(88 days)
No
The device description and intended use focus solely on providing a light source for fiber optic cables. There is no mention of image processing, AI, ML, or any related technologies. The performance studies section also indicates no performance data related to AI/ML was required or provided.
No
The device is a light source for observation during medical procedures, not a device that treats a disease or condition.
No
This device is a light source intended for observation and illumination during surgical procedures. It does not perform any diagnostic function.
No
The device description clearly outlines a physical cabinet containing a power supply, Xenon lamp, optics, attenuator, turret selector, and cooling system, all of which are hardware components.
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 high-intensity light source for illuminating body cavities, hollow organs, and surgical sites during procedures like endoscopy and open surgery. This is a direct interaction with the patient's body for visualization, not for testing samples taken from the body.
- Device Description: The description details the components of a light source (power supply, lamp, optics, connectors, cooling), which aligns with its intended use for illumination. There is no mention of components or functions related to analyzing biological samples.
- Lack of IVD Characteristics: The document does not mention any of the typical characteristics of an IVD, such as:
- Analyzing biological samples (blood, urine, tissue, etc.)
- Detecting or measuring substances in samples
- Providing diagnostic information based on sample analysis
- Using reagents or assays
The device is a medical device used for visualization during surgical and endoscopic procedures, which falls under a different regulatory category than IVDs.
N/A
Intended Use / Indications for Use
The 1300 XSBP - 300 Watt Xenon manufactured and marketed by Isolux America is intended to be used with fiber optic cables for endoscopes, surgical headlamps and other tools that contain fiberoptic bundles. Illumination from this device is to be used for observation of body cavities, hollow organs and other surgical sites. Specific areas of application include arthroscopy, laproscopy, gynecology, broncoscopy, urology and vascular endoscopy. The device is also intended for use as a light source for surgical headlights used in various surgical procedures.
The 1300 XSBP - 300 WATT XENON Illuminator is intended for use as a high intensity light to be used with fiberoptic cables. Applications include endoscopes, surgical headlights and other tools that contain fiberoptic bundles. Illumination from this device is intended to be used for observation of body cavities, hollow organs and other surgical sites. Specific areas of application include arthroscopy, laproscopy, gynecology, broncoscopy, urology and vascular endoscopy. The device is also intended for use as a light source for surgical headlights used in various open surgical procedures.
Product codes
HIE
Device Description
Isolux America has engineered the 1300 XSBP - 300 Watt Xenon to provide a high intensity white light source for fiber optic cables. The system consists of a single cabinet containing a power supply, a Xenon lamp with focusing optics, a variable attenuator, a turret selector for four standard fiber optic cable connectors and a forced air cooling system consisting of two fans.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
body cavities, hollow organs, and other surgical sites
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)
No performance data is required for this Class II device nor requested by the Food and Drug Administration (Office of Device Evaluation). However, performance data are given for the lamp and power supply in Attachment 4. A data base search has been performed to evaluate any adverse effects of devices which are currently marketed. The results are shown in Attachment 5. The Isolux America 1300 XSBP - 300 Watt Xenon medical illuminator provides up to 600,000 Lux of white light at the output of an eight foot long, 5.0 mm diameter fiber bundle. This level of light output is sufficient for all presently known endoscopic illumination tasks. The internal forced air cooled turret design in addition to providing greater control over the light delivered to the four different types of fiber bundle connectors, also serves to maintain temperature control of the bundle termination.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Karl Storz Cold Light Fountain Xenon 300, K951806, Maxenon, Brite Lite III
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 884.1720 Gynecologic laparoscope and accessories.
(a)
Identification. A gynecologic laparoscope is a device used to permit direct viewing of the organs within the peritoneum by a telescopic system introduced through the abdominal wall. It is used to perform diagnostic and surgical procedures on the female genital organs. This generic type of device may include: Trocar and cannula, instruments used through an operating channel, scope preheater, light source and cables, and component parts.(b)
Classification. (1) Class II (performance standards).(2) Class I for gynecologic laparoscope accessories that are not part of a specialized instrument or device delivery system, do not have adapters, connector channels, or do not have portals for electrosurgical, lasers, or other power sources. Such gynecologic laparosope accessory instruments include: the lens cleaning brush, biopsy brush, clip applier (without clips), applicator, cannula (without trocar or valves), ligature carrier/needle holder, clamp/hemostat/grasper, curette, instrument guide, ligature passing and knotting instrument, suture needle (without suture), retractor, mechanical (noninflatable), snare, stylet, forceps, dissector, mechanical (noninflatable), scissors, and suction/irrigation probe. The devices subject to this paragraph (b)(2) are exempt from the premarket notification procedures in subpart E of part 807 of this chapter, subject to the limitations in § 884.9.
0
K022384 111
510(k) Summary of Safety and Effectiveness 13.0
July 18, 2002
OCT 1 8 2002
- Xenon Light Source 1. Device Submitted: 1300 XSBP - 300 Watt Xenon 2. Proprietary Name: Xenon Fiber Optic Light Source for Medical Procedures 3. Common Usual Name: The 1300 XSBP - 300 Watt Xenon manufactured and marketed by Isolux Predicate Device: 4. America is substantially equivalent to the Karl Storz Cold Light Fountain Xenon 300 manufactured by Karl Storz Endoscopy-America, Inc., Culver City, CA. Also the Maxenon, manufactured by BFW, Lexington KY and Brite Lite III manufactured by Applied Fiberoptics, Sturbridge, MA. Isolux America has engineered the 1300 XSBP - 300 Watt Xenon to provide a Device Description: 5. high intensity white light source for fiber optic cables. The system consists of a single cabinet containing a power supply, a Xenon lamp with focusing optics, a variable attenuator, a turret selector for four standard fiber optic cable connectors and a forced air cooling system consisting of two fans. The Isolux America 1300 XSBP - 300 Watt Xenon is intended to be used with 6. Intended Use: fiber optic cables for endoscopes, surgical headlamps and other tools that contain fiberoptic bundles. Illumination from this device is to be used for observation of body cavities, hollow organs and other surgical sites. Specific areas of application include arthroscopy, laproscopy, gynecology, broncoscopy, urology and vascular endoscopy. The device is also intended for use as a light source for surgical headlights used in various surgical procedures. 7. Technological Characteristic Similarities: The Isolux America 1300 XSBP - 300 Watt Xenon is similar in use, design and function to the Karl Storz Xenon 300 BFW MID 3000 and the Applied Fiberoptics Brite Lite III. 8. Performance Data: No performance data is required for this Class II device nor requested by the Food and Drug Administration (Office of Device Evaluation). However, performance data are given for the lamp and power supply in Attachment 4. A data base search has been performed to evaluate any adverse effects of devices which are currently marketed. The results are shown in Attachment 5. ਹੈ. The Isolux America 1300 XSBP - 300 Watt Xenon medical illuminator Effectiveness: provides up to 600,000 Lux of white light at the output of an eight foot long, 5.0 mm diameter fiber bundle. This level of light output is sufficient for all presently known endoscopic illumination tasks. The internal forced air cooled turret design in addition to providing greater control over the light delivered to the four different types of fiber bundle connectors, also serves to maintain temperature control of the bundle termination.
1
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/1/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized caduceus symbol, which is a staff with two snakes entwined around it. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the caduceus symbol.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
CT 1 8 200
Isolux America Nikolaos Andreoulakis Ouality Control Manager 1479 Rail Head Boulevard Naples, Florida 34110-8444
Re: K022384
Trade/Device Name: Xenon Fiberoptic Light Source, Model 1300 XSBP Regulation Number: 884.1720 Regulation Name: Gynecologic laparoscope and accessories Regulatory Class: Class II Product Code: HIE Dated: July 18, 2002 Received: July 22, 2002
Dear Mr. Andreoulakis:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
2
Page 2 – Mr. Nikolaos Andreoulakis
This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801 and additionally 21 CFR Part 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4659. Additionally, for questions on the promotion and advertising of vour device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html
Sincerely yours.
uriam C. Provost
for Celia M. Witten, Ph.D., M.D. Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
3
510(k) NUMBER (IF KNOWN) :
DEVICE NAME :
INDICATIONS FOR USE :
The 1300 XSBP - 300 WATT XENON Illuminator is intended for use as a high intensity light to be used with fiberoptic cables. Applications include endoscopes, surgical headlights and other tools that contain fiberoptic bundles. Illumination from this device is intended to be used for observation of body cavities, hollow organs and other surgical sites. Specific areas of application include arthroscopy, laproscopy, gynecology, broncoscopy, urology and vascular endoscopy. The device is also intended for use as a light source for surgical headlights used in various open surgical procedures.
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED.)
Concurrent of CDRH, Office of Device Evaluation (ODE)
Prescription Use (Per 21 CFR 801.109)
OR
Over-The-Counter-Use (Optional Format 1-2-96)
Muriam C. Provost
Division of General, Restorative and Neurological Devices
Number K 022384