(81 days)
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No
The description focuses on the physical construction, materials, optical performance, and sterilization of a standard laparoscope, with no mention of AI or ML capabilities.
No
The device is described as a laparoscope for harvesting saphenous veins, similar to an endoscope, which is a surgical tool used for visualization during a procedure, not a device that treats or cures a disease or condition.
No
The device is described as a laparoscope used for harvesting the saphenous vein, which is a surgical procedure, not a diagnostic one.
No
The device description clearly details physical components made of stainless steel, plated brass, anodized aluminum, optical glass, and light transmission fibers, indicating it is a hardware device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for "Saphenous Vein Harvest," which is a surgical procedure performed on the body, not on a sample taken from the body.
- Device Description: The description details a laparoscope, which is a surgical instrument used for visualization during minimally invasive surgery. It describes materials, optical performance, and sterilization methods, all consistent with a surgical device.
- No mention of in vitro testing: There is no mention of analyzing samples (blood, tissue, etc.) outside of the body to diagnose a condition or monitor a treatment.
IVD devices are used to examine specimens (like blood, urine, or tissue) taken from the human body to provide information for diagnosis, monitoring, or treatment. This device is used directly on the patient during a surgical procedure.
N/A
Intended Use / Indications for Use
The Stryker Saphenous Vein Harvest Laparoscope is substantially equivalent to the Snowden Pencer Saphenous Vein Endoscope in intended use and is compatible for use with the Ethicon Subcu-Retractor for this purpose.
Product codes
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Device Description
The Stryker Saphenous Vein Harvest Laparoscope is identical in terms of materials and modes of construction, optical performance and safety to the existing line of Stryker 5mm Laparoscopes, differing only in working length. Materials of construction coming into patient contact, including structural components and cannula components which are of stainless steel, plated brass, and anodized aluminum, joined with adhesives and braze alloys, are demonstrated to be bio-compatible per the Tripartite scheme, and/or ISO 10993 and G95-1. The optical system consisting of optical glass, adhesives and coated brass components for spacing and mounting, and light transmission fibers are identical to those currently used in Stryker cleared laparoscopes. Stryker Saphenous Vein Harvest laparoscopes are reusable, and sold non-sterile, and are validated for cleanability, disinfection and re-sterilization. Sterilization methods include 100% EtO, Cidex® and Steris® processes. Those endoscopes labeled as "Autoclavable" will be validated for durability, cleanability, and sterilizability under specified cycles per appropriate AAMI guidelines.
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
Saphenous Vein
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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§ 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.
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K9644930
Image /page/0/Picture/1 description: The image shows the word "Stryker" in a bold, sans-serif font. The word is all in lowercase letters except for the first letter, which is capitalized. There is a horizontal line under the word. There is a small circle with an R in it in the upper right corner of the word.
2590 Walsh Avenue Santa Clara, CA 95051
FEB 2 8 1997
(408) 567-9100 (408) 567-2505 Fax
ﺗﮭﺎ ﮐﮧ
Stryker Saphenous Vein Harvest Laparoscope Device Name: Rigid Endoscope Classification Sponsor Stryker Endoscopy 2590 Walsh Ave. Santa Clara, CA 95051 FDA Registration # 2936485
Regulatory Class Class II
Safety and Effectiveness Summary:
The Stryker Saphenous Vein Harvest Laparoscope is identical in terms of materials and modes of construction, optical performance and safety to the existing line of Stryker 5mm Laparoscopes, differing only in working length. The Stryker Saphenous Vein Harvest Laparoscope is substantially equivalent to the Snowden Pencer Saphenous Vein Endoscope in intended use and is compatible for use with the Ethicon Subcu-Retractor for this purpose.
Materials of construction coming into patient contact, including structural components and cannula components which are of stainless steel, plated brass, and anodized aluminum, joined with adhesives and braze alloys, are demonstrated to be bio-compatible per the Tripartite scheme, and/or ISO 10993 and G95-1. The optical system consisting of optical glass, adhesives and coated brass components for spacing and mounting, and light transmission fibers are identical to those currently used in Stryker cleared laparoscopes.
Stryker Saphenous Vein Harvest laparoscopes are reusable, and sold non-sterile, and are validated for cleanability, disinfection and re-sterilization. Sterilization methods include 100% EtO, Cidex® and Steris® processes. Those endoscopes labeled as "Autoclavable" will be validated for durability, cleanability, and sterilizability under specified cycles per appropriate AAMI guidelines.
The Stryker Saphenous Vein Harvest Laparoscopes present no additional safety or effectiveness issues when compared to current Stryker laparoscopes and Snowden Pencer Saphenous Vein Endocospes. Therefore, the Stryker Saphenous Vein Harvest Laparoscopes are substantially equivalent to these devices.
A.V. Arre
Bob Dahla R&D Project Engineer
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