(57 days)
Not Found
Not Found
No
The summary describes a motorized surgical shaver and blades, with no mention of AI, ML, image processing, or data-driven features.
No.
The device is used to cut bone and tissue, which is a surgical tool, not a therapeutic device.
No
The device description states its function is for "controlled shaving, abrading and cutting of bone and tissue during arthroscopic surgical procedures," which are treatment or surgical actions, not diagnostic ones.
No
The device description explicitly states it is a "motorized surgical device" and includes "reusable and sterile, single use instruments" made of "surgical grade stainless steel," indicating it is a hardware device with physical components.
Based on the provided information, the Karl Storz Multidrive Mini Shaver and blades are not an In Vitro Diagnostic (IVD) device.
Here's why:
- Intended Use: The intended use is for "controlled shaving, abrading and cutting of bone and tissue during arthroscopic surgical procedures." This describes a surgical tool used directly on the patient's body during a procedure.
- Device Description: The description confirms it's a "motorized surgical device" and "instruments are long enough to gain access to the surgical area." This further reinforces its role as a surgical instrument.
- Lack of IVD Characteristics: IVD devices are used to examine specimens (like blood, urine, or tissue) outside of the body to provide information for diagnosis, monitoring, or screening. The provided information does not mention any such use or interaction with patient specimens.
Therefore, the Karl Storz Multidrive Mini Shaver and blades are classified as a surgical device, not an IVD.
N/A
Intended Use / Indications for Use
The Karl Storz Multidrive Mini Shaver and blades are designed to provide controlled shaving, abrading and cutting of bone and tissue during arthroscopic surgical procedures of the ankle, wrist, elbow and TMJ.
Product codes
Not Found
Device Description
The Karl Storz Multidrive Mini Shaver and blades are motorized surgical devices and include reusable and sterile, single use instruments are long enough to gain access to the surgical area and are designed to be used as accessories to arthroscopes. The body contact materials of the blades are surgical grade stainless steel.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
ankle, wrist, elbow and TMJ
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): 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.
Not Found
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
Image /page/0/Picture/0 description: The image shows the logo for Karl Storz Endoscopy. The logo consists of the word "STORZ" in a stylized font, with a target symbol in place of the letter "O". Below the word "STORZ" is the text "Karl Storz Endoscopy".
Karl Storz Endoscopy America, Inc.
600 Corporate Pointe Culver City, California 90230-7600 Phone 310 558 1500
Toll Free 800 421 0837 Fax 310 410 5527
510(k) SUMMARY OF SAFETY AND EFFECTIVENESS
MAR - 5 1997
This summary of 510(k) safety and effectiveness information is being submitted in accordance with the requirements of the Safe Medical Devices Act (SMDA) of 1990 and 21 CFR 807.92. All data included in this document are accurate and complete to the best of KSEA's knowledge.
| Applicant: | Karl Storz Endoscopy - America, Inc. |
|---|---|
| 600 Corporate Pointe | |
| Culver City, CA 90230 | |
| (310) 558-1500 | |
| Contact: | Renate A. MacLaren, Ph.D. |
| Senior Regulatory Affairs Specialist | |
| Device Identification: | Common Name |
| Shaver for Arthroscopy | |
| Arthroscopic Shaver Blades | |
| Trade Name |
Karl Storz Multidrive Mini Shaver Karl Storz Mini Shaver Blades
Indication: The Karl Storz Multidrive Mini Shaver and blades are designed to provide controlled shaving, abrading and cutting of bone and tissue during arthroscopic surgical procedures of the ankle, wrist, elbow and TMJ.
Device Description: The Karl Storz Multidrive Mini Shaver and blades are motorized surgical devices and include reusable and sterile, single use instruments are long enough to gain access to the surgical area and are designed to be used as accessories to arthroscopes. The body contact materials of the blades are surgical grade stainless steel.
Substantial Equivalence: The Karl Storz Multidrive Mini Shaver and blades are substantially equivalent to the predicate devices since the basic features, design and intended uses are the same. The minor differences in design and dimensions between the Karl Storz Multidrive Mini shaver, blades and the predicate devices raise no new issues of safety and effectiveness, as these design differences have no effect on the performance, function or intended use of these devices.
Signed:
Renate A. MacLaren, Ph.D. Senior Regulatory Affairs Specialist