(21 days)
Not Found
No
The document describes a physical embolization particle and its intended use, material composition, and packaging. There is no mention of software, algorithms, or any computational processing that would suggest the use of AI or ML. The "Mentions AI, DNN, or ML" and "Mentions image processing" sections are explicitly marked as "Not Found".
Yes
The device is described as "embolization particles" intended for "vascular occlusion or reduction of blood flow" to treat conditions like "peripheral hypervascularized tumors" and "peripheral arteriovenous malformations (AVMs)," which are therapeutic interventions.
No
The device is used for embolization of tumors and AVMs, which is a treatment procedure, not a diagnostic one. It functions by causing vascular occlusion or reduction of blood flow, not by detecting or identifying a condition.
No
The device description clearly states that the device is composed of physical particles made of crosslinked poly(vinyl alcohol) and is provided in a syringe. This indicates a physical medical device, not a software-only one.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In vitro diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections. They are used to provide information for diagnosis, monitoring, or screening.
- Device Function: The description clearly states that Bearing nsPVA Particles are used for the embolization of peripheral hypervascularized tumors and AVMs. This is a therapeutic procedure performed within the body to block blood vessels.
- No Sample Analysis: The device is directly introduced into the patient's vascular system and does not involve the analysis of a sample taken from the body.
Therefore, this device falls under the category of a therapeutic medical device, not an in vitro diagnostic device.
Yes
The "Predetermined Change Control Plan (PCCP) - All Relevant Information" section explicitly states: "FDA's substantial equivalence determination also included the review and clearance of your Predetermined Change Control Plan (PCCP)." This directly confirms that the device is authorized under a PCCP.
Intended Use / Indications for 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.
Product codes (comma separated list FDA assigned to the subject device)
NAJ, KRD
Device Description
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Peripheral hypervascularized tumors, including leiomyoma uteri and peripheral arteriovenous malformations (AVMs).
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)
Sterilization Validation:
- Sterilization validation was completed to a sterility assurance level (SAL) of 10-6 per ISO 11137-2:2013/Amd1:2022 and ISO 11737-1: 2018-01 [Including AMD1:2021].
- Tests of sterility performed in accordance with ISO 11737-2 Third edition 2019-12.
Pyrogenicity:
- Bearing nsPVA Express underwent routine pyrogen testing for each lot, utilizing the Limulus Amebocyte Lysate (LAL) test in accordance with USP General Chapter , Bacterial Endotoxins Test.
- Successfully met the acceptance criteria limit of
§ 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/0 description: The image contains the logos of the Department of Health and Human Services and the Food and Drug Administration (FDA). The Department of Health and Human Services logo is on the left, and the FDA logo is on the right. The FDA logo includes the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue text.
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.
1
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.
2
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 (DICE@fda.hhs.gov) or phone (1-800-638-2041 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
3
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)
CONTINUE ON A SEPARATE PAGE IF NEEDED.
This section applies only to requirements of the Paperwork Reduction Act of 1995.
DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.
The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:
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"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."
FORM FDA 3881 (8/23)
4
| 510(k) Summary | ||
|---|---|---|
| General | ||
| Provisions | Submitter Name: | Merit Medical Systems, Inc. |
| Address: | 1600 West Merit Parkway | |
| South Jordan, UT 84095 | ||
| Telephone Number: | +353 91 703761 | |
| Contact Person: | Mark Mullaney | |
| Registration Number: | 1721504 | |
| Correspondent Name: | Merit / Biosphere Medical, S.A. | |
| Address: | Parc des Nations - Paris Nord 2, | |
| 383 rue de la Belle Etoile | ||
| 95700 Roissy-en-France, France | ||
| Telephone Number: | +33 1 48 17 48 23 | |
| Fax Number: | +33 1 49 38 02 68 | |
| Contact Person: | Yves Wong | |
| Date of Preparation: | December 19, 2023 | |
| Registration Number: | 9615728 | |
| Subject | ||
| Device | Trade Name: | Bearing nsPVA Express™ |
| Common/Usual Name: | Polyvinyl Alcohol Embolic Microspheres | |
| Class: | II | |
| Product code: | NAJ (Agents, Embolic, For Treatment of Uterine | |
| Fibroids) | ||
| KRD (Device, Vascular, For Promoting | ||
| Embolization) | ||
| Classification Name: | Vascular Embolization Device | |
| Regulation Number: | 21 CFR 870.3300 | |
| Manufacturer: | Merit Medical Systems, Inc. | |
| Predicate | ||
| 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. |
5
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
| 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.
6
| | Device &
Predicate
Device(s): | K233813 | | K130259 | | Comment |
|----------------------------|---------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------|-----------|
| Comparison
to Predicate | Device &
Predicate
Device(s): | Bearing nsPVA
Embolization Particles in
syringe | | Bearing nsPVA
Embolization Particles in
vial | | Similar |
| | Indications | Bearing nsPVA is 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. | | Bearing nsPVA is 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. | | Same |
| | Shape of
particle | Irregular | | Irregular | | Same |
| | Particle size
(µm) | 45-150
150-250
250-355
355-500
500-710
710-1000
1000-1180 | | 45-150
150-250
250-355
355-500
500-710
710-1000
1000-1180 | | Same |
| | Delivery
Catheter
Minimum Inner
Diameter
(inches) | 0.020 | For particles
size (µm):
45-150
150-250
250-355
355-500 | 0.020 | For particles
size (µm):
45-150
150-250
250-355
355-500 | Same |
| | | 0.024 | For particles
size (µm):
500-710 | 0.024 | For particles
size (µm):
500-710 | Same |
| | | 0.027 | For particles
size (µm):
710-1000 | 0.027 | For particles
size (µm):
710-1000 | Same |
| | | 0.040 | For particles
size (µm):
1000-1180 | 0.040 | For particles
size (µm):
1000-1180 | Same |
| | Packaging | Sealed polycarbonate
syringe within peel away
pouch | | Sealed glass vial within
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)].
8
- 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 , Bacterial Endotoxins Test, and successfully met the acceptance criteria.
- The acceptance criteria limit of