(308 days)
When used with a fiberoptic endoscope, SPINAUT-V can be used for observing epidural anatomy, pathology and delivery of drugs approved for epidural indications.
The SPINAUT-S is intended to be used by physicians for the illumination and visualization of tissues of the epidural space in the lumbar and sacral spine for the purpose of assisting in the diagnosis of disease.
SPINAUT-I is intended for the percutaneous introduction and placement of a video guided catheter and/or an endoscope.
SPINAUT-V consists of a flexible catheter, steering handle and associated ports for access to the lumen. The catheter has built in steering mechanism that allows for guiding the soft tip through the epidural space and soft tissues for optimal access to the source of distress. The design allows the use of a flexible fiber optic endoscope for visual examination of the area and surrounding tissues at the distal end of the catheter. This visual examination then allows the physician to diagnose the potential causes of neural distress and pain. SPINAUT-V is a sterile, single use device. When placing SPINAUT-V into the patient, SPINAUT-I can be used instead of SPINUT-V as an introducer device.
SPINAUT-S is a surgically invasive flexible fiberoptic system that can be used either with a video guided catheter (SPINAUT-V or other video guided catheters with proper catheter size) or with an introducer device such as SPINAUT-I. The SPINIUT-S is a reusable device that is supplied non-sterile with instructions for cleaning, sterilization and re-use. The SPINAUT-S can be used with the light source and camera system.
SPINAUT-I is intended to be used to prepare or preserve a path for a video guided catheter or an endoscope. It is supplied sterile and for single use.
The provided document describes the substantial equivalence of the SPINAUT-V, SPINAUT-S, and SPINAUT-I devices to a predicate device, Myelotec Video Guided Catheter (K980734). It does not contain information about acceptance criteria and a study that proves the device meets those criteria in the context of a typical AI/ML medical device submission.
The document is a 510(k) summary for a traditional medical device (arthroscope/catheter/introducer) and focuses on bench testing, biocompatibility, and sterilization validation to demonstrate substantial equivalence to a predicate device, rather than clinical performance based on defined acceptance criteria like sensitivity/specificity/accuracy or multi-reader studies.
Therefore, many of the requested fields cannot be extracted directly from this document as they are not applicable to the type of device and submission described here.
Here's a breakdown of what can and cannot be provided based on the input:
1. A table of acceptance criteria and the reported device performance:
| Acceptance Criteria (Bench Test Type) | Reported Device Performance (Summary) | Device(s) |
|---|---|---|
| Appearance (Visual Inspection) | Met pre-set criteria | SPINAUT-V, SPINAUT-I |
| Leakage Test (Pressure gauge) | Met pre-set criteria | SPINAUT-V, SPINAUT-I |
| Tensile strength (ISO 10555-1) | Met pre-set criteria | SPINAUT-V, SPINAUT-I |
| Curved strength (Carved angle measurement) | Met pre-set criteria | SPINAUT-V |
| Fatigue test | Met pre-set criteria | SPINAUT-V |
| X-ray impermeable test | Met pre-set criteria (shown clearly) | SPINAUT-V |
| Corrosion resistance test (ISO 10555-1) | Met pre-set criteria | SPINAUT-V |
| Flexural Rigidity (MFDS Notification No. 2013-214) | Met pre-set criteria | SPINAUT-V, SPINAUT-I |
| Sterility test (Korean Pharmacopeia) | Met pre-set criteria | SPINAUT-V, SPINAUT-I |
| Direction of View (ISO 8600-3) | Met pre-set criteria | SPINAUT-S |
| Field of View (ISO 8600-3:2013) | 90° (Subject Device) vs 60° (Predicate Device) - Met specifications and performed as well as predicate. | SPINAUT-S |
| Observation Depth (Depth of Focus) (ISO 8600-1:2005, ISO 12233:2014) | 3 mm(f₁) ~ 20 mm(f₂) (Subject Device) vs 5 mm(f₁) ~ 7.0 mm(f₂) (Predicate Device) - Met specifications and performed as well as predicate. | SPINAUT-S |
| Internal Pressure (Capacity to Resist Pressure) (ISO 8600-1:2005) | Met pre-set criteria | SPINAUT-S |
| Dimensions (Total length, insertion portion, outer diameter) | Met pre-set criteria (Specific values provided for comparison but implicitly met; e.g., SPINAUT-S total length 950.5 mm vs predicate 994.0 mm) | SPINAUT-S |
| Connecting Part (Conical) Fitting (ISO 594-1, ISO 594:2) | Met pre-set criteria | SPINAUT-I |
| Biocompatibility (ISO 10993-4, 5, 10, 11 and USP 37 ) | Biocompatible | All Devices (SPINAUT-V, S, I) |
| Sterilization Validation (ISO 11137-1, 2, 3 and ISO 11737-1, 2, 3) | Met pre-set criteria | All Devices (SPINAUT-V, S, I) |
| Shelf Life Validation (ASTM F1980-07) | 3-year shelf life validated | All Devices (SPINAUT-V, S, I) |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective):
The document describes bench tests and validation tests rather than clinical studies with "test sets" in the context of diagnostic accuracy. Therefore, information on sample size for image/patient data and data provenance like country of origin or retrospective/prospective is not applicable/provided. The tests cited are standard methods for device manufacturing and safety.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience):
Not applicable. The tests performed are engineering and material science tests, not clinical performance evaluations requiring expert ground truth.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:
Not applicable.
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 is not an AI/ML device, and no MRMC study information is provided.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
Not applicable. This is not an AI/ML device.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc):
For the bench tests, the ground truth is the performance standards and specifications defined by the referenced ISO, ASTM, MFDS, and USP standards (e.g., a catheter must not leak under a certain pressure, a material must be biocompatible, a sterilization process must achieve a certain Sterility Assurance Level).
For the biocompatibility tests, the ground truth is adherence to specific biological response criteria as per ISO 10993 and USP standards.
For sterilization and shelf-life validation, the ground truth is the scientific principles and validated methodologies outlined in the relevant ISO and ASTM standards.
8. The sample size for the training set:
Not applicable. This is not an AI/ML device using training data.
9. How the ground truth for the training set was established:
Not applicable.
§ 888.1100 Arthroscope.
(a)
Identification. An arthroscope is an electrically powered endoscope intended to make visible the interior of a joint. The arthroscope and accessories also is intended to perform surgery within a joint.(b)
Classification. (1) Class II (performance standards).(2) Class I for the following manual arthroscopic instruments: cannulas, currettes, drill guides, forceps, gouges, graspers, knives, obturators, osteotomes, probes, punches, rasps, retractors, rongeurs, suture passers, suture knotpushers, suture punches, switching rods, and trocars. The devices subject to this paragraph (b)(2) are exempt from the premarket notification procedures in subpart E of part 807 of this chapter, subject to the limitations in § 888.9.