(264 days)
Not Found
No
The summary describes a physical embolic agent and its delivery method, with no mention of AI or ML in the device description, intended use, or performance studies.
Yes
The device is intended for the embolization of arteriovenous malformations and hypervascular tumors, including uterine fibroids, which are medical treatments for specific conditions.
No
The device is an embolic agent used for treatment (embolization of malformations and tumors), not for diagnosing conditions.
No
The device description clearly states it is a "pre-formed, compressible, precisely calibrated, spherical embolic agent consisting of a biocompatible hydrogel," which is a physical material, not software. The summary also details extensive pre-clinical testing on the physical properties and biological interactions of the microspheres.
Based on the provided information, the HydroPearl Microspheres are not an In Vitro Diagnostic (IVD) device.
Here's why:
- Intended Use: The intended use is for the embolization of arteriovenous malformations and hypervascular tumors. This is a therapeutic procedure performed within the body (in vivo) to block blood vessels.
- Device Description: The device is a physical embolic agent delivered through a catheter. It is designed to physically block blood flow.
- IVD Definition: In Vitro Diagnostics are devices used to examine specimens (like blood, urine, or tissue) taken from the human body to provide information for diagnosis, monitoring, or screening.
The HydroPearl Microspheres are a therapeutic device used for interventional procedures, not for testing samples outside the body.
N/A
Intended Use / Indications for Use
The HydroPearl Microspheres are intended for embolization of arteriovenous malformations and hypervascular tumors, including uterine fibroids.
Product codes (comma separated list FDA assigned to the subject device)
KRD, NAJ
Device Description
The HydroPearl Microspheres are a pre-formed, compressible, precisely calibrated, spherical embolic agent consisting of a biocompatible hydrogel. The HydroPearl Microspheres are offered in a variety of diameters ranging from 75-1100 um and are provided in a sterile syringe pre-filled with microspheres in phosphate buffered saline. The pre-filled syringe is packaged in a sealed sterile dispenser tray. The HydroPearl Microspheres are delivered to the treatment site through a delivery catheter.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Arteriovenous malformations and hypervascular tumors, including 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)
Pre-clinical Testing Results:
- Mechanical: Pass (temporary deformation, smooth passage through catheter, syringe to syringe transfer, delivery through catheter within force specification, maintains diameter, suspension for reference).
- Chemical: Meet (meets criteria for residuals, maintains pH, syringe does not leach into microsphere/PBS).
- Magnetic resonance compatibility: Pass (Tested to be MR Safe).
- Catheter compatibility: Pass (Microspheres can be delivered through a catheter of 0.017" - 0.041' ID).
- Compatibility with contrast agents: Pass (Microspheres are compatible with contrast agent per IFU).
- Shelf Life (product/packaging): Pass (After aging conditioning, the microspheres/packaging meet specifications).
- Animal testing - device compared to predicate device (1 day, 7 day, and 30 day): Pass (To assess embolization effectiveness and histopathological evaluation (necrosis, inflammation, and off-target embolization)).
- Bio-compatibility testing (ISO 10993-1) (Cytotoxicity, Sensitization/Irritation, Hemocompatibility, Systemic toxicity, Implantation, Genotoxicity): Pass (Subjected to full battery of biocompatibility testing).
- Packaging validation: Pass (Subjected to ISTA conditions - Packaging testing for adequacy).
- Sterilization validation: Pass (Meets criteria for ISO 17665-1).
Clinical Information:
Other information provided in the 510(k) included published studies/literature on devices for uterine fibroid embolization.
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.
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
Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized image of three human profiles facing to the right, stacked on top of each other.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
December 21, 2015
Microvention, Inc. Naomi Gong Sr. Regulatory Affairs Project Manager 1311 Valencia Ave Tustin, CA 92780
Re: K150870 Trade/Device Name: HydroPearl Microspheres, Regulation Number: 21 CFR 870.3300 Regulation Name: Vascular Embolization Device Regulatory Class: Class II Product Code: KRD, NAJ Dated: December 3, 2015 Received: December 4, 2015
Dear Naomi Gong,
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 (reporting of medical devicerelated adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in
1
the quality systems (OS) 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 contact the Division of Industry and Consumer Education 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. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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 Industry and Consumer Education 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,
Herbert P. Lerner -S
for Benjamin R. Fisher, Ph.D. Director Division of Reproductive, Gastro-Renal, and Urological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known) K150870
Device Name HydroPearl Microspheres
Indications for Use (Describe)
The HydroPearl Microspheres are intended for embolization of arteriovenous malformations and hypervascular tumors, including uterine fibroids.
| Type of Use (Select one or both, as applicable) | |
|---|---|
| Prescription Ice (Part 21 CER 801 Subnart D) | Over-The-Counter I Isa (21 CER 801 Subnart C) |
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510(k) Summary
| Trade Name: | HydroPear1TM Microspheres |
|---|---|
| Generic Name: | |
| Classification: | Vascular embolization device |
| Class II, 21 CFR 870.330 (KRD/NAJ) | |
| Submitted By: | MicroVention, Inc |
| 1311 Valencia Avenue | |
| Tustin, California U.S.A. | |
| Contact: | |
| Date: | Naomi Gong |
| March 30, 2015 | |
Predicate Devices:
| Number | Description | Clearance Date |
|---|---|---|
| K021397 | Biosphere (Merit Medical) Embosphere | |
| Microspheres | November 22, 2002 | |
| K991549 | Biosphere (Merit Medical) Embosphere | |
| Microspheres | April 26, 2000 |
Device Description:
The HydroPearl Microspheres are a pre-formed, compressible, precisely calibrated, spherical embolic agent consisting of a biocompatible hydrogel. The HydroPearl Microspheres are offered in a variety of diameters ranging from 75-1100 um and are provided in a sterile syringe pre-filled with microspheres in phosphate buffered saline. The pre-filled syringe is packaged in a sealed sterile dispenser tray. The HydroPearl Microspheres are delivered to the treatment site through a delivery catheter.
Indications For Use:
The HydroPearl Microspheres are intended for embolization of arteriovenous malformations and hypervascular tumors, including uterine fibroids.
| | Biosphere Medical
Embosphere
(K021397/K991549) | HydroPearl Microspheres |
|-----------------------------------|----------------------------------------------------------------------------------------------------------------------|----------------------------------------------------|
| Indications for Use | Intended for embolization of arteriovenous
malformations and hypervascular tumors,
including uterine fibroids. | Same |
| Microsphere
material | Acrylic polymer and impregnated with
porcine derived gelatin | Polyethylene glycol diacrylamide |
| Microsphere
diameter | 40-1200 μm | 75-1100 μm |
| Microsphere
container | Contained in a sterile, 20 ml
polycarbonate syringe | Same |
| Microsphere volume
per syringe | 1.0 or 2.0 mL
Storage media: physiological saline | 2.0 mL
Storage media: phosphate buffered saline |
| Delivery method | Delivered to treatment site by catheter under
fluoroscopic visualization | Same |
| Radiopacity method | Mixed with contrast media prior to injection | Same |
| Method of supply | Sterile and single use | Same |
| Sterilization
Method | Steam | Same |
Technological Comparison:
4
Verification and Test Summary:
| Pre-clinical Testing | Result | |
|---|---|---|
| Mechanical | ||
| • Compression | ||
| • Robustness | ||
| • Delivery force | ||
| • Dimensional | ||
| • Resilience | ||
| • Time to suspension/time in suspension | Microspheres are capable of: | |
| • Temporary deformation with smooth | ||
| passage through catheter | ||
| • Syringe to syringe transfer | ||
| • Delivery through catheter within force | ||
| specification | ||
| • Maintains diameter | ||
| • Suspension (for reference) | Pass | |
| Chemical | ||
| • Residual solvents testing | ||
| • pH test of solution | ||
| • Syringe leachables testing | • Meets criteria for residuals | |
| • Maintains pH | ||
| • Syringe does not leach into | ||
| microsphere/PBS | Meet | |
| Magnetic resonance compatibility | Tested to be MR Safe | Pass |
| Catheter compatibility | Microspheres can be delivered through a | |
| catheter of 0.017" - 0.041' ID | Pass | |
| Compatibility with contrast agents | Microspheres are compatible with contrast | |
| agent per IFU | Pass | |
| Shelf Life (product/packaging) | After aging conditioning, the | |
| microspheres/packaging meet specifications | Pass | |
| Animal testing - device compared to predicate | ||
| device (1 day, 7 day, and 30 day) | To assess embolization effectiveness and | |
| histopathological evaluation (necrosis, | ||
| inflammation, and off-target embolization) | Pass | |
| Bicompatibility testing (ISO 10993-1) | ||
| Cytotoxicity (ISO 10993-5) |
- MEM elution assay
- Agar diffusion assay
Sensitization/Irritation (ISO 10993-10) - Guinea pig maximization sensitization
- Intracutaneous reactivity
Hemocompatibility (ISO 10993-4) - Hemolysis (Direct and Indirect)
- Complement Activation
- UPTT
Systemic toxicity (ISO 10993-11) - Systemic toxicity
- Rabbit pyrogen test
Implantation (ISO 10993-6) - 2, 13, and 26 wk implantation
Genotoxicity (ISO 10993-3) - Ames Test
- Chromosomal aberration
- Rodent Bone Marrow Micronucleus | Subjected to full battery of biocompatibility
testing | Pass |
| Packaging validation | Subjected to ISTA conditions - Packaging
testing for adequacy | Pass |
| Sterilization validation | Meets criteria for ISO 17665-1 | Pass |
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Clinical Information:
Other information provided in the 510(k) included published studies/literature on devices for uterine fibroid embolization.
Conclusions:
The data presented in this submission demonstrates that the HydroPearl Microspheres are as safe, as effective, and perform as well the predicate device, Biosphere (Merit Medical) Embosphere Microspheres.
In summary, the HydroPearl Microspheres described in this substantially equivalent to the predicate device.