Bead Block (100 - 300µm, 1ml), Bead Block (300 - 500µm, 1ml), Bead Block (500 - 700µm, 1ml), Bead Block (700 - 900µm, 1ml), Bead Block (900 - 1200µm, 1ml), Bead Block (100 - 300µm, 2ml), Bead Block (300 - 500µm, 2ml), Bead Block (500 - 700µm, 2ml), Bead Block (700 - 900µm, 2ml), Bead Block (900 - 1200µm, 2ml)

K203276 · Biocompatibles UK Ltd (Part of Boston Scientific Corporation · NOY · Apr 20, 2021 · Gastroenterology, Urology

Device Facts

• Record ID: K203276
• Device Name: Bead Block (100 - 300µm, 1ml), Bead Block (300 - 500µm, 1ml), Bead Block (500 - 700µm, 1ml), Bead Block (700 - 900µm, 1ml), Bead Block (900 - 1200µm, 1ml), Bead Block (100 - 300µm, 2ml), Bead Block (300 - 500µm, 2ml), Bead Block (500 - 700µm, 2ml), Bead Block (700 - 900µm, 2ml), Bead Block (900 - 1200µm, 2ml)
• Applicant: Biocompatibles UK Ltd (Part of Boston Scientific Corporation
• Product Code: NOY · Gastroenterology, Urology
• Decision Date: Apr 20, 2021
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 876.5550
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

Bead Block microspheres are intended to be used for the embolization of hypervascular tumours, including uterine fibroids (UFE) and arteriovenous malformations (AVMs). Bead Block microspheres are also intended for embolization of prostatic arteries (PAE) for symptomatic benign prostatic hyperplasia (BPH).

Device Story

Bead Block is a permanent intravascular implant consisting of preformed, soft, compressible, hydrophilic, non-resorbable microspheres derived from polyvinyl alcohol (PVA). Microspheres are 90-95% water and compressible to ~30% diameter. Device is supplied sterile in syringes, suspended in phosphate buffered saline. Used by physicians in clinical settings; delivered via microcatheter to target vessels under radiographic imaging guidance. Microspheres occlude blood flow to target tissue (hypervascular tumors or prostatic arteries). Blue dye aids visualization in delivery syringe. MR safe due to non-ferrous composition. Benefits include effective, well-tolerated vessel occlusion for BPH and tumor management without impairing sexual function.

Clinical Evidence

Retrospective data review of 232 patients with moderate-to-severe LUTS due to BPH. Primary endpoints: IPSS, QoL, prostate volume, and urinary flow (Qmax, PVR) at 12 months. Results: 85% of patients showed ≥3 point decrease in IPSS; 62% improved by ≥1 symptom category. Statistically significant improvements (p<0.001) in IPSS, QoL, PSA, and prostate volume. No impairment of sexual function (IIEF). Adverse events were transient/non-serious (dysuria 41.4%, pollakiuria 45.3%).

Technological Characteristics

Polyvinyl alcohol (PVA) microspheres; 100-1200µm size range; hydrophilic; non-resorbable; steam sterilized; single-use. Delivery via microcatheter. Radiopaque contrast agent used for visualization. MR Safe (non-ferrous).

Indications for Use

Indicated for embolization of hypervascular tumors (uterine fibroids, AVMs) and prostatic artery embolization for symptomatic benign prostatic hyperplasia (BPH) in adult patients.

Regulatory Classification

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).

Special Controls

In combination with the general controls of the FD&C Act. the prostatic artery embolization device is subject to the following special controls:

*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.

Predicate Devices

• Embosphere Microspheres (DEN160040)
• Bead Block (K150876)

Submission Summary (Full Text)

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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 in blue, with the words "U.S. FOOD & DRUG" on top and "ADMINISTRATION" on the bottom.

April 20, 2021

Biocompatibles UK Ltd (part of Boston Scientific Corporation) % Christina Fischer Principal Regulatory Affairs Specialist Boston Scientific Medizintechnik GmbH Daniel-Goldbach-Straße 17 - 27 Ratingen, 40880 GERMANY

Re: K203276

> Trade/Device Name: Bead Block (100 - 300um, 1ml), Bead Block (300 - 500um, 1ml), Bead Block (500 - 700um, 1ml), Bead Block (700 - 900μm, 1ml), Bead Block (900 - 1200μm, 1ml), Bead Block (100 - 300um, 2ml), Bead Block (300 - 500um, 2ml), Bead Block (500 - 700μm, 2ml), Bead Block (700 - 900μm, 2ml), Bead Block (900 - 1200um, 2ml) Regulation Number: 21 CFR 876.5550 Regulation Name: Prostatic Artery Embolization Device Regulatory Class: II Product Code: NOY Dated: March 3, 2021 Received: March 4, 2021

Dear Christina Fischer:

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

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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 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 (QS) 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 ([e-mail]) or phone [phone] or 301-796-7100).

Sincerely,

for Mark Antonino, M.S. Assistant Director DHT3B: Division of Reproductive. Gynecology and Urology Devices OHT3: Office of GastroRenal, ObGyn, General Hospital and Urology Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health

Enclosure

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## Indications for Use

Submission Number (if known)

| K203276 |
|--------------------------------------------|
| Device Name |
| Bead Block (100 - 300μm, 1 ml) (EB1S103); |
| Bead Block (300 - 500μm, 1 ml) (EB1S305); |
| Bead Block (500 - 700μm, 1 ml) (EB1S507); |
| Bead Block (700 - 900μm, 1 ml) (EB1S709); |
| Bead Block (900 - 1200μm, 1 ml) (EB1S912); |
| Bead Block (100 - 300μm, 2 ml) (EB2S103); |
| Bead Block (300 - 500μm, 2 ml) (EB2S305); |
| Bead Block (500 - 700μm, 2 ml) (EB2S507); |
| Bead Block (700 - 900μm, 2 ml) (EB2S709); |
| Bead Block (900 - 1200μm, 2 ml) (EB2S912) |

Indications for Use (Describe)

Bead Block microspheres are intended to be used for the embolization of hypervascular tumours, including uterine fibroids (UFE) and arteriovenous malformations (AVMs). Bead Block microspheres are also intended 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)

#### CONTINUE ON A SEPARATE PAGE IF NEEDED.

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| 510(k) Summary | | | K203276<br>Page 1 of 3 | |
|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--|------------------------|--------------|
| Contact Details | | | 21 CFR 807.92(a)(1) | |
| Applicant Name | Biocompatibles UK Ltd (part of Boston Scientific Corporation) | | | |
| Applicant Address | Chapman House, Weydon Lane Surrey Farnham GU9 8QL United<br>Kingdom of Great Britain and Northern Ireland | | | |
| Applicant Contact Telephone | [phone] | | | |
| Applicant Contact | Mrs. Christina Fischer | | | |
| Applicant Contact Email | [e-mail] | | | |
| Device Name | 21 CFR 807.92(a)(2) | | | |
| Device Trade Name | Bead Block (100 - 300µm, 1 ml) (EB1S103);<br>Bead Block (300 - 500µm, 1 ml) (EB1S305);<br>Bead Block (500 - 700µm, 1 ml) (EB1S507);<br>Bead Block (700 - 900µm, 1 ml) (EB1S709);<br>Bead Block (900 - 1200µm, 1 ml) (EB1S912);<br>Bead Block (100 - 300µm, 2 ml) (EB2S103);<br>Bead Block (300 - 500µm, 2 ml) (EB2S305);<br>Bead Block (500 - 700µm, 2 ml) (EB2S507);<br>Bead Block (700 - 900µm, 2 ml) (EB2S709);<br>Bead Block (900 - 1200µm, 2 ml) (EB2S912) | | | |
| Common Name | Prostatic artery embolization device | | | |
| Classification Name | Agents, Embolic, For Treatment Of Benign Prostatic Hyperplasia | | | |
| Regulation Number | 876.5550 | | | |
| Product Code | NOY | | | |
| Legally Marketed Predicate Devices | 21 CFR 807.92(a)(3) | | | |
| Predicate # | Predicate Trade Name (Primary Predicate is listed first) | | | Product Code |
| DEN160040 | Embosphere Microspheres | | | NOY |
| K150876 | Bead Block | | | KRD |
| 21 CFR 807.92(a)(4) | | | | |
| Device Description Summary | | | | |
| Bead Block, a permanent intravascular implant, is made up of preformed soft, compressible, biocompatible, hydrophilic, non-resorbable<br>and precisely calibrated microspheres that occlude vessels for the purpose of blocking the blood flow to a target tissue. Bead Block<br>compressible microspheres consist of a macromer derived from polyvinyl alcohol (PVA). The fully polymerized microsphere is<br>approximately 90-95% water and is compressible to approximately 30% by diameter. Bead Block microspheres are dyed blue to aid in<br>the visualization of the microspheres in the delivery syringe. The microspheres can be suspended in contrast agents and delivered<br>through microcatheters to the target location.<br>Bead Block is available in bead sizes from 100 – 1200µm and supplied sterile in 20ml syringes which contain 1 or 2 ml of beads<br>suspended in 6 or 5 ml of phosphate buffered saline, respectively. The different bead sizes of the product are differentiated by differently<br>colored labels and syringe end caps. | | | | |

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Bead Block is provided as a single use, non-pyrogenic, sterile (steam sterilized) device.

## Intended Use/Indications for Use

Bead Block microspheres are intended to be used for the embolization of hypervascular tumours, including uterine fibroids (UFE) and arteriovenous malformations (AVMs). Bead Block microspheres are also intended for embolization of prostatic arteries (PAE) for symptomatic benign prostatic hyperplasia (BPH).

## Indications for Use Comparison

The subject device Bead Block and the predicate device Embospheres have the same intended use and indications for use. They are both intended for the embolization of hypervascular tumors, including uterine fibroids and for prostatic artery embolization for benign prostate hyperplasia. The subject device Bead Block has the same intended use (embolization of vessels) compared to the reference device, Bead Block (K150876) with an extension of the indication for use to include prostatic artery embolization.

# Technological Comparison

The subject device Bead Block and the predicate device Embospheres are size calibrated spherical microspheres delivered by microcatheters to occlude a target blood vessel. They have similar technological characteristics including the following: - Size callbrated microspheres for embolization in similar size ranges (Bead Block 100 - 1200um). The Bead Block size intended to be used for PAE (100 - 300μm) are identically available for the primary predicate device

- Steam sterilized, single use device

- Biocompatible, non-resorbable polymer

- Delivery via microcatheter to the site of desired embolization

- Visualization of the embolization process using radiographic imaging

Bead Block and the predicate device have minor different technological characteristics, as the subject device is made of polyvinyl alcohol and the predicate device is made of acrylic polymer and porcine delatin. However, the difference in technological characteristics between the subject and predicate device do not raise different questions of safety and effectiveness.

The Bead Block microspheres (subject device) are identical to the reference device, Biocompatible's Bead Block (K150876) in design / technological characteristics, manufacturing, material, packaging, sterilization method and principle of operation. MR safety is added to the labeling for Bead Block based on a scientific rational referring to the non-ferrous composition of the device.

#### Non-Clinical and/or Clinical Tests Summary & Conclusions 21 CFR 807 92(b)

The determination of substantial equivalence, for the Indication for Use to include prostatic artery embolization, did not require non-clinical performance testing performance testing, which includes bench testing, biocompatibility testing and animal studies, submitted in previous premarket submissions remain valid for Bead Block microspheres.

Previous bench testing of Bead Block included determination of residuals (starting material, solvents), visual defects, color, solution clarity), catheter delivery, including catheter clogging, formation of aggregates, ease of injection, and shape of embolization particle after injection of size range, particle fiber shedding, pH, packaging integrity, shelf life, sterility and endotoxins.

Previous biocompatibility testing for Bead Block included genotoxicity, implantation, sensitization, intracutaneous reactivity as well as acute, subchronic toxicity testing. The studies have shown that the Bead Block material is biocompatible for its intended use.

Six animal studies were previously performed for Bead Block to demonstrate the safety and effectiveness of Bead in its intended use as an embolic agent. These studies were conducted employing a swine arteriovenous malformation model, rabit, swine, and sheep renal and uterus embolization model in sheep uterus. Comparison to the predicate device Embosphere was studied in the swine model and similar behavior of the embolic devices was shown.

Bead Block is MR Safe, based on scientific rationale as per the requirements in the Guidance for Industry and Food and Drug Administration Staff Establishing Safety and Compatibility of Passive Implants in the Magnetic Resonance (MR) environment (Dec 2014). Bead Block's materials are non-ferrous therefore supporting the conclusion of MR Safe in the MR environment.

A retrospective data review was designed to collect data on the effects of Bead Block on safety as well as effectiveness. The data review assessed International Prostate Symptom Score (IPSS), erectile function (IIEF), Quality of Life (QoL), Prostate volume (PV) and objective measures of urinary flow in male patients with moderate to severe lower urinary tract symptoms (LUTS) due to BPH who underwent PAE procedure.

Overall, 232 patients were included in this study. Bead Block 100-300 um was used in 3 patients (1%), 300-500 um in 220 patients (95%) and unknown bead size in 9 patients (4%).

## 21 CFR 807.92(a)(5)

21 CFR 807.92(a)(6)

FR 807.92(a)(5)

K203276

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### K203276

Page 3 of 3

Baseline Characteristics (no of patients) Age (years) 65.2 ± 8.2 (226) IPSS 21.8 ± 7.0 (167) Quality of Life (QoL) 4.3 ± 1.0 (168) Prostate Volume (ml) 86.4 ± 47.4 (180) Qmax (peak urinary flow) (ml/s) 10.4 ± 6.5 (154) PVR (Post-void residual volume) (ml) 105.2 ± 116.7 (154)

The results show that at 12 months post-embolization, 85% of patients treated with Bead Block reported a decrease in their total IPSS by at least 3 points, and 62% patients dropped at least 1 symptom category, from severe to moderate to mild. Statistically significant and clinically relevant in total IPSS, QoL, PSA and prostate volume at 12 months (p<0.001) has been observed. Maximum urine flow (Qmax) and post-void residual (PVR) also showed improvement tendency at 12 months (p = 0.059 and 0.1). PAE using Bead Block did not impair sexual function as measured by IIEF.

Observed adverse events (AEs) were generally non-serious and transient. Overall, 149/232 patients (64.2%) reported at least one AE over the course of the study, most commonly renal and urinary disorders which were reported by 128 patients (15.2%). Dysuria (reported by 96/232 patients (41.4%)) and pollakiuria (reported by 105/232 patients (45.3%)) were the most common AEs.

Based on the technological characteristics and intended use along with the non-clinical and clinical data for Bead or referenced in this submission, it has been demonstrated that Bead Block used for the prostatic artery for treatment of benign prostatic hyperplasia is an effective and well tolerated treatment in the study population, with comparable outcomes to Embosphere Microspheres. Bead Block is considered substantially equivalent to the predicate Embospheres in safety and effectiveness for the embolization of the prostatic artery for treatment of benign prostatic hyperplasia.

Bead Block demonstrates compliance with the Special Controls under 21 CFR876.5550 for the expanded indication for use to include prostatic artery embolization. In addition, Bead Block is demonstrated to be MR safe ial characteristics in alignment with the requirements of the Guidance Document Establishing Safety and Compatibility of Passive Implants in the Magnetic Resonance (MR) Environment. The expansion of the indication for use and the addition of MR compatibility information to not raise new questions of safety or effectiveness.