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.

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.

AI/ML Overview

This report confirms that the ActivSight Intraoperative Imaging System (K231344) has been found substantially equivalent to its predicate device (K203550) by the FDA. This determination is primarily based on non-clinical testing related to a new sterilization method, as the device itself is identical in intended use and technology to the predicate. Therefore, detailed information regarding acceptance criteria and performance of an AI/human-in-the-loop system, as typically required for novel AI-powered medical devices, is largely not applicable to this specific submission.

However, based on the limited information provided, we can infer some aspects and highlight what is not present given the nature of the submission. Since the provided text is a 510(k) clearance letter and summary for a modification (specifically, a new sterilization method) to an existing device, it does not contain the detailed clinical study data typically found in original submissions for AI-powered devices.

Here's an analysis based on the context:

1. A table of acceptance criteria and the reported device performance

The provided documentation does not specify acceptance criteria and reported device performance related to diagnostic accuracy or clinical effectiveness, as this was a 510(k) submission for a modification (sterilization) rather than a de novo AI device.

The non-clinical testing performed focused on:

Acceptance Criteria (Implied)	Reported Device Performance
Sterility Assurance Level (SAL) of 10^-6	Achieved SAL of 10^-6 with listed VHP cycles
Functional reliability/performance after reprocessing	No impact on functional reliability or performance over multiple reprocessing cycles

2. Sample size used for the test set and the data provenance

For the sterilization efficacy testing:

Sample Size: Not explicitly stated, but typically involves a sufficient number of test articles (e.g., medical devices or biological indicators) to statistically validate a SAL of 10^-6.
Data Provenance: Not specified, but likely laboratory testing conducted under controlled conditions. This is not clinical data from patients.

For functional testing after reprocessing:

Sample Size: Not explicitly stated, but usually involves testing multiple units through a predefined number of reprocessing cycles.
Data Provenance: Not specified, but likely laboratory testing.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

This is not applicable to this type of submission. Ground truth, in the context of diagnostic accuracy, would involve expert radiologists or pathologists interpreting images or samples. The testing here is for sterility and functional reliability, not diagnostic performance.

4. Adjudication method for the test set

This is not applicable as there are no expert interpretations requiring adjudication.

5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

No MRMC study was performed or required for this 510(k) submission, as it relates to a modification of an existing imaging system's sterilization method, not its diagnostic or assistive AI capabilities. The device is an intraoperative imaging system that provides fluorescence and near-infrared imaging for surgeons, not an AI-powered diagnostic tool for human readers.

6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done

Not applicable. The ActivSight system is described as an "accessory to existing commercial surgical laparoscope systems" and "enables surgeons to visually assess," indicating it's a visualization tool used by surgeons, not a standalone AI algorithm producing interpretations.

7. The type of ground truth used

For sterilization testing, the ground truth is established by microbiological methods (e.g., culturing biological indicators after sterilization to confirm kill rates). For functional testing, the ground truth is the device's operational specifications and performance metrics (e.g., image quality, light output, mechanical integrity).

8. The sample size for the training set

Not applicable. This device is not an AI algorithm that requires a training set. Even if the original predicate device (K203550) involved some form of image processing or enhancement, the provided document does not indicate that it is an AI/ML-based device that would undergo a training phase.

9. How the ground truth for the training set was established

Not applicable for the same reason as point 8.

In summary:

This 510(k) clearance is for a change to an already cleared medical device (specifically, its sterilization method). Therefore, the detailed performance data, acceptance criteria, and study designs typically associated with new AI/ML-driven diagnostic or treatment devices are not present in this document. The "study" mentioned here refers to the non-clinical validation of the new sterilization processes and confirmation of the device's continued functional reliability after these processes.

Summary

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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 (1-800-638-2041 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)

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)

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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 PlaceBoston, MA 02210
Contact:Phone:Email:	Nicholas Child(617) 957-1434nchild@activsurgical.com
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

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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.

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.

Regulation Number and Section

§ 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.