(150 days)
No
The summary describes a physical embolization device and its performance testing, with no mention of AI or ML capabilities.
Yes
The device is intended to be used in the treatment of unresectable/inoperable hypervascularized tumors, which is a therapeutic application.
No
The device is described as an "artificial embolization device" intended for treatment, not for diagnosis.
No
The device description clearly states it is a "collagen-coated polymeric embolization microparticle," which is a physical material, not software.
Based on the provided information, the Occlusin® 500 Artificial Embolization Device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is to be used in the treatment of tumors as an artificial embolization device. This is a therapeutic intervention performed within the patient's body.
- Device Description: It is a physical device (microparticle) intended for implantation or delivery into the body.
- Lack of In Vitro Testing: The description of the device and its intended use does not involve testing samples (like blood, urine, tissue) outside of the body to diagnose a condition or monitor a treatment.
IVDs are devices used to examine specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes. The Occlusin® 500 is a therapeutic device used directly in the patient's body.
N/A
Intended Use / Indications for Use
The Occlusin® 500 Artificial Embolization Device is intended to be used as an artificial embolization device in the treatment of unresectable/inoperable hypervascularized tumors.
Product codes
KRD
Device Description
The Occlusin® 500 Artificial Embolization Device is a collagen-coated polymeric embolization microparticle. It is provided sterile and non-pyrogenic.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
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)
Prospectively defined verification and validation testing included biocompatibility testing in compliance with ISO 10993-1; stability testing; catheter compatibility testing; characterization of the finished product to demonstrate compliance with release specifications (including visual examination of appearance, packaging integrity, mass per vial, density, particle count per gram, particle size distribution, residual PVA, molecular weight, collagen content, sterility, endotoxin and melting range; shelf life); and in vivo testing in two animal models. Short term testing (acute and 1 month) was performed in the porcine model and long term testing (3 months, 6 months, and 12 months) was performed in the ovine model. These studies compared the performance of the Occlusin® 500 Artificial Embolization Device with the cited predicate device.
No clinical testing was conducted to support this submission.
Design verification and validation testing demonstrate that the Occlusin® 500 Artificial Embolization Device fulfills prospectively defined design specifications. Testing in the two well-accepted animal models shows that the Occlusin® 500 Artificial Embolization Device does not raise new issues of safety or effectiveness.
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).
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MAY 1 0 2010
Revised 510(k) Summary for IMBiotechnologies Ltd. Occlusin® 500 Artificial Embolization Device (per 21CFR 807.92)
(per 21 CFR 807.92 and http://www.fda.qov/MedicalDevices/DeviceRegulationandGuidance/default.htm)
1. SUBMITTER/510(K) HOLDER
IMBiotechnologies Ltd. Suite 113 - Advanced Technology Centre Edmonton Research Park 9650 20th Avenue, NW Edmonton, AB T6N 1G1
| Contact Person: | Michael W. Stewart |
|---|---|
| Telephone: | 780-945-6609 |
May 7, 2010 Date Prepared:
2. DEVICE NAME
| Proprietary Name: | Occlusin® 500 Artificial Embolization Device |
|---|---|
| Common/Usual Name: | Vascular embolization device |
| Classification Name: | Device, vascular, for promoting embolization |
3. PREDICATE DEVICES
Biosphere Medical Embosphere® (K021397; K991549)
4. DEVICE DESCRIPTION
The Occlusin® 500 Artificial Embolization Device is a collagen-coated polymeric embolization microparticle. It is provided sterile and non-pyrogenic.
5. INTENDED USE
The Occlusin® 500 Artificial Embolization Device is intended to be used as an artificial embolization device in the treatment of unresectable/inoperable hypervascularized tumors.
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6. TECHNOLOGICAL CHARACTERISTICS AND SUBSTANTIAL EQUIVALENCE
The claim of substantial equivalence of the Occlusin® 500 Artificial Embolization Device with the cited predicate device is based on indication for use, operational principles, and fundamental design and operational characteristics. The Occlusine 500 Artificial Embolization Device, like the predicate device, are microspheres delivered to target organs via catheter under angiographic control. Differences in technology were addressed with additional non-clinical testing.
7. SUMMARY OF PERFORMANCE TESTING AS THE BASIS FOR SUBSTANTIAL EQUIVALENCE
Prospectively defined verification and validation testing included biocompatibility testing in compliance with ISO 10993-1; stability testing; catheter compatibility testing; characterization of the finished product to demonstrate compliance with release specifications (including visual examination of appearance, packaging integrity, mass per vial, density, particle count per gram, particle size distribution, residual PVA, molecular weight, collagen content, sterility, endotoxin and melting range; shelf life); and in vivo testing in two animal models. Short term testing (acute and 1 month) was performed in the porcine model and long term testing (3 months, 6 months, and 12 months) was performed in the ovine model. These studies compared the performance of the Occlusin® 500 Artificial Embolization Device with the cited predicate device.
8. SUMMARY OF CLINICAL TESTING AS BASIS FOR SUBSTANTIAL EQUIVALENCE
No clinical testing was conducted to support this submission.
9. SUMMARY OF OTHER INFORMATION
Other information provided in the 510(k) included published studies of embolization.
10. CONCLUSIONS DRAWN FROM NON-CLINICAL AND CLINICAL TESTS
Design verification and validation testing demonstrate that the Occlusin® 500 Artificial Embolization Device fulfills prospectively defined design specifications. Testing in the two well-accepted animal models shows that the Occlusin® 500 Artificial Embolization Device does not raise new issues of safety or effectiveness.
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Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle with three curved lines representing its body and wings. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES-USA" is arranged in a circular fashion around the eagle symbol. The text is in all capital letters and is in a simple, sans-serif font.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room W-066-0609 Silver Spring, MD 20993-0002
MAY 1 0 2010
IMBiotechnologies Ltd. c/o Ms. Rosina Robinson Medical Device Consultants, Inc. 49 Plain Street North Attleboro, MA 02760
Re: K093813
Occlusin® 500 Artificial Embolization Device Regulation Number: 21 CFR 870.3300 Regulation Name: Vascular Embolization Device Regulatory Class: Class II Product Code: KRD Dated: April 22, 2010 Received: April 26, 2010
Dear Ms. Robinson:
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.
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Page 2 - Ms. Rosina Robinson
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 (reporting of medical device-related 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.html 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/ResourcesforYou/Industry/default.htm.
Sincerely yours,
Dina R. Holmes
Bram D. Zuckerman, M.D. Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known): K093813
Device Name: Occlusin® Artificial Embolization Device
Indications for Use:
The Occlusin® 500 Artificial Embolization Device is intended to be used as an artificial embolization device in the treatment of unresectable/inoperable hypervascularized tumors.
Prescription Use X (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)
Dunae R. Vihner
(Division Sign-Off) (Division Sign On) vascular Devices
510(k) Number_k og 38 | 3