(28 days)
No
The summary describes a mechanical thrombectomy device and its components. There is no mention of AI, ML, image processing, or any software-based analysis that would suggest the use of these technologies. The performance studies are focused on mechanical and biological properties.
Yes
The device is described as being used for "revascularization of patients with acute ischemic stroke secondary to intracranial large vessel occlusive disease," which is a therapeutic intervention.
No
Explanation: The device description states its purpose is "the revascularization of patients with acute ischemic stroke secondary to intracranial large vessel occlusive disease" and to "assist in the efficient removal of thrombus from the brain." This indicates a therapeutic or interventional function, not a diagnostic one.
No
The device description explicitly states it includes "additional components" and describes physical and mechanical properties, bench-top testing, and animal studies related to hardware. It is a system with physical components for thrombus removal.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for the "revascularization of patients with acute ischemic stroke secondary to intracranial large vessel occlusive disease." This describes a therapeutic intervention performed directly on the patient's body to restore blood flow.
- Device Description: The device is described as components of a system designed to "assist in the efficient removal of thrombus from the brain." This is a mechanical device used for a physical procedure.
- Lack of IVD Characteristics: IVD devices are used to examine specimens derived from the human body (like blood, urine, tissue) to provide information for diagnosis, monitoring, or screening. This device does not interact with such specimens in this manner.
- Performance Studies: The performance studies focus on biocompatibility, mechanical properties (bench-top testing), and animal studies evaluating safe use in a living organism. These are typical evaluations for therapeutic medical devices, not IVDs.
In summary, the Penumbra System is a therapeutic medical device used for a procedure within the body, not a diagnostic device used to analyze samples outside the body.
N/A
Intended Use / Indications for Use
The Penumbra System is intended for use in the revascularization of patients with acute ischemic stroke secondary to intracranial large vessel occlusive disease (in the internal carotid, middle cerebral - M1 and M2 segments, basilar, and vertebral arteries) within 8 hours of symptom onset.
Product codes
NRY
Device Description
The Penumbra System MAX components are additional components of the currently available Penumbra System. The Penumbra System MAX components provide a larger lumen to assist in the efficient removal of thrombus from the brain. The devices are provided sterile, non-pyrogenic, and intended for single use only.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
intracranial large vessel occlusive disease (in the internal carotid, middle cerebral - M1 and M2 segments, basilar, and vertebral arteries)
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)
Biocompatibility Testing:
- In Vitro Cytotoxicity (ISO Elution Test (MEM Extract)): No evidence of cell lysis or toxicity
- Acute Intracutaneous Reactivity (Irritation) (ISO Intracutaneous (Intradermal) Injection Test): No evidence of irritation
- Acute Systemic Toxicity (ISO Acute Systemic Injection Test): No evidence of systemic toxicity
- Rabbit Pyrogen Study (USP Material-Mediated Rabbit Pyrogen Test): No evidence of material-mediated pyrogenicity
- Sensitization (ISO Maximization Test for Delayed Hypersensitivity): Non-Sensitizing
- Hemo-compatibility (In Vitro Hemolysis, In Vitro Coagulation (PT, PTT), Complement Activation): Non-hemolytic, Coagulation times are within the normal range, Non-Thrombogenic, No greater biological response than corresponding control
Bench-top Testing:
- Pouch Seal (Pouch Seal Strength): Sample Size 30, Result Pass
- Dimensional / Visual Inspection: Result Pass
- Simulated Use (Intracranial Access & Thrombus Removal): Result Pass
- Reperfusion Catheter 3MAX / Reperfusion Catheter 4MAX (Hub /Shaft & Hub / HypotubeTensile Strength): Sample Size 30, Result Pass
- Reperfusion Catheter 3MAX / Reperfusion Catheter 4MAX (Joint Tensile Strength): Sample Size 30, Result Pass
- Reperfusion Catheter 3MAX / Reperfusion Catheter 4MAX (Hub Air Aspiration): Sample Size 30, Result Pass
- Reperfusion Catheter 3MAX / Reperfusion Catheter 4MAX (Burst Test): Sample Size 30, Result Pass
- Reperfusion Catheter 3MAX / Reperfusion Catheter 4MAX (Particulate Testing (Hydrophilic Coating)): Sample Size 10, Result Pass
- Reperfusion Catheter4MAX / Sheath or 8F Guide compatibility (Friction Force): Result Pass
- Reperfusion Catheter 4MAX / 0.014" Guidewire compatibility (Friction Force): Result Pass
- Reperfusion Catheter 3MAX / Reperfusion Catheter 054 (Friction Force): Sample Size 30, Result Pass
- Reperfusion Catheter 3MAX / 0.014" Guide wire compatibility (Friction Force): Result Pass
- Reperfusion Catheter 3MAX / Reperfusion Catheter 4MAX (Flow Rate): Sample Size 3, Result Pass
- Reperfusion Catheter 3MAX / Reperfusion Catheter 4MAX (Elongation to Failure): Sample Size 30, Result Pass
- Reperfusion Catheter 3MAX / Reperfusion Catheter 4MAX (Corrosion): Sample Size 30, Result Pass
- Reperfusion Catheter 3MAX / Reperfusion Catheter 4MAX (Torsion): Sample Size 30, Result Pass
- Separator 3MAX: Dimensional / Visual Inspection (all sizes): Result Pass
- Simulated Use: Hub Transition: N=30, Result Pass
- Reperfusion Catheter 3MAX / Separator 3MAX / Aspiration Tubing Assembly Performance (Tracking): N=30, Result Pass
- Separator 3MAX & Reperfusion Catheter Compatible: N=30, Result Pass
- Separator 3MAX / Reperfusion Catheter / Pump and accessories / Aspiration Tubing (Aspiration Remove Clot): N=30, Result Pass
- Separator 3MAX and Reperfusion Catheter Compatibility (Separator Advance / Retract): N=30, Result Pass
- Separator Bond Joint Test:
- Separator 054 and Wire Joint Break Force: N=30, Result Pass
- Separator 041 and Wire Joint Break Force: N=30, Result Pass
- Separator 032 and Wire Joint Break Force: N=30, Result Pass
- Separator 026 and Wire Joint Break Force: N=30, Result Pass
- Separator 3MAX and Wire Joint Break Force: N=30, Result Pass
Animal Study:
- Study concluded no vessel injury, no abnormal gross or histology findings, and no significant vascular response in test vessel segments.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 870.1250 Percutaneous catheter.
(a)
Identification. A percutaneous catheter is a device that is introduced into a vein or artery through the skin using a dilator and a sheath (introducer) or guide wire.(b)
Classification. Class II (performance standards).
0
NOV 2 3 2011
KIL3163 ps/5
10 510(k) Summary of Safety & Effectiveness
(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 Penumbra System® MAX components.
10.1 Sponsor/Applicant Name and Address
Penumbra, Inc. 1351 Harbor Bay Parkway Alameda, CA 94502, USA
10.2 Sponsor Contact Information
Seth Schulman Director, Regulatory Affairs Phone: (510) 748-3223 FAX: (510) 217-6414 Email: seth.schulman@penumbrainc.com
10.3 Date of Preparation of 510(k) Summary
October 24, 2011
10.4 Device Trade or Proprietary Name
Penumbra System® MAX
10.5 Device Classification
Regulatory Class: II Cardiovascular Classification Panel: Classification Name: Catheter, Thrombus Removal 21 CFR §870.1250 Regulation Number: Product Code: NRY
10.6 Predicate Devices
| 510(k) Number /
Clearance Date | Name of Predicate Device | Name of
Manufacturer |
|-----------------------------------|--------------------------------------------------------|-------------------------|
| K072718 [28Dec2007] | Penumbra System [026, 032, 041] | Penumbra, Inc. |
| K090752 [21Sep2009] | Penumbra System [054] | Penumbra, Inc. |
| K100769 [21May2010] | Penumbra System Separator Flex
[026, 032, 041, 054] | Penumbra, Inc. |
10.7 Device Description
The Penumbra System MAX components are additional components of the currently available Penumbra System. The Penumbra System MAX components provide a larger lumen to assist in the efficient removal of thrombus from the
1
KL13163
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brain. The devices are provided sterile, non-pyrogenic, and intended for single use only.
10.8 Intended Use
The Penumbra System is intended for use in the revascularization of patients with acute ischemic stroke secondary to intracranial large vessel occlusive disease (in the internal carotid, middle cerebral - M1 and M2 segments, basilar, and vertebral arteries) within 8 hours of symptom onset.
10.9 Summary of Non-Clinical Data
As required under Section 12, Part (a)(i)(3A) of the Safe Medical Devices Act of 1990, a summary of any information regarding safety and effectiveness of the device follows.
Included in this section are descriptions of the testing's, which substantiates the safe and effective performance of the Neuron MAX System as well as its substantial equivalence to the predicate devices:
- Biocompatibility .
- Design Verification (Bench-Top Testing) .
- Animal Study .
The subject Penumbra System MAX components met all established requirements.
10.9.1 Biocompatibility Testing
The Penumbra System MAX components were classified in accordance with ISO 10993 -1 guidelines (Biological Evaluation of Medical Devices) for limited duration ( Concurrence of CDRH, Office of Device Evaluation (ODE) JEFFREY TOY
(Division Sign-Off) Division of Ophthalmic, Neurological and Ear, Nose and Throat Devices
510(k) Number