Bearing nsPVA Express™

K233813 · Merit Medical Systems, Inc. · NAJ · Dec 21, 2023 · Cardiovascular

Device Facts

• Record ID: K233813
• Device Name: Bearing nsPVA Express™
• Applicant: Merit Medical Systems, Inc.
• Product Code: NAJ · Cardiovascular
• Decision Date: Dec 21, 2023
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 870.3300
• Device Class: Class 2
• Attributes: Therapeutic, PCCP

Intended Use

Bearing nsPVA Particles are used for the embolization of peripheral hypervascularized tumors, including leiomyoma uteri and peripheral arteriovenous malformations (AVMs). Do not use particles smaller than 355 microns for the treatment of leiomyoma uteri.

Device Story

Bearing nsPVA Express™ consists of irregularly-shaped, hydrophilic, non-resorbable, crosslinked poly(vinyl alcohol) particles used for vascular occlusion. Particles are provided sterile in a 20 mL polycarbonate syringe with a luer-lock connector. Physician selects particle size (45-1180 μm) based on target vessel diameter. Device is used in clinical settings for embolization of peripheral hypervascularized tumors and AVMs. Particles are delivered via catheter to the target vessel to reduce blood flow. The syringe-based delivery system simplifies preparation compared to vial-based predecessors. Output is mechanical vascular occlusion; clinical benefit is tumor devascularization or AVM flow reduction.

Clinical Evidence

Bench testing only. No clinical data. Testing included sterilization validation (ISO 11137-2, ISO 11737-1/2), pyrogenicity (USP <85>), design verification (visual inspection, hydration, suspension), and packaging integrity (ISO 11607-1/2, ASTM F1140, F1980, F2096, F88). Biocompatibility of the polycarbonate syringe was confirmed per ISO 10993-1 (cytotoxicity, sensitization, irritation, systemic toxicity, hemocompatibility, pyrogenicity).

Technological Characteristics

Material: 100% crosslinked poly(vinyl alcohol). Form: Irregularly-shaped particles in 7 size ranges (45-1180 μm). Delivery: 20 mL polycarbonate syringe. Sterilization: Gamma radiation. Standards: ISO 10993-1, ISO 11137-2, ISO 11737-1/2, ISO 11607-1/2, ASTM F1140, ASTM D4169, ASTM F1980, ASTM F2096, ASTM F88, USP <85>.

Indications for Use

Indicated for embolization of peripheral hypervascularized tumors, including leiomyoma uteri and peripheral arteriovenous malformations (AVMs). Contraindicated for use of particles smaller than 355 microns in leiomyoma uteri treatment.

Regulatory Classification

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.

Special Controls

*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).

Predicate Devices

• Bearing™ nsPVA Embolization Particles (K130259)

Submission Summary (Full Text)

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December 21, 2023

Merit Medical Systems, Inc. % Yves Wong Regulatory Affairs Specialist Biosphere Medical, S.A. Parc des Nations - Paris Nord 2 383 rue de la Belle Etoile Roissy-en-France, 95700 France

Re: K233813

Trade/Device Name: Bearing nsPVA Express™ Regulation Number: 21 CFR§ 870.3300 Regulation Name: Vascular Embolization Device Regulatory Class: II Product Code: NAJ, KRD Dated: November 30, 2023 Received: November 30, 2023

Dear Yves Wong:

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 (the 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 available 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.

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FDA's substantial equivalence determination also included the review and clearance of your Predetermined Change Control Plan (PCCP). Under section 515C(b)(1) of the Act, a new premarket notification is not required for a change to a device cleared under section 510(k) of the Act, if such change is consistent with an established PCCP granted pursuant to section 515C(b)(2) of the Act. Under 21 CFR 807.81(a)(3), a new premarket notification is required if there is a major change or modification in the intended use of a device. or if there is a change or modification in a device that could significantly affect the safety or effectiveness of the device, e.g., a significant change or modification in design, material, chemical composition, energy source, or manufacturing process. Accordingly, if deviations from the established PCCP result in a major change or modification in the intended use of the device, or result in a change or modification in the device that could significantly affect the safety or effectiveness of the a new premarket notification would be required consistent with section 515C(b)(1) of the Act and 21 CFR 807.81(a)(3). Failure to submit such a premarket submission would constitute adulteration and misbranding under sections 501(f)(1)(B) and 502(o) of the Act, respectively.

Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device" (https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download).

Your device is also subject to, among other requirements, the Quality System (QS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30, Design controls; 21 CFR 820.90, Nonconforming product; and 21 CFR 820.100. Corrective and preventive action. Please note that regardless of whether a change requires premarket review, the QS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181).

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 Part 803) for devices or postmarketing safety reporting (21 CFR Part 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 Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050.

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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.

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For comprehensive regulatory information about medical devices and radiation-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,

# Reginald K. Avery -S

for Jason R. Roberts, Ph.D. 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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#### DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration

#### Indications for Use

Form Approved: OMB No. 0910-0120 Expiration Date: 07/31/2026 See PRA Statement below.

510(k) Number (if known) K233813

Device Name Bearing nsPVA Express™

Indications for Use (Describe)

Bearing nsPVA Particles are used for the embolization of peripheral hypervascularized tumors, including leiomyoma uteri and peripheral arteriovenous malformations (AVMs).

Do not use particles smaller than 355 microns for the treatment of leiomyoma uteri.

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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FORM FDA 3881 (8/23)

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| 510(k) Summary | | |
|-------------------------------------------------------------------------|-------------------------|----------------------------------------------------------------------------------------------------------------------|
| General<br>Provisions | Submitter Name: | Merit Medical Systems, Inc. |
| | Address: | 1600 West Merit Parkway<br>South Jordan, UT 84095 |
| | Telephone Number: | [phone] |
| | Contact Person: | Mark Mullaney |
| | Registration Number: | 1721504 |
| | Correspondent Name: | Merit / Biosphere Medical, S.A. |
| | Address: | Parc des Nations - Paris Nord 2,<br>383 rue de la Belle Etoile<br>95700 Roissy-en-France, France |
| | Telephone Number: | [phone] |
| | Fax Number: | [phone] |
| | Contact Person: | Yves Wong |
| | Date of Preparation: | December 19, 2023 |
| | Registration Number: | 9615728 |
| Subject<br>Device | Trade Name: | Bearing nsPVA Express™ |
| | Common/Usual Name: | Polyvinyl Alcohol Embolic Microspheres |
| | Class: | II |
| | Product code: | NAJ (Agents, Embolic, For Treatment of Uterine<br>Fibroids)<br>KRD (Device, Vascular, For Promoting<br>Embolization) |
| | Classification Name: | Vascular Embolization Device |
| | Regulation Number: | 21 CFR 870.3300 |
| | Manufacturer: | Merit Medical Systems, Inc. |
| Predicate<br>Device | Trade Name: | Bearing™ nsPVA Embolization Particles |
| | Premarket Notification: | K130259 |
| | Manufacturer: | Merit Medical Systems, Inc. |
| The predicate device has not been subject to any design-related recall. | | |

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Bearing nsPVA particles are irregularly-shaped, hydrophilic, non-resorbable particles made of 100% crosslinked poly(vinyl alcohol). These embolization particles are intended to provide vascular occlusion or reduction of blood flow within target vessels upon placement through a catheter.

The particles of the subject device, the Bearing nsPVA Express, are provided sterile and for single use in a 20 mL polycarbonate syringe with a luer-lock connector, individually packaged in a sterile foil peel pouch.

Bearing nsPVA particles are calibrated and available in 7 size ranges (see table below) to enable the physician to choose depending on the diameter of the vessel to be embolized. Each syringe contains 100 mg of Bearing nsPVA particles.

| Device<br>Description | Reference Code | Particle Size (μm) | Packaging Color Code |
|-----------------------|----------------|--------------------|----------------------|
| | S100EP | 45-150 | Yellow |
| | S200EP | 150-250 | Purple |
| | S300EP | 250-355 | Dark Blue |
| | S400EP | 355-500 | Green |
| | S600EP | 500-710 | Orange |
| | S800EP | 710-1000 | Light Blue |
| | S1100EP | 1000-1180 | Red |

Bearing nsPVA is used for the embolization of peripheral hypervascularized tumors, including leiomyoma uteri and peripheral arteriovenous malformations Indications (AVMs). For Use Do not use particles smaller than 355 microns for the treatment of leiomyoma uteri.

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| | Device &<br>Predicate<br>Device(s): | K233813 | | K130259 | | Comment |
|----------------------------|---------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------|-----------|
| Comparison<br>to Predicate | Device &<br>Predicate<br>Device(s): | Bearing nsPVA<br>Embolization Particles in<br>syringe | | Bearing nsPVA<br>Embolization Particles in<br>vial | | Similar |
| | Indications | Bearing nsPVA is used for<br>the embolization of<br>peripheral<br>hypervascularized tumors,<br>including leiomyoma uteri<br>and peripheral<br>arteriovenous<br>malformations (AVMs).<br><br>Do not use particles smaller<br>than 355 microns for the<br>treatment of leiomyoma<br>uteri. | | Bearing nsPVA is used<br>for the embolization of<br>peripheral<br>hypervascularized<br>tumors, including<br>leiomyoma uteri and<br>peripheral arteriovenous<br>malformations (AVMs).<br><br>Do not use particles<br>smaller than 355<br>microns for the<br>treatment of leiomyoma<br>uteri. | | Same |
| | Shape of<br>particle | Irregular | | Irregular | | Same |
| | Particle size<br>(µm) | 45-150<br>150-250<br>250-355<br>355-500<br>500-710<br>710-1000<br>1000-1180 | | 45-150<br>150-250<br>250-355<br>355-500<br>500-710<br>710-1000<br>1000-1180 | | Same |
| | Delivery<br>Catheter<br>Minimum Inner<br>Diameter<br>(inches) | 0.020 | For particles<br>size (µm):<br>45-150<br>150-250<br>250-355<br>355-500 | 0.020 | For particles<br>size (µm):<br>45-150<br>150-250<br>250-355<br>355-500 | Same |
| | | 0.024 | For particles<br>size (µm):<br>500-710 | 0.024 | For particles<br>size (µm):<br>500-710 | Same |
| | | 0.027 | For particles<br>size (µm):<br>710-1000 | 0.027 | For particles<br>size (µm):<br>710-1000 | Same |
| | | 0.040 | For particles<br>size (µm):<br>1000-1180 | 0.040 | For particles<br>size (µm):<br>1000-1180 | Same |
| | Packaging | Sealed polycarbonate<br>syringe within peel away<br>pouch | | Sealed glass vial within<br>peel away pouch | | Different |
| | Sterilization | Gamma radiation | | Gamma radiation | | Same |
| | Shelf Life | 12 months | | 36 months | | Different |

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The subject device, Bearing nsPVA Express™, is packaged in a polycarbonate syringe and the predicate device, Bearing nsPVA Embolization Particles, are packaged in a glass vial. Both devices have the same intended use, and use the same embolization particle components and materials, with the same sizes available. The subject device has a 12 month shelf life while the predicate device has a 3 year shelf life. However, the differences do not raise different questions of safety and effectiveness for the subject device.

Where appropriate, the tests were based on the requirements of the following documents:

- . FDA guidance document: Use of International Standard ISO-10993-1, "Biological Evaluation of Medical Devices Part 1: Evaluation and Testing Within a Risk Management Process"
- . FDA Guidance - Class II Special Controls Guidance Document: Vascular and Neurovascular Embolization Devices (December 29, 2004)
- . FDA Guidance - "Submission and Review of Sterility Information in Premarket Notification (510(k)) Submissions for Devices Labelled as Sterile" - January 2016
- ISO 15223-1 Fourth edition 2021-07 Medical devices Symbols to be used ● with information to be supplied by the manufacturer - Part 1: General requirements

## Safety &

Performance The following is a list of all testing that was successfully completed to support the Tests determination of substantial equivalence.

#### Sterilization Validation

Bearing nsPVA Express are provided sterile and also labeled "non-pyrogenic." The subject device is sterilized by gamma radiation. The following testing was performed:

- . Sterilization validation was completed to a sterility assurance level (SAL) of 10-6 per the following standards:
- ISO 11137-2:2013/Amd1:2022 Sterilization of Health Care с Products - Radiations - Part 2: Establishing the sterilization dose.
- ISO 11737-1: 2018-01 [Including AMD1:2021] Sterilization of health O care products - Microbiological methods - Part 1: Determination of a population of microorganisms on product [Including Amendment 1 (2021)].

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- ISO 11737-2 Third edition 2019-12 Sterilization of medical devices o Microbiological methods - Part 2: Tests of sterility performed in the definition, validation and maintenance of a sterilization process
- Pyrogenicity .
- The Bearing nsPVA Express underwent routine pyrogen testing for O each lot, utilizing the Limulus Amebocyte Lysate (LAL) test in accordance with USP General Chapter <85>, Bacterial Endotoxins Test, and successfully met the acceptance criteria.
- The acceptance criteria limit of < 20.0 EU/device, in accordance O with the standards specified in the "FDA Guidance for Industry: Pyrogen and Endotoxins Testing: Questions and Answers," issued in June 2012 (section III.11) for general medical devices (blood contacting and implanted), was successfully met.

#### Design Verification (Performance) Testing

- Product: ●
- o nsPVA particles visual inspection
- . Foreign particles inside the nsPVA syringe
- l Cleanliness and white color of nsPVA particles
- nsPVA particles outside syringe O
- nsPVA particles moisture content O
- nsPVA particles hydration and suspension o
- Packaging: ●
- Compatibility of the syringe with contrast media O
- Visual inspections (syringe, pouch, carton and labels) O
- Pouch seal width O
- Pouch peel force O
- O Pouch burst test
- Pouch underwater bubble emission O

The following standards were used for evaluation of packaging verification:

- ISO 11607-1 Second edition 2019-02 Packaging for terminally sterilized ● medical devices - Part 1: Requirements for materials sterile barrier systems and packaging systems.
- ISO 11607-2 Second edition 2019-02 Packaging for terminally sterilized . medical devices - Part 2: Validation requirements for forming sealing and assembly processes.

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- . ASTM F1140/F1140M-13 (Reapproved 2020)e1 Standard Test Methods for Internal Pressurization Failure Resistance of Unrestrained Packages
- ASTM D4169-22 Standard Practice for Performance Testing of Shipping ● Containers and Systems
- ASTM F1980-21 Standard Guide for Accelerated Aging of Sterile Barrier ● Systems for Medical Devices
- . ASTM F2096-11 Standard Test Method for Detecting Gross Leaks in Packaging by Internal Pressurization (Bubble Test)
- . ASTM F88/F88M-21 Standard Test Method for Seal Strength of Flexible Barrier Materials

#### Biocompatibility Testing:

There was no change to the Bearing nsPVA embolic particles. Therefore, biocompatibility testing was not repeated for the embolic particles. However, as the packaging of the embolic particles has changed from a glass vial to a polycarbonate syringe, biocompatibility testing was conducted specifically on the 20mL Polycarbonate Syringe of the Bearing nsPVA Express. The syringe is an external communicating device with a blood path that is indirect, and the contact duration is <24 hours. This testing was performed in accordance with the 2023 FDA guidance document, "Use of International Standard ISO 10993-1, Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process." The biocompatibility testing results, provided in the table below, demonstrate that the Bearing nsPVA Express syringe is biocompatible.

| Biological Endpoint | Test Method | Results |
|-----------------------------------|------------------------------|-----------------------------------|
| Cytotoxicity | ISO 10993-5 | Non-Cytotoxic |
| Sensitization | ISO 10993-10 | Non-Sensitizing |
| Intracutaneous Irritation | ISO 10993-10<br>ISO 10993-23 | Non-irritating |
| Acute Systemic Toxicity | ISO 10993-11 | Not acutely systemically<br>toxic |
| Hemocompatibility | ISO 10993-4<br>ASTM F756-17 | Non-hemolytic |
| Material Mediated<br>Pyrogenicity | ISO 10993-11 | Non-pyrogenic |

Based on the non-clinical data, the subject device, Bearing nsPVA Express™, is Summary of as safe and effective as the predicate device Bearing nsPVA Embolization Substantial Particles. Therefore, the subject device is substantially equivalent to the predicate Equivalence device.