ActivSight Intraoperative Imaging System

K231344 · Activ Surgical, Inc. · OWN · Aug 2, 2023 · Gastroenterology, Urology

Device Facts

• Record ID: K231344
• Device Name: ActivSight Intraoperative Imaging System
• Applicant: Activ Surgical, Inc.
• Product Code: OWN · Gastroenterology, Urology
• Decision Date: Aug 2, 2023
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 876.1500
• Device Class: Class 2

Intended 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.

Device Story

ActivSight Intraoperative Imaging System functions as an accessory to existing commercial surgical laparoscope systems (cameras/video processors). It captures fluorescence and near-infrared signals to provide real-time visualization of vessels, blood flow, tissue perfusion, and biliary ducts during minimally invasive surgery. Surgeons use the system in the OR to augment standard white-light endoscopic views. Fluorescence imaging requires administration of Indocyanine Green (ICG). The device output assists surgeons in intraoperative decision-making regarding tissue perfusion and anatomical identification of bile ducts. The system is intended for use by surgeons in a surgical environment.

Clinical Evidence

No clinical data. Substantial equivalence supported by non-clinical bench testing, including sterilization efficacy validation per ANSI/AAMI/ISO 14937:2009/(R)2013 and functional testing of the device over multiple reprocessing cycles.

Technological Characteristics

Accessory to endoscopic systems; provides fluorescence and near-infrared imaging. Validated for sterilization via Vaporized Hydrogen Peroxide (VHP) cycles (STERRAD and V-PRO systems) per ANSI/AAMI/ISO 14937:2009/(R)2013. Achieves SAL of 10^-6. Operates as an add-on to existing laparoscope cameras and video processors.

Indications for Use

Indicated for patients undergoing minimally invasive surgery requiring real-time endoscopic fluorescence and near-infrared imaging for visual assessment of vessels, blood flow, tissue perfusion, and biliary ducts (cystic, common bile, or common hepatic). Not for stand-alone biliary duct visualization; must be used with standard white light and, if indicated, intraoperative cholangiography.

Regulatory Classification

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.

Special Controls

*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.

Predicate Devices

• ActivSight Intraoperative Imaging System (K203550)

Submission Summary (Full Text)

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August 2, 2023

Activ Surgical Inc. Nicholas Child Senior Manager, Quality Engineering 30 Thomson Place Boston, Massachusetts 02110

Re: K231344

Trade/Device Name: ActivSight Intraoperative Imaging System Regulation Number: 21 CFR 876.1500 Regulation Name: Endoscope And Accessories Regulatory Class: Class II Product Code: OWN Dated: May 5, 2023 Received: May 9, 2023

Dear Nicholas Child:

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.

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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 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 [phone] or 301-796-7100).

Sincerely.

Jessica Carr -S

Jessica Carr, PhD Acting Assistant Director 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

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# Indications for Use

510(k) Number (if known) K231344

Device Name ActivSight Intraoperative Imaging System

# Indications for Use (Describe)

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, 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)

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|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| <span style="font-size:10pt;"><b> <div style="display:inline-block; vertical-align:middle;"> <svg fill="none" height="16" viewbox="0 0 16 16" width="16" xmlns="http://www.w3.org/2000/svg"> <path d="M13.3333 2.66663H2.66663C1.9307 2.66663 1.33325 3.26399 1.33325 3.99992V12C1.33325 12.7359 1.9307 13.3333 2.66663 13.3333H13.3333C14.0693 13.3333 14.6666 12.7359 14.6666 12V3.99992C14.6666 3.26399 14.0693 2.66663 13.3333 2.66663Z" stroke="black" stroke-linecap="round" stroke-linejoin="round" stroke-width="1.33333"></path> </svg> </div> Over-The-Counter Use (21 CFR 801 Subpart C)</b></span> |

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#### 5. 510(k) Summary

This 510(k) summary is being submitted in accordance with 21 CFR 807.92

#### A. Submitter's Information

| Name: | Activ Surgical, Inc. |
|------------------------------|--------------------------------------------------------------|
| Address: | 30 Thomson Place<br>Boston, MA 02210 |
| Contact:<br>Phone:<br>Email: | Nicholas Child<br>[phone]<br>[e-mail] |
| Date Prepared: | July 28, 2023 |

#### B. Device Information

| Trade/Proprietary Name: | ActivSight Intraoperative Imaging System |
|-------------------------|--------------------------------------------|
| Common/Usual Name: | Confocal Optical Imaging |
| Classification Name: | Endoscope and Accessories, 21 CFR 876.1500 |
| Class: | II |
| Product Codes: | OWN |

#### C. Predicate Device

Activ Surgical, Inc.

ActivSight Intraoperative Imaging System, K203550

#### D. 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 nearinfrared 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.

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### E. Intended 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.

# F. Summary of Technological Characteristics Compared to Predicate

The modified device and the predicate device are the same device and are identical in intended use and technology. The modified device instructions for use provides for a new method of sterilization prior to each use.

### G. Non-Clinical Testing

To support substantial equivalence of the modified device to the predicate device, the following testing was performed:

- Sterilization efficacy according to ANSI/AAMI/ISO14937:2009/(R)2013. . Sterilization of health care products - General requirements for characterization of a sterilizing agent and the development, validation, and routine control of a sterilization process for medical devices.
Sterilization efficacy testing validated that the Imaging Modules achieved a Sterility Assurance Level (SAL) of 10-6 -when sterilized using the following sterilization methods:

| Vaporized Hydrogen Peroxide (VHP) Cycles |
|-------------------------------------------------------------------|
| STERRAD |
| NX (Standard & Advance Cycle) |
| NX AllClear (Standard & Advance Cycle) |
| 100NX (Express & Standard Cycle) |
| 100NX AllClear (Express & Standard Cycle) |
| Steris |
| V-PRO s2 (Non-Lumen, Lumen, Flexible, or Fast cycle) |
| V-PRO 60 (Non-Lumen, Lumen, or Flexible cycle) |
| V-PRO maX (Non-Lumen, Lumen, or Flexible cycle) |
| V-PRO maX 2 (Non-Lumen, Lumen, Flexible, or Fast Non-Lumen cycle) |

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- In addition, functional testing confirmed that reprocessing of the modified device does not impact the functional reliability or performance of the modified device over multiple reprocessing cycles.
The results of the testing support the claim that the ActivSight Intraoperative Imaging System is safe and effective for its intended use, when used according to the Instructions for Use.

# H. Clinical Testing

The proposed modification did not require clinical testing to demonstrate substantial equivalence.

# l. 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 proposed ActivSight Intraoperative Imaging System does not raise new questions of safety and efficacy, and is substantially equivalent to the ActivSight Intraoperative Imaging System.