(190 days)
Not Found
No
The description focuses on the physical components and function of a surgical instrument for illumination and manipulation, with no mention of AI, ML, image processing, or data-driven performance metrics.
No
The device is described as a hand-held surgical instrument used for illumination and manipulation during ophthalmic surgery, not for treating a disease or condition.
No
The device is described as a surgical instrument that provides illumination and manipulation during ophthalmic surgery, not for diagnosing conditions.
No
The device description clearly states it is a "hand held surgical instrument" consisting of a "stainless steel tube" and a "plastic fiberoptic filament," indicating it is a physical 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 "illumination of the operating field and/or the use of a manipulating tool during ophthalmic surgery." This describes a surgical instrument used during a procedure to aid the surgeon, not a device used to examine specimens in vitro (outside the body) to diagnose a condition.
- Device Description: The description details a "hand held surgical instrument" that provides light and manipulates tissue. This aligns with a surgical tool, not a diagnostic test performed on samples.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, tissue, etc.), detecting analytes, or providing diagnostic information based on in vitro testing.
Therefore, this device falls under the category of a surgical instrument, not an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The MBI device has the same intended use, illumination of the operating field and/or the use of a manipulating tool during ophthalmic surgery
Lighting of posterior segment of eye and/or tool for manipulation of elements in eye
Product codes
HBI
Device Description
The distal end that will contact the patient is a 20 ga. stainless steel tube enclosing a plastic fiberoptic filament whose flat end surface will give off the light needed by the surgeon. A small portion of the stainless steel tube is fashioned into a surgical instrument that extends past the fiberoptic element. All materials are identical to those used in the predicate devices.
The device will be marketed as a non-sterile not non-pyrogenic device.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
eye
Indicated Patient Age Range
Not Found
Intended User / Care Setting
surgeon
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)
Performance is identical to that of the predicate devices.
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
Image /page/0/Picture/1 description: The image shows a logo with the text "MBI INC." The letters "MBI" are larger than the "INC." The text is inside of a rounded rectangle. The logo is black and white.
Innovators In Medical Device Design
ાં 3 વિચ્ચ
William J. Buttermore President
Document Mail Center (HFZ-401) Center for Devices and Radiological Health
Food and Drug Administration 9200 Corporate Boulevard Rockville, MD 20850
14240 Reelfoot Lake Drive Chesterfield, MO 63017 (314) 576-5005 FAX (314) 576-5006
HOME OFFICE
MANUFACTURING CO. 1707 Madison Avenue
Granite City, IL 62040 (618) 451-2992
March 17, 1997
510(k) Summary
This summary of 510(k) safety and effectiveness information is being submitted in accordance with the requirements of SMDA 1990 and CFR 807.92.
The trade name of the device for which the determination of substantial equivalence is being sought is "MBI Illuminated Retinal Pick". The classification name of the device is Illuminator, Fiberoptic, Surgical Field. It is classified ad Illuminator, Fiberoptic, Surgical Field - HBI Reg 878.4580. There are no standards applying to it.
The device is equivalent to the MBI Fiberoptic Endo-illuminator K961036 combined with a hand held surgical instrument. It is virtually identical to the Trek 9801 Light Pipe Pick K875195. The MBI device has the same intended use, illumination of the operating field and/or the use of a manipulating tool during ophthalmic surgery, and the same technological characteristics (materials used and methods of manufacture). The applicant has been manufacturing light pipes for Storz Instrument Co. for the past six years and the submitted devise is but a small modification to the existing device.
Performance is identical to that of the predicate devices. When in use during ophthalmic surgery, part of the device will come into contact with the eye of the patient. The distal end that will contact the patient is a 20 ga. stainless steel tube enclosing a plastic fiberoptic filament whose flat end surface will give off the light needed by the surgeon. A small portion of the stainless steel tube is fashioned into a surgical instrument that extends past the fiberoptic element. All materials are identical to those used in the predicate devices. Just as in the predicate devices, except for the three plastic constituents which have white color added, all components are natural with no colorants added. Those constituents having white color added are the proximal end plug that is inserted into the light source device which is away from the patient, the sheathing for the fiber optic filament, and the surgeon's grasping point that holds the distal tube that is inserted into the patient's eye during surgery. The colorant is in the plastic material of which the components are made. No constituent to which color is added will come into contact with the patient. There are no changes from the color additives used in the predicate devices.
The device will be marketed as a non-sterile not non-pyrogenic device.
son table of the technological features of this and the predicate devise is attached.
1
Substantial Equivalence Comparison Chart
| | MBI Fiberoptic
Endo-
illuminator | Hand Held
Surgical
Instrument | Trek 9502
Light PipePick | Submitted
Device |
|--------------------------|-----------------------------------------|--------------------------------------------------------------|------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------|
| 510(k) No. | K961036 | Not Applicable | K875195 | K 964405 |
| Cannula
(tube) | Stainless Steel | N/A | Stainless Steel | Stainless Steel |
| Surgical Tool | Stainless Steel | Stainless Steel | Stainless Steel | Stainless Steel |
| Proximal
End | Acetel | N/A | unknown | Acetel |
| Fiberoptic
Filament | Polymethyl
methacrylate | N/A | Polymethyl
methacrylate | Polymethyl
methacrylate |
| Filamnet
Sheathing | Polytetra
fluoroethylene | N/A | unknown | Polytetra
fluoroethylene |
| Distal End | Acetel | N/A | unknown | Acetel |
| Cannula
Protector | Silicone | N/A | Silicone | Silicone |
| Adhesive
proximal end | none | N/A | unknown | none |
| Adhesive
distal end | cyanoacrylate | N/A | unknown | cyanoacrylate |
| Design of
Components | Engineering
drawings
attached | Instrument
design catalog
tab "E" | Virtually
Identical by
actual
measurement | Engineering
drawings
attached |
| Indications
for use | Lighting
posterior
segment of eye | Tool for
manipulation of
elements in
surgical field | Lighting of
posterior
segment of eye
and /or tool for
manipulation of
elements in eye | Lighting of
posterior
segment of eye
and/or tool for
manipulation of
elements in eye |
| Energy
delivered | Cool white light | N/A | Cool white light | Cool white light |
| Biocompat-
ability | not non-
pyrogenic | N/A | not non-
pyrogenic | not non-
pyrogenic |
2
Image /page/2/Figure/0 description: The image shows a diagram of an MBI Fiberoptic Endo-illuminator. The diagram labels the different parts of the device, including the fiberoptic filament, sheathing, acetel distal end, and stainless steel tubing. The diagram also includes an enlargement labeled "A". The length of the device is labeled as 3.355".
播
3
Image /page/3/Figure/1 description: The image shows a comparison between an existing device and a submitted device, both labeled with stainless steel tubing. The existing device, labeled as "Enlargement A," features a fiberoptic filament. The submitted device is identified as the MBI Illuminated Retinal Pick. The image provides a detailed view of the components and design of both devices.