(171 days)
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.
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.
The provided document is a 510(k) summary for the Surgica Corporation MicroStat™ Polyvinyl Alcohol (PVA) Foam Embolization Particles. This type of submission is for medical devices and focuses on demonstrating substantial equivalence to a legally marketed predicate device, rather than proving efficacy through clinical studies with specific acceptance criteria or performance metrics in the way AI/ML devices might.
Therefore, the document explicitly states: "Clinical Tests: None". This means there was no study conducted in the typical sense for this submission to "prove the device meets acceptance criteria." Instead, the acceptance is based on demonstrating similarity to an already approved device.
Given this, a direct answer to your request regarding acceptance criteria and a study to prove they are met cannot be fully provided from the given document as it would for a performance-based medical device claim. However, I can infer and frame the information within the constructs you've provided, addressing the aspects that are relevant and noting where information is not available due to the nature of the submission.
Here's a breakdown based on your requested information, making clear what is present and what is absent:
Acceptance Criteria and Device Performance (Derived from Equivalence):
As no clinical tests were performed, there are no specific quantitative "acceptance criteria" and "reported device performance" in terms of clinical outcomes or diagnostic accuracy from a study described in this document. The "acceptance" for this 510(k) relies on demonstrating substantial equivalence to the predicate device.
| Acceptance Criterion (Inferent from Equivalence to Predicate) | Reported Device Performance (Inherited/Assumed from Predicate) |
|---|---|
| Safety: Device is non-pyrogenic, sterilized, and for single use. | Similar safety profile to the predicate EMB™ PVA Foam Embolization Particle devices (K001678). No adverse events reported for the new device. |
| Basic Design & Construction: Similar material (PVA foam), form (embolization particles), and delivery mechanism (superselective catheter delivery with fluoroscopic guidance). | Basic design and construction are similar to the predicate. |
| Intended Use: Vascular occlusion of blood vessels in neurovascular systems for AVMs and neoplastic lesions, for presurgical devascularization. | Performs similarly to the predicate for the stated vascular occlusion and embolization purposes. |
| Performance Characteristics: Obstructs or reduces blood flow to hypervascular or neoplastic lesions. Provided in various size ranges for selection. | Similar performance characteristics to the predicate device in terms of embolization efficacy. |
Study Information (Based on the provided document):
-
Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective):
- Not Applicable. No clinical test set or study was conducted for this 510(k) submission. Therefore, there's no data provenance information.
-
Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience):
- Not Applicable. No ground truth establishment was described as no clinical study was performed. The ground truth for the predicate device's approval would have been established at that time, but not for this specific 510(k).
-
Adjudication method (e.g. 2+1, 3+1, none) for the test set:
- Not Applicable. No test set or study, hence no adjudication method.
-
If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:
- Not Applicable. This device is a physical medical implant (PVA foam embolization particles), not an AI/ML diagnostic or assistive device. Therefore, no MRMC study or AI assistance is relevant.
-
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Not Applicable. This is not an algorithm or software device.
-
The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- Not Applicable (for this submission). For the approval of this device, the "ground truth" was essentially the established safety and effectiveness of the predicate device (EMB™ PVA Foam Embolization Particle devices, K001678) demonstrated through its previous approval.
-
The sample size for the training set:
- Not Applicable. No AI/ML model or training set is involved.
-
How the ground truth for the training set was established:
- Not Applicable. No AI/ML model or training set is involved.
Summary of the K032619 Submission:
The approval of the Surgica Corporation MicroStat™ Polyvinyl Alcohol Fourn Embolizaion Particles (K032619) was based on demonstrating substantial equivalence to an existing predicate device (EMB™ PVA Foam Embolization Particle devices, K001678). This means the new device shares similar basic design, construction, intended use, and performance characteristics with the predicate. Because of this, no new clinical studies or tests were required or performed to establish "acceptance criteria" or "device performance" for this specific submission. The safety and effectiveness are inferred from the predicate's prior approval.
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FFB 1 3 2004
K032619
Page 1 of 1
Special 510(k) Summary
| Contact Information: | Surgica Corporation5090 Robert J. Mathews Pkwy., #4El Dorado Hills, CA 95762Telephone: 1(916) 933-5056Facsimile: 1(916) 933-5260Contact 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
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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.
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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
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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)
§ 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).