The Detachable Silicone Balloon (DSB) is intended for artificial embolization of the internal carotid artery in the presence of certain intracranial aneurysms in patients for whom, in the judgment of the neurosurgical management team, other medical or neurosurgical means would not be indicated.

Device Description

The DSB consists of a silicone balloon which is inflated with contrast agent and detached via catheter at the desired site of embolization.

AI/ML Overview

This is not an AI/ML device, therefore, the mentioned acceptance criteria and studies are not applicable.

The Detachable Silicone Balloon (DSB) is a medical device for artificial embolization. Device testing included biocompatibility testing and functional bench testing. Functional bench testing included cycle testing, rupture testing, pressure-volume testing, detachment force testing, inflation-deflation cycle rate testing, and catheter insertion valve testing. The results of these tests demonstrated the DSB to be safe for its intended use.

This device was determined to be substantially equivalent to predicate devices based on intended use, materials, manufacturing, design parameters, method of delivery, and method of deployment.

Summary

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1965071

SECTION 4 510(k) SUMMARY

Contact Person Lynn K. Bell Requlatory Affairs/Clinical Research Assistant Manager Target Therapeutics 47201 Lakeview Boulevard Fremont, California 94538-6530 Telephone: 510-440-7700 Fax: 510-440-7752

APR 21 1998

Date of Preparation

November 14, 1996

Device Name

Detachable Silicone Balloon (DSB) Artificial Embolization Device (21 CFR 882.5950)

Device Description

The DSB consists of a silicone balloon which is inflated with contrast agent and detached via catheter at the desired site of embolization.

Indications for Use

Device Testing

Biocompatibility testing was performed and the results demonstrated the device to be safe for its intended use.

Functional bench testing included cycle testing, rupture testing, pressure volume testing, detachment force testing, inflation-deflation cycle rate testing and catheter insertion valve testing. The results of these tests demonstrated the DSB to be safe for its intended use.

4-1

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Predicate Devices

Target Therapeutics Detachable Platinum Coil (GDC) .
Target Therapeutics (ITC) Radiopaque Spherical Emboli .
Target Therapeutics (ITC) Contour Emboli .
Target Therapeutics (ITC) Occlusion Balloon Catheter .

Intended use, materials, manufacturing, design parameters, method of delivery and method of deployment of the DSB are equivalent, if not identical, to the predicate devices, rendering the DSB substantially equivalent.

Please refer to the comparison chart on page 4-3.

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Substantial Equivalence Comparison Chart: Proposed and Predicate Devices

	Proposed	Predicate	Predicate	Predicate
	Detachable SiliconeBalloon (DSB)	Target TherapeuticsDetachablePlatinum Coil (GDC)K960705	Target Therapeutics(ITC) RadiopaqueSpherical Emboli(RSE)K871047	Target Therapeutics(ITC)Contour Emboli(CE)K944354
General description	Artificial embolizationdevice	Artificial embolizationdevice	Artificial embolizationdevice	Artificial embolizationdevice
Indications for use	Occlusion of internalcarotid artery inpresence of certainaneurysms	Occlusion of certainintracranialaneurysms andneurovasculararteriovenousmalformations andarteriovenous fistulas	Occlusion of cerebralarteriovenousmalformations,vascular aneurysms,hemangiomas andvascular occlusion	Occlusion ofhypervascular tumorsand arteriovenousmalformations
Device function	Creates a physicalbarrier to effectvascular occlusion	Creates a physicalbarrier to effectvascular occlusion	Creates a physicalbarrier to effectvascular occlusion	Creates a physicalbarrier to effectvascular occlusion
Material	Silicone elastomer	Platinum/Tungstenalloy	Silicone elastomer	Polyvinyl Alcohol
Delivery method	1.5 FR or 2.0 FRintravascularcatheter	2.0 or 2.5 FRintravascularcatheter	2.0 FR intravascularcatheter	2.0 FR intravascularcatheter
Deployment method	Controlleddetachment fromcatheter	Controlleddetachment fromcatheter	Injection throughcatheter	Injection throughcatheter

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Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of the department's name arranged in a circular fashion around a stylized eagle. The eagle is depicted with three profiles, suggesting a sense of forward movement and progress. The logo is rendered in black and white.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

APR 21 1998

Ms. Roxane K. Baxter ·Manager, Regulatory Affairs Target Therapeutics Incorporated 47201 Lakeview Boulevard Fremont, California 94538-6530

Re: K965071 Trade Name: Detachable Silicone Balloon (DSB) Regulatory Class: III Product Code: HBZ Dated: January 20, 1998 Received: January 21, 1998

Dear Ms. Baxter:

We have reviewed your-Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to 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). 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 reqistration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.

If your device is classified (see above) into either class II (Special Controls) or class III (Premarket Approval), 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 895. ਸ substantially equivalent determination assumes compliance with the current Good Manufacturing Practice requirement, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic (QS) inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in requlatory In addition, FDA may publish further announcements action. concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.

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Page 2 - Ms. Baxter

This letter will allow you to begin marketing your device as described in your 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 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4595. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its internet address "http://www.fda.gov/cdrh/dsmamain.html".

Sincerely yours,

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

Enclosure

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SECTION 3 STATEMENT OF INDICATIONS FOR USE

Company name: Target Therapeutics Detachable Silicone Balloon (DSB) Device name: Indications for use: The Detachable Silicone Balloon (DSB) is intended for artificial embolization of the internal carotid artery in the presence of certain intracranial aneurysms in patients for whom, in the judgment of the neurosurgical management team, other medical or neurosurgical means would not be indicated.

Prescription Use
(Per 21 CFR 801.109)

Acolla

(Division Sign-Off) Division of Cardiovascular, Respiratory, and Neurological Devices . . . . K965071 510(k) Number .

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).