(139 days)
Not Found
No
The summary describes a traditional endoscopic system for vessel harvesting and does not mention any AI or ML components or capabilities.
No
The device is described as an Endoscopic Vessel Harvesting System used for gaining access to, ligating and/or harvesting vessels. While it is used in a surgical procedure, its function is for harvesting, not for treating a disease or condition itself. Surgical tools are typically considered diagnostic or interventional, rather than therapeutic devices. The predicate devices are also for dissection/resection or harvesting, aligning with an interventional classification.
No
The device is described as an Endoscopic Vessel Harvesting System used for gaining access to, ligating, and harvesting vessels. This is a surgical or interventional procedure, not a diagnostic one.
No
The device description explicitly lists hardware components like an endoscope and associated accessories and ancillary equipment, indicating it is not software-only.
Based on the provided information, the Olympus Endoscopic Vessel Harvesting System is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices used to perform tests on samples taken from the human body (like blood, urine, tissue) to provide information about a person's health. These tests are performed outside the body.
- Device Function: The description clearly states the device is used for "endoscopically gaining access to, ligating and/or harvesting vessels... within the subcutaneous and subfacial surgical planes in the lower extremities." This is a surgical procedure performed inside the body.
- Lack of IVD Indicators: The description does not mention any testing of samples, analysis of biological materials, or any of the typical functions associated with IVD devices.
Therefore, the Olympus Endoscopic Vessel Harvesting System is a surgical device, not an In Vitro Diagnostic.
N/A
Intended Use / Indications for Use
The Olympus Endoscopic Vessel Harvesting System is specifically designed for subcutaneous endoscopy - - more specifically for endoscopically gaining access to, ligating and/or harvesting vessels (e.g. veins, arteries, ducts, nerve) within the subcutaneous and subfacial surgical planes in the lower extremities.
Product codes
Not Found
Device Description
Olympus Endoscopic System for Vessel Harvesting: endoscope, associated accessories and ancillary equipment.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
lower extremities
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)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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
DEC 31 1996 K963184
510(k) SUMMAR Y
OLYMPUS ENDOSCOPIC SYSTEM FOR VESSEL HARVESTING
| Device Name: | Olympus Endoscopic System for Vessel Harvesting:
endoscope, associated accessories and ancillary
equipment. |
|-----------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Common/Usual Name: | Olympus Endoscopic System for Vessel Harvesting |
| Classification Name: | Endoscope and Accessories |
| Predicate Devices: | Olympus Endoscopes for Subcutaneous
Dissection/Resection in Plastic/Reconstructive Surgery
and Aesthetic Surgery (K950076); Olympus Hand
Instruments for Subcutaneous Dissection/Resection in
Plastic/Reconstructive Surgery and Aesthetic Surgery
(K950103); Ethicon EndoSurgery Hand Retractors,
Dissectors for Vessel Harvesting (K955120). Refer to
Subsection I-A for additional list of predicate devices. |
| Submitted By:
(Contact Person) | Mr. Barry Sands
Olympus America Inc.
Endoscope Division
Two Corporate Center Drive
Melville, New York 11747-3157
(516) 844-5474 |
| Summary Preparation Date: | March 29, 1996 |
Statement of Intended Use
The Olympus Endoscopic Vessel Harvesting System is specifically designed for subcutaneous endoscopy - - more specifically for endoscopically gaining access to, ligating and/or harvesting vessels (e.g. veins, arteries, ducts, nerve) within the subcutaneous and subfacial surgical planes in the lower extremities.
Comparison to Predicate Device
The Endoscopic Vessel Harvesting System is identical or similar in design, function, and intended use to the Olympus Endoscopes for Subcutaneous Dissection/Resection in Plastic/Reconstructive Surgery and Aesthetic Surgery (K950076), Olympus Hand Instruments for Subcutaneous Dissection/Resection in Plastic/Reconstructive Surgery and Aesthetic Surgery (K950103), and Ethicon EndoSurgery Hand Retractors, Dissectors for Vessel Harvesting (K955120). Thus, when compared to the predicate devices, the Olympus System for Vessel Harvesting does not raise any questions regarding the safety of the subject device.