MICRUSFRAME 10/18, DELTAFILL 18, DELTAXSFT 10, GALAXY G3 FILL/XSFT STRETCH RESISTANT MICROCOIL DELIVERY SYSTEMS

K150319 · Codman & Shurtleff, Inc. · HCG · Jun 12, 2015 · Neurology

Device Facts

• Record ID: K150319
• Device Name: MICRUSFRAME 10/18, DELTAFILL 18, DELTAXSFT 10, GALAXY G3 FILL/XSFT STRETCH RESISTANT MICROCOIL DELIVERY SYSTEMS
• Applicant: Codman & Shurtleff, Inc.
• Product Code: HCG · Neurology
• Decision Date: Jun 12, 2015
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 882.5950
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

MICRUSFRAME, DELTAFILL, and DELTAXSFT Microcoil Delivery Systems are intended for endovascular embolization of intracranial aneurysms, other neurovascular abnormalities such as arteriovenous malformations and arteriovenous fistulae, and are also intended for arterial and venous embolizations in the peripheral vasculature. The GALAXY G3 Microcoil Delivery System is intended for endovascular embolization of intracranial aneurysms, other neurovascular abnormalities such as arteriovenous malformations and arteriovenous fistulae, and is also intended for arterial and venous embolizations in the peripheral vasculature. The GALAXY G3 XSFT Microcoil Delivery System is intended for endovascular embolization of intracranial aneurysms.

Device Story

System comprises microcoil, Device Positioning Unit (DPU), and Detachment Control System (Detachment Control Box and cable). Microcoil (platinum alloy wire, primary/secondary shapes) acts as implant. DPU (variable stiffness wire) delivers coil through microcatheter; features radiopaque marker and fluoro saver markers for positioning. Detachment Control Box provides energy for thermo-mechanical detachment of coil from DPU. Used in neurovascular/peripheral procedures by physicians. System inputs: manual manipulation of DPU; electrical energy from control box. Outputs: physical placement of embolic coil. Benefits: reduced/blocked blood flow in aneurysms/abnormalities. Modifications in this submission: DPU design changes (diameter, marker addition) to enhance performance.

Clinical Evidence

No clinical data. Substantial equivalence supported by bench testing, including microcatheter stability, coil detachment durability/reliability, track force, re-sheathing reliability, and biocompatibility (ISO 10993).

Technological Characteristics

Microcoil: platinum alloy wire, primary/secondary shapes, stretch-resistant (PGA/PP suture). DPU: variable stiffness wire, 0.0159" diameter, radiopaque markers. Delivery: thermo-mechanical detachment via EnPOWER Control Box. Sterilization: E-Beam radiation. Shelf life: 18 months.

Indications for Use

Indicated for endovascular embolization of intracranial aneurysms, neurovascular abnormalities (AVMs, AV fistulae), and peripheral arterial/venous embolizations. GALAXY G3 XSFT indicated for intracranial aneurysms only.

Regulatory Classification

Identification

A neurovascular embolization device is an intravascular implant intended to permanently occlude blood flow to cerebral aneurysms and cerebral ateriovenous malformations. This does not include cyanoacrylates and other embolic agents, which act by polymerization or precipitation. Embolization devices used in other vascular applications are also not included in this classification, see § 870.3300.

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 § 882.1(e).

Predicate Devices

• Micrus Microcoil Delivery System (K082739)

Reference Devices

• Micrus Microcoil System DELTAPLUSH (K083646)
• Micrus Modified Microcoil System, Cerecyte (K033813)
• Micrus Modified Microcoil 18-System, "Cerecyte" (K053160)
• Micrus Microcoil System "Presidio-18" (K062036)
• Micrus Microcoil Delivery System (K072173)
• Micrus Microcoil Delivery System (K080437)
• Micrus Microcoil Delivery System (K073442)
• ORBIT GALAXY G2 Microcoil Delivery System (K120686)
• DELTAMAXX 18 Microcoil System (K120274)
• CODMAN, DELTAMAXX, and ORBIT GALAXY G2 Microcoil Delivery Systems and Cables (K142429)
• ORBIT GALAXY Detachable Coil System (K093973)
• REVIVE Peripheral Vascular (PV) Thrombectomy Device (K132281)
• ENVOY Distal Access (DA) Guiding Catheter (K140080)
• Target Detachable Coils (K123377)

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 a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized image of three human profiles facing to the right, with flowing lines representing hair or clothing.

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

June 12, 2015

Codman & Shurtleff, Inc. Ms. Hannah Foley Senior Regulatory Affairs Specialist 325 Paramount Drive Raynham, Massachusetts 02767

Re: K150319

Trade/Device Name: MICRUSFRAME, DELTAFILL, DELTAXSFT, GALAXY G3, and GALAXY G3 XSFT Microcoil Delivery Systems Regulation Number: 21 CFR 882.5950 Regulation Name: Neurovascular Embolization Device Regulatory Class: Class II Product Code: HCG, KRD Dated: May 11, 2015 Received: May 13, 2015

Dear Ms. Foley:

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 device

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related 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.

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 -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

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## Indications for Use

#### 510(k) Number (if known) K150319

Device Name

MICRUSFRAME, DELTAFILL, DELTAXSFT, GALAXY G3, and GALAXY G3 XSFT Microcoil Delivery Systems

Indications for Use (Describe)

MICRUSFRAME, DELTAFILL, and DELTAXSFT Microcoil Delivery Systems are intended for endovascular embolization of intracranial aneurysms, other neurovascular abnormalities such as arteriovenous malformations and arteriovenous fistulae, and are also intended for arterial and venous embolizations in the peripheral vasculature.

The GALAXY G3 Microcoil Delivery System is intended for endovascular embolization of intracranial aneurysms, other neurovascular abnormalities such as arteriovenous malformations and arteriovenous fistulae, and is also intended for arterial and venous embolizations in the peripheral vasculature.

The GALAXY G3 XSFT Microcoil Delivery System is intended for endovascular embolization of intracranial aneurysms.

| Type of Use (Select one or both, as applicable) | |
|---------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------|
| <div> <span> <span style="font-size: 10px;">☑</span> Prescription Use (Part 21 CFR 801 Subpart D) </span> </div> | <div> <span> <span style="font-size: 10px;">□</span> Over-The-Counter Use (21 CFR 801 Subpart C) </span> </div> |

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# 510(k) Summary

## I. Submitter

Codman & Shurtleff, Inc. 325 Paramount Drive Raynham, MA 02767

Tel: [phone] Fax: [phone]

Contact Person: Hannah Foley Date Prepared: June 9, 2015

## II. Device

| Table 2: Device | |
|---------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Device Proprietary Name | MICRUSFRAME Microcoil Delivery System, DELTAFILL Microcoil Delivery System, DELTAXSFT Microcoil Delivery System, GALAXY G3 Microcoil Delivery System, GALAXY G3 XSFT Microcoil Delivery System |
| Common or Usual Name | Device, Neurovascular Embolization & Vascular, For Promoting Embolization |
| Classification Name | Device, Neurovascular Embolization, Class II, 21 CFR 882.5950 & Vascular, For Promoting Embolization, Class II 21 CFR 870.3300 |
| Regulatory Classification | II |
| Product Codes | HCG, KRD |

### III. Predicate Device

The corresponding predicate and reference devices that are listed in Table 3 below are applicable to the devices being bundled in this submission.

| Table 3 : Prior 510(k) Clearance | | | |
|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------|---------------------------------------------------------------------------------|-------------------------------------|
| 510(k) Number | Date Cleared | Name | Manufacturer |
| | | Predicate Device | |
| Predicate Device<br>K082739 | 10/17/2008 | Micrus Microcoil Delivery System** | Micrus Endovascular<br>Corporation* |
| | | Reference Devices | |
| Reference Device<br>K083646 | 01/02/2009 | Micrus Microcoil System DELTAPLUSH | Micrus Endovascular<br>Corporation* |
| Reference Device<br>K033813 | 04/04/2004 | Micrus Modified Microcoil System, Cerecyte | Micrus Endovascular<br>Corporation* |
| Reference Device<br>K053160 | 12/07/2005 | Micrus Modified Microcoil 18-System, "Cerecyte" | Micrus Endovascular<br>Corporation* |
| Reference Device<br>K062036 | 08/25/2006 | Micrus Microcoil System "Presidio-18" | Micrus Endovascular<br>Corporation* |
| Reference Device<br>K072173 | 10/05/2007 | Micrus Microcoil Delivery System | Micrus Endovascular<br>Corporation* |
| Reference Device<br>K080437 | 05/08/2008 | Micrus Microcoil Delivery System | Micrus Endovascular<br>Corporation* |
| Reference Device<br>K073442 | 02/26/2008 | Micrus Microcoil Delivery System | Micrus Endovascular<br>Corporation* |
| Reference Device<br>K120686 | 04/04/2012 | ORBIT GALAXY G2 Microcoil Delivery System | Codman & Shurtleff, Inc |
| Reference Device<br>K120274 | 03/02/2012 | DELTAMAXX 18 Microcoil System | Codman & Shurtleff, Inc |
| Reference Device<br>K142429 | 12/24/2014 | CODMAN, DELTAMAXX, and ORBIT GALAXY<br>G2 Microcoil Delivery Systems and Cables | Codman & Shurtleff, Inc |
| Reference Device<br>K093973 | 05/26/2010 | ORBIT GALAXY Detachable Coil System | Codman & Shurtleff, Inc |
| Reference Device<br>K132281 | 08/30/2013 | REVIVE Peripheral Vascular (PV) Thrombectomy<br>Device | Codman & Shurtleff, Inc |
| Reference Device<br>K140080 | 04/24/2014 | ENVOY Distal Access (DA) Guiding Catheter | Codman & Shurtleff, Inc |
| Reference Device<br>K123377 | 11/30/2012 | Target Detachable Coils | Stryker Neurovascular |
| *On 09/27/10, Micrus Endovascular Corporation was acquired by Johnson & Johnson and now operates as a wholly-owned<br>subsidiary of Codman & Shurtleff, Inc within the Johnson & Johnson family of companies. Medos International SARL (Medos) will<br>be the recognized legal manufacturer and Codman & Shurtleff, Inc. will be the subcontractor appointed by Medos.<br>** The predicate Device Positioning Unit 2-3 (DPU2-3) was cleared under this submission. | | | |

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The MICRUSFRAME, DELTAFILL, DELTAXSFT, GALAXY G3, GALAXY G3 IV. Device Description XSFT Microcoil Delivery Systems consist of three components, a Microcoil System, a connecting cable, and a Detachment Control Box (DCB). Each component is sold separately. As shown in Figure 1, the Microcoil System consists of a microcoil attached to a Device Positioning Unit (DPU).

Image /page/4/Figure/3 description: This image is a diagram of a microcoil system. The diagram labels the different parts of the system, including the hub connector, re-sheathing tool, introducer sheath body, introducer sheath tip, device positioning unit (DPU), and microcoil. The microcoil is located at the end of the system.

The Microcoil System is packaged in an introducer sheath designed to protect the coil in the packaging dispenser and to provide support for introducing the coil into the microcatheter catheter. The microcoil is the implantable segment of the device, and is detached from the Device Positioning Unit (DPU) using the Detachment Control System (Detachment Control Box and connecting cable).

- The microcoil is fabricated from a platinum alloy wire. The wire is wound into a primary coil which may contain either a polypropylene suture (SR) or an absorbable polymer suture and then formed into a secondary shape. The secondary shape may be spherical, complex, or helical.
- The DPU is a variable stiffness wire and has a radiopaque marker band located ● three (3) cm from its distal end. The Device Positioning Unit includes five (5) fluoro saver markers on the proximal section of the shaft. The markers are intended to indicate when the tip of the microcoil is approaching the tip of the microcatheter. When the distal-most marker reaches the proximal end of the Rotating Hemostatic Valve (RHV) on the microcatheter, the tip of the coil is approaching the tip of the microcatheter and fluoroscopy should be used to guide further coil insertion.
- . The introducer sheath has three main components: an introducer tip, a translucent introducer body, and a re-sheathing tool.

The EnPOWER Detachment Control Box (DCB) provides the energy necessary to allow for a thermo-mechanical detachment of the microcoil from the DPU. The connecting cable delivers the energy necessary to detach the embolic coil from the Microcoil System's detachment zone. The connecting cable is connected between the Microcoil System's hub connector on the DPU and the output connector on the DCB.

- The connecting cables may be one of two types: one with a remote detach . button (the EnPower Control Cable) catalog no. ECB000182-00, or one without a detach button (standard connecting cable) catalog no. CCB00157-00.
- The EnPower Detachment Control Box works with the EnPower Control Cable and with the standard connecting cable.

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The device in this submission includes design changes only to the Device Positioning IV. Device Unit (DPU) element of the microcoil system. There are no modifications to the Description (Cont.) microcoil components or to the EnPOWER Detachment Control system. The following is a summarized list of the modifications to the predicate and reference devices:

- . Minor design modifications to the Device Positioning Unit (DPU) to enhance the system's overall performance
- Labeling changes as a result of the minor design modifications and additional ● clarifications.
- . Rebranding Microcoil Systems with new Proprietary Names (Refer to Table 4)

The currently cleared microcoils will be attached to the proposed Device Positioning Unit. The proposed microcoil system will remain compatible with the EnPOWER Control Box and Connecting Cables. These microcoil systems are also being rebranded with new proprietary names. Table 4 provides a cross referenced summary of the currently cleared microcoils, secondary shape diameter and length, the 510(k) it was cleared under and new proprietary name with the proposed DPU.

| Table 4: Microcoil Proprietary Name Conversion | | | |
|------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------|----------------------|----------------------------------------------------------|
| Current Device Proprietary Names | Microcoil Secondary<br>Shape Diameter and<br>Length | 510(k)<br>Numbers | This Submission:<br>Proposed Device Proprietary<br>Names |
| MICRUSPHERE 10 &<br>PRESIDIO 10 CERECYTE Coils | 2mm-10mm x 1cm-30cm | K033813 | MICRUSFRAME S 10 Stretch<br>Resistant Coil |
| MICRUSPHERE 18 &<br>PRESIDIO 18 CERECYTE Coils | 2mm-20mm x 4cm-50cm | K062036 &<br>K053160 | MICRUSFRAME S 18 Stretch<br>Resistant Coil |
| CASHMERE 14 CERECYTE Coil | 2mm-12mm x 2.5cm-30cm | K072173 | MICRUSFRAME C 14 Stretch<br>Resistant Coil |
| DELTAPAQ 10 &<br>DELTAPLUSH 10 CERECYTE Coils | 1.5mm-10mm x 1cm-25cm | K080437 &<br>K083646 | DELTAXSFT 10 &<br>DELTAFILL 10 Stretch Resistant<br>Coil |
| DELTAMAXX 18 CERECYTE Coil | 3mm-24mm x 12cm-60cm | K120274 | DELTAFILL 18 Stretch Resistant<br>Coil |
| ORBIT GALAXY G2 FILL Stretch Resistant<br>Coil | 2mm-20mm x 1.5cm-30cm | K120686 | GALAXY G3 Stretch Resistant<br>Coil |
| ORBIT GALAXY G2 XSFT Stretch Resistant<br>Coil | 2mm-6mm x 1.5cm-8cm | K120686 | GALAXY G3 XSFT Stretch<br>Resistant Coil |
| S: Represents Spherical which is the Secondary Shape of the Microcoil.<br>C: Represents Complex which is the Secondary Shape of the Microcoil. | | | |

V. Indications MICRUSFRAME, DELTAFILL, and DELTAXSFT Microcoil Delivery Systems are intended for endovascular embolization of intracranial aneurysms, other neurovascular for Use abnormalities such as arteriovenous malformations and arteriovenous fistulae, and are also intended for arterial and venous embolizations in the peripheral vasculature.

> The GALAXY G3 Microcoil Delivery System is intended for endovascular embolization of intracranial aneurysms, other neurovascular abnormalities such as arteriovenous malformations and arteriovenous fistulae, and is also intended for arterial and venous embolizations in the peripheral vasculature.

> The GALAXY G3 XSFT Microcoil Delivery System is intended for endovascular embolization of intracranial aneurysms.

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VI. Comparison of Technological Characteristics With Predicate Device

Endovascular coil embolization is the technological principle for both the subject and predicate device. It is based on placing embolic coils in the neurovascular or peripheral vasculature in order to reduce or block blood flow. At a high level, the subject device and predicate device are based on the following same technological characteristics:

| Table 5: Technological Characteristics of the Predicate and Proposed Devices | | |
|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Description | Predicate Device:<br>(K082739) | This Submission:<br>MICRUSFRAME, DELTAFILL,<br>DELTAXSFT, GALAXY G3, and<br>GALAXY G3 XSFT Microcoil Delivery<br>Systems |
| Indications for Use | The CODMAN Microcoil Delivery<br>System is intended for endovascular<br>embolization of intracranial aneurysms,<br>other neurovascular abnormalities such as<br>arteriovenous malformations and<br>arteriovenous fistulae, and is also intended<br>for arterial and venous embolizations in<br>the peripheral vasculature.<br>The ORBIT GALAXY G2 FILL<br>Microcoil Delivery System is intended for<br>endovascular embolization of intracranial<br>aneurysms, other neurovascular<br>abnormalities such as arteriovenous<br>malformations and arteriovenous fistulae,<br>and is also intended for arterial and<br>venous embolizations in the peripheral<br>vasculature.<br>The XTRASOFT ORBIT GALAXY G2<br>Microcoil Delivery System is intended for<br>endovascular embolization of intracranial<br>aneurysms. | Same as predicate<br>MICRUSFRAME, DELTAFILL, and<br>DELTAXSFT Microcoil Delivery Systems<br>are intended for endovascular embolization<br>of intracranial aneurysms, other<br>neurovascular abnormalities such as<br>arteriovenous malformations and<br>arteriovenous fistulae, and are also<br>intended for arterial and venous<br>embolizations in the peripheral vasculature.<br>GALAXY G3 Microcoil Delivery System<br>is intended for endovascular embolization<br>of intracranial aneurysms, other<br>neurovascular abnormalities such as<br>arteriovenous malformations and<br>arteriovenous fistulae, and is also intended<br>for arterial and venous embolizations in the<br>peripheral vasculature. *<br>The GALAXY G3 XSFT Microcoil<br>Delivery System is intended for<br>endovascular embolization of intracranial<br>aneurysms. * |
| | Microcoil | |
| Microcoil Material | Platinum/Tungsten | Same as predicate |
| Microcoil Primary Wind | Triangular or Cylindrical | Same as predicate |
| Microcoil Secondary Shape | Complex, Helical, or Spherical | Same as predicate |
| Microcoil Stretch-Resistant | PGA= Polyglycolic Acid Suture<br>PP= Polypropylene Suture | Same as predicate |
| Primary Coil Wind Outer<br>Diameter (OD) | 0.009" - 0.016" | Same as predicate |
| Secondary Shape OD Ranges | 1.5mm - 24mm | Same as predicate |
| Microcoil Length Ranges | 1cm - 60cm | Same as predicate |
| | Delivery System | |
| Delivery System Type | Wire Shaft with radiopaque marker | Same as predicate |
| Delivery System Introducer Sheath | HDPE Introducer | Same as predicate |
| Delivery System Resheathing Tool | Nylon 12 | Same as predicate |
| Device Positioning Unit (DPU)<br>Delivery System Length | 190cm ± 5cm | Same as predicate |
| Device Positioning Unit Diameter | 0.0138" | 0.0159" |
| Fluoroscopy Saver Markers | None | Five Markers Located on the Proximal<br>Section of the Shaft ** |
| Fluoro Saver Marker<br>Microcatheter Compatibility | Not Applicable | 150cm Length** |
| Distal Segment of the Device<br>Positioning Unit | Device Positioning Unit 2-3 (DPU2-3) | Device Positioning Unit 3 (DPU3) Design<br>modified to enhance overall performance |
| Mechanism of Detachment | Connection to Microcoil System: Uses<br>Connecting Cable or EnPOWER Control<br>Cable<br>Detachment: Thermo-Mechanical System<br>uses the EnPOWER Detachment Control<br>Box (DCB) with EnPOWER Control<br>Cable or Connecting Cable | Same as predicate |
| | Sterilization and Shelf Life | |
| Sterilization Method | E-Beam Radiation | Same as predicate |
| Shelf Life | 5 years | 18 months |
| Packaging | Packaged in a plastic hoop and enclosed<br>in a pouch.…