(32 days)
No
The device description focuses on the physical components and materials of the microcoil delivery system, with no mention of software, algorithms, or data processing that would indicate the use of AI or ML. The performance studies are based on bench testing and comparison to predicate devices, not on the evaluation of AI/ML model performance.
Yes.
The device is intended for endovascular embolization of various neurovascular and peripheral vascular abnormalities, directly treating and altering the disease state.
No
The device is an embolic coil system designed for endovascular embolization of various vascular abnormalities (treatment), not for diagnosing them.
No
The device description clearly outlines physical components including an embolic coil, a device positioning unit, and packaging, indicating it is a hardware device, not software-only.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states that the device is for "endovascular embolization of intracranial aneurysms, other neurovascular abnormalities... and is also intended for arterial and venous embolizations in the peripheral vasculature." This describes a therapeutic procedure performed within the body to treat a medical condition.
- Device Description: The device is described as an "embolic coil" that is implanted into the body. This is a medical device used for treatment, not for testing samples outside the body.
- Lack of IVD Characteristics: There is no mention of the device being used to test biological samples (blood, urine, tissue, etc.) to diagnose a disease or condition. The description focuses on the physical properties and function of the coil for embolization.
IVD devices are specifically designed to be used in vitro (outside the body) to examine specimens from the human body to provide information for diagnosis, monitoring, or treatment. This device does not fit that description.
N/A
Intended Use / Indications for Use
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.
Product codes (comma separated list FDA assigned to the subject device)
HCG, KRD
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 fresh blood into the aneurysm. The aneurysm neck will be covered with loops of coils to help eliminate the influx of fresh 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 DELTAMAXX " 18 Microcoil System consists of an embolic coil ("Microcoil") attached to a Device Positioning Unit (DPU), and is compatible with commercially available 2-tip marker microcatheters which have internal lumen diameters between 0.0165 inches and 0.019 inches. The DELTAMAXX ™ 18 Microcoils are provided in Stretch Resistant (SR) or Cerecyte® models and will be offered in lengths up to 60 cm and diameters ranging from 3 mm to 24 mm.
The DELTAMAXX™ 18 Microcoils are fabricated from the same platinum alloy wire used in the DELTAPAQ® Microcoils. The wire is wound into a primary coil (containing either a polypropylene (SR) or absorbable polymer suture (Cerecyte®) inside the wind and then formed into a secondary helical coil shape. The Microcoil 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 coil is the implantable segment of the device, and is detached from the device positioning unit by the Micrus Detachment Control System.
The DELTAMAXX™ 18 Microcoil System is a line extension to the currently marketed DELTAPAQ® 10 Microcoil System, as submitted in premarket notification numbers K080379 and K080437. The modifications include minor design changes required to expand the product line to include larger diameters and longer lengths as well as a minor manufacturing process change.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Intracranial, 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 demonstrates that the device performs according to its description and intended use, and establishes the performance characteristics of the modifications to this device. The DELTAMAXX™18 Microcoil System passed equivalent bench testing as compared to the DELTAPAQ 10 System and PRESIDIO 18 System predicate devices. Clinical testing was not required to establish substantial equivalence.
Results of verification and validation conducted on the DELTAMAXX™18 Microcoil System demonstrates that the system · performs as designed, is suitable for the intended · use, is substantially equivalent to the predicate device and therefore, does not raise any different questions of safety and effectiveness.
The following tests were conducted to verify the modified design for both Stretch Resistant and Cerecyte® models:
- . Delivery Force Test
- System Delivery Force
- Microcatheter compatibility .
- Secondary Shape Retention Test ♥
- Coil Secondary Shape OD .
- Spring Constant Test .
- Primary Wind Coil Stiffness .
- Detachment Zone Tensile Test .
- Coil Socket Ring Tensile Strength .
- Detachment Fiber Tensile Strength
- Stretch resistance of suture/Tensile Strength l
- Durability and Detachability Test .
- Durability-Cyclic advancement and retrieval of the microcoil system 트
- Detachment of the microcoil from the delivery system .
- Coil damage after microcoil system delivery .
- Microcatheter compatibility ■
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.
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.
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
Codman & Shurtleff, Inc.
MAR - 2 2012
. Special 510(k) DELTAMAXX™ 18 Microcoil System
.
510(k) Summary
(As Required By 21 CFR 807.92(a))
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: | January 27, 2012 |
| B. Trade/Device Name: | DELTAMAXX™ 18 Microcoil System |
| Common Name: | Artificial embolization device |
| Classification Name: | Neurovascular Embolization Device |
| Regulation Number: | Class II per 21 CFR 882 5950 |
C. Predicate Devices:
| Device | Company | 510(k) Number/
Concurrence
Date | Product Code | Predicate For: |
|-----------------------------------------------------------------------------|-------------------------------------------------------------------------|---------------------------------------|--------------|-----------------------------------------------------------------------|
| Primary: Micrus
Microcoil
System
DELTAPAQ® 10
Stretch Resistant | Codman &
Shurtleff, Inc
(Previously Micrus
Endovascular, Corp) | K080379
6/30/2008 | HCG | Intended Use
Design
Materials
Manufacturing
Sterilization |
| Primary: Micrus
Microcoil
System,
DELTAPAQ® 10
Cerecyte® | Codman &
Shurtleff, Inc
(Previously Micrus
Endovascular, Corp) | K080437
5/8/2008 | HCG | Intended Use
Design
Materials
Manufacturing
Sterilization |
| Micrus Microcoil
System
PRESIDIO® 18 | Codman &
Shurtleff, Inc
(Previously Micrus
Endovascular, Corp) | K062036
8/25/2006 | HCG | Design |
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 fresh blood into the aneurysm. The aneurysm neck will be covered with loops of coils to help eliminate the influx of fresh 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 DELTAMAXX " 18 Microcoil System consists of an embolic coil ("Microcoil") attached to a Device Positioning Unit (DPU), and is compatible with commercially available 2-tip marker microcatheters which have internal lumen diameters between 0.0165 inches and 0.019 inches. The DELTAMAXX ™ 18 Microcoils are provided in Stretch Resistant (SR) or Cerecyte® models and will be offered in lengths up to 60 cm and diameters ranging from 3 mm to 24 mm.
The DELTAMAXX™ 18 Microcoils are fabricated from the same platinum alloy wire used in the DELTAPAQ® Microcoils. The wire is wound into a primary coil (containing either a polypropylene (SR) or absorbable polymer suture (Cerecyte®) inside the wind and then formed into a secondary helical coil shape. The Microcoil 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 coil is the implantable segment of the device, and is detached from the device positioning unit by the Micrus Detachment Control System.
The DELTAMAXX™ 18 Microcoil System is a line extension to the currently marketed DELTAPAQ® 10 Microcoil System, as submitted in premarket notification numbers K080379 and K080437. The modifications include minor design changes required to expand the product line to include larger diameters and longer lengths as well as a minor manufacturing process change.
2
E. Intended Use:
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.
F. Summary of technological characteristics of the proposed to the predicate device:
The DELTAMAXX™18 Microcoil System (including SR and Cerecyte® models) is substantially equivalent to the Micrus DELTAPAQ® 10 Microcoil System (including SR and Cerecyte® models). This modification expands the product line using existing technology and no new technological characteristics are being introduced with the proposed device.
The DELTAMAXX"18 Microcoil System has the same intended use as the DELTAPAQ® 10 Microcoil System and is similar with regard to design, manufacturing, sterilization process, and materials.
The DELTAMAXX™ 18 Microcoil System is also similar to the PRESIDIO® 18 Microcoil System with regard to the larger diameters and longer lengths.
A summary table including specifications of the proposed device compared with those of the predicate devices follows.
3
Codman & Shurtleff, Inc
ELTAMAXX™ 18 Microcoil System
rative Informatio
| Comparative Information
Characteristic | DELTAMAXX™ | DELTAPAQ® 10
(Primary Predicate) | PRESIDIO® 18
(Predicate) |
|---------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Intended Use | 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 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. | 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. |
| Component and or
material | | | |
| Implant material | Platinum Tungsten Alloy Wire | Platinum Tungsten Alloy Wire | Platinum Tungsten Alloy Wire |
| Internal suture
material | SR - Polypropylene
Cerecyte | SR - Polypropylene
Cerecyte | Cerecyte |
| Primary wind OD | 0.015" | 0.0105" | 0.015" |
| Profile of primary wind | Triangular | Triangular | Circular |
| Primary wind pattern
(Deltawind
Technology) | Rotated in a repeating pattern | Rotated in a repeating pattern | Cylindrical |
| Secondary Shape Coil
OD | 3mm – 24mm | 1.5mm to 10mm | 8mm – 20mm |
| Secondary shape | Helical | Helical | Spherical |
| Coil length | 12 cm minimum
60cm maximum | 2cm minimum
25cm maximum | 30cm minimum
50cm maximum |
| Characteristic | DELTAMAXX™ | DELTAPAQ® 10
(Primary Predicate) | PRESIDIO® 18
(Predicate) |
| DPU Delivery System
Length | 150 cm | 150 cm | 150 cm |
| Microcatheter
compatibility | Compatible with 2-tip marker micro
catheters of ID from 0.0165" to 0.019" | Compatible with 2-tip marker micro
catheters of ID from 0.014" to 0.017" | Compatible with 2-tip marker micro
catheters of ID from 0.017" to 0.021" |
| Detachment System | Uses Micrus Connecting Cable | Uses Micrus Connecting Cable | Uses Micrus Connecting Cable |
| | Uses Micrus Detachment Control Box | Uses Micrus Detachment Control Box | Uses Micrus Detachment Control Box |
| Sterilization | E-Beam Radiation | E-Beam Radiation | E-Beam Radiation |
| Packaging | Packaged in a plastic hoop and enclosed
in a pouch. | Packaged in a plastic hoop and enclosed
in a pouch. | Packaged in a plastic hoop and enclosed
in a pouch. |
4
Codman & Shurtleff, In
omparative Information (con
Note: The DELTAMAXX" 18 Microcoil System is also similar to the MicroPlex Coil System- Cosmos " (K093358) and the
5
G. Testing Summary:
Bench testing data demonstrates that the device performs according to its description and intended use, and establishes the performance characteristics of the modifications to this device. The DELTAMAXX™18 Microcoil System passed equivalent bench testing as compared to the DELTAPAQ 10 System and PRESIDIO 18 System predicate devices. Clinical testing was not required to establish substantial equivalence.
Results of verification and validation conducted on the DELTAMAXX™18 Microcoil System demonstrates that the system · performs as designed, is suitable for the intended · use, is substantially equivalent to the predicate device and therefore, does not raise any different questions of safety and effectiveness.
The following tests were conducted to verify the modified design for both Stretch Resistant and Cerecyte® models:
- . Delivery Force Test
- System Delivery Force
- Microcatheter compatibility .
- Secondary Shape Retention Test ♥
- Coil Secondary Shape OD .
- Spring Constant Test .
- Primary Wind Coil Stiffness .
- Detachment Zone Tensile Test .
- Coil Socket Ring Tensile Strength .
- Detachment Fiber Tensile Strength
- Stretch resistance of suture/Tensile Strength l
- Durability and Detachability Test .
- Durability-Cyclic advancement and retrieval of the microcoil system 트
- Detachment of the microcoil from the delivery system .
- Coil damage after microcoil system delivery .
- Microcatheter compatibility ■
6
Codman & Shurtleff, Inc.
The proposed DELTAMAXX™18 Microcoil System is similar to the currently marketed DELTAPAO 8 10 Microcoil System. The modifications include only minor design changes required to expand the product line to include larger diameters and longer lengths as well as a minor manufacturing process change.
The materials, suppliers, manufacturing process, packaging, and sterilization used in the DELTAMAXX" 18 Microcoil System are identical to the material, suppliers, manufacturing process, packaging, and sterilization used in the current DELTAPAQ® 10 Microcoil System with the exception of a minor manufacturing process change to the distal PET ring. The DELTAPAQ® 10 Microcoil System was previously demonstrated to be biocompatible and the data to support the biocompatibility was provided to FDA in the predicate device premarket notifications K080379 (6/30/08) and K080437 (5/8/2008).
The DELTAMAXX"18 Microcoil System continues to meet all the same biocompatibility requirements as the predicate device 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 DELTAMAXX™18 Microcoil System is substantially equivalent to the DELTAPAQ ® 10 Microcoil System, and therefore does not raise any new questions of safety and effectiveness.
7
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/7/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" arranged around the perimeter. Inside the circle is a stylized symbol that resembles an abstract caduceus, featuring three curved lines that converge at the bottom.
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002
MAR - 2 2012
Codman and Shurtleff, Inc. c/o Ms. Kim Fonda Manager Regulatory Affairs 325 Paramount Drive Raynham, MA 02767-0350
Re: K120274
Trade/Device Name: DELTAMAXX™ 18 Microcoil System Regulation Number: 21 CFR 882.5950 Regulation Name: Neurovascular Embolization Device Regulatory Class: Class II Product Code: HCG, KRD Dated: January 27, 2012 Received: January 30, 2012
Dear Ms. Fonda:
We have reviewed your Section 510(k) premarket notification of intent to market the device we nave reviewed your becared the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate for ass sured in the exercised of the enactment date of the Medical Device Amendments, or to conninered pror to May 20, 1978, the encordance with the provisions of the Federal Food, Drug, de nees that have been roomston of a premarket approval of a premarket approval application (PMA). and Costience Fee (11et) that as novice, subject to the general controls provisions of the Act. The Tou may, incretore, manxel the Act include requirements for annual registration, listing of general controls proficious practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability adulteration. Thease noter u, 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 If your device is classified (boo are t). Existing major regulations affecting your device can be may be subject to additions, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
8
Page 2 - Ms. Kim Fonda
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.
Sincerely vours.
signature
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
Codman & Shurtleff, Inc.
Indications for Use Form
510(k) Number (if known): K120274
Device Name: DELTAMAXX™ 18 Microcoil System
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.
Prescription Use × (Part 21 CFR 801 Subpart D) AND/OR
Over-The-Counter Use (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of In Vitro Diagnostic Devices (OIVD)
Jeffrey Toy
Division Sign-Off Office of In Vitro Diagnostic Device Evaluation and Safety
510(k) K12-0274
14