(170 days)
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No
The device description explicitly states it is "manually operated" and lists standard surgical instruments without any mention of AI/ML capabilities or related performance metrics.
No
The device is described as surgical instruments used for procedures like vein discission and paratibial fasciotomy, which are operative interventions rather than therapeutic treatments aimed at restoring health.
No
The device description clearly states "surgical devices" used for "endoscopic surgery" including "vein discission and paratibial fasciotomy," which are interventional procedures, not diagnostic ones.
No
The device description explicitly lists physical, manually operated surgical instruments (rigid endoscope, sheath, scissors, forceps, knives, and adapters), indicating it is a hardware-based medical device, not software-only.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states the device is for "endoscopic surgery of superficial veins and fascia of the lower extremities." This is a surgical procedure performed on the patient's body, not a test performed on a sample taken from the patient.
- Device Description: The device is described as a set of surgical instruments (endoscope, sheath, scissors, forceps, knives, adapters) used for surgical access and manipulation. This aligns with surgical tools, not diagnostic tests.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue, etc.), detecting analytes, or providing diagnostic information based on laboratory testing.
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
The KSEA Instrument Set for Endoscopic Surgery of Superficial Veins and Fascia of the Lower Extremities is intended for use by qualified surgeons during endoscopic surgery of superficial veins and fascia of the lower extremities, including vein discission and paratibial fasciotomy.
Product codes
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Device Description
The KSEA Instrument Set for Endoscopic Surgery of Superficial Veins and Fascia of the Lower Extremities are manually operated, reusable surgical devices consisting of a rigid endoscope, sheath, scissors, forceps, knives, and adapters. The instruments and endoscope are long enough to gain access to the surgical site. The body contact materials have a long history of use in medical devices and do not pose any new issues of safety and effectiveness
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
Superficial veins and fascia of the lower extremities
Indicated Patient Age Range
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Intended User / Care Setting
qualified 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 (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)
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Reference Device(s)
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Predetermined Change Control Plan (PCCP) - All Relevant Information
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§ 876.1500 Endoscope and accessories.
(a)
Identification. An endoscope and accessories is a device used to provide access, illumination, and allow observation or manipulation of body cavities, hollow organs, and canals. The device consists of various rigid or flexible instruments that are inserted into body spaces and may include an optical system for conveying an image to the user's eye and their accessories may assist in gaining access or increase the versatility and augment the capabilities of the devices. Examples of devices that are within this generic type of device include cleaning accessories for endoscopes, photographic accessories for endoscopes, nonpowered anoscopes, binolcular attachments for endoscopes, pocket battery boxes, flexible or rigid choledochoscopes, colonoscopes, diagnostic cystoscopes, cystourethroscopes, enteroscopes, esophagogastroduodenoscopes, rigid esophagoscopes, fiberoptic illuminators for endoscopes, incandescent endoscope lamps, biliary pancreatoscopes, proctoscopes, resectoscopes, nephroscopes, sigmoidoscopes, ureteroscopes, urethroscopes, endomagnetic retrievers, cytology brushes for endoscopes, and lubricating jelly for transurethral surgical instruments. This section does not apply to endoscopes that have specialized uses in other medical specialty areas and that are covered by classification regulations in other parts of the device classification regulations.(b)
Classification —(1)Class II (special controls). The device, when it is an endoscope disinfectant basin, which consists solely of a container that holds disinfectant and endoscopes and accessories; an endoscopic magnetic retriever intended for single use; sterile scissors for cystoscope intended for single use; a disposable, non-powered endoscopic grasping/cutting instrument intended for single use; a diagnostic incandescent light source; a fiberoptic photographic light source; a routine fiberoptic light source; an endoscopic sponge carrier; a xenon arc endoscope light source; an endoscope transformer; an LED light source; or a gastroenterology-urology endoscopic guidewire, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 876.9.(2) Class I for the photographic accessories for endoscope, miscellaneous bulb adapter for endoscope, binocular attachment for endoscope, eyepiece attachment for prescription lens, teaching attachment, inflation bulb, measuring device for panendoscope, photographic equipment for physiologic function monitor, special lens instrument for endoscope, smoke removal tube, rechargeable battery box, pocket battery box, bite block for endoscope, and cleaning brush for endoscope. The devices subject to this paragraph (b)(2) are exempt from the premarket notification procedures in subpart E of part 807of this chapter, subject to the limitations in § 876.9.
0
Image /page/0/Picture/0 description: The image shows a logo with the letters "ORZ" in a stylized font. The "O" is a circle with a smaller circle inside, and the "R" and "Z" are connected with thin lines. Below the logo, the words "Storz Endoscopy" are written in a simple font. The background of the image is a grainy texture.
Karl Storz Endoscopy-America, Inc.
ALG 22 1996
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 EFFECTIVENE
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:
Marika Anderson Regulatory Affairs Specialist
Device Identification:
Common Name Endoscope Telescope sheaths Knives Scissors Dissectors Bipolar Forceps and Cable Adapter Trade Name KSEA Instrument Set for Endoscopic Surgery of Superficial Veins and Fascia of the Lower Extremities
Indication: The KSEA Instrument Set for Endoscopic Surgery of Superficial Veins and Fascia of the Lower Extremities is intended for use by qualified surgeons during endoscopic surgery of superficial veins and fascia of the lower extremities, including vein discission and paratibial fasciotomy.
Device Description: The KSEA Instrument Set for Endoscopic Surgery of Superficial Veins and Fascia of the Lower Extremities are manually operated, reusable surgical devices consisting of a rigid endoscope, sheath, scissors, forceps, knives, and adapters. The instruments and endoscope are long enough to gain access to the surgical site. The body contact materials have a long history of use in medical devices and do not pose any new issues of safety and effectiveness
Substantial Equivalence: The KSEA Instrument Set for Endoscopic Surgery of Superficial Veins and Fascia of the Lower Extremities is substantially equivalent to the predicate devices since the basic features, design and inended uses are the same. The minor differences in design and dimensions between the KSEA Instrument Set for Endoscopic Surgery of Superficial Veins and Fascia of the Lower Extremities 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: Manka Anderson
Marika Anderson Regulatory Affairs Specialist