(114 days)
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No
The 510(k) summary describes a mechanical surgical blade and does not mention any software, algorithms, or AI/ML capabilities.
No.
The device is an arthroscopic blade used for shaving, abrading, debridement or cutting tissue during surgical procedures, not for therapy.
No
The device description states its function is for "controlled shaving, abrading, debridement or cutting of tissue during arthroscopic surgical procedures." These are therapeutic or surgical actions, not diagnostic ones. There is no mention of the device being used to identify or determine the nature of a disease or condition.
No
The device description explicitly states it is a "sterile, single use device" made of "surgical grade stainless steel," indicating it is a physical hardware device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states that the device is designed for "controlled shaving, abrading, debridement or cutting of tissue during arthroscopic surgical procedures." This describes a surgical tool used directly on the patient's body during a procedure.
- Device Description: The description reinforces this by stating it's a "sterile, single use device" used as an "accessory to arthroscopes" and made of "surgical grade stainless steel." These are characteristics of surgical instruments.
- Lack of IVD Characteristics: There is no mention of the device being used to examine specimens (like blood, urine, or tissue samples) in vitro (outside the body) to provide information about a patient's health status, diagnosis, or treatment.
IVD devices are used to perform tests on samples taken from the body, not to directly manipulate tissue during surgery.
N/A
Intended Use / Indications for Use
The KSEA Slotted Whisker Arthroscopic Blade is designed to provide controlled shaving, abrading, debridement or cutting of tissue during arthroscopic surgical procedures in both large joints (shoulder, hip, and knee) and small joints (elbow, wrist, ankle and TMI), including debridement in patellar chondromalacia and smoothing of meniscal edges, the glenoid labrum, or rotator cuff.
Product codes
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Device Description
The KSEA Slotted Whisker Arthroscopic Blade is sold as a sterile, single use device. The blade is long enough to gain access to the surgical area and is designed to be used as an accessory to arthroscopes. The body contact materials of the blades are surgical grade stainless steel.
Mentions image processing
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Mentions AI, DNN, or ML
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Input Imaging Modality
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Anatomical Site
large joints (shoulder, hip, and knee) and small joints (elbow, wrist, ankle and TMI)
Indicated Patient Age Range
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Intended User / Care Setting
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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)
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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.
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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.
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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).
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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
Image /page/0/Picture/0 description: The image shows the logo for Karl Storz Endoscopy. The logo is white and the background is black. The logo is stylized and modern.
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
NOV 2 7 1996
510(k) SUMMARY OF SAFETY AND EFFECTIVENESS
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: | Betty M. Johnson
Manager, Regulatory Affairs |
| Device Identification: | Common Name
Surgical Arthroscopic Blade |
Trade Name Karl Storz Slotted Whisker Arthroscopic Blade
The KSEA Slotted Whisker Arthroscopic Blade is designed to provide controlled Indication: shaving, abrading, debridement or cutting of tissue during arthroscopic surgical procedures in both large joints (shoulder, hip, and knee) and small joints (elbow, wrist, ankle and TMI), including debridement in patellar chondromalacia and smoothing of meniscal edges, the glenoid labrum, or rotator cuff.
Device Description: The KSEA Slotted Whisker Arthroscopic Blade is sold as a sterile, single use device. The blade is long enough to gain access to the surgical area and is designed to be used as an accessory to arthroscopes. The body contact materials of the blades are surgical grade stainless steel.
Substantial Equivalence: The KSEA Slotted Whisker Arthroscopic Blade is 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 KSEA Slotted Whisker Arthroscopic Blade 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:
: Marika Anderson
Marika Anderson
Senior Regulatory Affairs Specialist