Lantern Delivery Microcatheter

K152840 · Penumbra, Inc. · DQY · Dec 2, 2015 · Cardiovascular

Device Facts

• Record ID: K152840
• Device Name: Lantern Delivery Microcatheter
• Applicant: Penumbra, Inc.
• Product Code: DQY · Cardiovascular
• Decision Date: Dec 2, 2015
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 870.1250
• Device Class: Class 2

Intended Use

Lantern Delivery Microcatheter is intended to assist in the delivery of diagnostic agents, such as contrast media, and therapeutic devices, such as occlusion coils, to the peripheral and neuro vasculature.

Device Story

Single lumen intravascular catheter; designed to aid physician in accessing distal vasculature. Used with guide catheter and guide wire; provides reinforcing conduit for other intravascular devices. Operates in peripheral and neuro vasculature; used by physicians in clinical settings. Facilitates delivery of diagnostic/therapeutic agents; enables targeted treatment; improves access to distal sites.

Clinical Evidence

Bench testing only. No clinical data. Biocompatibility testing (ISO 10993-1) and mechanical performance testing (kink resistance, burst pressure, tensile strength, etc.) confirmed device meets specifications.

Technological Characteristics

Single lumen catheter; materials: Nylon, Polyether block amide (shaft/hub), Pt/Ir (marker band), Stainless Steel (strain relief), Polyolefin/PET (ID band). Hydrophilic coating. Dimensions: 0.037-0.040 in. OD, 0.025 in. ID. Sterilization: Ethylene Oxide (EN ISO 11135-1:2014).

Indications for Use

Indicated for assisting delivery of diagnostic agents (contrast media) and therapeutic devices (occlusion coils) to peripheral and neuro vasculature.

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

• PX 400 Delivery Microcatheter (K100826)

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 consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an emblem featuring a stylized representation of three human profiles facing to the right, stacked on top of each other.

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

December 2, 2015

Penumbra, Inc. Mr. Charles DeNault Regulatory Affairs Specialist III One Penumbra Place Alameda, California 94502

Re: K152840

Trade/Device Name: Lantern™ Delivery Microcatheter Regulation Number: 21 CFR 870.1250 Regulation Name: Percutaneous Catheter Regulatory Class: Class II Product Code: DQY Dated: October 30, 2015 Received: November 2, 2015

Dear Mr. DeNault:

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 the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

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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 -SD/Δ

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) K152840

Device Name Lantern™ Delivery Microcatheter

## Indications for Use (Describe)

Lantern Delivery Microcatheter is intended to assist in the delivery of diagnostic agents, such as contrast media, and therapeutic devices, such as occlusion coils, to the peripheral and neuro vasculature.

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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### 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 Lantern™ Delivery Microcatheter.

#### 1.1 Sponsor/Applicant Name and Address

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

#### Sponsor Contact Information 1.2

Charles DeNault Regulatory Affairs Specialist III Phone: [phone] Fax: [phone] Email: [e-mail]

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

October 30, 2015

### Device Trade or Proprietary Name 1.4

Lantern™ Delivery Microcatheter

### Device Classification 1.5

| Regulatory Class: | II |
|-----------------------|------------------------|
| Classification Panel: | Cardiovascular |
| Classification Name: | Catheter, percutaneous |
| Regulation Number: | 21 CFR 870.1250 |
| Product Code: | DQY |

#### 1.6 Predicate Device

| 510(k) Number | Clearance Date | Name of Predicate Device | Name of<br>Manufacturer |
|---------------|------------------|-------------------------------|-------------------------|
| K100826 | January 13, 2010 | PX 400 Delivery Microcatheter | Penumbra, Inc. |

#### 1.7 Predicate Comparison

| Attribute | Predicate Device | Subject Device |
|-------------|-------------------------------|--------------------------------|
| Device name | PX 400 Delivery Microcatheter | Lantern Delivery Microcatheter |

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| Attribute | Predicate Device | Subject Device |
|-------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------|
| Device name | PX 400 Delivery Microcatheter | Lantern Delivery Microcatheter |
| Classification | Class II, DQY | Same |
| Indications for Use | Intended to assist in the delivery of<br>diagnostic agents, such as contrast<br>media, and therapeutic devices, such as<br>occlusion coils, to the peripheral and<br>neuro vasculature. | Same |
| Shaft materials | Nylon, Polyether block amide | Same |
| Hub materials | Nylon | Same |
| ID Band | Polyolefin, PET | Same |
| Strain Relief | Stainless Steel | Same |
| Marker band materials | Pt/Ir | Same |
| Coating | Hydrophilic | Same |
| Effective length | 150 cm | 80, 110, 115, 130,<br>135, 150, 160 cm |
| Proximal outer diameter | 0.045 in. max | 0.040 in. max |
| Distal outer diameter | 0.040 in. max | 0.037 in. max |
| Inner diameter | 0.025 in. min | Same |
| Packaging materials | Polyethylene, PET, Polyester, Tyvek | Same |
| Packaging configuration | Individual catheter in tray, pouch, and<br>box | Individual catheter in tray, or hoop<br>attached to packaging card, pouch, and<br>box |
| Sterilization | EO | Same |
| Shelf life | 36 months | Same |

## 1.8 Device Description

Lantern Delivery Microcatheter is a single lumen intravascular catheter designed to aid physician in accessing distal vasculature. When used in conjunction with a guide catheter and guide wire, Lantern provides access to the target site. Once in place it provides a reinforcing conduit for other intravascular devices.

### 1.9 Indications for Use/Intended Use

Lantern Delivery Microcatheter is intended to assist in the delivery of diagnostic agents, such as contrast media, and therapeutic devices, such as occlusion coils, to the peripheral and neuro vasculature.

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# 1.10 Summary of Non-Clinical Data

Included in this section is a description of the testing, which substantiates the safe and effective performance of the Lantern Delivery Microcatheter as well as its substantial equivalence to the predicate device:

- . Biocompatibility
- Design Verification (Bench-Top Testing) .
- Sterilization ●
- . Shelf life

The subject Lantern Delivery Microcatheter met all predetermined requirements.

## 1.10.1 Biocompatibility Testing

Biocompatibility testing previously performed on the predicate device substantiates the biocompatibility of Lantern. Studies were selected in accordance with EN ISO 10993-1 guidelines (Biological Evaluation of Medical Devices). All studies were conducted pursuant to 21 CFR, Part 58, Good Laboratory Practices. The following tests were performed:

| Test | Acceptance Criteria | Results |
|----------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------|
| In vitro Cytotoxicity (MEM<br>Elution) | Sample extracts must yield cell lysis<br>grade $\le$ 2 | Grade: 1 (slight) |
| Sensitization (Magnusson-<br>Kligman Method) | Test Group shall yield Grade $<$ 1 score<br>on Magnusson and Kligman scale<br>(provided Control Grade $<$ 1) | Non-sensitizing |
| Irritation (Intracutaneous<br>Reactivity) | The difference in the mean test article<br>and mean control score must be grade<br>1.0 or lower | Non-irritant |
| Systemic Toxicity (Acute) | | |
| Acute Systemic Injection | Sample extracts must not cause<br>significant biological reaction greater<br>than control. That is:<br>Death in 2 or more animals Toxic signs (i.e. convulsions,<br>prostration) Weight loss > 10% in 3 or more<br>animals | Non-toxic |
| Material Mediated Rabbit<br>Pyrogen | Sample extracts must not cause a total<br>rise in body temperature of $\ge$ 0.5° C | Non-pyrogenic |
| Hemocompatibility | | |
| Hemolysis – Indirect Contact | Sample extracts must be nonhemolytic<br>( $\le$ 2% hemolytic index) | Non-hemolytic |
| Complement Activation | The concentrations of C3a and SC5b-9<br>in the test samples are statistically<br>similar to the predicate control and<br>statistically lower than the positive<br>control for all exposure times | No greater biological<br>response than corresponding<br>control |

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| Test | Acceptance Criteria | Results |
|-------------------------------------|---------------------------------------------------------------------------------------------|------------------|
| Thrombosis (Dog<br>Thrombogenicity) | Device must be non-thrombogenic after<br>4 hours in vivo when compared to<br>control device | Non-thrombogenic |

### 1.10.2 Bench-top Testing

Testing was based on the design specifications, risk analysis and available guidance documents. These guidance documents include:

- Guidance on Premarket Notification [510(k)] Submission for Short-Term and ● Long-Term Intravascular Catheters (FDA - 1995)
- . EN ISO 10555-1:2013,Sterile, single-use intravascular catheters – Part 1: General Requirements.

The physical and mechanical properties of Lantern Delivery Microcatheter were assessed using standard test methods and pre-determined acceptance criteria. Devices used for mechanical testing were assembled and packaged in the controlled production environment and sterilized twice using an ethylene oxide sterilization cycle. All established acceptance criteria were met. The following tests were performed:

- Packaging inspection ●
- Dimensional/visual inspection ●
- Inspection of design features
- Hub/ air aspiration ●
- Steam shaping
- Kink resistance ●
- Simulated use ●
- Torsion ●
- Corrosion ●
- Particulate ●
- Friction ●
- Static burst pressure ●
- Tensile / elongation ●

All testing met specification. 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 Lantern Delivery Microcatheter are acceptable for the intended use and substantially equivalent to the predicate device.

# 1.11 Sterilization

The Lantern Delivery Microcatheter is sterilized using a validated EO sterilization process in accordance with EN ISO 11135-1:2014. Sterilization of Health Care Products – Ethvlene Oxide – Part 1: Requirements for Development, Validation and Routine Control of a Sterilization Process for Medical Devices. Sterilization validation is based on prior testing performed with the modified predicate device.

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# 1.12 Pyrogenicity

The Lantern Delivery Microcatheter has established to be non-pyrogenic based on the prior material mediated rabbit pyrogen biocompatibility testing performed on the predicate, and LAL validation testing performed on the modified predicate. In the LAL validation, three lots of the longest effective length modified predicate were tested for inhibition via the kinetic turbidimetric test method. All three lots met the acceptance criteria of < 2.15 EU/ device. Therefore, production lots of both the predicate device and Lantern are routinely monitored to ensure < 2.15 EU/ device with existing LAL validation.

# 1.13 Shelf life

The Lantern Delivery Microcatheter has established a shelf life of 36 months based on prior testing performed with the modified predicate device.

# 1.14 Summary of Substantial Equivalence

The Lantern Delivery Microcatheter is substantially equivalent to the predicate devices with regard to intended use, operating principle, design concept, materials, shelf-life, packaging, and sterilization processes.