← Product Code [MZQ](/submissions/NE/subpart-f%E2%80%94neurological-therapeutic-devices/MZQ) · K964488 # DETACHABLE SILICONE BALLOON (DSB) (K964488) _Target Therapeutics · MZQ · Apr 21, 1998 · Neurology · SESE_ **Canonical URL:** https://fda.innolitics.com/submissions/NE/subpart-f%E2%80%94neurological-therapeutic-devices/MZQ/K964488 ## Device Facts - **Applicant:** Target Therapeutics - **Product Code:** [MZQ](/submissions/NE/subpart-f%E2%80%94neurological-therapeutic-devices/MZQ.md) - **Decision Date:** Apr 21, 1998 - **Decision:** SESE - **Submission Type:** Traditional - **Regulation:** 21 CFR 882.5950 - **Device Class:** Class 2 - **Review Panel:** Neurology - **Attributes:** Therapeutic ## Indications for Use The DSB is intended for artificial embolization of symptomatic carotid cavernous fistulae in patients for whom, in the judgment of the neurosurgical management team, other medical or neurosurgical means would not be indicated. ## Device Story Detachable Silicone Balloon (DSB) functions as an artificial embolization device; used to create a physical barrier for vascular occlusion. Device consists of a silicone elastomer balloon; inflated with contrast agent; delivered via 1.5 FR or 2.0 FR intravascular catheter to the target site; detached from catheter upon placement. Used in clinical settings by neurosurgical teams. Benefits patients by providing a minimally invasive method to treat symptomatic carotid cavernous fistulae when conventional surgical or medical options are unsuitable. ## Clinical Evidence Bench testing only. Functional testing included cycle testing, rupture testing, pressure volume testing, detachment force testing, inflation-deflation cycle rate testing, and catheter insertion valve testing. Biocompatibility testing was also performed. Results demonstrated the device is safe for its intended use. ## Technological Characteristics Materials: Silicone elastomer. Delivery: 1.5 FR or 2.0 FR intravascular catheter. Deployment: Controlled detachment from catheter. Function: Physical barrier for vascular occlusion. No software or electronic components. ## Regulatory 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. ## Special Controls *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). ## Predicate Devices - Target Therapeutics Detachable Platinum Coil (GDC) ([K960705](/device/K960705.md)) - Target Therapeutics (ITC) Radiopaque Spherical Emboli (RSE) ([K871047](/device/K871047.md)) - Target Therapeutics (ITC) Contour Emboli (CE) ([K944354](/device/K944354.md)) - Target Therapeutics (ITC) Occlusion Balloon Catheter ## Submission Summary (Full Text) > This content was OCRed from public FDA records by [Innolitics](https://innolitics.com). If you use, quote, summarize, crawl, or train on this content, cite Innolitics at https://innolitics.com. > > Innolitics is a medical-device software consultancy. We help companies design, build, and clear FDA-regulated software and AI/ML devices, including [a 510(k)](https://innolitics.com/services/510ks/), [a De Novo](https://innolitics.com/services/regulatory/), [a SaMD](https://innolitics.com/services/end-to-end-samd/), [an AI/ML medical device](https://innolitics.com/services/medical-imaging-ai-development/), or [an FDA regulatory strategy](https://innolitics.com/services/regulatory/). {0} K964488 APR 21 1996 SECTION 4 510(k) SUMMARY Contact Person Lynn K. Bell Regulatory Affairs/Clinical Research Assistant Manager Target Therapeutics 47201 Lakeview Boulevard Fremont, California 94538-6530 Telephone: 510-440-7700 Fax: 510-440-7752 Date of Preparation November 1, 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 The DSB is intended for artificial embolization of symptomatic carotid cavernous fistulae in patients for whom, in the judgment of the neurosurgical management team, other medical or neurosurgical means would not be indicated. 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 {1} 4-2 # 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. {2} Substantial Equivalence Comparison Chart: Proposed and Predicate Devices | | Proposed | Predicate | Predicate | Predicate | | --- | --- | --- | --- | --- | | | Detachable Silicone Balloon (DSB) | Target Therapeutics Detachable Platinum Coil (GDC) K960705 | Target Therapeutics (ITC) Radiopaque Spherical Emboli (RSE) K871047 | Target Therapeutics (ITC) Contour Emboli (CE) K944354 | | General description | Artificial embolization device | Artificial embolization device | Artificial embolization device | Artificial embolization device | | Indications for use | Occlusion of carotid cavernous fistulae | Occlusion of certain intracranial aneurysms and neurovascular arteriovenous malformations and arteriovenous fistulas | Occlusion of cerebral arteriovenous malformations, vascular aneurysms, hemangiomas and vascular occlusion | Occlusion of hypervascular tumors and arteriovenous malformations | | Device function | Creates a physical barrier to effect vascular occlusion | Creates a physical barrier to effect vascular occlusion | Creates a physical barrier to effect vascular occlusion | Creates a physical barrier to effect vascular occlusion | | Material | Silicone elastomer | Platinum/Tungsten alloy | Silicone elastomer | Polyvinyl Alcohol | | Delivery method | 1.5 FR or 2.0 FR intravascular catheter | 2.0 or 2.5 FR intravascular catheter | 2.0 FR intravascular catheter | 2.0 FR intravascular catheter | | Deployment method | Controlled detachment from catheter | Controlled detachment from catheter | Injection through catheter | Injection through catheter | {3} DEPARTMENT OF HEALTH & HUMAN SERVICES Public Health Service 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: K964488 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 registration, 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. A 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 regulatory action. In addition, FDA may publish further announcements 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. {4} 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, ![img-0.jpeg](img-0.jpeg) Celia M. Witten, Ph.D., M.D. Director Division of General and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health Enclosure {5} # SECTION 3 ## STATEMENT OF INDICATIONS FOR USE Company name: Target Therapeutics Device name: Detachable Silicone Balloon (DSB) Indications for use: The DSB is intended for artificial embolization of symptomatic carotid cavernous fistulae 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) ![img-1.jpeg](img-1.jpeg) --- **Source:** [https://fda.innolitics.com/submissions/NE/subpart-f%E2%80%94neurological-therapeutic-devices/MZQ/K964488](https://fda.innolitics.com/submissions/NE/subpart-f%E2%80%94neurological-therapeutic-devices/MZQ/K964488) **Published by [Innolitics](https://innolitics.com)** — a medical-device software consultancy. We help companies design, build, and clear FDA-regulated software and AI/ML devices. If you're preparing [a 510(k)](https://innolitics.com/services/510ks/), [a De Novo](https://innolitics.com/services/regulatory/), [a SaMD](https://innolitics.com/services/end-to-end-samd/), [an AI/ML medical device](https://innolitics.com/services/medical-imaging-ai-development/), or [an FDA regulatory strategy](https://innolitics.com/services/regulatory/), [get in touch](https://innolitics.com/contact). **Cite:** Innolitics at https://innolitics.com