(42 days)
No
The description focuses on optical and fiber optic technology for illumination and viewing, with no mention of AI, ML, or image processing.
No.
The device is described as an arthroscope used for illumination and viewing during orthopedic surgery, not for treating a condition or disease.
No
The device is described as being used for "illumination and viewing of joint capsules" in "orthopedic surgery," which points to a visualization tool rather than one used for diagnosis. There is no mention of it providing analytical or comparative information that would lead to a diagnosis.
No
The device description clearly states it is a reusable arthroscope with physical components like a fiber optic light transmission system and an optical system, indicating it is a hardware device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for "arthroscopic illumination and viewing of joint capsules" during orthopedic surgery. This is a direct visualization and surgical tool, not a device used to examine specimens (like blood, tissue, etc.) in vitro (outside the body) to diagnose a condition.
- Device Description: The description details an optical and fiber optic system for viewing and illuminating within the body. This aligns with a surgical instrument, not an IVD.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples, reagents, or any other typical components or processes associated with in vitro diagnostics.
Therefore, this device is a surgical instrument used for visualization during orthopedic procedures, not an IVD.
N/A
Intended Use / Indications for Use
"Both the Auto Suture* Arthroscope** and the Auto Suture* Disposable Arthroscope** (K933576) are intended to be used in orthopedic surgery for the arthroscopic illumination and viewing of joint capsules."
Product codes (comma separated list FDA assigned to the subject device)
Not Found
Device Description
"The Auto Suture* Arthroscope** is a reusable arthroscope which has a 30° field of view and a diameter maximum of 4.75 mm. The device utilizes a fiber optic light transmission system to illuminate the joint capsule and an optical system to view the capsule."
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
"joint capsules"
Indicated Patient Age Range
Not Found
Intended User / Care Setting
"orthopedic surgery"
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Not Found
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
"Auto Suture* Disposable Arthroscope** (K933576)"
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 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.
0
960805
APR - 8 1996
510(k) SUMMARY OF INFORMATION:
SUBMITTER:
United States Surgical Corporation 150 Glover Avenue Norwalk, CT 06856 (203) 845-1000
CONTACT PERSON: Janet G. Johnson
DATE PREPARED: February 27, 1996
CLASSIFICATION NAME: Arthroscope
COMMON NAME: Arthroscope
PROPRIETARY NAME:
Trademark name not yet determined.
DEVICE DESCRIPTION:
The Auto Suture* Arthroscope** is a reusable arthroscope which has a 30° field of view and a diameter maximum of 4.75 mm. The device utilizes a fiber optic light transmission system to illuminate the joint capsule and an optical system to view the capsule.
PREDICATE DEVICE:
Auto Suture* Disposable Arthroscope** (K933576)
INTENDED USE:
Both the Auto Suture* Arthroscope** and the Auto Suture* Disposable Arthroscope** (K933576) are intended to be used in orthopedic surgery for the arthroscopic illumination and viewing of joint capsules.
MATERIALS:
Both the Auto Suture* Arthroscope ** and the Auto Suture* Disposable Arthroscope ** (K933576) are comprised of biosafe materials, such as stainless steel, ABS plastic, and aluminum.