(193 days)
Not Found
No
The description focuses solely on the device's function as a light source for illumination during endoscopic procedures and does not mention any AI or ML capabilities.
No
The device provides illumination for visualization during endoscopic procedures; it does not directly treat a disease or condition.
No
The device provides illumination for visualization during endoscopic procedures, which is an assistive function rather than a diagnostic one. It does not analyze data or provide diagnostic information.
No
The device description clearly states it is a "light generating device" and mentions hardware components like a "LIGHT GUIDE port" and a "fiber optic light guide cable," indicating it is a hardware device, not software-only.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states it's for providing illumination during endoscopic procedures to illuminate the surgical site. This is an in-vivo (within a living organism) application, not an in-vitro (outside of a living organism) diagnostic test.
- Device Description: The description reinforces its use in conjunction with an endoscope inserted into the surgical site for visualization.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue, etc.), detecting specific analytes, or providing diagnostic information based on laboratory testing.
This device is a surgical light source used for visualization during procedures, which falls under the category of surgical equipment, not in-vitro diagnostics.
N/A
Intended Use / Indications for Use
The ConMed Linvatec 300W Xenon Light Source is intended to be used with an endoscope to provide illumination during endoscopic procedures.
Product codes
GCT
Device Description
The ConMed Linvatec 300W Xenon Light Source is a light generating device that when used in conjunction with an endoscope will illuminate the surgical site during minimally invasive surgical procedures.
The ConMed Linvatec 300W Xenon Light Source is used with a fiber optic light guide cable during endoscopic surgical procedures. The Light Source emits light from the "LIGHT GUIDE" port which accepts the fiber optic cable. The cable is connected to the illumination portion of an endoscope. The endoscope is inserted into the surgical site to provide illumination for the surgeon's visualization.
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
Not Found
Key Metrics
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
AUG 2 0 2007
Device Name 510(k) # Ko 7 0376 Date Page 1 of 2
SUMMARY OF SAFETY AND EFFECTIVENESS
In accordance with the requirements of the Safe Medical Device Act of 1990 and 21 CFR 807.92, Linvatec Corporation is hereby submitting the 510(k) Summary of Safety and Effectiveness for the 300W Xenon Light Source, 510(k) Number ________________________________________________________________________________________________________________________________________________________________
Submitter A.
ConMed Linvatec 11311 Concept Boulevard Largo, Florida 33773-4908
B. Company Contact
Elizabeth M. Paul Manager, Regulatory Affairs (727) 399-5234 Telephone (727) 399-5264 FAX
C. Device Name
Trade Name: ConMed Linvatec 300W Xenon Light Source Light Source Common Name:
↓
Classification Name: Endoscope and accessories
Classification Number: 21 CFR 876.1500
Proposed Class: Class II
GCT Product Code:
1
Summary of Safety and Effectiveness Device Name 510(k) # Ko703 76 Date Page 2 of 2
D. Predicate/Legally Marketed Devices
Linvatec Corporation Xenon 300W Light Source 510(k) #K031994
Karl Storz Endoscopy Xenon 300W Light Source 510(k) #K962595
ші Device Description
The ConMed Linvatec 300W Xenon Light Source is a light generating device that when used in conjunction with an endoscope will illuminate the surgical site during minimally invasive surgical procedures.
The ConMed Linvatec 300W Xenon Light Source is used with a fiber optic light guide cable during endoscopic surgical procedures. The Light Source emits light from the "LIGHT GUIDE" port which accepts the fiber optic cable. The cable is connected to the illumination portion of an endoscope. The endoscope is inserted into the surgical site to provide illumination for the surgeon's visualization.
ட் Intended Use
The ConMed Linvatec 300W Xenon Light Source is intended to be used with an endoscope to provide illumination during endoscopic procedures.
G. Substantial Equivalence
The ConMed Linvatec 300W Xenon Light Source described in this notification is similar in design, technology and intended use to the Linvatec Corporation 300 Xenon Light Source (K031994) and the Karl Storz Endoscopy Xenon 300W Light Source (K962595).
The differences between the ConMed Linvatec 300W Xenon Light Source and the predicate devices are minor and raise no new questions of safety and effectiveness. Accordingly, the Linvatec 300W Xenon Light Source is substantially equivalent to the predicate devices currently on the market.
2
Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a circle with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is a stylized symbol that resembles an eagle or bird in flight, represented by three curved lines.
Food and Drug Administration 9200 Corporate Blvd. Rockville MD 20850
AUG 2 0 2007
Ms. Elizabeth M. Paul Manager, Regulatory Affairs ConMed™ Linvatec 11311 Concept Boulevard LARGO FL 33773-4908
Re: K070376
Trade/Device Name: ConMed Linvatec 300W Xenon Light Source Regulation Number: 21 CFR §876.1500 Regulation Name: Endoscope and accessories Regulatory Class: II Product Code: GCT Dated: July 17, 2007 Received: July 19, 2007
Dear Ms. Paul:
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 (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 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
Image /page/2/Picture/10 description: The image is a circular logo with the text "1906-2006" at the top and "FDA Centennial" in the center. The letters "FDA" are prominently displayed in a bold, sans-serif font. There are three stars below the word "Centennial". The text around the circle reads "U.S. Department of Health and Human Services".
noting Public J
3
Page 2 -
Please be advised that FDA's issuance of a substantial equivalence determination does not mean r that FDA has made a determination that your device complies with other requirements of the Act that I Dr Has Intatutes and regulations administered by other Federal agencies. You must or any I 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 CI It Fart 607), adomig (DS) regulation (21 CFR Part 820); and if applicable, the electronic for at the quality by ovisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
This letter will allow you to begin marketing your device as described in your Section 510(k) I mis letter with a son finding of substantial equivalence of your device to a legally prematicated predicated 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), please contact the Office of Compliance at one of the following numbers, based on the regulation number at the top of this letter:
| 21 CFR 876.xxx | (Gastroenterology/Renal/Urology) | 240-276-0115 |
|---|---|---|
| 21 CFR 884.xxx | (Obstetrics/Gynecology) | 240-276-0115 |
| 21 CFR 894.xxx | (Radiology) | 240-276-0120 |
| Other | 240-276-0100 |
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). 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 (240) 276-3150
or at its Internet address http://www.fda.gov/cdrlv/industry/support/index.html.
Sincerely vours,
Nancy C Hogdon
Nancy C. Brogdon Director, Division of Reproductive, Abdominal, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
Indications for Use
K 670376 510(k) Number (if known):
ConMed Linvatec 300W Xenon Light Source Device Name:
Indications For Use:
The ConMed Linvatec 300W Xenon Light Source is intended to be used with an endoscope to provide illumination during endoscopic procedures.
Prescription Use
(Part 21 CFR 801 Subpart D)
AND/OR
Over-The-Counter Use (21 CFR 801 Subpart'C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Nancy Brogdon
(Division Sign. ate)
(Division Sign-Off) Division of Reproductive, Abdominal, and Radiological Devices
510(k) Number.
Page 1 of