(163 days)
The Artemis™ Eye System is indicated to provide visualization and illumination of intracranial tissue and fluids during diagnostic and therapeutic procedures.
The Artemis Eye System is indicated to provide visualization and illumination of intracranial tissue and fluids during diagnostic and therapeutic procedures. The System consists of two components:
- Artemis Eye a single-use neuro-endoscope consisting of a camera, two pathways for . irrigation and/or drain, and a working channel for a surgical tool.
- Artemis Eye Tablet a reusable component that connects to the Artemis Eye and . displays live imaging captured by the Artemis Eye camera.
This document is a 510(k) summary for the Penumbra Artemis Eye System, a neurological endoscope. It focuses on demonstrating substantial equivalence to a predicate device, rather than providing detailed acceptance criteria and study results for algorithm performance.
Therefore, many of the requested details about acceptance criteria for device performance, especially those related to AI or algorithm performance, cannot be extracted directly from this document. The document primarily discusses non-clinical testing for manufacturing, safety, and physical performance of the neuro-endoscope itself.
Here's what can be extracted based on the provided document:
1. Table of Acceptance Criteria and Reported Device Performance (Non-AI/Algorithm Related):
The document does not present a formal table of acceptance criteria with corresponding performance for the overall device's clinical efficacy or algorithm performance. Instead, it describes various non-clinical tests passed.
| Category | Test/Criterion | Reported Performance/Result |
|---|---|---|
| Sterilization | Be sterile in accordance with EN ISO 11135:2014 | Proved to be sterile |
| Biocompatibility | In Vitro Cytotoxicity (ISO Elution Test) | Non-Toxic |
| Sensitization (Magnusson-Kligman Method) | Non-Sensitizing | |
| Irritation (Intracutaneous Reactivity - ISO Intracutaneous (Intradermal) Injection Test) | Non-Irritant | |
| Systemic Toxicity (Acute - ISO Acute Systemic Injection Test) | Non-Toxic | |
| Material Mediated Pyrogen (USP Material-Mediated Rabbit Pyrogen Test) | Non-pyrogenic | |
| Hemo-compatibility (In-Vitro Hemolysis - ASTM Method) | Non-Hemolytic | |
| Coagulation (PT and PTT Test) | Non-Thrombogenic | |
| Bench-Top Performance (Design Verification) | Evaluate physical and mechanical properties; demonstrate substantial equivalence | All tests (Dimensional/visual inspection, Design Feature Testing, Simulated Use, Destructive Testing) passed successfully |
| Shelf-life | Maintain device performance for the duration of labeled shelf-life (12 months) | Test results confirm device stability for the proposed shelf-life |
| Software V&V | Comply with "Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices" | Documentation provided as recommended; software considered a "major" level of concern |
| Electrical Safety/EMC | Comply with requirements of IEC/EN 60601-1, IEC/EN 60601-1-2, IEC 60601-1-6, and IEC/EN 62366 | System complies with the requirements |
2. Sample size used for the test set and the data provenance:
- This information is not provided in the document. The document describes non-clinical engineering and safety tests rather than performance evaluations on a patient test set.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- This information is not provided as the document does not describe a clinical study or an AI/algorithm-based performance evaluation involving expert ground truth.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:
- This information is not provided as there is no mention of a test set requiring adjudication in this document.
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, an MRMC comparative effectiveness study is not mentioned in this document. This document is for a neurological endoscope, not an AI-assisted diagnostic tool in the typical sense that would involve human readers.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- This document is for a physical medical device (neuro-endoscope) with associated software for display. It does not describe a standalone algorithm performance in the context of diagnostic AI. The software is for displaying live imaging, not for autonomous analysis or diagnosis.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- This information is not applicable in the context of this document, as it focuses on the substantial equivalence of device components and safety, not on diagnostic accuracy against a ground truth.
8. The sample size for the training set:
- This information is not provided as the document does not describe the development or training of an AI algorithm.
9. How the ground truth for the training set was established:
- This information is not applicable as the document does not describe the development or training of an AI algorithm.
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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, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
August 30, 2019
Penumbra, Inc. Aditi Kolla Regulatory Affairs Specialist One Penumbra Place Alameda, California 94502
Re: K190719
Trade/Device Name: Artemis Eye System Regulation Number: 21 CFR 882.1480 Regulation Name: Neurological Endoscope Regulatory Class: Class II Product Code: GWG Dated: July 30, 2019 Received: August 1, 2019
Dear Aditi Kolla:
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.
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
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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 (OS) 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 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,
Matthew Krueger Assistant Director DHT5A: Division of Neurosurgical. Neurointerventional and Neurodiagnostic Devices OHT5: Office of Neurological and Physical Medicine Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known) K190719
Device Name Artemis™ Eye System
Indications for Use (Describe)
The Artemis™ Eye System is indicated to provide visualization and illumination of intracranial tissue and fluids during diagnostic and therapeutic procedures.
| Type of Use (Select one or both, as applicable) |
|---|
| ------------------------------------------------- |
X Prescription Use (Part 21 CFR 801 Subpart D)
| Over-The-Counter Use (21 CFR 801 Subpart C)
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Image /page/3/Picture/1 description: The image shows the word "Penumbra" in a bold, red font. To the right of the word is a red circle with a white "P" inside. The logo is simple and modern, with a focus on the company name and a stylized initial.
1 510(k) Summary
(as required by 21 CFR 807.92)
Pursuant to Section 12, Part (a)(i)(3A) of the Safe Medical Devices Act of 1990,
Penumbra, Inc. is providing the summary of Substantial Equivalence for the Artemis™ Eye System.
1.1 Sponsor/Applicant Name and Address
Penumbra, Inc. One Penumbra Place Alameda, CA 94502 USA
1.2 Sponsor Contact Information
Aditi Kolla Regulatory Affairs Specialist Phone: (510) 995-2010 FAX: (510) 217-6414 Email: akolla@penumbrainc.com
Date of Preparation of 510(k) Summary 1.3
August 29, 2019
Device Trade or Proprietary Name 1.4
Artemis™ Eye System
Primary Device Classification 1.5
Regulatory Class: II Classification Panel: Neurology Common Name: Neurological Endoscope Classification Name: Endoscope, neurological Regulation Number: 21 CFR 882.1480 Product Code: GWG
1.6 Predicate & Reference Devices
| 510(k)Number | Clearance Date | Device | Name ofManufacturer |
|---|---|---|---|
| Predicate Device | |||
| K002572 | November 16,2000 | Medtronic HighResolution ChannelNeuroendoscope | Medtronic PS Medical |
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| 510(k)Number | Clearance Date | Device | Name ofManufacturer |
|---|---|---|---|
| K162475 | September 16,2016 | Trice Mi-eye 2, Mi-eye 2Monitor | Trice Medical Inc. |
1.7 Predicate Comparison
| Table 1: Predicate Device Comparison | |||
|---|---|---|---|
| -------------------------------------- | -- | -- | -- |
| Attribute | Predicate Device | Subject Device |
|---|---|---|
| Trade Name | Medtronic High ResolutionChannel Neuroendoscope | Penumbra Artemis Eye System |
| 510(k) No. | K002572 | To be determined |
| Classification | Class II, GWG (882.1480) | Class II, GWG (882.1480) |
| Indications For Use | The High Resolution ChannelNeuro-endoscope is indicated fordiagnostic and intraoperativeprocedures where the physiciandesires direct vision of intracranialtissue where cerebrospinal fluid(CSF) may be contacted. | The Artemis Eye System isindicated to provide visualizationand illumination of intracranialtissue and fluids during diagnosticand therapeutic procedures. |
| Intended Use | Intended for visualization ofintracranial tissue during diagnosticand intraoperative procedures. | SAME |
| Portability | Hand-Held | SAME |
| Weight | Not published in the 510(k)Summary | ≤ 300 g |
| Video Output | LCD monitor | SAME |
| Illumination LightSource | 1 mm CAMLite Light Cable | Surface Mount LED |
| Neuroendoscope ProbeMaterial | Stainless Steel | SAME |
| Working Length | 13 cm or 21.6 cm | 15 cm |
| Total Length | 17.2 cm or 25.8 cm | 25 cm |
| Working Tube/ProbeOD | 4.2 mm | 6 mm |
| Working ChannelDiameter | 2.15 mm | 3.1 mm |
| Camera Resolution | High (30,000 optical fibres) orStandard (10,000 optical fibres) | 200 pixels x 200 pixels |
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| Table 1: Predicate Device Comparison | ||
|---|---|---|
| Attribute | Predicate Device | Subject Device |
| Trade Name | Medtronic High ResolutionChannel Neuroendoscope | Penumbra Artemis Eye System |
| Video Output/ TabletDimensions | Not Applicable | 31.0 x 20.0 x 3.8 cm(12.2 x 7.9 x 1.5 in.) |
| Display ScreenResolution | Not Applicable | ≥ 1920 pixels x 1280 pixels |
| Video Output/ TabletBattery Life | Not Applicable | 3 hours (may vary based uponusage) |
| Accessories | Peelaway Introducer Sheath | Stopcock |
| Neuro-Endoscope Use | Single-Use | SAME |
| Sterilization | EO | SAME |
| Shelf-Life | 36-Months | Artemis Eye: 12-Month datacurrently available |
Device Description 1.8
The Artemis Eye System is indicated to provide visualization and illumination of intracranial tissue and fluids during diagnostic and therapeutic procedures. The System consists of two components:
- Artemis Eye a single-use neuro-endoscope consisting of a camera, two pathways for . irrigation and/or drain, and a working channel for a surgical tool.
- Artemis Eye Tablet a reusable component that connects to the Artemis Eye and . displays live imaging captured by the Artemis Eye camera.
1.9 Indications for Use
The Artemis™ Eye System is indicated to provide visualization and illumination of intracranial tissue and fluids during diagnostic and therapeutic procedures.
1.10 Summary of Non-Clinical Data
Pursuant to Section 12, Part (a)(i)(3A) of the Safe Medical Devices Act of 1990, a summary of any information regarding substantial equivalence of the devices follows.
Included in this section is a summary description of the testing, which substantiates the performance of the subject Artemis Eye System.
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1.10.1 Sterilization
The subject Artemis Eye has proved to be sterile in accordance with EN ISO 11135:2014.
1.10.2 Biocompatibility Testing
Biocompatibility test studies were selected in accordance Guidance for Industry and FDA Staff: Use of International Standard ISO 10993-1, "Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process" (issued June 16, 2016). All studies were conducted pursuant to 21 CFR, Part 58, Good Laboratory Practices. The following tests were successfully conducted on the patient-contacting Artemis Eye component of the subject device:
| Test | Method | Results |
|---|---|---|
| In Vitro Cytotoxicity | ISO Elution Test (MEM Extract) | Non-Toxic |
| Sensitization | Magnusson-Kligman Method | Non-Sensitizing |
| Irritation (IntracutaneousReactivity) | ISO Intracutaneous (Intradermal)Injection Test | Non-Irritant |
| Systemic Toxicity (Acute) | ||
| Acute Systemic Toxicity | ISO Acute Systemic Injection Test | Non-Toxic |
| Material MediatedPyrogen | USP Material-Mediated RabbitPyrogen Test | Non-pyrogenic |
| Hemo-compatibility | ||
| In-Vitro Hemolysis | ASTM Method (Indirect & DirectContact) | Non-Hemolytic |
| Coagulation | PT and PTT Test | Non-Thrombogenic |
1.10.3 Bench-Top Performance (Design Verification)
Performance testing was conducted to evaluate the physical and mechanical properties of the Artemis Eye System and to demonstrate substantial equivalence to the predicate device. The following tests were performed and all tests passed successfully:
- Dimensional / visual inspection ●
- . Design Feature Testing
- . Simulated Use
- Destructive Testing .
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1.10.4 Shelf-life
The physical and mechanical performance of the Artemis Eye was evaluated for 12 months through accelerated aging studies to demonstrate device stability for the duration of the labeled shelf-life. Test results confirm the subject device will maintain device performance for the entirety of the proposed shelf-life.
1.10.5 Software Verification & Validation
Software verification and validation testing and documentation for the Artemis Eye System was provided as recommended by FDA's Guidance for Industry and FDA Staff, "Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices" (issued May 11, 2005). The software for this device was considered as a "major" level of concern.
1.10.6 Electrical Safety/EMC Testing
Electrical safety and EMC testing were conducted on the Artemis Eye System. The system complies with the requirements of IEC/EN 60601-1, IEC/EN 60601-1-2, IEC 60601-1-6, and IEC/EN 62366.
1.11 Summary of Substantial Equivalence
The subject Artemis Eye System is substantially equivalent to the predicate device. The subject device has an identical intended use as the predicate device. The subject and the predicate devices differ slightly in regards to minor technological variations, while maintaining the same fundamental scientific technology. However, these differences do not raise different questions of safety and effectiveness.
The device testing described in the 510(k) Summary demonstrate the subject devices are substantially equivalent to the predicate device in regards to operating principle, fundamental technology and device performance. It also demonstrates the Artemis Eye System should perform as intended in the specified use conditions.
§ 882.1480 Neurological endoscope.
(a)
Identification. A neurological endoscope is an instrument with a light source used to view the inside of the ventricles of the brain.(b)
Classification. Class II (performance standards).