(262 days)
The Penumbra System is intended for use in the revascularization of patients with acute ischemic stroke secondary to intracranial large vessel occlusive disease (within the internal carotid, middle cerebral - M1 and M2 segments, basilar, and vertebral arteries) within 8 hours of symptom onset. The Reperfusion Catheters ACE 64 and ACE 68 are intended for use in revascularization within the Internal Carotid Artery (ICA) within 8 hours of symptom onset.
The Penumbra System ACE components are additional components to the currently available Penumbra System / Penumbra System MAX. The Penumbra System ACE components provide a larger lumen to assist in the removal of thrombus from the neurovasculature. The devices are provided sterile, non-pyrogenic, and intended for single use only.
Here's an analysis of the provided text regarding the acceptance criteria and study for the Penumbra System ACE 64 and ACE 68 Reperfusion Catheters:
1. Table of Acceptance Criteria and Reported Device Performance
| Test | Acceptance Criteria | Reported Device Performance | Pass / Fail |
|---|---|---|---|
| Biocompatibility Testing | |||
| In Vitro Cytotoxicity | Sample extracts must yield cell lysis grade 2 or lower | Grade 1: Slight | Pass |
| Sensitization | Test Group shall yield Grade < 1 score on Magnusson and Kligman scale (provided control Grade < 1) | Grade 0: No visible change | Pass |
| Acute Intracutaneous Reactivity | The difference in the mean test article and mean control score must be grade 1.0 or lower | Grade ≤ 1.0 difference between mean test article and mean control score | Pass |
| Acute Systemic Toxicity | Sample extracts must not cause: > 10% weight loss in 3 or more test animals, Mortality of 2 or more test animals, Abnormal behavior in 2 or more test animals | No evidence of systemic toxicity from sample extracts: No weight loss (all gained weight), No death, All test animals appeared normal | Pass |
| Rabbit Pyrogen Study | Sample Extracts must not cause a total rise in body temperature of ≥ 0.5°C | Non-pyrogenic: No evidence of material-mediated pyrogenicity; no single animal had a total body temperature rise of ≥ 0.5°C | Pass |
| Hemocompatibility In Vitro Hemolysis | Sample extracts must be non-hemolytic (≤ 2% hemolytic index) | Non-hemolytic: Hemolytic Index = 0.70%, Corrected Hemolytic index = 0.00% | Pass |
| Complement Activation | The concentrations of C3a and SC5b-9 in the test samples are statistically similar to the predicate (Exposure Control & Ref Material) control and statistically lower than the positive control for all exposure times | The test sample concentrations of C3a and SC5b-9 were statistically similar or lower than the predicate control sample concentrations, and statistically lower than the positive control sample concentrations at all three exposure times | Pass |
| Dog Thrombogenicity | The device must be non-thrombogenic after 4 hours in vivo when compared to a control device (Boston Scientific Excelsior SL-10 microcatheter) | No significant thrombosis with a Grade of 0 was observed in 2 out 2 test site and 2 out of 2 control sites. Based on the evaluation criteria, the amount of thrombosis was not considered significant | Pass |
| Bench-top Testing | |||
| Dimensional/Visual Inspection | Units meet all inspection criteria for release of finished goods (clinically acceptable) product. | Pass | Pass |
| Simulated Use (Intracranial Access, Vessel Access Entry Performance & Clot Removal) | Effectiveness of devices to remove clots and that Reperfusion Catheter does not collapse under vacuum. | 100% Pass | Pass |
| Coating Integrity | Coating has not delaminated, peeled, or flaked after simulated use. | 100% Pass | Pass |
| Particulate Testing (Hydrophilic Coating) | Max particles: ≥ 10 um ≤ 6000 particles; ≥ 25 um ≤ 600 particles. | 10um 100% Pass; 25 um 100% Pass | Pass |
| Particulate Testing (Catheter/Separator) | Max particles: ≥ 10 um ≤ 6000 particles; ≥ 25 um ≤ 600 particles. | 10μm 100% Pass; 25 um 100% Pass | Pass |
| Coating Integrity (after particulate testing) | Coating is not grossly damaged after undergoing particulate testing. | 100% Pass | Pass |
| Hub/Catheter Air Aspiration | When negative pressure is pulled, no air may leak into hub. | 100% Pass | Pass |
| Pressure Test | 45 psi for 30 sec MIN | 100% Pass | Pass |
| Reperfusion Catheter/Sheath or 8F Guide & 0.014" Guidewire compatibility (Friction Force) | Maximum value per specification. | 100% Pass | Pass |
| Markerband Section Bond Strength | Minimum value per specification. | 100% Pass | Pass |
| Joint Sections Bond Strength | Minimum value per specification. | 100% Pass | Pass |
| Hub to Shaft & Hub to Hypotube Bond Strength | Minimum value per specification. | 100% Pass | Pass |
| Steam-Shaped Distal Tip Tensile | Minimum value per specification. | 100% Pass | Pass |
| Elongation to Failure | % Elongation ≥ 5% | 100% Pass | Pass |
| Kink Resistance | No kinking when formed in a defined radius. | 100% Pass | Pass |
| Corrosion | No visible corrosion on Reperfusion Catheter immediately after Corrosion Testing procedure. | 100% Pass | Pass |
| Animal Study | |||
| Vessel Injury | No vessel injury on final angiograms. | No vessel injury was noted. | Pass |
| Gross/Histology Findings | No abnormal gross or histology findings in test vessel segments. | No abnormal gross or histology findings were noted. | Pass |
| Vascular Response | No significant vascular response. | No significant vascular response. | Pass |
2. Sample Size and Data Provenance (for test sets, where applicable)
-
Biocompatibility Testing:
- In Vitro Cytotoxicity: Not specified in terms of sample size for the test itself, but implies multiple samples for extract testing.
- Sensitization: "Test Group" - size not specified.
- Acute Intracutaneous Reactivity: "mean test article and mean control score" - implies multiple samples, size not specified.
- Acute Systemic Toxicity: "3 or more test animals" (for weight loss criteria), "2 or more test animals" (for morality/behavior) - implies at least 3 animals for each extract/test (likely mice or rats, as common for this test).
- Rabbit Pyrogen Study: "No single animal" suggests multiple rabbits, specific number not stated.
- Hemocompatibility In Vitro Hemolysis: Sample extracts, size not specified.
- Complement Activation: "test samples" compared to "predicate (Exposure Control & Ref Material) control" and "positive control" at "all three exposure times." Specific number of samples not stated.
- Dog Thrombogenicity: "2 out of 2 test site and 2 out of 2 control sites" - suggests at least two test animals (dogs) for the in-vivo evaluation.
- Data Provenance: Retrospective, conducted by the manufacturer, or by external labs following GLP. Country of origin not specified, but following EN ISO 10993 guidelines.
-
Bench-top Testing:
- Sample sizes are not explicitly stated for all individual tests, but most indicate "100% Pass," which suggests the testing was performed on a sample of devices and all met the criteria. For particulate testing, the maximum number suggests a specific measurement from a sample.
- Data Provenance: Retrospective, conducted by the manufacturer.
-
Animal Study:
- Sample Size: A "swine model" was used. The number of individual animals (swine) is not explicitly stated, but the conclusions "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," and "The use of the Penumbra System ACE devices resulted in no significant vascular response in these experimental conditions," suggest sufficient animal subjects were used to support the claim.
- Data Provenance: Prospective, animal study (GLP Animal Testing).
3. Number of Experts Used and Qualifications (for ground truth establishment)
- Biocompatibility Testing: Experts in toxicology, microbiology, and animal studies would have been involved in the design and interpretation of these studies. Their specific number and qualifications are not detailed in this summary.
- Bench-top Testing: Engineers and material scientists within the manufacturer's R&D and Quality departments would have developed the specifications and assessed the results.
- Animal Study: Veterinarians, interventionalists (to perform the procedures), pathologists (for gross and histology findings), and researchers expert in animal models for vascular devices.
- Note: This document does not pertain to AI/ML or image data, so the concept of experts establishing ground truth for a test set (e.g., radiologist for image interpretation) as typically understood in AI studies is not directly applicable here. The "ground truth" here is physical/biological measurements and observations.
4. Adjudication Method (for the test set)
- Not applicable in the context of this device's non-clinical testing. Adjudication methods (like 2+1 or 3+1) are typically used for medical image interpretation where there is subjective assessment by multiple human readers (e.g., radiologists) that needs to be reconciled to establish a ground truth. The tests described are objective physical, chemical, or biological measurements.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
- No, a MRMC comparative effectiveness study was not done. This document describes the pre-market non-clinical testing of a physical medical device (catheter), not an AI/ML algorithm for diagnostic imaging or similar applications where human reader performance is augmented.
6. Standalone (Algorithm Only) Performance Study
- No, this is not an AI/ML device. Therefore, a standalone algorithm performance study was not performed.
7. Type of Ground Truth Used
- Biocompatibility Testing: The ground truth is objective biological and chemical reactions/measurements (e.g., cell lysis grade, inflammation scores, weight changes, temperature changes, hemolytic index, C3a/SC5b-9 concentrations, histopathology for thrombogenicity).
- Bench-top Testing: The ground truth is objective physical and mechanical measurements against technical specifications (e.g., dimensions, force measurements, flow rates, visual integrity, particulate counts).
- Animal Study: The ground truth is direct in-vivo observation and pathological assessment (e.g., angiographic evidence of injury, gross pathology findings, histological examination of vessel segments).
8. Sample Size for the Training Set
- Not applicable. This is a physical medical device, not an AI/ML algorithm that requires a training set. The "training" for such devices involves engineering design, material selection, and iterative prototyping based on established engineering principles and prior knowledge.
9. How the Ground Truth for the Training Set Was Established
- Not applicable, as there is no "training set" in the AI/ML sense for this device. The development process relies on engineering specifications, material science data, and established test methods, rather than a labeled dataset for algorithm training.
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Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features the department's name in a circular arrangement around a stylized symbol. The symbol consists of three human profiles facing right, with flowing lines beneath them, representing the department's mission to protect the health of all Americans.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
May 22, 2015
Penumbra, Inc. Ms. Michaela Mahl Senior Manager Regulatory Affairs 1351 Harbor Bav Parkway Alameda, California 94502
Re: K142458
Trade/Device Name: Penumbra System ACE 64 and ACE 68 Reperfusion Catheters Regulation Number: 21 CFR 870.1250 Regulation Name: Percutaneous Catheter Regulatory Class: Class II Product Code: NRY Dated: April 10, 2015 Received: April 13, 2015
Dear Ms. Michaela Mahl,
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 (reporting of medical devicerelated adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in
{1}------------------------------------------------
the quality systems (OS) 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 yours,
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) K142458
Device Name
Penumbra System ACE 64 and ACE 68 Reperfusion Catheters
Indications for Use (Describe)
The Penumbra System is intended for use in the revascularization of patients with acute ischemic stroke secondary to intracranial large vessel occlusive disease (within the internal carotid, middle cerebral - M1 and M2 segments, basilar, and vertebral arteries) within 8 hours of symptom onset. The Reperfusion Catheters ACE 64 and ACE 68 are intended for use in revascularization within the Internal Carotid Artery (ICA) within 8 hours of symptom onset.
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
(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 ACE 64 and ACE 68 Reperfusion Catheters.
1 Sponsor/Applicant Name and Address
Penumbra. Inc. 1351 Harbor Bay Parkway Alameda, CA 94502 USA
2 Sponsor Contact Information
Michaela Mahl Senior Manager, Regulatory Affairs Phone: (510) 748-3288 FAX: (510) 217-6414 Email: michaela.mahl@penumbrainc.com
3 Date of Preparation of 510(k) Summarv
May 07, 2015
4 Device Trade or Proprietary Name
Penumbra System ACE 64 and ACE 68 Reperfusion Catheters
5 Device Classification
Regulatory Class: II Classification Panel: Neurology Percutaneous Catheter Classification Name: Regulation Number: 21 CFR §870.1250 Product Code: NRY (Catheter, Thrombus Removal)
6 Predicate Devices
| 510(k) Number / ClearanceDate | Name of Predicate Device | Name of Manufacturer |
|---|---|---|
| K072718 [28Dec2007],K090752 [21Sep2009],K100769 [21May2010],K113163 [28NOV2011],K133317 [13MAY2014] | Penumbra System / ®Penumbra System MAX | Penumbra, Inc.1351 Harbor Bay ParkwayAlameda, CA 94502 USA |
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7 Predicate Comparison
| System Name | Penumbra SystemReperfusion Catheter | Penumbra System ACEReperfusion Catheter | |
|---|---|---|---|
| Device Name | 5MAX ACE | ACE 64 | ACE 68 |
| 510(k) No. | K090752 | K142458 | SAME |
| Classification | Class II, NRY | SAME | |
| Indication | The Penumbra System isintended for use in therevascularization of patientswith acute ischemic strokesecondary to intracranial largevessel occlusive disease (withinthe internal carotid, middlecerebral - M1 and M2segments, basilar, and vertebralarteries) within 8 hours ofsymptom onset. | The Penumbra System is intended foruse in the revascularization of patientswith acute ischemic stroke secondaryto intracranial large vessel occlusivedisease (within the internal carotid,middle cerebral – M1 and M2segments, basilar, and vertebralarteries) within 8 hours of symptomonset. The Reperfusion Catheters ACE64 and ACE 68 are intended for use inrevascularization within the InternalCarotid Artery (ICA) within 8 hours ofsymptom onset. | |
| Materials | |||
| Proximal hub | Grilamid (TR55-LX) | SAME | |
| Strain Relief [Hub Sleeve] | Grilamid (TR55) | SAME | |
| Strain Relief | Stainless Steel, 304 | SAME | |
| ID Band | Polyolefin, PET yellow [blackink] | SAME | |
| Catheter Shaft | |||
| Distal Extrusions | Tecoflex 80A, Pellethane 80A,Pebas 35D, Pebax 35D/40DBlend, Pebax 40D, Pebax 55D,Pebax 63D | Pellethane 80A, Tecoflex 80A,Tecoflex 80A/Pebax 35D, Pebax 35D,Pebax 35D/40D Blend, Pebax 40D,Pebax 40D/55D Blend, Pebax 55D,Pebax 63D | |
| Proximal Extrusions | Pebax 55D, Pebax 72D,Vestamid | Pebax 55D, Pebax72D, Vestamid | Pebax 55D/72DBlend, Pebax72D, Vestamid |
| Proximal CoilReinformcement | SS flat (0.002 in x 0.007 in) | SS flat (0.0015 in x0.006 in) and SSround (0.0025 in) | SS flat (0.0015in x 0.006 in)and NiTi round(0.0025 in) |
| Extrusion Colorants | Clear/ Natural or Purple | SAME | |
| Tip Shape | Straight | SAME | |
| Markerband | C-cut Pt/Ir band | SAME | |
| Coating | SRDX Harmony (proprietary) | SAME | |
| Dimensions | |||
| Proximal OD | 0.083 in Max | 0.084 in Max | 0.084 in Max |
| Proximal ID | 0.068 in Min | 0.068 in Min | 0.068 in Min |
| Distal OD | 0.074 in Max | 0.080 in Max | 0.084 in Max |
| System Name | Penumbra SystemReperfusion Catheter | Penumbra System ACEReperfusion Catheter | |
| Device Name | 5MAX ACE | ACE 64 | ACE 68 |
| Distal ID | 0.060 in Min | 0.064 in Min | 0.068 in Min |
| Effective Length | 125, 127, 132 cm | 115, 120, 125, 127, 132 cm | |
| Coating Length | 30 cm | SAME | |
| Accessories | |||
| Peelable Sheath | PTFE | SAME | |
| Rotating Hemostasis Valve | Polycarbonate, silicone o-ring | SAME | |
| Shaping Mandrel | 0.038in OD | SAME | |
| Packaging Materials | |||
| Pouch | Polyester/Polyethylene/Tyvek® | SAME | |
| Packaging Hoop | Polyethylene | SAME | |
| Packaging Card | Polyethylene | SAME | |
| Display Carton | SBS Paperboard | SAME | |
| Packaging Configuration | Individual | SAME | |
| Sterilization | EO | SAME | |
| Shelf-Life | 36 Months | SAME |
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Device Description 8
The Penumbra System ACE components are additional components to the currently available Penumbra System / Penumbra System MAX. The Penumbra System ACE components provide a larger lumen to assist in the removal of thrombus from the neurovasculature. The devices are provided sterile, non-pyrogenic, and intended for single use only.
9 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 (within the internal carotid, middle cerebral - M1 and M2 segments, basilar, and vertebral arteries) within 8 hours of symptom onset. The Reperfusion Catheters ACE 64 and ACE 68 are intended for use in revascularization within the Internal Carotid Artery (ICA) within 8 hours of symptom onset.
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10 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 substantial equivalence of the device follows.
Included in this section are summary descriptions of the testing, which substantiates the performance of the subject Penumbra System ACE 64 and ACE 68 as well as its substantial equivalence to the predicate devices:
- . Biocompatibility
- Design Verification (Bench-Top Testing) •
- Design Validation (GLP Animal Testing) .
The subject Penumbra System ACE 64 and ACE 68 devices met all established requirements.
10.1 Biocompatibility Testing
Biocompatibility tests conducted on the materials of the Penumbra System ACE devices were selected in accordance with EN 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 ACE devices to be biocompatible according to the requirements of EN ISO 10993 requirements. The following tests were performed and all tests passed successfully:
| Test | Acceptance Criteria | Results | Pass / Fail |
|---|---|---|---|
| In Vitro Cytotoxicity | Sample extracts must yield celllysis grade 2 or lower | Grade 1: Slight | Pass |
| Sensitization | Test Group shall yield Grade <1 score on Magnusson andKligman scale (providedcontrol Grade < 1) | Grade 0: No visible change | Pass |
| Acute IntracutaneousReactivity (Irritation) | The difference in the mean testarticle and mean control scoremust be grade 1.0 or lower | Grade ≤ 1.0 differencebetween mean test articleand mean control score | Pass |
| Acute Systemic Toxicity | Sample extracts must not causethe following:• > 10% weight loss in 3 ormore test animals• Mortality of 2 or more testanimals• Abnormal behavior in 2 ormore test animals | No evidence of systemictoxicity from sampleextracts• No weight loss (all gainedweight)• No death• All test animals appearednormal | Pass |
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| Test | Acceptance Criteria | Results | Pass / Fail |
|---|---|---|---|
| Rabbit Pyrogen Study | Sample Extracts must notcause a total rise in bodytemperature of $≥0.5°C$ | Non-pyrogenic: Noevidence of material-mediated pyrogenicity; nosingle animal had a totalbody temperature rise of$≥0.5°C$ | Pass |
| HemocompatibilityIn Vitro Hemolysis | Sample extracts must be non-hemolytic ( $≤$ 2% hemolyticindex) | Non-hemolytic:Hemolytic Index = 0.70%Corrected Hemolytic index= 0.00% | Pass |
| Complement Activation | The concentrations of C3a andSC5b-9 in the test samples arestatistically similar to thepredicate (Exposure Control &Ref Material) control andstatistically lower than thepositive control for allexposure times | The test sampleconcentrations of C3a andSC5b-9 were statisticallysimilar or lower than thepredicate control sampleconcentrations, andstatistically lower than thepositive control sampleconcentrations at all threeexposure times | Pass |
| Dog Thrombogenicity | The device must be non-thrombogenic after 4 hours invivo when compared to acontrol device (BostonScientific Excelsior SL-10microcatheter) | No significant thrombosiswith a Grade of 0 wasobserved in 2 out 2 test siteand 2 out of 2 control sites.Based on the evaluationcriteria, the amount ofthrombosis was notconsidered significant | Pass |
In summary non-clinical testing substantiates that the Penumbra System ACE devices are non-cytotoxic, non-sensitizing, non-irritating, non-toxic, nonpyrogenic, non-hemolytic, and non-thrombogenic.
10.2 Bench-top Testing
The physical and mechanical properties of the Penumbra System ACE devices were assessed using standard test methods and pre-determined acceptance criteria. The following tests were performed and all tests passed successfully:
| Attribute | Specification | Acceptance Criteria | Results |
|---|---|---|---|
| Dimensional/Visual Inspection | These evaluations confirm that the units used in thisDesign Verification testing meet all inspectioncriteria for release of finished goods (clinicallyacceptable) product. | Pass | |
| Attribute | Specification | AcceptanceCriteria | Results |
| Simulated Use(IntracranialAccess, VesselAccess EntryPerformance &Clot Removal) | Simulated use testing of the Reperfusion Catheterand Separator was performed with accessorydevices in an anatomical model which simulated thetortuosity of the neurovasculature. Devices weredelivered through the tortuous anatomical model toevaluate the effectiveness of the devices to removeclots and that the Reperfusion Catheter does notcollapse under vacuum. | 100% Pass | |
| Torsion(ReperfusionCatheter) | Number of turns will berecorded | Data was recorded for informationalpurposes only | |
| Injection FlowRate | Injection flow rate will berecorded for various pressuresettings | Data was recorded for informationalpurposes only | |
| Flow Rate | Flow rate (cc/min) with andwithout Separator in test articlelumen will be reported | Data was recorded for informationalpurposes only | |
| ReperfusionCatheter TipPressure | Aspiration (Suction) Pressureand Pump MAX vacuumpressure will be reported | Data was recorded for informationalpurposes only | |
| Coating Integrity | Coating has not delaminated.peeled, or flaked after simulateduse | 100% MustmeetSpecification | 100% Pass |
| ParticulateTesting(ReperfusionCatheterHydrophilicCoating) | The maximum number ofparticles:≥ 10 um will be ≤ 6000 particles≥ 25 um will be ≤ 600 particles. | 100% MustmeetSpecification | 10um100% Pass25 um100% Pass |
| ≥ 75 µm & ≥ 125 µm will berecorded | Data was recorded for informationalpurposes only | ||
| ParticulateTesting(ReperfusionCatheter/Separator) | The maximum number ofparticles:≥ 10 um will be ≤ 6000 particles≥ 25 um will be ≤ 600 particles. | 100% MustmeetSpecification | 10μm100% Pass25 um100% Pass |
| ≥ 75 um & ≥ 125 um will berecorded | Data was recorded for informationalpurposes only | ||
| Coating Integrity | Coating is not grossly damagedafter undergoing particulatetesting | 100% MustmeetSpecification | 100% Pass |
| Hub/Catheter AirAspiration | When negative pressure ispulled, no air may leak into hub | 100% MustmeetSpecification | 100% Pass |
| Pressure Test | 45 psi for 30 sec MIN | 100% MustmeetSpecification | 100% Pass |
| Attribute | Specification | AcceptanceCriteria | Results |
| ReperfusionCatheter/Sheathor 8F Guide &0.014"Guidewirecompatibility(Friction Force) | Maximum value perspecification | 100% MustmeetSpecification | 100% Pass |
| MarkerbandSection BondStrength | Minimum value per specification | 100% MustmeetSpecification | 100% Pass |
| Joint SectionsBond Strength | Minimum value per specification | 100% MustmeetSpecification | 100% Pass |
| Hub to Shaft &Hub to HypotubeBond Strength | Minimum value per specification | 100% MustmeetSpecification | 100% Pass |
| Steam-ShapedDistal TipTensile | Minimum value per specification | 100% MustmeetSpecification | 100% Pass |
| Elongation toFailure -ReperfusionCatheter | % Elongation ≥ 5% | 100% MustmeetSpecification | 100% Pass |
| Kink Resistance | No kinking when formed in adefined radius | 100% MustmeetSpecification | 100% Pass |
| Corrosion | No visible corrosion onReperfusion Catheterimmediately after CorrosionTesting procedure | 100% MustmeetSpecification | 100% Pass |
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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 subject Penumbra System ACE devices are acceptable for the intended use and substantially equivalent to the predicate device.
10.3 Animal Study
An animal study was conducted to evaluate the safe use of the Penumbra System ACE devices 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.
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- The use of the Penumbra System ACE devices resulted in no significant • vascular response in these experimental conditions.
10.4 Summary of Substantial Equivalence
The subject Penumbra System ACE devices are substantially equivalent to the predicate device with regard to intended use, operating principle, design concept, materials, shelf-life, packaging and sterilization processes.
§ 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).