(84 days)
Not Found
No
The description focuses on the physical components and function as a light source, with no mention of AI/ML terms or capabilities.
No.
The device is described as an accessory light source to facilitate viewing during ophthalmic surgical procedures, not as providing therapy itself.
No
The device is described as a light source to facilitate viewing during surgical procedures, not to diagnose a condition.
No
The device description clearly outlines physical components such as optical fiber, plastic tubing, molded ends, and a stainless steel housing and tip, indicating it is a hardware 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 that the device is a light source to facilitate viewing during ophthalmic surgical procedures. This is an in-vivo application, meaning it is used directly on a living organism (the patient's eye).
- Device Description: The description details a fiberoptic endoilluminator, which is a surgical tool used to provide light inside the body. This aligns with an in-vivo surgical application, not an in-vitro diagnostic test.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue, etc.) or providing diagnostic information based on such analysis. IVDs are designed to be used outside the body to diagnose conditions.
Therefore, the MVS 1011A is a surgical accessory used for illumination during ophthalmic surgery, not an in-vitro diagnostic device.
N/A
Intended Use / Indications for Use
The MVS 1011A is intended to be used as an accessory to the Storz PREMIERE® and Storz DAISY™ Microsurgical Systems, as a light source to facilitate viewing of the posterior segment of the eye during ophthalmic surgical procedures.
Product codes (comma separated list FDA assigned to the subject device)
HBI
Device Description
The device consists of an optical fiber encased in plastic tubing; a molded nylon proximal end which connects the device to the microsurgical unit; and a molded acetal distal end, from which protrudes the fiberoptic enclosed within a stainless steel housing. The stainless steel tip, which is the point of light emission, is covered by a plastic protective sleeve that attaches to the molded distal end, and which is removed prior to use of the endoilluminator.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
posterior segment of the eye
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): 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.
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.
Not Found
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).
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
Image /page/0/Picture/1 description: The image shows the word "storz" in white letters against a black background. The letters are bold and slightly stylized. There is a registered trademark symbol in the upper right corner of the black background.
MAR 26 1996
Premarket Notification Storz Instrument Company
510(k) SUMMARY OF SAFETY AND EFFECTIVENESS
The following information is submitted in accordance with the requirements of 21 CFR 807.92:
Contact Person: Audrey Swearingen, Regulatory Affairs Associate
December 29, 1995 Date Prepared:
Proprietary Names: Storz MVS 1011A Fiberoptic Endoilluminator.
Common/Usual Names: Fiberoptic Lightpipe
Classification Name: Illuminator, Fiberoptic, Surgical Field; 79(HBI).
Device Description/Intended Use: The MVS 1011A is intended to be used as an accessory to the Storz PREMIERE® and Storz DAISY™ Microsurgical Systems, as a light source to facilitate viewing of the posterior segment of the eye during ophthalmic surgical procedures. The device consists of an optical fiber encased in plastic tubing; a molded nylon proximal end which connects the device to the microsurgical unit; and a molded acetal distal end, from which protrudes the fiberoptic enclosed within a stainless steel housing. The stainless steel tip, which is the point of light emission, is covered by a plastic protective sleeve that attaches to the molded distal end, and which is removed prior to use of the endoilluminator.
Predicate Device: The Storz MVS 1011A Fiberoptic Endoilluminator is substantially equivalent to its predecessor, the Storz MVS 1011 Fiberoptic Endoilluminator (K854587).
Predicate Comparison: A chart comparing the Storz MVS 1011A with the Storz MVS 1011, showing substantial equivalence, is attached.
Submitted by:
Audrey Swearingen
Audrey Swearingen Storz Instrument Company 3365 Tree Court Industrial Blvd. St. Louis, MO 63122 Ph. 314/225-5051
35 Troo Correndastral Blvd 10 - 130 - 120 - 12 - 134 . D: : 201 : 0 : 0317 : 0 17
1
Storz MVS 1011A Fiberoptic Endoilluminator
Device Comparison Chart
| Device Characteristic | Storz MVS 1011A Fiberoptic
Endoilluminator | Storz MVS 1011 Fiberoptic
Endoilluminator |
|-------------------------------------|---------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------|
| Intended Use | Light source for posterior
ophthalmic surgery | Light source for posterior
ophthalmic surgery |
| Recommended Microsurgical
System | Storz PREMIERE® and
Storz DAISYTM | Storz PREMIERE® and
Storz DAISYTM |
| Device Components | Molded distal and proximal
ends, polymer optical fiber,
stainless steel tubing, epoxy,
tip protector | Molded distal and proximal
ends, polymer optical fiber,
stainless steel tubing, epoxy,
tip protector |
| Total Device Length | 74 inches | 74 inches |
| Tip Protector Description | Molded, vented plastic; 2.75
inch length | Silicone tubing; 3.0 inch
length |
| Provided Sterile? | Yes | Yes |
| Intended to be Reusable? | No | No |
| Device Packaging | Double pouch | Single pouch |
| Performance Specification? | Y es | No |