The Fill Orbit Galaxy G2 Microdelivery System is intended for endovascular embolization of intracranial aneurysms, other neurovascular abnormalities such as arteriovenous malformations and arteriovenous fistulae, and is 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 ORBIT GALAXY® G2 Microcoil Delivery System consists of a Microcoil System, a Connecting Cable (CC), and an ENPOWER Detachment Control Box (DCB). Each component is sold separately. ORBIT GALAXY® G2 Microcoil Systems are provided as Stretch Resistant, with Fill and XTRASOFT™ microcoil models, and will be offered in lengths ranging from 1.5 cm to 30 cm and diameters ranging from 2 mm to 20 mm. The ORBIT GALAXY® G2 Microcoil System is compatible with commercially available 2-tip marker microcatheters which have internal lumen diameters between 0.0165 inches and v 0.019 inches.

The Microcoil System consists of an embolic microcoil attached to a device positioning unit (DPU) which is covered by an introducer sheath. The Fill ORBIT GALAXY® G2 Microcoils are provided in complex shape, and the XTRASOFT™ ORBIT GALAXY® G2 Microcoils are provided in complex and helical shapes. The DPU is a variable stiffness pushing system and has a radiopaque marker band located three (3) cm from its distal end. The introducer sheath system has three main components: an introducer tip, a translucent introducer body, and a re-sheathing tool. The Microcoil System is packaged individually in a protective hoop and sealed in a film pouch. A Microcoil System carton contains one Microcoil System and the associated Instructions for Use, and is provided as a sterile and single-use product.

The Connecting Cable delivers the energy needed to detach the microcoil from the Microcoil System's detachment zone. The connecting cable connects the DPU to the DCB. The DCB provides the energy necessary to allow for a thermo-mechanical detachment of the microcoil from the DPU.

AI/ML Overview

The provided text describes a Special 510(k) submission for the ORBIT GALAXY® G2 Microcoil System. This type of submission is typically for modifications to a previously cleared device, asserting substantial equivalence to existing predicate devices based on non-clinical testing. Therefore, the study described here is primarily a non-clinical bench testing study.

Here's the breakdown of the acceptance criteria and the study that proves the device meets them, based on the provided document:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly state "acceptance criteria" with numerical targets in a table format for a specific performance metric. Instead, it describes a comparative approach where the modified device (ORBIT GALAXY® G2 Microcoil System) is tested against the predicate devices (CASHMERE® SR Microcoil System and ORBIT GALAXY® Detachable Coil System) and is deemed to perform "equivalently" or "as designed." The acceptance criteria, therefore, are implied to be meeting the performance of the predicate devices for each test conducted.

Acceptance Criteria Category	Reported Device Performance (ORBIT GALAXY® G2 Microcoil System)
Delivery Force	Performed according to its description and intended use, demonstrating `System Delivery Force` and `Microcatheter compatibility`. Passed equivalent bench testing as compared to the CASHMERE® SR System predicate device.
Secondary Shape Retention	Performed effectively, demonstrating `Coil Secondary Shape OD`. Passed equivalent bench testing as compared to the CASHMERE® SR System predicate device.
Detachment Zone Tensile Strength	Demonstrated performance for `Coil Socket Ring Tensile Strength`, `Detachment Suture Tensile Strength`, `Stretch resistance of suture/Tensile Strength`, and `Ball Tip Tensile Strength`. Passed equivalent bench testing as compared to the CASHMERE® SR System predicate device.
Durability and Detachability	Demonstrated `Durability-Cyclic advancement and retrieval of the microcoil system`, `Detachment of the microcoil from the delivery system`, `Coil damage after microcoil system delivery`, and `Microcatheter compatibility`. Passed equivalent bench testing as compared to the CASHMERE® SR System predicate device.
Biocompatibility	Successfully performed biocompatibility screening testing. Meets all the same biocompatibility requirements as the predicate devices and as specified by ISO 10993 Part I and General Program Memorandum # G95-1. (Full biocompatibility testing was previously conducted on predicate devices: ORBIT GALAXY® Detachable Coil System (K093973) and CASHMERE SR System (K072173), with the G2 system's materials, packaging, and sterilization being identical to the CASHMERE SR system, and hence, subject to screening for final confirmation).
Material, Packaging, and Sterilization Characteristics	Identical to the materials, packaging, and sterilization used in the current CASHMERE SR Microcoil System.
Overall Performance for Intended Use and Description	Bench testing data demonstrated that the ORBIT GALAXY® G2 Microcoil System performed according to its description and intended use, and established the performance characteristics of this device. Results of verification and validation testing demonstrated the system performed as designed and is suitable for the intended use and substantially equivalent to the predicate devices.

2. Sample Size for the Test Set and Data Provenance

Sample Size: The document does not specify the exact sample sizes (number of coils or tests) used for each bench test conducted. It states "bench testing data" and "results of verification and validation testing."
Data Provenance: The data is from non-clinical bench testing performed by the manufacturer, Codman & Shurtleff, Inc. No information regarding country of origin of the data beyond the manufacturer's location in Raynham, MA (USA) is provided. It's an internal test, not a retrospective or prospective study in the typical human trials sense.

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

This section is not applicable as the study is a non-clinical bench testing study of a medical device, not a study involving human data, medical imaging, or expert interpretation for ground truth. Ground truth for device performance is typically established by engineering specifications, validated test methods, and comparison to established predicate device performance.

4. Adjudication Method for the Test Set

This section is not applicable as the study is a non-clinical bench testing study. Adjudication methods like 2+1 or 3+1 typically apply to clinical studies where opinions of multiple human reviewers or experts need to be reconciled.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done

No. A Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done. This type of study involves human readers evaluating cases, often in radiology or pathology, with and without AI assistance to measure reader improvement. The described study is non-clinical bench testing.

6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) was done

No. This section is not applicable either in the sense of an "algorithm" or "AI." The device is a physical embolization microcoil system, not an AI or software algorithm that would have standalone performance. The testing performed is for the physical device's characteristics.

7. The Type of Ground Truth Used

The "ground truth" for this non-clinical bench testing is engineering specifications, validated test methods, and the established performance characteristics of the predicate devices. The new device's performance in mechanical tests (delivery force, shape retention, tensile strength, durability, detachability) and material characteristics (biocompatibility, sterilization) is measured against these established benchmarks to demonstrate substantial equivalence.

8. The Sample Size for the Training Set

This section is not applicable. There is no "training set" as this is a physical medical device, not a machine learning model.

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

This section is not applicable for the same reason as above.

Summary

{0}------------------------------------------------

Codman & Shurtleff, Inc.

1686

Special 510(k) ORBIT GALAXY® G2 Microcoil System

510(k) Summary

(As Required By 21 CFR 807.92(a))

APR - 4 2012

A. Submitter Information

Submitter's name:	Codman & Shurtleff, Inc.
Address:	325 Paramount Drive
	Raynham, MA 02767
Telephone:	408-433-1420
Fax:	408-433-1585
Contact Person:	Kim Fonda
Date of Submission:	March 5, 2012
B. Trade/Device Name:	ORBIT GALAXY ® G2 Microcoil Delivery System
Common Name:	Artificial embolization device

Neurovascular Embolization Device Classification Name:

Class II per 21 CFR 882.5950 Regulation Number:

C, Predicate Devices:

Device	Company	510(k)Number/ConcurrenceDate	ProductCode	Predicate For:
Micrus MicrocoilSystem,CASHMERE® SR(Primary predicate)	Codman & Shurtleff, Inc(Previously MicrusEndovascular Corp.)	K072173(10/5/2007)	HCG	Intended UseDesignMaterialsManufacturingSterilization
ORBIT GALAXY®Detachable CoilSystem	Codman & Shurtleff, Inc	K093973(5/26/2010)	HCG	Intended UseDesignMaterialsManufacturing

ﮯ ﺗﯿ

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

D. Device Description:

The intent of endovascular treatment using embolic microcoils is to pack the lumen of the aneurysm with the microcoil mass, thereby eliminating the influx of blood into the aneurysm. The aneurysm neck will be covered with loops of coils to help eliminate the influx of blood, a blood flow pathway is then re-established down the lumen of the parent artery, and the weakened wall of the aneurysm is isolated from arterial pressures. The existing blood and soft clot trapped within the lumen of the aneurysm begins to solidify, ultimately becoming hardened clot and scar tissue. The process will re-establish blood flow down the lumen of the parent artery and thromboses the aneurysm.

{2}------------------------------------------------

The ORBIT GALAXY® G2 Microcoil System is a modification to the currently marketed CASHMERE® SR Microcoil System (K072173), and to the ORBIT GALAXY® Detachable Coil System (K093973). The ORBIT GALAXY® G2 Microcoil System uses the same Device Positioning Unit, Introducer Sheath System, Detachment Control Box, and Connecting Cable components as the CASHMERE® SR Microcoil System (predicate device). The ORBIT GALAXY® G2 System offers a microcoil similar to the CASHMERE® SR and ORBIT GALAXY® Microcoils (predicate devices). The ORBIT GALAXY® G2 microcoil is similar to the CASHMERE® SR predicate device in regards to microcoil size, material, monofilament suture used for stretch resistance, primary wind profile, secondary shape, outer diameter and length. Device modifications include design and manufacturing process changes necessary to expand the product line to include additional microcoil shapes and sizes.

E. Intended Use:

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.

F. Summary of technological characteristics of the proposed to the predicate device:

The ORBIT GALAXY® G2 Microcoil Delivery System is similar to the CASHMERE® SR Microcoil System with regard to intended use, function, design, materials, manufacturing, and sterilization processes.

The ORBIT GALAXY® G2 Microcoil Delivery System is similar to the ORBIT GALAXY® Detachable Coil System with regard to the intended use, function, microcoil material, shape and dimensions, and microcoil manufacturing processes.

{3}------------------------------------------------

Device modifications include design and manufacturing process changes necessary to expand the product line to include additional microcoil shapes and sizes. No new technological characteristics are being introduced with the proposed device.

A summary table including specifications of the proposed device compared with those of the predicate devices follows.

{4}------------------------------------------------

Codman & Shurtleff, Inc

ORBIT GALAXY® G2 Microcoil System

Characteristic	Proposed DeviceG2 System	Comparative InformationPredicate DeviceCASHMERE SR System	Predicate DeviceGALAXY System
Intended Use	The Fill ORBIT GALAXY G2Microcoil Delivery System isintended for endovascularembolization of intracranialaneurysms, other neurovascularabnormalities such as arteriovenousmalformations and arteriovenousfistulae, and is also intended forarterial and venous embolizations inthe peripheral vasculature.	The Micrus Microcoil DeliverySystem is intended for endovascularembolization of intracranialaneurysms, other neurovascularabnormalities such as arteriovenousmalformations and arteriovenousfistulae, and are also intended forarterial and venous embolizations inthe peripheral vasculature.As modified per premarket notificationK073442 (2/26/08)	The Fill ORBIT GALAXYDetachable Coil and the FrameORBIT GALAXY Detachable Coilare indicated for embolizingintracranial aneurysms and othervascular malformations such asarteriovenous malformations andarteriovenous fistulae of theneurovasculature.
	The XTRASOFT ORBIT GALAXYG2 Microcoil Delivery System isintended for endovascularembolization of intracranialaneurysms	K072173 (10/5/07)The Micrus Microcoil DeliverySystem is intended forendovascular embolization ofintracranial aneurysms.	The Fill ORBIT GALAXYDetachable Coil and the FrameORBIT GALAXY Detachable Coilare also intended for arterial andvenous embolization in theperipheral vasculature.The XTRASOFT ORBIT GALAXYDetachable Coil is indicated forembolizing intracranial aneurysms
Characteristic	Proposed DeviceG2 System	Comparative Information	Predicate DeviceCASHMERE SR System	Predicate DeviceGALAXY System
MicrocoilCharacteristicsConfigurations	XTRASOFT Stretch Resistantand Fill Stretch ResistantPlatinum Tungsten Alloy Wire	ComplexStretch resistantPlatinum Tungsten Alloy Wire	XTRASOFT Stretch Resistantand Fill Stretch ResistantPlatinum Tungsten Alloy Wire
Embolic Microcoilmaterial	Polypropylene	Polypropylene	Polypropylene
Internal suturematerial	0.012 inches	0.0135 inches	0.012 inches
Primary Coil WindOD	Cylindrical	Cylindrical	Cylindrical
Profile of PrimaryCoil Wind	Fills -ComplexXTRASOFT -Complex and Helical	Complex	Fills -ComplexXTRASOFT -Complex and Helical
Secondary shape	2-20 mm	2-12 mm	2-20 mm
Secondary ShapeCoil OD	1.5-30 cm	2.5-30cm	1.5-30 cm
Coil length
SystemCharacteristicsDelivery SystemType	Wire shaft with radiopaque markers.	Wire shaft with radiopaque markers.	Hypotube welded to support coil withwelded in-line marker bands
Delivery SystemIntroducer Sheath	HDPE Introducer	HDPE Introducer	Nylon/HDPE Introducer
Delivery SystemResheathing tool	Nylon 12	Nylon 12	HDPE
Characteristic	Proposed DeviceG2 System	Comparative InformationPredicate DeviceCASHMERE SR System	Predicate DeviceGALAXY System
DPU Delivery SystemLength	190 cm (185-195cm)	190 cm (185-195cm)	155-210 cm
Microcathetercompatibility	Compatible with 2-tip markermicrocatheters of ID from 0.0165 to0.019 inches	Compatible with 2-tip markermicrocatheters of ID from 0.0165 to0.019 inches	Compatible with 0.014" or 0.018"guidewire compatible infusion catheter,150 cm long, dual marker band
DetachmentMechanism	Connection to Microcoil System: UsesConnecting Cable	Connection to Microcoil System: UsesConnecting Cable	Hydraulic Detachment System usesTRUFILL DCS Syringe 11
	Detachment: Thermo-mechanicalSystem uses ENPOWER DetachmentControl Box (DCB) with ENPOWERControl Cable	Detachment: Thermo-mechanicalSystem uses ENPOWER DetachmentControl Box (DCB) with ENPOWERControl Cable
Sterilization	E-Beam Radiation	E-Beam Radiation	ETO
Packaging	Packaged in a plastic hoop and enclosedin a sealed LD Polyethylene/Polyesterfilm pouch.	Packaged in a plastic hoop and enclosedin a sealed LD Polyethylene/Polyesterpouch.	Packaged in a plastic hoop and enclosedin a sealed Nylon/Tyvek pouch.

{5}------------------------------------------------

Codman & Shurtleff, Inc.

ORBIT GALAXY® G2 Microcoil System

l
time the state the the state the time the state the state the finalismes the finitial the finaly the finaly the finaly the finaly the finaly the finaly the finaly the final

{6}------------------------------------------------

Codman & Shurtleff, Inc

ORBIT GALAXY® C2 Microcoil System

{7}------------------------------------------------

G. Testing Summary:

Bench testing data demonstrated that the ORBIT GALAXY® G2 Microcoil System performed according to its description and intended use, and established the performance characteristics of this device. The ORBIT GALAXY®G2 Microcoil System passed equivalent bench testing as compared to the CASHMERE® SR System predicate device. Clinical testing was not required to establish substantial equivalence.

Results of verification and validation testing conducted on the ORBIT GALAXY G2 Microcoil System demonstrated that the system performed as designed, is suitable for the intended use, and is substantially equivalent to the predicate devices.

The following tests were conducted to verify the modified design:

· Delivery Force Test
- · System Delivery Force
- · Microcatheter compatibility
· Secondary Shape Retention Test
- Coil Secondary Shape OD
· Detachment Zone Tensile Test
- · Coil Socket Ring Tensile Strength
- · Detachment Suture Tensile Strength
- · Stretch resistance of suture/Tensile Strength
- · Ball Tip Tensile Strength
Durability and Detachability Test
- Durability-Cyclic advancement and retrieval of the microcoil system .
- Detachment of the microcoil from the delivery system 트
- Coil damage after microcoil system delivery 0
- I Microcatheter compatibility

The materials, packaging, and sterilization used in the ORBIT GALAXY® G2 Microcoil Delivery System are identical to the materials, packaging, and sterilization used in the current CASHMERE SR Microcoil System. Full biocompatibility testing in accordance with ISO 10993-1 was previously successfully conducted on the ORBIT GALAXY® Detachable Coil System (K093973); additional biocompatibility testing was performed on the CASHMERE SR System (K072173).

{8}------------------------------------------------

Codman & Shurtleff, Inc.

For final confirmation biocompatibility screening testing was successfully performed. Results demonstrated that the ORBIT GALAXY® G2 Microcoil Delivery System meets all the same biocompatibility requirements as the predicate devices and as specified by the ISO 10993 Part I, and the General Program Memorandum # G95-1 on Biological Evaluation of Medical Devices.

Based upon the design, materials, function, intended use, comparison with currently marketed devices and the non-clinical testing performed by Codman & Shurtleff, Inc., it is concluded that the ORBIT GALAXY® G2 Microcoil Delivery System is substantially equivalent to the CASHMERE® Microcoil Delivery System and to the ORBIT GALAXY® Detachable Coil System and, therefore, does not raise any new questions of safety and effectiveness.

{9}------------------------------------------------

Image /page/9/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle with three lines representing its body and wings. The eagle is facing to the right. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the eagle.

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

Codman & Shurtleff, Inc. % Ms. Kim Fonda 325 Paramount Drive Raynham, MA 02767

APR - 4 2012

Re: K120686

Trade/Device Name: Orbit Galaxy® G2 Microcoil Delivery System Regulation Number: 21 CFR 882.5950 Regulation Name: Neurovascular embolization device Regulatory Class: Class II Product Code: HCG, KRD Dated: March 5, 2012 Received: March 6, 2012

Dear Ms. Fonda:

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 I least oc advised that I Drivedants or vour device complies with other requirements of the Act that I Dr has Intacted and regulations administered by other Federal agencies. You must or any I carated and the registernents, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical

{10}------------------------------------------------

Page 2-Ms. Kim Fonda ·

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/Resourcesfor You/Industry/default.htm.

Sincerely yours,

Debrah Falls

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

{11}------------------------------------------------

Indications for Use

510(k) Number (if known): K120686

Device Name: Orbit Galaxy® G2 Microcoil Delivery System

Indications for Use:

The Xtrasoft Orbit Galaxy® G2 Microcoil Delivery System is intended for endovascular embolization of intracranial aneurysms.

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 LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

JOE HUTTER

Page 1 of

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

K 120686

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).