(529 days)
No
The summary describes a physical medical device (a balloon) used for embolization and mentions only standard performance and biocompatibility testing, with no indication of software, image processing, or AI/ML components.
Yes
The device is used for "artificial embolization of symptomatic carotid cavernous fistulae," which is a treatment for a medical condition, making it a therapeutic device.
No
The device is used for artificial embolization, a treatment procedure, rather than for diagnosing a disease or condition.
No
The device description clearly states it consists of a silicone balloon and is a physical medical device used for embolization.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for "artificial embolization of symptomatic carotid cavernous fistulae". This is a therapeutic procedure performed in vivo (within the body) to block blood flow.
- Device Description: The device is a "silicone balloon which is inflated with contrast agent and detached via catheter at the desired site of embolization". This describes a medical device used for a therapeutic intervention, not for analyzing samples in vitro (outside the body).
- Lack of IVD Characteristics: The description does not mention any analysis of biological samples (blood, urine, tissue, etc.) or any diagnostic purpose. IVDs are used to diagnose diseases or conditions by examining these samples.
Therefore, this device is a therapeutic medical device, not an In Vitro Diagnostic.
N/A
Intended Use / 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.
Product codes
HBZ
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
carotid cavernous fistulae
Indicated Patient Age Range
Not Found
Intended User / Care Setting
neurosurgical management team
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)
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.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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).
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 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 |
. .
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 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)
(Division Sign-Off) Division of Cardiovascular, Res and Neurological Devices 8 96449 510(k) Number ________________________________________________________________________________________________________________________________________________________________