(35 days)
Not Found
No
The description focuses on hardware components, light output, and control mechanisms, with no mention of AI or ML technologies. The term "intelligent cooling concept" likely refers to automated thermal management, not AI/ML.
No.
The device is a cold light source used for illumination during endoscopic diagnostic and surgical procedures, which is an ancillary function rather than a therapeutic one.
Yes
The "Intended Use / Indications for Use" states that cold light sources are designed to supply light for "endoscopic diagnostic and surgical procedures," and the "Device Description" confirms that the power LED 175 is used for "endoscopic diagnostic and surgical procedures."
No
The device description explicitly states it is a "high power medical cold light source" and lists hardware components such as the light source itself, power cord, and connection cable. It also mentions performance testing related to light output, indicating a physical device. While software verification is mentioned, it is in the context of controlling the hardware device.
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 designed to "supply light for endoscopic diagnostic and surgical procedures." This describes a device used during a medical procedure to illuminate the surgical field, not a device used to test samples (like blood, urine, or tissue) outside the body to diagnose a condition.
- Device Description: The description reinforces this by explaining that the light is transmitted through an optical cable and scope to illuminate surgical sites. This is consistent with a surgical or diagnostic tool used directly on or within the patient.
- Lack of IVD Characteristics: The description does not mention any of the typical characteristics of an IVD, such as:
- Testing of biological samples.
- Analysis of biomarkers or analytes.
- Use in a laboratory setting for diagnostic testing.
Therefore, the device described is a medical device used for illumination during endoscopic procedures, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
Cold light sources are designed to supply light for endoscopic diagnostic and surgical procedures.
Product codes
FCW, NTN
Device Description
The power LED 175 is a high power medical cold light source used for endoscopic diagnostic and surgical procedures. The device can be controlled via buttons on the front panel or via SCB (STORZ Communication Bus). This device provides high light intensity at low power consumption with intelligent cooling concept for minimal noise emission. This device includes a cold light source power LED 175, power cord, and the 100 cm SCB connection cable. The light is transmitted through an optical cable and a scope to illuminate surgical sites during minimally invasive surgical 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
The performance testing to verify light output of Power LED 175 was done as per the Comparative Bench Testing attached in Enclosure # 6. Design Verification Testing (DVT) demonstrates that the device functions as it is intended and its performance does not raise any new issues of safety and effectiveness. Software verification was done and is attached in Enclosure # 5.
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.
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K123956
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510(K) Summary of Safety and Effectiveness
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JAN 2 5 2013
| Submitter: | KARL STORZ Endoscopy America Inc. |
|---|---|
| Date of Preparation: | January 16, 2013 |
| Sponsor Company Name: | KARL STORZ Endoscopy America Inc. (KSEA) |
| Phone Number: | (424) 218 8322 |
| Street Address: | 2151 East Grand Avenue |
| Fax Number: | (424) 218 8519 |
| City: | El Segundo |
| State: | California |
| Country: | USA |
| Zip Code: | 90245 |
| Contact Name: | Shiven Gandhi |
| Contact Tittle: | Regulatory Affairs Associate |
| Email Address: | shiven.gandhi@karlstorz.com |
| Manufacturing Company Name: | Karl Storz GmbH & Co. KG |
|---|---|
| Street Address: | Mittelstrasse 8 |
| City: | Tuttlingen |
| State/Province: | Baden-Wurttemburg |
| Country: | Germany |
| Zip Code: | 78532 |
| Trade Name: | Power LED 175 |
|---|---|
| Model Number: | 20161420-1 |
| Common Name: | LED Light source |
| Classification Name: | FCW - Light Source, Fiber Optic, Routine |
| NTN - LED Light Source |
Information about devices to which Substantial Equivalence is claimed:
| 510 (K) Number | Trade/ Proprietary Name/Model Number | Manufacturer/ |
|---|---|---|
| K091968 | LED NOVA 100 Cold Light Fountain | Karl Storz GmbH & Co. KG |
| K962595 | 300 Watt Xenon Light Source | Karl Storz GmbH & Co. KG |
1
Introduction:
Device Trade Name: Common Name: Classification Name: Regulation Number: Product Code:
Power LED 175 Light source, Fiber Optic, Routine Endoscope and accessories 21 CFR 876.1500 FCW, NTN
Device Description:
The power LED 175 is a high power medical cold light source used for endoscopic diagnostic and surgical procedures. The device can be controlled via buttons on the front panel or via SCB (STORZ Communication Bus). This device provides high light intensity at low power consumption with intelligent cooling concept for minimal noise emission. This device includes a cold light source power LED 175, power cord, and the 100 cm SCB connection cable. The light is transmitted through an optical cable and a scope to illuminate surgical sites during minimally invasive surgical procedures.
Indication for Use
Cold light sources are designed to supply light for endoscopic diagnostic and surgical procedures.
2
Technological Characteristics:
| Parameter | Power LED 175
Cold Light Fountain
(Subject Device) | LED NOVA 100
Cold Light Fountain
(Predicate Device) | 300 Watt Xenon
Light Source
(Predicate Device) |
|----------------|--------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------|
| Applicant | KARL STORZ
Endoscopy America
Inc. | KARL STORZ
Endoscopy America
Inc. | KARL STORZ
Endoscopy America
Inc. |
| 510(k) number | K123956 | K091968 | K962595 |
| Type of Device | Light Source | Light Source | Light Source |
| Intended Use | Cold light sources
-are designed to
supply light for
endoscopic
diagnostic and
surgical procedures. | Used as a light source
in conjunction with
rigid and flexible
endoscopes as well as
other light providing
instruments to
illuminate the
operating field during
minimally invasive
endoscopic surgical
procedures | The device is
designed to supply
light for endoscopic
diagnostic and
surgical procedures. |
| Lamp Type | LED | LED | Xenon |
| Color | 6500 K | 5600 K | 6000 K |
| Temperature | | | |
| Used With | Fluid Optic or Fluid
Light Cable, Rigid
or Flexible
Endoscope | Fluid Optic or Fluid
Light Cable, Rigid or
Flexible Endoscope | Fluid Optic or Fluid
Light Cable, Rigid or
Flexible Endoscope |
Performing Testing
The performance testing to verify light output of Power LED 175 was done as per the Comparative Bench Testing attached in Enclosure # 6. Design Verification Testing (DVT) demonstrates that the device functions as it is intended and its performance does not raise any new issues of safety and effectiveness. Software verification was done and is attached in Enclosure # 5.17 Performance standards under section 514 of the Codc of Federal Regulations Title 21 have not been developed for this device however the manufacturer complies with the following voluntary standards:
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- IEC 60601-1 Medical Electrical Equipment, Part 1- General Safety Requirements 트
- IEC 60601-1-2:2001 (CISPR 11 Class B) Electromagnetic Compatibility ●
- IEC 60601-2-18 Medical Electrical Equipment, Part 2-18 Particular requirements for I the basic safety and essential performance of endoscopic equipment
Summary of Substantial Equivalence:
The Power LED 175 is substantially equivalent to the existing 510(k) cleared devices on the market i.e. KARL STORZ LED NOVA 100 Cold Light Fountain (K091968 cleared September 14, 2009) and KARL STORZ 300 Watt Xenon Light Source (K962595 cleared September 4, 1996). The indication for use of the Power LED 175 is identical to the predicate devices. The Power LED 175 does not incorporate any special technology or characteristics when compared to its predicate devices.
Conclusion:
The Karl Storz Power LED 175 is substantially equivalent to the predicate device(s) mentioned above and the non-clinical performance testing demonstrates that the device is as safe and effective and performs as well as or better than the legally marketed devices
Contact:
Shiven Gandhi
Shiven Gandhi KARL STORZ Endoscopy-America, Inc. 2151 E. Grand Avenue El Segundo, CA 90245 Phone: (424)-218-8322 Shiven Gandhi Regulatory Affairs Associate Email: shiven.gandhi@karlstorz.com
01/16/2013
Date:
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Image /page/4/Picture/0 description: The image shows the logo for the U.S. Department of Health & 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 resembling a caduceus, with three lines forming a shape that could be interpreted as a person or a symbol of health.
DEPARTMENT OF HEALTH & HUMAN SERVICES
Public Health Service
January 25, 2013
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
Karl Storz Endoscopy-America, Incorporated % Mr. Shiven Gandhi Regulatory Affairs Associate 2151 East Grand Avenue El Segundo, California 90245-5017
Re: K123956
Trade/Device Name: Power LED 175 Cold Light Fountain Regulation Number: 21 CFR 876.1500
· Regulation Name: Endoscope and accessories Regulatory Class: II
Product Code: FCW, NTN Dated: December 18, 2012 Received: December 12, 2012
Dear Mr. Gandhi:
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.
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Page 2 - Mr. Shiven Gandhi
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), please contact the Office of Compliance at (240) 276-0115. 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/cdrh/industry/support/index.html.
Sincerely yours,
Peter D. Rumm -S
Mark N. Melkerson Acting Director Division of Surgical Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
6
Indication for Use:
510(k) Number: K123956
Device Name: Power LED 175 Cold Light Fountain
Indication for use: Cold light sources are designed to supply light for endoscopic diagnostic and surgical procedures.
Prescription Use_ ✔___________________________________________________________________________________________________________________________________________________________ ´ AND/OR (Part 21 CFR 801.109 i.e. Subpart D)
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) Neil R Ogden 2013.01.29 17:01:25 -05′00′
(Division Sign-Off) for my my Division of Surgical Devices 510(k) Number K123956