Predicate Devices

Reference Devices

Not Found

AI/ML (Artificial Intelligence / Machine Learning)

No
The device description and performance studies focus on the mechanical and electrical aspects of a microcoil delivery system for embolization. There is no mention of AI or ML in the intended use, device description, or performance testing.

Therapeutic

Yes
The device is used for endovascular embolization of aneurysms and other neurovascular and peripheral vasculature abnormalities, which is a therapeutic intervention.

Diagnostic

No

The device is an embolization microcoil system, which is used for therapeutic purposes (endovascular embolization of aneurysms and vascular malformations), not for diagnosing conditions.

SaMD (Software as a Medical Device)

No

The device description explicitly details hardware components including a Microcoil System, Connecting Cable, and ENPOWER Detachment Control Box, along with various physical tests performed on these components.

IVD (In Vitro Diagnostic)

Based on the provided information, this device is not an IVD (In Vitro Diagnostic).

Here's why:

Intended Use: The intended use clearly describes a device used for endovascular embolization procedures within the body (intracranial and peripheral vasculature). This is an in vivo procedure, meaning it is performed within a living organism.
Device Description: The description details a physical system of microcoils, delivery systems, and detachment mechanisms designed to be inserted into blood vessels. This is consistent with an in vivo medical device.
Lack of IVD Characteristics: There is no mention of the device being used to examine specimens derived from the human body (like blood, urine, tissue, etc.) to provide information for diagnosis, monitoring, or compatibility testing. This is the core function of an IVD.

Therefore, the Fill Orbit Galaxy G2 Microdelivery System is an in vivo medical device, not an IVD.

PCCP (Predetermined Change Control Plan) Authorized

N/A

Overview

Intended Use / Indications for 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.

Product codes (comma separated list FDA assigned to the subject device)

HCG, KRD

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.

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.

Mentions image processing

Not Found

Mentions AI, DNN, or ML

Not Found

Input Imaging Modality

Not Found

Anatomical Site

Intracranial, Neurovascular, Peripheral vasculature

Indicated Patient Age Range

Not Found

Intended User / Care Setting

Not Found

Description of the training set, sample size, data source, and annotation protocol

Not Found

Description of the test set, sample size, data source, and annotation protocol

Not Found

Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)

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
- Coil damage after microcoil system delivery
- 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). 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.

Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)

Not Found

Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.

K072173, K093973

Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.

Not Found

Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).

Not Found

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).

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/
Concurrence
Date | Product
Code | Predicate For: |
|--------------------------------------------------------------------|----------------------------------------------------------------------|------------------------------------------|-----------------|-----------------------------------------------------------------------|
| Micrus Microcoil
System,
CASHMERE® SR
(Primary predicate) | Codman & Shurtleff, Inc
(Previously Micrus
Endovascular Corp.) | K072173
(10/5/2007) | HCG | Intended Use
Design
Materials
Manufacturing
Sterilization |
| ORBIT GALAXY®
Detachable Coil
System | Codman & Shurtleff, Inc | K093973
(5/26/2010) | HCG | Intended Use
Design
Materials
Manufacturing |

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.

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.

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 Device
G2 System | Comparative Information
Predicate Device
CASHMERE SR System | Predicate Device
GALAXY System | |
|------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------|
| 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 Micrus Microcoil Delivery
System is intended for endovascular
embolization of intracranial
aneurysms, other neurovascular
abnormalities such as arteriovenous
malformations and arteriovenous
fistulae, and are also intended for
arterial and venous embolizations in
the peripheral vasculature.
As modified per premarket notification
K073442 (2/26/08) | 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 XTRASOFT ORBIT GALAXY
G2 Microcoil Delivery System is
intended for endovascular
embolization of intracranial
aneurysms | K072173 (10/5/07)
The Micrus Microcoil Delivery
System is intended for
endovascular embolization of
intracranial aneurysms. | 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.

5

Codman & Shurtleff, Inc.

.

ORBIT GALAXY® G2 Microcoil System

21

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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 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.

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_