(106 days)
No
The document describes an advanced imaging system with visible and near-infrared light capabilities and image processing, but it does not mention the use of AI or ML algorithms for image analysis, interpretation, or any other function. The "Advanced Imaging Modality (AIM)" refers to the imaging technology itself, not necessarily AI/ML.
No.
The device is an imaging system (camera, light source, endoscope) used to visualize anatomical structures during surgery. It does not directly treat or prevent a disease or condition.
No
The device is an imaging system designed to provide real-time visible and near-infrared fluorescence imaging during surgery. It is used for visualization during surgical procedures, not for reaching a medical diagnosis.
No
The device description explicitly lists multiple hardware components: a Camera System, a Light Source and SafeLight Cable, an Endoscope, and the IRIS Ureteral Kit. While there is a software component for image processing, the device is not solely software.
Based on the provided information, this device is not an In Vitro Diagnostic (IVD).
Here's why:
- IVDs are used to examine specimens from the human body. The intended use and device description clearly state that this system is used for in vivo visualization and imaging during surgical procedures on patients. It directly interacts with the patient's body (laparoscopy, endoscopy, etc.) rather than analyzing samples taken from the body.
- The device's function is visualization and illumination. While it processes images, the primary purpose is to provide real-time visual information to the surgeon during surgery. This is distinct from the analytical or diagnostic function of an IVD, which typically measures or detects substances in a sample to provide diagnostic information.
- The use of SPY AGENT GREEN is for in vivo fluorescence imaging. The contrast agent is administered to the patient, not added to a sample in vitro.
Therefore, the AIM System, including the 1688 4K Camera System, L11 LED Light Source, SafeLight Cable, and Precision S 4K Sinuscope, is a surgical imaging system used in vivo, not an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
Indications for Use
510(k) Number (if known) K211202
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, ear endoscopy, sinuscopy, neurosurgery and plastic surgery whenever a laparoscope/ arthroscope/ sinuscope/ sinuscope is indicated for use. The 1688 Video Camera is indicated for adults and pediatric patients.
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, neurosurgeons 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 are 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 standard endoscopic 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, common bile duct and common hepatic duct) in adults and pediativ 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.
Additionally, the L11 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 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.
Precision S 4K Sinuscope:
The Precision S 4K Sinuscope is intended for use in otolaryngology and head and heck procedures, including thinology, endoscopic plastic and reconstructive surgery. The Precision S 4K Sinuscope is also intended for use in minimally invasive cranial neurosurgery in adults and pediatric patients and endonasal skull base surgery in adults and pediatric patients > 6 years ofage.
Product codes (comma separated list FDA assigned to the subject device)
GCJ, GWG, OWN, FSC, FCW, GWG, EOB, GWG
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 nearinfrared 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) An Endoscope for visible light and near-infrared light illumination and imaging; (4) The IRIS Ureteral Kit for transillumination of the ureters; and, (5) SPY AGENT 104 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
Visible light, Near-infrared light
Anatomical Site
General laparoscopy, ear endoscopy, sinuscopy, neurosurgery, plastic surgery, extra-hepatic bile ducts (cystic duct, common bile duct and common hepatic duct), lymphatic system (lymphatic vessels and lymph nodes), ureter, head and neck, skull base.
Indicated Patient Age Range
Adults and pediatric patients, pediatric patients aged one month and older, pediatric patients 12 to 17 years of age, pediatric patients > 6 years of age.
Intended User / Care Setting
General and pediatric surgeons, gynecologists, cardiac surgeons, thoracic surgeons, plastic surgeons, orthopedic surgeons, neurosurgeons 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)
Performance – Bench: In accordance with device input specifications - Pass
Performance - Animal: In accordance with device user needs, intended uses Comparative testing to currently legally marketed device in compliance with 21 CFR Part 58. Good Laboratory Practice - Pass
Clinical Data: Published literature was provided to support a reasonable assurance of safety and effectiveness for the AIM System for use in the neurosurgery indications.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 882.1480 Neurological endoscope.
(a)
Identification. A neurological endoscope is an instrument with a light source used to view the inside of the ventricles of the brain.(b)
Classification. Class II (performance standards).
0
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August 6, 2021
Stryker April Malmborg Senior Director, Regulatory Affairs 5900 Optical Court San Jose. California 95138
Re: K211202
Trade/Device Name: 1688 4K Camera System, L11 LED Light Source with AIM, AIM SafeLight Cable, Precision S 4K Sinuscopes Regulation Number: 21 CFR 876.1500 Regulation Name: Endoscope and Accessories Regulatory Class: Class II Product Code: GCJ, GWG, OWN, FCS, FCW, EOB Dated: July 8, 2021 Received: July 9, 2021
Dear April Malmborg:
We have reviewed vour 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
1
Page
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 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 (QS) 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 medical devices and radiation-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,
for
Adam Pierce Assistant Director DHT5A: Division of Neurosurgical, Neurointerventional and Neurodiagnostic Devices OHT5: Office of Neurological and Physical Medicine Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known) K211202
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, ear endoscopy, sinuscopy, neurosurgery and plastic surgery whenever a laparoscope/ arthroscope/ sinuscope/ sinuscope is indicated for use. The 1688 Video Camera is indicated for adults and pediatric patients.
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, neurosurgeons 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 are 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 standard endoscopic 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 pediativ 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.
Additionally, the L11 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 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.
Precision S 4K Sinuscope:
The Precision S 4K Sinuscope is intended for use in otolaryngology and head and neck procedures, including thinology, endoscopic plastic and reconstructive surgery. The Precision S 4K Sinuscope is also intended for use in minimally invasive cranial neurosurgery in adults and pediatric patients and endonasal skull base surgery in adults and pediatric patients > 6 years ofage.
Type of Use (Select one or both, as applicable)
X Prescription Use (Part 21 CFR 801 Subpart D)
Over-The-Counter Use (21 CFR 801 Subpart C)
3
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4
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).
Submitter:
| Applicant: | Stryker Endoscopy
5900 Optical Court
San Jose, CA 95138 |
|-----------------|--------------------------------------------------------------------------------|
| Contact Person: | Jessie Duong
Manager, Regulatory Affairs
Email: jessie.duong@stryker.com |
| Date Prepared: | July 7, 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 |
|---|---|
| Common or | |
| Usual Name | 3-chip Video Camera |
| Classification | |
| Name: | Laparoscope, General and Plastic Surgery (21 C.F.R. §876.1500) |
| Endoscope, Neurological (21 C.F.R. §882.1480) | |
| Regulatory Class: | II |
| Product Code: | GCJ |
| GWG | |
| 510(k) Review | |
| Panel: | General & Plastic Surgery |
| Neurology |
| Name of Device: | L11 LED Light Source with Advanced Imaging Modality |
|---|---|
| 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) | |
| Endoscope, Neurological (21 C.F.R. §882.1480) | |
| Regulatory Class: | II |
| Product Code: | OWN1 |
| FSC2 | |
| FCW3 | |
| GWG4 | |
| 510(k) Review | |
| Panel: | General & Plastic Surgery1 |
| Gastroenterology/ Urology2,3 | |
| Neurology4 |
5
Image /page/5/Picture/1 description: The image shows the word "stryker" in a bold, sans-serif font. The letters are black and the background is white. The word is likely a logo or brand name.
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.
4 When used to provide standard endoscopic visible light and near-infrared imaging during minimally invasive cranial
neurosurgery and endonasal skull base surgery.
| Name of Device | Precision S 4K Sinuscope |
|---|---|
| Common or Usual Name | Sinuscope |
| Classification Name | Nasopharyngoscope (21 C.F.R. §874.4760) |
| Endoscope, Neurological (21 C.F.R. §882.1480) | |
| Regulatory Class | Class II |
| Product Code | EOB |
| GWG | |
| 510(k) Review Panel: | Ear Nose & Throat |
| Neurology |
Predicate Device(s):
| Karl Storz ICG Imaging System | K180146 (primary) |
|---|---|
| AIM System: 1688 4K Camera | |
| System, L11 LED Light Source and | |
| SafeLight Cable | K210088 (secondary) |
NOTE: The predicate device has not been subject to a design-related recall.
Reference Device(s):
| Precision S 4K Sinuscope | K191102 |
|---|---|
| -------------------------- | --------- |
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 nearinfrared 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) An Endoscope for visible light and near-infrared light illumination and imaging; (4) The IRIS Ureteral Kit for transillumination of the ureters; and, (5) SPY AGENT 104 GREEN (indocyanine green for injection, USP) an optical imaging agent used for fluorescence imaging.
6
Indications for Use:
| Subject Device | Predicate Devices | |
|---|---|---|
| AIM System | ||
| This Submission | Karl Storz ICG Imaging System | |
| (K180146, primary) | AIM System | |
| (K210088, secondary) | ||
| Intended Use: | ||
| Endoscopic white light and near-infrared | ||
| illumination and imaging during endoscopic | ||
| procedures. | Intended Use: | |
| Same as subject device | Intended Use: | |
| Same as subject device. | ||
| Indications for Use: | ||
| L11 LED Light Source with AIM and | ||
| SafeLight Cable | Indications for Use: | |
| Karl Storz ICG Imaging System | Indications for Use: | |
| 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 are 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 standard endoscopic | ||
| visual 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 near-infrared imaging. | The KARL STORZ ICG Imaging | |
| System is intended to provide real- | ||
| time visible (VIS) and near-infrared | ||
| (NIR) fluorescence imaging. |
The KARL STORZ Endoscopic ICG
System enables surgeons to perform
minimally invasive surgery using
standard endoscopic visible light as
well as visual assessment of vessels,
blood flow and related tissue
perfusion, or 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 KARL STORZ
Endoscopic ICG System is intended
for use with standard of care white
light and, when indicated,
intraoperative cholangiography. The
device is not intended for standalone
use for biliary duct visualization. | 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 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. |
| 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. | Additionally, the KARL STORZ
Endoscopic ICG System enables
surgeon to perform minimally
invasive cranial neurosurgery in
adults and pediatrics and endonasal
skull base surgery in adults and
pediatrics > 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. | 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. |
| Additionally, the L11 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. | The KARL STORZ VITOM II ICG
System is intended for capturing and
viewing fluorescent images for the
visual assessment of blood flow, as
an adjunctive method for the
evaluation of tissue perfusion, and
related tissue-transfer circulation in
tissue and free flaps used in plastic,
micro- and reconstructive surgical
procedures. The VITOM II ICG | 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 |
| 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. | | |
| Subject Device | | Predicate Devices |
| AIM System
This Submission | Karl Storz ICG Imaging System
(K180146, primary) | AIM System
(K210088, secondary) |
| The L11 LED Light Source is also intended
to transilluminate the ureter during open or
laparoscopic surgical procedures. | magnified view of the surgical field
in standard white light. | |
| 1688 4K Camera System
The 1688 Video Camera is indicated for use
in general laparoscopy, nasopharyngoscopy,
ear endoscopy, sinuscopy, neurosurgery and
plastic surgery whenever a laparoscope/
endoscope/ arthroscope/ sinuscope is
indicated for use. The 1688 Video Camera
is indicated for adults and pediatric patients.
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.
The users of the 1688 Video Camera are
general and pediatric surgeons,
gynecologists, cardiac surgeons, thoracic
surgeons, plastic surgeons, orthopedic
surgeons, ENT surgeons, neurosurgeons
and urologists. | | 1688 4K Camera System
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 indicated for
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, 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 and pediatric surgeons,
gynecologists, cardiac surgeons,
thoracic surgeons, plastic surgeons,
orthopedic surgeons, ENT/surgeons
and urologists.
N/A |
| Precision S 4K Sinuscope
The Precision S 4K Sinuscope is intended
for use in otolaryngology and head and
neck procedures, including rhinology,
endoscopic plastic and reconstructive
surgery.
The Precision S 4K Sinuscope is also
intended for use in minimally invasive
cranial neurosurgery in adults and pediatric
patients and endonasal skull base surgery in
adults and pediatric patients > 6 years of
age. | | |
7
8
Comparison of Technological Characteristics with the Predicate Device:
| Item | Subject Device | Predicate Device | ||
|---|---|---|---|---|
| AIM System | ||||
| (This Submission) | Karl Storz ICG Imaging | |||
| System (K180146, primary) | AIM System | |||
| (K210088 secondary) | ||||
| Manufacturer | Stryker | Karl Storz | Stryker | |
| Imaging Modes | White Light | |||
| Near-infrared - fluorescence | ||||
| Near-infrared - transillumination | White Light | |||
| Near-infrared - fluorescence | Same as subject | |||
| device. | ||||
| System Components | Camera System | |||
| Light Source and Light Cable | ||||
| Endoscopes | ||||
| IRIS Ureteral Kit | ||||
| SPY AGENT GREEN | Camera System | |||
| Light Source and Light | ||||
| Cable | ||||
| Endoscopes | ||||
| 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 | IEC 60601-1 | |||
| IEC 60601-2-18 | ||||
| IEC 60601-1-2 | ||||
| Camera | ||||
| System | Image | |||
| Processing/ | ||||
| Video Output | Digital | Same as subject device | ||
| Light Source/ | ||||
| Laser | RGB LEDs | |||
| Infrared Laser | Xenon Lamp | |||
| Light | ||||
| Source | Infrared | |||
| Wavelengths | 806nm (used for NIR fluorescence) | |||
| 830nm (used for NIR transillumination) | 690-790nm | |||
| Laser Safety | ||||
| Classification | Class 1M | Not applicable | ||
| Endoscope | Endoscope Type | Rigid rod lens | Same as subject device | Reference device |
| Endoscope | ||||
| Performance | ||||
| Standards | ISO 8600-1 | Same as subject device | (K191102) is the | |
| same as subject | ||||
| device | ||||
| Transmission | ||||
| Spectrum | Visible and near-infrared | Same as subject device | ||
| Outer Diameter | 3.1mm, 4.0mm | 4mm | ||
| 5mm, 10mm | ||||
| Working Length | ||||
| (Outer | ||||
| Diameter) | 125mm - 180mm | |||
| (3.1mm, 4.0mm) | 180mm (4mm OD) | |||
| 290mm (5mm OD) | ||||
| 310mm (10mm OD) | ||||
| Field of View | 80° - 105° | 80° | ||
| Depth of Field | 7mm - 35mm | 8mm - 38mm | ||
| Biocompatibility | ISO 10993-1 | |||
| ISO 10993-5 | ||||
| ISO 10993-10 | ||||
| ISO 10993-11 | Same as subject device | |||
| Cleaning | Manual and Automated | Same as subject device | ||
| Sterilization | Moist Heat | |||
| Hydrogen Peroxide | Moist Heat |
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Performance Data:
Testing was completed in accordance with the following:
| Test | Method | Result |
|---|---|---|
| Electrical Safety | ANSI/AAMI ES60601-1:2005 + A1:2012; | Pass |
| IEC 60601-2-18:2009 | ||
| IEC 60601-1-6:2013 | ||
| EMC Testing | IEC 60601-1-2:2014 | Pass |
| Laser Safety | IEC 60825-1:2014 | Pass |
| Biocompatibility | ISO 10993-1:2009 | Pass |
| ISO 10993-5:2009 | ||
| ISO 10993-10:2010 | ||
| ISO 10093-11:2017 | ||
| Cleaning | AAMI TIR30:2011 | Pass |
| ISO 15883-5:2005 | ||
| Sterilization | ISO 14937:2009 | Pass |
| AAMI TIR12:2010 | ||
| AAMI TIR30:2011 | ||
| Software Validation & | ||
| Verification | IEC 62304:2006 | Pass |
| Usability | IEC 62366-1:2015 | Pass |
| Performance – Bench | In accordance with device input specifications | Pass |
| Performance - Animal | In accordance with device user needs, intended uses | |
| Comparative testing to currently legally marketed device in | ||
| compliance with 21 CFR Part 58. Good Laboratory Practice | Pass |
Clinical Data:
Published literature was provided to support a reasonable assurance of safety and effectiveness for the AIM System for use in the neurosurgery indications.
Conclusions:
The AIM System is substantially equivalent in design, intended use, principles of operation, technological characteristics and safety features to the predicate devices. There are no new issues of safety and/or effectiveness introduced by the AIM System for 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.