(52 days)
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No
The summary describes mechanical surgical instruments and their intended use, with no mention of AI or ML capabilities. The use of imaging modalities is for navigation, not for processing or analysis by the device itself.
Yes
The device is used for partial or complete removal of intervertebral disc material to decompress spinal structures, which is a therapeutic intervention aimed at treating medical conditions.
No
Explanation: The device is described as an instrument used for surgical removal of disc material and decompression of spinal structures. Its purpose is therapeutic intervention, not diagnosis. It is supported by diagnostic imaging modalities (CT, MRI), but the device itself does not perform diagnostic functions.
No
The device description explicitly states the instruments are made of medical grade stainless steel, indicating a physical hardware component.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices used to perform tests on samples taken from the human body (like blood, urine, tissue) to provide information about a person's health. These tests are performed outside of the body.
- Device Function: The description clearly states that these instruments are used for "Percutaneous Lumbar Disc Decompression," which involves the removal of disc material within the human body. This is a surgical procedure performed in vivo.
- Intended Use: The intended use is to decompress spinal structures by removing disc material, not to analyze samples for diagnostic purposes.
The device is a surgical instrument used for a therapeutic procedure, not a diagnostic test performed on a sample.
N/A
Intended Use / Indications for Use
The instruments are used for Percutaneous Lumbar Disc Decompression. This involves partial or complete removal of human intervertebral disc hemias or degenerative diseases within the lumbar region. The goal is to decompress spinal structures like roots of nerves. Performing procedures like the mentioned PDD (Percutaneous Disc Decompression) is restricted to trained surgeons. The procedure is normally supported by the use of navigational systems (e.g. CT's, MRI, or Neuronavigation).
Product codes
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Device Description
Discectorny Instruments are made of medical grade stainless steel. They are used for partial or complete removal of intravertebral disc material in patients suffering from spinal compression syndromes. Percutaneous access is achieved by small incisions and introduction of sleeves.
Mentions image processing
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Mentions AI, DNN, or ML
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Input Imaging Modality
CT's, MRI, or Neuronavigation
Anatomical Site
intravertebral disc material in the lumbar region
Indicated Patient Age Range
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Intended User / Care Setting
trained surgeons
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
Instruments have been tested to assure there is no breakage of the jaw or other parts of the instrument. No Clinical tests were performed.
Key Metrics
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Predicate Device(s)
510(k) Arthroscopy instruments sold by Richard Wolf, Discectorny devices sold by AcuFlex, Smith + Nephew, and Aesculap.
Reference Device(s)
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Predetermined Change Control Plan (PCCP) - All Relevant Information
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§ 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
960222
510(k) Summary of Safety and Effectiveness
- 1.0 Classification Name: Orthopedic Manual Surgical Instruments
Kacodd
2.0 Common / Usual Name:
Percutaneous Discectorny System
3.0 Trade Name:
Forceps, dilator, working sleeves, cannulas, trephines, deflectors
4.0 Equivalence:
These devices are equivalent to existing 510(k) Arthroscopy instruments sold by Richard Wolf, Discectorny devices sold by AcuFlex, Smith + Nephew, and Aesculap.
5.0 Description:
Discectorny Instruments are made of medical grade stainless steel. They are used for partial or complete removal of intravertebral disc material in patients suffering from spinal compression syndromes. Percutaneous access is achieved by small incisions and introduction of sleeves.
6.0 Intended Use:
The instruments are used for Percutaneous Lumbar Disc Decompression. This involves partial or complete removal of human intervertebral disc hemias or degenerative diseases within the lumbar region. The goal is to decompress spinal structures like roots of nerves. Performing procedures like the mentioned PDD (Percutaneous Disc Decompression) is restricted to trained surgeons.
The procedure is normally supported by the use of navigational systems (e.g. CT's, MRI, or Neuronavigation).
7.0 Technological Characteristics:
Basic arthroscopic instruments are equipped with longer shafts and integrated in a set of tubular sheaths to establish access. As the intended use includes punching, grasping, cutting, as well as suction / imgation, all the functions are provided in the selected instruments.
8.0 Performance Data:
Instruments have been tested to assure there is no breakage of the jaw or other parts of the instrument.
1
Clinical Tests: 9.0
By:
No Clinical tests were performed.
Data Conclusion: 10.0
Data Conclusion:
The new Richard Wolf Discectory Instruments are substantially equivalent to existing The new Richard Wolf Discectorry Instruments are substantially of the agencing and breakage.
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28 ______________________________________________________________________________________________________________________________________________________________________________ asana le
Robert L. Casarsa Quality Assurance Manager Quality Assurance Manager
RICHARD WOLF MEDICAL INSTRUMENT CORPORATION