(118 days)
No
The device description and performance studies focus on the physical properties and clinical outcomes of the microspheres themselves, with no mention of AI or ML being used in the device's function, analysis of data, or decision-making processes. The retrospective data analysis is a standard clinical study methodology, not indicative of AI/ML use within the device.
Yes
The device is intended for the embolization of arteriovenous malformations, hypervascular tumors, uterine fibroids, and for embolization of prostatic arteries, all of which are treatments for medical conditions, making it a therapeutic device.
No
The device description clearly states "The HydroPearl® Microspheres are intended for the embolization of arteriovenous malformations and hypervascular tumors, including uterine fibroids, and for embolization of prostatic arteries (PAE) for symptomatic benign prostatic hyperplasia (BPH)." This indicates a therapeutic, not a diagnostic, purpose.
No
The device description clearly states that the device is a physical embolic agent consisting of biocompatible hydrogel microspheres provided in a sterile syringe. This is a hardware device, not software.
Based on the provided information, this device is not an In Vitro Diagnostic (IVD).
Here's why:
- Intended Use: The intended use is for the embolization of various anatomical structures (arteriovenous malformations, tumors, uterine fibroids, prostatic arteries). This is a therapeutic procedure performed in vivo (within the body) 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.
- Lack of IVD Characteristics: An IVD is a medical device intended for use in vitro (outside the body) for the examination of specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes. This device does not perform any such examination of specimens.
The device is clearly intended for a therapeutic intervention performed directly on the patient's anatomy, which is the opposite of an IVD.
N/A
Intended Use / Indications for Use
The HydroPearl® Microspheres are intended for the embolization of arteriovenous malformations and hypervascular tumors, including uterine fibroids, and for embolization of prostatic arteries (PAE) for symptomatic benign prostatic hyperplasia (BPH).
Product codes
NOY, KRD, NAJ
Device Description
The HydroPearl TM Microspheres are a pre-formed, compressible, precisely calibrated, spherical embolic agent consisting of a biocompatible hydrogel. The HydroPearl TM Microspheres are offered in a variety of diameters ranging from 75-1100µm 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 TM 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
Radiographic imaging (for delivery method)
Anatomical Site
Arteriovenous malformations, hypervascular tumors (including uterine fibroids), prostatic arteries
Indicated Patient Age Range
The clinical study included patients with a mean age of 70 (range; 55-85).
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
Description of the test set: Existing real-world data from a single, US center was analyzed retrospectively for the purpose of expanding the existing indication for the HydroPearl Microspheres to include embolization of prostatic artery embolization (PAE) for symptomatic benign prostatic hyperplasia (BPH).
Sample size: 17 patients
Data source: Retrospective analysis of clinical data from a single US center.
Annotation protocol: The primary objective was to collect data of the procedure safety and efficacy, which included age, prostate volume baseline International Prostate Symptom Score + Quality of Life score (IPSS+QoL), unilateral embolization, size of particles used, complications and follow-up IPSS+QoL. The primary endpoint was reduction in IPSS score during the follow-up period.
Summary of Performance Studies
Study Type: Retrospective clinical study and literature review.
Sample Size: 17 patients for the retrospective clinical study.
Key Results:
* Demographics and Baseline Characteristics: Mean age of 70 (range; 55-85), mean prostate volume of 63 ml (range; 27-140). All 17 patients underwent bilateral prostatic artery embolization with 75 um HydroPearl (n=2), 200 um HydroPearl (n=3) or 75 um followed by 200 um HydroPearl (n=12).
* Primary Endpoint Results: Mean follow up period was 8.6 months (range; 1-12). Mean baseline International Prostate Symptom Score was 20.7 (range; 4-30) at baseline and 9.1 (range; 2-18) at latest follow-up (p
§ 876.5550 Prostatic artery embolization device.
(a)
Identification. A prostatic artery embolization device is an intravascular implant intended to occlude the prostatic arteries to prevent blood flow to the targeted area of the prostate, resulting in a reduction of lower urinary tract symptoms related to benign prostatic hyperplasia. This does not include cyanoacrylates and other embolic agents which act by in situ polymerization or precipitation, or embolization devices used in neurovascular applications (see 21 CFR 882.5950).(b)
Classification. Class II (special controls). The special controls for this device are:(1) The device must be demonstrated to be biocompatible.
(2) Non-clinical performance testing must demonstrate that the device performs as intended under anticipated conditions of use. The following performance characteristics must be tested:
(i) Evaluation of suitability for injection through catheters intended for use in embolization; and
(ii) Evaluation of the size distribution of the device.
(3) Performance data must support the sterility and pyrogenicity of the device.
(4) Performance data must support the shelf life of the device by demonstrating continued sterility, package integrity, and device functionality over the identified shelf life.
(5) Clinical data must evaluate post-embolization damage due to non-target embolization under anticipated use conditions.
(6) The labeling must include:
(i) Specific instructions on safe device preparation and use;
(ii) The device shelf life;
(iii) Data regarding urinary retention; and
(iv) Data regarding post-prostatic artery embolization syndrome.
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Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which consists of the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue text.
January 22, 2020
MicroVention, Inc. Ms. Analia Staubly Sr. Project Manager, Regulatory Affairs 35 Enterprise Aliso Viejo, California 92656
Re: K192684
Trade/Device Name: HydroPearl Microspheres Regulation Number: 21 CFR 876.5550 Regulation Name: Prostatic Artery Embolization Device Regulatory Class: Class II Product Code: NOY, KRD, NAJ, Dated: September 25, 2019 Received: September 26, 2019
Dear Ms. Staubly:
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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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
1
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 adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
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 https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
for Angel Soler-Garcia, Ph.D. Acting Assistant Director Incontinence and Male Urological Devices Team (THT3B3) DHT3B: Division of Reproductive, Gynecological, and Urological Devices OHT3: Office of Gastrorenal, ObGyn, General Hospital and Urology Devices and Infection Control Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known) K192684
Device Name HYDROPEARL® Microspheres
Indications for Use (Describe)
The HydroPearl® Microspheres are intended for the embolization of arteriovenous malformations and hypervascular tumors, including uterine fibroids, and for embolization of prostatic arteries (PAE) for symptomatic benign prostatic hyperplasia (BPH).
| Type of Use (Select one or both, as applicable) |
|---|
| ------------------------------------------------- |
| Prescription Use (Part 21 CFR 801 Subpart D) |
|---|
| Over-The-Counter Use (21 CFR 801 Subpart C) |
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| TRADE NAME: | HydroPearl TM Microspheres |
|---|---|
| COMMON NAME: | Embolization device |
| REGULATION NAMES: | Prostatic artery embolization device |
| Vascular embolization device | |
| CLASSIFICATION: | II, 21 CFR 876.5550 (NOY) |
| II, 21 CFR 870.3300 (KRD/NAJ) | |
| PRODUCT CODE: | NOY/KRD/NAJ |
| APPLICANT: | MicroVention, Inc. |
| 35 Enterprise | |
| Aliso Viejo, CA 92656 | |
| ESTABLISHMENT | |
| REGISTRATION NUMBER: | 3013556777 |
| CONTACT: | Analia Staubly |
| Sr. Project Manager, Regulatory Affairs | |
| analia.staubly@microvention.com | |
| DATE SUMMARY PREPARED: | September 25, 2019 |
| PREDICATE DEVICE: | BioSphere Medical S.A. |
| Embosphere Microspheres (DEN160040) | |
| REFERENCE DEVICE: | HydroPearl TM Microspheres (K150870) |
| DEVICE DESCRIPTION: | The HydroPearl TM Microspheres are a pre-formed, |
| compressible, precisely calibrated, spherical embolic | |
| agent consisting of a biocompatible hydrogel. The | |
| HydroPearl TM Microspheres are offered in a | |
| variety of diameters ranging from 75-1100µm 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 TM Microspheres are delivered to the | |
| treatment site through a delivery catheter. | |
| INDICATIONS FOR USE: | The HydroPearl TM Microspheres are intended for the |
| embolization of arteriovenous malformations and | |
| hypervascular tumors, including uterine fibroids, and | |
| for embolization of prostatic arteries (PAE) for | |
| symptomatic benign prostatic hyperplasia (BPH). |
4
TECHNOLOGICAL CHARACTERISTICS AND PRODUCT FEATURE COMPARISON:
| Characteristics | Predicate Device:
Embosphere Microspheres
(DEN160040) | Reference Device:
HydroPearl Microspheres
(K150870) | Subject Device:
HydroPearl
Microspheres |
|--------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------|
| Intended Use | Indicated for use in embolization
of arteriovenous malformations,
hypervascular tumors, including
symptomatic uterine fibroids and
prostatic arteries for
symptomatic benign prostatic
hyperplasia (BPH). | Intended for the
embolization of
arteriovenous
malformations and
hypervascular tumors,
including uterine fibroids. | Same as
Predicate Device |
| TECHNICAL | | | |
| Microsphere
Material | Acrylic polymer impregnated
with porcine delivered gelatin. | Polyethylene glycol
diacrylamide and glycerol
monomethacrylate | Same as
Reference
Device |
| Microsphere
Diameter | Size Range: 40 – 1200 $\mu$ m
Labeled size range:
40 - 120 $\mu$ m
100 - 300 $\mu$ m
300 - 500 $\mu$ m
500 - 700 $\mu$ m
700 - 900 $\mu$ m
900 - 1200 $\mu$ m | Size Range: 75 – 1100 $\mu$ m
Labeled size:
75 $\mu$ m
200 $\mu$ m
400 $\mu$ m
600 $\mu$ m
800 $\mu$ m
1100 $\mu$ m | Same as
Reference
Device |
| Microsphere
Container | Contained in a sterile, 20 ml
polycarbonate syringe. | Same as Predicate Device | Same as
Predicate Device |
| Microsphere
volume per
syringe | 1.0 or 2.0 ml, in physiological
saline. | 2.0 ml in phosphate
buffered saline (PBS) | Same as
Reference
Device |
| Radiopacity
Method | Mixed with contrast media prior
to injection. | Same as Predicate Device | Same as
Predicate Device |
| Delivery Method | Via catheter under radiographic
imaging. | Same as Predicate Device | Same as
Predicate Device |
| STERILIZATION AND PACKAGING | | | |
| Sterilization
Method. | Steam sterilization. | Same as Predicate Device | Same as
Predicate Device |
| Packaging | Pre-filled syringe, placed in a
polycarbonate tray and sealed
with a peel away Tyvek lid,
placed inside bleached sulfate
carton box. | Same as Predicate Device | Same as
Predicate Device |
| Method of
Supply | Sterile and single use. | Same as Predicate Device | Same as
Predicate Device |
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VERIFICATION AND TEST SUMMARY:
Non-clinical testing was performed on the HydroPearl Microspheres, reference device, to provide reasonable assurance that the proposed device has been designed and tested to assure conformance to special requirements for its intended use. A risk assessment has been performed and demonstrates that the expanded indication did not require additional bench, biocompatibility, packaging or sterilization. All existing testing in the previous HydroPearl Microsphere premarket submission remains applicable.
Comparative mechanical testing was conducted to compare the performance of the HydroPearl Microspheres to that of legally marketed devices for the same indication. The HydroPearl Microspheres performed equivalently to the Embosphere Microspheres, predicate device, in comparative mechanical testing. Pre-clinical animal testing was also performed in animal models representing the renal and prostatic vasculature. The HydroPearl performed similarly to the Embosphere Microspheres and had favorable embolization results in both studies.
CLINICAL INFORMATION:
Existing real-world data from a single, US center was analyzed retrospectively for the purpose of expanding the existing indication for the HydroPearl Microspheres to include embolization of prostatic artery embolization (PAE) for symptomatic benign prostatic hyperplasia (BPH). The retrospective analysis consisted of 17 patients that underwent prostatic artery embolization (PAE) using HydroPearl Microspheres for the treatment of symptomatic benign prostatic hyperplasia (BPH). The primary objective was to collect data of the procedure safety and efficacy, which included age, prostate volume baseline International Prostate Symptom Score + Quality of Life score (IPSS+QoL), unilateral embolization, size of particles used, complications and follow-up IPSS+OoL. The primary endpoint was reduction in IPSS score during the follow-up period.
Demographics and Baseline Characteristics:
Twenty-three patients were identified. 17 patients returned consent forms and their data was included in this study.
The mean age of the patients included was 70 (range; 55-85) and their mean prostate volume was 63 ml (range; 27-140). One of the patients relied on clean intermittent catheterization (CIC) for voiding and the rest were able to void without a catheter. Fourteen of seventeen patients were on BPH medications at the time of PAE.
All 17 patients underwent bilateral prostatic artery embolization was performed with either 75 um HydroPearl (n=2), 200 um HydroPearl (n=3) or 75 um followed by 200 um HydroPearl (n=12).
Primary Endpoint Results:
Mean follow up period was 8.6 months (range; 1-12). Mean baseline International Prostate Symptom Score was 20.7 (range; 4-30) at baseline and 9.1 (range; 2-18) at latest follow-up (p