(117 days)
Not Found
No
The summary describes a light source for endoscopic procedures and does not mention any AI or ML capabilities.
No
The device provides illumination for endoscopic procedures, which is a supportive function and not directly therapeutic.
No
The device is a light source used for illumination during endoscopic procedures, not for diagnosing medical conditions. Its function is to provide light, not to interpret or analyze medical data to inform a diagnosis.
No
The device description clearly states it is a "light generating device" and a "light source," indicating it is a hardware component used for illumination, not a software-only device.
Based on the provided information, the AlphaXenon Light 300W and 180W light source is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is to "provide illumination during endoscopic procedures." This is a function performed in vivo (within a living organism) to aid in visualization during a medical procedure.
- Device Description: The description reinforces this by stating it illuminates the "surgical site during Endoscopic procedures."
- Lack of IVD Characteristics: The description 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 biological samples
- Providing information for diagnosis, monitoring, or screening based on sample analysis.
IVDs are devices used to examine specimens taken from the human body to provide information about a person's health. The AlphaXenon Light simply provides light for visualization during a procedure performed directly on the patient.
N/A
Intended Use / Indications for Use
AlphaXenon Light 300W and 180W light source is used with an endoscope to provide illumination during endoscopic procedures.
Product codes
GCT
Device Description
AlphaXenon Light is a light generating device that when used with in conjunction with endoscopes to illuminate surgical site during Endoscopic procedures.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
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 (study type, sample size, AUC, MRMC, standalone performance, key results)
Not Found
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
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
VII. 510(k) Summary of Safety and Effectiveness
In accordance with the requirements of the Safe Medical Devices Act of 1990 and 21 CFR 807.92, GIMMI GmbH is hereby submitting the 510(k) Summary of Safety and Effectiveness for AlphaXenon Light (510(k) number K093125.
Submitter A.
GIMMI GmbH Carl-Zeiss-Str. 6 78532 Tuttlingen Germany
JAN 2 7 2010
B. Company contact
Ulrich Henzler Quality Assurance Director Carl-Zeiss-Str. 6 78532 Tuttlingen Phone +49-7461-96590.0 E-mail: u.henzler@gimmi.de
Gabriela Trompler QM-Manager Carl-Zeiss-Str. 6 78532 Tuttlingen +49-017461-96590.0 g.trompler@gimmi.de
C. Device Name
Trade Name:
AlphaXenon Light 300 W and AlphaXenonLight 180 W
Light Source, Endoscopic Common Name:
Endoscope and accessories Classification name:
Classification number: 876.1500
Proposed Class: II
Product Code: GCT
- D. Pedicate/Legally Market Devices
Linvatec 300 W Xenon Light Source (K031994) Karl Storz Xenon Light 300 W (K962595) World of Medicine Lemke GmbH Model XL300/L5 (K021717)
1
Image /page/1/Picture/0 description: The image shows the word "GIMMI" in a bold, sans-serif font, followed by the registered trademark symbol. To the right of the word is a stylized letter "G" inside of a circle. The text and logo are white against a black background. There is a horizontal line below the text and logo.
- E. Device Description .
AlphaXenon Light is a light generating device that when used with in conjunction with endoscopes to illuminate surgical site during Endoscopic procedures.
F. Intended Use
AlphaXenon Light 300W and 180W light source is used with an endoscope to provide illumination during endoscopic procedures.
- G. Sustantial Equivalence
AlphaXenon Light described in this notification is similar in design, technology and intended use to
The differences between AlphaXenon Light and the predicate devices are minor and raise no new questions of safety and effectiveness. Accordingly, we GIMMI GmbH believes, that the AlphaXenon Light is equivalent to the predicate devices currently on the market.
Tuttlingen December 15, 2009
Ulrich Henzler
Quality Assurance Director
GIMMI®
GIMMI GMBH
Carl Zeiss-Str. 6 • D-78532 Tuttlingen
Tel. 0 74 61 / 965 90 - 0 • Fax 965 90-33
A.fiße
Alexander Geisse
ander Geisser Product Manager
2
Image /page/2/Picture/1 description: The image shows the seal of the Department of Health & Human Services USA. The seal is circular, with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" arranged around the perimeter. In the center of the seal is a stylized symbol that resembles three overlapping lines or waves. The symbol is positioned diagonally, with the lines appearing to ascend from the lower left to the upper right.
Food and Drug Administration 10903 New Hampshire Avenue Document Mail Center - WO66-G609 Silver Spring, MD 20993-0002
Mr. Ulrich Henzler Quality Assurance Director Gimmi GmbH Carl-Zeiss-StraBe 6 D-78532 TUTTLINGEN GERMANY
JAN 2 7 2010
Re: K093125
Trade/Device Name: Alpha Xenon Light, 180 W and 300 W Regulation Number: 21 CFR§ 876.1500 Regulation Name: Endoscopes and accessories Regulatory Class: II Product Code: GCT Dated: December 17, 2009 Received: January 13, 2010
Dear Mr. Henzler:
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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to 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); medical device reporting of medical device-related
3
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adverse events) (21 CFR 803); 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.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to
http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.
Sincerely yours anine M. Morri
Acting Director, Division of Reproductive, Abdominal, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
Abbreviated 510(k)
| 510(k) Number: | K093125 |
|---|---|
| Common Name: | Light Source, Endoscope, Xenon |
| Device Name: | AlphaXenon Light, 180 W and 300 W |
| Predicate Device | |
| Name: | The AlphaXenon Light is substantially equivalent to the following |
| predicate devices: | |
| Linvatec 300 W Xenon Light Source (K031994) | |
| Karl Storz Xenon Light 300 W (K962595) | |
| World of Medicine Lemke GmbH, model XL300/L5 (K021717) | |
| Classification: | 21 CFR § 876.1500 Product code GCT |
| Class II | |
| Indications for use | |
| AlphaXenon Light 300W and 180W light source is used with an endoscope to provide | |
| illumination during endoscopic procedures. |
Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use
..
、・
く
Or Over-The-Counter Use
Heidi Leiner
(Division Sign-Off)
Division of Reproductive, Abdominal,
and Radiological Devices 193125
510(k) Number _