(98 days)
The Artemis™ Neuro Evacuation Device is used for the controlled aspiration of tissue and/or fluid during surgery of the Ventricular System or Cerebrum in conjunction with a Penumbra Aspiration Pump.
Penumbra Aspiration Pump:
The Penumbra Aspiration Pump is indicated as a vacuum source for the Penumbra Aspiration Systems.
The Artemis™ Neuro Evacuation Device, is a surgical instrument designed to aid a physician in the removal of tissue and/or fluid during image-guided neurosurgery. The Artemis Wand has two functions. These functions are control and transfer of aspiration and generation of rotational energy. Aspiration is generated by a Penumbra Aspiration Pump, which the Artemis Wand connects to through its flexible tubing. The Artemis Wand has a rigid hypotube containing a wire to facilitate removing tissue and/or fluid with the assistance of rotational energy and aspiration.
The Artemis Wand is designed to be image-guided, allowing visualization of the procedure. The method of removal is vacuum aspiration, which draws the tissue and/or fluid into the lumen of the Wand hypotube. The integrated wire is fully contained within the lumen of the Wand hypotube, and has rotational capability facilitating movement of any tissue and/or fluid that may otherwise clog the hypotube lumen.
The provided text describes the Penumbra Artemis™ Neuro Evacuation Device and its substantial equivalence to a predicate device, the Apollo System. This document is a 510(k) summary, which focuses on demonstrating substantial equivalence rather than presenting a comparative effectiveness study with human readers or a standalone algorithm performance study.
Therefore, the information required to answer the following points is not available in the provided text:
- A table of acceptance criteria and the reported device performance: While some tests are listed with "100% Pass" or descriptions like "Non-toxic," specific numerical acceptance criteria (e.g., minimum aspiration rates, maximum force tolerances) and their corresponding performance values are not detailed. The provided information summarizes categories of tests and their overall success.
- Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective): The text mentions "Design Verification (Bench-Top Testing)" and "Simulated Use" but does not specify the sample sizes (number of devices or simulated clots) used for these tests. Data provenance is also not mentioned.
- Number of experts used to establish the ground truth for the test set and the qualifications of those experts: This information is not relevant to the non-clinical, bench-top testing described.
- Adjudication method (e.g., 2+1, 3+1, none) for the test set: Not applicable to the non-clinical testing.
- 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: This study type is not mentioned or implied, as the device is a mechanical neuro evacuation device, not an AI diagnostic tool.
- If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable, as the device is a mechanical instrument.
- The type of ground truth used (expert consensus, pathology, outcomes data, etc): For the non-clinical tests, the "ground truth" would be established engineering specifications and successful execution of the test methods (e.g., passing a specific force test, achieving a certain vacuum level, being non-toxic per ISO standards).
- The sample size for the training set: Not applicable, as this is not an AI/machine learning device.
- How the ground truth for the training set was established: Not applicable.
However, based on the provided text, here is a summary of the acceptance criteria and study information that is mentioned:
Acceptance Criteria and Reported Device Performance (Based on available summary data):
| Test Category | Test Method Summary | Reported Performance (Conclusion) |
|---|---|---|
| Biocompatibility | ||
| In vitro Cytotoxicity | MEM Elution Test | Non-toxic |
| Sensitization | ISO Guinea Pig Maximization Sensitization Test | Non-sensitizing |
| Irritation | ISO Tests for Irritation and Skin Sensitization | Non-irritant |
| Systemic Toxicity | ISO Acute Systemic Injection Test | Non-toxic |
| Material Mediated Pyrogen | ISO Materials-Mediated Rabbit Pyrogen Test | Non-pyrogenic |
| Hemocompatibility | Thrombogenicity Study in Dogs - ISO | Non-Thrombogenic |
| Coagulation (PT) | Prothrombin Time (PT) Test | Non-hemolytic |
| Coagulation (PTT) | Partial Thromboplastin Time (PTT) Test | Non-hemolytic |
| Hematology (Hemolysis) - Direct Contact | ASTM Hemolysis (Direct Contact Method) | Non-hemolytic |
| Hematology (Hemolysis) - Indirect Contact | ASTM Hemolysis (Extract Method) | Non-hemolytic |
| Genotoxicity | Ames Test | Non-mutagenic |
| ISO In Vivo Mouse Micronucleus Assay | Non-mutagenic | |
| Design Verification (Bench-Top Testing) | ||
| Packaging Inspection | Confirm the packaging outputs meet all product specifications. | 100% Pass |
| Dimensional / Visual Inspection | Confirm the dimensions / visual outputs meet all product specifications. | 100% Pass |
| Dynamic Vacuum Testing | Wand can sustain maximum vacuum and transfer vacuum to distal tip of wand. | 100% Pass |
| Simulated Use | Evaluate the effectiveness of the device to generate rotational energy to remove simulated clot. | 100% Pass |
| Tensile/Torque | All components are tested to ensure connections/joints meet all product specifications. | 100% Pass |
| Electric Safety Testing | Compliant to requirements of IEC 60601-1 (3rd Ed.), IEC 60601-1-2, 60601-1-6, and IEC 62366. | 100% Pass |
| Sterilization | Gamma irradiation sterilization to a 6-log sterility assurance utilizing the VDmax25. | Validated (in accordance with ISO 11137 and ISO 11737) |
| Shelf-Life | 12-month Shelf-life |
Additional Information from the text:
- Study Types: The studies conducted are primarily non-clinical bench-top testing and biocompatibility testing. This is a type of standalone performance testing in the sense that it evaluates the device's physical and biological properties in a controlled environment, not its performance in humans or with human interaction for diagnostic purposes.
- Ground Truth for Non-clinical Tests: For biocompatibility, the ground truth is established by the specified international and FDA guidelines (EN ISO 10993-1, 21 CFR, Part 58 Good Laboratory Practices). For bench-top testing, the ground truth is against pre-defined product specifications and engineering requirements.
- No Multi-Reader Multi-Case (MRMC) Study or AI/ML Algorithm Performance: The Artemis™ Neuro Evacuation Device is a physical medical instrument, not an AI-powered diagnostic tool. Therefore, studies involving human readers, AI algorithms, training sets, or expert consensus for image interpretation are not applicable and were not performed or reported in this document.
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Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
August 14. 2017
Penumbra, Inc. Mary Rose Director, Regulatory Affairs One Penumbra Place Alameda, California 94502
Re: K171332
Trade/Device Name: Artemis Neuro Evacuation Device Regulation Number: 21 CFR 882.1480 Regulation Name: Neurological Endoscope Regulatory Class: Class II Product Code: GWG Dated: July 14, 2017 Received: July 17, 2017
Dear Ms. Rose:
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. 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 requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting of medical device
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related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. 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
http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely,
Carlos L. Pena -S
Carlos L. Peña, PhD, MS Director Division of Neurological and Physical Medicine Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known) K171332
Device Name ArtemisTM Neuro Evacuation Device
Indications for Use (Describe)
The Artemis™ Neuro Evacuation Device is used for the controlled aspiration of tissue and/or fluid during surgery of the Ventricular System or Cerebrum in conjunction with a Penumbra Aspiration Pump.
Penumbra Aspiration Pump:
The Penumbra Aspiration Pump is indicated as a vacuum source for the Penumbra Aspiration Systems.
| 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 1
(as required by 21 CFR 807.92)
Sponsor/Applicant Name and Address 1.1
Penumbra Inc. One Penumbra Place Alameda, CA 94502, USA
Sponsor Contact Information 1.2
Mary Rose Director, Regulatory Affairs Phone: 510-748-3346 FAX: 510-217-6414 email: mary.rose@penumbrainc.com
1.3 Date of Preparation of 510(k) Summary
July 14, 2017
Device Trade or Proprietary Name 1.4
Artemis™ Neuro Evacuation Device
Device Common/Usual or Classification Name 1.5
Endoscope, neurological (Product Code: GWG)
Primary Device Classification 1.6
| Regulatory Class: | II |
|---|---|
| Classification Panel: | Neurology |
| Classification Name: | Endoscope, neurological |
| Regulation Number: | 21 CFR 882.1480 |
| Product Code: | GWG |
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Predicate Devices 1.7
| 510(k)Number | ClearanceDate | Name of Predicate Device | Name ofManufacturer |
|---|---|---|---|
| K132931 | 01/17/14 | Apollo System | Penumbra, Inc. |
| K152699 | 03/17/16 | Apollo System | Penumbra, Inc. |
| Reference Devices | |||
| K160533 | 05/24/16 | Penumbra Embolectomy Aspiration System(INDIGOTM Aspiration System) | Penumbra, Inc. |
| K160449 | 05/25/16 | Penumbra System® and Penumbra Pump MAX | Penumbra, Inc. |
1.8 Predicate Comparison
| Apollo™ System | Subject Device:Artemis™ Neuro EvacuationDevice | |
|---|---|---|
| 510(k) No. | K132931, K152699 | K171332 |
| Classification | Class II, GWG | Class II, GWG |
| Intended Use | Used for the controlled | SAME |
| aspiration of tissue and/or | ||
| fluid during surgery of the | ||
| Ventricular System or | ||
| Cerebrum. | ||
| Aspiration Control | Fingertip controlled via | SAME |
| vacuum regulator hole on | ||
| Wand handle. | ||
| Mechanism of Action | Vacuum Aspiration aided byVibrational Energy | Vacuum Aspiration aided byRotational Energy |
| Power Source forMechanism of Action | Apollo Generator | Primary Cell Lithium IonBattery, 1.5 Volt DC Motorcontained within the handle |
| Aspiration Source | Apollo Pump | Penumbra Aspiration Pump |
| Wand Hypotube | 304 Stainless Steel | SAME |
| Wand Materials | Polymer, Metal | SAME |
| Wand Dimensions | L: 27.0 cm – 28.0 cm | L: 26.1 cm - 27.0 cm |
| ID: 0.060″ — 0.088″ | ID: 00.048″ — 0.100″ | |
| OD: 0.072″ — 0.101″ | OD: 00.058″ — 0.109″ | |
| Aspiration Tubing | Polymer | SAME |
| Material |
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| Apollo™ System | Subject Device:Artemis™ Neuro EvacuationDevice | |
|---|---|---|
| Aspiration TubingDimensions | OD: 0.188"ID: 0.088" | OD: 0.263"ID: 0.163" |
| Single Use orReusable | Single Use | SAME |
| Sterilization | EO | Gamma |
| Shelf-Life | 12-Months - Wand | SAME |
| Aspiration Pump | Apollo System Pump | Penumbra Aspiration Pump |
| IEC 60601-1Compliance | Yes | SAME |
| IEC 60601-1-2Compliance | Yes | SAME |
| Voltage | 100-115 VAC/230 VAC | SAME |
| Frequency | 50 Hz/60 Hz | SAME |
| Maximum Vacuum | 29 inHg | SAME |
| Maximum Flow rate | 0.8 SCFM | SAME |
1.9 Device Description
The Artemis™ Neuro Evacuation Device, is a surgical instrument designed to aid a physician in the removal of tissue and/or fluid during image-guided neurosurgery. The Artemis Wand has two functions. These functions are control and transfer of aspiration and generation of rotational energy. Aspiration is generated by a Penumbra Aspiration Pump, which the Artemis Wand connects to through its flexible tubing. The Artemis Wand has a rigid hypotube containing a wire to facilitate removing tissue and/or fluid with the assistance of rotational energy and aspiration.
The Artemis Wand is designed to be image-guided, allowing visualization of the procedure. The method of removal is vacuum aspiration, which draws the tissue and/or fluid into the lumen of the Wand hypotube. The integrated wire is fully contained within the lumen of the Wand hypotube, and has rotational capability facilitating movement of any tissue and/or fluid that may otherwise clog the hypotube lumen.
Intended users for this device are physicians who have received appropriate training in image-guided neurosurgery.
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1.10 Indications for Use
The Artemis™ Neuro Evacuation Device is used for the controlled aspiration of tissue and/or fluid during surgery of the Ventricular System or Cerebrum in conjunction with a Penumbra Aspiration Pump.
Penumbra Aspiration Pump:
The Penumbra Aspiration Pump is indicated as a vacuum source for the Penumbra Aspiration Systems.
1.11 Summary of Non-clinical Data
Included in this section is a description of the testing, which substantiates the safe and effective performance of the subject Artemis™ Neuro Evacuation Device as well as its substantial equivalence to the predicate device:
- Biocompatibility .
- Design Verification (Bench-Top Testing) ●
- EMC ●
- Sterilization
- . Shelf-life
1.11.1 Biocompatibility
Biocompatibility testing was performed on the subject Artemis™ Neuro Evacuation Device. Tests were selected in accordance with EN ISO 10993-1 guidelines (Biological Evaluation of Medical Devices) and FDA Guidance. All studies were conducted pursuant to 21 CFR, Part 58, Good Laboratory Practices.
| Test | Method | Conclusions |
|---|---|---|
| In vitro Cytotoxicity | MEM Elution Test | Non-toxic |
| Sensitization (Magnusson-Kligman Method) | ISO Guinea Pig Maximization Sensitization Test | Non-sensitizing |
The following tests were performed based contact type and duration:
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| Test | Method | Conclusions |
|---|---|---|
| Irritation (IntracutaneousReactivity (ISO)) | ISO Tests for Irritation and Skin Sensitization | Non-irritant |
| Systemic Toxicity | ||
| Systemic Injection (ISO) | ISO Acute Systemic Injection Test | Non-toxic |
| Material Mediated Pyrogen | ISO Materials-Mediated Rabbit Pyrogen Test | Non-pyrogenic |
| Hemocompatibility | ||
| Thrombosis (DogThrombogenicity) | Thrombogenicity Study in Dogs - ISO | Non-Thrombogenic |
| Coagulation (PT) | Prothrombin Time (PT) Test | Non-hemolytic |
| Coagulation (PTT) | Partial Thromboplastin Time (PTT) Test | Non-hemolytic |
| Hematology (Hemolysis) -Direct Contact | ASTM Hemolysis (Direct Contact Method) | Non-hemolytic |
| Hematology (Hemolysis) -Indirect Contact | ASTM Hemolysis (Extract Method) | Non-hemolytic |
| Genotoxicity | ||
| Ames Mutagenicity | Ames Test | Non-mutagenic |
| In vivo Mouse micronucleus | ISO In Vivo Mouse Micronucleus Assay | Non-mutagenic |
The non-clinical testing found the Penumbra Artemis™ Neuro Evacuation Device to be biocompatible according to EN ISO 10993 requirements. Therefore, Penumbra Artemis™ Neuro Evacuation Device is substantial equivalent to the predicate device.
1.11.2 Bench-Top Testing
Design Verification testing was conducted to evaluate the physical and mechanical properties of the Artemis™ Neuro Evacuation Device and demonstrate substantial equivalence to predicate. The following tests were successfully performed:
| Test | Test Method Summary | Results |
|---|---|---|
| Packaging Inspection | Confirm the packaging outputs meet all productspecifications. | 100%Pass |
| Dimensional / VisualInspection | Confirm the dimensions / visual outputs meet allproduct specifications. | 100%Pass |
| Dynamic VacuumTesting | Wand can sustain maximum vacuum and transfervacuum to distal tip of wand. | 100%Pass |
| Simulated Use | Evaluate the effectiveness of the device to generaterotational energy to remove simulated clot. | 100%Pass |
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| Tensile/Torque | All components are tested to ensure connections/joints meet all product specifications. | 100% |
|---|---|---|
| Pass | ||
| Electric Safety Testing | Compliant to requirements of IEC 60601-1 (3rd Ed.),IEC 60601-1-2, 60601-1-6, and IEC 62366. | 100% |
| Pass |
Design Verification (Bench-Top Testing) found the Penumbra Artemis™ Neuro Evacuation Device to meet all design inputs. Therefore, Penumbra Artemis™ Neuro Evacuation Device is substantially equivalent to the predicate device.
1.11.3 Sterilization
The Artemis™ Neuro Evacuation Device was validated for gamma irradiation sterilization to a 6-log sterility assurance utilizing the VDmax25 sterilization validation in accordance with ISO 11137 and ISO 11737.
1.11.4 Shelf Life
The Artemis™ Neuro Evacuation Device has a 12-month Shelf-life
1.12 Summary of Substantial Equivalence
The subject Artemis™ Neuro Evacuation Device is equivalent to the predicate Apollo System™. The subject device has an identical intended use as the predicate device. The subject device and predicate device differ slightly in regards to technological and material variations. However, these differences do not raise different questions of safety and effectiveness. The device testing described in Section 1.11 demonstrate the subject device is equivalent to the predicate device in regards to operating principle fundamental technology, materials, and device performance.
§ 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).