(39 days)
Not Found
No
The device description focuses on the physical properties and intended use of embolization particles, with no mention of software, algorithms, or data processing that would indicate AI/ML.
Yes
The Contour Embolization Particles are "used for the embolization of peripheral hypervascular tumors, including leiomyoma uteri and peripheral arteriovenous malformations (AVMs)," which is a therapeutic intervention aimed at treating medical conditions.
No
This device is an embolization device used for therapeutic purposes (occluding blood vessels), not for diagnosing medical conditions.
No
The device description clearly states that the device is "artificial embolization devices" made of "polyvinyl alcohol," which are physical particles intended for vascular occlusion. There is no mention of software as a component or the primary function of the device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostic devices are used to examine specimens (like blood, urine, or tissue) taken from the human body to provide information about a person's health. This testing is done outside of the body (in vitro).
- Device Function: The Contour Embolization Particles are physical devices that are introduced into the body (in vivo) via a catheter to block blood vessels. They are used for therapeutic purposes (embolization) to treat conditions like tumors and AVMs.
- Lack of Diagnostic Activity: The description focuses on the physical properties of the particles and their use in a medical procedure. There is no mention of analyzing biological samples or providing diagnostic information.
Therefore, the Contour Embolization Particles are a therapeutic medical device, not an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The Contour Embolization Particles are used for the embolization of peripheral hypervascular tumors, including leiomyoma uteri and peripheral arteriovenous malformations (AVMs).
Do not use particles smaller than 355 microns for the treatment of leiomyoma uteri.
Product codes
NAJ
Device Description
Contour Embolization Particles are artificial embolization devices.
These devices are intended to provide vascular occlusion upon selective.placement via an angiographic catheter. Contour Embolization Particles are packaged sterile by gamma irradiation. Each vial is intended for single patient use only.
The Contour™ Embolization particles are packaged in 1 cc dry volume per vial. The vials (glass with screw cap closure) are contained within a poly/Tyvek® pouch. The pouches are placed in boxes, in either a 2 vial/box or 5 vial/box configurations. All vials and boxes are appropriately labeled. The labels are color coded to differentiate between the different size ranges. The device is sterilized by gamma irradiation and labeled with a 26 month shelf life.
The Contour Embolization Particles are available in a range of sizes as tabulated below:
| Size | Minimum Compatible Catheter ID |
|---|---|
| 45-150 µm | 0.53 mm (0.021 in) (e.g. Renegade™ 18, Renegade STC) |
| 150-250 µm | |
| 250-355 µm | |
| 355-500 µm | |
| 500-710 µm | 0.69 mm (0.027 in) (e.g. Renegade Hi-Flo) |
| 710-1000 µm | |
| 1000-1180 µm | 1.12 mm (0.044 in) (e.g. Imager™ II Selective) |
The Contour Embolization Particles are made of polyvinyl alcohol, which has been used for embolization procedures since 1972.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
peripheral
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)
Not Found
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
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
K100663
pg. 1 of 2
510(k) Summary
Per 21 CFR §807.92
،
APR 1 6 ZOTA
| Submitter's Name and Address | Boston Scientific Corporation
One Scimed Place
Maple Grove, MN 55311 |
|------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Contact Name and Information | Debbie McIntire
Senior Regulatory Affairs Specialist
Phone: (408) 935-4679
Fax: (763) 494 2981 |
| Date Prepared | March 5, 2010 |
| Proprietary Name(s) | Contour™ Embolization Particles |
| Common Name | Contour Embolization Particles |
| Product Code | NAJ |
| Classification of Device | Class II, 21 CFR Part 870.3300 |
| Predicate Device | Contour™ Embolization Particles K030966 September 23, 2003 |
| Device Description | Contour Embolization Particles are artificial embolization devices.
These devices are intended to provide vascular occlusion upon selective.placement via an angiographic catheter. Contour Embolization Particles are packaged sterile by gamma irradiation. Each vial is intended for single patient use only.
The Contour™ Embolization particles are packaged in 1 cc dry volume per vial. The vials (glass with screw cap closure) are contained within a poly/Tyvek® pouch. The pouches are placed in boxes, in either a 2 vial/box or 5 vial/box configurations. All vials and boxes are appropriately labeled. The labels are color coded to differentiate between the different size ranges. The device is sterilized by gamma irradiation and labeled with a 26 month shelf life.
The Contour Embolization Particles are available in a range of sizes as tabulated below: |
:
1
K100663
PG 2 of 2
Device Description (continued)
| Size | Minimum Compatible
Catheter ID |
|--------------|------------------------------------------------------------|
| 45-150 µm | 0.53 mm (0.021 in)
(e.g. Renegade™ 18, Renegade
STC) |
| 150-250 µm | |
| 250-355 µm | |
| 355-500 µm | |
| 500-710 µm | 0.69 mm (0.027 in)
(e.g. Renegade Hi-Flo) |
| 710-1000 µm | |
| 1000-1180 µm | 1.12 mm (0.044 in)
(e.g. Imager™ II Selective) |
The Contour Embolization Particles are made of polyvinyl alcohol, which has been used for embolization procedures since 1972.
| Intended Use of
Device | Boston Scientific's Contour Embolization Particles are used for the
embolization of peripheral hypervascular tumors, including leiomyoma
uteri and peripheral arteriovenous malformations (AVMs). |
|---------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Comparison of
Technological
Characteristics | The materials and design of the Contour Embolization Particles are
equivalent to the predicate Contour Embolization Particles. |
| Support of
Substantial
Equivalence | Boston Scientific Corporation considers the proposed Contour
Embolization Particles to be substantially equivalent to the existing
Contour Embolization Particles (K030966, cleared September 23, 2003).
This assessment is based upon identical device materials and design
characteristics. The only change being initiated is to the labeling. The
510(k) is being submitted to delete two contraindications from the
Directions for Use and add two new contraindications. |
| Conclusion | Based on the indications for use and the technological characteristics, the
Contour Embolization Particles has been shown to be equivalent in
intended use and is considered to be substantially equivalent to the
Contour Embolization Particles (K030966; cleared September 23, 2003). |
2
Image /page/2/Picture/0 description: The image shows the seal for the Department of Health & Human Services - USA. The seal is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. In the center of the seal is an abstract image of an eagle.
Food and Drug Administration 10903 New Hampshire Avenue Document Mail Center - WO66-G609 Silver Spring, MD 20993-0002
Ms. Debbie McIntire Senior Regulatory Affairs Specialist Boston Scientific Corporation One Scimed Place MAPLE GROVE MN 55311
APR 1 6 2010
Re: K100663
Trade Name: Contour™ Embolization Particles Regulation Number: 21-CFR § 870.3300 Regulation Name: Vascular embolization device Regulatory Class: II Product Code: NAJ Dated: March 5, 2010 Received: March 8, 2010
Dear Ms. McIntire:
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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to 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); medical device reporting of medical device-related
3
Page 2 -
adverse events) (21 CFR 803); 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.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to
http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
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) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.
Sincerely yours,
Janine M. Morris
Acting Director, Division of Reproductive, Abdominal, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
Indications for Use Statement
K100663 510(k) Number:
Device Name: Contour™ Embolization Particles
Indications for Use:
The Contour Embolization Particles are used for the embolization of peripheral hypervascular tumors, including leiomyoma uteri and peripheral arteriovenous malformations (AVMs).
Do not use particles smaller than 355 microns for the treatment of leiomyoma uteri.
Prescription Use × (Part 21 CFR 801 Subpart D) AND/OR
Over-the-Counter Use (21 CFR 807 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
(Division Sign-Off) Division of Reproductive, Abdominal, and Radiological Devices 510(k) Number_
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