(450 days)
No
The description focuses on the technical specifications of an LED light source for surgical illumination and does not mention any AI or ML capabilities.
No
Explanation: The device is described as an illuminator for surgical sites, providing light to assist in visualization during procedures, rather than directly treating a disease or condition.
No
Explanation: The device is a light source used to illuminate the surgical site during minimally invasive procedures. Its purpose is illumination, not to detect, diagnose, treat, or prevent disease or other conditions.
No
The device description clearly describes a physical hardware device (LED light source) used to illuminate surgical sites, not a software-only product.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is to illuminate the surgical site during minimally invasive procedures. This is a direct interaction with the patient's body for visualization during surgery.
- Device Description: The description focuses on the technical aspects of the light source for illumination purposes.
- Lack of IVD Characteristics: There is no mention of the device being used to examine specimens derived from the human body (like blood, tissue, urine, etc.) to provide information for diagnosis, monitoring, or screening.
IVD devices are specifically designed to perform tests on biological samples outside of the body to provide diagnostic information. This device is a surgical light source used during a procedure on the patient.
N/A
Intended Use / Indications for Use
The NovaProbe Inc. LED Light is used to illuminate the site of the surgery during minimally invasive surgical procedures in Arthroscopy (orthopedic surgery), Laparoscopy (general and gynecological surgery) and Endoscopy (general, gastroenterological and ENT surgery). The light is transmitted from the source through an optical cable and a scope.
Product codes
FCW, NTN
Device Description
The NOVAPROBE LED LEUKOS 175 is specifically designed to provide the cold light intensity required for modern day Endoscopic procedures. The LED light provides the color temp of 6500 deg K also known as white light. The white light offers unmatched quality for the single chip, three chip and HD cameras. The LED light intensity is controlled digitally. Using LED nullifies any skin burning problems that may occur due to the use of arc lamps. The NovaProbe LED Light source assures that the light passing through the fiber optic cable is a cold light.
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)
Design verification testing demonstrates that the devices function as intended, and the Performance did not raise any new issues of safety and effectiveness, and that formal user training is not required. No clinical data was required to confirm safety and effectiveness.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
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
K131226 JUL 2 4 2014
Image /page/0/Picture/1 description: The image shows the word "NovaProbe" in a stylized font. The word is in black and has a line above the "Nova" portion. There is a symbol above the "o" in "Probe" and a registered trademark symbol to the right of the "e" in "Probe".
2333 W. Main Street Suite 210 Lansdale PA 19446 Tel: 215-259-3673 http://www.NovaProbe.com Email: ingle@novaprobe.com
510(k) SUMMARY OF SAFETY AND EFFECTIVENESS
| Submitter | Date of Preparation: June 27, 2014 | ||
|---|---|---|---|
| Company Name/ Institution Name: | FDA Establishment Registration Number: | ||
| NovaProbe Incorporated | 3010120217 | ||
| Division Name(If Applicable) | Phone Number ( include area code): | ||
| N/A | 215-259-3673 | ||
| Street Address: | FAX number (include area code): | ||
| 2333 W. Main Street Suite 210 | 267-295-8411 | ||
| City: | State/Province: | Country: | Zip / Postal code |
| Lansdale | Pennsylvania | USA | 19446 |
| Contact Person: | |||
| Manish Ingle | |||
| Contact Title: | |||
| President | |||
| Product Information: | |||
| Trade Name: | Model number: | ||
| NOVAPROBE LED Light Source | LEUKOS 175 | ||
| Common Name: | Classification: | ||
| Light source, Fiber Optic, Routine | |||
| LED Light Source | Endoscope and Accessories, Class II | ||
| (21CFR 876.1500, Product Code FCW, NTN) | |||
| Information on devices to which substantial equivalence is claimed: | |||
| 510(K) Number | Trade or Proprietary or Model Name | Manufacturer | |
| 1 K082813 | 1. LED Light Source L9000 | 1. Stryker Endoscopy | |
| 2 K103813 | 2. LED Light Source | ||
| SOPRO 281 | 2 SOPRO. | ||
| 3 K121724 | 3 5160 ENDOLIGHT light Source | 3 Richard Wolf Medical Instruments Corporation Inc. |
© 2014 NovaProbe Inc. Confidential and Proprietary Information
1
Image /page/1/Picture/0 description: The image shows the word "NovaProbe" in a stylized font. The word is written in black, with the first letter "N" being outlined in white. There is a symbol above the "o" in "Probe" that looks like a plus sign, and there is a registered trademark symbol next to the "e" in "Probe".
2333 W. Main Street Suite 210 Lansdale PA 19446 Tel: 215-259-3673 http://www.NovaProbe.com Email: ingle@novaprobe.com
Introduction:
Device Trade Name: NOVAPROBE LED Light Source (LEUKOS 175)
Common Name: Light source, Fiber Optic, Routine
Classification Name: Endoscope and accessories ------
Regulation Number: 21 CER 876.1500
Product Code: FCW, NTN
Device Description:
The NOVAPROBE LED LEUKOS 175 is specifically designed to provide the cold light intensity required for modern day Endoscopic procedures. The LED light provides the color temp of 6500 deg K also known as white light. The white light offers unmatched quality for the single chip, three chip and HD cameras. The LED light intensity is controlled digitally. Using LED nullifies any skin burning problems that may occur due to the use of arc lamps. The NovaProbe LED Light source assures that the light passing through the fiber optic cable is a cold light.
Intended Use:
The NovaProbe Inc. LED Light is used to illuminate the site of the surgery during minimally invasive surgical procedures in Arthroscopy (orthopedic surgery a Laparoscopy (general and gynecological surgery) and Endoscopy (general, gastroenterological and ENT surgery). The light is transmitted from the source through an optical cable and a scope.
Comparison of Technological Characteristics:
The technology of the NOVAPROBE LED LEUKOS 175 Light Source System is similar to the referenced predicate devices of LED Light Sources as they utilize the similar components as shown below.
© 2014 NovaProbe Inc. Confidential and Proprietary Information
Section 4 Page 2 of 5
2
Image /page/2/Picture/0 description: The image shows the logo for NovaProbe. The logo is in black and white, with the word "NovaProbe" in a stylized font. There is a line going through the top of the "v" in Nova. There is also a small cross above the "b" and a registered trademark symbol next to the "e".
2333 W. Main Street Suite 210 Lansdale PA 19446 Tel: 215-259-3673 http://www.NovaProbe.com Email: ingle@novaprobe.com
DEVICE COMPARISONS:
| Device | 510K
Number | Intended Use | Lamp | Color
Temperature |
|--------------------------------------------------------------------------------------------|----------------|---------------------------------------------------------------------------------------------------|------|----------------------|
| NOVAPROBE INC.
LED LEUKOS 175 | K131226 | Cold Light Sources are
Designed to supply light for
endoscopic and diagnostic
procedures | LED | 6500K |
| Stryker Endoscopy
LED Light Source
L9000 | K082813 | Cold Light Sources are
Designed to supply light for
endoscopic and diagnostic
procedures | LED | 6500K |
| SOPRO
LED Light Source
SOPRO 281 | K103813 | Cold Light Sources are
Designed to supply light for
endoscopic and diagnostic
procedures | LED | 6000K |
| Richard Wolf Medical
Instruments
Corporation Inc..
5160 ENDOLIGHT
light Source | K121724 | Cold Light Sources are
Designed to supply light for
endoscopic and diagnostic
procedures | LED | 6000K |
| Sunoptic Technologie
LLS-050 LED light
Source | K093792 | Cold Light Sources are
Designed to supply light for
endoscopic and diagnostic
procedures | LED | 6000K |
| Device | 510K
Number | Bio
compatibility | Used with | Light source Safety |
|------------------------------------------------|----------------|----------------------|----------------------------------------------------------------|--------------------------------------------------------------------------------|
| NOVAPROBE INC.
LED LEUKOS 175 | K131226 | N/A | Fiber-optic light
cable, Rigid and
Flexible
Endoscope | Light Source output
identical to LED light
source K121724 and
K082813 |
| Stryker Endoscopy
LED Light Source
L9000 | K082813 | N/A | Fiber-optic light
cable, Rigid and
Flexible
Endoscope | Light Source Safety
demonstrated in 510k
submission |
| SOPRO
LED Light Source
SOPRO 281 | K103813 | N/A | Fiber-optic light
cable, Rigid and
Flexible
Endoscope | Light Source Safety
demonstrated in 510k
submission |
| Richard Wolf
Medical Instruments | K121724 | N/A | Fiber-optic light
cable, Rigid and
Flexible | Light Source Safety
demonstrated in 510k |
© 2014 NovaProbe Inc. Confidential and Proprietary Information
Section 4 Page 3 of 5
3
Image /page/3/Picture/0 description: The image shows the logo for NovaProbe. The logo is in black and white, with the word "NovaProbe" in a stylized font. There is a four-pointed star above the "b" in "Probe", and a small circle with a dot in the center above the "e". The logo is simple and modern.
2333 W. Main Street Suite 210 Lansdale PA 19446 Tel: 215-259-3673 http://www.NovaProbe.com Email: ingle@novaprobe.com
| Corporation Inc..
5160 ENDOLIGHT
light Source | | | Flexible
Endoscope | submission |
|---------------------------------------------------------|---------|-----|----------------------------------------------------------------|-----------------------------------------------------------|
| Sunoptic
Technologies
LLS-050 LED light
Source | K093792 | N/A | Fiber-optic light
cable, Rigid and
Flexible
Endoscope | Light Source Safety
demonstrated in 510k
submission |
Sterilization:
This system is a non-sterile system. The Light Source is to be cleaned with a soft cloth moistened with surface disinfectant, alcohol or spirit as defined in instruction manual.
Rational for Substantial Equivalence:
The NovaProbe Inc. LED LEUKOS 175 Light Source is substantially equivalent to Stryker Endoscopy LED light Source L9000 (K0828813), SOPRO LED light source 281 (K103813), Richard Wolf ENDOLIGHT light source (K121724) and Sun optic Technologies LLS-050 LED(K093792) light Source due to the fact that they appliutilize similar components and technology as the NovaProbe Inc. LED LEUKOS 17511 ight Source for the same approved intended uses. Further, the NovaProbe Inc. J ED LEUKOS 175 Light Source introduces no new patient risks or concerns.
The NovaProbe Inc. LED LEUKOS 175 Light Sources were non-clinically tested to determine the safety and efficacy under the indications for use and meet affected ioned safety standards, same as the predicate devices.
Performance Data:
Design verification testing demonstrates that the devices function as intended, and the Performance did not raise any new issues of safety and effectiveness, and that formal user training is not required.
No applicable mandatory performance standards or special controls exists for this device.
Clinical Data:
No clinical data was required to confirm safety and effectiveness.
© 2014 NovaProbe Inc. Confidential and Proprietary Information
Section 4 Page 4 of 5
4
Image /page/4/Picture/0 description: The image shows the logo for NovaProbe. The logo is in black and white, with the word "NovaProbe" in a stylized font. There is a line going through the word "Nova" and a plus sign above the "o" in Probe. The logo also has the registered trademark symbol.
2333 W. Main Street Suite 210 Lansdale PA 19446 Tel: 215-259-3673 http://www.NovaProbe.com Email: ingle@novaprobe.com
Conclusion:
Testing has shown that the NovaProbe Inc. LED LUEKOS 175 Light Source performs to its specifications, operates as intended, is safe and effective, and is substantially equivalent to legally marketed devices.
Contact:
Date:
27 June 2014
Manish Ingle President NovaProbe Inc. 2333 W. Main Street Suite 210 Lansdale PA 19446 USA 215-259-3673 ext 801 Email: ingle@novaprobe.com
© 2014 NovaProbe Inc. Confidential and Proprietary Information
Section 4 Page 5 of 5
5
Image /page/5/Picture/0 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is circular and contains the department's seal. The seal features an abstract image of an eagle with its wings spread, along with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the top of the circle.
DEPARTMENT OF HEALTH & HUMAN SERVICES
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
July 24, 2014
NovaProbe Incorporated Mr. Manish Ingle President 2333 West Main Street, Suite 210 Lansdale, Pennsylvania 19446
Re: K131226
Trade/Device Name: NovaProbe LED Light Source (LEUKOS 175) Regulation Number: 21 CFR 876.1500 Regulation Name: Endoscope and accessories Regulatory Class: Class II Product Code: FCW Dated: June 18, 2014 Received: June 24, 2014
Dear Mr. Ingle:
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 (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set
6
Page 2 - Mr. Manish Ingle
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 contact the Division of Industry and Consumer Education 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. 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 Industry and Consumer Education 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,
David Krause -S
for
Binita S. Ashar, M.D., M.B.A., F.A.C.S. Director Division of Surgical Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
7
DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration
Indications for Use
510(k) Number (if known) K131226
Device Name
NovaProbe LED Light Source (LEUKOS 175)
Indications for Use (Describe)
The NovaProbe Inc. LED Light is used to illuminate the site of the surgery during minimally invasive surgical procedures in Arthroscopy (orthopedic surgery), Laparoscopy (general and gynecological surgery) and Endoscopy (general, gastroenterological and ENT surgery). The light is transmitted from the source through an optical cable and a scope.
Type of Use (Select one or both, as applicable)
Prescription Use (Part 21 CFR 801 Subpart D)
Over-The-Counter Use (21 CFR 801 Subpart C)
Form Approved: OMB No. 0910-0120
Expiration Date: January 31, 2017
See PRA Statement below.
PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON A SEPARATE PAGE IF NEEDED.
FOR FDA USE ONLY
Concurrence of Center for Devices and Radiological Health (CDRH) (Signature)
Neil R Ogden -S 2014.07.23 16:48:01 -04'00'
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