(181 days)
No
The device description and intended use describe a purely mechanical and optical surgical instrument with no mention of computational processing, algorithms, or data analysis.
No
The device is described as a surgical instrument for manipulating elements in the eye, aspiration, irrigation, and illumination, which are procedural tools rather than devices directly providing therapy for a disease or condition.
No
The device is described as a surgical instrument for manipulation, aspiration, and irrigation, and illumination during ophthalmic surgery. Its intended use does not involve diagnosing conditions or identifying diseases.
No
The device description clearly outlines a physical, hand-held surgical instrument made of stainless steel and fiberoptic filaments, with a lumen for aspiration or irrigation. It is a 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 for lighting, manipulation, aspiration, and irrigation within the posterior segment of the eye. This is a surgical procedure performed directly on the patient's body.
- Device Description: The device is a surgical instrument used during ophthalmic surgery. It's a physical tool for manipulating tissues and fluids.
- Lack of Diagnostic Purpose: There is no mention of the device being used to analyze samples (like blood, urine, or tissue) to diagnose a disease or condition. IVDs are specifically designed for in vitro (outside the body) examination of specimens.
The device is clearly intended for in vivo (within the body) surgical use.
N/A
Intended Use / Indications for Use
illumination of the operating field and/or the use of a manipulating tool and/or use of irrigation or aspiration during ophthalmic surgery
Product codes (comma separated list FDA assigned to the subject device)
HBI
Device Description
The device is equivalent to the MBI Fiberoptic Endo-illuminator K961036 combined with a hand held surgical instrument. It is very similiar 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 and/or use of irrigation or aspiration during ophthalmic surgery, and the same technological characteristics (materials, except for Helioseal" K813015, used and methods of manufacture). The applicant has been manufacturing light pipes (K961036) for Storz Instrument Co. for the past six years and the submitted devise has but three small modification to the existing device as follows: 1. The one large fiberoptic filament is replaced with six smaller filaments of the same material. 2. The tool which in the 9801 Trek pick comes from the bottom of the stainless steel tubing now comes from the center of the instrument, and has a lumen that can accomplish aspiration or irrigation during surgery. 3. Where there was no sealant at the distal end of the fibers there is now a small amount of "Helioseal" (K813015) to position and prevent leakage between the fibers and the tool.
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
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)
Performance is identical to that of the predicate devices.
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.
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/0 description: The image shows the logo for MBI Inc. The logo is in black and white and features the letters "MBI" in large, bold font, with "INC." in smaller font to the right. The entire logo is enclosed in a rounded rectangle.
K964553 Innovators In Medical Device Design
MAY 1 3 1997
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
William J. Buttermore
Document Mail Center (HFZ-401) Center for Devices and Radiological Health
Food and Drug Administration 9200 Corporate Boulevard Rockville, MD 20850
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 Coaxial 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 very similiar 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 and/or use of irrigation or aspiration during ophthalmic surgery, and the same technological characteristics (materials, except for Helioseal" K813015, used and methods of manufacture). The applicant has been manufacturing light pipes (K961036) for Storz Instrument Co. for the past six years and the submitted devise has but three small modification to the existing device as follows: 1. The one large fiberoptic filament is replaced with six smaller filaments of the same material. 2. The tool which in the 9801 Trek pick comes from the bottom of the stainless steel tubing now comes from the center of the instrument, and has a lumen that can accomplish aspiration or irrigation during surgery. 3. Where there was no sealant at the distal end of the fibers there is now a small amount of "Helioseal" (K813015) to position and prevent leakage between the fibers and the tool.
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 stainless steel tube enclosing a plastic fiber-optic 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, except for the "Helioseal" as noted. No parts to which color has been added will come in contact with the eye.
The device will be marketed as a non-sterile not non-pyrogenic device.
omparison table of the technological features of this and the predicate devise is attached.
Kiel Kuttner
Bill Buttermore
ﺔ ﻣﻦ ﺍﻟﻤﺴﺎﺣﺔ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ
1
Substantial Equivalence Comparison Chart
| | MBI Fiberoptic
Endo-
illuminator | Hand Held
Surgical
Instrument | Trek 9502
Light Pipe Pick | Submitted
Device: Coaxial
Illuminated
Retinal Pick |
|--------------------------|------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| 510(k) No. | K961036 | Not Applicable | K875195 | K964553 |
| 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
between the
fiber and the
tubing but at
the proximal
end of the
tubing not
entering the
eye. | N/A | unknown | cyanoacrylate
or "Helioseal"
(K813015)
between the
tubing and the
fibers on the
proximal tubing
end. "Helioseal"
at the distal end
that enters the
eye. |
| Design of
Components | Engineering
drawings
attached | Instrument
design catalog
tab "E" | Virtually
Identical by
actual
measurement | Engineering
drawings
attached |
| Continued | MBI Fiberoptic
Endo-
illuminator | Hand Held
Surgical
Instrument | Trek 9502
Light Pipe Pick | Submitted
Device:
Coaxial
Illuminated
Pick |
| Indications
for use | Lighting
posterior
segment of eye | Tool for
manipulation of
elements in
surgical field or
providing
aspiration or
irrigation within
the eye. | 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
or aspiration
and irrigation
within the eye. |
| Energy
delivered | Cool white light | N/A | Cool white light | Cool white light |
| Biocompatibility | not non-
purogenic | N/A | not non-
pyrogenic | not non-
pyrogenic |
2
.
:
:
المقامة
المقاطع
المقالب المستق
.
3
Image /page/3/Figure/0 description: The image shows a diagram of a 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 the measurement 3.355". The text at the bottom of the image indicates that the device is an MBI Fiberoptic Endo-illuminator K961036, manufactured by Storz Inst. Co. MVS 1011 K896549.
के बाद
4
Image /page/4/Figure/0 description: The image shows a diagram of an MBI illuminated retinal pick. The diagram includes two circles, one labeled "Enlargement A - Existing Device" and the other labeled "MBI Illuminated Retinal Pick - not yet". The diagram also includes labels for "Fiberoptic Filament" and "Stainless Steel Tubing".
approved K961036
{
approved. Identical to Trek 9802 approved K875195
出身体
参考文献
5
Image /page/5/Figure/0 description: The image contains two technical drawings of a fiberoptic filament and a coaxial illuminated retinal pick. The first drawing shows a fiberoptic filament inside a circle, with an arrow pointing to the stainless steel tubing, labeled as 20 ga. The second drawing depicts a coaxial illuminated retinal pick, with labels indicating components such as stainless steel tubing (-20 ga), a manipulating tool with lumen, "Helioseal" (K813015) used to seal gaps, and one of six fiberoptic filaments.
Here is the markdown representation of the image: