(90 days)
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Not Found
No
The device description focuses on the physical components and function of a fiberoptic transillumination system, with no mention of software, algorithms, or data processing that would indicate AI/ML. The "Mentions AI, DNN, or ML" and "Description of the training set..." sections are also marked as "Not Found".
No
The device aids in structure identification through transillumination, which is a diagnostic or procedural aid function, not a direct therapeutic intervention.
No
The device is designed to aid in identification of anatomical structures through transillumination, which is an assistive function for visualization during procedures, not a diagnostic one. It doesn't analyze data to provide a medical diagnosis of a condition or disease.
No
The device description clearly outlines physical components such as a fiberoptic bundle, silicone tubing, a ball-shaped fitting, silicone tips, and a light source connector. It is a hardware device that utilizes light transmission for transillumination.
Based on the provided information, the ENDOLUMINA® II Transillumination System is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is to aid in the identification of anatomical structures during surgical procedures (laparoscopy, thoracoscopy, or open procedures) by transillumination. This is a direct interaction with the patient's body during a medical procedure.
- Device Description: The device is a fiberoptic system designed to transmit light into the body for visualization. It does not involve the examination of samples taken from the body (like blood, urine, tissue, etc.) which is the hallmark of an in vitro diagnostic device.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples, detecting analytes, or providing diagnostic information based on laboratory testing.
IVD devices are used to examine specimens obtained from the human body to provide information for the diagnosis, monitoring, or treatment of diseases or conditions. The ENDOLUMINA® II operates within the body to aid visualization during surgery, which falls under the category of a surgical or endoscopic device, not an IVD.
N/A
Intended Use / Indications for Use
The ENDOLUMINA II Transillumination System (EIB II) is a medical device designed to aid in the identification of the esophagus, rectum, and other structures by transillumination during laparoscopy, thoracoscopy, or open procedures.
Product codes
Not Found
Device Description
The ENDOLUMINA II Transillumination System (EIB II) is a medical device designed to aid in the identification of the esophagus, rectum, and other structures by transillumination during laparoscopy, thoracoscopy, or open procedures. The EIB II consists of a glass fiberoptic bundle inserted into a length of silicone elastomer tubing in a configuration similar to a fiberoptic cable. Attached to the cable's proximal end is a ball-shaped fitting which allows a clear, flexible, and detachable silicone tip to be attached or removed by means of a "pop-fit" The EIB II is This tip is available in both blunt and tapered configurations. connection. available in sizes ranging from 4 to 60 Fr. A light source connector/fitting is permanently attached to the distal end of the cable and is designed to be inserted into a commercially-available light source. Light generated from the light source is transmitted through the cable's fiberoptic bundle and down into the clear silicone tip, where it is deflected radially to enhance transillumination. The EIB II is supplied with one (1) cable assembly, which is supplied nonsterile and is designed to be reusable by the customer. Instructions for methods for cleaning and sterilizing the EIB II cable assembly are provided. The EIB II also contains three (3) detachable tips which are individually packaged in a double pouch system and labeled as sterile and for single use only. The sterilization method for the tips has been qualified and validated to provide a sterility assurance level (SAL) of 10-6.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
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Anatomical Site
esophagus, rectum, and other structures
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)
ENDOLUMINA® I Illuminated Bougie
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 876.4530 Gastroenterology-urology fiberoptic retractor.
(a)
Identification. A gastroenterology-urology fiberoptic retractor is a device that consists of a mechanical retractor with a fiberoptic light system that is used to illuminate deep surgical sites.(b)
Classification. Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 876.9.
0
FEB 11 1997
Image /page/0/Picture/1 description: The image shows the logo for BioEnterics Corporation. The logo consists of a stylized DNA strand on the left, followed by the word "BioEnterics" in a bold, sans-serif font. Below "BioEnterics" is the word "CORPORATION" in a smaller, serif font with wide letter spacing.
× 805 684-0817
Contact person: Keith Lowrey, Regulatory Affairs Manager
510(k) SUMMARY OF SAFETY AND EFFECTIVENESS:
This summary of 510(k) safety and effectiveness information is being submitted in accordance with the requirements of the Safe Medical Device Act of 1990 and 21 CFR 807.92.
Substantially Equivalent Device which is legally marketed:
BioEnterics Corporation (BEC) considers the ENDOLUMINA® II Transillumination System to be substantially equivalent in design and use to the ENDOLUMINA® I Illuminated Bougie.
Description of Premarket Notification Device:
The ENDOLUMINA II Transillumination System (EIB II) is a medical device designed to aid in the identification of the esophagus, rectum, and other structures by transillumination during laparoscopy, thoracoscopy, or open procedures. The EIB II consists of a glass fiberoptic bundle inserted into a length of silicone elastomer tubing in a configuration similar to a fiberoptic cable.
Attached to the cable's proximal end is a ball-shaped fitting which allows a clear, flexible, and detachable silicone tip to be attached or removed by means of a "pop-fit" The EIB II is This tip is available in both blunt and tapered configurations. connection. available in sizes ranging from 4 to 60 Fr.
A light source connector/fitting is permanently attached to the distal end of the cable and is designed to be inserted into a commercially-available light source. Light generated from the light source is transmitted through the cable's fiberoptic bundle and down into the clear silicone tip, where it is deflected radially to enhance transillumination.
The EIB II is supplied with one (1) cable assembly, which is supplied nonsterile and is designed to be reusable by the customer. Instructions for methods for cleaning and sterilizing the EIB II cable assembly are provided. The EIB II also contains three (3) detachable tips which are individually packaged in a double pouch system and labeled as sterile and for single use only. The sterilization method for the tips has been qualified and validated to provide a sterility assurance level (SAL) of 10-6.
Comparison to the Legally Marketed Device (Substantially Equivalent):
In comparison to the ENDOLUMINA Bougie (EIB I), BioEnterics Corporation considers the ENDOLUMINA Bougie II (EIB II) to be substantially equivalent in design, indications, and Both devices are slender, flexible, and cylindrical instruments for introduction intended use. into intact natural channels as well as surgically created pockets. Both devices consist of a glass fiberoptic bundle inserted into a length of silicone elastomer tubing in a configuration similar to a fiberoptic cable. One end of the cable is attached to a clear silicone elastomer tip and the other
Image /page/0/Picture/16 description: The image shows the number 219 in a bold, black font. The numbers are closely spaced together and are easily readable. The background is plain white, which makes the numbers stand out.
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510(k) Summary of Safety and Effectiveness of the ENDOLUMINA II Transillumination System
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end connects to commercially-available light sources. Materials used to fabricate both devices have been evaluated and have passed requirements for biocompatibility.
The EIB I consists of a clear silicone elastomer tip which is permanently attached to the proximal end of an approximately 25.6 inch long cable. A connector/fitting is attached to the cable's distal end to facilitate connection to a commercially-available light source cable. Like the EIB II cable, the EIB I can be cleaned, sterilized, and reused.
In comparison, the EIB II has a cable which is approximately 96.Iinches long and is designed to connect directly to a commercially available light source. When connected to a high intensity light source and left at maximum intensity until the temperature stabilizes, the "heat build-up" or maximum temperature of the tips is not hot enough to cause damage to surrounding The EIB II is designed to have detachable tips which are packaged, sterilized by a tissues. validated cycle, and provided separate from the cable assembly.
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