(125 days)
No
The summary describes image processing for visualization but does not mention any AI/ML techniques or algorithms.
No
The device is an imaging system designed to provide enhanced visualization for surgeons during minimally invasive procedures. It does not directly provide therapy or treatment to the patient. Its function is to aid diagnosis and procedural guidance, which is a diagnostic/imaging function, not therapeutic.
Yes
The device enables surgeons to visually assess vessels, blood flow, related tissue perfusion, and major bile ducts (cystic duct, common bile duct, or common hepatic duct) using fluorescence and near-infrared imaging during minimally invasive surgery, which aids in determining the physiological status of these structures. This assessment provides information that can be used for diagnosis or to guide surgical decisions.
No
The device description explicitly lists multiple hardware components, including an Imaging Module, Light Engine, Light Cable, and Sterilization Tray. It also mentions disposable hardware components like a Sterile Drape and Calibration Target. While it includes software for video processing, it is not solely software.
Based on the provided information, the ActivSight Intraoperative Imaging System is not an In Vitro Diagnostic (IVD) device.
Here's why:
- IVD Definition: In Vitro Diagnostic devices are used to examine specimens (like blood, urine, or tissue) taken from the human body to provide information about a person's health. This testing is done outside the body (in vitro).
- ActivSight's Function: The ActivSight system is used during surgery (intraoperative) to provide real-time imaging inside the body. It visualizes vessels, blood flow, tissue perfusion, and bile ducts directly within the surgical field.
- No Specimen Testing: The device does not analyze any specimens removed from the patient. It works by using fluorescence and near-infrared imaging to visualize structures within the body in real-time.
Therefore, the ActivSight Intraoperative Imaging System falls under the category of a surgical imaging device used in vivo, not an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
ActivSight is intended to provide real-time endoscopic fluorescence and near infrared imaging. ActivSight enables surgeons to visually assess vessels, blood flow, and related tissue perfusion using fluorescence and nearing, and at least one of the major bile duct, common bile duct or common hepatic duct) using fluorescence, all during minimally invasive surgery.
Fluorescence imaging of biliary ducts with ActivSight is intended for use with standard of care white light, and when indicated, intraoperative cholangiography. The device is not intended for stand-alone use for biliary duct visualization.
Product codes
GCJ, OWN, DPT
Device Description
The ActivSight Intraoperative Imaging System (ActivSight) is an accessory to existing commercial surgical laparoscope systems, including cameras and video processor units. ActivSight provides real-time endoscopic fluorescence and near-infrared imaging. These imaging features allow surgeons to visually assess vessels, blood flow, and tissue perfusion (using fluorescence and near-infrared imaging), and to visually assess at least one of the major bile ducts (cystic duct, common bile duct, or common hepatic duct) using fluorescence. Fluorescence imaging is enabled through use of any commercially available Indocyanine Green (ICG). These visualization features are available for surgeons to use during minimally invasive surgery. ActivSight is intended to be used in a surgical environment.
ActivSight consists of the following reusable components:
- ActivSight Imaging Module, consisting of optics and sensing electronics. The imaging module attaches physically between the third-party laparoscope and the third-party imaging system camera. Reprocessing of this component requires cleaning and disinfection between uses.
- ActivSight Light Engine, equipment consisting of system electronics that provide laser fluorescence and near-infrared illumination, processing of video input from both the third-party Camera Control Unit (CCI) and the ActivSight lmaging Module, and outputs video to the surgical monitor. This component does not require reprocessing between uses.
- ActivSight Light Cable, component consisting of a Y-shaped bifurcated light a cable that connects to the third party white-light source, the ActivSight Light Engine, and the third party laparoscope light post (providing white-light illumination of the surgical site through the laparoscope). Reprocessing of this component requires cleaning and steam sterilization.
- ActivSight Sterilization Tray, stainless-steel sterilization tray designed to a properly secure the ActivSight Light Cable for disinfection and sterilization. Reprocessing of this component is accomplished in its use- cleaning and steam sterilization.
ActivSight consists of the following disposable components:
- ActivSight Sterile Drape, a sterilized plastic drape that is provided for each use = to provide a sterile barrier between the imaging module and the patient.
- ActivSight Calibration Target, a sterilized paper imaging target containing a checkerboard pattern for calibration of the ActivSight imaging module prior to each use of the device.
Mentions image processing
Yes
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Endoscopic fluorescence, near infrared imaging
Anatomical Site
vessels, blood flow, tissue, major bile ducts (cystic duct, common bile duct, or common hepatic duct)
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Surgeons, surgical environment
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
Safety and performance of the ActivSight Intraoperative Imaging System has been evaluated and verified in accordance with design specifications and applicable performance standards, including risk management, basic safety and essential performance, electromagnetic disturbances, human factors and usability, software lifecycle processes, safety of laser products. Activ Surgical has performed design validation in an animal study, comparatively visualizing blood flow and perfusion in specific structures with both ActivSight Perfusion (speckle laser) and ActivSight ICG (fluorescence) modes against the predicate's ICG mode. The following performance testing have also been conducted.
- Basic safety and essential performance testing completed in accordance with . IEC 60601-1:2005/R(2012) and A1:2012: Medical Electrical Equipment- Part 1: General Requirements for Basic Safety and Essential Performance (IEC 60601-1:2005. MOD). Testing indicates that the proposed device conforms to this standard.
- Electrical safety and electromagnetic compatibility testing completed in . accordance with IEC 60601-1-2 Edition 4.0 2014-02 Medical Electrical Equipment- Part 1-2: General requirements for basic safety and essential performance- Collateral Standard: Electromagnetic disturbances: Requirements and tests. Testing indicates that the proposed device conforms to this standard.
- Human factors and usability testing completed in accordance with IEC 62366-1: . 2015 Medical Devices - Application of Usability Engineering to Medical Devices-Evaluation and reporting. Testing indicates that the proposed device presents no unacceptable risk to the user during its intended use, and that the device conforms to this standard.
- Software development and software life cycle processes competed in accordance with ANSI AAMI IEC 62304:2006/A1:2016 Medical Device Software-Software Life Cycle Processes, Evaluation, Testing, and Reporting. Testing indicates that the proposed device conforms to this standard.
- Laser safety testing completed in accordance with /EC 60825-1 Ed. 3.0 b:2014 Safety of Laser Products- Part 1: Equipment Classification and Requirements. Testing indicates that the proposed device conforms to this standard.
- Safety of endoscopic equipment testing completed in accordance with IEC . 60601-2-18: Edition 3.0 2009-08 Medical Electrical Equipment- Part 2-18: Particular Requirements for the Basic Safety and Essential Performance of Endoscopic Equipment. Testing indicates that the proposed device conforms to this standard.
The results of these studies demonstrate that the proposed device is as safe and effective as the predicate.
Key Metrics
Not Found
Predicate Device(s)
Reference Device(s)
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 876.1500 Endoscope and accessories.
(a)
Identification. An endoscope and accessories is a device used to provide access, illumination, and allow observation or manipulation of body cavities, hollow organs, and canals. The device consists of various rigid or flexible instruments that are inserted into body spaces and may include an optical system for conveying an image to the user's eye and their accessories may assist in gaining access or increase the versatility and augment the capabilities of the devices. Examples of devices that are within this generic type of device include cleaning accessories for endoscopes, photographic accessories for endoscopes, nonpowered anoscopes, binolcular attachments for endoscopes, pocket battery boxes, flexible or rigid choledochoscopes, colonoscopes, diagnostic cystoscopes, cystourethroscopes, enteroscopes, esophagogastroduodenoscopes, rigid esophagoscopes, fiberoptic illuminators for endoscopes, incandescent endoscope lamps, biliary pancreatoscopes, proctoscopes, resectoscopes, nephroscopes, sigmoidoscopes, ureteroscopes, urethroscopes, endomagnetic retrievers, cytology brushes for endoscopes, and lubricating jelly for transurethral surgical instruments. This section does not apply to endoscopes that have specialized uses in other medical specialty areas and that are covered by classification regulations in other parts of the device classification regulations.(b)
Classification —(1)Class II (special controls). The device, when it is an endoscope disinfectant basin, which consists solely of a container that holds disinfectant and endoscopes and accessories; an endoscopic magnetic retriever intended for single use; sterile scissors for cystoscope intended for single use; a disposable, non-powered endoscopic grasping/cutting instrument intended for single use; a diagnostic incandescent light source; a fiberoptic photographic light source; a routine fiberoptic light source; an endoscopic sponge carrier; a xenon arc endoscope light source; an endoscope transformer; an LED light source; or a gastroenterology-urology endoscopic guidewire, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 876.9.(2) Class I for the photographic accessories for endoscope, miscellaneous bulb adapter for endoscope, binocular attachment for endoscope, eyepiece attachment for prescription lens, teaching attachment, inflation bulb, measuring device for panendoscope, photographic equipment for physiologic function monitor, special lens instrument for endoscope, smoke removal tube, rechargeable battery box, pocket battery box, bite block for endoscope, and cleaning brush for endoscope. The devices subject to this paragraph (b)(2) are exempt from the premarket notification procedures in subpart E of part 807of this chapter, subject to the limitations in § 876.9.
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Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). The FDA logo is composed of two parts: the Department of Health and Human Services logo on the left and the FDA acronym along with the full name of the agency on the right. The Department of Health and Human Services logo is a stylized depiction of a human figure embracing a sphere. The FDA acronym is in a blue square, and the full name of the agency, "U.S. Food & Drug Administration," is in blue text.
Activ Surgical, Inc. Matthew King Director of Regulatory Affairs and Quality Assurance 840 Summer Street Boston, Massachusetts 02127
April 8, 2021
Re: K203550
Trade/Device Name: ActivSight Intraoperative Imaging System Regulation Number: 21 CFR 876.1500 Regulation Name: Endoscope and accessories Regulatory Class: Class II Product Code: GCJ, OWN, DPT, Dated: March 8, 2021 Received: March 9, 2021
Dear Matthew King:
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 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
1
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 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.
Image /page/1/Picture/5 description: The image shows the name "Neil R.P. Ogden" in a large, bold font. To the right of the name, there is the text "Digitally s" followed by "Neil R.P. O" and "Date: 202" and "19:43:42 -". The text on the right appears to be part of a digital signature.
Digitally signed by Neil R.P. Ogden Date: 2021.04.08 19:43:42 -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)
K203550
Device Name ActivSight
Indications for Use (Describe)
ActivSight is intended to provide real-time endoscopic fluorescence and near infrared imaging. ActivSight enables surgeons to visually assess vessels, blood flow, and related tissue perfusion using fluorescence and nearing, and at least one of the major bile duct, common bile duct or common hepatic duct) using fluorescence, all during minimally invasive surgery.
Fluorescence imaging of biliary ducts with ActivSight is intended for use with standard of care white light, and when indicated, intraoperative cholangiography. The device is not intended for stand-alone use for biliary duct visualization.
| 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)
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Image /page/3/Picture/0 description: The image shows the logo for Activ Surgical. The word "ACTIV" is in large, blue, sans-serif font. Below that, the word "SURGICAL" is in a smaller, light gray, sans-serif font. The logo is simple and modern.
510(k) SUMMARY (21 CFR 807.92)
1. General Information
| Submitter Name: | Activ Surgical, Inc. |
|---|---|
| Submitter Address: | 840 Summer Street, Suite 108 |
| Boston, MA 02127 | |
| Contact Person: | Matthew King |
| Director of Regulatory Affairs and Quality | |
| Assurance | |
| Activ Surgical, Inc. | |
| Contact Information: | Email: mking@activsurgical.com |
| Phone: 603-459-9755 | |
| Fax: 617-977-0992 | |
| Submission Type | Traditional 510(k) |
| Date Prepared | December 4, 2020 |
2. Proposed Device
| Proprietary Name | ActivSight Intraoperative Imaging System |
|---|---|
| Device Common Name | Light Source, Imaging Module, Light Cable |
| Device Model Number | 450-00001 |
| Device Classification Name | Confocal Optical Imaging |
| Regulation Number | 21 CFR 876.1500 |
| Product Code | OWN |
| Device Classification | II |
| Review Panel | General and Plastic Surgery |
| Premarket Review | General and Surgery Devices (DHT4A) |
3. Predicate Device and Reference Device
| Predicate Device | Reference Device | |
|---|---|---|
| Proprietary Name | Stryker Infrared Fluorescence | |
| (IRF) Imaging System | Perimed PeriCam PSI | |
| 510(k) Number | K142310 | K120884 |
| Device Classification | ||
| Name | Confocal Optical Imaging | Extravascular blood flow probe |
| Regulation Number | 21 CFR 876.1500 | 21 CFR 870.2120 |
| Product Code | OWN | DPT |
| Device Classification | II | II |
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Image /page/4/Picture/0 description: The image shows the logo for Activ Surgical. The word "ACTIV" is in blue, with each letter in a bold, sans-serif font. Below "ACTIV" is the word "SURGICAL" in a smaller, light gray, sans-serif font. The logo is simple and modern.
4. Device Description:
The ActivSight Intraoperative Imaging System (ActivSight) is an accessory to existing commercial surgical laparoscope systems, including cameras and video processor units. ActivSight provides real-time endoscopic fluorescence and near-infrared imaging. These imaging features allow surgeons to visually assess vessels, blood flow, and tissue perfusion (using fluorescence and near-infrared imaging), and to visually assess at least one of the major bile ducts (cystic duct, common bile duct, or common hepatic duct) using fluorescence. Fluorescence imaging is enabled through use of any commercially available Indocyanine Green (ICG). These visualization features are available for surgeons to use during minimally invasive surgery. ActivSight is intended to be used in a surgical environment.
ActivSight consists of the following reusable components:
- 글 ActivSight Imaging Module, consisting of optics and sensing electronics. The imaging module attaches physically between the third-party laparoscope and the third-party imaging system camera. Reprocessing of this component requires cleaning and disinfection between uses.
- = ActivSight Light Engine, equipment consisting of system electronics that provide laser fluorescence and near-infrared illumination, processing of video input from both the third-party Camera Control Unit (CCI) and the ActivSight lmaging Module, and outputs video to the surgical monitor. This component does not require reprocessing between uses.
- ActivSight Light Cable, component consisting of a Y-shaped bifurcated light a cable that connects to the third party white-light source, the ActivSight Light Engine, and the third party laparoscope light post (providing white-light illumination of the surgical site through the laparoscope). Reprocessing of this component requires cleaning and steam sterilization.
- ActivSight Sterilization Tray, stainless-steel sterilization tray designed to a properly secure the ActivSight Light Cable for disinfection and sterilization. Reprocessing of this component is accomplished in its use- cleaning and steam sterilization.
ActivSight consists of the following disposable components:
- ActivSight Sterile Drape, a sterilized plastic drape that is provided for each use = to provide a sterile barrier between the imaging module and the patient.
- -ActivSight Calibration Target, a sterilized paper imaging target containing a checkerboard pattern for calibration of the ActivSight imaging module prior to each use of the device.
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Image /page/5/Picture/0 description: The image shows the logo for Activ Surgical. The word "ACTIV" is in large, blue, sans-serif font. Below that, in a smaller, light gray, sans-serif font, is the word "SURGICAL". The logo is simple and modern.
5. Indications for Use
The ActivSight Intraoperative Imaging System (ActivSight) is intended to provide realtime endoscopic fluorescence and near infrared imaging. ActivSight enables surgeons to visually assess vessels, blood flow, and related tissue perfusion using fluorescence and near infrared imaging, and at least one of the major bile ducts (cystic duct, common bile duct, or common hepatic duct) using fluorescence, all during minimally invasive surgery.
Fluorescence imaging of biliary ducts with ActivSight is intended for use with standard of care white light, and when indicated, intraoperative cholangiography. The device is not intended for stand-alone use for biliary duct visualization.
6. Performance Data
Safety and performance of the ActivSight Intraoperative Imaging System has been evaluated and verified in accordance with design specifications and applicable performance standards, including risk management, basic safety and essential performance, electromagnetic disturbances, human factors and usability, software lifecycle processes, safety of laser products. Activ Surgical has performed design validation in an animal study, comparatively visualizing blood flow and perfusion in specific structures with both ActivSight Perfusion (speckle laser) and ActivSight ICG (fluorescence) modes against the predicate's ICG mode. The following performance testing have also been conducted.
- Basic safety and essential performance testing completed in accordance with . IEC 60601-1:2005/R(2012) and A1:2012: Medical Electrical Equipment- Part 1: General Requirements for Basic Safety and Essential Performance (IEC 60601-1:2005. MOD). Testing indicates that the proposed device conforms to this standard.
- Electrical safety and electromagnetic compatibility testing completed in . accordance with IEC 60601-1-2 Edition 4.0 2014-02 Medical Electrical Equipment- Part 1-2: General requirements for basic safety and essential performance- Collateral Standard: Electromagnetic disturbances: Requirements and tests. Testing indicates that the proposed device conforms to this standard.
- Human factors and usability testing completed in accordance with IEC 62366-1: . 2015 Medical Devices - Application of Usability Engineering to Medical Devices-Evaluation and reporting. Testing indicates that the proposed device presents no unacceptable risk to the user during its intended use, and that the device conforms to this standard.
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Image /page/6/Picture/0 description: The image shows the logo for Activ Surgical. The word "ACTIV" is in a large, sans-serif font and is colored blue. Below "ACTIV" is the word "SURGICAL" in a smaller, sans-serif font and is colored gray. The logo is simple and modern.
- Software development and software life cycle processes competed in accordance with ANSI AAMI IEC 62304:2006/A1:2016 Medical Device Software-Software Life Cycle Processes, Evaluation, Testing, and Reporting. Testing indicates that the proposed device conforms to this standard.
- · Laser safety testing completed in accordance with /EC 60825-1 Ed. 3.0 b:2014 Safety of Laser Products- Part 1: Equipment Classification and Requirements. Testing indicates that the proposed device conforms to this standard.
- Safety of endoscopic equipment testing completed in accordance with IEC . 60601-2-18: Edition 3.0 2009-08 Medical Electrical Equipment- Part 2-18: Particular Requirements for the Basic Safety and Essential Performance of Endoscopic Equipment. Testing indicates that the proposed device conforms to this standard.
The results of these studies demonstrate that the proposed device is as safe and effective as the predicate.
7. Substantial Equivalence
The ActivSight Intraoperative Imaging System (subject) is substantially equivalent to the Stryker® Infrared Fluorescence (IRF) Imaging System (predicate).
The subject device and predicate device have nearly identical Indications for Use. Both devices provide real-time endoscopic near-infrared fluorescence imaging during minimally invasive surgery. Both are indicated to enable surgeons visually assess blood flow, tissue perfusion, and at least one of the major bile ducts (cystic duct, common bile duct, or common hepatic duct). Fluorescence imaging of biliary ducts with both devices is intended for use with standard care white light, and when indicated, intraoperative cholangiography.
Both devices achieve their intended use through use of an FDA approved contrast drug agent (indocyanine green (ICG)).
Neither device is intended for stand-alone use for biliary duct visualization.
Differences between the two devices are ActivSight's capability to visualize blood flow and perfusion through speckle laser illumination, and ActivSight does not include laparoscopic equipment or a white light source. Laser speckle illumination is achieved through near-infrared laser diodes, imaging hardware, and imaging software that together display blood flow and perfusion without the aid of an imaging agent, such as ICG. ActivSight is interoperable with the existing laparoscopic equipment of the Stryker Infrared Fluorescence (IRF) Imaging System.
CONFIDENTIAL
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Image /page/7/Picture/0 description: The image shows the logo for Activ Surgical. The logo is blue and features the word "ACTIV" in large, bold letters. Below the word "ACTIV" is the word "SURGICAL" in smaller, thinner letters. The logo is simple and modern.
Table 5.1: Comparison to Predicate
| | ActivSight Intraoperative
Imaging System | Stryker Infrared
Fluorescence (IRF) Imaging
System (K142310) - Predicate | Perimed PeriCam
PSI (K120884) -
Reference Device | |
|---------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------|
| Intended Use | Confocal Optical Imaging
(OWN) | Confocal Optical Imaging
(OWN) | Probe, Blood-Flow,
Extravascular (DPT) | |
| Indications
for Use | The ActivSight
Intraoperative Imaging
System (ActivSight) is
intended to provide real-
time endoscopic
fluorescence and near
infrared imaging. ActivSight
enables surgeons to
visually assess vessels,
blood flow, and related
tissue perfusion using
fluorescence and near
infrared imaging, and at
least one of the major bile
ducts (cystic duct, common
bile duct, or common
hepatic duct) using
fluorescence, all during
minimally invasive surgery.
Fluorescence imaging of
biliary ducts with ActivSight
is intended for use with
standard of care white light,
and when indicated,
intraoperative
cholangiography. The
device is not intended for
stand-alone use for biliary
duct visualization. | The Stryker® IRF Light Source
and SafeLight Cable are
indicated for use to provide
real-time endoscopic visible
and near-infrared fluorescence
imaging. The Stryker® IRF
Light Source and SafeLight
Cable enable surgeons to
perform minimally invasive
surgery using standard
endoscope visible 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 Stryker® IRF
Light Source and SafeLight
Cable are 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. | The PeriCam PSI is
intended for non-
invasive two-
dimensional imaging
of peripheral tissue
blood perfusion. | |
| Technological Characteristics | | | | |
| | ActivSight Intraoperative Imaging
System
ActivSight
Perfusion | Stryker Infrared
Fluorescence
(IRF) Imaging
System
(K142310) -
Predicate | Perimed
PeriCam PSI
(K120884) -
Reference
Device | |
| Mode of Action | Laser Speckle | Fluorescence | Laser Speckle | |
| Contrast Agent | None | ICG | None | |
| Information
Presentation
Format | Heatmap signal
overlayed on
red/green/blue
(RGB) or heatmap
signal only | Green Signal
overlayed on
red/green/blue
(RGB) | Green signal
overlayed on
grayscale | Heatmap signal
only with option
for adjacent
color image. |
| Light Source(s) | Coherent 852 nm
laser | 808nm laser | 808nm laser | 785nm laser |
| Light Source
Power Rating | Class 3R out of
Light Cable, class 1
out of scope | Class 3R out of
Light Cable, class
1 out of scope | Class 1M | Class 1 |
| Light Capture | IR sensitive camera | IR sensitive
camera | IR sensitive
camera | IR sensitive
camera |
| Active Area of
imaging sensor | 1/2.9" CMOS,
4.98x3.74mm | 1/2.9" CMOS,
4.98x3.74mm | 1/3" CMOS,
4.8x3.6mm | Unknown |
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Image /page/8/Picture/0 description: The image shows the logo for Activ Surgical. The word "ACTIV" is in large, blue, sans-serif font. Below that, in a smaller, light gray, sans-serif font, is the word "SURGICAL". The logo is simple and modern.
8. Conclusion
Based on the information provided in this premarket notification, and based on a comparison to the indications for use, performance testing, and technological characteristics of the predicate, the ActivSight Intraoperative Imaging System is shown to raise no new questions of safety and efficacy, and is substantially equivalent to the Stryker Infrared Fluorescence (IRF) Imaging System.