(264 days)
The HydroPearl Microspheres are intended for embolization of arteriovenous malformations and hypervascular tumors, including uterine fibroids.
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.
Here's an analysis of the provided text regarding the acceptance criteria and study information for the HydroPearl Microspheres:
This document is a 510(k) Summary for a medical device called HydroPearl Microspheres. It provides a summary of the pre-clinical testing performed to demonstrate substantial equivalence to a predicate device, rather than a clinical study establishing specific performance metrics against pre-defined acceptance criteria for diagnostic efficacy.
Therefore, the requested information elements related to diagnostic performance (like sample size for test sets, ground truth establishment, expert qualifications, MRMC studies, standalone performance, and training set details) are not applicable in the context of this 510(k) submission. This submission focuses on pre-clinical equivalency, biocompatibility, and functional performance.
Acceptance Criteria and Reported Device Performance
The provided document details various pre-clinical tests and their outcomes, indicating a "Pass" or "Meet" result against internal criteria rather than specific numerical acceptance criteria for diagnostic accuracy.
| Category | Specific Test/Criteria | Reported Device Performance (Pass / Meet means acceptable) |
|---|---|---|
| Mechanical | Compression (Temporary deformation with smooth passage through catheter) | Pass |
| Robustness (Syringe to syringe transfer) | Pass | |
| Delivery force (Delivery through catheter within force specification) | Pass | |
| Dimensional (Maintains diameter) | Pass | |
| Resilience | Pass | |
| Time to suspension/time in suspension | Pass | |
| Chemical | Residual solvents testing (Meets criteria for residuals) | Meet |
| pH test of solution (Maintains pH) | Meet | |
| Syringe leachables testing (Syringe does not leach into microsphere/PBS) | Meet | |
| MR Compatibility | Tested to be MR Safe | Pass |
| Catheter Comp. | Microspheres can be delivered through a catheter of 0.017" - 0.041" ID | Pass |
| Contrast Agents | Microspheres are compatible with contrast agent per IFU | Pass |
| Shelf Life | After aging conditioning, the microspheres/packaging meet specifications | Pass |
| Animal Testing | Embolization effectiveness and histopathological evaluation (necrosis, inflammation, and off-target embolization) compared to predicate device (1, 7, 30 days) | Pass |
| Biocompatibility | Cytotoxicity (MEM elution, Agar diffusion) | Pass (Subjected to full battery of testing) |
| Sensitization/Irritation (Guinea pig maximization, Intracutaneous reactivity) | Pass (Subjected to full battery of testing) | |
| Hemocompatibility (Hemolysis, Complement Activation, UPTT) F | Pass (Subjected to full battery of testing) | |
| Systemic toxicity (Systemic toxicity, Rabbit pyrogen) | Pass (Subjected to full battery of testing) | |
| Implantation (2, 13, and 26 wk implantation) | Pass (Subjected to full battery of testing) | |
| Genotoxicity (Ames Test, Chromosomal aberration, Rodent Bone Marrow Micronucleus) | Pass (Subjected to full battery of testing) | |
| Packaging Valid. | Subjected to ISTA conditions - Packaging testing for adequacy | Pass |
| Sterilization Val. | Meets criteria for ISO 17665-1 | Pass |
Information Not Applicable/Provided for this 510(k) Summary:
As this is a 510(k) submission focused on substantial equivalence through pre-clinical testing, it does not include the detailed diagnostic study information typically associated with AI/software devices aiming to establish diagnostic performance.
- Sample size used for the test set and the data provenance: Not applicable. The "test set" primarily refers to physical samples of the device components and animal models for pre-clinical evaluation, not a diagnostic data set.
- Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. Ground truth, in a diagnostic sense, is not established for this type of submission. Animal testing involved histopathological evaluation, implicitly performed by qualified personnel, but not for establishing a "ground truth" for a diagnostic algorithm.
- Adjudication method for the test set: Not applicable.
- If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance: Not applicable. This is a physical embolic device, not an AI/software diagnostic tool.
- If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable.
- The type of ground truth used (expert consensus, pathology, outcomes data, etc.): For the animal study, histopathology was used to evaluate embolization effectiveness and tissue response (necrosis, inflammation, off-target embolization). This serves as a biological ground truth for the device's effect in vivo, not a diagnostic ground truth.
- The sample size for the training set: Not applicable. There is no algorithm training set for this device.
- How the ground truth for the training set was established: Not applicable.
Summary of the Study (Verification and Test Summary):
The study described is a series of pre-clinical bench tests and animal studies designed to evaluate the physical, chemical, and biological performance of the HydroPearl Microspheres and to demonstrate their substantial equivalence to a legally marketed predicate device (Biosphere Embosphere Microspheres).
- Mechanical Tests: Evaluated the microspheres' ability to deform, maintain their dimensions, transfer between syringes, and be delivered through catheters within specifications.
- Chemical Tests: Assessed residual solvents, pH stability, and leachables from the syringe.
- Safety Tests: Included MR safety, catheter compatibility, compatibility with contrast agents, shelf life, and extensive biocompatibility testing according to ISO 10993 standards (cytotoxicity, sensitization/irritation, hemocompatibility, systemic toxicity, implantation, and genotoxicity).
- Animal Testing: Compared the HydroPearl Microspheres to the predicate device in an animal model to assess embolization effectiveness and histopathological responses (necrosis, inflammation, and off-target embolization) at 1, 7, and 30 days post-embolization.
- Other Validations: Packaging and sterilization validations were also performed.
Conclusion: All tests passed or met the established criteria, leading to the conclusion that the HydroPearl Microspheres are as safe, effective, and perform as well as the predicate device. The submission leveraged existing published studies/literature for uterine fibroid embolization for additional clinical information, but did not present a new clinical study with specific acceptance criteria for diagnostic performance.
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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
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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 deviceClass II, 21 CFR 870.330 (KRD/NAJ) |
| Submitted By: | MicroVention, Inc1311 Valencia AvenueTustin, California U.S.A. |
| Contact:Date: | Naomi GongMarch 30, 2015 |
Predicate Devices:
| Number | Description | Clearance Date |
|---|---|---|
| K021397 | Biosphere (Merit Medical) EmbosphereMicrospheres | November 22, 2002 |
| K991549 | Biosphere (Merit Medical) EmbosphereMicrospheres | 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 MedicalEmbosphere(K021397/K991549) | HydroPearl Microspheres | |
|---|---|---|
| Indications for Use | Intended for embolization of arteriovenousmalformations and hypervascular tumors,including uterine fibroids. | Same |
| Microspherematerial | Acrylic polymer and impregnated withporcine derived gelatin | Polyethylene glycol diacrylamide |
| Microspherediameter | 40-1200 μm | 75-1100 μm |
| Microspherecontainer | Contained in a sterile, 20 mlpolycarbonate syringe | Same |
| Microsphere volumeper syringe | 1.0 or 2.0 mLStorage media: physiological saline | 2.0 mLStorage media: phosphate buffered saline |
| Delivery method | Delivered to treatment site by catheter underfluoroscopic visualization | Same |
| Radiopacity method | Mixed with contrast media prior to injection | Same |
| Method of supply | Sterile and single use | Same |
| SterilizationMethod | Steam | Same |
Technological Comparison:
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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 smoothpassage through catheter• Syringe to syringe transfer• Delivery through catheter within forcespecification• 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 intomicrosphere/PBS | Meet |
| Magnetic resonance compatibility | Tested to be MR Safe | Pass |
| Catheter compatibility | Microspheres can be delivered through acatheter of 0.017" - 0.041' ID | Pass |
| Compatibility with contrast agents | Microspheres are compatible with contrastagent per IFU | Pass |
| Shelf Life (product/packaging) | After aging conditioning, themicrospheres/packaging meet specifications | Pass |
| Animal testing - device compared to predicatedevice (1 day, 7 day, and 30 day) | To assess embolization effectiveness andhistopathological evaluation (necrosis,inflammation, and off-target embolization) | Pass |
| Bicompatibility testing (ISO 10993-1)Cytotoxicity (ISO 10993-5)- MEM elution assay- Agar diffusion assaySensitization/Irritation (ISO 10993-10)- Guinea pig maximization sensitization- Intracutaneous reactivityHemocompatibility (ISO 10993-4)- Hemolysis (Direct and Indirect)- Complement Activation- UPTTSystemic toxicity (ISO 10993-11)- Systemic toxicity- Rabbit pyrogen testImplantation (ISO 10993-6)- 2, 13, and 26 wk implantationGenotoxicity (ISO 10993-3)- Ames Test- Chromosomal aberration- Rodent Bone Marrow Micronucleus | Subjected to full battery of biocompatibilitytesting | Pass |
| Packaging validation | Subjected to ISTA conditions - Packagingtesting 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.
§ 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).