Penumbra System Penumbra JET 7X

K191946 · Penumbra, Inc. · NRY · Feb 27, 2020 · Cardiovascular

Device Facts

• Record ID: K191946
• Device Name: Penumbra System Penumbra JET 7X
• Applicant: Penumbra, Inc.
• Product Code: NRY · Cardiovascular
• Decision Date: Feb 27, 2020
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 870.1250
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

Penumbra Reperfusion Catheters and Separators As part of the Penumbra System, the Reperfusion Catheters and Separators are indicated 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. Patients who are ineligible for intravenous tissue plasminogen activator (IV t-PA) or who fail IV t-PA therapy are candidates for treatment. Penumbra 3D Revascularization Device As part of the Penumbra System, the Penumbra 3D Revascularization Device is indicated 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) within 8 hours of symptom onset. Patients who are ineligible for intravenous tissue plasminogen activator (IV t-PA) or who fail IV t-PA therapy are candidates for treatment. Penumbra Aspiration Tubing As part of the Penumbra System, the Penumbra Sterile Aspiration Tubing is indicated to connect the Penumbra Reperfusion Catheters to the Penumbra Aspiration Pump. Penumbra Aspiration Pump The Penumbra Aspiration Pump is indicated as a vacuum source for Penumbra Aspiration Systems.

Device Story

The Penumbra JET 7MAX consists of a JET 7 Reperfusion Catheter and an optional MAX Delivery Device (Access Assist Tool). The device is used in neurointerventional procedures to remove thrombus from intracranial vessels. The MAX Delivery Device is inserted into the catheter to assist in navigating tortuous neurovasculature and is removed prior to aspiration. Aspiration is delivered from an external Penumbra Aspiration Pump through the catheter to the occlusion site. The device is operated by a physician in a clinical setting. The output is the mechanical removal of thrombus, which restores blood flow to the brain, potentially improving clinical outcomes for acute ischemic stroke patients.

Clinical Evidence

No clinical study was conducted. Substantial equivalence is supported by bench-top design verification testing, biocompatibility testing, and a literature review of clinical outcomes for technologically equivalent devices.

Technological Characteristics

Materials: Nylon 12, Copolyester, Polyolefin, Polyurethane, Polyether Block Amide, PTFE, Platinum/Tungsten, Hydrophilic Coating. Dimensions: 0.018in ID, 0.071in OD, 1.5cm extension length. Sterilization: Ethylene Oxide (EO). Single-use, disposable. Mechanical aspiration principle.

Indications for Use

Indicated for revascularization of patients with acute ischemic stroke secondary to intracranial large vessel occlusive disease (internal carotid, M1/M2 middle cerebral, basilar, vertebral arteries) within 8 hours of symptom onset. Candidates include patients ineligible for or failing IV t-PA therapy.

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 JET™ 7 Reperfusion Catheter (K190010)

Reference Devices

• Penumbra System® – Penumbra JET™ 7 Reperfusion Catheter (K173761)
• Neuron Intracranial Access System – Neuron Select Catheter 070 (K083125)

Submission Summary (Full Text)

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February 27, 2020

Penumbra, Inc. Micaela Victoria Regulatory Affairs Specialist III One Penumbra Place Alameda, California 94502

Re: K191946

Trade/Device Name: Penumbra System® JET™ 7 Reperfusion Catheter with MAX Delivery Device (JETTM 7MAX)] Regulation Number: 21 CFR 870.1250

Regulation Name: Percutaneous Catheter Regulatory Class: Class II Product Code: NRY Dated: January 27, 2020 Received: January 28, 2020

Dear Micaela Victoria:

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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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

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requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

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 https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.

For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email ([e-mail]) or phone [phone] or 301-796-7100).

Sincerely,

Xiaolin Zheng, Ph.D., M.S. Director DHT5A: Division of Neurosurgical, Neurointerventional and Neurodiagnostic Devices OHT5: Office of Neurological and Physical Medicine Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health

Enclosure

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# Indications for Use

510(k) Number (if known) K191946

### Device Name

Penumbra System® [JET™ 7 Reperfusion Catheter with MAX Delivery Device (JET™ 7MAX)]

### Indications for Use (Describe)

Penumbra Reperfusion Catheters and Separators

As part of the Penumbra System, the Reperfusion Catheters and Separators are indicated 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. Patients who are ineligible for intravenous tissue plasminogen activator (IV t-PA) or who fail IV t-PA therapy are candidates for treatment.

Penumbra 3D Revascularization Device

As part of the Penumbra System, the Penumbra 3D Revascularization Device is indicated 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) within 8 hours of symptom onset. Patients who are ineligible for intravenous tissue plasminogen activator (IV t-PA) or who fail IV t-PA therapy are candidates for treatment.

Penumbra Aspiration Tubing

As part of the Penumbra System, the Penumbra Sterile Aspiration Tubing is indicated to connect the Penumbra Reperfusion Catheters to the Penumbra Aspiration Pump.

Penumbra Aspiration Pump The Penumbra Aspiration Pump is indicated as a vacuum source for Penumbra Aspiration Systems.

Type of Use (Select one or both, as applicable)

| <span style="font-size:10px">☒</span> Prescription Use (Part 21 CFR 801 Subpart D) |
|------------------------------------------------------------------------------------|
| <span style="font-size:10px">☐</span> Over-The-Counter Use (21 CFR 801 Subpart C) |

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Image /page/3/Picture/1 description: The image shows the word "Penumbra" in a red font. To the right of the word is a red circle with a white "P" inside. The logo is simple and modern. The registered trademark symbol is visible in the bottom right corner of the circle.

#### 1 510(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® Penumbra JET™ 7MAX (Penumbra JETTM 7 Reperfusion Catheter with MAX Delivery Device)

#### 1.1 Sponsor/Applicant Name and Address

Penumbra, Inc. One Penumbra Place Alameda, CA 94502 USA

#### 1.2 Sponsor Contact Information

Micaela Victoria Regulatory Affairs Specialist III Phone: [phone] FAX: [phone] Email: [e-mail]

#### 1.3 Date of Preparation of 510(k) Summary

January 24, 2020

#### 1.4 Device Trade or Proprietary Name

Penumbra System® [JET™ 7 Reperfusion Catheter with MAX Delivery Device (JET™ 7MAX)]

#### 1.5 Device Classification

| Regulatory Class: | II |
|-----------------------|----------------------------------|
| Classification Panel: | Neurology |
| Classification Name: | Percutaneous Catheter |
| Regulation Number: | 21 CFR §870.1250 |
| Product Code: | NRY (Catheter, Thrombus Removal) |

#### 1.6 Predicate Devices

| 510(k) Number / Clearance Date | Name of Device | Name of Manufacturer |
|----------------------------------|----------------------------------------------------------------|---------------------------------------------------------------|
| Primary Predicate Device | | |
| K190010 cleared on June 16, 2019 | Penumbra System® -<br>Penumbra JETTM 7 Reperfusion<br>Catheter | Penumbra, Inc.<br>One Penumbra Place<br>Alameda, CA 94502 USA |
| Reference Device | | |

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Image /page/4/Picture/1 description: The image shows the word "Penumbra" in a red font, followed by a red circle with a white "P" inside. The "P" is formed by a white line that extends from the left side of the circle to the right side, creating the shape of the letter. The logo is simple and modern, with a focus on the company name and a stylized initial.

| K173761 cleared on August 8, 2018<br>(Animal Testing only) | Penumbra System® –<br>Penumbra JETT™ 7 Reperfusion<br>Catheter | Penumbra, Inc.<br>One Penumbra Place<br>Alameda, CA 94502 USA |
|----------------------------------------------------------------------------|----------------------------------------------------------------------|---------------------------------------------------------------|
| K083125 cleared on November 21,<br>2008 (Biocompatibility Testing<br>only) | Neuron Intracranial Access<br>System – Neuron Select Catheter<br>070 | Penumbra, Inc.<br>One Penumbra Place<br>Alameda, CA 94502 USA |

#### 1.7 Predicate Comparison

| System Name | Penumbra System® | |
|---------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Device Name | Penumbra JET 7<br>(Predicate) | Penumbra JET 7MAX<br>(Subject) |
| 510(k) No. | K190010 (applicable for Penumbra JET 7 with<br>Access Assist Tool)<br>K173761 (applicable for Animal Testing -<br>Reference Device) | K191946 |
| Classification | Class II, NRY | SAME |
| System Name | Penumbra System® | |
| Device Name | Penumbra JET 7<br>(Predicate) | Penumbra JET 7MAX<br>(Subject) |
| Indication | Penumbra Reperfusion Catheters and Separators<br>As part of the Penumbra System, the<br>Reperfusion Catheters and Separators are<br>indicated for use in the revascularization of<br>patients with acute ischemic stroke secondary to<br>intracranial large vessel occlusive disease<br>(within the internal carotid, middle cerebral –<br>M1 and M2 segments, basilar, and vertebral<br>arteries) within 8 hours of symptom onset.<br>Patients who are ineligible for intravenous tissue<br> | SAME |
| Reperfusion Catheter | Penumbra JET™ 7 | SAME |
| Accessories | | |
| Peelable Sheath | PTFE | SAME |
| Rotating Hemostasis Valve | Polycarbonate, silicone o-ring | SAME |
| System Name | Penumbra System® | |
| Device Name | Penumbra JET 7<br>(Predicate) | Penumbra JET 7MAX<br>(Subject) |
| Shaping Mandrel | Stainless Steel | SAME |
| Access Assist Tool | N/A – not included | Materials:<br>Nylon 12, Copolyester, Polyolefin,<br>Polyurethane, Polyether Block<br>Amide, PTFE, Platinum/Tungsten,<br>Hydrophilic Coating<br>Dimensions:<br>ID: 0.018in<br>OD: 0.071in<br>Extension Length: 1.5cm |
| Packaging Materials | | |
| Pouch | Polyester/Polyethylene/Tyvek | SAME |
| Packaging Tray<br>(Kit Configuration) | Polyethylene terephthalate, Polystyrene | SAME |
| Display Carton | SBS Paperboard | SAME |
| Kit Packaging<br>Configuration | Tray/Retainer/Lid/Aspiration Tubing/Accessory<br>Pouch/Pouch/Box | SAME |
| Sterilization | EO | SAME |
| Shelf-Life | 36 Months | 12 Months |
| Use | Single use, disposable | SAME |

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Image /page/5/Picture/1 description: The image shows the word "Penumbra" in a red, sans-serif font. To the right of the word is a circular logo, also in red, with a white "P" inside. The logo has a white line extending from the left side of the "P" to the edge of the circle, creating a visual connection between the text and the logo.

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Image /page/6/Picture/1 description: The image shows the Penumbra logo. The word "Penumbra" is written in a red sans-serif font. To the right of the word is a red circle with a white "P" inside. The logo is simple and modern.

#### Device Description 1.8

The Penumbra JET 7 with MAX Delivery Device, known as Penumbra JET 7MAX, is an additional configuration being added to the currently available Penumbra System. The MAX Delivery Device is an optional accessory for use with the Penumbra JET 7 Reperfusion Catheter and is removed prior to aspiration. The Reperfusion Catheter Penumbra JET 7 delivers aspiration from the Aspiration Pump directly to the site of occlusion to assist in the removal of thrombus from the neurovasculature. The devices are provided sterile, nonpyrogenic, and intended for single use only.

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Image /page/7/Picture/1 description: The image shows the Penumbra company logo. The word "Penumbra" is written in a red, sans-serif font. To the right of the word is a red circle with a white "P" inside. The logo is simple and modern.

#### 1.9 Indications for Use

# Penumbra Reperfusion Catheters and Separators

As part of the Penumbra System, the Reperfusion Catheters and Separators are indicated 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. Patients who are ineligible for intravenous tissue plasminogen activator (IV t-PA) or who fail IV t-PA therapy are candidates for treatment.

## Penumbra 3D Revascularization Device

As part of the Penumbra System, the Penumbra 3D Revascularization Device is indicated 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) within 8 hours of symptom onset. Patients who are ineligible for intravenous tissue plasminogen activator (IV t-PA) or who fail IV t-PA therapy are candidates for treatment.

## Penumbra Aspiration Tubing

As part of the Penumbra System, the Penumbra Sterile Aspiration Tubing is indicated to connect the Penumbra Reperfusion Catheters to the Penumbra Aspiration Pump.

## Penumbra Aspiration Pump

The Penumbra Aspiration Pump is indicated as a vacuum source for Penumbra Aspiration Systems.

## 1.10 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 safe and effective performance of the subject Penumbra JET 7 with MAX Delivery Device as well as its substantial equivalence to the predicate and reference devices:

- Biocompatibility ●
- Design Verification (Bench-Top Testing) ●
- Design Validation (GLP Animal Testing) ●

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Image /page/8/Picture/1 description: The image shows the word "Penumbra" in a red, sans-serif font. To the right of the word is a red circle with a white "P" inside. The "P" is stylized with a horizontal line extending from the left side of the "P" to the edge of the circle. The logo is simple and modern.

The subject Penumbra JET 7 with MAX Delivery Device met all established requirements.

# 1.10.1 Biocompatibility Testing

Biocompatibility was conducted on the subject Penumbra JET 7 with MAX Delivery Device. The studies were selected in accordance with ISO 10993-1 guidelines (Biological Evaluation of Medical Devices) for a limited exposure (< 24 hours), externally communicating device with circulating blood contact. All studies were conducted pursuant to 21 CFR, Part 58, Good Laboratory Practices (GLP). Reperfusion Catheter testing was previously performed on the predicate Penumbra JET 7 [K190010]; therefore, the scope of the testing (in the table below) was only performed on the MAX Delivery Device.

| Tests | Acceptance Criteria | Results | Conclusion |
|-----------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------|
| Cytotoxicity:<br>MEM Elution<br>(10993-5) | Sample extracts must have a<br>cytotoxic reactivity score of grade<br>2 or lower | Grade = 0 (Reactivity None) | Pass<br>Non-cytotoxic |
| Sensitization:<br>Magnusson-<br>Kligman Method<br>(10993-10) | Test Group shall yield Grade < 1<br>score on Magnusson and Kligman<br>scale (provided Control Group<br>yields Grade < 1) | NaCl Extract<br>Grade = 0<br>CSO Extract<br>Grade = 0 | Pass<br>Non-sensitizing |
| Irritation:<br>Intracutaneous<br>Reactivity<br>(10993-10) | The difference between the<br>average scores for the extract of<br>the test article and the control is<br>≤ 1.0 | NaCl Extract<br>Difference = 0.0<br>CSO Extract<br>Difference = 0.0 | Pass<br>Non-irritating |
| Systemic Toxicity:<br>Acute Systemic<br>Injection<br>(10993-11) | Sample extracts must not cause<br>significant biological reaction<br>greater than control. That is:<br>• Death in 2 or more animals<br>• Signs of toxicity in 2 or more<br>animals (i.e. convulsions,<br>prostration)<br>• Weight loss > 10% in 3 or<br>more animals | No evidence of systemic<br>toxicity from sample extracts<br>(both NaCl and CSO extracts).<br>That is:<br>No deaths<br>• No signs consistent with<br>toxicity<br>No weight loss > 10% | Pass<br>Non-toxic |
| Systemic Toxicity:<br>Material Mediated<br>Pyrogen<br>(10993-11, USP) | Sample extracts must not cause a<br>total rise in body temperature of<br>≥ 0.5 °C | Non-pyrogenic: no single<br>animal had an individual rise<br>in body temperature ≥ 0.5 °C | Pass<br>Non-pyrogenic |
| Hemocompatibility:<br>Prothrombin Time<br>(PT) | Clotting times of test article must<br>be similar to predicate values using<br>analysis of variance. | Test article coagulation times<br>are statistically similar to<br>predicate | Pass<br>Hemocompatible |

| Biocompatibility Test Results | | | |
|-------------------------------|--|--|--|
|-------------------------------|--|--|--|

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Image /page/9/Picture/1 description: The image shows the word "Penumbra" in a red, sans-serif font. To the right of the word is a red circle with a white "P" inside. The logo is simple and modern, and the colors are bold and eye-catching. The wordmark and the symbol are well-balanced and create a strong visual identity.

| Tests | Acceptance Criteria | Results | Conclusion |
|----------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------|
| (10993-4) | | | |
| Hemocompatibility:<br>Partial<br>Thromboplastin<br>Time (PTT)<br>(10993-4) | Clotting times of test article must<br>be similar to predicate values using<br>analysis of variance | Test article coagulation times<br>are statistically similar to<br>predicate | Pass<br>Hemocompatible |
| Hemocompatibility:<br>Complement<br>Activation<br>(10993-4) | The concentration of SC5b-9 of<br>test article must be similar to<br>predicate values using analysis of<br>variance | SC5b-9<br>Test article concentrations are<br>statistically similar to predicate<br>at all exposure time points:<br>• 30min<br>• 60min<br>• 90min | Pass<br>Hemocompatible |
| Hemocompatibility:<br>Hemolysis (indirect<br>contact)<br>(10993-4) | Sample extracts must be non-<br>hemolytic (≤ 2% hemolytic<br>index) | Hemolytic Index = 0.22% | Pass<br>Non-hemolytic |
| Hemocompatibility:<br>Hemolysis (direct<br>contact)<br>(10993-4) | Sample must be non-<br>hemolytic (≤ 2% hemolytic<br>index) | Hemolytic Index = 0.00% | Pass<br>Non-hemolytic |
| Hemocompatibility:<br><i>In vitro</i><br>Thrombogenicity<br>(10993-4) | Device must be non-thrombogenic<br><i>in vitro</i> when compared to<br>predicate device | Test article performed equal or<br>better than predicate in three<br>separate <i>in vitro</i> assays | Pass<br>Non-thrombogenic |

In summary, non-clinical testing substantiates that the Penumbra System Penumbra JET 7 with MAX Delivery Device is non-cytotoxic, non-sensitizing, non-irritating, non-toxic, non-pyrogenic, non-hemolytic, and non-thrombogenic.

# 1.10.2 Design Verification - Bench Top Testing

The physical and mechanical properties of the subject Penumbra JET 7 with MAX Delivery Device was assessed using standard test methods and pre-determined acceptance criteria. The following tests were performed and all tests passed successfully:

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| Attribute | Specification | Results |
|--------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------|
| Dimensional/<br>Visual Inspection | These evaluations confirm that the units used in this Design<br>Verification testing meet all product specifications. | Pass |
| Simulated Use<br>[Intracranial<br>Access & Vessel<br>Access Entry<br>Performance.<br>Delivery/Retrieval<br>Forces] | Simulated use testing of the Access Assist Tool with Penumbra JET<br>7 Reperfusion Catheter and relevant accessory devices in an<br>anatomical model which simulated the tortuosity of the<br>neurovasculature. Devices were delivered through the tortuous<br>anatomical model to evaluate the effectiveness of the device to<br>assist in the delivery of the Reperfusion Catheter to the target site. | Pass |
| Reperfusion<br>Catheter / Access<br>Assist Tool<br>compatibility<br>(Friction Force) | Maximum value per specification | Pass |
| Access Assist<br>Tool / 0.016"<br>Guidewire<br>compatibility<br>(Friction Force) | Maximum value per specification | Pass |
| Markercoil<br>Visibility | The markercoil is fluoroscopically visible | Pass |
| Torsion | Number of turns will be recorded for informational purposes only<br>[FIPO]. | FIPO |
| Corrosion | No visible corrosion immediately after Corrosion Testing procedure | Pass |
| Particulate<br>Testing | ≥ 10 um will be ≤ 6000 particles | Pass |
| | ≥ 25 um will be ≤ 600 particles | Pass |
| | ≥ 75 um particles will be recorded for informational purposes only<br>[FIPO] | FIPO |
| | ≥ 125 um particles will be recorded for informational purposes only<br>[FIPO] | FIPO |
| Coating Integrity<br>(Pre-Inspection) | Coating has not delaminated, peeled, or flaked prior to simulated<br>use particulate testing | Pass |
| Coating Integrity<br>(Post-Inspection) | Coating has not delaminated, peeled, or flaked after simulated use<br>particulate testing | Pass |
| Attribute | Specification | Results |
| Hub/Air<br>Aspiration | When negative pressure is pulled, no air may leak into hub | Pass |
| Bond Strength<br>Distal Joint 1 | Minimum value per specification | Pass |
| Bond Strength<br>Distal Joint 2 | Minimum value per specification | Pass |
| Bond Strength<br>Midjoint 1 | Minimum value per specification | Pass |
| Bond Strength<br>Midjoint 2 | Minimum value per specification | Pass |
| Proximal Joint | Minimum value per specification | Pass |
| Hub to Shaft<br>Bond Strength | Minimum value per specification | Pass |
| Elongation to<br>Failure - Access<br>Assist Tool | Meets value per specification | Pass |
| Pressure Test | Minimum value per specification | Pass |

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Image /page/11/Picture/1 description: The image shows the word "Penumbra" in a red, sans-serif font. To the right of the word is a red circle with a white "P" inside. The logo is simple and modern, with the wordmark and symbol working together to create a recognizable brand identity. The red color is bold and eye-catching, while the white "P" provides contrast and visual interest.

# 1.10.3 Design Validation - Animal Study

The safety and efficacy of the reference device, Penumbra JET 7 Reperfusion Catheter (Penumbra JET 7) was evaluated in the accepted porcine model [K173761]. The purpose of this study was to evaluate the aspiration vascular response of the reference device Penumbra JET 7. The subject Penumbra JET 7 with MAX Delivery Device consists of a Penumbra JET 7 Reperfusion Catheter and optional catheter accessory, which is removed from the Reperfusion Catheter prior to aspiration. The subject, Penumbra JET 7 with MAX Delivery Device, Reperfusion Catheter dimensions are identical to that of the reference device Penumbra JET 7. As a result, no additional animal testing was required.

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Image /page/12/Picture/1 description: The image shows the word "Penumbra" in a red, sans-serif font. To the right of the word is a red circle with a white "P" inside. The logo is simple and modern.

# 1.11 Performance Data – Clinical:

No clinical study was conducted as bench and previously performed animal testing was determined sufficient for verification and validation purposes. A review was conducted considering published clinical study articles for devices with similar dimensions used for direct aspiration. The literature review was used to support the determination of substantial equivalence by using clinical outcomes from devices that are considered technologically equivalent.

# 1.12 Summary of Substantial Equivalence

The Penumbra JET 7 with MAX Delivery Device is substantially equivalent to the predicate and reference devices, provided in Section 1.6, with regard to indications, intended use, design, performance, materials, sterilization and packaging.