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, with no mention of AI or ML technologies.

Therapeutic

Yes
The device is intended for endovascular embolization of intracranial aneurysms, which is a therapeutic intervention to treat a medical condition.

Diagnostic

No

The device is an embolic coil system intended for the treatment (embolization) of intracranial aneurysms, which is a therapeutic intervention, not a diagnostic one.

SaMD (Software as a Medical Device)

No

The device description explicitly details physical components like an embolic coil, a Device Positioning Unit (DPU), and materials like platinum alloy wire and absorbable polymer suture. The performance studies also focus on physical characteristics and interactions (e.g., animal testing, friction, tensile strength, durability). There is no mention of software as a component or the primary function of the device.

IVD (In Vitro Diagnostic)

No, this device is not an IVD (In Vitro Diagnostic).

Here's why:

Intended Use: The intended use is "endovascular embolization of intracranial aneurysms." This is a therapeutic procedure performed within the body to treat a medical condition.
Device Description: The device is a physical implant (embolic coil) delivered into the body.
IVD Definition: In Vitro Diagnostics are tests performed on samples taken from the human body (like blood, urine, tissue) to provide information about a person's health.

This device is clearly a therapeutic medical device used for treatment, not a diagnostic test performed on samples outside the body.

PCCP (Predetermined Change Control Plan) Authorized

N/A

Overview

Intended Use / Indications for Use

The Micrus MicroCoil Delivery System is intended for endovascular embolization of intracranial aneurysms.

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

HCG

Device Description

The Micrus Modified MicroCoil System consists of an embolic coil ("MicroCoil") attached to a Device Positioning Unit (DPU) (single use, sterile). The Micros Modified MicroCoils are available in a 10-System size, compatible with 10 and 14 sized microcatheters. They are available in helical and spherical shapes and are available in various diameters/lengths: Coil lengths range from 1 to 30 centimeters. Coil diameters range from 2 to 10 millimeters. Micrus Modified MicroCoils are fabricated from a platinum alloy wire, which is first wound into a primary coil (containing an absorbable polymer suture inside the wind) and then formed into a secondary helical or spherical shape. The difference between the Micros Modified MicroColl and the Micros Stretch Resistant MicroCoil is that the Modified MicroCoil and the MicroCoil contains absorbable polyglycolic acid (PGA) suture whereas the Stretch Resistant MicroCoil contains non-absorbable polypropylene suture. The Modified MicroCoils are available in both stretch resistant and non-stretch resistant configurations with different stiffers resistant and non-stretch illustrates the softness characteristics and character illustrates the softness characteristics and stretch resistant properties of the various size/shape combinations available for the Modified MicroCoil.

Mentions image processing

Not Found

Mentions AI, DNN, or ML

Not Found

Input Imaging Modality

Not Found

Anatomical Site

intracranial (aneurysms)

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)

Test	Micrus Modified MicroCoil System Test Result	Substantial Equivalence
Acute Animal Testing V0327-acute outcome	Characteristic: Aneurysm occlusion and detachment reliability. Test data: Coils detached with the first detachment cycle in > 95% of detachments and ≥90% aneurysm occlusion was obtained in all 5 aneurysms.	Substantially equivalent.
Chronic Animal Testing for Coil Stability & Aneurysm Occlusion V0327-chronic outcome	Characteristic: Positional stability and aneurysm occlusion. Test data: Positional stability and aneurysm occlusion maintained through 6 months of implant. No coil compaction present at 6-month angio. Histology showed chronic biocompatibility per study V0401.	Substantially equivalent.
Coil Stiffness/Softness for Wide Pitch Modified MicroCoils V0396	Characteristic: Stiffness limits for the modified coils manufactured with a looser wind (wide pitch). No change was made that would affect the stiffness of the tightly wound coils. Test data: The loosely wound (wide pitch) Helical and Spherical Modified MicroCoils met the stiffness specifications.	Substantially equivalent.
Friction in the Microcatheter (Delivery Force) V0429	Characteristic: Average push force must be substantially equivalent to predicates. Test data: The Modified MicroCoil had average push forces that are comparable to those of the predicate.	Substantially equivalent.
Biocompatibility of Materials V0401 & V0435	Characteristics: Meets the requirements of ISO 10993. Test data: The only new material in the Micrus Modified MicroCoil is absorbable suture, which passed ISO 10993 biocompatibility testing.	Meets ISO 10993
Sterilization Validation V0394	Characteristic: Minimum Sterility Assurance Level of 10-6. Test data: Passed minimum sterility assurance level of 10-6.	Substantially equivalent.
Shelf Life Test V0397	Characteristic: No performance degradation after 3 year of shelf life aging. Test data: Minimum tensile strength after 3 year accelerated aging shows no degradation.	Substantially equivalent
Tensile Strength: Stretch Resistant Modified MicroCoils (at the detachment zone, PGA to polypropylene junction and suture ball tip to MicroCoil) V0427	Characteristic: Pre-detachment tensile strength of the suture ball tip and MicroCoil to DPU must be substantially equivalent to the stretch resistant predicate. Test data: Tensile strength meets desired strength criteria.	Substantially equivalent to the stretch resistant predicate
Tensile Strength: Non-Stretch Resistant Modified MicroCoils (at the detachment zone) V0398	Characteristic: Pre-detachment tensile strength of the MicroCoil to DPU must be substantially equivalent to the non-stretch resistant predicate. Test data: Tensile strength meets desired strength criteria.	Substantially equivalent to the non-stretch resistant predicate
Tensile Strength: Non-Stretch Resistant (at the suture ball tip) V0428	Characteristic: Pre-detachment tensile strength of the suture ball tip and MicroCoil must be substantially equivalent to the non-stretch resistant predicate. Test data: Tensile strength meets desired strength criteria.	Substantially equivalent to the non-stretch resistant predicate
Durability (Reliability after Fatigue) V0405	Characteristic: Withstand deployment and retraction 6 times in a tortuous anatomy. Test data: No knotting, no breakage, no stretching occurred. Durability meets desired durability criteria.	Substantially equivalent
MRI Compatibility of Implant	No change was made which would impact MRI compatibility.	Substantially equivalent
Package Integrity V0399	Characteristic: Demonstrate package integrity per ISO 11607 Test: Meets ISO 11607 criteria	Meets ISO 11607 criteria
Ship/Transit V0400	Characteristic: Successfully withstand domestic and international distribution environment Test: Does successfully withstand domestic and international distribution environment.	Substantially equivalent

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.

K022420, K002056

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

Not Found

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

Not Found

Regulation Number and Section

§ 882.5950 Neurovascular embolization device.

(a)
Identification. A neurovascular embolization device is an intravascular implant intended to permanently occlude blood flow to cerebral aneurysms and cerebral ateriovenous malformations. This does not include cyanoacrylates and other embolic agents, which act by polymerization or precipitation. Embolization devices used in other vascular applications are also not included in this classification, see § 870.3300.(b)
Classification. Class II (special controls.) The special control for this device is the FDA guidance document entitled “Class II Special Controls Guidance Document: Vascular and Neurovascular Embolization Devices.” For availability of this guidance document, see § 882.1(e).

Summary

0

055813

page 1 . 4 14

Safety and Effectiveness Summary ll.

A. Contact Information

Margaret Webber Director, Regulatory and Clinical Affairs Micrus Corporation 610 Palomar Avenue Sunnyvale, CA 94085 Tel:

408-830-5900, ext. 108 Fax: 408-830-5910

B. Device Name

Micrus Modified MicroCoil System, "Cerecyte"

Device, Artificial Embolization

Regulation Number: 882.5950

Product Code: HCG

Device Class: !!!

C. Predicate Device(s)

| Number | Description | Clearance
Date |
|---------|-------------------------------------------|-------------------|
| K022420 | Micrus Stretch Resistant MicroCoil System | 10/22/02 |
| K002056 | Micrus MicroCoil Delivery System | 01/11/01 |

D. Device Description

The Micrus Modified MicroCoil System consists of an embolic coil ("MicroCoil") attached to a Device Positioning Unit (DPU) (single use, sterile).

The Micros Modified MicroCoils are available in a 10-System size, compatible with 10 and 14 sized microcatheters. They are available in helical and spherical shapes and are available in various diameters/lengths:

Coil lengths range from 1 to 30 centimeters. .
Coil diameters range from 2 to 10 millimeters.

Micrus Modified MicroCoils are fabricated from a platinum alloy wire, which is first wound into a primary coil (containing an absorbable polymer suture inside the wind) and then formed into a secondary helical or spherical shape. The difference between the Micros Modified MicroColl and the Micros Stretch Resistant MicroCoil is that the Modified MicroCoil and the MicroCoil contains absorbable polyglycolic acid (PGA) suture whereas the Stretch Resistant MicroCoil contains
non-absorbable nolveropylone auture non-absorbable polypropylene suture.

The Modified MicroCoils are available in both stretch resistant and non-stretch resistant configurations with different stiffers resistant and non-stretch
illustrates the softness characteristics and character illustrates the softness characteristics and stretch resistant properties of the various size/shape combinations available for the Modified MicroCoil.

1

035 803

2 of 14 િવેલું કુદ

Modified MicroCoil ("Cerecyte") Shape/Size Combinations and Resulting Characteristics

| Catalogue
Designation | Shape | Diameter
"mm" | Length
"cm" | Stretch
Resistant
(Yes/No) | Characteristics |
|--------------------------|-----------|------------------|----------------|----------------------------------|------------------------------------------------------|
| Helical Modified Coils | | | | | |
| "CFS" | Helical | 2–4 | 1–8 | Yes | Soft finishing coil
• 0.0015"
platinum wire |
| "CHS" | Helical | 2–10 | 1–30 | Yes | Regular filling coil
• 0.00175"
platinum wire |
| "CHE" | Helical | 2–10 | 1–30 | No | Regular filling coil
• 0.002"
platinum wire |
| Spherical Modified Coils | | | | | |
| "CSS" | Spherical | 2–4 | 2.5–7.5 | Yes | Soft framing coil
• 0.00175"
platinum wire |
| "CSP" | Spherical | 2–10 | 2.5–20.5 | No | Regular framing
coil
• 0.002"
platinum wire |

The Modified MicroCoils maintain the same design features as the current Micrus MicroCoil Systems. Compared with the current design, Modified MicroCoils have:
MicroCoil Systems. Compared with the current design, Modified MicroCoils have:
. . . . The sam

The same intended use ●
Connect to the same connecting cables .
Detach using the same Detachment Control Box. .

It is important to reiterate, the Micrus Modified MicroCoils are identical to the current CE Marked / The Micros Mounted MicroColls are identical to the following 2 exceptions:

Non-Stretch Resistant Modified MicroCoils Spacing. The current non-1. stretch resistant MicroColl uses 0.00175" platinum wire wound with a 0.00175" pitch or 0.002" platinum wire wound with a 0.002" pitch. The Modified non-stretch resistant MicroCoil uses 0.002" pitch. The wound with a 0.004" pitch.
Absorbable suture in all Modified MicroCoils: Biocompatible, absorbable 2. sure has been inserted inside the primary wind of all Modified MicroCoils.

2

Page 3 of 14

Comparison of Current and Modified Non-Stretch Resistant MicroCoils

Image /page/2/Figure/4 description: The image shows a diagram of a "Current Micrus Non-Stretch Resistant MicroCoil". The diagram labels the different parts of the microcoil, including the DPU, detachment fiber, coil, and platinum ball tip. According to the text, the current FDA cleared MicroCoil configuration has a platinum ball tip, no suture, and a 0.00175" or 0.002" pitch.

Image /page/2/Figure/5 description: This image shows a diagram of a modified non-stretch resistant microcoil. The diagram labels the different parts of the microcoil, including the DPU, detachment fiber, wide pitch coil, PGA suture, and polypropylene ball tip. The modified configuration has a polyethylene ball tip, PGA suture inside the primary wind that does not extend to the detachment zone, and a 0.004" pitch.

3

K033815

ise

y of 14

Comparison of Current and Modified Stretch Resistant MicroCoils

Image /page/3/Figure/3 description: This image shows a diagram of a "Current Micrus Stretch Resistant MicroCoil". The diagram labels the different parts of the microcoil, including the DPU, detachment fiber, coil, polypropylene suture, and polypropylene ball tip. The text at the bottom of the image describes the current configuration, which includes a polypropylene ball tip, a polypropylene suture that extends to the detachment zone, and a 0.00175" or 0.002" pitch.

Image /page/3/Figure/4 description: The image shows a "Modified Stretch Resistant MicroCoil". The different parts of the microcoil are labeled, including the DPU, detachment fiber, coil, PGA suture, and polypropylene ball tip. The modified configuration has a polyethylene ball tip, PGA suture inside the primary wind that extends to the detachment zone, and 0.0175" or 0.002" pitch.

4

K033873

E. Intended Use

Page 5 of 14

Intended Use of the Micrus Modified MicroCoil Delivery System per the IFU: The MicroCoil Delivery System is intended for endovascular embolization of intracranial aneurysms.

Intended Use of the Predicate Micrus MicroCoil Delivery System per the IFU: The MicroCoil Delivery System is intended for endovascular embolization of intracranial aneurysms.

5

Technological Comparison

MicroColl System

に

Microcoil System

Characteristic	Micrus MicroCoil System Predicate	Micrus Stretch Resistant Predicate	Micrus Modified MicroCoil System
How Supplied	Sterile, Single Use	Sterile, Single Use	Same as predicates
	MicroCoil attached to DPU.	Coil attached to pusher wire.	Same as predicates
	Polyethylene introducer over coil.	Polyethylene introducer over coil.	Same as predicates
	In plastic packaging hoop.	In plastic packaging hoop.	Same as predicates
Characteristic	Micrus MicroCoil Predicate	Micrus Stretch Resistant
Predicate	Micrus Modified MicroCoil
System
Materials of
Construction	Platinum/Tungsten alloy wire &
Au/Sn solder.	Platinum/Tungsten alloy wire &
Au/Sn solder.	Same as predicates
Shape	No suture	Polypropylene suture.	PGA suture
Dimensions	2 mm – 30 mm	2 mm – 15 mm	2 – 30 cm
	Various diameters and lengths to
treat a variety of aneurysm sizes.	Various diameters and lengths
to treat a variety of aneurysm
sizes.	Same as predicates
Radiopacity	Radiopaque from Pt alloy wire.	Radiopaque from Pt alloy wire.	Same as predicates
MRI Compatibility	Yes	Yes	Same as predicates
Method of Attachment
to DPU	High tensile strength, highly
oriented polyethylene fiber.	High tensile strength, highly
oriented polyethylene fiber.	Same as predicates
Method of
Detachment from
DPU	Shear polyethylene fiber with a
loop of resistively heated coil.	Shear polyethylene fiber with a
loop of resistively heated coil.	Same as predicates
Provided:	Sterile, single use	Sterile, single use	Same as predicates

lmplantable Embolic Coil

K033803

6

Device Positioning Unit

Positioning Unit Characteristic	Micrus MicroCoil Predicate	Micrus Stretch Resistant Predicate	Micrus Modified MicroCoil System
	Variable stiffness.
Composite introducer.
Most flexible distally, medium flexibility in mid-section and stiffest proximally to allow pushing of the embolic coil through the tortuous cerebral vasculature.
Stainless steel hypotube (proximal), stainless steel braid (mid) and polymer (distal) sheathing for 2 conduction wires and distal RH coil.	Variable stiffness.
Composite introducer.
Most flexible distally, medium flexibility in mid-section and stiffest proximally to allow pushing of the embolic coil through the tortuous cerebral vasculature.
Stainless steel hypotube (proximal), stainless steel braid (mid) and polymer (distal) sheathing for 2 conduction wires and distal RH coil.	Same as predicates
Same as predicates
Same as predicates
Length	195 cm	195 cm	Same as predicates
Package Configuration	In plastic packaging hoop.
Introducer in place (for introduction of MicroCoil into the microcatheter).
Low density polyethylene & polyester outer package	In plastic packaging hoop.
Introducer in place (for introduction of coil into the microcatheter).
Low density polyethylene & polyester outer package	Same as predicates
Foil pouch with a low density polyethylene coating on inside and polyester coating on outside
Compatible with:	Microcatheters with minimum 0.14" i.d. ("10" sized systems), or 0.16" i.d. ("18" sized systems).
2 radiopaque tip markers 3 cm apart (examples: Tracker 10, Tracker 18, Excel 14, Prowler 10, Prowler 14).	Microcatheters with minimum 0.14" i.d. ("10" sized systems).
2 radiopaque tip markers 3 cm apart (examples: Tracker 10, Tracker 18, Excel 14, Prowler 10, Prowler 14).	Same as predicates "10" sized systems
Same as predicates

KOSS 803

Pizze Fof 14

7

Connecting Cables (Unchanged for Micrus Modified MicroCoi

| Characteristic | Micrus MicroCoil Predicate | Micrus Stretch Resistant
Predicate | Micrus Modified MicroCoil
System |
|----------------|---------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------|-------------------------------------|
| How supplied | Sterile, single use | Sterile, single use | Same as predicates |
| Physical | Single cable with proprietary
connectors to fit only the Micrus
Detachment Control Box and the
Micrus MicroCoil System | Single cable with proprietary
connectors to fit only the Micrus
Detachment Control Box and the
Micrus MicroCoil System | Same as predicates |
| Length | 262 cm. | 262 cm. | Same as predicates |

Detachment Control Box (Unchanged for Micrus Modified MicroCoil)

Characteristic	Micrus MicroCoil Predicate	Micrus Stretch Resistant Predicate	Micrus Modified MicroCoil System
How supplied	Non-Sterile, reusable.	Non-Sterile, reusable.	Same as predicates
Power Source	Used outside the sterile field.	Used outside the sterile field.	Same as predicates
Displays	Alkaline batteries.	Alkaline batteries.	Same as predicates
	Voltage, Current, Low Battery, Fault, Detach Cycle	Voltage, Current, Low Battery, Fault, Detach Cycle	Same as predicates
Detachment Cycle Duration	5 seconds	5 seconds	Same as predicates
Output Voltage	6.5 VDC	6.5 VDC	Same as predicates
Output Current	125 mA nominal, 200 mA max.	125 mA nominal, 200 mA max.	Same as predicates

Kogs805 Page 8 of 14

8

Detachment Control Box Continued (Unchanged for Micrus Modified Mic

Detachment Control Box Continued (Unchanged for Micrus Modified MicroCoil)
Characteristic	Micrus MicroCoil Predicate	Micrus Stretch Resistant Predicate	Micrus Modified MicroCoil System
"Detach" feedback	"Detach Cycle" light goes from
illuminated to off. Also, a beep
sounds once a second for 5
seconds to provide an audible
countdown of the 5 second
detachment time. Clinician
verifies detachment
fluoroscopically per device
labeling.	"Detach Cycle" light goes from
illuminated to off. Also, a beep
sounds once a second for 5
seconds to provide an audible
countdown of the 5 second
detachment time. Clinician
verifies detachment
fluoroscopically per device
labeling.	Same as predicates
Method to attach
Connecting Cable to
Detachment Box	Proprietary connector; fits only
one-way to assure proper polarity.	Proprietary connector; fits only
one-way to assure proper polarity.	Same as predicates
Flow of Current	From positive terminal, through
positive lead in connecting cable,
through positive conductor of
DPU, through resistance heating
coil, through negative conductor
of DPU, through negative lead in
connecting cable, back to
negative terminal of detachment
control box.	From positive terminal, through
positive lead in connecting cable,
through positive conductor of
DPU, through resistance heating
coil, through negative conductor
of DPU, through negative lead in
connecting cable, back to
negative terminal of detachment
control box.	Same as predicates

Koss 8033805 Page Got 14

f 16

9

Accessories

| Characteristic | Accessory Products
Required to Perform
the Procedure. | Micrus MicroCoil Predicate | Micrus Stretch Resistant Predicate | Micrus Modified MicroCoil
System |
|-----------------------------------------------------------------------------------------------------------|-------------------------------------------------------------|----------------------------------------------|------------------------------------|-------------------------------------|
| - Not provided as part
of the system, chosen
based upon physician
experience and
preference. | Micrus Sterile Connecting Cable | Micrus Sterile Connecting Cable | Same as predicates | |
| | Micrus Detachment Control Box | Micrus Detachment Control Box | Same as predicates | |
| | 5-7F Guide Catheter | 5-7F Guide Catheter* | Same as predicates | |
| | Microcatheter (see above)* | Microcatheter (see above)* | Same as predicates | |
| | Guide wire compatible with
microcatheter* | Guide wire compatible with
microcatheter* | Same as predicates | |
| | Continuous saline/heparin saline
flush* | Continuous saline/heparin saline
flush* | Same as predicates | |
| | Rotating haemostatic valves* | Rotating haemostatic valves* | Same as predicates | |
| | 3-Way stopcock* | 3-Way stopcock* | Same as predicates | |
| | 1-Way valve* | 1-Way valve* | Same as predicates | |
| | IV pole* | IV pole* | Same as predicates | |
| | Femoral Sheath* | Femoral Sheath* | Same as predicates | |
| | Alkaline Batteries* | Alkaline Batteries* | Same as predicates | |

This technological comparison demonstilly equivalent technologies used in the Micrus Morifed MicroCoil Delivery
System as compared with the 2 predicate MicroCoil Systems: (1)

KO33803 Page 10 of 14

10

iscussion of Non-Clinical Tests and Conclusio G.

The non-cinical tests periormed on the MicroColl System were based toe of the device, ite performan
the predicale devices Microcoll Delivery System and the Microchi System) a

he following table outlines the important device characteristics and the non-clinical test of also

Test	Micrus Modified MicroCoil System Test Result	Substantial Equivalence
Acute Animal Testing
V0327-acute outcome	Characteristic: Aneurysm occlusion and detachment reliability.
Test data: Coils detached with the first detachment cycle in > 95% of detachments and ≥90% aneurysm occlusion was obtained in all 5 aneurysms.	Substantially equivalent.
Chronic Animal Testing for
Coil Stability &
Aneurysm Occlusion
V0327-chronic outcome	Characteristic: Positional stability and aneurysm occlusion.
Test data: Positional stability and aneurysm occlusion maintained through 6 months of implant. No coil compaction present at 6-month angio. Histology showed chronic biocompatibility per study V0401.	Substantially equivalent.
Coil Stiffness/Softness for
Wide Pitch Modified
MicroCoils
V0396	Characteristic: Stiffness limits for the modified coils manufactured with a looser wind (wide pitch). No change was made that would affect the stiffness of the tightly wound coils.
Test data: The loosely wound (wide pitch) Helical and Spherical Modified MicroCoils met the stiffness specifications.	Substantially equivalent.
Friction in the Microcatheter
(Delivery Force)
V0429	Characteristic: Average push force must be substantially equivalent to predicates.
Test data: The Modified MicroCoil had average push forces that are comparable to those of the predicate.	Substantially equivalent.
Biocompatibility of Materials
V0401 & V0435	Characteristics: Meets the requirements of ISO 10993.
Test data: The only new material in the Micrus Modified MicroCoil is absorbable suture, which passed ISO 10993 biocompatibility testing.	Meets ISO 10993

Koss 811 Fire

11

Sterilization Validation	Characteristic:
V0394	Characteristic: Minimum Sterility Assurance Level of 10-6.
Test data: Passed minimum sterility assurance level of 10-6.	Substantially equivalent.
Shelf Life Test
V0397	Characteristic: No performance degradation after 3 year of shelf life aging.
Test data: Minimum tensile strength after 3 year accelerated aging shows no degradation.	Substantially equivalent
Tensile Strength: Stretch
Resistant Modified
MicroCoils (at the
detachment zone, PGA to
polypropylene junction and
suture ball tip to MicroCoil)
V0427	Characteristic: Pre-detachment tensile strength of the suture ball tip and MicroCoil to DPU must be substantially equivalent to the stretch resistant predicate.
Test data: Tensile strength meets desired strength criteria.	Substantially equivalent
to the stretch resistant
predicate
Tensile Strength: Non-
Stretch Resistant Modified
MicroCoils (at the
detachment zone)
V0398	Characteristic: Pre-detachment tensile strength of the MicroCoil to DPU must be substantially equivalent to the non-stretch resistant predicate.
Test data: Tensile strength meets desired strength criteria.	Substantially equivalent
to the non-stretch
resistant predicate
Tensile Strength: Non-
Stretch Resistant (at the
suture ball tip)
V0428	Characteristic: Pre-detachment tensile strength of the suture ball tip and MicroCoil must be substantially equivalent to the non-stretch resistant predicate.
Test data: Tensile strength meets desired strength criteria.	Substantially equivalent
to the non-stretch
resistant predicate
Durability (Reliability after
Fatigue)
V0405	Characteristic: Withstand deployment and retraction 6 times in a tortuous anatomy.
Test data: No knotting, no breakage, no stretching occurred. Durability meets desired durability criteria.	Substantially equivalent
MRI Compatibility of
Implant	No change was made which would impact MRI compatibility.	Substantially equivalent

KO358LS
July 17 of 14

f

12

Package Integrity	Characteristic: Demonstrate package integrity per ISO 11607	Meets ISO 11607 criteria
V0399	Test: Meets ISO 11607 criteria
Ship/Transit
V0400	Characteristic: Successfully withstand domestic and international
distribution environment
Test: Does successfully withstand domestic and international
distribution environment.	Substantially equivalent

This nor-clinical testing has demonstrated the substantially equivalent performance of the MicroColl System with the s
predicale devices: (1) Micrus MicroColl Delivery System

K033843
Page 13 of 14

13

KA33815
Page 14 of 14

Summary of Safety and Effectiveness H.

Based upon the design, materials, function, intended use, comparison with
currently market devices and the non-clinical testing performed by the many is
Corporation, it is co Delivery System in safety and effectiveness.

lik 1 ..............................................................................................................................................................................

Margaret Webber Director, Regulatory and Clinical Affairs Micrus Corporation December 5, 2003

14

DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/14/Picture/1 description: The image shows the text "Public Health Service" in a bold, sans-serif font. The text is black against a white background. The words are stacked on top of each other, with "Public" on the top line, "Health" on the second line, and "Service" on the third line.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Image /page/14/Picture/3 description: The image shows a partial view of a logo or emblem. The visible portion includes a stylized graphic element, possibly representing a natural form like a plant or wave, rendered in black. Adjacent to this graphic is a segment of text arranged in a circular fashion, also in black, suggesting the name or title of the organization or entity the logo represents. The text is oriented along the curve of a circle, indicating it is part of a larger circular design.

FEB - 4 2004

Ms. Margaret Webber Director, Regulatory and Clinical Affairs Micrus Corporation 610 Palomar Avenue Sunnyvale, California 94085

Re: K033813

Trade/Device Name: Micrus Modified Microcoil System, Cerecyte Regulation Number: 21 CFR 882.5950 Regulation Name: Artificial Embolization Device Regulatory Class: III Product Code: HCG Dated: December 5, 2003 Received: December 9, 2003

Dear Ms. Webber:

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 Mcdical 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.

If your device is classified (see above) into cither class II (Special Controls) or class III (PMA), it may be subject to such 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 not the Act or any liedcral 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); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the eccerver product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

15

Page 2 - Ms. Margarct Webber

This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), plcasc contact the Office of Compliance at (301) 594-4659. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). 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) 638-201 or 1 (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html

Sincerely yours,

Miriam C. Provost

(Celia M. Witten, Ph.D., M.D. Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

16

K035813

Indications for Use

510(k) Number (if known): K033813

Device Name:

Micrus Modified Microcoil System, Cerecyte

Indications For Use:

The Micrus MicroCoil Delivery System is intended for

endovascular embolization of intracranial aneurysms.

× Prescription Usc (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)

Muriam C. Provost

Division Sign-Off) Division of General, Restorative and Neurological Devices

10(%) Number_K633813

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