Who is the manufacturer of Penumbra System ACE?

Penumbra, Inc. filed the 510(k) submission for Penumbra System ACE (K142458).

What is the FDA product code for Penumbra System ACE?

NRY. It is classified under 21 CFR 870.1250 as a Class 2 device in the Cardiovascular panel.

What is the regulatory pathway for Penumbra System ACE?

510(k) clearance (submission type: Traditional).

What are the predicate devices for Penumbra System ACE?

Penumbra System / Penumbra System MAX (K072718, K090752, K100769, K113163, K133317).

Who can help prepare an FDA 510(k) submission like Penumbra System ACE?

Innolitics — a medical-device software consultancy — provides regulatory and engineering support for FDA 510(k) submissions. See https://innolitics.com/services/510ks/ or contact https://innolitics.com/contact.

Penumbra System ACE

K142458 · Penumbra, Inc. · NRY · May 22, 2015 · Cardiovascular

Device Facts

Record ID	K142458
Device Name	Penumbra System ACE
Applicant	Penumbra, Inc.
Product Code	NRY · Cardiovascular
Decision Date	May 22, 2015
Decision	SESE
Submission Type	Traditional
Regulation	21 CFR 870.1250
Device Class	Class 2
Attributes	Therapeutic

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 (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.

Device Story

Penumbra System ACE 64 and ACE 68 are reperfusion catheters designed to provide a larger lumen for thrombus removal from neurovasculature. Used in clinical settings by physicians for treating acute ischemic stroke. Catheters are delivered to the occlusion site; vacuum aspiration is applied to remove thrombus. Devices feature a multi-segment shaft with varying polymer extrusions (Pellethane, Tecoflex, Pebax, Vestamid) and coil reinforcement (stainless steel/NiTi). Output is the physical removal of the clot, visualized via angiography. Benefits include revascularization of occluded vessels, potentially improving patient outcomes in stroke cases.

Clinical Evidence

No human clinical data provided. Evidence consists of bench-top testing (dimensional, simulated use, coating integrity, particulate, pressure, tensile, kink resistance, corrosion) and GLP animal study (swine model). Animal study showed no vessel injury, no abnormal histology, and no significant vascular response.

Technological Characteristics

Percutaneous catheter for thrombus removal. Materials: Grilamid, stainless steel 304, polyolefin, PET, Pellethane 80A, Tecoflex 80A, Pebax (various durometers), Vestamid, NiTi, Pt/Ir marker bands. Coating: SRDX Harmony. Sterilization: Ethylene Oxide (EO). Dimensions: 0.084" max proximal OD, 0.068" min proximal ID, 0.064"-0.068" distal ID. Single-use, sterile, non-pyrogenic.

Indications for Use

Indicated for patients with acute ischemic stroke secondary to intracranial large vessel occlusive disease (internal carotid, middle cerebral M1/M2, basilar, and vertebral arteries) within 8 hours of symptom onset. ACE 64 and ACE 68 specifically indicated for revascularization within the Internal Carotid Artery (ICA).

Regulatory Classification

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.

Predicate Devices

Penumbra System / Penumbra System MAX (K072718, K090752, K100769, K113163, K133317)

Reference Devices

Boston Scientific Excelsior SL-10 microcatheter

Related Devices

K161640 — Penumbra System ACE 68 Reperfusion Catheter · Penumbra, Inc. · Jul 12, 2016
K161064 — Penumbra System ACE 68 Reperfusion Catheter · Penumbra, Inc. · Jun 12, 2016
K152541 — Penumbra System ACE 64 and ACE 68 Reperfusion Catheters · Penumbra, Inc. · Jan 13, 2016
K211411 — Penumbra System (RED 68 Reperfusion Catheter) · Penumbra, Inc. · Jul 1, 2021
K173761 — Penumbra System Reperfusion Catheter JET 7 · Penumbra, Inc. · Aug 17, 2018

Submission Summary (Full Text)

{0}------------------------------------------------ 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 {2}------------------------------------------------ ## 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) | ### CONTINUE ON A SEPARATE PAGE IF NEEDED. This section applies only to requirements of the Paperwork Reduction Act of 1995. ### *DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.* The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to: > Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff@fda.hhs.gov "An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number." {3}------------------------------------------------ ### 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 / Clearance Date | 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 Parkway Alameda, CA 94502 USA | {4}------------------------------------------------ #### 7 Predicate Comparison | System Name | Penumbra System Reperfusion Catheter | | Penumbra System ACE Reperfusion Catheter | |---------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------| | Device Name | 5MAX ACE | ACE 64 | ACE 68 | | 510(k) No. | K090752 | K142458 | SAME | | Classification | Class II, NRY | SAME | | | Indication | 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 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. | | | 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 [black ink] | SAME | | | Catheter Shaft | | | | | Distal Extrusions | Tecoflex 80A, Pellethane 80A, Pebas 35D, Pebax 35D/40D Blend, 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, Pebax 72D, Vestamid | Pebax 55D/72D Blend, Pebax 72D, Vestamid | | Proximal Coil Reinformcement | SS flat (0.002 in x 0.007 in) | SS flat (0.0015 in x 0.006 in) and SS round (0.0025 in) | SS flat (0.0015 in 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 System Reperfusion Catheter | Penumbra System ACE Reperfusion 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 | | {5}------------------------------------------------ #### 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. {6}------------------------------------------------ ### 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 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 (Irritation) | 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 the following: • > 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 | {7}------------------------------------------------ | Test | Acceptance Criteria | Results | Pass / Fail | |------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------| | 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 | 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 this Design Verification testing meet all inspection criteria for release of finished goods (clinically acceptable) product. | | Pass | | Attribute | Specification | Acceptance Criteria | Results | | Simulated Use (Intracranial Access, Vessel Access Entry Performance & Clot Removal) | Simulated use testing of the Reperfusion Catheter and Separator was performed with accessory devices in an anatomical model which simulated the tortuosity of the neurovasculature. Devices were delivered through the tortuous anatomical model to evaluate the effectiveness of the devices to remove clots and that the Reperfusion Catheter does not collapse under vacuum. | | 100% Pass | | Torsion (Reperfusion Catheter) | Number of turns will be recorded | | Data was recorded for informational purposes only | | Injection Flow Rate | Injection flow rate will be recorded for various pressure settings | Data was recorded for informational purposes only | | | Flow Rate | Flow rate (cc/min) with and without Separator in test article lumen will be reported | Data was recorded for informational purposes only | | | Reperfusion Catheter Tip Pressure | Aspiration (Suction) Pressure and Pump MAX vacuum pressure will be reported | Data was recorded for informational purposes only | | | Coating Integrity | Coating has not delaminated. peeled, or flaked after simulated use | 100% Must meet Specification | 100% Pass | | Particulate Testing (Reperfusion Catheter Hydrophilic Coating) | The maximum number of particles: ≥ 10 um will be ≤ 6000 particles ≥ 25 um will be ≤ 600 particles. | 100% Must meet Specification | 10um 100% Pass 25 um 100% Pass | | | ≥ 75 µm & ≥ 125 µm will be recorded | Data was recorded for informational purposes only | | | Particulate Testing (Reperfusion Catheter /Separator) | The maximum number of particles: ≥ 10 um will be ≤ 6000 particles ≥ 25 um will be ≤ 600 particles. | 100% Must meet Specification | 10μm 100% Pass 25 um 100% Pass | | | ≥ 75 um & ≥ 125 um will be recorded | Data was recorded for informational purposes only | | | Coating Integrity | Coating is not grossly damaged after undergoing particulate testing | 100% Must meet Specification | 100% Pass | | Hub/Catheter Air Aspiration | When negative pressure is pulled, no air may leak into hub | 100% Must meet Specification | 100% Pass | | Pressure Test | 45 psi for 30 sec MIN | 100% Must meet Specification | 100% Pass | | Attribute | Specification | Acceptance Criteria | Results | | Reperfusion Catheter/Sheath or 8F Guide & 0.014" Guidewire compatibility (Friction Force) | Maximum value per specification | 100% Must meet Specification | 100% Pass | | Markerband Section Bond Strength | Minimum value per specification | 100% Must meet Specification | 100% Pass | | Joint Sections Bond Strength | Minimum value per specification | 100% Must meet Specification | 100% Pass | | Hub to Shaft & Hub to Hypotube Bond Strength | Minimum value per specification | 100% Must meet Specification | 100% Pass | | Steam-Shaped Distal Tip Tensile | Minimum value per specification | 100% Must meet Specification | 100% Pass | | Elongation to Failure - Reperfusion Catheter | % Elongation ≥ 5% | 100% Must meet Specification | 100% Pass | | Kink Resistance | No kinking when formed in a defined radius | 100% Must meet Specification | 100% Pass | | Corrosion | No visible corrosion on Reperfusion Catheter immediately after Corrosion Testing procedure | 100% Must meet Specification | 100% Pass | {8}------------------------------------------------ {9}------------------------------------------------ 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. {10}------------------------------------------------ - 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.