(281 days)
Not Found
No
The 510(k) summary describes physical embolization particles and their delivery method. There is no mention of software, algorithms, or any technology that would suggest the use of AI or ML. The "Mentions AI, DNN, or ML" section explicitly states "Not Found".
Yes
The device is described as an "artificial embolization device" intended for "permanent embolization of hypervascular lesions and arteriovenous malformations (AVMs)," which directly addresses a medical condition for therapeutic purposes.
No
Explanation: The device is an embolization particle used for treating hypervascular tumors and AVMs, which is a therapeutic purpose, not a diagnostic one. While it is delivered under fluoroscopic guidance, the device itself does not perform any diagnostic function.
No
The device description clearly states that the device is comprised of "artificial embolization devices" which are physical particles, not software.
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 embolization of hypervascular tumors and arteriovenous malformations (AVMs). This is a therapeutic procedure performed within the body to block blood vessels.
- Device Description: The device is described as artificial embolization particles delivered via catheter. This is a medical device used for treatment, not for analyzing samples outside the body.
- IVD Definition: In Vitro Diagnostics (IVDs) are devices used to examine specimens, including blood, tissue, and urine, from the human body to provide information for diagnosis, monitoring, or screening. This device does not fit this description.
The device is a therapeutic medical device used for embolization.
N/A
Intended Use / Indications for Use
Ultra IVALON and Ultra DRIVALON PVA Embolization Particles are intended for the embolization of hypervascular tumors and arteriovenous malformations (AVMs).
Product codes (comma separated list FDA assigned to the subject device)
HCG, KRD
Device Description
Ultra IVALON and Ultra DRIVALON PVA Embolization Particles are artificial embolization devices used for permanent embolization of hypervascular lesions and arteriovenous malformations (AVMs) via superselective catheter delivery. The embolization particles are supplied in various size ranges to enable appropriate size selection for the lesion to be treated. Ultra IVALON and Ultra DRIVALON PVA Embolization Particles are designed to be delivered under fluoroscopic guidance through compatible infusion/delivery catheters.
Ultra IVALON PVA Embolization Particles are suspended in 0.9% saline (NaCI) solution. Uttra DRIVALON PVA Embolization Particles are packaged in a dry form. Each unit contains 0.1g of particles.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
fluoroscopic guidance
Anatomical Site
hypervascular tumors and arteriovenous malformations (AVMs)
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
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)
Testing has shown the subject device to be safe and effective 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
K042297 ps. lot 2
JUN 1 - 2005
Abbreviated 510(k) Premarket Notification Ultra IVALON and Ultra DRIVALON PVA Embolization Paticies
510(k) Summary IV.
This summary of safety and effectiveness is being submitted in accordance with the requirements of the Safe Medical Devices Act of 1990 and 21 CFR §807.92.
A. Date Prepared
August 12, 2004
B. General Information
Manufacturer: Acta Vascular Systems, Inc. 247 Marchmont Drive Los Gatos, CA 95032
Contact: Richard M. Ruedy Vice President, Regulatory and Clinical Affairs and Quality Systems (408) 828-7281 phone (408) 748-1642 fax
C. Device Information
760112
| Common, Usual or Classification Name: | Artificial Embolization Device |
|---|---|
| Device Classification: | III |
| Product Code: | HCG |
| Classification Regulation: | 21 CFR §882.5950 |
D. Predicate Device Identification
1000 -1180
| Product
(Trade
Name) | Manufacturer | 510(k) Premarket
Notification
Number and Date | Intended Use |
|-----------------------------|----------------------------------------------------------------------------|-----------------------------------------------------|------------------------------------------------------------------------------------------------------------|
| Contour
PVA
Particles | Interventional
Therapeutics/Target
Therapeutics/Boston
Scientific | K944354
December 13, 1994 | This device is intended for
embolization of hypervascular
tumors and arteriovenous
malformations. |
Contour PVA Particles are available in the following configurations ! Order No. Particle Size (μm) 760012 45 –150 760022 150 - 250 760032 250 - 355 760042 355 - 200 760062 500 - 710 760082 710 -1000
1 Particle sizes were obtained from the Product Information sheet published by the manufacturer.
1
042297 ps. dofa
Abbreviated 510(k) Premarket Notification Ultra IVALON and Ultra DRIVALON PVA Embolization Particles
Intended Use E.
Ultra IVALON and Ultra DRIVALON PVA Embolization Particles are intended for the embolization of hypervascular turnors and arteriovenous malformations (AVMs).
F. Product Description
Ultra IVALON and Ultra DRIVALON PVA Embolization Particles are artificial embolization devices used for permanent embolization of hypervascular lesions and arteriovenous malformations (AVMs) via superselective catheter delivery. The embolization particles are supplied in various size ranges to enable appropriate size selection for the lesion to be treated. Ultra IVALON and Ultra DRIVALON PVA Embolization Particles are designed to be delivered under fluoroscopic guidance through compatible infusion/delivery catheters.
Ultra IVALON PVA Embolization Particles are suspended in 0.9% saline (NaCI) solution. Uttra DRIVALON PVA Embolization Particles are packaged in a dry form. Each unit contains 0.1g of particles.
| Catalog Number | Size Range | Compatible Catheter Inner Diameter |
|---|---|---|
| UI001 and UD001 | 50 - 150 μm | 0.018" |
| UI002 and UD002 | 150 - 250 μm | 0.018" |
| UI003 and UD003 | 250 - 400 μm | 0.018" |
| UI004 and UD004 | 400 - 600 μm | 0.025" |
| UI005 and UD005 | 600 - 1000 μm | 0.044" |
Substantial Equivalence G.
The subject device is equivalent in intended use, design, and technological characteristics to the predicate devices listed above.
H. Non-clinical Test Results
Testing has shown the subject device to be safe and effective for its intended use.
. Summary
New York Callery
Based on the information provided in this notification, the subject device is substantially equivalent to the predicate devices in intended use, technological characteristics, and design.
J. Signature of Preparer
Richard M. Ruedy
Richard M. Ruedy Vice President, Regulatory and Clinical Affairs and Quality Systems Acta Vascular Systems, Inc.
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JUN 1 - 2005
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Mr. Richard M. Ruedy Vice President, Regulatory and Clinical Affairs and Quality Systems Acta Vascular Systems Incorporated 247 Marchmont Drive Los Gatos, California 95032
Re: K042297
Trade/Device Name: Ultra IVALON and Ultra DRIVALON PVA Embolization Particles Regulation Number: 21 CFR 882. 5950 Regulation Name: Artificial embolization device Regulatory Class: II Product Code: HCG, KRD Dated: March 30, 2005 Received: April 1, 2005
Dear Mr. Ruedy:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate 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) that do not require approval of a premarket approval application (PMA). 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 (PMA), 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 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
3
Page 2- Mr. Richard M. Ruedy
This letter will allow you to begin marketing your device as described in your Section 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), please contact the Office of Compliance at (240) 276-0115 . Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours,
Miriam C. Provost, Ph
Miriam C. Provost, Ph.D. Acting Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Acta Vascular
Abbreviated 510(k) Premarket Notification
Ultra IVALON and Ultra DRIVALON PVA Embolization Particles
II. Statement of Indications for Use
Indications for Use
| 510(k) Number (if known): | |
|---|---|
| Device Name: | Ultra IVALON and Ultra DRIVALON PVA Embolization Particles |
| Indications for Use: |
Ultra IVALON and Ultra DRIVALON PVA Embolization Particles are intended for the embolization of hypervascular tumors and arteriovenous malformations (AVMs).
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
| Prescription Use | OR | Over-The Counter Use |
|---|---|---|
| (Per 21 CFR 801.109) | (Optional Format 1-2-96) |
Division of General, Restorative
and Neurological Devices
4