(36 days)
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No
The summary describes a mechanical device (arthroscope and accessories) and makes no mention of software, image processing, AI, or ML.
No
The device is described as an arthroscope used for visualization during endoscopic carpal ligament release and includes accessories like knives and dilators. While used in a therapeutic procedure, the device itself is an instrument for viewing and assisting, rather than directly providing a therapeutic effect (e.g., drug delivery, energy therapy). Its function is to allow the surgeon to see and perform the therapeutic release.
No
Explanation: The "Intended Use / Indications for Use" states that these devices are indicated for use in endoscopic carpal ligament release, which is a surgical procedure, not a diagnostic one. The "Device Description" also describes surgical tools (arthroscopes, knives, dilators, retractor). There is no mention of diagnosing conditions.
No
The device description explicitly details physical hardware components like arthroscopes, sheaths, obturators, knives, dilators, and a retractor.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is "endoscopic carpal ligament release." This is a surgical procedure performed on the patient's body, not a test performed on a sample taken from the body.
- Device Description: The device is described as an arthroscope and accessories used for a surgical procedure. This aligns with a surgical instrument, not a diagnostic test.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue, etc.), detecting specific substances, or providing diagnostic information based on laboratory analysis.
IVD devices are used to examine specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes. This device is a surgical tool used for treatment.
N/A
Intended Use / Indications for Use
These devices are indicated for use in endoscopic carpal ligament release.
Product codes
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Device Description
The KSEA arthroscopes for use in endoscopic carpal ligament release are straight-shafted, rod-lens telescopes. Accessories are available for use with the arthroscopes include sheaths, obturators, knives, dilators, and a retractor with guiding tube. The body contact materials present in these devices are commonly used in medical devices for a wide range of applications, and have a long history of biocompatability for human use.
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
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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 Karl Storz Endoscopy logo. The logo is white and has a stylized font. The background is a grainy black and white texture.
scopy An erica, Inc.
600 Corporate Pointe Culver City, California 90230-7600 Phone 310 558 1500
Tcll Free 800 421 0837 Fax 310 410 5527
96/244
510(K) SUMMARY OF SAFETY AND EFFECTIVE
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 CRF 807.92. All data included in this documents 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 arthroscopes knives dilators sheaths obturators retractor with guiding tube |
Indication: These devices are indicated for use in endoscopic carpal ligament release.
Device Description: The KSEA arthroscopes for use in endoscopic carpal ligament release are straight-shafted, rod-lens telescopes. Accessories are available for use with the arthroscopes include sheaths, obturators, knives, dilators, and a retractor with guiding tube. The body contact materials present in these devices are commonly used in medical devices for a wide range of applications, and have a long history of biocompatability for human use.
Substantial Equivalence: The KSEA instruments for endoscopic carpal ligament release are substantially equivalent to the predicate devices, since the basic features, design and intended uses are the same. The minor differences between the KSEA instruments for the endoscopic treatment of carpal tunnel syndrome 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 the devices.
Signed:
Betty M. Johnson
Betty M. Johnson
Manager, Regulatory Affairs
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