The XTRASOFT™ ORBIT GALAXY™ Detachable Coil is indicated for embolizing intracranial aneurysms.
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 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.

AI/ML Overview

Here's an analysis of the acceptance criteria and the study that proves the device meets them, based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance:

The provided document describes a medical device, the ORBIT GALAXY™ Detachable Coil System, seeking 510(k) clearance. For this type of device, acceptance criteria are primarily demonstrated through equivalence to a predicate device and a series of bench, in-vivo, and in-vitro tests rather than a single, overarching performance metric like accuracy or sensitivity often seen in AI/diagnostic devices. The key "acceptance criteria" here relate to meeting the same specifications and safety profiles as the predicate.

2. Sample Sizes and Data Provenance:

Bench Tests: The document lists "Coils Tested" for each bench test, including "Xtrasoft," "Fill," and "Frame." It doesn't specify the number of coils tested for each type for each criterion.
In-vivo Simulated Use Test: Conducted in an "in-vivo porcine model." The number of animals is not specified.
In-vitro Simulated Use Test: Conducted in an "in-vitro aneurysm model." The number of models or tests is not specified.
Biocompatibility Tests: Sample sizes are not explicitly stated for individual tests (e.g., number of guinea pigs, mice, or rabbit implants), but the conclusion is that the requirements were met.
Data Provenance: The document does not specify country of origin for the data. All studies are described as "in-vitro laboratory bench top testing," "in-vivo and in-vitro simulated use test," and "biocompatibility testing," implying prospective studies conducted for this submission.

3. Number of Experts and Qualifications:

The document does not mention the involvement of experts to establish ground truth or review data in the context of diagnostic performance, as this device is an embolization coil and not a diagnostic AI device. The evaluation is based on engineering specifications, biocompatibility standards, and simulated use.

4. Adjudication Method:

Not applicable. This is not a diagnostic device involving expert adjudication of results.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:

No MRMC study was done, as this is an embolization coil, not an AI-assisted diagnostic tool for human readers. There is no "human readers improve with AI vs without AI assistance" effect size to report.

6. Standalone (Algorithm Only) Performance:

Not applicable. This device is a physical medical implant, not an algorithm.

7. Type of Ground Truth Used:

The "ground truth" for this device's acceptance is based on:

Pre-defined engineering specifications and manufacturing tolerances.
Compliance with established biocompatibility standards (ISO 10993 Part 1, G95-1).
Demonstration of performance in simulated use environments (in-vitro aneurysm models, in-vivo porcine models) against expected functional outcomes.
Substantial equivalence to a legally marketed predicate device (TRUFILL® DCS ORBIT™ Detachable Coil System) as the primary benchmark.

8. Sample Size for the Training Set:

Not applicable. This is a physical medical device, not an AI model requiring a training set.

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

Not applicable for the same reason as above.

Summary

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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: (508) 880-8097

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)Number /ConcurrenceDate	ProductCode	Predicate for:
TRUFILL® DCSORBIT™Detachable CoilSystem	Codman &Shurtleff,Inc.	K080967 /5-02-08	HCG	Intended UseEmbolic CoilDelivery SystemDetachment MechanismManufacturingSterilization

MAY 2 6 2010

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Device Description:

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.

Intended Use:

1. The XTRASOFT™ ORBIT GALAXY™ Detachable Coil is indicated for embolizing intracranial aneurysms.
1. 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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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(Component and/or Material)	TRUFILL DCS ORBIT™ Detachable Coil(K080967)	ORBIT GALAXY™ Detachable Coil(K093973)
Intended Use	The TRUFILL DCS ORBIT™ Detachable Coil isindicated for embolizing intracranial aneurysms andother vascular malformations such as arteriovenousmalformations and arteriovenous fistulae of theneurovasculature.	1) The XTRASOFT™ ORBIT GALAXY™Detachable Coil is indicated forembolizing intracranial aneurysms.
	The TRUFILL DCS ORBIT™ Detachable Coil is alsointended for arterial and venous embolization in theperipheral vasculature.	2) The Fill ORBIT GALAXY™ DetachableCoil and the Frame ORBIT GALAXY™Detachable Coil are indicated forembolizing intracranial aneurysms andother vascular malformations such asarteriovenous malformations andarteriovenous fistulae of theneurovasculature.The Fill ORBIT GALAXY™ DetachableCoil and the Frame ORBIT GALAXY™Detachable Coil are also intended forarterial and venous embolization in theperipheral vasculature.
Embolic Coil	Headpiece manufactured using Platinum/Tungsten;includesGold/tin & Flux to SolderNomenclatureFills, StandardsNo stretch resistant suture	No Change
Coil Wire Diameter	$0.0015 - 0.0040$ inches	No Change
Primary CoilDiameter	$0.010 - 0.016$ inches	No Change
Softness Levels	NomenclatureFills, Standards	NomenclatureFills, Frames, and Xtrasoft
Secondary CoilDiameter	$2 - 20$ mm	$2 - 26$ mm
Secondary Shapes	Helical, Complex, and Mini Complex	No Change
Primary Coil Length	$1.5 - 30.0$ cm	No Change
Delivery SystemUseable 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-linemarker bands	No Change
	Introducer:• Self splitting• Contains a zipper that also functions as a holderBlue 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 CoilLength Verification	Xtrasoft and Frame	Met same specifications as predicate
Embolic CoilDiameterVerification	Xtrasoft, Fill, and Frame	Met same specifications as predicate
Embolic CoilShape VisualInspection	Xtrasoft, Fill, and Frame	Met same specifications as predicate
Headpiece LengthVerification	Xtrasoft, Fill, and Frame	Met same specifications as predicate
Coil Softness	Xtrasoft, Frame, and Standard (control)	Met same specifications as predicate
Stretch ResistanceStrength	Xtrasoft, Fill, and Frame	Met the acceptance criteria for theproposed device
HeadpieceAttachmentStrength	Xtrasoft, Fill, and Frame	Met same specifications as predicate
Atraumatic BeadVisual Inspection	Xtrasoft, Fill, and Frame	Met same specifications as predicate
Embolic CoilPlacement Stability– In-vitro HighFlow Vessel Model	Fill, FrameXtrasoft	Xtrasoft coils are finishing coilsindicated for embolizing intracranialaneurysms only.
Embolic CoilAttachmentStrength	Xtrasoft, Fill, and Frame	Met same specifications as predicate
Embolic CoilDetachmentPressure	Xtrasoft, Fill, and Frame	Met same specifications as predicate
Luer Valve BurstTest	Luer Valve	Met same specifications as predicate
Test	Coils Tested	Results
Embolic CoilRadiopacity	Xtrasoft	Met same specifications as predicate
Embolic CoilProtrusion	Xtrasoft, Fill, and Frame	Met same specifications as predicate
Coil Conformability	Xtrasoft, Fill, and Frame	Met same specifications as predicate
Coil PlacementStability	Xtrasoft, Fill, and Frame	Met same specifications as predicate
Packing of EmbolicCoils	Xtrasoft, Fill, and Frame	Met same specifications as predicate
Retrievability ofEmbolic Coils	Xtrasoft, Fill, and Frame	Met same specifications as predicate
Deliverabilitythrough aMicrocatheter	Xtrasoft, Fill, and Frame	Met same specifications as predicate
Pushability	Xtrasoft, Fill, and Frame	Met same specifications as predicate
Ability to PurgeProduct withAccessory Valve	Delivery tube and luer valve weretested	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
In vitro Cytotoxicity Assay -ISO MEM Elution	No evidence of cytotoxicity	Non-cytotoxic
Sensitization - Guinea PigMaximization	No evidence of irritation/sensitization	Non-sensitizing
ISO IntracutaneousReactivity	No evidence of irritation	Non-irritant
ISO Acute Systemic Toxicity	No signs of toxicity.	Non-toxic
Materials MediatedPyrogenicity	No increase in body temperature	Non-pyrogenic
In vitro Ames BacterialMutagenicity Assay	No significant increase in mutation frequencies	Non-mutagenic
In vitro Mouse LymphomaMutagenicity Assay	No significant increase in mutation frequencies	Non-mutagenic
In vitro ChromosomeAberration Assay	No significant increase in chromosome aberrations	Non-clastogenic / non-mutagenic
In vivo Mouse Bone MarrowMicronucleus Study	No significant increase in chromosome aberrations ofbone marrow erythrocytes for Orbit SR Coils or Luer Valve	Non-hemolytic
ASTM Hemolysis - DirectContact & Extract	Pass with a hemolytic score less than 2%	Non-hemolytic .
Partial Thromboplastin Time	Average clotting of Orbit SR Coils was 52% of thenegative control. Average clotting time of Orbit DeliverySystem and Luer Valve was 100% of the negative control.	Orbit SR Coils passed as a mildactivator of the intrinsiccoagulation pathway. OrbitDelivery System and LuerValve non-activator of theintrinsic coagulation pathway
Platelet & Leukocyte Count	Platelet & Leukocyte counts fell within 25% of the averagereference material value.	Pass
Complement Activation C3a& SC5b-9 Assays	Activation was 0.8% (or less) of the normalized C3a andSC5b-9 concentrations produced by CVF.	Non-activator of complementactivation pathways
180-day Rabbit CerebralCortex Implant TissueResponse Study	Comparable, very slight tissue reaction to Orbit SR Coilsand control Orbit Coils without SR suture after 30 and 180-day implantation in cerebral cortex of rabbits. No implanttesting conducted on delivery system or Luer Valve.	Orbit SR coils well tolerated incerebral cortex of rabbits
Physiochemical AqueousExtraction 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

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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 (800) 638-2041 or (301) 796-7100 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.
1. 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_________________________________________________________________________________________________________________________________________________________________

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).

Test Category / Criterion	Acceptance Criteria (typically "Met same specifications as predicate" or "Met the acceptance criteria for the proposed device")	Reported Device Performance
Bench Tests:
Embolic Coil Length Verification	Met same specifications as predicate	Met same specifications as predicate
Embolic Coil Diameter Verification	Met same specifications as predicate	Met same specifications as predicate
Embolic Coil Shape Visual Inspection	Met same specifications as predicate	Met same specifications as predicate
Headpiece Length Verification	Met same specifications as predicate	Met same specifications as predicate
Coil Softness	Met same specifications as predicate	Met same specifications as predicate
Stretch Resistance Strength	Met the acceptance criteria for the proposed device	Met the acceptance criteria for the proposed device
Headpiece Attachment Strength	Met same specifications as predicate	Met same specifications as predicate
Atraumatic Bead Visual Inspection	Met same specifications as predicate	Met same specifications as predicate
Embolic Coil Placement Stability – In-vitro High Flow	Implied: Demonstrate stability. (Note: Xtrasoft coils are finishing coils for intracranial aneurysms only)	Xtrasoft coils are finishing coils indicated for embolizing intracranial aneurysms only. (This is a statement of intended function/limitation, not a direct performance result for stability test, but implies it meets the intended purpose for these coils).
Embolic Coil Attachment Strength	Met same specifications as predicate	Met same specifications as predicate
Embolic Coil Detachment Pressure	Met same specifications as predicate	Met same specifications as predicate
Luer Valve Burst Test	Met same specifications as predicate	Met same specifications as predicate
Embolic Coil Radiopacity	Met same specifications as predicate	Met same specifications as predicate
Embolic Coil Protrusion	Met same specifications as predicate	Met same specifications as predicate
Coil Conformability	Met same specifications as predicate	Met same specifications as predicate
Coil Placement Stability	Met same specifications as predicate	Met same specifications as predicate
Packing of Embolic Coils	Met same specifications as predicate	Met same specifications as predicate
Retrievability of Embolic Coils	Met same specifications as predicate	Met same specifications as predicate
Deliverability through a Microcatheter	Met same specifications as predicate	Met same specifications as predicate
Pushability	Met same specifications as predicate	Met same specifications as predicate
Ability to Purge Product with Accessory Valve	Met same specifications as predicate	Met same specifications as predicate
Biocompatibility Tests:	Meet ISO 10993 Part 1 and G95-1 requirements	All tests indicated "Non-cytotoxic," "Non-sensitizing," "Non-irritant," "Non-toxic," "Non-pyrogenic," "Non-mutagenic," "Non-clastogenic," "Non-hemolytic," "Pass" for platelet/leukocyte count, "Non-activator of complement activation pathways," "well tolerated," and "Passed" for aqueous extraction.
In-vivo and In-vitro Simulated Use Tests:	Adequately address user needs and evaluate coil performance for aneurysm treatment.	Performed in a porcine model and in an in-vitro aneurysm model. Specific performance metrics are not detailed but the summary implies they were successful.