(85 days)
Not Found
No
The device description and intended use focus on the physical properties and delivery method of PVA particles for embolization, with no mention of AI or ML capabilities. The "Mentions AI, DNN, or ML" field is explicitly marked as "Not Found".
Yes.
The device is used for arterial embolization and vascular occlusion to treat medical conditions like AVMs and hypervascular tumors, which describes therapeutic action aimed at treating or alleviating a disease or condition.
No
The device, PVA particles, is used for arterial embolization and vascular occlusion, which are therapeutic procedures, not diagnostic ones. Its purpose is to treat conditions (AVMs, hypervascular tumors), not to identify or characterize them.
No
The device description clearly states the device is made of physical particles (polyvinyl alcohol foam) and is delivered via a syringe and catheter, indicating it is a physical medical device, 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 arterial embolization and vascular occlusion within the neurovascular and peripheral vascular systems. This is a therapeutic procedure performed directly on the patient's body.
- Device Description: The device is a physical particle delivered through a catheter to block blood vessels. It is not used to examine specimens from the human body.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue, etc.), detecting analytes, or providing diagnostic information based on in vitro testing.
IVD devices are used to examine specimens from the human body to provide information for diagnosis, monitoring, or screening. This device is a therapeutic embolization agent used in a surgical/interventional procedure.
N/A
Intended Use / Indications for Use
PVA Plus™, MaxiStat™, and MicroStat™ PVA Foam Embolization Particles may be used for vascular occlusion of blood vessels within the neurovascular and peripher a vascular system. They are intended for arterial embolization of arteriovenous malformations (AVMs) and hypervascular turnors in the peripheral vasculature, and for vascular occlusion of blood vessels within the neurovascular system for the embolization of AVMs and neoplastic lesions.
Product codes (comma separated list FDA assigned to the subject device)
KRD, HCG
Device Description
The subject devices are particles of nonabsorbable synthetic polyvinyl alcohol (PVA) foam. The devices do not contain any colorant or other additive, and are uncol ted. Each is offered in a range of particle sizes, from which the clinician may saleot the particle size most appropriate for the desired effect and targeted vasculature. The devices are delivered to the selected vascular location by means of a syringe, through an infusion catheter of diameter appropriate for the selected particle size. The subject devices are manufactured for PPT by Surgica Corporation, 5090 Robert J. Matthews Parkway, No. 4, El Dorado Hills, CA 95762.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
blood vessels within the neurovascular and peripher a vascular system
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)
Nonclinical tests, both in vitro and in vivo, have demonstrated the substantial equivalence of the subject devices to commercially-available predicates in terms of performance.
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.
K053548, K034068, K030966, K021397
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
§ 870.3300 Vascular embolization device.
(a)
Identification. A vascular embolization device is an intravascular implant intended to control hemorrhaging due to aneurysms, certain types of tumors (e.g., nephroma, hepatoma, uterine fibroids), and arteriovenous malformations. This does not include cyanoacrylates and other embolic agents, which act by polymerization or precipitation. Embolization devices used in neurovascular applications are also not included in this classification, see § 882.5950 of this chapter.(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 § 870.1(e).
0
5.0 510(k) SUMMARY
In accordance with Title 21 of the Code of Federal Regulations Part 807 (21 CFR §807), and in particular §807.92, the following summary of safety and effectiveness information is provided:
SEP 1 9 2006
5.1 Submitted By
Protein Polymer Technologies, Inc. (PPTI) 10655 Sorrento Valley Road, San Diego, California 92121 Telephone: (858) 558-6064
Radine Ganz Pobuda, RAC Contact: Director, Quality Systems & Regulatory Affairs
Date Prepared: May 5, 2006
5.2 Device Name
| Trade or Proprietary Names: | PVA Plus ™ Foam Embolization Particles | |
|---|---|---|
| MaxiStat ™ PVA Foam Embolization Particles | ||
| MicroStat ™ PVA Foam Embolization Particles | ||
| Common or Usual Name: | Polyvinyl alcohol (PVA) foam embolization particles | |
| Classification Name: | Vascular embolization device |
ર્ટ.૩ Predicate Devices
The subject devices are substantially equivalent to the following predicate devices:
- PVA Plus™ Foam Embolization Particles (PPTI; K053548) .
- . MaxiStar™ PVA Foam Embolization Particles (PPTI; K053548)
- MicroStat™ PVA Foam Embolization Particles (PPTI; K053548) .
- Contour SETM Microspheres (Boston Scientific; K034068)
- . Contour® Emboli PVA (Boston Scientific; K030966)
- Embosphere® Microspheres (Biosphere Medical; K021397) .
Device Description 5.4
The subject devices are particles of nonabsorbable synthetic polyvinyl alcohol (PVA) foam. The devices do not contain any colorant or other additive, and are uncol ted. Each is offered in a range of particle sizes, from which the clinician may saleot the particle size most appropriate for the desired effect and targeted vasculature. The devices are delivered to the selected vascular location by means of a syringe, through an infusion catheter of diameter appropriate for the selected particle size. The subject devices are manufactured for PPT by Surgica Corporation, 5090 Robert J. Matthews Parkway, No. 4, El Dorado Hills, CA 95762.
1
5.5 Intended Use
PVA Plus™, MaxiStat™, and MicroStat™ PVA Foam Embolization Particles may be used for vascular occlusion of blood vessels within the neurovascular and peripher a vascular system. They are intended for arterial embolization of arteriovenous malformations (AVMs) and hypervascular turnors in the peripheral vasculature, and for vascular occlusion of blood vessels within the neurovascular system for the embolization of AVMs and neoplastic lesions.
ર્ટ ર્ Comparison to Predicate Devices
The subject devices do not differ in any regard from PPTI's predicate PVA Plus™ MaxiStar™, and MicroStat™ devices currently cleared for market in the U.S. Further, the subject devices are substantially equivalent to other predicate devices cleared for commercial distribution in the U.S., in terms of material composition, particle configuration, range of sizes offered, biocompatibility, packaging, how supplied, indications, and method of use. Among these predicates are the Contour® Emboli PVA and Contour SE™ Microsphere devices marketed by Boston Scientific (K030966 and K034068, respectively), and Embosphere® Microspheres, marketed by Biosphere Medical (K021397).
5.7 Summary of Non-Clinical Tests
Nonclinical tests, both in vitro and in vivo, have demonstrated the substantial equivalence of the subject devices to commercially-available predicates in terms of performance.
5.8 Summary of Clinical Tests
(Not applicable)
5.9 Conclusions of Non-Clinical and Clinical Tests
The results of all testing demonstrated the substantial equivalence of the subject devices to the predicate devices.
2
Image /page/2/Picture/1 description: The image shows the logo for the Department of Health and Human Services (HHS). The logo consists of a stylized caduceus, which is a symbol often associated with medicine and healthcare. The text "DEPARTMENT OF HEALTH AND HUMAN SERVICES, USA" is arranged in a circular pattern around the caduceus.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Protein Polymer Technologies, Inc. % Radine Pobuda, RAC Director, Quality Systems and Regulatory Affairs 10655 Sorrento Valley Road San Diego, California 92121
SEP 1 9 2006
Re: K061790
Trade/Device Name: PVA Plus™ Foam Embolization Pareticles; MaxiStat™ PVA Foam Embolization Particles: and MicroStat™ PVA Foam Embolization Particles Regulation Number: 21 CFR 870.3300 Regulation Name: Vascular embolization device Regulatory Class: II Product Code: KRD, HCG Dated: June 23, 2006 Received: June 26, 2006
Dear Radine Pobuda:
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
3
Page 2 - Radine Pobuda, RAC
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.
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 nuraber (800) 638-2041 or (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours,
Mark N. Melkerson Director Division of General. Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
Protein Polymer Technologies, Inc
Indications for Use
510(k) Number (if known): K061790
PVA Plus™ Foam Embolization Particles; Device Names: MaxiStar™ PVA Foam Embolization Particles; and MicroStat™ PVA Foam Embolization Particles
Indications for Use:
PVA particles are indicated for arterial embolization of arteriovenous malformations (AVMs) and hypervascular tumors in the peripheral vasculature, and for vascular occlusion of blood vessels within the neurovascular system for the embolization of AVMs and neoplastic lesions.
Prescription Use (Part 21 CFR 801 Subpart D)
AND/OR
Over-The-Counter Use (21 CFR 801 Subpart C)
ಕ್ಟಾ. ಸ
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
(Division Sign-On)
Division of General, Restorative,
and Neurological Devices
510(k) Number: 061790