(171 days)
Not Found
No
The summary describes a physical embolization device and its intended use, with no mention of software, algorithms, or AI/ML capabilities.
Yes
The device is described as an artificial embolization device used to obstruct or reduce blood flow to lesions, which are therapeutic interventions.
No
The device, Surgica Corporation MicroStat™ PVA Foam Embolization Particles, is described as an artificial embolization device used to obstruct or reduce blood flow, which is a therapeutic function, not a diagnostic one.
No
The device description clearly states it is a physical product, "Polyvinyl Alcohol (PVA) foam cmbolization particles," and describes its physical properties and delivery method. It is not a software-only device.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices used to examine specimens taken from the human body (like blood, urine, or tissue) to provide information about a person's health. This testing is done outside of the body (in vitro).
- Device Function: The Surgica Corporation MicroStat™ PVA Foam Embolization Particles are designed to be delivered into the body (in vivo) to physically block blood vessels. They are a therapeutic device, not a diagnostic one.
- Intended Use: The intended use clearly states they are for "vascular occlusion of blood vessels within the neurovascular systems" and "endovascular management of arteriovenous malformations (AVMs) and neoplastic lesions." This is a treatment, not a diagnostic test.
- Device Description: The description details how the particles are delivered via catheter and obstruct blood flow. This is an in-body intervention.
The device is an implantable medical device used for therapeutic purposes.
N/A
Intended Use / Indications for Use
The MicroStat™ Surgica Corporation Polyvinyl Alcohol Foam Embolizaion Particles may be used for vascular occlusion of blood vessels within the neurovascular systems. They are in the endovascular management of arteriovenous malformations (AVMs) and neoplastic lesions when presurgical devascularization is desirable.
Product codes (comma separated list FDA assigned to the subject device)
HCG
Device Description
Surgica Corporation MicroStat™ Polyvinyl Alcohol (PVA) foam cmbolization particles are artificial embolization devices used to obstruct or reduce the blood flow to hypervascular or neoplastic lesions via superselective catheter delivery. The embolization particles are supplied in various size ranges to enable appropriate size selection for the lesion to be treated. Polyviny) Alcohol (PVA) foam embolization particles are designed to be delivered under fluoroscopic guidance through compatible infusion catheters. The product is delivered sterilized with radiation, is nonpyrogenic, and is for single use only.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
neurovascular systems
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)
None
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
FFB 1 3 2004
K032619
Page 1 of 1
Special 510(k) Summary
| Contact Information: | Surgica Corporation
5090 Robert J. Mathews Pkwy., #4
El Dorado Hills, CA 95762
Telephone: 1(916) 933-5056
Facsimile: 1(916) 933-5260
Contact Person: Lou Matson |
|----------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Trade Name: | MicroStat™ Polyvinyl Alcohol Foam Embolization Particles |
| Common Name: | PVA Foam Embolization Particles |
| Classification Name: | Artificial Embolization Device |
| Device Product Code: | HCG |
| Regulation Number: | 882.5950 |
Substantial Equivalence: The Surgica Corporation MicroStaTM Polyvinyl Alcohol Fourn Embolizaion Particles are similar in their basic design, construction for use, and performance characteristics to other commercially available polyvinyl alcohol particles.
Device Description: Surgica Corporation MicroStat™ Polyvinyl Alcohol (PVA) foam cmbolization particles are artificial embolization devices used to obstruct or reduce the blood flow to hypervascular or neoplastic lesions via superselective catheter delivery. The embolization particles are supplied in various size ranges to enable appropriate size selection for the lesion to be treated. Polyviny) Alcohol (PVA) foam embolization particles are designed to be delivered under fluoroscopic guidance through compatible infusion catheters. The product is delivered sterilized with radiation, is nonpyrogenic, and is for single use only.
Indications For Use: The MicroStat™ Surgica Corporation Polyvinyl Alcohol Foam Embolizaion Particles may be used for vascular occlusion of blood vessels within the neurovascular systems. They are in the endovascular management of arteriovenous malformations (AVMs) and neoplastic lesions when presurgical devascularization is desirable.
Predicate Devices: The EMB™ PVA Foam Embolization Particle devices marketed by Surgica Corporation (K001678) is the predicate device for the Surgica Corporation MicroStat™ Polyvinyl Foam Embolizaion Particles.
Clinical Tests: None
Adverse S&E Information: None
Louies K. Miotti
Louis R. Matson President & C.E.O.
8-19-03
Date
1
Image /page/1/Picture/1 description: The image shows the logo for the Department of Health & Human Services - USA. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is an emblem featuring a stylized representation of three human figures, possibly symbolizing health, family, and community.
Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
FEB 1 3 2004
Mr. Louis R. Matson President & CEO Surgica Corporation 5090 Robert J. Mathews Pkwy., #4 El Dorado Hills, California 95762
Re: K032619
Trade/Device Name: PVA Foam Embolization Particles Regulation Number: 21 CFR 882.5950 Regulation Name: Artificial embolization device Regulatory Class: III Product Code: HCG Dated: January 15, 2004 Received: January 16, 2004
Dear Mr. Matson:
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 cither 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.
2
Page 2 - Mr. Louis R. Matson
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 (301) 594-4659. 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/dsma/dsmamain.html
Sincerely yours.
Miriam C. Provoost
C
Celia M. Witten, Ph.D., M.D. Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
3
510(k) Number (if known):_
Device Name: PVA Foam Embolization Particles
Indications For Use:
The Surgica Corporation MicroStat™ PVA Foam Embolization Particles are intended for the following indication:
PVA particles may be used for vascular occlusion of blood vessels within the neurovascular systems. They are intended for use in the endovascular management of arteriovenous malformations (AVMs) and neoplastic lesions when presurgical devascularization is desirable.
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE) miriam C. Movert (Division Sign-Off) Division of General, Restorative, and Neurological Devices 510(k) Number_4033 k19 OR Over-The-Counter Use_ Prescription Use (Per 21 CFR 801.109)
(Optional Format 1-2-96)