(41 days)
No
The device description and performance studies focus on the physical properties and delivery method of the PVA particles, with no mention of AI or ML.
Yes
The device is intended for vascular occlusion, specifically for arteriovenous malformations (AVMs) and neoplastic lesions, which are therapeutic interventions.
No
Explanation: The device is described as "PVA particles" intended for "vascular occlusion of blood vessels" and "presurgical devascularization." This indicates a therapeutic or interventional function, not a diagnostic one.
No
The device description clearly states the device is made of "particles of nonabsorbable synthetic polyvinyl alcohol (Pva) foam," which are physical components intended for vascular occlusion. This is a hardware device, not software.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for the vascular occlusion of blood vessels within the neurovascular system. This is a therapeutic intervention performed in vivo (within the body) to block blood flow.
- Device Description: The device is a physical particle intended to be delivered into blood vessels.
- Lack of IVD Characteristics: IVD devices are used to examine specimens (like blood, urine, tissue) in vitro (outside the body) to provide information for diagnosis, monitoring, or screening. This device does not perform any such analysis on biological samples.
The device described is a medical device used for embolization, a procedure performed directly on the patient's vascular system.
N/A
Intended Use / Indications for Use
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.
Product codes
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 uncoated. Each is offered in a range of particle sizes, from which the clinician may select the particle size most appropriate for the desired effect and targeted vasculature. The devices are intended to be delivered to the selected anatomical site by means of a syringe, through an infusion catheter of appropriate diameter. The devices are provided sterile, non-pyrogenic, and are intended for single-use.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
neurovascular 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
Not Applicable (Non-clinical testing restricted to sterility and shelf life due to modification being only in packaging configuration; Clinical tests not applicable). All such tests conform to recognized standards.
Key Metrics
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
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).
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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:
5.1 Submitted By
Protein Polymer Technologies, Inc. 10655 Sorrento Valley Road San Diego, California 92121 Telephone: (858) 558-6064
Contact: R. Stephen Reitzler Vice President, Regulatory Affairs & Quality Assurance
Date Prepared: December 19, 2005
Device Name 5.2
| | Trade or Proprietary Names: Modified Pva-PlusTM Foam Embolization Particles
Modified MaxiStatTM Pva Foam Embolization Particles
Modified MicroStatTM Pva Foam Embolization Particles |
|-----------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Common or Usual Name: | Polyvinyl alcohol (Pva) foam embolization particles |
| Classification Name: | Neurovascular embolization device |
5.3 Predicate Devices
The subject devices are substantially equivalent to the following predicate devices:
- Pva-Plus™ Foam Embolization Particles (Surgica Corp .; K001678) .
- MaxiStat™ Pva Foam Embolization Particles (Surgica Corp .; K020033) .
- MicroStat™ Pva Foam Embolization Particles (Surgica Corp .; K032619) .
5.4 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 uncoated. Each is offered in a range of particle sizes, from which the clinician may select the particle size most appropriate for the desired effect and targeted vasculature. The devices are intended to be delivered to the selected anatomical site by means of a syringe, through an infusion catheter of appropriate diameter. The devices are provided sterile, non-pyrogenic, and are intended for single-use.
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5.5 Intended Use
Modified Pva-Phus™, Modified MaxiStur™, and Modified MicroStat™ Pva Foam Embolization Particles may be used for vascular occlusion of blood vessels within the neurovascular system. They are intended for use in the endovascular management of arteriovenous malformations (AVMs) and neoplastic lesions when presurgical devascularization is desirable.
5.6 Comparison to Predicate Devices
The subject devices differ from the predicate devices only in packaging configuration. The primary unit package form has been modified from that of the predicates to facilitate ease of use by the clinician, and the modification does not alter essential device design characteristics or indications for use. Specifically, the primary unit package has been changed from a sealed glass vial to a thermoformed blister with peel-off TYVEK® lid, and now includes the hydration/delivery syringe(s) necessary for administration of the devices. With respect to material composition, particle configuration and range of sizes offered, manufacturing, biocompatibility, how supplied, indications, and method of use, the subject devices are unchanged from the predicate devices.
5.7 Summary of Non-Clinical Tests
In that the modification that is the basis for this 510(k) submission impacts only the unit package configuration, non-clinical testing is restricted to that which verifies or validates sterility, and shelf life. All such tests conform to recognized standards.
5.8 Summary of Clinical Tests
(Not applicable)
Conclusions of Non-Clinical and Clinical Tests 5.9
The results of all testing demonstrated the substantial equivalence of the subject devices to the predicate devices.
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Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo features a stylized caduceus symbol, which is a staff with two snakes coiled around it, on the right side. On the left side, the text "DEPARTMENT OF HEALTH AND HUMAN SERVICES. USA" is arranged in a circular pattern around the caduceus symbol. The logo is black and white.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
JAN 3 0 2006
Mr. R. Stephen Reitzler Vice President, Regulatory Affairs and Quality Assurance Protein Polymer Technologies, Inc. 10655 Sorrento Valley Road San Diego, California 92121
Re: K053548
Trade/Device Names: Modified Pva-Plus™ Foam Embolization Particles, Modified MaxiStat™ Pva Foam Embolization Particles, and Modified MicroStat™ Foam Embolization Particles Regulation Number: 21 CFR 882.5950 Regulation Name: Neurovascular embolization device Regulatory Class: II Product Code: HCG Dated: December 19, 2005 Received: December 21, 2005
Dear Mr. Reitzler:
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
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Page 2 - Mr. Reitzler
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" (21 CFR 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,
Вашае Времи
Mark N. Melkerson Acting Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known): ____________________________________________________________________________________________________________________________________________________
Device Names: Modified Pva-Plus™ Foam Embolization Particles; Modified MaxiStat™ Pva Foam Embolization Particles; and Modified MicroStat™ Pva Foam Embolization Particles
Indications for Use:
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.
Prescription Use (Part 21 CFR 801 Subpart D)
AND/OR
Over-The-Counter Use (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Barbara
(Division Sign-Off)
M
Division of General. Restorative,
Neurological Devices
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510(k) N