Histolog® Scanner (Hardware 2.4, Software 3.3)

K241275 · Samantree Medical SA · OWN · Aug 19, 2024 · Gastroenterology, Urology

Device Facts

• Record ID: K241275
• Device Name: Histolog® Scanner (Hardware 2.4, Software 3.3)
• Applicant: Samantree Medical SA
• Product Code: OWN · Gastroenterology, Urology
• Decision Date: Aug 19, 2024
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 876.1500
• Device Class: Class 2

Intended Use

The Histolog® Scanner is a confocal laser system intended to allow imaging of the internal microstructure of tissues including, but not limited to, the identification of cells, vessels and their organization or architecture.

Device Story

Histolog® Scanner is a digital microscopy scanner for excised human tissue; utilizes confocal fluorescence microscopy with 488 nm laser (Class 1). Massively parallel signal acquisition enables fast digital imaging over large areas (4.8 cm x 3.6 cm) without image stitching or blending. Each pixel intensity corresponds to light collected at specific scan positions. Operated by trained healthcare professionals in clinical settings. Provides high-resolution, micrometer-scale images of tissue microstructure; assists clinicians in visualizing cellular/vascular architecture. Benefits include rapid, detailed assessment of excised tissue samples.

Clinical Evidence

Bench testing only. No clinical data provided. Testing included biocompatibility (not applicable), basic safety (IEC 61010-1), EMC (IEC 60601-1-2), laser safety (IEC 60825-1), imaging quality, and performance verification. All tests passed.

Technological Characteristics

Confocal laser scanning microscopy; 488 nm laser source; Class 1 laser (IEC 60825-1:2014-05); 2 µm lateral resolution; 4.8 cm x 3.6 cm field of view; massively parallel signal acquisition; no patient-applied part; standalone digital microscopy scanner.

Indications for Use

Indicated for imaging internal microstructure of excised human tissues, including identification of cells, vessels, and their organization/architecture. For use by trained healthcare professionals.

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

• Cellvizio 100 Series Confocal laser Imaging systems and their Confocal Miniprobes (K183640)

Submission Summary (Full Text)

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August 19, 2024

SamanTree Medical SA % Cindy Domecus Principal Domecus Consulting Services LLC 1171 Barroilhet Drive Hillsborough, California 94010

Re: K241275

Trade/Device Name: Histolog® Scanner (Hardware 2.4, Software 3.3) Regulation Number: 21 CFR 876.1500 Regulation Name: Endoscope And Accessories Regulatory Class: Class II Product Code: OWN Dated: July 18, 2024 Received: July 18, 2024

Dear Cindy Domecus:

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 (the 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 available 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.

Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device" (https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download).

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Your device is also subject to, among other requirements, the Quality System (QS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30, Design controls; 21 CFR 820.90, Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review, the QS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181).

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 Part 803) for devices or postmarketing safety reporting (21 CFR Part 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 Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050.

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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 ([e-mail]) or phone [phone] or 301-796-7100).

Sincerely,

# Jessica Carr -S

Jessica Carr, Ph.D. Assistant Director DHT4A: Division of General Surgery Devices OHT4: Office of Surgical and Infection Control Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health

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Enclosure

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## Indications for Use

Submission Number (if known)

K241275

Device Name

Histolog® Scanner (Hardware 2.4, Software 3.3)

Indications for Use (Describe)

The Histolog® Scanner is a confocal laser system intended to allow imaging of the internal microstructure of tissues including, but not limited to, the identification of cells, vessels and their organization or architecture.

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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### 510(k) Summary

This Summary of 510(k) safety and effectiveness information is submitted in accordance with the requirements of 21 CFR 807.92.

#### l. APPLICANT INFORMATION

| Date prepared: | August 16, 2024 |
|------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Submitter: | Olivier Delporte, CEO<br>SamanTree Medical SA<br>Avenue de Provence 12, 1007 Lausanne, Switzerland<br>[phone]<br>[e-mail] |
| Submission<br>Correspondent: | Cindy Domecus, R.A.C.<br>Principal, Domecus Consulting Services LLC<br>Regulatory Consultant to SamanTree Medical SA<br>[phone]<br>[e-mail] |

#### II. DEVICE INFORMATION

| Device Trade Name: | Histolog® Scanner |
|----------------------|--------------------------|
| Classification Name: | Confocal Optical Imaging |
| Product Code: | OWN |
| Classification: | Class II |

#### lll. PREDICATE DEVICE

The predicate device is the Cellvizio 100 Series Confocal laser Imaging systems and their Confocal Miniprobes, Mauna Kea Technologies, K183640.

#### IV. DEVICE DESCRIPTION

The Histolog® Scanner is a digital microscopy scanner for use on excised human tissue. Its operating principle is based on confocal fluorescence microscopy and uses non-ionizing, lowpower optical radiation (Class 1 laser product as per IEC 60825-1:2014-05). The Histolog® Scanner acquires digital images with high, micrometer-range resolution and enables the visualization of tissue microstructures down to the cellular level.

The Histolog® Scanner is based on a massively parallel signal acquisition and processing technology providing fast digital imaging over large areas. Image reconstruction does not involve any image stitching or any other similar image blending algorithms. Each pixel in the image is assigned an intensity value based on the light intensity collected by the detector for this particular position in the scan pattern.

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The Histolog® Scanner and its accessory devices are intended to be operated by trained healthcare professionals.

#### INDICATIONS FOR USE V.

The Histolog® Scanner is a confocal laser system intended to allow imaging of the internal microstructure of tissues including, but not limited to, the identification of cells, vessels and their organization or architecture.

#### COMPARISON OF TECHNOLOGICAL CHARACTERISTICS WITH THE PREDICATE VI. DEVICE

| Technological<br>Characteristic | Subject Device | Predicate Device | Comment |
|---------------------------------|--------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Measurement<br>Technique | Laser-scanning<br>optical microscopy<br>[Confocal Laser<br>Scanning Microscopy] | Laser-scanning<br>optical microscopy<br>[Confocal Laser<br>Scanning Microscopy] | SAME |
| Optical Source | Laser | Laser | SAME |
| Center Wavelength | 488 nm | 488 nm | SAME |
| Optical Radiation<br>Safety | Safe for Indicated<br>Use,<br>Class 1 Laser | Safe for Indicated<br>Use,<br>Class 2M Laser | SIMILAR<br>This difference does<br>not raise different<br>questions of safety<br>and effectiveness.<br>Both are laser<br>products evaluated as<br>per IEC 60825-1. The<br>subject device has<br>lower accessible<br>irradiation level than<br>the predicate device. |
| Lateral Resolution | 2 µm | 1 µm or 3.5 µm<br>depending on the<br>model of Confocal<br>Miniprobe | SIMILAR<br>This difference does<br>not raise different<br>questions of safety<br>and effectiveness.<br>Both devices allow<br>visualizing tissue<br>microstructures at the<br>micrometer scale. |
| Patient Applied Part | No Patient Applied<br>Part | Handheld Fiber Optic<br>Probe | DIFFERENT<br>This difference does<br>not raise different<br>questions of safety |
| Technological<br>Characteristic | Subject Device | Predicate Device | Comment |
| | | | and effectiveness, as<br>discussed above. |
| Field of view | Square<br>250 µm x 250 µm<br>(individual miniprobe)<br>4.8 cm x 3.6 cm<br>(array of 192 x 144<br>miniprobes) | Circular<br>240 µm, 325 µm or<br>600 µm diameter<br>depending on the<br>Confocal Miniprobe<br>model | DIFFERENT<br>The individual image<br>size of the Histolog is<br>substantially the<br>same as Cellvizio; 240<br>round versus 250<br>square.<br>This difference does<br>not raise different<br>questions of safety<br>and effectiveness, as<br>discussed above. |

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#### VII. PERFORMANCE DATA

The performance tests summarized in the table below, demonstrate that the use of Histolog® Scanner is as safe and effective as the predicate device.

| Test Performed | Acceptance Criteria | Test Results<br>Subject device |
|----------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------|
| Biocompatibility (Cytotoxicity,<br>Sensitization, Irritation<br>or Intracutaneous reactivity &<br>Systemic toxicity) | ISO 10993-1 Edition 5<br><br>All applicable<br>requirements met | Not applicable, as<br>device does not<br>have direct or<br>indirect patient<br>contact |
| Basic Safety | IEC 61010-1 Edition 3.1 +<br>gaps towards IEC 60601-1<br>Edition 3.2<br><br>All applicable<br>requirements met | PASS |
| EMC | IEC 60601-1-2 Edition 4.1<br><br>All applicable<br>requirements met | PASS |
| Laser safety | IEC 60825-1 Edition 3.0<br><br>All applicable<br>requirements met | PASS |
| Imaging Quality | Histolog® Scanner system<br>imaging requirements<br>verification protocols. | PASS |

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| Test Performed | Acceptance Criteria | Test Results<br>Subject device |
|----------------|--------------------------------------------------------------------------------------------------------------|--------------------------------|
| | All requirements met | |
| Performance | All requirements met<br>Histolog® Scanner system<br>performance requirements<br>verification protocols. | PASS |
| Cleaning | All requirements met<br>Cleaning Agent<br>Compatibility Verification<br>for Cleaning<br>All requirements met | PASS |

#### VIII. CONCLUSIONS

The Histolog® Scanner, has been shown to be substantially equivalent to the cleared predicate device and can be used as intended to image the internal microstructure of tissues in a variety of anatomical locations.

Based upon the intended use; product technical information; and performance, safety and effectiveness data provided in this submission, the subject device is substantially equivalent to the predicate device. The subject device can safely and effectively be used to visualize excised human tissue microstructure.