(25 days)
Not Found
No
The document describes image processing but does not mention AI, ML, or deep learning, nor does it provide details about training or test sets typically associated with AI/ML models.
No.
The device is used to provide real-time endoscopic visible and near infrared fluorescence imaging for visual assessment and visualization during surgical procedures, not for treatment.
No
The device is an imaging system designed to visualize anatomical structures, perfusion, and the lymphatic system during surgery. It does not perform diagnostic functions like analyzing an image to provide a diagnosis or characterizing a disease directly. Its use is primarily for intraoperative guidance and visualization rather than diagnosis.
No
The device description explicitly states it is a "Light Source" and part of a "System" that includes hardware components like an LED Light Source, SafeLight Cable, optical light guide, endoscope, coupler, and image sensors. While it involves image processing software, it is not solely software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections. They are used outside of the body (in vitro).
- Device Function: The L12 LED Light Source with AIM and SafeLight Cable is an imaging system used during surgical procedures (in vivo). It provides illumination and visualization of internal structures and blood flow within the patient's body.
- Intended Use: The intended use clearly describes its application in surgical settings for real-time imaging of vessels, bile ducts, lymphatic systems, and tissues that have taken up specific drugs. This is an in-vivo application.
- Device Description: The description details a light-generating unit and imaging system used to illuminate surgical sites and acquire image data from within the body.
The device is a surgical imaging system, not a diagnostic test performed on samples outside the body.
N/A
Intended Use / Indications for Use
Upon intravenous administration of SPY AGENT GREEN (indocyanine green for injection, USP), the L12 LED Light Source with AIM and SafeLight Cable are used with SPY AGENT GREEN to provide real-time endoscopic visible and near infrared fluorescence imaging. The L12 Light Source with AIM and SafeLight Cable enable surgeons to perform minimally invasive surgery using standard endoscopic visible light as well as visual assessment of vessels, blood flow and related tissue perfusion in adults and pediatric patients aged one month and older, and visualization of at least one of the major extra-hepatic bile duct, common bile duct and common hepatic duct) in adults and pediatric patients 12 to 17 years of age, using near-infrared imaging.
Fluorescence imaging of biliary ducts with the L12 Light Source with AIM and SafeLight Cable is intended for use with standard-of-care white light and, when indicated, intraoperative cholangiography. The devices are not intended for standalone use for biliary duct visualization.
Additionally, the L12 LED Light Source with AIM and SafeLight Cable enable surgeons to perform minimally invasive cranial neurosurgery in adults and pediatric patients and endonasal skull base surgery in adults and pediatric patients > 6 years of age using standard endoscopic visible light as well as visual assessment of vessels, blood flow and related tissue perfusion using near infrared imaging.
Upon interstitial administration of SPY AGENT GREEN, the L12 LED Light Source with AIM and SafeLight Cable are used to perform intraoperative fluorescence imaging and visualization of the lymphatic system, including lymphatic vessels and lymph nodes.
Upon administration and use of pafolacianine consistent with its approved label, the L12 LED Light Source with AIM and SafeLight™ Cable are used to perform intraoperative fluorescence imaging of tissues that have taken up the drug.
The L12 LED Light Source with AIM is also intended to transilluminate the ureter during open or laparoscopic surgical procedures.
Product codes
OWN, FCS, GWG, FCW
Device Description
The L12 LED Light Source with AIM is part of the Advanced Imaging Modality (AIM) System. The system is an endoscopic real-time 4K visible white light and near-infrared illumination and transillumination imaging system. Near-infrared illumination is used for fluorescence imaging using indocyanine green and pafolacianine injection. Near-infrared illumination is also intended for use during transillumination of the ureters using the IRIS Ureteral Kit during minimally invasive and open surgical procedures. The L12 LED Light Source is a light-generating until designed to illuminate surgical sites in the following applications: visible light, near-infrared fluorescence, and near-infrared transillumination.
Mentions image processing
The image data is processed to provide a video stream that is then sent to a display for viewing.
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
endoscopic visible and near infrared fluorescence imaging, near-infrared imaging, near infrared imaging, intraoperative fluorescence imaging
Anatomical Site
vessels, blood flow and related tissue perfusion, major extra-hepatic bile ducts (cystic duct, common bile duct and common hepatic duct), biliary ducts, lymphatic system, lymphatic vessels and lymph nodes, ureter
Indicated Patient Age Range
adults and pediatric patients aged one month and older, adults and pediatric patients 12 to 17 years of age, adults and pediatric patients, pediatric patients > 6 years of age
Intended User / Care Setting
surgeons, minimally invasive surgery, minimally invasive cranial neurosurgery, endonasal skull base surgery, open or laparoscopic surgical procedures
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)
Software:
Light Source Software Functional Test - PASS
Light Source Communication - PASS
Performance Testing - Bench:
Light Source Light Output - PASS
Light Source Power Draw - PASS
Light Source Cable Compatibility - PASS
Light Source Timing - PASS
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
Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health & Human Services logo on the left and the FDA logo on the right. The FDA logo features the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue text.
April 11, 2023
Stryker April Malmborg Senior Director, Regulatory Affairs 5900 Optical Court San Jose, California 95138
Re: K230754
Trade/Device Name: L12 LED Light Source with AIM Regulation Number: 21 CFR 876.1500 Regulation Name: Endoscope And Accessories Regulatory Class: Class II Product Code: OWN, FCS, GWG, FCW Dated: March 17, 2023 Received: March 17, 2023
Dear April Malmborg:
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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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
1
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 adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
Jessica Carr -S
Jessica Carr, Ph.D. Acting Assistant Director DHT4A: Division of General Surgery Devices OHT4: Office of Surgical and Infection Control Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known) K230754
Device Name L12 LED Light Source with AIM
Indications for Use (Describe)
Upon intravenous administration of SPY AGENT GREEN (indocyanine green for injection, USP), the L12 LED Light Source with AIM and SafeLight Cable are used with SPY AGENT GREEN to provide real-time endoscopic visible and near infrared fluorescence imaging. The L12 Light Source with AIM and SafeLight Cable enable surgeons to perform minimally invasive surgery using standard endoscopic visible light as well as visual assessment of vessels, blood flow and related tissue perfusion in adults and pediatric patients aged one month and older, and visualization of at least one of the major extra-hepatic bile duct, common bile duct and common hepatic duct) in adults and pediatric patients 12 to 17 years of age, using near-infrared imaging.
Fluorescence imaging of biliary ducts with the L12 Light Source with AIM and SafeLight Cable is intended for use with standard-of-care white light and, when indicated, intraoperative cholangiography. The devices are not intended for standalone use for biliary duct visualization.
Additionally, the L12 LED Light Source with AIM and SafeLight Cable enable surgeons to perform minimally invasive cranial neurosurgery in adults and pediatric patients and endonasal skull base surgery in adults and pediatric patients > 6 years of age using standard endoscopic visible light as well as visual assessment of vessels, blood flow and related tissue perfusion using near infrared imaging.
Upon interstitial administration of SPY AGENT GREEN, the L12 LED Light Source with AIM and SafeLight Cable are used to perform intraoperative fluorescence imaging and visualization of the lymphatic system, including lymphatic vessels and lymph nodes.
Upon administration and use of pafolacianine consistent with its approved label, the L12 LED Light Source with AIM and SafeLight™ Cable are used to perform intraoperative fluorescence imaging of tissues that have taken up the drug.
The L12 LED Light Source with AIM is also intended to transilluminate the ureter during open or laparoscopic surgical procedures.
| 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) |
CONTINUE ON A SEPARATE PAGE IF NEEDED.
3
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4
stryker
This 510(k) summary of safety and effectiveness information is being submitted in accordance with the requirements of 21 C.F.R Part 807.92(c).
510(k) Number : K230754
Submitter:
| Applicant: | Stryker Endoscopy
5900 Optical Court
San Jose, CA 95138 |
|-----------------|-------------------------------------------------------------------------------------------|
| Contact Person: | April Malmborg
Senior Director Regulatory Affairs
Email: april.malmborg@stryker.com |
| Date Prepared: | April 3, 2023 |
Subject Device:
| Name of Device: | L12 LED Light Source with AIM |
|---|---|
| Common or | |
| Usual Name | Light Source, Illuminator |
| Classification | |
| Name: | Endoscope and Accessories1,3 (21 C.F.R. §876.1500) |
| Fiberoptic light ureteral catheter2 (21 C.F.R. §876.4020) | |
| Endoscope, Neurological4 (21 C.F.R. §882.1480) | |
| Regulatory Class: | II |
| Product Code: | OWN1 |
| FCS2 | |
| FCW3 | |
| GWG4 | |
| 510(k) Review | |
| Panel: | General & Plastic Surgery1 |
| Gastroenterology/ Urology2,3 | |
| Neurology4 |
'When used for assessment of vessels, blood flow and related tissue perfusion, and at least one of the major extra-hepatic bile ducts (cystic duct, common bile duct and common hepatic duct), using near-infrared imaging
2When used to transilluminate the ureter during open or laparoscopic surgical procedures
3When used to provide standard endoscopic visible light to support real-time endoscopic visible imaging.
4When used to provide standard endoscopic visible light and near-infrared imaging during minimally invasive cranial neurosurgery and endonasal skull base surgery.
Predicate Device(s):
| 780 nm L11 LED Light Source with AIM (Stryker Endoscopy) | K221611* |
|---|---|
| K214046 |
*primary predicate
5
strvk
Device Description:
The L12 LED Light Source with AIM is part of the Advanced Imaging Modality (AIM) System. The system is an endoscopic real-time 4K visible white light and near-infrared illumination and transillumination imaging system. Near-infrared illumination is used for fluorescence imaging using indocyanine green and pafolacianine injection. Near-infrared illumination is also intended for use during transillumination of the ureters using the IRIS Ureteral Kit during minimally invasive and open surgical procedures. The L12 LED Light Source is a light-generating until designed to illuminate surgical sites in the following applications: visible light, near-infrared fluorescence, and near-infrared transillumination.
Indications for Use:
Upon intravenous administration of SPY AGENT™GREEN (indocyanine green for injection, USP), the L12 LED Light Source with AIM and SafeLight™ Cable are used with SPY AGENT GREEN to provide real-time endoscopic visible and near infrared fluorescence imaging. The L12 LED Light Source with AIM and SafeLight Cable enable surgeons to perform minimally invasive surgery using standard endoscopic visible light as well as visual assessment of vessels, blood flow and related tissue perfusion in adults and pediatric patients aged one month and older, and visualization of at least one of the major extra-hepatic bile ducts (cystic duct, common bile duct and common hepatic duct) in adults and pediatric patients 12 to 17 years of age, using nearinfrared imaging.
Fluorescence imaging of biliary ducts with the L12 LED Light Source with AIM and SafeLight Cable is intended for use with standard-of-care white light and, when indicated, intraoperative cholangiography. The devices are not intended for standalone use for biliary duct visualization.
Additionally, the L12 LED Light Source with AIM and SafeLight Cable enable surgeons to perform minimally invasive cranial neurosurgery in adults and pediatric patients and endonasal skull base surgery in adults and pediatric patients > 6 years of age using standard endoscopic visible light as well as visual assessment of vessels, blood flow and related tissue perfusion using near infrared imaging.
Upon interstitial administration of SPY AGENT GREEN, the L12 LED Light Source with AIM and SafeLight Cable are used to perform intraoperative fluorescence imaging and visualization of the lymphatic system, including lymphatic vessels and lymph nodes.
Upon administration and use of pafolacianine consistent with its approved label, the L12 LED Light Source with AIM and SafeLight™ Cable are used to perform intraoperative fluorescence imaging of tissues that have taken up the drug.
The L12 LED Light Source with AIM is also intended to transilluminate the ureter during open or laparoscopic surgical procedures.
6
stryker
Comparison of Technological Characteristics with the Predicate Device:
| Item | Subject Device
L12 LED Light Source with AIM | Predicate Device
780 nm L11 LED Light Source
with AIM |
|-----------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------|
| Manufacturer | Stryker | Same as subject device. |
| Submission Reference | Current submission | K221611, K214046 |
| Intended Use | Endoscopic white light and near-infrared illumination and imaging during endoscopic procedures. | Same as subject device |
| Indications for Use | NOTE 1 | Same as subject device |
| Imaging
Modes | White Light
Manual
Autolight | Same as subject device |
| | Near-infrared Fluorescence
ENV
Contrast
Overlay
- Without IRIS
- With IRIS | ENV
Contrast
Overlay - Without IRIS |
| | Near-infrared transillumination
IRIS | Same as subject device |
| | Imaging Agents
SPY AGENTTM GREEN
(indocyanine green for injection, USP)
pafolacianine | Same as subject device |
| | Principles of Operation
Via an optical light guide, endoscope and coupler, light is projected from a light source and either reflected or absorbed and fluoresced onto one or more complementary metal oxide semiconductor image sensors which acquire a continuous stream of image data. The image data is processed to provide a video stream that is then sent to a display for viewing. | Same as subject device. |
| System Components | Light Source (subject of this submission)
SafeLight Cable
Camera System
Laparoscopes
IRIS Ureteral Kit
NOTE: This represents the components of the AIM System. | Same as subject device. |
| Safety Standards | IEC 60601-1
IEC 60601-2-18
IEC 60601-1-2
IEC 60601-1-6
IEC 60825-1 | Same as subject device. |
| Laser Safety Classification | Class 1M | Same as subject device. |
| Light Source/
Laser | RGB LEDs/
Infrared Laser | Same as subject device. |
| Excitation Wavelength(s) | Near-infrared fluorescence: 780 nm
Near-infrared transillumination: 830 | Same as subject device. |
7
NOTE 1: Upon intravenous administration of SPY AGENT™ GREEN (indocyanine green for injection, USP), the L12 LED Light Source with AIM and SafeLight™ Cable are used with SPY AGENT GREEN to provide real-time endoscopic visible and near infrared fluorescence imaging. The L12 LED Light Source with AIM and SafeLight Cable enable surgeons to perform minimally invasive surgery using standard endoscopic visible light as well as visual assessment of vessels, blood flow and related tissue perfusion in adults and pediatric patients aged one month and older, and visualization of at least one of the major extrahepatic bile ducts (cystic duct, common bile duct and common hepatic duct) in adults and pediatic patients 12 to 17 years of age, using near-infrared imaging. Fluorescence imaging of biliary ducts with the L12 Light Source with AIM and SafeLight Cable is intended for use with standard-of-care white light and, when indicated, intraoperative cholangiography. The devices are not intended for standalone use for bilization. Additionally, the L12 Light Source with AIM and SafeLight Cable enable surgeons to perform minimally invasive cranial neurosurgery in adults and pediatric patients and endonasal skull base surgery in adults and pediatric patients > 6 years of age using standard endoscopic visible light as well as visual assessment of vessels, blood flow and related tissue perfusion using near infrared imaging. Upon interstitial administration of SPY AGENT GREEN, the L12 LED Light Source with AIM and SafeLight Cable is used to perform intraoperative fluorescence imaging and visualization of the lymphatic system, including lymphatic vessels and lymph nodes. Upon administration and use of pafolacianine consistent with its approved label, the L12 LED Light Source and SafeLight™ Cable is used to perform intraoperative fluorescence imaging of tissues that have taken up the drug. The L12 Light Source with AIM is also intended to transilluminate the ureter during open or laparoscopic surgical procedures.
| Test | Method | Result |
|---|---|---|
| Software | Light Source Software Functional Test | PASS |
| Light Source Communication | PASS | |
| Performance Testing - Bench | Light Source Light Output | PASS |
| Light Source Power Draw | PASS | |
| Light Source Cable Compatibility | PASS | |
| Light Source Timing | PASS |
Performance Data:
NOTE: The L12 LED Light Source with AIM is not patient contacting; therefore, biocompatibility testing was not required to support the determination of substantial equivalence.
NOTE: The L12 LED Light Source does not require clinical studies to support the determination of substantial equivalence.
Conclusions:
The L12 LED Light Source with AIM is the same or similar in design, intended use, principles of operation, technological characteristics and safety features to the predicate devices. In summary, the L12 LED Light Source with AIM is the same or similar with respect to safety and effectiveness to the legally marketed predicate devices.