(123 days)
Not Found
No
The device description focuses on the physical components, materials, and sterilization process of a fiberoptic illuminator, with no mention of software, algorithms, or data processing that would indicate AI/ML. The comparison to the predicate device is based on identical intended use and technological characteristics (materials and manufacturing).
No.
The device's intended use is "illumination of the operating field during ophthalmic surgery." It does not directly treat or diagnose a medical condition, which is the primary function of a therapeutic device.
No
The device is described as an "illumination of the operating field during ophthalmic surgery." Its purpose is to provide light for the surgeon, not to diagnose a condition or disease.
No
The device is a physical fiberoptic illuminator with a stainless steel tube and plastic components, designed for surgical use and requiring sterilization. It is not software.
Based on the provided text, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is "illumination of the operating field during ophthalmic surgery." This is a surgical tool used for visualization during a procedure.
- Device Description: The description clearly states it's a "Fiberoptic Endo-Illuminator" and is classified as "Illuminator, Fiberoptic, Surgical Field." This classification is for surgical instruments, not diagnostic devices.
- Lack of Diagnostic Function: The device's function is to provide light. It does not analyze biological samples (blood, tissue, etc.) or provide information about a patient's health status based on such analysis, which is the core function of an IVD.
The text focuses on the device's physical characteristics, materials, sterilization, and equivalence to a predicate surgical illuminator. There is no mention of any diagnostic purpose or interaction with biological samples for analysis.
N/A
Intended Use / Indications for Use
illumination of the operating field during ophthalmic surgery
Product codes
HBI Reg 878.4580
Device Description
The distal end that will contact the patient is a 20 ga. stainless steel tube enclosing a plastic fiber-optic filament whose flat end surface will give off the light needed by the surgeon. All materials are identical to those used in the predicate device. Just as in the predicate device, except for three plastic constituents white color added, all components are natural with no colorants added. Those constituents having white color added are the proximal end plug. that is insected 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 colorant is added will come into contact with the patient. There are no changes from the color additives used in the predicate device. The device will be marketed as a single-use, sterile device. As with the prodicate device, sterility will be obtained by packaging the device in a clean, sealed envelope having a clear plastic window as one side and gas-permeable non-woven plastic (Tyvek) as the other side. In a process identical to that used for the predicate device, sealed envelopes containing the device will be sterilized by ethylene oxide gas which will penetrate the gas-permeable non-woven plastic fabric killing all pathogens on the device. Maximum residual levels of ethylene oxide, ethylene chlorohydrin, and ethylene glycol on the device are 250 PPM, 250 PPM, and 5000 PPM respectively. Successful sterilization will be confirmed by culturing spoor strips embedded in the lot to be sterilized. The device will meet sterility assurance level 10°. The constituents of the envelope are impenetrable by pathogens ensuring that sterility is maintained as long as package integrity is not compromised. The device is not considered non-pyrogenic.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
eye of the patient
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 device.
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.
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Image /page/0/Picture/0 description: The image shows the logo for MBI Inc. The letters "MBI" are in large, bold, sans-serif font, with "INC." in a smaller, subscript font next to the "I". The logo is enclosed in a rounded rectangle with thick black borders. The background is white.
Image /page/0/Picture/1 description: The image contains the text "Innovators In Medical Device Design". The text is written in a bold, serif font. The text is centered in the image and takes up most of the space.
HOME OFFICE
14240 Reelfoot Lake Drive Chesterfield, MO 63017 (314) 576-5005 FAX (314) 576-5006
MANUFACTURING CO.
1707 Madison Avenue Granite City, IL 62040 (618) 451-2992
March 8, 1996
510(k) Summary
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
JI 15 1996
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 Fiberoptic Endo-Illuminator". The classification name of the device is Illuminator, Fiberoptic, Surgical Field. It is classified as Illuminator, Fiberoptic, Surgical Field - HBI Reg 878.4580. There are no standards applying to it.
The device is identical to the Storz, MVS Disposable Fiberoptic Lightpipe marketed as a class II postamendment device by Storz Ophthalmics, Inc. under 510(k) marketing clearance issued by FDA as document control number K854587. The MBI device has the same intended use (illumination of the operating field during ophthalmic surgery) and the same technological characteristics (materials used and methods of manufacture). The applicant has been functioning as a capive manufacturing site producing. the predicate device for Storz and now intends to produce and sell to other customers the same device it has been manufacturing for Storz.
Performance is identical to that of the predicate device. 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 fiber-optic filament whose flat end surface will give off the light needed by the surgeon. All materials are identical to those used in the predicate device. Just as in the predicate device, except for three plastic constituents white color added, all components are natural with no colorants added. Those constituents having white color added are the proximal end plug. that is insected 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 colorant is added will come into contact with the patient. There are no changes from the color additives used in the predicate device.
The device will be marketed as a single-use, sterile device. As with the prodicate device, sterility will be obtained by packaging the device in a clean, sealed envelope having a clear plastic window as one side and gas-permeable non-woven plastic (Tyvek) as the other side. In a process identical to that used for the predicate device, sealed envelopes containing the device will be sterilized by ethylene oxide gas which will penetrate the gas-permeable non-woven plastic fabric killing all pathogens on the device. Maximum residual levels of ethylene oxide, ethylene chlorohydrin, and ethylene glycol on the device are 250 PPM, 250 PPM, and 5000 PPM respectively. Successful sterilization will be confirmed by culturing spoor strips embedded in the lot to be sterilized. The device will meet sterility assurance level 10°. The constituents of the envelope are impenetrable by pathogens ensuring that sterility is maintained as long as package integrity is not compromised. The device is not considered non-pyrogenic.
Wayne C. Mosher
Chief Executive Officer