The "ground truth" for the described testing would be:
- Sterility Validation: Confirmation that sterilization processes render the devices sterile according to established microbiological standards (e.g., AAMI, ISO standards).
- Cleanliness Validation: Confirmation that cleaning protocols effectively remove biological and other contaminants to acceptable levels.
- Functional Integrity: Confirmation that the devices maintain their physical properties and intended function after multiple cleaning and sterilization cycles (e.g., no material degradation, no loss of structural integrity).
This is established through laboratory testing and adherence to recognized standards, not expert consensus, pathology, or outcomes data in a clinical sense.
8. The Sample Size for the Training Set
This information is not applicable. The device is a physical medical instrument, not an AI/algorithm-based system that requires a "training set" of data.
9. How the Ground Truth for the Training Set Was Established
This information is not applicable as there is no training set for this type of device.
§ 892.2050 Medical image management and processing system.
(a)
Identification. A medical image management and processing system is a device that provides one or more capabilities relating to the review and digital processing of medical images for the purposes of interpretation by a trained practitioner of disease detection, diagnosis, or patient management. The software components may provide advanced or complex image processing functions for image manipulation, enhancement, or quantification that are intended for use in the interpretation and analysis of medical images. Advanced image manipulation functions may include image segmentation, multimodality image registration, or 3D visualization. Complex quantitative functions may include semi-automated measurements or time-series measurements.(b)
Classification. Class II (special controls; voluntary standards—Digital Imaging and Communications in Medicine (DICOM) Std., Joint Photographic Experts Group (JPEG) Std., Society of Motion Picture and Television Engineers (SMPTE) Test Pattern).