(75 days)
Not Found
No
The summary describes a standard Xenon light source for illumination during endoscopic procedures and does not mention any AI or ML components or functionalities.
No
The device is intended for illumination to aid observation, not for treating any condition or disease.
No
The device provides illumination for observation, but it does not analyze or interpret medical data for diagnostic purposes.
No
The device description clearly outlines physical hardware components (light source control unit, fiber optic cables, housing, lamp, circuit, etc.) and their physical characteristics (dimensions, weight, voltage, frequency). This indicates it is a hardware device, not software-only.
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 light source for illuminating body cavities, hollow organs, and surgical sites for observation. This is a direct interaction with the patient's body for visualization during procedures.
- Device Description: The description details a light source and fiber optic cables, which are components used for illumination and light delivery.
- Lack of IVD Characteristics: There is no mention of the device being used to examine specimens (blood, tissue, etc.) outside of the body, which is a defining characteristic of IVD devices. The device is used in vivo (within the living body).
IVD devices are used to perform tests on samples taken from the human body to provide information for diagnosis, monitoring, or screening. This device's function is purely for illumination during surgical and endoscopic procedures.
N/A
Intended Use / Indications for Use
Aesculap's Xenon Light Source is intended for use as a high intensity light to be used with Fiberoptic cables. Applications include endoscopes, surgical headlamps, and other lighted 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, laparoscopy, gynecology, broncoscopy, urology, neuroendoscopy and vascular endoscopy.
Product codes
FSS
Device Description
The Xenon Light Source consists of a light source control unit and fiber optic cables. Technological characteristics are provided below:
Design: Light Source in stainless steel / aluminum housing
Dimensions: 305mm x 305mm x 82mm
Weight: 6.5kg
Lamp: 180W Xenon
Circuit: Transistorized
Voltage: 100 - 240V
AC Power Freq.: 50 - 60 HZ
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. Specific areas of application include arthroscopy, laparoscopy, gynecology, broncoscopy, urology, neuroendoscopy and vascular endoscopy.
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)
K980044, K890716, K934559, K952696
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 878.4580 Surgical lamp.
(a)
Identification. A surgical lamp (including a fixture) is a device intended to be used to provide visible illumination of the surgical field or the patient.(b)
Classification. Class II (special controls). The device, when it is an operating room lamp, a surgical instrument light, a surgical floor standing light, an endoscopic surgical light, a surgical light connector, a ceiling mounted surgical light, a surgical light carrier, surgical light accessories, a surgical lamp, a remote illuminator, or an incandescent surgical lamp, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 878.9.
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FEB 1 1999
Image /page/0/Picture/1 description: The image shows the logo for AESCULAP. On the left side of the logo is a symbol of a staff with a snake wrapped around it, enclosed in a circle. To the right of the symbol is the word "AESCULAP" in bold, uppercase letters.
510(k) Summary of Safety and Effectiveness in Accordance with SMDA of 1990
Aesculap Xenon Light Source
November 17, 1998
Submitted by:
Aesculap®, Inc. 1000 Gateway Blvd. So. San Francisco, CA 94080 Contact: Mary Ellen Holden (650) 624-5072 Phone: FAX: (650) 589-3007
Product: Aesculap Xenon Light Source Common Name: Xenon Light Source
Intended Use
Aesculap's Xenon Light Source is intended for use as a high intensity light to be used with Fiberoptic cables. Applications include endoscopes, surgical headlamps, and other lighted 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, laparoscopy, gynecology, broncoscopy, urology, neuroendoscopy and vascular endoscopy.
Device Description
The Xenon Light Source consists of a light source control unit and fiber optic cables. Technological characteristics are provided below:
| Design: | Light Source in stainless steel / aluminum housing |
|---|---|
| Dimensions: | 305mm x 305mm x 82mm |
| Weight: | 6.5kg |
| Lamp: | 180W Xenon |
| Circuit: | Transistorized |
| Voltage: | 100 - 240V |
| AC Power Freq.: | 50 - 60 HZ |
AN EQUAL OPPORTUNITY EMPLOYER
1
Performance Standards
No applicable performance standards have been promulgated under Section 514 of the Food, Drug and Cosmetic Act for these devices. However, Aesculap's Xenon Light Source complies with the following standards which appear on the FDA List of Recognized Consensus Standards:
- International Electrotechnical Commission; Medical IEC 60601-1 Electrical Equipment, Part 1: General Requirements for Safetv.
- IEC 60601-1-2 International Electrotechnical Commission; Medical Electrical Equipment, General Requirements for Safety: Electromagnetic Compatibility - Requirements and Tests.
In addition, the Xenon Light Source meets the requirements of the following Underwriters Laboratories standard.
- Underwriters laboratories; medical electrical equipment, UL 2601-1 general requirements for safety.
Sterilization
The Xenon Light Source control unit is not intended for use in the sterile field. The Fiber Optic Cable provided with the Xenon Light Source is provided nonsterile and must be sterilized prior to use. The cable may be sterilized by steam sterilization.
Substantial Equivalence
Aesculap's Xenon Light Source shares similar features and function with corresponding devices distributed by: EG&G Electro-Optics (K980044)
Lutex (K890716) Karl Storz (K934559) Wolf (K952696)
0005
2
Image /page/2/Picture/1 description: The image is a black and white logo for the U.S. Department of Health and Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized symbol that resembles a caduceus, which is a traditional symbol of medicine, but in this case, it is a modern interpretation of the symbol.
Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
FEB 1 1999
Ms. Mary Ellen Holden Senior Regulatory Associate Aesculap, Inc. 1000 Gateway Boulevard South San Francisco, California 94080-7028
Re: K984124 Trade Name: Aesculap Xenon Light Source Regulatory Class: II Product Code: FSS Dated: November 17, 1998 Received: November 18, 1998
Dear Ms. Holden:
We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to 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). 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 (Premarket Approval), 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 895. A substantially equivalent determination assumes compliance with the current Good Manufacturing Practice requirement, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic (QS) inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.
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Page 2 -- Ms. Mary Ellen Holden
This letter will allow you to begin marketing your device as described in your 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 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4595. Additionally, for questions on the promotion and advertising of your 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 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its internet address "http://www.fda.gov/cdrh/dsmamain.html".
Sincerely yours,
Stup Rhodes
Celia M. Witten, Ph.D., M.D. Director Division of General and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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INDICATION FOR USE STATEMENT
×984124
510(k) Number (if known): ____________________________________________________________________________________________________________________________________________________
Device Name:
Aesculap Xenon Light Source
Indication for Use:
Aesculap's Xenon Light Source is intended for use as a high intensity light to be used with Fiberoptic cables. Applications include endoscopes, surgical headlamps, and other lighted 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, laparoscopy, gynecology, broncoscopy, urology, neuroendoscopy and vascular endoscopy.
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
| Concurrence of CDRH, Office of Device Evaluation (ODE) | |
|---|---|
| (Division Sign-Off) | |
| Division of Reproductive, Abdominal, and Radiological Devices | K984124 |
| Prescription Use X (Per 21 CFR 801.109) | OR Over-The-Counter Use |