(28 days)
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.
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.
The Penumbra System® MAX components are additional components of the currently available Penumbra System. The summary of non-clinical data details the testing that substantiates the safe and effective performance of the Neuron MAX System and its substantial equivalence to predicate devices. This includes Biocompatibility testing, Design Verification (Bench-Top Testing), and an Animal study.
Here's a breakdown of the requested information:
1. Table of Acceptance Criteria and the Reported Device Performance
The acceptance criteria for each test were "Pass," meaning the device met the established requirements for each attribute.
| Test / Test Subject | Attribute | Reported Device Performance (Result) |
|---|---|---|
| Biocompatibility Testing | ||
| In Vitro Cytotoxicity | No evidence of cell lysis or toxicity | No evidence of cell lysis or toxicity |
| Acute Intracutaneous Reactivity (Irritation) | No evidence of irritation | No evidence of irritation |
| Acute Systemic Toxicity | No evidence of systemic toxicity | No evidence of systemic toxicity |
| Rabbit Pyrogen Study | No evidence of material-mediated pyrogenicity | No evidence of material-mediated pyrogenicity |
| Sensitization | Non-Sensitizing | Non-Sensitizing |
| Hemo-compatibility - In Vitro Hemolysis | Non-hemolytic | Non-hemolytic |
| Hemo-compatibility - In Vitro Coagulation (PT, PTT) | Coagulation times are within the normal range; Non-Thrombogenic | Within normal range; Non-Thrombogenic |
| Hemo-compatibility - Complement Activation | No greater biological response than corresponding control | No greater biological response than corresponding control |
| Bench-top Testing (Reperfusion Catheters) | ||
| Pouch Seal | Pouch Seal Strength | Pass |
| Dimensional / Visual Inspection | Units meet all inspection criteria for release of finished goods (clinically acceptable) product. | Pass |
| Simulated Use [Intracranial Access & Thrombus Removal] | Units meet all inspection criteria for release of finished goods (clinically acceptable) product. | Pass |
| Reperfusion Catheter 3MAX / Reperfusion Catheter 4MAX | Hub /Shaft & Hub / HypotubeTensile Strength | Pass |
| Reperfusion Catheter 3MAX / Reperfusion Catheter 4MAX | Joint Tensile Strength | Pass |
| Reperfusion Catheter 3MAX / Reperfusion Catheter 4MAX | Hub Air Aspiration | Pass |
| Reperfusion Catheter 3MAX / Reperfusion Catheter 4MAX | Burst Test | Pass |
| Reperfusion Catheter 3MAX / Reperfusion Catheter 4MAX | Particulate Testing (Hydrophilic Coating) | Pass |
| Reperfusion Catheter4MAX / Sheath or 8F Guide compatibility (Friction Force) | Pass | |
| Reperfusion Catheter 4MAX / 0.014" Guidewire compatibility (Friction Force) | Pass | |
| Reperfusion Catheter 3MAX / Reperfusion Catheter 054 (Friction Force) | Friction Force | Pass |
| Reperfusion Catheter 3MAX / 0.014" Guide wire compatibility (Friction Force) | Pass | |
| Reperfusion Catheter 3MAX / Reperfusion Catheter 4MAX | Flow Rate | Pass |
| Reperfusion Catheter 3MAX / Reperfusion Catheter 4MAX | Elongation to Failure | Pass |
| Reperfusion Catheter 3MAX / Reperfusion Catheter 4MAX | Corrosion | Pass |
| Reperfusion Catheter 3MAX / Reperfusion Catheter 4MAX | Torsion | Pass |
| Bench-top Testing (Separator 3MAX) | ||
| Dimensional / Visual Inspection (all sizes) | Units meet all inspection criteria for release of finished goods (clinically acceptable) product. | Pass |
| Simulated Use: Hub Transition | Pass | |
| Reperfusion Catheter 3MAX / Separator 3MAX / Aspiration Tubing Assembly Performance | Tracking | Pass |
| Reperfusion Catheter 3MAX / Separator 3MAX / Aspiration Tubing Assembly Performance | Separator 3MAX & Reperfusion Catheter Compatible | Pass |
| Reperfusion Catheter 3MAX / Separator 3MAX / Aspiration Tubing Assembly Performance | Separator 3MAX / Reperfusion Catheter / Pump and accessories / Aspiration Tubing (Aspiration Remove Clot) | Pass |
| Reperfusion Catheter 3MAX / Separator 3MAX / Aspiration Tubing Assembly Performance | Separator 3MAX and Reperfusion Catheter Compatibility (Separator Advance / Retract) | Pass |
| Separator Bond Joint Test | Separator 054 and Wire Joint Break Force | Pass |
| Separator Bond Joint Test | Separator 041 and Wire Joint Break Force | Pass |
| Separator Bond Joint Test | Separator 032 and Wire Joint Break Force | Pass |
| Separator Bond Joint Test | Separator 026 and Wire Joint Break Force | Pass |
| Separator Bond Joint Test | Separator 3MAX and Wire Joint Break Force | Pass |
| Animal Study | ||
| Safe use of Penumbra System MAX in swine model | No vessel injury noted on final angiograms following the vessel response procedure. No abnormal gross or histology findings in test vessel segments. No significant vascular response. | No vessel injury; No abnormal findings; No significant vascular response |
2. Sample Size Used for the Test Set and the Data Provenance
- Bench-top Testing: Sample sizes for individual tests ranged from 3 to 30 units (e.g., N=30 for Pouch Seal Strength, N=10 for Particulate Testing, N=3 for Flow Rate). The data provenance is internal laboratory testing ("All studies were conducted using good scientific practices and statistical sampling methods as required by the Penumbra Design Control procedures. All testing was performed using units which were 2x sterilized and met finished goods release requirements."). This is considered retrospective data from a manufacturing/design verification process.
- Biocompatibility Testing: The document does not specify exact sample sizes for each biocompatibility test but states that "All studies were conducted pursuant to 21 CFR, Part 58, Good Laboratory Practices," which implies standard laboratory animal testing where applicable (e.g., Rabbit Pyrogen Study, Acute Intracutaneous Reactivity, Acute Systemic Toxicity, Sensitization). This data is from controlled laboratory experiments.
- Animal Study: The document mentions "An animal study was conducted to evaluate the safe use of the Penumbra System MAX in a swine model." The exact sample size for the animal study is not explicitly provided in the summary, but it refers to "experimental conditions" and "test vessel segments," suggesting a controlled study within a lab setting. This is prospective animal data.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and the Qualifications of those Experts
Not applicable. The studies described are non-clinical (bench-top, biocompatibility, animal studies) and do not involve human diagnostic or treatment decision-making where expert consensus would establish ground truth for a test set. The "ground truth" here is determined by objective physical, mechanical, biological, or physiological measurements against predefined engineering and biological safety standards.
4. Adjudication Method for the Test Set
Not applicable. As noted above, these are non-clinical studies. The results are objective measurements/observations (e.g., "Pass," "No evidence of toxicity," "No vessel injury") rather than interpretations requiring adjudication among human experts.
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
Not applicable. This document describes the safety and effectiveness testing of a physical medical device (catheter system) for mechanical thrombus removal, not an AI or imaging-based diagnostic device that would involve human readers.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
Not applicable. This document describes a physical medical device.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
The ground truth for these non-clinical studies was established by:
- Predefined engineering specifications and performance parameters for mechanical and physical properties.
- Established international and national standards for biocompatibility (e.g., ISO 10993, USP, ASTM, 21 CFR Part 58).
- Physiological observations, angiographic evaluations, gross pathology, and histology in the animal model.
8. The Sample Size for the Training Set
Not applicable. This document refers to the testing of a physical medical device. There is no "training set" in the context of machine learning or AI. The design verification and biocompatibility testing involved various "test units" or "samples" for specific tests, as detailed in the table, to ensure the device met its design specifications.
9. How the Ground Truth for the Training Set was Established
Not applicable, for the same reason as #8. Ground truth in this context refers to the defined specifications and standards the device was designed to meet and was tested against.
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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 ofManufacturer |
|---|---|---|
| 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
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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 (<24 hours), external-communicating devices, contacting circulating blood. All studies were conducted pursuant to 21 CFR, Part 58, Good Laboratory Practices. In summary, non-clinical testing found the Penumbra System MAX components to be biocompatible according to the requirements of ISO 10993 requirements, including:
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| Test | Method | Results |
|---|---|---|
| In VitroCytotoxicity | ISO Elution Test (MEMExtract) | No evidence of cell lysis ortoxicity |
| AcuteIntracutaneousReactivity(Irritation) | ISO Intracutaneous(Intradermal) Injection Test | No evidence of irritation |
| Acute SystemicToxicity | ISO Acute Systemic InjectionTest | No evidence of systemictoxicity |
| Rabbit PyrogenStudy | USP Material-MediatedRabbit Pyrogen Test | No evidence of material-mediated pyrogenicity |
| Sensitization | ISO Maximization Test forDelayed Hypersensitivity | Non-Sensitizing |
| Hemo-compatibility | ||
| -In VitroHemolysis | ASTM Methode (Extraction &Direct Contact) | Non-hemolytic |
| -In VitroCoagulation (PT,PTT) | Prothrombin Time (PT) Assay | Coagulation times are withinthe normal rang |
| Partial Thromboplastin Time(PTT) Assay | Non-Thrombogenic | |
| -ComplementActivation | C3a and SC5b-9 throughEnzyme Assay | No greater biological responsethan corresponding control |
10.9.2 Bench-top Testing
The physical, mechanical and performance testing of the Penumbra System MAX components demonstrates that the devices are substantially equivalent to the currently marketed predicate devices:
Design Verification testing was conducted to evaluate the physical and mechanical properties of the Penumbra System MAX components. All studies were conducted using good scientific practices and statistical sampling methods as required by the Penumbra Design Control procedures. All testing was performed using units which were 2x sterilized and met finished goods release requirements. The tests performed on the Penumbra System MAX components included:
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113163 P. 4/5
| Test / Test Subject | Attribute | Sample Size | Result |
|---|---|---|---|
| Pouch Seal | Pouch Seal Strength | 30 | Pass |
| Dimensional / VisualInspection | These evaluations confirm that the units used in this Design Verification testing meetall inspection criteria for release of finished goods (clinically acceptable) product. | Pass | |
| Simulated Use[Intracranial Access &Thrombus Removal] | These evaluations confirm that the units used in this Design Verification testing meetall inspection criteria for release of finished goods (clinically acceptable) product. | Pass | |
| Reperfusion Catheter 3MAX /Reperfusion Catheter 4MAX | Hub /Shaft & Hub / HypotubeTensile Strength | 30 | Pass |
| Reperfusion Catheter 3MAX /Reperfusion Catheter 4MAX | Joint Tensile Strength | 30 | Pass |
| Reperfusion Catheter 3MAX /Reperfusion Catheter 4MAX | Hub Air Aspiration | 30 | Pass |
| Reperfusion Catheter 3MAX /Reperfusion Catheter 4MAX | Burst Test | 30 | Pass |
| Reperfusion Catheter 3MAX /Reperfusion Catheter 4MAX | Particulate Testing (Hydrophilic Coating) | 10 | Pass |
| Reperfusion Catheter4MAX/Sheath or 8F Guidecompatibility(Friction Force) | Pass | ||
| Reperfusion Catheter 4MAX/0.014" Guidewire compatibility(Friction Force) | Pass | ||
| Reperfusion Catheter 3MAX/Reperfusion Catheter 054(Friction Force) | Friction Force | 30 | Pass |
| Reperfusion Catheter 3MAX/0.014" Guide wirecompatibility(Friction Force) | Pass | ||
| Reperfusion Catheter 3MAX /Reperfusion Catheter 4MAX | Flow Rate | 3 | Pass |
| Reperfusion Catheter 3MAX /Reperfusion Catheter 4MAX | Elongation to Failure | 30 | Pass |
| Reperfusion Catheter 3MAX /Reperfusion Catheter 4MAX | Corrosion | 30 | Pass |
| Reperfusion Catheter 3MAX /Reperfusion Catheter 4MAX | Torsion | 30 | Pass |
Design Verification (Bench-Top Testing) Summary – Reperfusion Catheters
Design Verification (Bench-Top Testing) Summary - Separator 3MAX
| Test / Test Subject | Attribute | SampleSize | Result |
|---|---|---|---|
| Dimensional / Visual Inspection(all sizes) | These evaluations confirm that the units used in this DesignVerification testing meet all inspection criteria for release offinished goods (clinically acceptable) product. | Pass | |
| Simulated Use: | Hub Transition | N=30 | Pass |
| Reperfusion Catheter 3MAX /Separator 3MAX / AspirationTubing Assembly Performance | Tracking | N=30 | Pass |
| Separator 3MAX & Reperfusion CatheterCompatible | N=30 | Pass | |
| Separator 3MAX / Reperfusion Catheter / Pumpand accessories / Aspiration Tubing (AspirationRemove Clot) | N=30 | Pass | |
| Separator 3MAX and Reperfusion Catheter | N=30 | Pass |
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| Test / Test Subject . | Attribute | SampleSize | Result |
|---|---|---|---|
| Compatibility (Separator Advance / Retract) | |||
| Separator Bond Joint Test | Separator 054 and Wire Joint Break Force | N=30 | Pass |
| Separator Bond Joint Test | Separator 041 and Wire Joint Break Force | N=30 | Pass |
| Separator Bond Joint Test | Separator 032 and Wire Joint Break Force | N=30 | Pass |
| Separator Bond Joint Test | Separator 026 and Wire Joint Break Force | N=30 | Pass |
| Separator Bond Joint Test | Separator 3MAX and Wire Joint Break Force | N=30 | Pass |
The results of the tests appropriately address the physical and mechanical performance expectations of the device. This is further supported by the surgical handling and performance results reported in the in vivo study. Based on these overall results, the physical and mechanical properties of the Penumbra System MAX components are acceptable for the intended use and substantially equivalent to the predicate devices.
10.9.3 Animal Study
An animal study was conducted to evaluate the safe use of the Penumbra System MAX in a swine model. The study concluded that:
- No vessel injury was noted on the final angiograms following the vessel . response procedure.
- . No abnormal gross or histology findings were noted in test vessel segments.
- . The use of the Penumbra System MAX components resulted in no significant vascular response in these experimental conditions.
10.9.4 Summary of Substantial Equivalence
The Penumbra System MAX components are substantially equivalent to the predicate devices with regard to intended use, operating principle, design concept, materials, shelf-life, packaging and sterilization processes.
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Image /page/5/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle with three lines representing its wings, and the text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" arranged in a circular fashion around the eagle. The logo is black and white and appears to be a simple, vectorized design.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002
Penumbra, Inc. c/o Mr. Seth A. Schulman Director, Regulatory Affairs 1351 Harbor Bay Parkway Alameda, CA 94502
NOV 2 3 2011
Re: K113163
Trade/Device Name: Penumbra System® MAX Regulation Number: 21 CFR 870.1250 Regulation Name: Percutaneous Catheter Regulatory Class: Class II Product Code: NR Y Dated: October 25, 2011 Received: October 26, 2011
Dear Mr. Schulman:
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.
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Page 2 - Mr. Seth A. Schulman
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 (reporting of medical device-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 go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR 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 Small Manufacturers, International and Consumer Assistance 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.
Sincerety Vours.
.
Melvin R. Felder, MD
Malvina B. Eydelman, M.D. Director Division of Ophthalmic, Neurological, and Ear. Nose and Throat Devices Office of Device Evaluation · Center for Devices and Radiological Health
Enclosure
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Statement of Indication for Use 11
| Indications for Use |
|---|
| --------------------- |
| 510(k) Number (if known): | K113163 |
|---|---|
| Device Name: | Penumbra System® MAX |
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.
Prescription Use X (Part 21 CFR 801 Subpart D)
AND/OR Over The Counter Use (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)
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
§ 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).