(98 days)
No
The description focuses on mechanical and aspiration functions, with no mention of AI/ML terms or data-driven decision making.
Yes
The device is used for the controlled aspiration of tissue and/or fluid during surgery, which directly addresses a medical condition or performs a medical function, making it a therapeutic device.
No
The Artemis™ Neuro Evacuation Device is described as a surgical instrument used to remove tissue and/or fluid, not to diagnose a condition.
No
The device description clearly outlines a physical surgical instrument ("Artemis Wand") with mechanical components (hypotube, wire) and functions (aspiration control, rotational energy generation). It connects to a physical pump and is used for physical removal of tissue/fluid. This is not a software-only device.
Based on the provided information, the Artemis™ Neuro Evacuation Device is not an IVD (In Vitro Diagnostic) device.
Here's why:
- Intended Use: The intended use is for the controlled aspiration of tissue and/or fluid during surgery of the Ventricular System or Cerebrum. This is a surgical procedure performed directly on the patient's body.
- Device Description: The device is described as a surgical instrument used for the removal of tissue and/or fluid during image-guided neurosurgery. It operates by vacuum aspiration and rotational energy to remove material from the patient's body.
- IVD Definition: In Vitro Diagnostic devices are used to examine specimens (like blood, urine, or tissue samples) outside of the body to provide information for diagnosis, monitoring, or screening.
The Artemis™ Neuro Evacuation Device is a surgical tool used in vivo (within the living body) to remove material directly from the patient during a surgical procedure. It does not analyze samples in vitro.
N/A
Intended Use / Indications for Use
The ArtemisTM 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.
Product codes
GWG
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Ventricular System or Cerebrum
Indicated Patient Age Range
Not Found
Intended User / Care Setting
physicians who have received appropriate training in image-guided neurosurgery.
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)
Summary of Non-clinical Data:
- Biocompatibility: Tests were selected in accordance with EN ISO 10993-1 guidelines and FDA Guidance. All studies were conducted pursuant to 21 CFR, Part 58, Good Laboratory Practices. Results indicate the device is non-toxic, non-sensitizing, non-irritant, non-pyrogenic, non-thrombogenic, non-hemolytic, and non-mutagenic.
- Design Verification (Bench-Top Testing): Evaluated physical and mechanical properties. Tests successfully performed include Packaging Inspection (100% Pass), Dimensional / Visual Inspection (100% Pass), Dynamic Vacuum Testing (100% Pass), Simulated Use (100% Pass), Tensile/Torque (100% Pass), and Electric Safety Testing (100% Pass, compliant with IEC 60601-1, IEC 60601-1-2, 60601-1-6, and IEC 62366).
- Sterilization: Validated for gamma irradiation sterilization to a 6-log sterility assurance utilizing the VDmax25 sterilization validation in accordance with ISO 11137 and ISO 11737.
- Shelf-life: 12-month Shelf-life.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Predetermined Change Control Plan (PCCP) - All Relevant Information
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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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
1
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
2
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 | Clearance
Date | Name of Predicate Device | Name of
Manufacturer |
|-------------------|-------------------|------------------------------------------------------------------------|-------------------------|
| 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 Evacuation
Device |
|-----------------------------------------|--------------------------------------------------|---------------------------------------------------------------------------------------|
| 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 by
Vibrational Energy | Vacuum Aspiration aided by
Rotational Energy |
| Power Source for
Mechanism of Action | Apollo Generator | Primary Cell Lithium Ion
Battery, 1.5 Volt DC Motor
contained 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 Evacuation
Device |
|---------------------------------|--------------------------|--------------------------------------------------------|
| Aspiration Tubing
Dimensions | OD: 0.188"
ID: 0.088" | OD: 0.263"
ID: 0.163" |
| Single Use or
Reusable | Single Use | SAME |
| Sterilization | EO | Gamma |
| Shelf-Life | 12-Months - Wand | SAME |
| Aspiration Pump | Apollo System Pump | Penumbra Aspiration Pump |
| IEC 60601-1
Compliance | Yes | SAME |
| IEC 60601-1-2
Compliance | 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 (Intracutaneous | ||
| Reactivity (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 (Dog | ||
| Thrombogenicity) | 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 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 |
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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.