(117 days)
No reference devices were used in this submission.
No
The device description focuses on the mechanical and electrical components for delivering and detaching a microcoil. There is no mention of software, algorithms, or data processing that would indicate the use of AI/ML.
Yes
The device is intended for endovascular embolization of various neurovascular abnormalities, which is a therapeutic procedure to treat medical conditions.
No.
The device is intended for endovascular embolization, which is a therapeutic (treatment) procedure, not a diagnostic one.
No
The device description clearly outlines physical components including a microcoil, connecting cable, and Detachment Control Box, which are hardware.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly describes the device as being used for endovascular embolization of various vascular abnormalities within the body. This is a therapeutic procedure performed in vivo (within a living organism).
- Device Description: The device description details a system for delivering microcoils into blood vessels. This is consistent with an in vivo therapeutic device, not a device used to examine specimens in vitro (outside the body).
- Lack of IVD Characteristics: There is no mention of the device being used to test or analyze biological specimens (like blood, urine, tissue, etc.) to provide diagnostic information. The device's function is to physically block blood flow.
IVD devices are used to perform tests on samples taken from the body to diagnose diseases or conditions. This device is used to treat a condition directly within the body.
N/A
Intended Use / Indications for Use
CODMAN Microcoil Delivery System is intended for endovascular embolization of intracranial aneurysms, other neurovascular abnormalities such as arteriovenous malformations and arteriovenous fistulae, and is also intended for arterial and venous embolizations in the peripheral vasculature.
The DELTAMAXX Microcoil Delivery System is intended for endovascular embolization of intracranial aneurysms, other neurovascular abnormalities such as arteriovenous malformations and is also intended for arterial and venous embolizations in the peripheral vasculature.
The Fill ORBIT GALAXY G2 Microcoil Delivery System is intended for endovascular embolization of intracranial aneurysms, other neurovascular abnormalities such as arteriovenous malformations and is also intended for arterial and venous embolizations in the peripheral vasculature.
The Xtrasoft ORBIT GALAXY G2 Microcoil Delivery System is intended for endovascular embolization of intracranial aneurysms.
Product codes (comma separated list FDA assigned to the subject device)
HCG, KRD
Device Description
The CODMAN® Microcoil Delivery System, DELTAMAXX Microcoil Delivery System, and ORBIT GALAXY® G2 Microcoil Delivery System consist of three components, a Microcoil System, a connecting cable, and a Detachment Control Box (DCB). Each component is sold separately. The Microcoil System consists of an microcoil attached to a Device Positioning Unit (DPU). The Microcoil System is packaged in an introducer sheath designed to protect the coil in the packaging dispenser and to provide support for introducing the coil into the infusion catheter. The microcoil is the implantable segment of the device, and is detached from the Device Positioning Unit (DPU) using the Detachment Control System (Detachment Control Box and connecting cable). The microcoil is fabricated from a platinum alloy wire. The wire is wound into a primary coil which may contain either a polypropylene suture (SR) or an absorbable polymer suture (Cerecyte®) and then formed into a secondary shape. The secondary shape may be straight, spherical, complex, or helical. The DPU is a variable stiffness wire and has a radiopaque marker band located three (3) cm from its distal end. The introducer sheath has three main components: an introducer tip, a translucent introducer body, and a re-sheathing tool. The Detachment Control Box (DCB) provides the energy necessary to allow for a thermo-mechanical detachment of the microcoil from the DPU. The connecting cable delivers the energy necessary to detach the embolic coil from the Microcoil System's detachment zone. The connecting cable is connected between the Microcoil System's hub connector on the DPU and the output connector on the DCB. The detachment control box may be one of two types: the blue EnPower Detachment Control Box or the black Detachment Control Box. The connecting cables may be one of two types: one with a remote detach button (the EnPower Control Cable) catalog no. ECB000182-00, or one without a detach button (standard connecting cable) catalog no. CCB00157-00. The EnPower Detachment Control Box works with the EnPower Control Cable and with the standard connecting cable. The black Detachment Control Box works only with the standard connecting cable. Both cables and Detachment Control Box are sold separately.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
intracranial (aneurysms, other neurovascular abnormalities such as arteriovenous malformations and arteriovenous fistulae), peripheral vasculature (arterial and venous embolizations)
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Prescription Use
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)
Packaging Integrity Testing: Demonstrated that the sterile barrier system of the proposed pouch maintains packaging integrity after exposure to sterilization, simulated handling and distribution. The validation also demonstrates that the packaging design and materials are acceptable for the CODMAN®, DELTAMAXX, ORBIT GALAXY® G2 Microcoils Delivery System. Tests performed: Visual Inspection, Dye Leak, Seal Strength, Product Functional Testing on EnPower Control Cable, Characterization Testing: Moisture and Humidity Creep.
Sterile Pouch Shelf-Life Testing: Visual inspection demonstrated that the proposed pouch's integrity was maintained. The inspected seals were complete and uniform throughout the entire seal area of the proposed pouch for each time interval (Accelerated Aging: time-zero, 1yr, 3yr, 5yr, 10yr) (Real-Time Aging: time-zero, 1 yr, 3 yr) in the sterilized test groups. There were no detected negative trends in seal strength. These results demonstrate that the seals maintain their strength over time. Testing confirmed that the device will remain sterile through the proposed shelf life and integrity of its packaging are not compromised during transportation and distribution. Tests performed: Visual Inspection, Seal Strength.
Sterilization: Sterilization method validation in accordance with ISO 11137: 2006. All of the bioburden related test results met the acceptance criteria for the representative products as packaged in the new pouch, and the full shipper weights and densities remain within the acceptable dose mapped results. Tests performed: Bioburden measurement, Identification of top three organisms, Bacteriostasis/Fungistasis (B/F), Bioburden recovery study (Extraction efficiency).
Animal Testing: No animal studies were required.
Clinical Testing: No clinical studies were required.
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.
K082739, K083646, K120686, K120274, K072173, K073442, K032872, K062036, K053160
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.
No reference devices were used in this submission.
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
§ 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).
0
Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is a stylized image of three human profiles facing to the right, with a design element resembling a wing or a flowing fabric above them.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
December 24, 2014
Codman & Shurtleff, Inc. Ms. Hannah Foley Regulatory Affairs Specialist II 325 Paramount Drive Raynham, Massachusetts 02767
Re: K142429
Trade/Device Name: CODMAN Microcoil Delivery System, DELTAMAXX Microcoil Delivery System, ORBIT GALAXY G2 Microcoil Delivery System, EnPower Control Cable, and Connecting Cable Regulation Number: 21 CFR 882.5950 Regulation Name: Neurovascular Embolization Device Regulatory Class: Class II Product Code: HCG. KRD Dated: December 4, 2014 Received: December 5, 2014
Dear Ms. Hannah Foley.
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food. Drug. and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR
1
Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical devicerelated adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to
http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely yours.
Carlos L. Pena -S FD/△
Carlos L. Peña, PhD, MS Director Division of Neurological and Physical Medicine Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known) K142429
Device Name CODMAN Microcoil Delivery System DELTAMAXX Microcoil Delivery System ORBIT GALAXY G2 Microcoil Delivery System
Indications for Use (Describe)
CODMAN Microcoil Delivery System is intended for endovascular embolization of intracranial aneurysms, other neurovascular abnormalities such as arteriovenous malformations and arteriovenous fistulae, and is also intended for arterial and venous embolizations in the peripheral vasculature.
The DELTAMAXX Microcoil Delivery System is intended for endovascular embolization of intracranial aneurysms, other neurovascular abnormalities such as arteriovenous malformations and is also intended for arterial and venous embolizations in the peripheral vasculature.
The Fill ORBIT GALAXY G2 Microcoil Delivery System is intended for endovascular embolization of intracranial aneurysms, other neurovascular abnormalities such as arteriovenous malformations and is also intended for arterial and venous embolizations in the peripheral vasculature.
The Xtrasoft ORBIT GALAXY G2 Microcoil Delivery System is intended for endovascular embolization of intracranial aneurysms.
| Type of Use (Select one or both, as applicable) | |
|---|---|
| Prescription Use (Part 21 CFR 801 Subpart D) | Over-The-Counter Use (21 CFR 801 Subpart C) |
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3
510(k) Summary
- Codman & Shurtleff, Inc. I. Submitter 325 Paramount Drive Raynham, MA 02767
Tel: (305) 265-6810 Fax: (305) 265-6889
Contact Person: Hannah Foley Date Prepared: December 22, 2014
II. Device
| Table 1: Device | |
|---|---|
| Device Proprietary Name | CODMAN® Microcoil Delivery System, DELTAMAXX Microcoil Delivery System, ORBIT GALAXY® G2 Microcoil Delivery System, EnPower Control Cable (ECB) and Connecting Cable (CCB) |
| Common or Usual Name | Device, Neurovascular Embolization & Device, Vascular, For Promoting Embolization |
| Classification Name | Device, Neurovascular Embolization, Class II, 21 CFR 882.5950 & Device, Vascular, For Promoting Embolization, Class II 21 CFR 870.3300 |
| Regulatory Classification | II |
| Product Codes | HCG, KRD |
The corresponding predicate devices that are listed in Table 2 below pertain to the III. Predicate devices being bundled in this submission. Refer to Table 3 for proprietary names of the Device all applicable products.
| Table 2: Prior 510(k) Clearances | |||
|---|---|---|---|
| 510(k) Number | Date Cleared | Name | Manufacturer |
| Predicate | |||
| K082739 | 10/17/2008 | Micrus Microcoil Delivery System | |
| (Includes Cables) | Micrus Endovascular | ||
| Corporation* | |||
| Predicate | |||
| K083646 | 01/02/2009 | DELTAPLUSH 10 Stretch-Resistant DPL | |
| and DELTAPLUSH 10 Cerecyte CPL | |||
| (Includes Cables) | Micrus Endovascular | ||
| Corporation* | |||
| Predicate | |||
| K120686 | 04/04/2012 | ORBIT GALAXY® G2 Microcoil | |
| Delivery System (Includes Cables) | Codman & Shurtleff, Inc. | ||
| Predicate | |||
| K120274 | 03/02/2012 | DELTAMAXX 18 Microcoil System | |
| (Includes Cables) | Codman & Shurtleff, Inc. | ||
| Predicate | |||
| K072173 | 10/05/2007 | Micrus Microcoil System “Cashmere” | Micrus Endovascular |
| Corporation* | |||
| Predicate | |||
| K073442 | 02/26/2008 | Micrus Microcoil Delivery System | Micrus Endovascular |
| Corporation* | |||
| Predicate | |||
| K032872 | 11/28/2003 | Micrus Microcoil Delivery System Long | |
| Spherical Coils | Micrus Endovascular | ||
| Corporation* | |||
| Predicate | |||
| K062036 | 08/25/2006 | Micrus Microcoil Delivery System | |
| Presidio-18 | Micrus Endovascular | ||
| Corporation* | |||
| Predicate | |||
| K053160 | 12/07/2005 | Micrus Microcoil Delivery System | |
| Cerecyte-18 | Micrus Endovascular | ||
| Corporation* | |||
| *On 09/27/10, Micrus Endovascular Corporation was acquired by Johnson & Johnson and now operates as a wholly-owned subsidiary | |||
| of Codman & Shurtleff, Inc within the Johnson & Johnson family of companies. Medos International SARL (Medos) will be the | |||
| recognized legal manufacturer and Codman & Shurtleff, Inc. will be the subcontractor appointed by Medos. |
No reference devices were used in this submission.
4
The CODMAN® Microcoil Delivery System, DELTAMAXX Microcoil Delivery IV. Device Description System, and ORBIT GALAXY® G2 Microcoil Delivery System consist of three components, a Microcoil System, a connecting cable, and a Detachment Control Box (DCB). Each component is sold separately. As shown in Figure 1, the Microcoil System consists of an microcoil attached to a Device Positioning Unit (DPU).
Image /page/4/Figure/4 description: The image shows a diagram of a microcoil system. The system includes a hub connector on the left side, followed by a re-sheathing tool, an introducer sheath body, and an introducer sheath tip on the right side. The microcoil is located at the far right of the system. A device positioning unit (DPU) is labeled along the length of the system.
The Microcoil System is packaged in an introducer sheath designed to protect the coil in the packaging dispenser and to provide support for introducing the coil into the infusion catheter. The microcoil is the implantable segment of the device, and is detached from the Device Positioning Unit (DPU) using the Detachment Control System (Detachment Control Box and connecting cable).
-
. The microcoil is fabricated from a platinum alloy wire. The wire is wound into a primary coil which may contain either a polypropylene suture (SR) or an absorbable polymer suture (Cerecyte®) and then formed into a secondary shape. The secondary shape may be straight, spherical, complex, or helical. The DPU is a variable stiffness wire and has a radiopaque marker band located three (3) cm from its distal end. The introducer sheath has three main components: an introducer tip, a translucent introducer body, and a re-sheathing tool.
The Detachment Control Box (DCB) provides the energy necessary to allow for a thermo-mechanical detachment of the microcoil from the DPU. The connecting cable delivers the energy necessary to detach the embolic coil from the Microcoil System's detachment zone. The connecting cable is connected between the Microcoil System's hub connector on the DPU and the output connector on the DCB. -
. The detachment control box may be one of two types: the blue EnPower Detachment Control Box or the black Detachment Control Box.
-
The connecting cables may be one of two types: one with a remote detach button (the EnPower Control Cable) catalog no. ECB000182-00, or one without a detach button (standard connecting cable) catalog no. CCB00157-00.
-
The EnPower Detachment Control Box works with the EnPower Control Cable and with the standard connecting cable. The black Detachment Control Box works only with the standard connecting cable. Both cables and Detachment Control Box are sold separately.
5
Table 3 provides a summary of the of the Microcoil Delivery Systems and Cables, IV. Device proprietary names, product model description, product catalog prefix, diameter and length, Description and predicate 510(k) numbers. (Cont.)
| Table 3: CODMAN®, DELTAMAXX, and ORBIT GALAXY® G2 Microcoil Delivery Systems and Cables | |||
|---|---|---|---|
| Proprietary Names / Product Model Description | Product | ||
| Catalog | |||
| Prefix | Diameter (mm) x | ||
| Length (cm) | |||
| Ranges | 510(k) | ||
| No. | |||
| CODMAN® Microcoil Delivery System: | |||
| MICRUSPHERE 10 Platinum Coil | SPH10 | 2-10mm x 2.5-30cm | K082739 |
| MICRUSPHERE 18 Platinum Coil | SPH18 | 2-19mm x 2.5-30cm | K082739 |
| HELIPAQ 10 Platinum Coil | HEL10 | 2-10mm x 2-30cm | K082739 |
| HELIPAQ 18 Platinum Coil | HEL18 | 2-20mm x 4-30cm | K082739 |
| INTERPAQ Straight 10 Platinum Coil | STR10 | 2-6mm x 4-30cm | K082739 |
| ULTIPAQ 10 Stretch Resistant Coil | FSR10 | 2-4mm x 1-8cm | K082739 |
| HELIPAQ 10 Stretch Resistant Coil | HSR10 | 2-10mm x 1-30cm | K082739 |
| CASHMERE 14 Stretch Resistant Coil | SRC14 | 2-12mm x 2.5-30cm | K072173 |
| MICRUSPHERE XL 10 Stretch Resistance Coil | SSR10 | 2-8mm x 2.5-25mm | K073442, |
| K032872 | |||
| MICRUSPHERE XL 18 Stretch Resistance Coil | SSR18 | 8-18mm x 25-40cm | K073442, |
| K062036, | |||
| K053160 | |||
| DELTAPAQ 10 Stretch Resistant Coil | DFS10 | 1.5-10mm x 1-25cm | K082739 |
| DELTAPLUSH 10 Stretch Resistant Coil | DPL10 | 1.5-4mm x 1-8cm | K083646 |
| PRESIDIO 10 Platinum Coil | PP410 | 4-8mm x 11.5-29cm | K082739 |
| DELTAMAXX 18 Stretch Resistant Coil | DMX18 | 3-24mm x 12-60cm | K120274 |
| ORBIT GALAXY® G2 Stretch Resistant Complex Coil Fill | 641CF | 2-20mm x 1.5-30cm | K120686 |
| ORBIT GALAXY® G2 Stretch Resistant Complex Coil XTRASOFT | 641CX | 2-6mm x 1.5-20cm | K120686 |
| ORBIT GALAXY® G2 Stretch Resistant Helical Coil XTRASOFT | 641HX | 2mm x 1.5-8cm | K120686 |
| EnPower Control Cable (Microcoil Delivery Systems' Cable) | ECB | 5-6ft | K082739, |
| K083646, | |||
| K120686, | |||
| K120274 | |||
| Connecting Cable (Microcoil Delivery Systems' Cable) | CCB | 5-6ft | K082739, |
| K083646, | |||
| K120686, | |||
| K120274 |
6
CODMAN® Microcoil Delivery System is intended for endovascular embolization of V. Indications intracranial aneurysms, other neurovascular abnormalities such as arteriovenous for Use malformations and arteriovenous fistulae, and is also intended for arterial and venous embolizations in the peripheral vasculature.
The DELTAMAXX Microcoil Delivery System is intended for endovascular embolization of intracranial aneurysms, other neurovascular abnormalities such as arteriovenous malformations and arteriovenous fistulae, and is also intended for arterial and venous embolizations in the peripheral vasculature.
The Fill ORBIT GALAXY® G2 Microcoil Delivery System is intended for endovascular embolization of intracranial aneurysms, other neurovascular abnormalities such as arteriovenous malformations and arteriovenous fistulae, and is also intended for arterial and venous embolizations in the peripheral vasculature.
The Xtrasoft ORBIT GALAXY® G2 Microcoil Delivery System is intended for endovascular embolization of intracranial aneurysms.
7
VI. Comparison of Technological Characteristics With Predicate Device
There are no new technological characteristics being introduced with the proposed packaging change to the CODMAN®, DELTAMAXX, ORBIT GALAXY® G2 Microcoil Delivery Systems and Cables. The CODMAN®, DELTAMAXX, ORBIT GALAXY® G2 Microcoil Delivery Systems and Cables were shown to be substantially equivalent to the predicate devices through comparison of indications for use, function, operating principle, bench testing, sterilization, biocompatibility, and materials.
The modifications proposed in this submission are for packaging only. Therefore the summary table provided below is a comparison of technological characteristics focused on the CODMAN®, DELTAMAXX, ORBIT GALAXY® G2 Microcoil Delivery Systems and Cables' packaging.
| Table 4: Product Packaging Comparison Information | ||
|---|---|---|
| Characteristics | Predicate Devices: CODMAN® Microcoil Delivery System (K082739, K073442, K072173, K083646) DELTAMAXX Microcoil Delivery System (K120274) ORBIT GALAXY® G2 Microcoil Delivery System (K120686) | This Submission: CODMAN® Microcoil Delivery System DELTAMAXX Microcoil Delivery System ORBIT GALAXY® G2 Microcoil Delivery System |
| Dimensions | ||
| Pouch Size | 11" x 10" | 14" x 10" |
| Carton Size | 10.125" x 11" x 0.703" | Same as Predicates |
| Dispenser Hoop | Length: 260cm & Diameter: 8.75" | Same as Predicates |
| Material | ||
| Pouch Material | TPF-0521 PET/adhesive/LDPE/w/heat seal coating sealed to TPF-0501A PET/ LDPE | TPS-4050 Nylon/LDPE Film w/ heat seal coating sealed to TPS-4050 Nylon/LDPE Film |
| Dispenser Hoop Material | Tubing: Medical Grade Polyethylene Clip: Medical Grade MDPE | Same as Predicates |
| EnPower Control(ECB)/Connecting (CCB) Cable Mounting Card Material | 0.024" Clay Coated Solid Bleached Sulfate | Same as Predicates |
| Carton Material | 0.024" Clay Coated Solid Bleached Sulfate | Same as Predicates |
| Source | ||
| Pouch Vendor | Tolas Health Care Packaging | Same as Predicates |
| Carton Vendor | Royal Paper Box &Constellation Anderson DDB Health & Lifestyles | Same as Predicates |
| Dispenser Hoops | Contech Packaging, Inc. | Same as Predicates |
| Pouch Sealing Method | ||
| Sealer | Sencorp Model 12-PV/2 | Same as Predicates |
| Sterilization | ||
| Sterilization Method | E-Beam Radiation | Same as Predicates |
| Microcoil Delivery Systems' Target Surface Dose | 37kGy | Same as Predicates |
| EnPower Control (ECB) / Connecting (CCB) Cables Target Surface Dose | 42kGy | Same as Predicates |
| Shelf-Life | ||
| Microcoil Delivery Systems' Product Shelf Life | 5 years | Same as Predicates |
| EnPower Control (ECB) / Connecting (CCB) Cables Product Shelf Life | 3 years | Same as Predicate |
| Note: The EnPower Control (ECB) and Connecting (CCB) Cables are part of all Microcoil Delivery Systems Listed. |
8
There were no changes made that affect the CODMAN®, DELTAMAXX, VII. Performance ORBIT GALAXY® G2 Microcoil Delivery Systems and Cables' intended use, operational principle, design principle, product materials, manufacturing or Data sterilization processes. The modifications proposed in this submission are for the packaging only. Therefore, design verification and validation of the product was
Verification and validation activities were focused on demonstrating package integrity of the proposed pouches. Appropriate testing was identified based on a review of the products' risk analyses and previous use of the Nylon/LDPE Film pouch. Testing was conducted as appropriate for the inclusion of the proposed pouches based on current standards, and all testing was performed on final sterile product, unless otherwise specified. The following performance data were provided in support of the substantial equivalence determination.
Packaging Integrity Testing
not warranted.
Packaging Integrity testing demonstrated that the sterile barrier system of the proposed pouch maintains packaging integrity after exposure to sterilization, simulated handling and distribution. The validation also demonstrates that the packaging design and materials are acceptable for the CODMAN®, DELTAMAXX, ORBIT GALAXY® G2 Microcoils Delivery System. The following tests were performed:
- . Visual Inspection
- . Dye Leak
- Seal Strength
- . Product Functional Testing on EnPower Control Cable
Characterization Testing: Moisture and Humidity Creep
Sterile Pouch Shelf-Life Testing
Pouch Shelf Life visual inspection demonstrated that the proposed pouch's integrity was maintained. The inspected seals were complete and uniform throughout the entire seal area of the proposed pouch for each time interval (Accelerated Aging: time-zero, 1yr, 3yr, 5yr, 10yr) (Real-Time Aging: time-zero, 1 yr, 3 yr) in the sterilized test groups. There were no detected negative trends in seal strength. These results demonstrate that the seals maintain their strength over time. Testing confirmed that the device will remain sterile through the proposed shelf life and integrity of its packaging are not compromised during transportation and distribution. The following tests were performed:
- Visual Inspection
- . Seal Strength
9
- . In vitro Cytotoxicity
Sterilization
Sterilization method validation in accordance with ISO 11137: 2006. Only the material and size of the pouch are changing. There are no changes to the product. All of the bioburden related test results met the acceptance criteria for the representative products as packaged in the new pouch, and the full shipper weights and densities remain within the acceptable dose mapped results. Therefore, the packaging change to the CODMAN®, DELTAMAXX, ORBIT GAXALY® G2 Microcoil Delivery Systems, EnPower Control and Connecting Cables are considered acceptable. The following tests were performed:
- Bioburden measurement
- Identification of top three organisms
- Bacteriostasis/Fungistasis (B/F)
- Bioburden recovery study (Extraction efficiency) .
Animal Testing
No animal studies were required as appropriate verification and validation of the packaging modifications were achieved based on the similarities of the proposed device to the predicate device, and from results of bench testing.
Summary of Clinical Testing
No clinical studies were required as appropriate verification and validation of the packaging modifications were achieved based on the similarities of the proposed device to the predicate device, and from results of bench testing.
10
Based upon the design, materials, function, intended use, and the non-clinical VIII. Conclusion testing performed by Codman, it is concluded that the proposed packaging for CODMAN®, DELTAMAXX, ORBIT GALAXY® G2 Microcoil Delivery Systems and Cables is substantially equivalent to the currently marketed CODMAN®, DELTAMAXX, ORBIT GALAXY® G2 Microcoil Delivery Systems and Cables and therefore, does not raise any new questions of safety and effectiveness.