(488 days)
Not Found
No
The description focuses on a physical device (silicone balloon) and its mechanical function for embolization. There is no mention of software, algorithms, image processing, or any terms related to AI/ML.
Yes
The device is intended for artificial embolization of the internal carotid artery in patients with intracranial aneurysms, which is a medical intervention to treat a condition.
No
The device is described as an artificial embolization device, which is a therapeutic intervention, not a diagnostic one. Its purpose is to treat intracranial aneurysms by occluding arteries, not to identify or characterize a medical condition.
No
The device description clearly states it is a physical silicone balloon and catheter, indicating it is a hardware device, not software-only.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for the artificial embolization of the internal carotid artery, which is a therapeutic procedure performed in vivo (within the body).
- Device Description: The device is a physical object (a balloon) used to block a blood vessel in vivo.
- Lack of IVD Characteristics: There is no mention of the device being used to examine specimens derived from the human body (like blood, urine, tissue, etc.) to provide information for diagnosis, monitoring, or treatment.
IVD devices are used to perform tests in vitro (outside the body) on biological samples. This device is used in vivo for a therapeutic purpose.
N/A
Intended Use / 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.
Product codes (comma separated list FDA assigned to the subject device)
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
internal carotid artery
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): 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.
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
§ 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
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
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 neurosurqical 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
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 internal | |||
| carotid artery in | ||||
| presence of certain | ||||
| aneurysms | 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
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.
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,
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 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 .