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

The Fill ORBIT GALAXY G2 Microcoil Delivery System is intended for endovascular embolization of intracranial aneurysms, other neurovascular abnormalities such as arteriovenous malformations and is also intended for arterial and venous embolizations in the peripheral vasculature.

The Xtrasoft ORBIT GALAXY G2 Microcoil Delivery System is intended for endovascular embolization of intracranial aneurysms.

Device Description

The CODMAN® Microcoil Delivery System, DELTAMAXX Microcoil Delivery System, and ORBIT GALAXY® G2 Microcoil Delivery System 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 an microcoil attached to a Device Positioning Unit (DPU).

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 infusion 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 (Cerecyte®) and then formed into a secondary shape. The secondary shape may be straight, 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 introducer sheath has three main components: an introducer tip, a translucent introducer body, and a re-sheathing tool.
The 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 detachment control box may be one of two types: the blue EnPower Detachment Control Box or the black Detachment Control Box.
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. The black Detachment Control Box works only with the standard connecting cable. Both cables and Detachment Control Box are sold separately.

AI/ML Overview

The provided document is a 510(k) premarket notification for a medical device focusing on a packaging change. It does not contain information about the performance of the neurovascular embolization devices themselves, but rather the performance of the packaging.

Here's an analysis based on the provided text regarding the packaging acceptance criteria and study:

1. Table of Acceptance Criteria and Reported Device Performance (Packaging):

Acceptance Criteria Category	Specific Test/Evaluation	Reported Device Performance (Packaging)
Packaging Integrity	Visual Inspection (after sterilization, handling, distribution)	Sterile barrier system maintains packaging integrity; inspected seals were complete and uniform throughout the entire seal area of the proposed pouch for each time interval (accelerated and real-time aging).
	Dye Leak	Packaging integrity maintained.
	Seal Strength	No detected negative trends in seal strength; seals maintain their strength over time.
	Product Functional Testing (on EnPower Control Cable)	Implied successful, as the overall conclusion states the packaging does not raise new questions of safety and effectiveness, and the packaging modifications were validated. (Specific functional results are not detailed, but implied to be acceptable within packaging context)
	Characterization Testing: Moisture and Humidity Creep	Implied successful (no negative findings reported).
Sterile Pouch Shelf-Life	Visual Inspection	Proposed pouch's integrity was maintained; inspected seals were complete and uniform throughout the entire seal area for all time intervals (time-zero, 1yr, 3yr, 5yr, 10yr accelerated, and time-zero, 1yr, 3yr real-time).
	Seal Strength	No detected negative trends in seal strength; seals maintain their strength over time. Testing confirmed the device will remain sterile through the proposed shelf life and integrity of its packaging are not compromised.
Sterilization	Bioburden measurement	Met acceptance criteria for representative products as packaged in the new pouch.
	Identification of top three organisms	Specific results not detailed, but met acceptance criteria.
	Bacteriostasis/Fungistasis (B/F)	Specific results not detailed, but met acceptance criteria.
	Bioburden recovery study (Extraction efficiency)	Specific results not detailed, but met acceptance criteria.

2. Sample Size Used for the Test Set and Data Provenance:

Test Set Sample Size: The document does not explicitly state the specific number of units or pouches tested for each packaging integrity and shelf-life test. It mentions testing "representative products" and "each time interval" for shelf-life, implying multiple samples were used.
Data Provenance: The studies were conducted internally by Codman & Shurtleff, Inc. This is a retrospective analysis of the modified packaging, comparing it to the predicate device's packaging characteristics and ensuring the new packaging maintains similar performance.

3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications:

Not Applicable. For packaging integrity and sterilization validation, "ground truth" is established through standardized physical, chemical, and microbiological testing methods (e.g., visual inspection, seal strength measurement, dye leak tests, bioburden assays) and comparison against pre-defined engineering and regulatory specifications, rather than expert consensus on a clinical outcome.

4. Adjudication Method for the Test Set:

Not Applicable. As the tests are objective physical and microbiological measurements of packaging performance, an adjudication method for conflicting expert opinions is not relevant. The results would be interpreted against established acceptance criteria for each test.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:

No. This is a packaging modification submission for an existing neurovascular embolization device. It does not involve AI, image analysis, or human readers.

6. If a Standalone (i.e. algorithm only without human-in-the loop performance) was done:

No. This submission is about medical device packaging, not an algorithm.

7. The Type of Ground Truth Used (Expert Consensus, Pathology, Outcomes Data, etc.):

For the packaging validation, the "ground truth" is defined by established engineering standards, regulatory guidelines (e.g., ISO 11137 for sterilization), and predefined acceptance criteria for physical (e.g., seal strength, visual integrity) and microbiological (e.g., bioburden levels) properties of the sterile barrier system.

8. The Sample Size for the Training Set:

Not Applicable. This is not an AI/machine learning device; therefore, there is no "training set."

9. How the Ground Truth for the Training Set was Established:

Not Applicable. As there is no training set.

Summary

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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 a stylized image of three human profiles facing to the right, with a design element resembling a wing or a flowing fabric above them.

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

December 24, 2014

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

Re: K142429

Trade/Device Name: CODMAN Microcoil Delivery System, DELTAMAXX Microcoil Delivery System, ORBIT GALAXY G2 Microcoil Delivery System, EnPower Control Cable, and Connecting Cable Regulation Number: 21 CFR 882.5950 Regulation Name: Neurovascular Embolization Device Regulatory Class: Class II Product Code: HCG. KRD Dated: December 4, 2014 Received: December 5, 2014

Dear Ms. Hannah 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

{1}------------------------------------------------

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.

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 (800) 638-2041 or (301) 796-7100 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 (800) 638-2041 or (301) 796-7100 or at its Internet address

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

Sincerely yours.

Carlos L. Pena -S FD/△

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) K142429

Device Name CODMAN Microcoil Delivery System DELTAMAXX Microcoil Delivery System ORBIT GALAXY G2 Microcoil Delivery System

Indications for Use (Describe)

The Xtrasoft ORBIT GALAXY G2 Microcoil Delivery System is intended for endovascular embolization of intracranial aneurysms.

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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510(k) Summary

Codman & Shurtleff, Inc. I. Submitter 325 Paramount Drive Raynham, MA 02767
Tel: (305) 265-6810 Fax: (305) 265-6889

Contact Person: Hannah Foley Date Prepared: December 22, 2014

II. Device

Table 1: Device
Device Proprietary Name	CODMAN® Microcoil Delivery System, DELTAMAXX Microcoil Delivery System, ORBIT GALAXY® G2 Microcoil Delivery System, EnPower Control Cable (ECB) and Connecting Cable (CCB)
Common or Usual Name	Device, Neurovascular Embolization & Device, Vascular, For Promoting Embolization
Classification Name	Device, Neurovascular Embolization, Class II, 21 CFR 882.5950 & Device, Vascular, For Promoting Embolization, Class II 21 CFR 870.3300
Regulatory Classification	II
Product Codes	HCG, KRD

The corresponding predicate devices that are listed in Table 2 below pertain to the III. Predicate devices being bundled in this submission. Refer to Table 3 for proprietary names of the Device all applicable products.

Table 2: Prior 510(k) Clearances
510(k) Number	Date Cleared	Name	Manufacturer
PredicateK082739	10/17/2008	Micrus Microcoil Delivery System(Includes Cables)	Micrus EndovascularCorporation*
PredicateK083646	01/02/2009	DELTAPLUSH 10 Stretch-Resistant DPLand DELTAPLUSH 10 Cerecyte CPL(Includes Cables)	Micrus EndovascularCorporation*
PredicateK120686	04/04/2012	ORBIT GALAXY® G2 MicrocoilDelivery System (Includes Cables)	Codman & Shurtleff, Inc.
PredicateK120274	03/02/2012	DELTAMAXX 18 Microcoil System(Includes Cables)	Codman & Shurtleff, Inc.
PredicateK072173	10/05/2007	Micrus Microcoil System “Cashmere”	Micrus EndovascularCorporation*
PredicateK073442	02/26/2008	Micrus Microcoil Delivery System	Micrus EndovascularCorporation*
PredicateK032872	11/28/2003	Micrus Microcoil Delivery System LongSpherical Coils	Micrus EndovascularCorporation*
PredicateK062036	08/25/2006	Micrus Microcoil Delivery SystemPresidio-18	Micrus EndovascularCorporation*
PredicateK053160	12/07/2005	Micrus Microcoil Delivery SystemCerecyte-18	Micrus EndovascularCorporation*
*On 09/27/10, Micrus Endovascular Corporation was acquired by Johnson & Johnson and now operates as a wholly-owned subsidiaryof Codman & Shurtleff, Inc within the Johnson & Johnson family of companies. Medos International SARL (Medos) will be therecognized legal manufacturer and Codman & Shurtleff, Inc. will be the subcontractor appointed by Medos.

No reference devices were used in this submission.

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The CODMAN® Microcoil Delivery System, DELTAMAXX Microcoil Delivery IV. Device Description System, and ORBIT GALAXY® G2 Microcoil Delivery System 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 an microcoil attached to a Device Positioning Unit (DPU).

Image /page/4/Figure/4 description: The image shows a diagram of a microcoil system. The system includes a hub connector on the left side, followed by a re-sheathing tool, an introducer sheath body, and an introducer sheath tip on the right side. The microcoil is located at the far right of the system. A device positioning unit (DPU) is labeled along the length of the system.

. 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 (Cerecyte®) and then formed into a secondary shape. The secondary shape may be straight, 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 introducer sheath has three main components: an introducer tip, a translucent introducer body, and a re-sheathing tool.
The 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 detachment control box may be one of two types: the blue EnPower Detachment Control Box or the black Detachment Control Box.
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. The black Detachment Control Box works only with the standard connecting cable. Both cables and Detachment Control Box are sold separately.

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Table 3 provides a summary of the of the Microcoil Delivery Systems and Cables, IV. Device proprietary names, product model description, product catalog prefix, diameter and length, Description and predicate 510(k) numbers. (Cont.)

Table 3: CODMAN®, DELTAMAXX, and ORBIT GALAXY® G2 Microcoil Delivery Systems and Cables
Proprietary Names / Product Model Description	ProductCatalogPrefix	Diameter (mm) xLength (cm)Ranges	510(k)No.
CODMAN® Microcoil Delivery System:
MICRUSPHERE 10 Platinum Coil	SPH10	2-10mm x 2.5-30cm	K082739
MICRUSPHERE 18 Platinum Coil	SPH18	2-19mm x 2.5-30cm	K082739
HELIPAQ 10 Platinum Coil	HEL10	2-10mm x 2-30cm	K082739
HELIPAQ 18 Platinum Coil	HEL18	2-20mm x 4-30cm	K082739
INTERPAQ Straight 10 Platinum Coil	STR10	2-6mm x 4-30cm	K082739
ULTIPAQ 10 Stretch Resistant Coil	FSR10	2-4mm x 1-8cm	K082739
HELIPAQ 10 Stretch Resistant Coil	HSR10	2-10mm x 1-30cm	K082739
CASHMERE 14 Stretch Resistant Coil	SRC14	2-12mm x 2.5-30cm	K072173
MICRUSPHERE XL 10 Stretch Resistance Coil	SSR10	2-8mm x 2.5-25mm	K073442,K032872
MICRUSPHERE XL 18 Stretch Resistance Coil	SSR18	8-18mm x 25-40cm	K073442,K062036,K053160
DELTAPAQ 10 Stretch Resistant Coil	DFS10	1.5-10mm x 1-25cm	K082739
DELTAPLUSH 10 Stretch Resistant Coil	DPL10	1.5-4mm x 1-8cm	K083646
PRESIDIO 10 Platinum Coil	PP410	4-8mm x 11.5-29cm	K082739
DELTAMAXX 18 Stretch Resistant Coil	DMX18	3-24mm x 12-60cm	K120274
ORBIT GALAXY® G2 Stretch Resistant Complex Coil Fill	641CF	2-20mm x 1.5-30cm	K120686
ORBIT GALAXY® G2 Stretch Resistant Complex Coil XTRASOFT	641CX	2-6mm x 1.5-20cm	K120686
ORBIT GALAXY® G2 Stretch Resistant Helical Coil XTRASOFT	641HX	2mm x 1.5-8cm	K120686
EnPower Control Cable (Microcoil Delivery Systems' Cable)	ECB	5-6ft	K082739,K083646,K120686,K120274
Connecting Cable (Microcoil Delivery Systems' Cable)	CCB	5-6ft	K082739,K083646,K120686,K120274

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CODMAN® Microcoil Delivery System is intended for endovascular embolization of V. Indications intracranial aneurysms, other neurovascular abnormalities such as arteriovenous for Use malformations and arteriovenous fistulae, and is also intended for arterial and venous embolizations in the peripheral vasculature.

The DELTAMAXX 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 Fill ORBIT GALAXY® G2 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 Xtrasoft ORBIT GALAXY® G2 Microcoil Delivery System is intended for endovascular embolization of intracranial aneurysms.

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VI. Comparison of Technological Characteristics With Predicate Device

There are no new technological characteristics being introduced with the proposed packaging change to the CODMAN®, DELTAMAXX, ORBIT GALAXY® G2 Microcoil Delivery Systems and Cables. The CODMAN®, DELTAMAXX, ORBIT GALAXY® G2 Microcoil Delivery Systems and Cables were shown to be substantially equivalent to the predicate devices through comparison of indications for use, function, operating principle, bench testing, sterilization, biocompatibility, and materials.

The modifications proposed in this submission are for packaging only. Therefore the summary table provided below is a comparison of technological characteristics focused on the CODMAN®, DELTAMAXX, ORBIT GALAXY® G2 Microcoil Delivery Systems and Cables' packaging.

Table 4: Product Packaging Comparison Information
Characteristics	Predicate Devices: CODMAN® Microcoil Delivery System (K082739, K073442, K072173, K083646) DELTAMAXX Microcoil Delivery System (K120274) ORBIT GALAXY® G2 Microcoil Delivery System (K120686)	This Submission: CODMAN® Microcoil Delivery System DELTAMAXX Microcoil Delivery System ORBIT GALAXY® G2 Microcoil Delivery System
	Dimensions
Pouch Size	11" x 10"	14" x 10"
Carton Size	10.125" x 11" x 0.703"	Same as Predicates
Dispenser Hoop	Length: 260cm & Diameter: 8.75"	Same as Predicates
	Material
Pouch Material	TPF-0521 PET/adhesive/LDPE/w/heat seal coating sealed to TPF-0501A PET/ LDPE	TPS-4050 Nylon/LDPE Film w/ heat seal coating sealed to TPS-4050 Nylon/LDPE Film
Dispenser Hoop Material	Tubing: Medical Grade Polyethylene Clip: Medical Grade MDPE	Same as Predicates
EnPower Control(ECB)/Connecting (CCB) Cable Mounting Card Material	0.024" Clay Coated Solid Bleached Sulfate	Same as Predicates
Carton Material	0.024" Clay Coated Solid Bleached Sulfate	Same as Predicates
	Source
Pouch Vendor	Tolas Health Care Packaging	Same as Predicates
Carton Vendor	Royal Paper Box &Constellation Anderson DDB Health & Lifestyles	Same as Predicates
Dispenser Hoops	Contech Packaging, Inc.	Same as Predicates
	Pouch Sealing Method
Sealer	Sencorp Model 12-PV/2	Same as Predicates
	Sterilization
Sterilization Method	E-Beam Radiation	Same as Predicates
Microcoil Delivery Systems' Target Surface Dose	37kGy	Same as Predicates
EnPower Control (ECB) / Connecting (CCB) Cables Target Surface Dose	42kGy	Same as Predicates
	Shelf-Life
Microcoil Delivery Systems' Product Shelf Life	5 years	Same as Predicates
EnPower Control (ECB) / Connecting (CCB) Cables Product Shelf Life	3 years	Same as Predicate
Note: The EnPower Control (ECB) and Connecting (CCB) Cables are part of all Microcoil Delivery Systems Listed.

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There were no changes made that affect the CODMAN®, DELTAMAXX, VII. Performance ORBIT GALAXY® G2 Microcoil Delivery Systems and Cables' intended use, operational principle, design principle, product materials, manufacturing or Data sterilization processes. The modifications proposed in this submission are for the packaging only. Therefore, design verification and validation of the product was

Verification and validation activities were focused on demonstrating package integrity of the proposed pouches. Appropriate testing was identified based on a review of the products' risk analyses and previous use of the Nylon/LDPE Film pouch. Testing was conducted as appropriate for the inclusion of the proposed pouches based on current standards, and all testing was performed on final sterile product, unless otherwise specified. The following performance data were provided in support of the substantial equivalence determination.

Packaging Integrity Testing

not warranted.

Packaging Integrity testing demonstrated that the sterile barrier system of the proposed pouch maintains packaging integrity after exposure to sterilization, simulated handling and distribution. The validation also demonstrates that the packaging design and materials are acceptable for the CODMAN®, DELTAMAXX, ORBIT GALAXY® G2 Microcoils Delivery System. The following tests were performed:

. Visual Inspection
. Dye Leak
Seal Strength
. Product Functional Testing on EnPower Control Cable

Characterization Testing: Moisture and Humidity Creep

Sterile Pouch Shelf-Life Testing

Pouch Shelf Life visual inspection demonstrated that the proposed pouch's integrity was maintained. The inspected seals were complete and uniform throughout the entire seal area of the proposed pouch for each time interval (Accelerated Aging: time-zero, 1yr, 3yr, 5yr, 10yr) (Real-Time Aging: time-zero, 1 yr, 3 yr) in the sterilized test groups. There were no detected negative trends in seal strength. These results demonstrate that the seals maintain their strength over time. Testing confirmed that the device will remain sterile through the proposed shelf life and integrity of its packaging are not compromised during transportation and distribution. The following tests were performed:

Visual Inspection
. Seal Strength

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. In vitro Cytotoxicity

Sterilization

Sterilization method validation in accordance with ISO 11137: 2006. Only the material and size of the pouch are changing. There are no changes to the product. All of the bioburden related test results met the acceptance criteria for the representative products as packaged in the new pouch, and the full shipper weights and densities remain within the acceptable dose mapped results. Therefore, the packaging change to the CODMAN®, DELTAMAXX, ORBIT GAXALY® G2 Microcoil Delivery Systems, EnPower Control and Connecting Cables are considered acceptable. The following tests were performed:

Bioburden measurement
Identification of top three organisms
Bacteriostasis/Fungistasis (B/F)
Bioburden recovery study (Extraction efficiency) .

Animal Testing

No animal studies were required as appropriate verification and validation of the packaging modifications were achieved based on the similarities of the proposed device to the predicate device, and from results of bench testing.

Summary of Clinical Testing

No clinical studies were required as appropriate verification and validation of the packaging modifications were achieved based on the similarities of the proposed device to the predicate device, and from results of bench testing.

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Based upon the design, materials, function, intended use, and the non-clinical VIII. Conclusion testing performed by Codman, it is concluded that the proposed packaging for CODMAN®, DELTAMAXX, ORBIT GALAXY® G2 Microcoil Delivery Systems and Cables is substantially equivalent to the currently marketed CODMAN®, DELTAMAXX, ORBIT GALAXY® G2 Microcoil Delivery Systems and Cables and therefore, does not raise any new questions of safety and effectiveness.

Regulation Number and Section

§ 882.5950 Neurovascular embolization device.

(a)
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.(b)
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).