(105 days)
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.
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.
The provided text does not contain the detailed information required to fulfill all aspects of the request regarding the device's acceptance criteria and the study proving it meets them. The document focuses on the regulatory submission and comparison to a predicate device, rather than a detailed clinical performance study.
Here's a breakdown of what can and cannot be extracted from the provided text:
What can be extracted:
- Acceptance Criteria for Non-Clinical Tests: The document lists acceptance criteria for various non-clinical performance and safety tests.
- Results for Non-Clinical Tests: The document states "PASS" for all listed internal validation tests.
What cannot be extracted (critical for a clinical performance study):
- Table of Acceptance Criteria and Reported Device Performance for Imaging Quality (Clinical): While "Imaging Quality" is listed as a test, the specific acceptance criteria (e.g., sensitivity, specificity, accuracy for a specific diagnostic task) and the actual reported performance values are not provided. The text only says "Histolog® Scanner system imaging requirements verification protocols. All requirements met." This is insufficient for a clinical performance study.
- Sample size used for the test set and data provenance: No information on the number of images/patients, or whether the data was retrospective/prospective or its origin.
- Number of experts used to establish ground truth and qualifications: No mention of experts or their qualifications.
- Adjudication method for the test set: No information.
- MRMC comparative effectiveness study details: No mention of human readers or AI assistance in a comparative study.
- Standalone (algorithm only) performance: While the device images tissue, there's no mention of an algorithm being evaluated in a standalone capacity against a ground truth. The device itself is the "scanner."
- Type of ground truth used: No mention of ground truth (e.g., pathology, outcomes).
- Sample size for the training set: The document discusses validation, not training.
- How the ground truth for the training set was established: Not applicable, as training data and ground truth establishment for AI are not mentioned.
Based on the provided text, here is the information that can be extracted and a clear indication of what is missing:
1. Table of Acceptance Criteria and Reported Device Performance
For non-clinical safety and performance tests:
| Test Performed | Acceptance Criteria | Reported Device Performance |
|---|---|---|
| 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 | Histolog® Scanner system performance requirements verification protocols. All requirements met. | PASS |
| Cleaning | Cleaning Agent Compatibility Verification for Cleaning. All requirements met. | PASS |
Missing: Specific quantitative acceptance criteria (e.g., sensitivity, specificity, accuracy) and corresponding reported performance metrics for "Imaging Quality" related to the device's diagnostic capabilities or image interpretation for identifying specific microstructures (cells, vessels, organization). The document confirms internal verification protocols were met, but doesn't detail these protocols or their outcomes for clinical relevance.
2. Sample size used for the test set and the data provenance
Missing: No information regarding the sample size of any test set (e.g., number of tissue samples, patients, or images) used for evaluating the device's clinical performance or imaging quality related to microstructure identification. Data provenance (country of origin, retrospective/prospective) is also not provided.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
Missing: The document does not describe any expert involvement in establishing ground truth for a test set.
4. Adjudication method for the test set
Missing: No information on an adjudication method.
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
Missing: No MRMC study is described. The device is a scanner intended for imaging the microstructure of tissues, not explicitly an AI-assisted diagnostic tool for human readers based on this submission.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Missing: While the device performs standalone imaging, the document doesn't describe a separate "algorithm only" performance evaluation that would assess, for example, automated detection or classification capabilities without human interpretation of the images. The device itself is the imaging system.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
Missing: No information on the type of ground truth used for any clinical performance or imaging quality assessment.
8. The sample size for the training set
Missing: No information on a training set, as the document focuses on device performance validation rather than machine learning model development.
9. How the ground truth for the training set was established
Missing: Not applicable, as detailed training data and its ground truth establishment are not mentioned.
Conclusion: The provided FDA submission letter and summary focus explicitly on demonstrating substantial equivalence to a predicate device primarily through non-clinical performance and safety data, and a high-level statement about meeting "imaging quality" requirements. It does not present a clinical performance study with detailed acceptance criteria, sample sizes, ground truth establishment, or human reader performance metrics that would be typical for an AI/CADe device or a device requiring such detailed clinical validation.
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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).
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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 (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
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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)
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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, CEOSamanTree Medical SAAvenue de Provence 12, 1007 Lausanne, Switzerland+32 475 95 8054olivier.delporte@samantree.com |
| SubmissionCorrespondent: | Cindy Domecus, R.A.C.Principal, Domecus Consulting Services LLCRegulatory Consultant to SamanTree Medical SA+1 650-773-3445Cindy@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.
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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
| TechnologicalCharacteristic | Subject Device | Predicate Device | Comment |
|---|---|---|---|
| MeasurementTechnique | Laser-scanningoptical microscopy[Confocal LaserScanning Microscopy] | Laser-scanningoptical microscopy[Confocal LaserScanning Microscopy] | SAME |
| Optical Source | Laser | Laser | SAME |
| Center Wavelength | 488 nm | 488 nm | SAME |
| Optical RadiationSafety | Safe for IndicatedUse,Class 1 Laser | Safe for IndicatedUse,Class 2M Laser | SIMILARThis difference doesnot raise differentquestions of safetyand effectiveness.Both are laserproducts evaluated asper IEC 60825-1. Thesubject device haslower accessibleirradiation level thanthe predicate device. |
| Lateral Resolution | 2 µm | 1 µm or 3.5 µmdepending on themodel of ConfocalMiniprobe | SIMILARThis difference doesnot raise differentquestions of safetyand effectiveness.Both devices allowvisualizing tissuemicrostructures at themicrometer scale. |
| Patient Applied Part | No Patient AppliedPart | Handheld Fiber OpticProbe | DIFFERENTThis difference doesnot raise differentquestions of safety |
| TechnologicalCharacteristic | Subject Device | Predicate Device | Comment |
| and effectiveness, asdiscussed above. | |||
| Field of view | Square250 µm x 250 µm(individual miniprobe)4.8 cm x 3.6 cm(array of 192 x 144miniprobes) | Circular240 µm, 325 µm or600 µm diameterdepending on theConfocal Miniprobemodel | DIFFERENTThe individual imagesize of the Histolog issubstantially thesame as Cellvizio; 240round versus 250square.This difference doesnot raise differentquestions of safetyand effectiveness, asdiscussed 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 ResultsSubject device |
|---|---|---|
| Biocompatibility (Cytotoxicity,Sensitization, Irritationor Intracutaneous reactivity &Systemic toxicity) | ISO 10993-1 Edition 5All applicablerequirements met | Not applicable, asdevice does nothave direct orindirect patientcontact |
| Basic Safety | IEC 61010-1 Edition 3.1 +gaps towards IEC 60601-1Edition 3.2All applicablerequirements met | PASS |
| EMC | IEC 60601-1-2 Edition 4.1All applicablerequirements met | PASS |
| Laser safety | IEC 60825-1 Edition 3.0All applicablerequirements met | PASS |
| Imaging Quality | Histolog® Scanner systemimaging requirementsverification protocols. | PASS |
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| Test Performed | Acceptance Criteria | Test ResultsSubject device |
|---|---|---|
| All requirements met | ||
| Performance | All requirements metHistolog® Scanner systemperformance requirementsverification protocols. | PASS |
| Cleaning | All requirements metCleaning AgentCompatibility Verificationfor CleaningAll 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.
§ 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.