(32 days)
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Not Found
No
The summary describes a light source, a purely hardware device, with no mention of software, algorithms, or any AI/ML related terms.
No.
The device is described as a light source for medical applications, primarily for illumination of headlights and endoscopes, and does not claim to treat or diagnose any medical condition.
No
Explanation: The device is a light source for medical applications. Its stated purpose is to provide illumination for existing medical products, not to diagnose a condition or disease.
No
The device description clearly states it is a "Light Source," which is a hardware component providing illumination. There is no mention of software as the primary or sole function.
Based on the provided information, the Welch Allyn 300 Watt Xenon Light Source is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use/Indications for Use: The intended use is for "medical lighting applications requiring a remotely located, high intensity illumination." This describes a device used on or in the body for visualization during medical procedures, not for testing samples outside the body.
- Device Description: The description reinforces this by stating its purpose is to "provide lighting for medical applications" and specifically mentions providing illumination for "headlights and various existing and approved rigid or flexible endoscopes." These are all devices used for direct visualization during procedures.
- 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 information for diagnosis, monitoring, or screening based on sample analysis
Therefore, the Welch Allyn 300 Watt Xenon Light Source is a medical device used for illumination during procedures, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
The Welch Allyn 300 Watt Xenon Light Source is indicated for medical lighting applications requiring a remotely located, high intensity illumination. The device is not indicated for neonate transillumination.
Product codes
78 GCT, FCW
Device Description
The purpose of the Welch Allyn 300 Watt Xenon Light Source is to provide lighting for medical applications requiring high intensity illumination. The intended use is to provide illumination for medical products such as existing and approved headlights and various existing and approved rigid or flexible endoscopes. The Welch Allyn 300 Watt Xenon Light Source is effective for its intended use.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
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Input Imaging Modality
Not Found
Anatomical Site
Not Found
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
Not Found
Key Metrics
Not Found
Predicate Device(s)
Luxtec Model 9300 Xenon Light Source
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.
0
P192
"510(k) SUMMARY" FEB 2 7 1998 Summary of Safety and Effectiveness
| Submitter's Name & Address: | Welch Allyn Inc. |
|---|---|
| 4619 Jordan Road, Box 187 | |
| Skaneateles Falls, New York 13153-0187 |
Contact Person & Telephone: Kathy Lowther (315) 685-2897
Date Summary Prepared: January 19, 1998
Classification Name - Endoscope and Accessories Device Name: Common/Usual Name - Xenon 300 Light Source Proprietary Name - Welch Allyn Xenon 300 Light Source
- Predicate Device: Luxtec Model 9300 Xenon Light Source (A 510(k) could not be located for this device. However, the following Luxtec 510(k) numbers may be appropriate: K864385, K890716, or K864380. It is assumed Luxtec is utilizing one of the above 510(k) numbers as an equivalent device.)
Device Description, intended Use & Effectiveness:
The purpose of the Welch Allyn 300 Watt Xenon Light Source is to provide lighting for medical applications requiring high intensity illumination. The intended use is to provide illumination for medical products such as existing and approved headlights and various existing and approved rigid or flexible endoscopes. The Welch Allyn 300 Watt Xenon Light Source is effective for its intended use.
Technological Characteristics:
See Attachment "A" for a comparison of the features and specifications of the Welch Allyn 300 Watt Xenon Light Source to the predicate device.
Summary of Safety:
The Welch Allyn 300 Watt Xenon Light Source is designed to provide electrical safety to the patient as well as the user. The system is designed to meet the following standards related to electrical safety: UL 2601, CSA 601-1, and IEC 601-1.
To provide mechanical safety to the user, all contact surfaces shall be rounded, textured, or deburred where possible and if necessary.
1
130281
P292
ACGIH TLV's (American Conference of Governmental Industrial Hygienists Threshold Limit Values (1994 - 1995.) Ultraviolet, Light, and Near Infrared Sections) equations will be used as a basis of comparison for the Welch Allyn 300 Watt Light Source and the predicate device in their intended application. The system will also be certified to the following standards:
IEC601-1-2
- Conforms with provisions of European Council Directive 93/42/EEC CE Mark concerning medical devices.
Summary of Effectiveness:
The Welch Allyn 300 Watt Xenon Light Source is effective for its intended use of providing illumination for medical products such as existing and approved headlights and various existing and approved rigid or flexible endoscopes.
2
Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of the department's name arranged in a circular fashion around a symbol. The symbol is composed of four stylized human figures, each represented by a curved line, stacked on top of each other.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
FEB 2 7 1998
Ms. Kathy Lowther Quality Engineer Welch Allyn, Inc. 4619 Jordan Road, Box 187 Skaneateles Falls, New York 13153-0187 Re: K980281 Welch Allyn 300 Watt Xenon Light Source Dated: January 20, 1998 Received: January 26, 1998 Regulatory Class: II 21 CFR §876.1500/Product Codes: 78 GCT & FCW
Dear Ms. Lowther:
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 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, Drue, 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 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 does not affect any obligation you might have under sections 531 through 542 of the Act for devices under Radiation Control provisions, or other Federal laws or regulations.
This letter will allow you to begine as described in your 5100k) 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) 594-4613. Additionally, for question 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.
Kilian Uhr
Lillian Yin, Ph.D. Director, Division of Reproductive, Abdominal, Ear, Nose and Throat, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health
3
510(k) Number (if known): ____________________________________________________________________________________________________________________________________________________
Device Name: Welch Allyn 300 Watt Xenon Light Source
Indications For Use:
The Welch Allyn 300 Watt Xenon Light Source is indicated for medical lighting applications requiring a remotely located, high intensity illumination. The device is not indicated for neonate transillumination.
Rober D. Sattler/
Concurrence of CDRH, Office of Device Evaluation (ODE)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF
(Division Sign-Off) Division of Reproductive, Abdominal, ENT, and Radiological Devices 1980281 510(k) Number _
Prescription Use __
NEEDED)
OR
Over-The-Counter Use__________________________________________________________________________________________________________________________________________________________
(Optional Format 1-2-96)