(86 days)
No
The summary describes a basic arthroscope with standard optical components and no mention of AI/ML, image processing, or data analysis capabilities.
No
The device is described for examination, biopsy, diagnosis, and providing a clear view of joint structures, which are diagnostic purposes, not therapeutic.
Yes
The "Intended Use / Indications for Use" section explicitly states that the device is indicated for "diagnosis of joint disease."
No
The device description explicitly details hardware components such as an eyepiece, body, light guide, and shaft, including tubes and optical systems. This indicates it is a physical medical device, not software-only.
Based on the provided information, the AMO Arthroscope is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are tests performed on samples such as blood, urine, or tissue taken from the human body to detect diseases, conditions, or infections. They are used to examine these samples outside of the body.
- AMO Arthroscope Function: The description clearly states the AMO Arthroscope is used for "minimally invasive procedures of the knee, shoulder and ankle joints, for joint examination, biopsy, arthroscopy, diagnosis of joint disease." It provides a "clear view of the joint structures." This is a device used within the body to visualize and potentially take samples from the body, not to test samples outside the body.
The device is an endoscope used for direct visualization of internal body structures.
N/A
Intended Use / Indications for Use
Like other legally marketed arthroscopes, the AMO Arthroscope is indicated for use in minimally invasive procedures of the knee, shoulder and ankle joints, for joint examination, biopsy, arthroscopy, diagnosis of ioint disease.
The device provides a clear view of the joint structures such as femoral condyles, medial meniscus, cruciate ligament, and other anatomical structures.
Product codes
Not Found
Device Description
The AMO Arthroscope is a device that will be provided non-sterile for arthroscopic procedures. The device has a basic design similar to those already sold legally in the U.S.A. Its construction consists of an eyepiece, body, light guide and a shaft. The shaft contains an outer tube, an inner tube, with light-carrying fibers sandwiched between these tubes. The inner tube contains the optical system.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
knee, shoulder and ankle joints
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
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)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
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
SEP 11 1996
SUMMARY OF SAFETY AND EFFECTIVENESS American Microptiks, Inc. "AMO Arthroscope" 501K Number K962330 Updated as of September 6th, 1996
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- Submitter information:
| Name and Address | American Microptiks, Inc. |
|---|---|
| 420 East Main St. | |
| Building 3, Unit 18 | |
| Branford CT 06437 |
| Phone | (203) 483-6428 |
|---|---|
| Fax | (203) 483-9829 |
Dr. George Hallack Contact Person
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- Device Name:
Classification Name: Arthroscope Proprietary Name: AMO Arthroscope
- Device Name:
3. Predicate Device:
An equivalent device to the AMO Arthroscope is the Storz (Karl Storz) 7200BW Arthroscope, manufactured in Germany at:
Mittelstrasse 8 D-4200 Tuttlingers Postfach 230
This device is distributed in this country by Karl Storz Endoscopy - America, Inc, Charleston MA.
The above identified equivalent device uses the same basic design principles and technological features as the proposed AMO Arthroscope.
1
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Description of Device: 4.
The AMO Arthroscope is a device that will be provided non-sterile for arthroscopic procedures. The device has a basic design similar to those already sold legally in the U.S.A. Its construction consists of an eyepiece, body, light guide and a shaft. The shaft contains an outer tube, an inner tube, with light-carrying fibers sandwiched between these tubes. The inner tube contains the optical system. -
- Indications for Use:
Like other legally marketed arthroscopes, the AMO Arthroscope is indicated for use in minimally invasive procedures of the knee, shoulder and ankle joints, for joint examination, biopsy, arthroscopy, diagnosis of ioint disease.
- Indications for Use:
The device provides a clear view of the joint structures such as femoral condyles, medial meniscus, cruciate ligament, and other anatomical structures.
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- Description of Safety and Substantial Equivalence:
The biological safety of the AMO arthroscope has been defined through the selection of materials that demonstrated appropriate levels of biocompatibility. The proposed AMO Arthroscope was designed with similar base materials. These materials are similar to those used in other legally marketed brands of arthroscopes, including the predicate device which is marketed for the same indications.
- Description of Safety and Substantial Equivalence:
In summary, biocompatibility, function and device design have been developed to ensure the device is safe, effective, and substantially equivalent in materials, function and intended use to commercially available arthroscopes.
The device will be sold non-sterile, to be sterilized prior to each procedure by the user. Our recommended sterilization method, to be validated, is ethylene oxide gas.