(253 days)
Not Found
No
The summary describes a mechanical device for tissue removal and does not mention any AI/ML components or functions.
Yes
The device is used for "therapy with endoscopic accessories" to remove tissue and bone during surgical procedures, directly treating a condition or injury.
No
The device description indicates it is used for "remove tissue during endoscopic procedures" and lists therapeutic applications like "resection of meniscus," "removal of soft tissue," and "intra-articular severing or abrading of bone tissue." These are all interventional or therapeutic actions, not diagnostic ones.
No
The device description explicitly mentions hardware components like a "RIWO Drive Generator with motor handle" and "Power Cutters and Burrs" which are driven by the motor handle. This indicates it is a hardware device with a driving mechanism, not solely software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are devices intended for use in the collection, preparation, and examination of specimens taken from the human body (such as blood, urine, or tissue) to provide information for diagnostic purposes.
- Device Function: The RIWO Drive Generator with motor handle and associated cutters/burrs is used to physically remove tissue during endoscopic surgical procedures. It is a surgical tool, not a device that analyzes biological samples.
- Intended Use: The intended use clearly states it is for "therapy with endoscopic accessories" and describes surgical procedures like tissue resection and bone abrasion.
Therefore, this device falls under the category of a surgical instrument or system, not an In Vitro Diagnostic.
N/A
Intended Use / Indications for Use
The RIWO Drive Generator with motor handle serves to drive Wolf Power Cutters and Burrs to remove tissue during endoscopic procedures.
Indication and field of application:
For therapy with endoscopic accessories:
- . in arthroscopy, e.g., for resection of meniscus, for removal of soft tissue, as well as for intra-articular severing or abrading of bone tissue, e.g., ACL or shoulder procedures
- . in sinus surgery, e.g. for removal of polyps
- . in spine surgery (arthroscopic mirco disectomy (AMD), spinal endsoscopy)
Product codes (comma separated list FDA assigned to the subject device)
HRX
Device Description
The power Cutters and Burrs consist of a hollow, fenestrated tube, containing a rotating twoedged cylindrical blade (cutter) or an abrader (burr) that spins within the hollow tube. They are driven by a motor handle.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
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Indicated Patient Age Range
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Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
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Description of the test set, sample size, data source, and annotation protocol
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Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
No known performance standard exists.
No clinical tests were performed.
These devices are designed and tested to guarantee the safety and effectiveness, when used according to the instructions manual.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
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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.
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.
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