(163 days)
No
The description focuses on visualization and illumination, and the performance studies are standard for medical devices, not indicative of AI/ML. There are no mentions of AI, ML, or related concepts.
No.
The Artemis™ Eye System is indicated for visualization and illumination during diagnostic and therapeutic procedures, but it does not directly provide therapy itself. It is a tool for a healthcare professional to perform diagnostic or therapeutic procedures.
No
The device provides visualization and illumination during diagnostic and therapeutic procedures, but it does not perform the diagnosis itself. It is a tool for a clinician to use in those procedures.
No
The device description clearly states the system consists of two components: a single-use neuro-endoscope (Artemis Eye) and a reusable tablet (Artemis Eye Tablet). The neuro-endoscope is a hardware component containing a camera and other physical elements. The performance studies also include hardware-related testing such as sterilization, biocompatibility, bench-top performance, shelf-life, and electrical safety/EMC testing, in addition to software verification and validation.
Based on the provided information, the Artemis™ Eye System is not an IVD (In Vitro Diagnostic) device.
Here's why:
- Intended Use: The intended use is "to provide visualization and illumination of intracranial tissue and fluids during diagnostic and therapeutic procedures." This describes a device used during a procedure to aid the clinician, not a device that analyzes samples in vitro (outside the body) to diagnose a condition.
- Device Description: The description details a neuro-endoscope and a tablet for displaying live imaging. This aligns with a visualization tool used during surgery or diagnostic procedures, not a device for analyzing biological samples.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue samples, etc.), performing tests on these samples, or providing diagnostic information based on such analysis.
IVD devices are specifically designed to examine specimens derived from the human body to provide information for the diagnosis, prevention, monitoring, treatment, or alleviation of disease. The Artemis Eye System's function is to provide visual access to an anatomical site in vivo.
N/A
Intended Use / Indications for Use
The Artemis™ Eye System is indicated to provide visualization and illumination of intracranial tissue and fluids during diagnostic and therapeutic procedures.
Product codes (comma separated list FDA assigned to the subject device)
GWG
Device Description
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
intracranial tissue and fluids
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
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)
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 .
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.
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
§ 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).
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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
1
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
2
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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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 of
Manufacturer |
|------------------|----------------------|--------------------------------------------------------|-------------------------|
| Predicate Device | | | |
| K002572 | November 16,
2000 | Medtronic High
Resolution Channel
Neuroendoscope | Medtronic PS Medical |
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| 510(k)
Number | Clearance Date | Device | Name of
Manufacturer |
|------------------|-----------------------|-------------------------------------|-------------------------|
| K162475 | September 16,
2016 | Trice Mi-eye 2, Mi-eye 2
Monitor | Trice Medical Inc. |
1.7 Predicate Comparison
| Table 1: Predicate Device Comparison | |||
|---|---|---|---|
| -------------------------------------- | -- | -- | -- |
| Attribute | Predicate Device | Subject Device |
|---|---|---|
| Trade Name | Medtronic High Resolution | |
| Channel 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 Channel | |
| Neuro-endoscope is indicated for | ||
| diagnostic and intraoperative | ||
| procedures where the physician | ||
| desires direct vision of intracranial | ||
| tissue where cerebrospinal fluid | ||
| (CSF) may be contacted. | The Artemis Eye System is | |
| indicated to provide visualization | ||
| and illumination of intracranial | ||
| tissue and fluids during diagnostic | ||
| and therapeutic procedures. | ||
| Intended Use | Intended for visualization of | |
| intracranial tissue during diagnostic | ||
| and intraoperative procedures. | SAME | |
| Portability | Hand-Held | SAME |
| Weight | Not published in the 510(k) | |
| Summary | ≤ 300 g | |
| Video Output | LCD monitor | SAME |
| Illumination Light | ||
| Source | 1 mm CAMLite Light Cable | Surface Mount LED |
| Neuroendoscope Probe | ||
| Material | 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/Probe | ||
| OD | 4.2 mm | 6 mm |
| Working Channel | ||
| Diameter | 2.15 mm | 3.1 mm |
| Camera Resolution | High (30,000 optical fibres) or | |
| Standard (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 Resolution | |
| Channel Neuroendoscope | Penumbra Artemis Eye System | |
| Video Output/ Tablet | ||
| Dimensions | Not Applicable | 31.0 x 20.0 x 3.8 cm |
| (12.2 x 7.9 x 1.5 in.) | ||
| Display Screen | ||
| Resolution | Not Applicable | ≥ 1920 pixels x 1280 pixels |
| Video Output/ Tablet | ||
| Battery Life | Not Applicable | 3 hours (may vary based upon |
| usage) | ||
| Accessories | Peelaway Introducer Sheath | Stopcock |
| Neuro-Endoscope Use | Single-Use | SAME |
| Sterilization | EO | SAME |
| Shelf-Life | 36-Months | Artemis Eye: 12-Month data |
| currently 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 (Intracutaneous | ||
| Reactivity) | ISO Intracutaneous (Intradermal) | |
| Injection Test | Non-Irritant | |
| Systemic Toxicity (Acute) | ||
| Acute Systemic Toxicity | 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 (Indirect & Direct | |
| Contact) | 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.