(529 days)
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.
The DSB consists of a silicone balloon which is inflated with contrast agent and detached via catheter at the desired site of embolization.
The provided document describes the FDA 510(k) submission for the Detachable Silicone Balloon (DSB) Artificial Embolization Device. The submission focuses on establishing substantial equivalence to predicate devices rather than presenting a performance study with acceptance criteria in the typical sense of a clinical trial for AI/software devices. Therefore, much of the requested information regarding acceptance criteria, sample sizes, expert involvement, and ground truth for an AI-like device is not applicable to this 1998 medical device submission.
Here's a breakdown based on the available information:
1. Table of Acceptance Criteria and Reported Device Performance
The device testing mentioned in the document is primarily bench testing and biocompatibility testing, not performance metrics based on clinical outcomes relevant to AI. Acceptance criteria are implied by successful completion of these tests to demonstrate safety and functional validity for its intended use and substantial equivalence to predicate devices. Specific quantitative acceptance criteria or reported device performance in a clinical context were not provided in detail.
| Criteria Category | Details from Document | Performance Demonstrated |
|---|---|---|
| Biocompatibility | Performed | Safe for intended use |
| Functional Bench Testing (implied acceptance: successful operation) | Cycle testing | Safe for intended use |
| Rupture testing | Safe for intended use | |
| Pressure volume testing | Safe for intended use | |
| Detachment force testing | Safe for intended use | |
| Inflation-deflation cycle rate testing | Safe for intended use | |
| Catheter insertion valve testing | Safe for intended use |
2. Sample Size for the Test Set and Data Provenance
Not applicable. The submission describes bench testing and biocompatibility testing, not a clinical study with a "test set" of patient data in the context of an AI device.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications of Those Experts
Not applicable. This is not a study involving expert review of images or data for ground truth establishment.
4. Adjudication Method for the Test Set
Not applicable.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
Not applicable. This is not an AI device, and no MRMC study was conducted.
6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study
Not applicable. This is a physical medical device, not an algorithm.
7. Type of Ground Truth Used
The "ground truth" for this device's safety and effectiveness relies on successful completion of biocompatibility and functional bench tests, and the demonstration of substantial equivalence to existing predicate devices. This is a regulatory pathway, not a data-driven ground truth for an AI algorithm.
8. Sample Size for the Training Set
Not applicable. There is no AI model or "training set" for this physical device.
9. How the Ground Truth for the Training Set Was Established
Not applicable.
Summary of Relevant Information from the Document:
- Device Name: Detachable Silicone Balloon (DSB) Artificial Embolization Device
- Intended Use: Artificial embolization of symptomatic carotid cavernous fistulae in patients for whom other medical or neurosurgical means would not be indicated.
- Testing Performed:
- Biocompatibility testing
- Functional bench testing: cycle testing, rupture testing, pressure volume testing, detachment force testing, inflation-deflation cycle rate testing, and catheter insertion valve testing.
- Outcome of Testing: Demonstrated the device to be safe for its intended use.
- Regulatory Pathway: 510(k) premarket notification, where the primary focus is demonstrating substantial equivalence to legally marketed predicate devices.
- Predicate Devices:
- Target Therapeutics Detachable Platinum Coil (GDC)
- Target Therapeutics (ITC) Radiopaque Spherical Emboli (RSE)
- Target Therapeutics (ITC) Contour Emboli (CE)
- Target Therapeutics (ITC) Occlusion Balloon Catheter (mentioned conceptually, but not in the detailed comparison)
- Substantial Equivalence: Claimed based on equivalence/identity in intended use, materials, manufacturing, design parameters, method of delivery, and method of deployment to the predicate devices. The comparison chart specifically details similarities in general description, indications, device function, material (though DSB is silicone, GDC is platinum/tungsten, RSE is silicone, CE is Polyvinyl Alcohol), delivery, and deployment methods.
This document clearly outlines a 510(k) submission for a physical medical device, not a software or AI-driven device. Therefore, the questions tailored for AI/software performance studies do not directly apply.
{0}------------------------------------------------
APR 21 1998
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.
{1}------------------------------------------------
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}------------------------------------------------
| 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 carotidcavernous fistulae | 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 |
. .
and the control consisted
Substantial Equivalence Comparison Chart: Proposed and Predicate Devices
{3}------------------------------------------------
Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle or bird design formed by three curved lines, representing the department's mission of protecting the health of all Americans and providing essential human services. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" are arranged in a circular pattern around the bird symbol. The logo is 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: K96488 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. ਸੇ 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,
Cola M. Whitten, Ph.D., M.
Witten, Ph.D., M.D. la M. 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 symptomaticcarotid cavernous fistulae in patients for whom, in the judgmentof the neurosurgical management team, other medical orneurosurgical means would not be indicated. |
Prescription Use
(Per 21 CFR 801.109)
(Division Sign-Off) Division of Cardiovascular, Res and Neurological Devices 8 96449 510(k) Number ________________________________________________________________________________________________________________________________________________________________
§ 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).