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.

Device Description

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.

AI/ML Overview

This document focuses on the Codman & Shurtleff, Inc. DELTAMAXX™ 18 Microcoil System, a neurovascular embolization device. The submission is a Special 510(k) for a line extension.

Here's an analysis of the provided information regarding acceptance criteria and the study:

1. Table of Acceptance Criteria and Reported Device Performance:

The document doesn't explicitly define acceptance criteria as pass/fail thresholds for specific performance metrics in a numbered or bulleted list. Instead, it states that the device "passed equivalent bench testing as compared to the DELTAPAQ 10 System and PRESIDIO 18 System predicate devices." The inherent acceptance criterion is that the DELTAMAXX™ 18 Microcoil System performs demonstrably similarly or equivalently to its predicate devices in various bench tests.

Here's a table summarizing the types of tests conducted and the general performance outcome:

Acceptance Criteria Category (Implied)	Reported Device Performance
Delivery Force	Performed equivalently to predicate devices
System Delivery Force	-
Microcatheter compatibility	-
Secondary Shape Retention	Performed equivalently to predicate devices
Coil Secondary Shape OD	-
Spring Constant	Performed equivalently to predicate devices
Primary Wind Coil Stiffness	-
Detachment Zone Tensile	Performed equivalently to predicate devices
Coil Socket Ring Tensile Strength	-
Detachment Fiber Tensile Strength	-
Stretch resistance of suture/Tensile Strength	-
Durability and Detachability	Performed equivalently to predicate devices
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	-
Biocompatibility	Continues to meet all the same biocompatibility requirements as the predicate device and as specified by ISO 10993 Part I and G95-1.

Explanation: The document emphasizes substantial equivalence to predicate devices (DELTAPAQ® 10 and PRESIDIO® 18). Therefore, the "acceptance criteria" are implied to be that the DELTAMAXX™ 18 performs within the established safety and effectiveness profiles of these legally marketed devices for each tested characteristic. Specific quantitative pass/fail values are not provided in this summary.

2. Sample Size Used for the Test Set and Data Provenance:

Sample Size for Test Set: Not explicitly stated. The document refers to "bench testing data" (Section G, page 5) but does not specify the number of devices or components tested for each category.
Data Provenance: The data is from bench testing conducted by the manufacturer, Codman & Shurtleff, Inc. It is prospective in the sense that these tests were performed specifically to support the 510(k) submission for the DELTAMAXX™ 18. There is no information regarding the country of origin of the data beyond it being generated by the submitter.

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

This information is not applicable as the study is entirely bench testing of a physical device, not an AI/software device that requires human expert review for establishing ground truth or performance assessment.

4. Adjudication Method for the Test Set:

This information is not applicable for bench testing. Bench tests typically involve objective measurements against predefined specifications or comparative performance with predicate devices.

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

No, an MRMC comparative effectiveness study was not done. The submission explicitly states: "Clinical testing was not required to establish substantial equivalence." (Section G, page 5). This directly indicates that no human reader studies (with or without AI assistance) were conducted.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done:

No, this is not an AI/algorithm-based device. The DELTAMAXX™ 18 Microcoil System is a physical medical device (embolization microcoil). Therefore, "standalone" algorithm performance is not relevant or applicable.

7. The Type of Ground Truth Used (Expert Consensus, Pathology, Outcomes Data, etc.):

For this physical medical device, "ground truth" for the bench tests would be established through engineering specifications, physical measurements, and comparison to the established performance characteristics of the predicate devices. For example, the "true" diameter of a coil is determined by precise measurement, not expert consensus or pathology. Similarly, tensile strength is measured against engineering standards.
For biocompatibility, the ground truth is established by adherence to recognized standards like ISO 10993 Part I.

8. The Sample Size for the Training Set:

This information is not applicable as this is a physical medical device, not an AI/machine learning algorithm that requires a training set.

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

This information is not applicable as this is a physical medical device and does not involve a training set.

In summary: The submission demonstrates substantial equivalence of the DELTAMAXX™ 18 Microcoil System to its predicate devices through comprehensive bench testing. The "acceptance criteria" are implicitly met by demonstrating performance that is equivalent to, or within the established safety and effectiveness parameters of, the predicate devices for key mechanical and material characteristics. No clinical studies, human reader studies, or AI algorithm testing were conducted or required for this 510(k) submission.

Summary

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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/ConcurrenceDate	Product Code	Predicate For:
Primary: MicrusMicrocoilSystemDELTAPAQ® 10Stretch Resistant	Codman &Shurtleff, Inc(Previously MicrusEndovascular, Corp)	K0803796/30/2008	HCG	Intended UseDesignMaterialsManufacturingSterilization
Primary: MicrusMicrocoilSystem,DELTAPAQ® 10Cerecyte®	Codman &Shurtleff, Inc(Previously MicrusEndovascular, Corp)	K0804375/8/2008	HCG	Intended UseDesignMaterialsManufacturingSterilization
Micrus MicrocoilSystemPRESIDIO® 18	Codman &Shurtleff, Inc(Previously MicrusEndovascular, Corp)	K0620368/25/2006	HCG	Design

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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 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.

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E. Intended Use:

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.

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Codman & Shurtleff, Inc

ELTAMAXX™ 18 Microcoil System

rative Informatio

Comparative InformationCharacteristic	DELTAMAXX™	DELTAPAQ® 10(Primary Predicate)	PRESIDIO® 18(Predicate)
Intended Use	The DELTAMAXX MicrocoilDelivery System is intended forendovascular embolization ofintracranial aneurysms, otherneurovascular abnormalities such asarteriovenous malformations andarteriovenous fistulae, and is alsointended for arterial and venousembolizations in the peripheralvasculature.	The Micrus Microcoil Delivery Systemis intended for endovascularembolization ofintracranial aneurysms, otherneurovascular abnormalities such asarteriovenous malformations andarteriovenous fistulae, and are alsointended for arterial and venousembolizations in the peripheralvasculature.	The Micrus Microcoil Delivery Systemis intended for endovascularembolization ofintracranial aneurysms, otherneurovascular abnormalities such asarteriovenous malformations andarteriovenous fistulae, and are alsointended for arterial and venousembolizations in the peripheralvasculature.
Component and ormaterial
Implant material	Platinum Tungsten Alloy Wire	Platinum Tungsten Alloy Wire	Platinum Tungsten Alloy Wire
Internal suturematerial	SR - PolypropyleneCerecyte	SR - PolypropyleneCerecyte	Cerecyte
Primary wind OD	0.015"	0.0105"	0.015"
Profile of primary wind	Triangular	Triangular	Circular
Primary wind pattern(DeltawindTechnology)	Rotated in a repeating pattern	Rotated in a repeating pattern	Cylindrical
Secondary Shape CoilOD	3mm – 24mm	1.5mm to 10mm	8mm – 20mm
Secondary shape	Helical	Helical	Spherical
Coil length	12 cm minimum60cm maximum	2cm minimum25cm maximum	30cm minimum50cm maximum
Characteristic	DELTAMAXX™	DELTAPAQ® 10(Primary Predicate)	PRESIDIO® 18(Predicate)
DPU Delivery SystemLength	150 cm	150 cm	150 cm
Microcathetercompatibility	Compatible with 2-tip marker microcatheters of ID from 0.0165" to 0.019"	Compatible with 2-tip marker microcatheters of ID from 0.014" to 0.017"	Compatible with 2-tip marker microcatheters 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 enclosedin a pouch.	Packaged in a plastic hoop and enclosedin a pouch.	Packaged in a plastic hoop and enclosedin a pouch.

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Codman & Shurtleff, In

omparative Information (con

Note: The DELTAMAXX" 18 Microcoil System is also similar to the MicroPlex Coil System- Cosmos " (K093358) and the

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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 ■

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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.

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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.

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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

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Codman & Shurtleff, Inc.

Indications for Use Form

510(k) Number (if known): K120274

Device Name: DELTAMAXX™ 18 Microcoil System

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

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).