The Caterpillar and Caterpillar Micro Arterial Embolization Devices

K191532 · C.R. Bard, Inc. · KRD · Feb 4, 2020 · Cardiovascular

Device Facts

• Record ID: K191532
• Device Name: The Caterpillar and Caterpillar Micro Arterial Embolization Devices
• Applicant: C.R. Bard, Inc.
• Product Code: KRD · Cardiovascular
• Decision Date: Feb 4, 2020
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 870.3300
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Caterpillar and Caterpillar Micro Arterial Embolization Devices are indicated for arterial embolization in the peripheral vasculature. The Caterpillar Micro Arterial Embolization Devices are contraindicated for use in vessels subject to cyclic bending, such as highly locomotive joints or muscle beds.

Device Story

Self-expanding arterial occlusion plugs for permanent peripheral vasculature embolization. Device components: cobalt-chrome stem, nickel-titanium fibers, platinum-iridium radiopaque marker bands, polyurethane/polyethylene occlusion membrane. System includes implant, loader, dispenser hoop, detachable delivery wire, and torque tool. Delivered via catheter to target artery; self-expands to occlude vessel. Used in clinical settings by physicians. Radiopaque markers facilitate fluoroscopic visualization during deployment. Provides permanent arterial occlusion to treat vascular conditions. System provided sterile for single use.

Clinical Evidence

No human clinical data. Evidence based on non-clinical bench testing and a chronic ovine animal study. Bench testing included dimension, radial force, luer connection, radiopacity, simulated use (delivery/deployment/detachment), fatigue resistance, material safety (corrosion, nickel leaching, particulate), MRI compatibility, and ISO 10993 biocompatibility. Ovine study evaluated migration resistance, occlusion efficiency, recanalization, and thrombogenicity, demonstrating performance equivalent or superior to control devices.

Technological Characteristics

Self-expanding occlusion plug. Materials: cobalt-chrome stem, nickel-titanium fibers, platinum-iridium radiopaque markers, polyurethane/polyethylene membrane. Delivery system includes hydrophilic (Micro) or PTFE hydrophobic (standard) coated wires. Dimensions vary by target artery diameter (1.5-7mm). Sterile, single-use. No software or electronic components.

Indications for Use

Indicated for arterial embolization in the peripheral vasculature. Contraindicated for use in vessels subject to cyclic bending, such as highly locomotive joints or muscle beds.

Regulatory Classification

Identification

A vascular embolization device is an intravascular implant intended to control hemorrhaging due to aneurysms, certain types of tumors (e.g., nephroma, hepatoma, uterine fibroids), and arteriovenous malformations. This does not include cyanoacrylates and other embolic agents, which act by polymerization or precipitation. Embolization devices used in neurovascular applications are also not included in this classification, see § 882.5950 of this chapter.

Special Controls

*Classification.* Class II (special controls.) The special control for this device is the FDA guidance document entitled “Class II Special Controls Guidance Document: Vascular and Neurovascular Embolization Devices.” For availability of this guidance document, see § 870.1(e).

Predicate Devices

• Amplatzer™ Vascular Plug II (AVP II) (K071699)

Reference Devices

• Amplatzer™ Vascular Plug 4 (AVP4) (K113658)

Submission Summary (Full Text)

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Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, with the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG" in blue, and then the word "ADMINISTRATION" in a smaller font below.

February 4, 2020

ClearStream Technologies Ltd. Melanie Hadlock Regulatory Affairs Specialist II Moyne Upper Enniscorthy, Co. Wexford, Ireland

# Re: K191532

Trade/Device Name: Caterpillar™ and Caterpillar™ Micro Arterial Embolization Device

Regulation Number: 21 CFR 870.3300 Regulation Name: Vascular Embolization Device Regulatory Class: Class II Product Code: KRD Dated: December 30, 2019 Received: December 31, 2019

# Dear Melanie Hadlock:

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 requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part

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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 (QS) 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,

For

Misti Malone Assistant Director DHT2C: Division of Coronary and Peripheral Intervention Devices OHT2: Office of Cardiovascular Devices Office of Product Evaluation and Ouality Center for Devices and Radiological Health

Enclosure

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# DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration

# Indications for Use

Form Approved: OMB No. 0910-0120 Expiration Date: 06/30/2020 See PRA Statement below.

Page 685

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510(k) Number (if known) K191532

## Device Name

Caterpillar™ and Caterpillar™ Micro Arterial Embolization Devices

Indications for Use (Describe)

The Caterpillar and Caterpillar Micro Arterial Embolization Devices are indicated for arterial embolization in the peripheral vasculature. The Caterpillar Micro Arterial Embolization Devices are contraindicated for use in vessels subject to cyclic bending, such as highly locomotive joints or muscle beds.

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

# CONTINUE ON A SEPARATE PAGE IF NEEDED.

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# Caterpillar™ and Caterpillar TM Micro Arterial Embolization Device 510(k) Summary

#### 21 CFR 807.92

As required by the Safe Medical Devices Act of 1990, coded under Section 513, Part (1)(3)(A) of the Food, Drug and Cosmetic Act, a 510(k) summary upon which substantial equivalence determination is based is as follows:

### Submitter Information:

ClearStream Technologies Ltd Moyne Upper, Enniscorthy, Co. Wexford, Ireland Tel: [phone].894.9515 Fax: [phone] Contact Person: Melanie Hadlock, Senior Regulatory Specialist

# Date of Submission: June 7, 2019

### Subject Device:

| Device Trade Name: | Caterpillar™ and Caterpillar™ Micro Arterial Embolization Device |
|-----------------------|------------------------------------------------------------------|
| Common or Usual Name: | Device, Vascular, for Promoting Embolization |
| Classification: | Class II |
| Classification Name: | Vascular Embolization Device, KRD |
| Review Panel: | Cardiovascular |
| Regulation Number: | 21 CFR 870.3300 |

#### Predicate Device:

| Device Trade Name: | Amplatzer™ Vascular Plug II (AVP II) |
|-----------------------|----------------------------------------------|
| Common or Usual Name: | Device, Vascular, for Promoting Embolization |
| Classification: | Class II |
| Classification Name: | Vascular Embolization Device, KRD |
| Review Panel: | Cardiovascular |
| Regulation Number: | 21 CFR 870.3300 |
| 510(k) Numbers: | K071699, cleared August 15, 2007 |

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### Reference Device:

| Device Trade Name: | Amplatzer™ Vascular Plug 4 (AVP4) |
|-----------------------|----------------------------------------------|
| Common or Usual Name: | Device, Vascular, for Promoting Embolization |
| Classification: | Class II |
| Classification Name: | Vascular Embolization Device, KRD |
| Review Panel: | Cardiovascular |
| Regulation Number: | 21 CFR 870.3300 |
| 510(k) Number: | K113658, cleared June 12, 2012 |

#### Device Description:

The Caterpillar™ and Caterpillar™ Micro Arterial Embolization Devices are self-expanding arterial occlusion plugs. The devices consist of the following components and are intended to be a permanent implant: cobalt-chrome stem, nickel-titanium fibers, platinum-iridium radiopaque marker bands, and a polyurethane and polyethylene occlusion membrane.

The Caterpillar™ and Caterpillar™ Micro Arterial Embolization Device Systems are packaged as a single unit with the implant, loader, dispenser hoop, detachable delivery wire, and torque tool. The Caterpillar™M Micro delivery wire is coated with a hydrophilic coating. While the Caterpillar™ delivery wire has a PTFE hydrophobic coating. The system is provided sterile and non-pyrogenic and is intended for single use only.

The Caterpillar™ and Caterpillar™ Micro Arterial Embolization Device is designed for a specific arterial diameter range. The artery diameter range and required delivery catheter (ID)) for deployment are provided in the table below.

| Product Name | Product<br>Reference | Target Artery<br>Diameter (mm) | Delivery Catheter<br>Compatibility: Inner<br>Diameter (in/mm) | Marker to<br>Marker<br>Length<br>(mm)1 | Maximum<br>Deployed<br>Length<br>(mm)2 | Delivery<br>Wire<br>Length<br>(cm) |
|-----------------------|----------------------|--------------------------------|---------------------------------------------------------------|----------------------------------------|----------------------------------------|------------------------------------|
| Caterpillar™<br>Micro | 027 | 1.5 - 4 | 0.027 / 0.686 | 7 | 16 | 170 |
| Caterpillar™ | 038 | 3 - 6 | 0.038 / 0.965 | 17 | 26 | 155 |
| Caterpillar™ | 056 | 5 - 7 | 0.056/ 1.422 | 18 | 37 | 155 |

The Marker to Marker Length is the distal radiopaque marker band to the most proximal radiopaque marker 1. band.

2. The Maximum Deployed Length is the length from the distal fibers in the minimum target artery diameter.

# Indications for Use:

The Caterpillar™ and Caterpillar™ Micro Arterial Embolization Devices are indicated for arterial embolization in the peripheral vasculature. The devices are contraindicated for use in vessels subject to cyclic bending, such as locomotive joints or muscle beds.

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### Comparison to Predicate device:

The Caterpillar™ and Caterpillar™ Micro Arterial Embolization Device have the following similarities to the predicate device, the Amplazter™ Vascular Plug II, AVP II (K071699, cleared August 15, 2007):

- Same intended use
- . Similar target population
- Similar technological characteristics
- Similar user interface
- Same mechanism of action
- Same sterility assurance level and method of sterilization ●
- Similar materials ●

The reference device Amplazter™ Vascular Plug 4. AVP4 (K113658, cleared June 12, 2012) has the above similarities and was used to support the methods used for characterization of delivery system performance based on similarities of the delivery system.

The subject devices, the Caterpillar™ and Caterpillar™ Micro Arterial Embolization Device, have the following changes:

- Contraindication ●
- A new implant design
- A modified delivery system ●

# Performance Data:

To demonstrate substantial equivalence of the subject device to the predicate devices, its technological characteristics and performance criteria were evaluated. Using FDA Guidance Documents on non-clinical testing of medical devices, consensus standards, and internal risk assessment procedures, the following tests were performed on the subject device:

- . Dimension
- Implant Length o
- O Catheter Compatibility
- O Delivery Wire Length and Outer Diameter
- Radial Force ●
- Luer Connection Testing ●
- Radiopacity ●
- Simulated Use
- Visual Inspection o
- Delivery, Load, Track and Deployment Forces O
- Accuracy of Deployment O
- Detachment Time and Detachment Mechanism Reliability o
- Tensile and Torsional Strength o
- Recapture and Resheathing for Removal o
- Delivery System Removal (withdrawal) ●
- Fatigue Resistance
- Pulsatile and Pinching Compression O
- . Material Safety Testing
- Corrosion Resistance O

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- Nickel Leaching o
- Particulate O
- MRI Compatibility and Safety ●
- Packaging Testing .
- Biocompatibility per ISO 10993 ●
- Cytotoxicity, sensitization (guinea pig maximization test), intracutaneous reactivity, acute o systemic toxicity, material-mediated pyrogenicity, genotoxicity (in vitro bacterial reverse mutation assay and in vitro mouse lymphoma assay), hemolysis (direct and indirect), and complement activation.
- Biocompatibility endpoints for subchronic toxicity, implantation, chronic toxicity, and in vivo O thrombogenicity were addressed within the chronic ovine animal study.
- Biocompatibility endpoints for genotoxicity, chronic toxicity, and carcinogenicity were evaluated O with chemical characterization testing and toxicological assessment

### Pre-Clinical Animal Study:

A chronic ovine study was performed to evaluate the chronic safety and performance of the Caterpillar and Caterpillar Micro Arterial Embolization Devices. The animal study included evaluations for migration resistance, ease of delivery, occlusion efficiency, recanalization, deliverability, hemostasis after procedure, thrombogenicity, device safety, and freedom from complications for the study. The results demonstrated that the study device performance was equivalent or superior to control devices across each of the evaluated endpoints.

### Conclusions:

The subject devices, the Caterpillar™ and Caterpillar™ Micro Arterial Embolization Device, met all predetermined acceptance criteria of design verification as specified by applicable standards, guidance, test protocols and/or customer inputs. The Caterpillar™ and Caterpillar™ Micro Arterial Embolization Device are substantially equivalent to the legally marketed predicate device, the Amplatzer™ Vascular Plug II, AVP II (K071699, cleared August 15, 2007) and the reference device Amplatzer™ Vascular Plug 4, AVP 4 (K113658, cleared June 12, 2012).