Penumbra System 110 Aspiration Tubing

K151623 · Penumbra, Inc. · NRY · Aug 6, 2015 · Cardiovascular

Device Facts

• Record ID: K151623
• Device Name: Penumbra System 110 Aspiration Tubing
• Applicant: Penumbra, Inc.
• Product Code: NRY · Cardiovascular
• Decision Date: Aug 6, 2015
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 870.1250
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Penumbra System / Penumbra System MAX are 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.

Device Story

The Penumbra System 110 Aspiration Tubing connects a pump canister to reperfusion catheters to provide vacuum for thrombus removal; operated by physicians in clinical settings. The device features a flow control switch allowing manual start/stop of aspiration. The tubing assembly is a single-use, sterile, non-pyrogenic component. By providing a larger inner diameter (0.110in) compared to predicate devices, it accommodates larger clot burdens during revascularization procedures. The output is the application of vacuum pressure to the catheter system, facilitating the removal of occlusive material from intracranial vessels. This assists in restoring blood flow, potentially improving clinical outcomes for acute ischemic stroke patients.

Clinical Evidence

Bench testing only. No clinical data provided. Testing included biocompatibility (cytotoxicity, sensitization, irritation per EN ISO 10993) and mechanical design verification (simulated use, leak testing, and destructive joint strength testing). All tests met established specifications.

Technological Characteristics

Materials: Polycarbonate, Isoplast 2530, EPDM, Silicone, Acrylated Urethane (Loctite 3311), Polyvinylchloride, Polyurethane (Pellethane 2363-80A), Nylon, Polyolefin. Dimensions: 0.110in ID, 0.188in OD, 112in length. Principle: Vacuum-based aspiration. Connectivity: Standalone tubing assembly. Sterilization: Ethylene Oxide (EO). Shelf-life: 36 months.

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.

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 and Penumbra System MAX (K133317)
• Penumbra System ACE 64 and ACE 68 Reperfusion Catheters (K142458)

Submission Summary (Full Text)

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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 is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. In the center of the logo is a stylized image of three human profiles facing to the right, with a flowing ribbon-like element beneath them.

Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

August 6, 2015

Penumbra, Inc. Ms. Michaela Mahl Senior Manager Regulatory Affairs One Penumbra Place Alameda, California 94502

Re: K151623

Trade/Device Name: Penumbra System 110 Aspiration Tubing Regulation Number: 21 CFR 870.1250 Regulation Name: Percutaneous Catheter Regulatory Class: Class II Product Code: NRY Dated: July 6, 2015 Received: Julv 7, 2015

Dear Ms. 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

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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 [phone] or [phone] 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 [phone] or [phone] or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely yours,

Carlos L. Pena =5)/△

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) K151623

### Device Name

Penumbra System 110 Aspiration Tubing

### Indications for Use (Describe)

The Penumbra System / Penumbra System MAX are 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.

| Type of Use (Select one or both, as applicable) | |
|---------------------------------------------------------------|--------------------------------------------------------------|
| <div> Prescription Use (Part 21 CFR 801 Subpart D) </div> | <div> Over-The-Counter Use (21 CFR 801 Subpart C) </div> |

### CONTINUE ON A SEPARATE PAGE IF NEEDED.

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"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."

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## Indications for Use

510(k) Number (if known) K151623

### Device Name

Penumbra System 110 Aspiration Tubing

### 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) | |
|-------------------------------------------------------------------------------------------------|--|
| <label><input checked="" type="checkbox"/> Prescription Use (Part 21 CFR 801 Subpart D)</label> | |
| <label><input type="checkbox"/> Over-The-Counter Use (21 CFR 801 Subpart C)</label> | |

### 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 [e-mail]

"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."

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#### 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 110 Aspiration Tubing.

#### Sponsor/Applicant Name and Address 1.1

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

#### 1.2 Sponsor Contact Information

Michaela Mahl Senior Manager, Regulatory Affairs Phone: [phone] FAX: [phone] Email: [e-mail]

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

August 06, 2015

#### 1.4 Device Trade or Proprietary Name

Penumbra System® 110 Aspiration Tubing

#### 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<br>Date | Name of Predicate Device | Name of Manufacturer |
|-----------------------------------|-------------------------------------------------------------|---------------------------------------------------------------|
| K133317 [13MAY2014] | Penumbra System® and<br>Penumbra System MAX® | Penumbra, Inc.<br>One Penumbra Place<br>Alameda, CA 94502 USA |
| K142458 [22May2015] | Penumbra System® ACE 64 and<br>ACE 68 Reperfusion Catheters | Penumbra, Inc.<br>One Penumbra Place<br>Alameda, CA 94502 USA |

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#### 1.7 Predicate Comparison

# Predicate 1:

| | Predicate Device | Subject Device |
|----------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------|
| Device Name | MAX Aspiration Tubing | 110 Aspiration Tubing |
| 510(k) No. | K133317 | K151623 |
| Classification | Class II, NRY | SAME |
| Indication | The Penumbra System / Penumbra System<br>MAX are intended for use in the<br>revascularization of patients with acute<br>ischemic stroke secondary to intracranial<br>large vessel occlusive disease (within the<br>internal carotid, middle cerebral - M1 and<br>M2 segments, basilar, and vertebral arteries)<br>within 8 hours of symptom onset. | SAME |
| Materials | | |
| Luer fittings | Polycarbonate (2018-15-FC030004 or<br>equivalent); Isoplast 2530; EPDM RED,<br>Silicone coated | SAME |
| Adhesive | Loctite 3311 (Acrylated Urethane) | SAME |
| Solvent | Cyclohexanone, MEK solvent | SAME |
| Vacuum connector | Polyvinylchloride | SAME |
| Tubing | Polyurethane (Pellethane 2363-80A) and<br>Nylon | SAME |
| Male/Female adaptor Luer | Polycarbonate (Makrolon or equivalent) | SAME |
| Flow control switch | Polycarbonate (Lexan or equiv); Acetal<br>(Hostaform or equiv); ABS; Silicone | SAME |
| OFF label | Polyolefin (red) | SAME |
| ON label | MARAPROP PP black ink (solvent naphtha<br>(petroleum); 2-methoxy-1-methylethyl<br>acetate; xylene; ethylbenzene) | SAME |
| Dimensions | | |
| Tubing OD | $0.188in \pm 0.005in$ | SAME |
| Tubing ID | $0.088in \pm 0.005in$ | $0.110in \pm 0.005in$ |
| Overall Length | $112.0in \pm 7.0in$ | SAME |
| Distal Length | $7.0in \pm 2.0in$ | SAME |
| Accessories | None | SAME |
| Packaging Materials | | |
| Pouch | Polyester/Polyethylene/<br>Tyvek® | SAME |
| Display Carton | SBS Paperboard | SAME |
| Packaging Configuration | Individual | SAME |
| Sterilization | EO | SAME |
| Shelf-Life | 36 Months | SAME |
| | Predicate Device | Subject Device |
| Device Name | MAX Aspiration Tubing | 110 Aspiration Tubing |
| 510(k) No. | K142458 | K151623 |
| Classification | Class II, NRY | SAME |
| Indication | The Penumbra System is intended for use in<br>the revascularization of patients with acute<br>ischemic stroke secondary to intracranial<br>large vessel occlusive disease (within the<br>internal carotid, middle cerebral - M1 and<br>M2 segments, basilar, and vertebral arteries)<br>within 8 hours of symptom onset. The<br>Reperfusion Catheters ACE 64 and ACE 68<br>are intended for use in revascularization<br>within the Internal Carotid Artery (ICA)<br>within 8 hours of symptom onset. | SAME |
| Materials | | |
| Luer fittings | Polycarbonate (2018-15-FC030004 or<br>equivalent); Isoplast 2530; EPDM RED,<br>Silicone coated | SAME |
| Adhesive | Loctite 3311 (Acrylated Urethane) | SAME |
| Solvent | Cyclohexanone, MEK solvent | SAME |
| Vacuum connector<br>Tubing | Polyvinylchloride<br>Polyurethane (Pellethane 2363-80A) and<br>Nylon | SAME |
| Male/Female adaptor Luer | Polycarbonate (Makrolon or equivalent) | SAME |
| Flow control switch | Polycarbonate (Lexan or equiv); Acetal<br>(Hostaform or equiv); ABS; Silicone | SAME |
| OFF label | Polyolefin (red) | SAME |
| ON label | MARAPROP PP black ink (solvent naphtha<br>(petroleum); 2-methoxy-1-methylethyl<br>acetate; xylene; ethylbenzene) | SAME |
| Dimensions | | |
| Tubing OD | $0.188in \pm 0.005in$ | SAME |
| Tubing ID | $0.088in \pm 0.005in$ | $0.110in \pm 0.005in$ |
| Overall Length | $112.0in \pm 7.0in$ | SAME |
| Distal Length | $7.0in \pm 2.0in$ | SAME |
| Accessories | None | SAME |
| Packaging Materials | | |
| Pouch | Polyester/Polyethylene/<br>Tyvek® | SAME |
| Display Carton | SBS Paperboard | SAME |
| Packaging Configuration | Individual | SAME |
| Sterilization | EO | SAME |
| Shelf-Life | 36 Months | SAME |

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## Predicate 2:

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#### 1.8 Device Description

The subject Penumbra System 110 Aspiration Tubing Assembly connects the Pump Canister to the Reperfusion Catheters, providing a means for introducing vacuum during procedures, which is identical to the predicate MAX Aspiration Tubing [K133317 and K142458]. Furthermore, the 110 Aspiration Tubing has a flow valve that allows the physician to start and stop the flow of aspiration, which is identical to the predicate MAX Aspiration Tubing [K133317 and K142458]. The Penumbra System 110 Aspiration Tubing has a slightly larger inner diameter of 0.110in compared to the predicate to accommodate larger clot burdens, this is the only difference to the predicate MAX Aspiration Tubing [K133317 and K142458]. The Penumbra System 110 Aspiration Tubing is compatible with all Penumbra System Reperfusion Catheters and Separators included in K133317 and K142458. The device is provided sterile, non-pyrogenic, and intended for single use only, which is identical to the predicate MAX Aspiration Tubing [K133317 and K142458].

#### Indications For Use 1.9

The Penumbra System / Penumbra System MAX are 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.

## and

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.

## 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.

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Included in this section are summary descriptions of the testing, which substantiates the performance of the subject Penumbra System 110 Aspiration Tubing as well as its substantial equivalence to the predicate device:

- Biocompatibility
- . Design Verification (Bench-Top Testing)

The subject Penumbra System 110 Aspiration Tubing device met all established requirements.

## 1.10.1 Biocompatibility Testing

Evidence of the biocompatibility of the 110 Aspiration Tubing materials is derived from a series of previously successfully performed studies on the predicate device. The studies were selected in accordance with EN ISO 10993-1 guidelines. The studies were selected in accordance with EN ISO 10993-1 guidelines (Biological Evaluation of Medical Devices) for a limited exposure (ك 24 hours), surface device, with skin contact. All studies were conducted pursuant to 21 CFR, Part 58, Good Laboratory Practices (GLP). The following tests were previously performed and all tests passed successfully:

| Test / Standard | Acceptance Criteria | Results | Pass / Fail |
|--------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------|-------------|
| Cytotoxicity (MEM Elution)<br>/ EN ISO 10993-5 | Sample extracts must yield a<br>cell lysis grade of 2 or lower | Grade 0: None | Pass |
| Sensitization / EN ISO<br>10993-10 | Test Group shall yield Grade <<br>1 score on Magnusson and<br>Kligman scale (provided<br>Control Grade < 1) | Grade 0: No visible change | Pass |
| Irritation (Intracutaneous<br>Reactivity Irritation Test) /<br>EN ISO 10993-10 | The difference in the mean test<br>article and mean control score<br>must be grade 1.0 or lower | Grade 0.1 difference (saline<br>extract) and Grade 0.2<br>difference (cottonseed oil<br>extract) | Pass |

As all materials of the subject 110 Aspiration Tubing are identical to the materials of the predicate device [K133317 and K142458] biocompatibility is established. In summary, non-clinical testing found the 110 Aspiration Tubing materials to be non-cytotoxic, non-sensitizing, and a non-irritant.

## 1.10.2 Bench-top Testing

The physical and mechanical properties of the Penumbra System 110 Aspiration Tubing was assessed using the identical test methods and acceptance criteria as

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the predicate [K133317 and K142458]. The following tests were performed and all tests passed successfully:

| Attribute | Specification | Acceptance Criteria | Results |
|--------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------|---------|
| Dimensional/<br>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 |
| Performance/Simulated<br>Use and Leak Test | | | |
| Suction Connector | 110 Aspiration Tubing securely attaches to canister lid | 100% Must meet<br>Specification | Pass |
| RHV Compatibility | 110 Aspiration Tubing Assembly distal luer securely connects to RHV port | 100% Must meet<br>Specification | Pass |
| Lumen Ovalization | 110 Aspiration Tubing maintains functionality and maintains an open lumen at vacuum pressure of 25inHg minimum for 30 seconds minimum | 100% Must meet<br>Specification | Pass |
| Joints Leak | 110 Aspiration Tubing Assembly maintains functionality with no leaks at vacuum pressure of 25inHg minimum for 30 seconds minimum | 100% Must meet<br>Specification | Pass |
| Destructive Testing | | | |
| Suction Connector /<br>Tubing Joint | 2.0 lbf minimum | 100% Must meet<br>Specification | Pass |
| Distal Rotating Male<br>Luer / Tubing Joint | 2.0 lbf minimum | 100% Must meet<br>Specification | Pass |
| Proximal Rotating<br>Male Luer / Tubing<br>Joint | 2.0 lbf minimum | 100% Must meet<br>Specification | Pass |
| Female Luer / Tubing<br>Joint | 2.0 lbf minimum | 100% Must meet<br>Specification | Pass |

The results of the tests appropriately address the physical and mechanical performance expectations of the device. Based on these overall results, the physical and mechanical properties of the subject Penumbra System 110 Aspiration Tubing is acceptable for the intended use and substantially equivalent to the predicate device.

## 1.10.3 Summary of Substantial Equivalence

The subject Penumbra System 110 Aspiration Tubing is substantially equivalent to the predicate device [K133317 and K142458] with regard to intended use, operating principle, design concept, materials, shelf-life, packaging and sterilization processes.