(107 days)
Cook Lens Cleaner (Unknown), Wiest Optic Shaft (Unknown), DevMed Lap wash (Unknown)
LTF-V
No
The description focuses on mechanical cleaning, irrigation, and suction capabilities, with no mention of AI or ML.
No
The device is described as a lens cleaning sheath for an endoscope, offering lens cleaning, irrigation, and suction capabilities. Its purpose is to clean the objective lens surface during endoscopic procedures, not to provide therapy to a patient.
No
The device is described as a "Lens Cleaning Sheath" designed to clean the objective lens surface of a videoscope, and to offer irrigation and suction capabilities during endoscopic procedures. Its function is to facilitate clear viewing, not to diagnose medical conditions itself. It's an accessory for an endoscopic procedure, not a diagnostic tool.
No
The device description clearly states it is a "Lens Cleaning Sheath" and describes physical components and functions (cleaning, irrigation, suction) used with a videoscope, indicating it is a hardware device.
Based on the provided information, the A4907 Lens Cleaning Sheath is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is to clean the objective lens surface of a videoscope during endoscopic procedures. This is a function related to the operation and maintenance of a medical device used in vivo (within the body), not for testing samples in vitro (outside the body).
- Device Description: The description focuses on its mechanical function (cleaning, irrigation, suction) and its use with a videoscope during procedures.
- Lack of IVD Characteristics: The description does not mention any of the typical characteristics of an IVD, such as:
- Analyzing biological samples (blood, urine, tissue, etc.)
- Detecting or measuring substances in samples
- Providing information for diagnosis, monitoring, or screening of diseases or conditions based on sample analysis.
The device is clearly designed to facilitate the visual examination of internal body structures during an endoscopic procedure, which is an in vivo activity.
N/A
Intended Use / Indications for Use
The A4907 Lens Cleaning Sheath has been specifically designed to be used with the Olympus A4908 Valve and LTF-V OES V Laparo-Thoraco Videoscope to clean of the objective lens surface.
Product codes
Not Found
Device Description
The A4907 Lens Cleaning Sheath has been specifically designed for use with the Olympus A4908 Valve and LTF-V OES Laparo-Thoraco Videoscope. It will be included in the standard set of LTF-V Laparo-Thoraco Videoscope and will also be marketed separately.
When connected to the main body of LTF-V videoscope, it offers lens cleaning, irrigation, and suction capabilities to the user during endoscopic procedures. It is substantially equivalent in design, intended use, and method of operation to the "Lens Cleaner" manufactured by Cook, "Optic Shaft" manufactured by Wiest, and "Lap Wash System" manufactured by DevMed Group Inc.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
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
Not Found
Key Metrics
Not Found
Predicate Device(s)
Cook Lens Cleaner (Unknown), Wiest Optic Shaft (Unknown), DevMed Lap wash (Unknown)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 884.1720 Gynecologic laparoscope and accessories.
(a)
Identification. A gynecologic laparoscope is a device used to permit direct viewing of the organs within the peritoneum by a telescopic system introduced through the abdominal wall. It is used to perform diagnostic and surgical procedures on the female genital organs. This generic type of device may include: Trocar and cannula, instruments used through an operating channel, scope preheater, light source and cables, and component parts.(b)
Classification. (1) Class II (performance standards).(2) Class I for gynecologic laparoscope accessories that are not part of a specialized instrument or device delivery system, do not have adapters, connector channels, or do not have portals for electrosurgical, lasers, or other power sources. Such gynecologic laparosope accessory instruments include: the lens cleaning brush, biopsy brush, clip applier (without clips), applicator, cannula (without trocar or valves), ligature carrier/needle holder, clamp/hemostat/grasper, curette, instrument guide, ligature passing and knotting instrument, suture needle (without suture), retractor, mechanical (noninflatable), snare, stylet, forceps, dissector, mechanical (noninflatable), scissors, and suction/irrigation probe. 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 § 884.9.
0
AUG 2 9 1996
510 (k) SUMMARY
Olympus A4907 Lens Cleaning Sheath
| Device Name: | Olympus A4907 Lens Cleaning Sheath | |
|---|---|---|
| Common/Usual Name: | Lens Cleaning Tube | |
| Classification Name: | Endoscope and Accessories | |
| 21 CFR 876.1500, Class II | ||
| Predicate Devices: | Cook | Lens Cleaner (Unknown) |
| Wiest | Optic Shaft (Unknown) | |
| DevMed | Lap wash (Unknown) | |
| Submitted By: | ||
| (Contact Person) | Subhash Patel | |
| Olympus America Inc. | ||
| Endoscope Division | ||
| Two Corporate Center Drive | ||
| Melville, New York 11747-3157 | ||
| (516) 844-5481 | ||
| Summary Preparation Date: | May 8, 1996 |
Statement of Intended Use
The A4907 Lens Cleaning Sheath has been specifically designed to be used with the Olympus A4908 Valve and LTF-V OES V Laparo-Thoraco Videoscope to clean of the objective lens surface.
Device Description
The A4907 Lens Cleaning Sheath has been specifically designed for use with the Olympus A4908 Valve and LTF-V OES Laparo-Thoraco Videoscope. It will be included in the standard set of LTF-V Laparo-Thoraco Videoscope and will also be marketed separately.
When connected to the main body of LTF-V videoscope, it offers lens cleaning, irrigation, and suction capabilities to the user during endoscopic procedures. It is substantially equivalent in design, intended use, and method of operation to the "Lens Cleaner" manufactured by Cook, "Optic Shaft" manufactured by Wiest, and "Lap Wash System" manufactured by DevMed Group Inc.
General Safety
When compared with the predicate devices, Olympus A4907 Lens Cleaning Sheath does not incorporate any significant change in intended use, method of operation, material, or design that could affect the safety or effectiveness of the subject device.