TRUFILL DCS ORBIT DETACHABLE COIL SYSTEM

K093973 · Codman & Shurtleff, Inc. · HCG · May 26, 2010 · Neurology

Device Facts

• Record ID: K093973
• Device Name: TRUFILL DCS ORBIT DETACHABLE COIL SYSTEM
• Applicant: Codman & Shurtleff, Inc.
• Product Code: HCG · Neurology
• Decision Date: May 26, 2010
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 882.5950
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

1) The XTRASOFT™ ORBIT GALAXY™ Detachable Coil is indicated for embolizing intracranial aneurysms. 2) The Fill ORBIT GALAXY™ Detachable Coil and the Frame ORBIT GALAXY™ Detachable Coil are indicated for embolizing intracranial aneurysms and other vascular malformations such as arteriovenous malformations and arteriovenous fistulae of the neurovasculature. The Fill ORBIT GALAXY™ Detachable Coil and the Frame ORBIT GALAXY™ Detachable Coil are also intended for arterial and venous embolization in the peripheral vasculature.

Device Story

The ORBIT GALAXY™ Detachable Coil System is an artificial embolization device used by physicians to treat intracranial aneurysms and vascular malformations. The system comprises a delivery tube (functioning as a guidewire and mini infusion catheter), a coil introducer, and a stretch-resistant embolic coil. The coil, made of platinum alloy wire with an integrated polymer monofilament, is delivered to the target site via the catheter. A proprietary hydraulic release mechanism, activated by a separately sold TRUFILL® DCS Syringe II, detaches the coil from the delivery tube. The device is used in clinical settings; the physician navigates the coil to the site and triggers detachment to occlude the vessel or aneurysm. This procedure helps stabilize or eliminate the aneurysm, reducing the risk of rupture. The system includes a luer valve for purging and is supplied sterile.

Clinical Evidence

Bench testing only. In-vitro testing verified coil length, diameter, shape, softness, stretch resistance, attachment strength, radiopacity, and deliverability. Simulated use testing was conducted in an in-vivo porcine model and an in-vitro aneurysm model to confirm user needs. Biocompatibility was established per ISO 10993, including cytotoxicity, sensitization, systemic toxicity, pyrogenicity, mutagenicity, and hemocompatibility assays.

Technological Characteristics

Materials: Platinum alloy wire, polymer monofilament, Pebax 55D. Principle: Hydraulic detachment mechanism. Dimensions: 0.014"-0.018" guidewire compatible; secondary coil diameter 2-26 mm. Sterilization: 100% Ethylene Oxide. Shelf life: 2 years. Connectivity: None (mechanical).

Indications for Use

Indicated for embolizing intracranial aneurysms, arteriovenous malformations, and arteriovenous fistulae of the neurovasculature, as well as arterial and venous embolization in the peripheral vasculature.

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

• TRUFILL® DCS ORBIT™ Detachable Coil System (K080967)

Submission Summary (Full Text)

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## SECTION 5. 510(k) SUMMARY

K093973

(As Required By 21 CFR 807.92(a))

Company Name: Codman & Shurtleff, Inc.

Company Address: 325 Paramount Drive Raynham, MA 02767-0350

Phone: [phone]

Contact Person: Amarilys Machado Manager, Regulatory Affairs

Submission Date: 12/23/09

Name of the Device: ORBIT GALAXY™ Detachable Coil System

Propriety / Trade Name: ORBIT GALAXY™ Detachable Coil System

Common Name: Artificial Embolization Device

Classification: Class II per 21 CFR 882.5950 (HCG)

#### Predicate Device:

The predicate device is listed in the table below:

| Device | Company | 510(k)<br>Number /<br>Concurrence<br>Date | Product<br>Code | Predicate for: |
|-----------------------------------------------------|--------------------------------|-------------------------------------------|-----------------|-----------------------------------------------------------------------------------------------------------|
| TRUFILL® DCS<br>ORBIT™<br>Detachable Coil<br>System | Codman &<br>Shurtleff,<br>Inc. | K080967 /<br>5-02-08 | HCG | Intended Use<br>Embolic Coil<br>Delivery System<br>Detachment Mechanism<br>Manufacturing<br>Sterilization |

MAY 2 6 2010

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## Device Description:

The ORBIT GALAXY™ Detachable Coil System consists of a delivery system (delivery tube and coil introducer) and a stretch resistant embolic coil. The delivery tube and coil introducer of the ORBIT GALAXY™ Detachable Coil System are identical to the delivery tube and coil introducer of the TRUFILL DCS ORBIT™ Detachable Coil System. The delivery tube is the body of the device and functions as a guidewire and a mini infusion catheter. The coil introducer is designed to protect the coil in the packaging dispenser and to provide support for introducing the coil into the infusion catheter. The coil is the implantable segment of the device. It is comprised of a platinum alloy wire and integrates a stretch resistant polymer monofilament through the inner diameter of the coil.

The TRUFILL® DCS Syringe II (sold separately) is required to properly purge and detach the coil. The coil is detached from the delivery tube by a proprietary hydraulic release mechanism.

The ORBIT GALAXY™ Detachable Coil System is packaged inside a protective dispenser tube. The product is held in place by means of a hub-to-dispenser tube clip. The entire system is packaged inside a sealed protective pouch. A luer valve is provided with the system if the user prefers to remove the syringe from the hub of the delivery tube after purging and prior to detaching the coil. The luer valve is attached to the packaging dispenser with a clip.

#### Intended Use:

- 1) The XTRASOFT™ ORBIT GALAXY™ Detachable Coil is indicated for embolizing intracranial aneurysms.
- 2) The Fill ORBIT GALAXY™ Detachable Coil and the Frame ORBIT GALAXY™ Detachable Coil are indicated for embolizing intracranial aneurysms and other vascular malformations such as arteriovenous malformations and arteriovenous fistulae of the neurovasculature.

The Fill ORBIT GALAXY™ Detachable Coil and the Frame ORBIT GALAXY™ Detachable Coil are also intended for arterial and venous embolization in the peripheral vasculature.

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t

# Summary of Technological Characteristics of the Proposed to the Predicate Device:

The table below provides a comparative summary of the general characteristics of the proposed device to the predicate device.

| Characteristics<br>(Component and<br>/or Material) | TRUFILL DCS ORBIT™ Detachable Coil<br>(K080967) | ORBIT GALAXY™ Detachable Coil<br>(K093973) |
|----------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Intended Use | The TRUFILL DCS ORBIT™ Detachable Coil is<br>indicated for embolizing intracranial aneurysms and<br>other vascular malformations such as arteriovenous<br>malformations and arteriovenous fistulae of the<br>neurovasculature. | 1) The XTRASOFT™ ORBIT GALAXY™<br>Detachable Coil is indicated for<br>embolizing intracranial aneurysms. |
| | The TRUFILL DCS ORBIT™ Detachable Coil is also<br>intended for arterial and venous embolization in the<br>peripheral vasculature. | 2) The Fill ORBIT GALAXY™ Detachable<br>Coil and the Frame ORBIT GALAXY™<br>Detachable Coil are indicated for<br>embolizing intracranial aneurysms and<br>other vascular malformations such as<br>arteriovenous malformations and<br>arteriovenous fistulae of the<br>neurovasculature.<br><br>The Fill ORBIT GALAXY™ Detachable<br>Coil and the Frame ORBIT GALAXY™<br>Detachable Coil are also intended for<br>arterial and venous embolization in the<br>peripheral vasculature. |
| Embolic Coil | Headpiece manufactured using Platinum/Tungsten;<br>includes<br>Gold/tin & Flux to Solder<br>Nomenclature<br>Fills, Standards<br>No stretch resistant suture | No Change |
| Coil Wire Diameter | $0.0015 - 0.0040$ inches | No Change |
| Primary Coil<br>Diameter | $0.010 - 0.016$ inches | No Change |
| Softness Levels | Nomenclature<br>Fills, Standards | Nomenclature<br>Fills, Frames, and Xtrasoft |
| Secondary Coil<br>Diameter | $2 - 20$ mm | $2 - 26$ mm |
| Secondary Shapes | Helical, Complex, and Mini Complex | No Change |
| Primary Coil Length | $1.5 - 30.0$ cm | No Change |
| Delivery System<br>Useable Length | $155 - 210$ cm | No Change |
| Delivery System | 0.014" and 0.018" guidewire compatible delivery system | No Change |
| | Hypotube welded to support coil with welded in-line<br>marker bands | No Change |
| | Introducer:<br>• Self splitting<br>• Contains a zipper that also functions as a holder<br>Blue Strain Relief | No Change |
| Colorants | Distal joint sleeve made of green Pebax 55D | No Change |
| | Blue Strain Relief | No Change |
| Operating Principle | Hydraulic detachment mechanism | No Change |
| Shelf Life | 2 years | No Change |
| Sterilization | 100% Ethylene Oxide | No Change |

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## Bench Test Summary:

In-vitro laboratory bench top testing was conducted to demonstrate the safety and effectiveness of the device, and to demonstrate that the device performs as it is intended. The following invitro bench top tests were conducted:

(

.

| Test | Coils Tested | Results |
|-----------------------------------------------------------------------------|---------------------------------------------|------------------------------------------------------------------------------------------------|
| Embolic Coil<br>Length Verification | Xtrasoft and Frame | Met same specifications as predicate |
| Embolic Coil<br>Diameter<br>Verification | Xtrasoft, Fill, and Frame | Met same specifications as predicate |
| Embolic Coil<br>Shape Visual<br>Inspection | Xtrasoft, Fill, and Frame | Met same specifications as predicate |
| Headpiece Length<br>Verification | Xtrasoft, Fill, and Frame | Met same specifications as predicate |
| Coil Softness | Xtrasoft, Frame, and Standard (control) | Met same specifications as predicate |
| Stretch Resistance<br>Strength | Xtrasoft, Fill, and Frame | Met the acceptance criteria for the<br>proposed device |
| Headpiece<br>Attachment<br>Strength | Xtrasoft, Fill, and Frame | Met same specifications as predicate |
| Atraumatic Bead<br>Visual Inspection | Xtrasoft, Fill, and Frame | Met same specifications as predicate |
| Embolic Coil<br>Placement Stability<br>– In-vitro High<br>Flow Vessel Model | Fill, Frame<br>Xtrasoft | Xtrasoft coils are finishing coils<br>indicated for embolizing intracranial<br>aneurysms only. |
| Embolic Coil<br>Attachment<br>Strength | Xtrasoft, Fill, and Frame | Met same specifications as predicate |
| Embolic Coil<br>Detachment<br>Pressure | Xtrasoft, Fill, and Frame | Met same specifications as predicate |
| Luer Valve Burst<br>Test | Luer Valve | Met same specifications as predicate |
| Test | Coils Tested | Results |
| Embolic Coil<br>Radiopacity | Xtrasoft | Met same specifications as predicate |
| Embolic Coil<br>Protrusion | Xtrasoft, Fill, and Frame | Met same specifications as predicate |
| Coil Conformability | Xtrasoft, Fill, and Frame | Met same specifications as predicate |
| Coil Placement<br>Stability | Xtrasoft, Fill, and Frame | Met same specifications as predicate |
| Packing of Embolic<br>Coils | Xtrasoft, Fill, and Frame | Met same specifications as predicate |
| Retrievability of<br>Embolic Coils | Xtrasoft, Fill, and Frame | Met same specifications as predicate |
| Deliverability<br>through a<br>Microcatheter | Xtrasoft, Fill, and Frame | Met same specifications as predicate |
| Pushability | Xtrasoft, Fill, and Frame | Met same specifications as predicate |
| Ability to Purge<br>Product with<br>Accessory Valve | Delivery tube and luer valve were<br>tested | Met same specifications as predicate |

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## In-vivo and in-vitro Simulated Use Test Summary:

In-vivo and in-vitro testing was conducted to ensure that the user needs were adequately addressed. The performance of the coil was evaluated for aneurysm treatment in an in-vivo porcine model and in an in-vitro aneurysm model. The following attributes were tested in both the in-vivo porcine model and in the in-vitro aneurysm model.

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# Biocompatibility:

The ORBIT GALAXY Detachable Coil System met all the biocompatibility requirements as specified by the ISO 10993 Part 1, and the General Program Memorandum # G95-1 on Biological Evaluation of Medical Devices. The table below provides a summary of the biocompatibility test results and conclusions.

| Test | Results2 | Conclusions2 |
|--------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| <i>In vitro</i> Cytotoxicity Assay -<br>ISO MEM Elution | No evidence of cytotoxicity | Non-cytotoxic |
| Sensitization - Guinea Pig<br>Maximization | No evidence of irritation/sensitization | Non-sensitizing |
| ISO Intracutaneous<br>Reactivity | No evidence of irritation | Non-irritant |
| ISO Acute Systemic Toxicity | No signs of toxicity. | Non-toxic |
| Materials Mediated<br>Pyrogenicity | No increase in body temperature | Non-pyrogenic |
| <i>In vitro</i> Ames Bacterial<br>Mutagenicity Assay | No significant increase in mutation frequencies | Non-mutagenic |
| <i>In vitro</i> Mouse Lymphoma<br>Mutagenicity Assay | No significant increase in mutation frequencies | Non-mutagenic |
| <i>In vitro</i> Chromosome<br>Aberration Assay | No significant increase in chromosome aberrations | Non-clastogenic / non-<br>mutagenic |
| <i>In vivo</i> Mouse Bone Marrow<br>Micronucleus Study | No significant increase in chromosome aberrations of<br>bone marrow erythrocytes for Orbit SR Coils or Luer Valve | Non-hemolytic |
| ASTM Hemolysis - Direct<br>Contact & Extract | Pass with a hemolytic score less than 2% | Non-hemolytic . |
| Partial Thromboplastin Time | Average clotting of Orbit SR Coils was 52% of the<br>negative control. Average clotting time of Orbit Delivery<br>System and Luer Valve was 100% of the negative control. | Orbit SR Coils passed as a mild<br>activator of the intrinsic<br>coagulation pathway. Orbit<br>Delivery System and Luer<br>Valve non-activator of the<br>intrinsic coagulation pathway |
| Platelet & Leukocyte Count | Platelet & Leukocyte counts fell within 25% of the average<br>reference material value. | Pass |
| Complement Activation C3a<br>& SC5b-9 Assays | Activation was 0.8% (or less) of the normalized C3a and<br>SC5b-9 concentrations produced by CVF. | Non-activator of complement<br>activation pathways |
| 180-day Rabbit Cerebral<br>Cortex Implant Tissue<br>Response Study | Comparable, very slight tissue reaction to Orbit SR Coils<br>and control Orbit Coils without SR suture after 30 and 180-<br>day implantation in cerebral cortex of rabbits. No implant<br>testing conducted on delivery system or Luer Valve. | Orbit SR coils well tolerated in<br>cerebral cortex of rabbits |
| Physiochemical Aqueous<br>Extraction Test | Met the limits of the USP & EP Aqueous Extraction Tests. | Passed |

| | Orbit Galaxy Detachable Coil System Biocompatibility Summary" | | | | |
|--|---------------------------------------------------------------|--|--|--|--|
|--|---------------------------------------------------------------|--|--|--|--|

Results and conclusions are summarized for all three components (delivery system, embolic coils, and Luer Valve) unless otherwise noted.

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## Summary of Substantial Equivalence:

A comparison of the technological characteristics of the proposed device (ORBIT GALAXY™ Detachable Coil system) to the predicate device (TRUFILL DCS ORBIT™ Detachable Coil System) show the proposed device has the following same or similar technological characteristics to the device which received 510(k) clearance:

- Same intended use .
- Same operating principle .
- Similar materials ●
- Similar device dimensional specifications .
- Similar manufacturing process .
- Same shelf life and sterilization process .

In summary, the ORBIT GALAXY™ Detachable Coil System is, in our opinion, substantially equivalent to the predicate device, TRUFILL® DCS ORBIT™ Detachable Coil.

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## DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/7/Picture/1 description: The image shows the seal of the Department of Health & Human Services (HHS) of the United States. The seal features the department's name arranged in a circular pattern around the perimeter. In the center is a stylized depiction of an eagle, which is a common symbol of the United States.

#### Public Health Service

Food and Drug Administration 10903 New Hampshire Avenue Document Control Room W-066-0609 Silver Spring, MD 20993-0002

# MAY 2 6 2010

Codman & Shurtleff, Inc. c/o Ms. Amarilys Machado Manager, Regulatory Affairs 325 Paramount Drive Raynham, MA 02767-0350

Re: K093973

Trade/Device Name: ORBIT GALAXY™ Detachable Coil System Regulation Number: 21 CFR 882.5950 Regulation Name: Neurovascular Embolization Device Regulatory Class: Class II Product Code: HCG, KRD Dated: May 3, 2010 Received: May 6, 2010

Dear Ms. Machado:

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.

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Page 2 - Ms. Amarilys Machado

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-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 go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR 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 Small Manufacturers, International and Consumer Assistance at its toll-free number [phone] or [phone] or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm

Sincerely yours,

Keoia Alexander

Image /page/8/Picture/7 description: The image contains a handwritten word "for" in cursive script. The letter 'f' has a long, descending stroke that loops back up, and the 'o' and 'r' are connected with a smooth, flowing line. The writing appears to be done with a pen or marker, and the strokes vary in thickness, suggesting varying pressure applied during writing.

Malvina B. Eydelman, M.D. Director Division of Ophthalmic, Neurological, and Ear, Nose and Throat Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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#### Indications for Use

510(k) Number (if known): K093973

Device Name: ORBIT GALAXY™ Detachable Coil System XTRASOFT™ ORBIT GALAXY™ Detachable Coil Fill ORBIT GALAXY™ Detachable Coil Frame ORBIT GALAXYTM Detachable Coil

Indications for Use:

- 1) The XTRASOFT™ ORBIT GALAXY™ Detachable Coil is indicated for embolizing intracranial aneurysms.
- 2) The Fill ORBIT GALAXY™ Detachable Coil and the Frame ORBIT GALAXY™ Detachable Coil are indicated for embolizing intracranial aneurysms and other vascular malformations such as arteriovenous malformations and arteriovenous fistulae of the neurovasculature.

The Fill ORBIT GALAXY™ Detachable Coil and the Frame ORBIT GALAXY™ Detachable Coil are also intended for arterial and venous embolization in the peripheral vasculature.

Prescription Use X (Part 21 CFR 801 Subpart D)

.

AND/OR

Over-The-Counter Use (21 CFR 807 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

JEFFREY. Toy

(Division Sign-Off) Division of Ophthalmic, Neurological and Ear, Nose and Throat Devices

K093973 510(k) Number_________________________________________________________________________________________________________________________________________________________________