(105 days)
Not Found
No
The document describes image acquisition and processing but does not mention AI, ML, or any related technologies like deep learning or neural networks. The image reconstruction is explicitly stated to not involve stitching or blending algorithms, which are sometimes associated with more complex image processing, but not necessarily AI/ML.
No.
The device is an imaging system designed for the visualization of tissue microstructures, not for therapeutic intervention or treatment.
Yes
The device is intended to allow imaging of tissue microstructure, including the identification of cells and their organization, which are used by trained healthcare professionals to understand tissue characteristics and pathology, thereby aiding in diagnosis. The predicate device also suggests a diagnostic use.
No
The device description explicitly states it is a "confocal laser system" and a "digital microscopy scanner," which are hardware components. It also mentions using "non-ionizing, low-power optical radiation (Class 1 laser product)" and a "detector," further indicating hardware. While it involves signal acquisition and processing, the core device is a physical scanner, not solely software.
Based on the provided information, the Histolog® Scanner is likely not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use describes the device as a system for imaging the internal microstructure of tissues to identify cells, vessels, and their organization. While this involves analyzing biological material, the primary function described is imaging and visualization, not performing a diagnostic test on a sample to determine a specific condition or state of health.
- Device Description: The description reinforces the idea of a digital microscopy scanner for use on excised human tissue. It focuses on the imaging technology (confocal fluorescence microscopy) and the process of acquiring and reconstructing images.
- Lack of Diagnostic Claims: There are no mentions of the device being used to diagnose, monitor, or predict a specific disease, condition, or physiological state based on the analysis of the tissue sample.
- Comparison to Predicate Device: The predicate device, the Cellvizio 100 Series, is also described as a "Confocal laser Imaging system." This further suggests that the Histolog® Scanner falls under the category of imaging devices rather than IVDs.
What makes a device an IVD?
An IVD is a medical device intended for use in vitro for the examination of specimens, including blood, tissue, and urine, derived from the human body, solely or principally for the purpose of providing information concerning a physiological or pathological state, or a congenital abnormality, or to determine the safety and compatibility with potential recipients, or to monitor therapeutic measures.
In this case, the Histolog® Scanner provides information about the structure of the tissue, which can be used by a trained healthcare professional to make a diagnosis, but the device itself is not performing the diagnostic test. It's a tool for visualization and analysis, similar to a microscope.
Therefore, based on the provided information, the Histolog® Scanner appears to be classified as a medical imaging device rather than an In Vitro Diagnostic device.
N/A
Intended Use / Indications for 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.
Product codes (comma separated list FDA assigned to the subject device)
OWN
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.
Mentions image processing
Yes
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Confocal fluorescence microscopy
Anatomical Site
Tissues (excised human tissue)
Indicated Patient Age Range
Not Found
Intended User / Care Setting
trained healthcare professionals
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)
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 Subject device |
|---|---|---|
| Biocompatibility (Cytotoxicity, Sensitization, Irritation or Intracutaneous reactivity & Systemic toxicity) | ISO 10993-1 Edition 5 All applicable requirements met | Not applicable, as device does not have direct or indirect patient contact |
| Basic Safety | IEC 61010-1 Edition 3.1 + gaps towards IEC 60601-1 Edition 3.2 All applicable requirements met | PASS |
| EMC | IEC 60601-1-2 Edition 4.1 All applicable requirements met | PASS |
| Laser safety | IEC 60825-1 Edition 3.0 All applicable requirements met | PASS |
| Imaging Quality | Histolog® Scanner system imaging requirements verification protocols. All requirements met | PASS |
| Performance | All requirements met Histolog® Scanner system performance requirements verification protocols. | PASS |
| Cleaning | All requirements met Cleaning Agent Compatibility Verification for Cleaning All requirements met | PASS |
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.
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.
Not Found
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
§ 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.
0
Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo in blue. Underneath the FDA logo is the word "ADMINISTRATION".
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).
1
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 (DICE@fda.hhs.gov) or phone (1-800-638-2041 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
Page 2
Enclosure
2
Indications for Use
Submission Number (if known)
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)
CONTINUE ON A SEPARATE PAGE IF NEEDED.
This section applies only to requirements of the Paperwork Reduction Act of 1995.
DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.
The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:
Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff@fda.hhs.gov
"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."
3
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 |
| SamanTree Medical SA | |
| Avenue de Provence 12, 1007 Lausanne, Switzerland | |
| +32 475 95 8054 | |
| olivier.delporte@samantree.com | |
| Submission | |
| Correspondent: | Cindy Domecus, R.A.C. |
| Principal, Domecus Consulting Services LLC | |
| Regulatory Consultant to SamanTree Medical SA | |
| +1 650-773-3445 | |
| Cindy@DomecusConsulting.com |
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.
4
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
| Characteristic | Subject Device | Predicate Device | Comment |
|---|---|---|---|
| Measurement | |||
| Technique | Laser-scanning | ||
| optical microscopy | |||
| [Confocal Laser | |||
| Scanning Microscopy] | Laser-scanning | ||
| optical microscopy | |||
| [Confocal Laser | |||
| Scanning Microscopy] | SAME | ||
| Optical Source | Laser | Laser | SAME |
| Center Wavelength | 488 nm | 488 nm | SAME |
| Optical Radiation | |||
| Safety | Safe for Indicated | ||
| Use, | |||
| Class 1 Laser | Safe for Indicated | ||
| Use, | |||
| Class 2M Laser | SIMILAR | ||
| This difference does | |||
| not raise different | |||
| questions of safety | |||
| and effectiveness. | |||
| Both are laser | |||
| products evaluated as | |||
| per IEC 60825-1. The | |||
| subject device has | |||
| lower accessible | |||
| irradiation level than | |||
| the predicate device. | |||
| Lateral Resolution | 2 µm | 1 µm or 3.5 µm | |
| depending on the | |||
| model of Confocal | |||
| Miniprobe | SIMILAR | ||
| This difference does | |||
| not raise different | |||
| questions of safety | |||
| and effectiveness. | |||
| Both devices allow | |||
| visualizing tissue | |||
| microstructures at the | |||
| micrometer scale. | |||
| Patient Applied Part | No Patient Applied | ||
| Part | Handheld Fiber Optic | ||
| Probe | DIFFERENT | ||
| This difference does | |||
| not raise different | |||
| questions of safety | |||
| Technological | |||
| Characteristic | Subject Device | Predicate Device | Comment |
| and effectiveness, as | |||
| discussed above. | |||
| Field of view | Square | ||
| 250 µm x 250 µm | |||
| (individual miniprobe) | |||
| 4.8 cm x 3.6 cm | |||
| (array of 192 x 144 | |||
| miniprobes) | Circular | ||
| 240 µm, 325 µm or | |||
| 600 µm diameter | |||
| depending on the | |||
| Confocal Miniprobe | |||
| model | DIFFERENT | ||
| The individual image | |||
| size of the Histolog is | |||
| substantially the | |||
| same as Cellvizio; 240 | |||
| round versus 250 | |||
| square. | |||
| This difference does | |||
| not raise different | |||
| questions of safety | |||
| and effectiveness, as | |||
| discussed above. |
5
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
Subject device |
|----------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------|
| Biocompatibility (Cytotoxicity,
Sensitization, Irritation
or Intracutaneous reactivity &
Systemic toxicity) | ISO 10993-1 Edition 5
All applicable
requirements met | Not applicable, as
device does not
have direct or
indirect patient
contact |
| Basic Safety | IEC 61010-1 Edition 3.1 +
gaps towards IEC 60601-1
Edition 3.2
All applicable
requirements met | PASS |
| EMC | IEC 60601-1-2 Edition 4.1
All applicable
requirements met | PASS |
| Laser safety | IEC 60825-1 Edition 3.0
All applicable
requirements met | PASS |
| Imaging Quality | Histolog® Scanner system
imaging requirements
verification protocols. | PASS |
6
| Test Performed | Acceptance Criteria | Test Results
Subject device |
|----------------|--------------------------------------------------------------------------------------------------------------|--------------------------------|
| | All requirements met | |
| Performance | All requirements met
Histolog® Scanner system
performance requirements
verification protocols. | PASS |
| Cleaning | All requirements met
Cleaning Agent
Compatibility Verification
for Cleaning
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.