(186 days)
Not Found
No
The device description and intended use focus on the physical properties and delivery method of embolization particles, with no mention of AI or ML. The performance studies rely on clinical data from existing devices and registries, not on the development or validation of an AI/ML algorithm.
Yes
The device is intended for the "embolization of the blood supply to symptomatic uterine fibroids," which is a therapeutic intervention to treat a medical condition.
No
The device is described as embolization particles used to block the blood supply to uterine fibroids, which is a therapeutic intervention, not a diagnostic one.
No
The device is described as physical particles made of polyvinyl alcohol, intended for delivery via catheter. This clearly indicates a hardware-based medical device, not software only.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are devices used to examine specimens taken from the human body (like blood, urine, tissue) to provide information for diagnosis, monitoring, or screening.
- Device Description and Intended Use: The description clearly states that these are physical particles intended for embolization (blocking blood vessels) within the body to treat uterine fibroids. They are delivered via a catheter and used under fluoroscopic control. This is an in vivo (within the living body) procedure, not an in vitro (in glass/outside the body) test.
The information provided describes a medical device used for a therapeutic procedure, not a diagnostic test performed on a sample.
N/A
Intended Use / Indications for Use
The Cook Polyvinyl Alcohol Foam Embolization Particles are intended for embolization of the blood supply to symptomatic uterine fibroids.
Product codes (comma separated list FDA assigned to the subject device)
NAJ
Device Description
Cook Incorporated Polyvinyl Alcohol Foam Embolization Particles are small, flexible, particles made of cross-linked polyvinyl alcohol. The particles are packaged dry and are provided sterile in sealed vials. They are intended for delivery to the target site by a catheter under fluoroscopic control.
Embolization particle sizes appropriate for use in symptomatic uterine fibroid treatment are 300-500 microns and 500-710 microns.
There have been no changes in the design, dimensions, or materials of the device.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
uterine fibroids
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)
Clinical data was leveraged to support the substantial equivalence of this proposed device to predicate devices. Clinical data from Cook Incorporated's Polyvinyl Alcohol Foam Embolization Particles were obtained from published studies and from data generated by the FIBROID clinical registry.
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.
Cook Incorporated's Polyvinyl Alcohol Foam Embolization Particles marketed prior to 1976, K030966, K034068, 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).
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Cook Incorporated--December 22, 2008 Cook Polyvinyl Alcohol (PVA) Foam Embolization Particles K081768—Response to Request for Additional Information
DEC 2 3 2008
510(k) Summary
Polyvinyl Alcohol Foam Embolization Particles 510(k) Summary 21 CFR 807.92 Date Prepared: 22 December 2008
1. Submitter Information:
| Applicant: | Cook Incorporated |
|---|---|
| Address: | 750 Daniels Way, |
| P.O. Box 489 | |
| Bloomington, IN 47402 | |
| Phone Number: | 1 (800) 468-1379 |
| Fax Number: | (812) 332-0281 |
| Contact: | Susanne Galin, RAC, Regulatory Affairs Specialist |
| Contact Address: | Cook Incorporated |
| 750 Daniels Way | |
| P.O. Box 489 | |
| Bloomington, IN 47402 | |
| Contact Phone Number: | 812-339-2235 x2296 |
| Contact Fax Number: | 812-332-0281 |
2. Device Information:
| Trade name: | Polyvinyl Alcohol Foam Embolization Particles |
|---|---|
| Common name: | Polyvinyl Alcohol Foam Embolization Particles |
| Classification: | Class II |
| Regulation: | 21 CFR §870.3300, |
| Product Code: | NAJ |
1
Cook Incorporated-December 22, 2008 Cook Polyvinyl Alcohol (PVA) Foam Embolization Particles K081768-Response to Request for Additional Information
3. Predicate Device:
Cook Incorporated's Polyvinyl Alcohol Foam Embolization Particles with their expanded indications for use statement are substantially equivalent (identical except for indication) to the Cook Incorporated's Polyvinyl Alcohol Foam Embolization Particles marketed prior to 1976.
Cook Incorporated's Polyvinyl Alcohol Foam Embolization Particles are also substantially equivalent in terms of materials and use to the Contour™ Emboli PVA cleared for market in K030966, Contour™ SE Microspheres cleared for market in K034068, and in terms of use to the Embosphere Microspheres, cleared for market in K021397.
4. Device Description:
Cook Incorporated Polyvinyl Alcohol Foam Embolization Particles are small, flexible, particles made of cross-linked polyvinyl alcohol. The particles are packaged dry and are provided sterile in sealed vials. They are intended for delivery to the target site by a catheter under fluoroscopic control.
Embolization particle sizes appropriate for use in symptomatic uterine fibroid treatment are 300-500 microns and 500-710 microns.
There have been no changes in the design, dimensions, or materials of the device.
5. Intended Use:
The Cook Polyvinyl Alcohol Foam Embolization Particles are intended for cmbolization of the blood supply to symptomatic utcrine fibroids.
2
Cook Incorporated -------- December 22, 2008 Cook Polyvinyl Alcohol (PVA) Foam Embolization Particles K081768------ Response to Request for Additional Information
6. Technological Characteristics:
Cook Incorporated's Polyvinyl Alcohol Foam Embolization Particles described in this submission are physically identical to the predicate Cook Incorporated Polyvinyl Alcohol Foam Embolization Particles in terms of technological characteristics (design, dimensions and materials). They are also identical in terms of manufacturing process, sterilization, and packaging.
7. Clinical Data:
Clinical data was leveraged to support the substantial equivalence of this proposed device to predicate devices. Clinical data from Cook Incorporated's Polyvinyl Alcohol Foam Embolization Particles were obtained from published studies and from data generated by the FIBROID clinical registry.
3
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized eagle with three stripes extending from its back, representing health, human services, and well-being. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the eagle.
Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
DEC 2 3 2008
Ms. Susanne Galin, RAC Regulatory Affairs Specialist COOK® Inc. 750 Daniels Way, P.O. Box 489 BLOOMINGTON IN 47402-0489
Re: K081768
Trade/Device Name: Polyvinyl Alcohol Foam Embolization Particles Regulation Number: 21 CFR §870.3300 Regulation Name: Vascular embolization device Regulatory Class: II Product Codes: NAJ Dated: December 12, 2008 Received: December 15, 2008
Dear Ms. Galin:
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.
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Page 2
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.
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 one of the following numbers, based on the regulation number at the top of this letter:
| 21 CFR 876.xxx | (Gastroenterology/Renal/Urology) | 240-276-0115 |
|---|---|---|
| 21 CFR 884.xxx | (Obstetrics/Gynecology) | 240-276-0115 |
| 21 CFR 894.xxx | (Radiology) | 240-276-0120 |
| Other | 240-276-0100 |
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometrics' (OSB's) Division of Postmarket Surveillance at 240-276-3474. For questions regarding the reporting of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at 240-276-3464. 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 (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours,
Joppu M. Whang
Joyce M. Whang, Ph.D. Acting Director, Division of Reproductive. Abdominal, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
5
Cook Incorporated-December 22, 2008 Cook Polyviny1 Alcohol (PVA) Foam Embolization Particles K081768-Response to Request for Additional Information
4. Indications for Use Statement
510(k) Number (if known): K081768
Device Name: Polyvinyl Alcohol Foam Embolization Particles
Indications for Use:
The Cook Polyvinyl Alcohol Foam Embolization Particles are intended for embolization of the blood supply to symptomatic uterine fibroids.
Prescription Use X Over-The-Counter Use AND/OR (Part 21 CFR 801 Subpart D) (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)
Hulstene
(Division Sign-Off Division of Reproductive, Abdomin and Radiological Devices 510(k) Number