(90 days)
Not Found
No
The summary mentions "Advanced Imaging Modality" and "image processing" but does not contain any terms or descriptions indicative of AI/ML, such as "artificial intelligence," "machine learning," "deep learning," "neural network," or descriptions of training/test data sets. The focus is on real-time visible and near-infrared fluorescence imaging.
No.
The device is an imaging system used during surgical procedures to visualize internal structures, not to directly treat a condition or disease.
No
The device is an imaging system and light source intended for visualization during surgical procedures, not for diagnosing conditions. It aids surgeons in performing minimally invasive surgery by providing real-time endoscopic visible and near infrared fluorescence imaging of anatomical structures.
No
The device description explicitly lists multiple hardware components: a Camera System, a Light Source and SafeLight Cable, and a Laparoscope. While it includes image processing, it is part of a larger hardware system.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostic devices are used to examine specimens taken from the human body (like blood, urine, or tissue) to provide information for diagnosis, monitoring, or screening.
- Device Function: The 1688 4K Camera System with AIM is an endoscopic imaging system used during surgical procedures to visualize internal anatomy in real-time. It uses visible light and near-infrared light, sometimes in conjunction with an injected imaging agent (SPY AGENT GREEN), to help surgeons see structures like vessels, blood flow, bile ducts, and the lymphatic system.
- No Specimen Analysis: The device does not analyze samples taken from the body. It provides direct visualization within the body during surgery.
While the system uses an imaging agent (SPY AGENT GREEN) which is administered to the patient, the device itself is not performing a diagnostic test on a biological specimen. It's a surgical imaging tool.
N/A
Intended Use / Indications for Use
Indications for Use (Describe)
1688 4K Camera System with Advanced Imaging Modality (AIM):
The 1688 Video Camera is indicated for use in general laparoscopy, ear endoscopy, sinuscopy, sinuscopy and plastic surgery whenever a laparoscope/ arthroscope is indicated for use. The 1688 Video Camera is indicated for use in adults and pediatric patients aged one month or older.
A few examples of the more common endoscope surgeries are Laparoscopic cholecystectomy, Laparoscopic hernia repair, Laparoscopic appendectomy, Laparoscopic pelvic lymph node detection, Laparoscopically assisted hysterectomy, Laparoscopic and thorascopic anterior spinal fusion, Anterior cruciate ligament reconstruction, Knee arthroscopy, Small joint arthroscopy, Decompression fixation, Wedge resection, Lung biopsy, Dorsal sympathectomy, Pleurodesis, Internal mammary artery dissection for coronary artery bypass grafting where endoscopic visualization is indicated and Examination of the evacuated cardiac chamber during performance of valve replacement.
The users of the 1688 Video Camera are general and pediatric surgeons, gynecologists, cardiac surgeons, thoracic surgeons, plastic surgeons, orthopedic surgeons, ENT surgeons and urologists.
L11 LED Light Source with Advanced Imaging Modality (AIM) and SafeLight Cable:
Upon intravenous administration of SPY AGENTTM GREEN (indocyanine green for injection, USP), the L11 LED Light Source with AIM and SafeLightTM Cable is used with SPY AGENT GREEN to provide real-time endoscopic visible and near infrared fluorescence imaging. The L11 LED Light Source with AIM and SafeLight Cable enable surgeons to perform minimally invasive surgery using endoscope visual assessment of vessels, blood flow and related tissue perfusion in adults and pediatric patients aged one month or 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 near-infrared imaging.
Fluorescence imaging of biliary ducts with the L11 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. Upon interstitial administration of SPY AGENT GREEN, the L11 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.
The L11 LED Light Source is also intended to transilluminate the ureter during open or laparoscopic surgical procedures.
Advanced Imaging Modality (AIM) HD Autoclavable Laparoscope:
The AIM HD Autoclavable Laparoscope is intended to be used for gynecological and general procedures that clinicians deem appropriate for adults and pediatric patients aged one month or older, when the dimensions of the AIM HD Autoclavable Laparoscope are appropriate for the patient size and anatomy.
Product codes
GCJ, OWN, FCS, FCW
Device Description
The AIM (Advanced Imaging Modality) System is an endoscopic real-time 4K visible white light and near-infrared light illumination and imaging system. The AIM (Advanced Imaging Modality) System includes the following components: (1) A Camera System for processing near-infrared and visible light images; (2) A Light Source and SafeLight Cable for emitting light within the visible light as well as near-infrared light spectrum; (3) A Laparoscope for visible light and near-infrared light illumination and imaging; (4) SPY AGENT GREEN (indocyanine green for injection, USP) an optical imaging agent used for fluorescence imaging.
Mentions image processing
Yes
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Endoscopic visible light, Near-infrared fluorescence imaging, Near-infrared transillumination
Anatomical Site
General laparoscopy, ear, sinus, various sites for plastic surgery, vessels, blood flow and related tissue perfusion, extra-hepatic bile ducts (cystic duct, common bile duct and common hepatic duct), lymphatic system (lymphatic vessels and lymph nodes), ureter, gynecological and general surgical sites.
Indicated Patient Age Range
Adults and pediatric patients aged one month or older for all uses. For visualization of major extra-hepatic bile ducts, the age range is adults and pediatric patients 12 to 17 years of age.
Intended User / Care Setting
General and pediatric surgeons, gynecologists, cardiac surgeons, thoracic surgeons, plastic surgeons, orthopedic surgeons, ENT surgeons and urologists.
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)
- Non-Clinical Testing: Cytotoxicity, Sensitization, Irritation or Intracutaneous Reactivity, Acute Systemic Toxicity, Material Mediated Pyrogenicity, Cleaning, disinfection, and sterilization validations.
- Clinical Performance Data: Published clinical literature was provided to support the safety and effectiveness of the AIM System when used in the pediatric patient population.
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). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo in blue. Underneath the FDA logo is the word "ADMINISTRATION".
Stryker Jessie Duong Manager, Regulatory Affairs 5900 Optical Court San Jose. California 95138
April 13, 2021
Re: K210088
Trade/Device Name: AIM (Advanced Imaging Modality) System Regulation Number: 21 CFR 876.1500 Regulation Name: Endoscope and Accessories Regulatory Class: Class II Product Code: GCJ, OWN, FCS, FCW Dated: March 17, 2021 Received: March 18, 2021
Dear Jessie Duong:
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 Mav 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 requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part
1
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(@;tda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely.
Image /page/1/Picture/6 description: The image shows the name "Neil R.P." in a large, bold, sans-serif font. The text is black and stands out against a background that appears to be a light blue or white. The letters are clearly legible and well-spaced.
Ogden
Digitally signed by Neil R.P. Ogden Date: 2021.04.13 11:30:32 -04'00'
Neil R.P. Ogden Assistant Director, THT4A4 DHT4A: Division of General Surgery Devices OHT4: Office of Surgical and Infection Control Devices Office of Product Evaluation and Ouality Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known) K210088
Device Name AIM (Advanced Imaging Modality) System
Indications for Use (Describe)
1688 4K Camera System with Advanced Imaging Modality (AIM):
The 1688 Video Camera is indicated for use in general laparoscopy, ear endoscopy, sinuscopy, sinuscopy and plastic surgery whenever a laparoscope/ arthroscope is indicated for use. The 1688 Video Camera is indicated for use in adults and pediatric patients aged one month or older.
A few examples of the more common endoscope surgeries are Laparoscopic cholecystectomy, Laparoscopic hernia repair, Laparoscopic appendectomy, Laparoscopic pelvic lymph node detection, Laparoscopically assisted hysterectomy, Laparoscopic and thorascopic anterior spinal fusion, Anterior cruciate ligament reconstruction, Knee arthroscopy, Small joint arthroscopy, Decompression fixation, Wedge resection, Lung biopsy, Dorsal sympathectomy, Pleurodesis, Internal mammary artery dissection for coronary artery bypass grafting where endoscopic visualization is indicated and Examination of the evacuated cardiac chamber during performance of valve replacement.
The users of the 1688 Video Camera are general and pediatric surgeons, gynecologists, cardiac surgeons, thoracic surgeons, plastic surgeons, orthopedic surgeons, ENT surgeons and urologists.
L11 LED Light Source with Advanced Imaging Modality (AIM) and SafeLight Cable:
Upon intravenous administration of SPY AGENTTM GREEN (indocyanine green for injection, USP), the L11 LED Light Source with AIM and SafeLightTM Cable is used with SPY AGENT GREEN to provide real-time endoscopic visible and near infrared fluorescence imaging. The L11 LED Light Source with AIM and SafeLight Cable enable surgeons to perform minimally invasive surgery using endoscope visual assessment of vessels, blood flow and related tissue perfusion in adults and pediatric patients aged one month or 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 near-infrared imaging.
Fluorescence imaging of biliary ducts with the L11 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. Upon interstitial administration of SPY AGENT GREEN, the L11 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.
The L11 LED Light Source is also intended to transilluminate the ureter during open or laparoscopic surgical procedures.
Advanced Imaging Modality (AIM) HD Autoclavable Laparoscope:
The AIM HD Autoclavable Laparoscope is intended to be used for gynecological and general procedures that clinicians deem appropriate for adults and pediatric patients aged one month or older, when the dimensions of the AIM HD Autoclavable Laparoscope are appropriate for the patient size and anatomy.
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
This 510(k) summary is prepared in accordance with the requirements of 21 C.F.R Part 807.92.
Submitter:
| Applicant: | Stryker Endoscopy
5900 Optical Court
San Jose, CA 95138 |
|-----------------|---------------------------------------------------------------------------------------------------------|
| Contact Person: | Jessie Duong
Manager, Regulatory Affairs
Phone: (408) 754-2077
Email: jessie.duong@stryker.com |
| Date Prepared: | April 8, 2021 |
Subject Device:
The subject device is the AIM (Advanced Imaging Modality) System specifically the following system components:
| Name of Device: | 1688 4K Camera System with Advanced Imaging Modality (AIM) |
|---|---|
| Common or | |
| Usual Name | 3-chip Video Camera |
| Classification | |
| Name: | Laparoscope, General and Plastic Surgery (21 C.F.R. §876.1500) |
| Regulatory Class: | II |
| Product Code: | GCJ |
| 510(k) Review | |
| Panel: | General & Plastic Surgery |
| Name of Device: | L11 LED Light Source with Advanced Imaging Modality (AIM) and SafeLight Cable |
|---|---|
| Common or Usual Name | Light Source, Illuminator |
| Classification Name: | Confocal Optical Imaging1 (21 C.F.R. §876.1500) |
| Fiberoptic light ureteral catheter2 (21 C.F.R. §876.4020) | |
| Light Source, Fiberoptic, Routine3 (21 C.F.R. §876.4020) | |
| Regulatory Class: | II |
| Product Code: | OWN1 |
| FCS2 | |
| FCW3 | |
| 510(k) Review Panel: | General & Plastic Surgery1 |
| Gastroenterology/ Urology2,3 |
1When 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.
5
| Name of Device | Advanced Imaging Modality (AIM) HD Autoclavable Laparoscope |
|---|---|
| Common or | |
| Usual Name | Laparoscope |
| Classification | |
| Name | Laparoscope, General and Plastic Surgery (21 C.F.R. §876.1500) |
| Regulatory Class | Class II |
| Product Code | GCJ |
| 510(k) Review | |
| Panel: | General & Plastic Surgery |
Predicate Device(s):
Primary Predicate - Advanced Imaging Modality System (1688 4K Camera System with Advanced Imaging Modality, L11 LED Light Source with Advanced Imaging Modality), cleared via K202592.
Reference Predicate - Stryker® IRF Light Source and Safelight Cable, cleared via K142310
NOTE: The predicate device has not been subject to a design-related recall.
Device Description:
The AIM (Advanced Imaging Modality) System is an endoscopic real-time 4K visible white light and near-infrared light illumination and imaging system. The AIM (Advanced Imaging Modality) System includes the following components: (1) A Camera System for processing near-infrared and visible light images; (2) A Light Source and SafeLight Cable for emitting light within the visible light as well as near-infrared light spectrum; (3) A Laparoscope for visible light and near-infrared light illumination and imaging; (4) SPY AGENT GREEN (indocyanine green for injection, USP) an optical imaging agent used for fluorescence imaging.
Indications for Use:
| Subject Device | Predicate Device |
|---|---|
| AIM System (1688, L11) | AIM System (1688, L11) |
| This Submission | K202592 |
| Intended Use: | Intended Use: |
| Endoscopic white light and near-infrared illumination and | |
| imaging during endoscopic procedures. | Same as subject device |
| Indications for Use: | Indications for Use: |
| L11 LED Light Source with Advanced Imaging Modality | |
| (AIM) and SafeLight Cable | L11 LED Light Source with AIM and SafeLight Cable |
| Upon intravenous administration of SPY AGENTTM GREEN | |
| (indocyanine green for injection, USP), the L11 LED Light | |
| Source with AIM and SafeLightTM Cable is used with SPY | |
| AGENT GREEN to provide real-time endoscopic visible and | |
| near infrared fluorescence imaging. The L11 LED Light | Upon intravenous administration of SPY AGENTTM GREEN |
| (Indocyanine green for injection, USP), the L11 LED Light | |
| Source and SafeLightTM Cable is used with SPY AGENT | |
| GREEN to provide real-time endoscopic visible and near | |
| infrared fluorescence imaging. The L11 LED Light Source and | |
| SafeLight Cable enable surgeons to perform minimally | |
| Subject Device | Predicate Device |
| AIM System (1688, L11) | AIM System (1688, L11) |
| This Submission | K202592 |
| Source with AIM and SafeLight Cable enable surgeons to | |
| perform minimally invasive surgery using endoscope visual | |
| light as well as visual assessment of vessels, blood flow and | |
| related tissue perfusion in adults and pediatric patients aged | |
| one month or 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 near-infrared imaging. | invasive surgery using standard endoscope visual light as well |
| as visual 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. | |
| Fluorescence imaging of biliary ducts with the L11 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. | Fluorescence imaging of biliary ducts with the L11 LED Light |
| Source 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. | |
| Upon interstitial administration of SPY AGENT GREEN, the | |
| L11 LED Light Source with AIM and SafeLight Cable is used | |
| to perform intraoperative fluorescence imaging and | |
| visualization of the lymphatic system, including lymphatic | Upon interstitial administration of SPY AGENT GREEN, the |
| L11 LED Light Source and SafeLightTM Cable is used to | |
| perform intraoperative fluorescence imaging and visualization | |
| of the lymphatic system, including lymphatic vessels and | |
| lymph nodes. | |
| vessels and lymph nodes. | |
| The L11 LED Light Source is also intended to transilluminate | |
| the ureter during open or laparoscopic surgical procedures. | The L11 LED Light Source is also intended to transilluminate |
| the ureter during open or laparoscopic surgical procedures. | |
| 1688 4K Camera System with Advanced Imaging Modality | |
| (AIM) | |
| The 1688 Video Camera is indicated for use in general | |
| laparoscopy, nasopharyngoscopy, ear endoscopy, sinuscopy | |
| and plastic surgery whenever a laparoscope/ endoscope/ | |
| arthroscope is indicated for use. The 1688 Video Camera is | 1688 4K Camera System with Advanced Imaging Modality |
| The 1688 Video Camera is indicated for use in general | |
| laparoscopy, nasopharyngoscopy, ear endoscopy, sinuscopy | |
| and plastic surgery whenever a laparoscope/ endoscope/ | |
| arthroscope is indicated for use. | |
| indicated for use in adults and pediatric patients aged one | |
| month or older. | A few examples of the more common endoscope surgeries are |
| Laparoscopic cholecystectomy, Laparoscopic hernia repair, | |
| Laparoscopic appendectomy, Laparoscopic pelvic lymph node | |
| A few examples of the more common endoscope surgeries are | |
| Laparoscopic cholecystectomy, Laparoscopic hernia repair, | |
| Laparoscopic appendectomy, Laparoscopic pelvic lymph node | |
| detection, Laparoscopically assisted hysterectomy, | |
| Laparoscopic and thorascopic anterior spinal fusion, Anterior | |
| cruciate ligament reconstruction, Knee arthroscopy, Small joint | |
| arthroscopy, Decompression fixation, Wedge resection, Lung | |
| biopsy, Pleural biopsy, Dorsal sympathectomy, Pleurodesis, | |
| Internal mammary artery dissection for coronary artery bypass, | |
| Coronary artery bypass grafting where endoscopic | |
| visualization is indicated and Examination of the evacuated | |
| cardiac chamber during performance of valve replacement. | detection, Laparoscopically assisted hysterectomy, |
| Laparoscopic and thorascopic anterior spinal fusion, Anterior | |
| cruciate ligament reconstruction, Knee arthroscopy, Small joint | |
| arthroscopy, Decompression fixation, Wedge resection, Lung | |
| biopsy, Pleural biopsy, Dorsal sympathectomy, Pleurodesis, | |
| Internal mammary artery dissection for coronary artery bypass, | |
| Coronary artery bypass grafting where endoscopic | |
| visualization is indicated and Examination of the evacuated | |
| cardiac chamber during performance of valve replacement. | |
| The users of the 1688 Video Camera are general surgeons, | |
| gynecologists, cardiac surgeons, thoracic surgeons, plastic | |
| surgeons, orthopedic surgeons, ENT surgeons and urologists. | |
| The users of the 1688 Video Camera are general and pediatric | |
| surgeons, gynecologists, cardiac surgeons, thoracic surgeons, | |
| plastic surgeons, orthopedic surgeons, ENT surgeons and | |
| urologists. |
6
stryker
7
stryker
| Subject Device | Predicate Device | ||
|---|---|---|---|
| AIM System (AIM HD Autoclavable Laparoscope) | Infrared Fluorescence System (IRF Laparoscope) | ||
| This Submission | K142310 | ||
| Intended Use: | Intended Use: | ||
| Endoscopic white light and near-infrared illumination and | |||
| imaging during endoscopic procedures. | Same as subject device | ||
| Indications for Use: | Indications for Use: | ||
| The AIM HD Autoclavable Laparoscope is intended to be used | |||
| for gynecological and general procedures that clinicians deem | |||
| appropriate for adults and pediatric patients aged one month or | |||
| older, when the dimensions of the AIM HD Autoclavable | |||
| Laparoscope are appropriate for the patient size and anatomy. | The Stryker® IRF Laparoscope is intended to be used for | ||
| gynecological and general procedures that clinicians deem | |||
| appropriate for the patient. |
Comparison of Technological Characteristics with the Predicate Device:
| Subject Device | Predicate Device | |
|---|---|---|
| Item | AIM System (1688, L11) | |
| This Submission | AIM System (1688, L11) | |
| K202592 | ||
| Manufacturer | Stryker | Same as subject device |
| Imaging Modes | White Light | |
| Near-infrared - fluorescence | ||
| Near-infrared - transillumination | Same as subject device | |
| Device System | ||
| Components | Camera System | |
| Light Source and Light Cable | ||
| Laparoscopes | ||
| IRIS Ureteral Kit | Same as subject device | |
| Imaging Agent | SPY AGENT GREEN | Same as subject device |
| Principles of Operations | Via an optical endoscope and coupler, light is projected from a | |
| light source 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 | |
| Safety Standards | IEC 60601-1 | |
| IEC 60601-2-18 | ||
| IEC 60601-1-2 | ||
| IEC 60825-1 | Same as subject device | |
| Camera System | Image Processing/ Video Output | |
| Resolution | Same as subject device | |
| Digital | ||
| 4K (up to 3840 x 2160) | Same as subject device | |
| Light Source | Light Source/ Laser | Same as subject device |
| RGB LEDs | ||
| Infrared Laser | Same as subject device | |
| Infrared Wavelengths | Same as subject device | |
| 806nm (used for NIR | ||
| fluorescence) | ||
| 830nm (used for NIR | ||
| transillumination) | Same as subject device | |
| Laser Safety Classification | Same as subject device | |
| Class 1M | Same as subject device |
8
| Subject Device | Predicate Device | |
|---|---|---|
| Item | AIM System | |
| (AIM HD Autoclavable Laparoscope) | ||
| This Submission | Infrared Fluorescence System (IRF Laparoscope) | |
| K142310 | ||
| Manufacturer | Stryker | Same as subject device |
| Endoscope Type | Rigid rod lens | Same as subject device |
| Outer Diameter | 5.4mm, 10mm | 10mm |
| Working Length | 300 mm for 5.4mm diameter laparoscope | |
| 330 mm for 10mm diameter laparoscope | 330 mm for 10mm diameter laparoscope | |
| Direction of View | 0°, 30° | Same as subject device |
| Transmission Spectrum | Visible and Near-Infrared | Same as subject device |
| Biocompatibility | ISO 10993-1 | |
| ISO 10993-5 | ||
| ISO 10993-10 | ||
| ISO 10993-11 | Same as subject device | |
| How Provided | Non-Sterile | Same as subject device |
| Processing | Cleaning, Disinfection (optional), Sterilization | Same as subject device |
Non-Clinical Testing
The following non-clinical testing were performed and data/test reports were provided to support substantial equivalence.
- Cytotoxicity (ISO 10993-5, MEM Elution Method)
- Sensitization (ISO 10993-10, Guinea Pig Maximization Test)
- Irritation or Intracutaneous Reactivity (ISO 10993-10, Intracutaneous Injection in Rabbits)
- Acute Systemic Toxicity (ISO 10993-11, Injection in Mice)
- Material Mediated Pyrogenicity (ISO 10993-11, Injection in Rabbits)
- Cleaning, disinfection, and sterilization validations
Clinical Performance Data
Published clinical literature was provided to support the safety and effectiveness of the AIM System when used in the pediatric patient population.
Conclusions:
The modified AIM System is substantially equivalent in design, intended use, principles of operation, technological characteristics and safety features to the predicate device. There are no different questions of safety and/or effectiveness introduced by the modified AIM System when used in the pediatric patient population as instructed during endoscopic imaging using visible white light or near-infrared imaging utilizing SPY AGENT GREEN.