Predicate Devices

Reference Devices

Not Found

AI/ML (Artificial Intelligence / Machine Learning)

No
The device description and performance studies focus on the physical properties and mechanical performance of the embolic coil and delivery system. There is no mention of software, algorithms, or data processing that would indicate the use of AI/ML.

Therapeutic

Yes

The device is indicated for embolizing intracranial aneurysms and other vascular malformations, which involves sealing off blood vessels to treat conditions or stop bleeding, thus directly providing a therapeutic effect.

Diagnostic

No

Explanation: The device is an embolic coil system used for embolizing aneurysms and vascular malformations, which is a therapeutic intervention, not a diagnostic one.

SaMD (Software as a Medical Device)

No

The device description clearly details physical components like a delivery system (delivery tube and coil introducer), a stretch resistant embolic coil made of platinum alloy wire and polymer monofilament, and packaging. It also mentions the required use of a separate physical device (TRUFILL® DCS Syringe II) for detachment. This is not a software-only device.

IVD (In Vitro Diagnostic)

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

Here's why:

Intended Use: The intended use is for embolizing intracranial aneurysms and other vascular malformations. This is a therapeutic procedure performed in vivo (within the body) to treat a medical condition.
Device Description: The device is an implantable coil and a delivery system designed to be used within the patient's vasculature.
Lack of IVD Characteristics: The description does not mention any of the typical characteristics of an IVD, such as:
- Analyzing samples (blood, urine, tissue, etc.) in vitro (outside the body).
- Providing information for diagnosis, monitoring, or screening.
- Reagents, calibrators, or controls used in laboratory testing.

The device is clearly designed for direct therapeutic intervention within the patient's body, which is the domain of medical devices, not in vitro diagnostics.

PCCP (Predetermined Change Control Plan) Authorized

N/A

Overview

Intended Use / 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.

Product codes

HCG, KRD

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.

Mentions image processing

Not Found

Mentions AI, DNN, or ML

Not Found

Input Imaging Modality

Not Found

Anatomical Site

intracranial, neurovasculature, 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

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. Tests included: Embolic Coil Length Verification, Embolic Coil Diameter Verification, Embolic Coil Shape Visual Inspection, Headpiece Length Verification, Coil Softness, Stretch Resistance Strength, Headpiece Attachment Strength, Atraumatic Bead Visual Inspection, Embolic Coil Placement Stability – In-vitro High Flow Vessel Model, Embolic Coil Attachment Strength, Embolic Coil Detachment Pressure, Luer Valve Burst Test, Embolic Coil Radiopacity, Embolic Coil Protrusion, Coil Conformability, Coil Placement Stability, Packing of Embolic Coils, Retrievability of Embolic Coils, Deliverability through a Microcatheter, Pushability, Ability to Purge Product with Accessory Valve. All tests met the same specifications as the predicate device or met the acceptance criteria for the proposed device.

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.

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. Tests included: In vitro Cytotoxicity Assay - ISO MEM Elution, Sensitization - Guinea Pig Maximization, ISO Intracutaneous Reactivity, ISO Acute Systemic Toxicity, Materials Mediated Pyrogenicity, In vitro Ames Bacterial Mutagenicity Assay, In vitro Mouse Lymphoma Mutagenicity Assay, In vitro Chromosome Aberration Assay, In vivo Mouse Bone Marrow Micronucleus Study, ASTM Hemolysis - Direct Contact & Extract, Partial Thromboplastin Time, Platelet & Leukocyte Count, Complement Activation C3a & SC5b-9 Assays, 180-day Rabbit Cerebral Cortex Implant Tissue Response Study, Physiochemical Aqueous Extraction Test. All tests concluded the device to be non-cytotoxic, non-sensitizing, non-irritant, non-toxic, non-pyrogenic, non-mutagenic, non-hemolytic, non-activator of complement activation pathways, and well tolerated.

Key Metrics

Not Found

Predicate Device(s)

K080967

Reference Device(s)

Not Found

Predetermined Change Control Plan (PCCP) - All Relevant Information

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

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 /
Concurrence
Date | Product
Code | Predicate for: |
|-----------------------------------------------------|--------------------------------|-------------------------------------------|-----------------|-----------------------------------------------------------------------------------------------------------|
| TRUFILL® DCS
ORBIT™
Detachable Coil
System | Codman &
Shurtleff,
Inc. | K080967 /
5-02-08 | HCG | Intended Use
Embolic Coil
Delivery System
Detachment Mechanism
Manufacturing
Sterilization |

MAY 2 6 2010

1

Device Description:

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

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

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

Intended Use:

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

2

t

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

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

| Characteristics
(Component and
/or Material) | TRUFILL DCS ORBIT™ Detachable Coil
(K080967) | ORBIT GALAXY™ Detachable Coil
(K093973) |
|----------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Intended Use | The TRUFILL DCS ORBIT™ Detachable Coil is
indicated for embolizing intracranial aneurysms and
other vascular malformations such as arteriovenous
malformations and arteriovenous fistulae of the
neurovasculature. | 1) The XTRASOFT™ ORBIT GALAXY™
Detachable Coil is indicated for
embolizing intracranial aneurysms. |
| | The TRUFILL DCS ORBIT™ Detachable Coil is also
intended for arterial and venous embolization in the
peripheral vasculature. | 2) The Fill ORBIT GALAXY™ Detachable
Coil and the Frame ORBIT GALAXY™
Detachable Coil are indicated for
embolizing intracranial aneurysms and
other vascular malformations such as
arteriovenous malformations and
arteriovenous fistulae of the
neurovasculature.

3

Bench Test Summary:

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

(

.

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

4

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.

5

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

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

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

6

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.

7

DEPARTMENT OF HEALTH & HUMAN SERVICES

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

Public Health Service

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

MAY 2 6 2010

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

Re: K093973

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

Dear Ms. Machado:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

8

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

9

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_________________________________________________________________________________________________________________________________________________________________