(126 days)
Bearing ™ nsPVA Embolization 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.
The Bearing™ nsPVA Embolization Particles are particles of They are noncross-linked polyvinyl alcohol (PVA). resorbable (permanent), hydrophilic and deformable particles that can be injected through a variety of catheters, depending on the size range, and are generally mixed with radiopaque contrast agent prior to their injection.
The provided text describes Merit Medical Systems, Inc.'s Bearing™ nsPVA Embolization Particles and their substantial equivalence to a predicate device, Boston Scientific's Contour™ Embolization Particles. The submission centers around demonstrating that the new device has characteristics that are substantially equivalent to a device already on the market, rather than proving performance against specific acceptance criteria through a full-scale clinical study with a detailed test set, ground truth, and statistical analysis as would be done for novel devices or AI systems.
Therefore, many of the requested elements for describing "acceptance criteria and the study that proves the device meets the acceptance criteria" are not directly applicable or explicitly stated in the context of this 510(k) summary, which relies on the concept of "substantial equivalence."
Here's an attempt to extract and interpret the information based on the provided document, addressing each point as much as possible:
1. A table of acceptance criteria and the reported device performance
The document does not present a formal table of "acceptance criteria" for clinical performance with specific metrics like sensitivity, specificity, or accuracy that would be typical for an AI/diagnostic device. Instead, the "acceptance criteria" are implied by the demonstration of substantial equivalence to an existing predicate device based on various non-clinical tests and a literature review.
The "reported device performance" is essentially that the Bearing™ nsPVA Embolization Particles perform equivalently to the predicate device, Contour™ Embolization Particles, in achieving vascular occlusion for the indicated uses.
Here's a summary of the types of performance aspects assessed:
| Acceptance Criteria (Implied by Substantial Equivalence to Predicate) | Reported Device Performance |
|---|---|
| Material Composition (Same chemical formula, structure, process materials, cross-linking) | Chemical Analysis: Subject and predicate devices are characterized as having the same chemical formula (polyvinyl alcohol), chemical structure, residual process materials, and degree of cross-linking. |
| Mechanical & Physical Properties (Ability to allow embolization to desired location via catheters, occlusion mechanism) | Demonstrated through various tests: - Polyvinyl Alcohol (PVA) Particle Testing - Particle Size Ranges (granulometry) - Assessment of Particle Size Compatibility with Recommended Delivery Catheter(s) - Evaluation of the Uniform Dispersion and Suspension of Particles within a Catheter. The principle of operation is stated as the same. |
| Intended Use (Embolization of peripheral hypervascularized tumors, including leiomyoma uteri and peripheral AVMs) | Same indications for use as the predicate device. |
| Safety & Biocompatibility (Non-toxic, non-pyrogenic, sterile, no adverse biological reactions) | Biocompatibility: Conforms to ISO 10993 standards (e.g., cytotoxicity, irritation, sensitization, systemic toxicity, implantation effects). Sterilization: Conforms to ISO and NF EN standards for sterility assurance (SAL 10-6). Endotoxins: Tested on each batch, limit per device 20 EU, labeled nonpyrogenic. |
| Shelf Life & Packaging (Maintains integrity and sterility over time) | Packaging Performance: Visual inspection, bubble emission, peel strength, sterile barrier maintenance after simulated transportation/storage. Accelerated Aging: Product (visual inspection, granulometric, residual formaldehyde, IR analysis) and Primary Packaging (visual inspection, seal width, label inspection, burst test, seal strength test). |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Sample Size for Test Set: Not applicable in the traditional sense of a clinical trial test set. The validation was primarily based on non-clinical bench testing and a literature review.
- Data Provenance: The literature review analyzed existing clinical data on PVA particles. The document does not specify the country of origin of this data but refers to "medical/scientific databases, PubMed, and Cochrane Database of Systematic Reviews (CDSR)." This implies a broad, international scope of retrospective clinical evidence.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
Not applicable. There was no specific "test set" requiring expert ground truth establishment for this 510(k) submission, as it relied on non-clinical testing and a review of existing clinical literature for similar devices.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable. No clinical test set requiring adjudication was performed.
5. 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 device is an embolization particle, not an AI-assisted diagnostic tool.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This device is an embolization particle, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
For the literature review, the "ground truth" would be the clinical outcomes and safety profiles reported in previously conducted clinical trials and applications of similar PVA embolic devices. The document states that "the absence of materovigilance reports concerning similar PVA embolic devices are sufficient to establish the efficacy and safety." This points towards real-world outcomes data and safety surveillance as the basis.
For the non-clinical tests, the "ground truth" was established by standard laboratory testing methods (e.g., chemical analysis, granulometry, biocompatibility assays) comparing the subject device's properties to established norms or the predicate device's characteristics.
8. The sample size for the training set
Not applicable. This device is an embolization particle, not a machine learning model, so there is no "training set."
9. How the ground truth for the training set was established
Not applicable. No training set was used.
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JUN 7 2013
MERIT MEDICAL SYSTEMS, INC
1600 WEST MERIT PARKWAY
SOUTH JORDAN, UTAH 84095
PHONE 801-253-1600
FAX 801-253-1688
www.merit.com
510(k) Summary
Bearing™ nsPVA Embolization Particles
| Labels | Values |
|---|---|
| Submitter Name: | Merit Medical Systems, Inc. |
| Address: | 1600 West Merit Parkway South Jordan, UT 84095 |
| General Provisions Telephone Number: | (781) 681-7963 |
| Fax Number: | (781) 871-2325 |
| Contact Person: | Linda Varroso |
| Date of Preparation: | January 28, 2013 |
| Registration Number: | 1721504 |
| Labels | Values |
|---|---|
| Trade Name: | Bearing™ nsPVA Embolization Particles |
| Subject Device Common/Usual Name: | PVA Embolization Particles |
| Classification Name: | Vascular Embolization Device |
| Labels | Values |
|---|---|
| Trade Name: | Contour™ Embolization Particles |
| Classification Name: | Vascular Embolization Device |
| Predicate Device Premarket Notification: | K100663 |
| Manufacturer: | Boston Scientific Corporation |
| Labels | Values |
|---|---|
| Class: | II |
| 21 CFR: | 870.3300 |
| Classification FDA Product Code: | KRD and NAJ |
| Review Panel: | Cardiovascular, Obstetrics and Gynecology |
| Labels | Values |
|---|---|
| Intended Use | Bearing ™ nsPVA Embolization 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. |
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Section 5 510(k) Summary
Merit's Bearing™ nsPVA Embolization Particles are irregularly-shaped, biocompatible, hydrophilic, nonresorbable particles produced from polyvinyl alcohol. Bearing™ nsPVA Embolization Particles are contained in a sterile, 15 mL glass vial with a screw top-cap, packaged individually in a sterile peel pouch. Each vial contains 100 mg of Bearing™ nsPVA Embolization Particles, packaged dry. Each sterile vial is intended for single patient use. These embolization particles are intended to provide vascular occlusion or reduction of blood flow within target vessels upon selective placement through a variety of catheters.
Bearing™ nsPVA Embolization Particles are available in a variety of size ranges, depicted below.
| CatalogNumber | SizeRange(μm) | Color Code | Minimum CompatibleCatheter ID(inch) |
|---|---|---|---|
| V100EP | 45-150 | Yellow | |
| V200EP | 150-250 | Purple | 0.020 |
| V300EP | 250-355 | Dark Blue | 0.020 |
| V400EP | 355-500 | Green | |
| V600EP | 500-710 | Orange | 0.024 |
| V800EP | 710-1000 | Light Blue | 0.027 |
| V1100EP | 1000-1180 | Red | 0.040 |
Device Description
The Bearing™ nsPVA Embolization Particles are particles of They are noncross-linked polyvinyl alcohol (PVA). resorbable (permanent), hydrophilic and deformable particles that can be injected through a variety of catheters, depending on the size range, and are generally mixed with radiopaque contrast agent prior to their injection.
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Section 5 510(k) Summary
The technological characteristics of the subject device, Bearing ™ nsPVA Embolization Particles, are substantially equivalent to the predicate device, Boston Scientific's Contour™ Embolization Particles. Based on the results of chemical analysis and testing, the subject and predicate devices are characterized as having the same chemical formula (polyvinyl alcohol). Both devices have the same chemical structure, residual process materials, and degree of cross-linking. The mechanical and physical properties are the same in that the injected particles allow embolization to the desired location in the body through a variety of catheters. The physician injects the particles to the targeted area under fluoroscopic visualization until the desired endpoint has been reached. The Embolization Particles occlude blood flow in a vessel lumen via mechanical means by obstructing the lumen of the vessel after iniection. The occlusion can be the result of a single Embolization Particle obstructing the lumen or aggregation of multiple Embolization Particles creating a mechanical obstruction with thrombus filling the inter-particulate voids. The principle of operation for both devices is the same; they are designed to be used for the embolization of peripheral hypervascularized tumors, including leiomyoma uteri and peripheral arteriovenous malformations (AVMs). The subject and predicate device have the same fundamental design features irregularly shaped dry particle size range characteristics, permanent implant duration of use, and color coded particle size labeling.
There are minor differences between the subject and predicate device. The subject device's recommended catheter's minimum inner diameter (ID) sizes vary slightly from the predicate device. The selection of the ID sizes for the subject device allows more flexibility for the physician to target smaller arteries and deliver embolization particles as distally as possible to desired location. The predicate and subject device Instructions for Use are similar in that the physician is instructed to choose appropriate embolization particle sizes based on clinical presentation that best matches the desired level of occlusion for optimal clinical outcome. In addition, the subject and predicate device shelf life expectancy differs. These minor differences do not affect the safety and efficacy; therefore the subject device is substantially equivalent to the predicate device.
Polyvinyl alcohol particles (PVA) have been used for more than thirty years in the field of embolization for the treatment of peripheral hypervascularized tumors, including leiomyoma uteri (uterine fibroids) and arteriovenous malformations (Specifically Boston Scientific's Contour™ Embolization Particles (K100663).
Comparison to Predicate including
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Section 5 510(k) Summary
Performance Standards and Guidance
No performance standards applicable to this device have been adopted under Section 514 of the Act. However, vascular embolization devices are subject to the special controls specified in "Guidance for Industry and FDA Staff - Class II Controls Guidance Document: Vascular and Special Neurovascular Embolization Devices," December 29, 2004.
Biocompatibility Standards
- · ISO 10993-1:2009, Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process
- · ISO 10993-1:2010, Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process Technical Corrigendum 1
- · ISO 10993-3:2003, Biological evaluation of medical for genotoxicity, Part 3: Tests devices carcinogenicity and reproductive toxicity
- · ISO 10993-4:2002. Biological evaluation of medical devices - Part 4: Selection for tests for interactions with blood
- · ISO 10993-5:2009, Biological evaluation of medical devices Part 5: Tests for in vitro cvtotoxicity
- · ISO 10993-6:2007, Biological evaluation of medical Test for local effects after devices - Part 6: implantation
- · ISO 10993-10:2010, Biological evaluation of medical devices - Part 10: Tests for irritation and skin sensitization
- · ISO 10993-11:2006. Biological evaluation of medical devices - Part 11: Tests for systemic toxicity
- · NF EN ISO 10993-17:2009, Biological evaluation of medical devices- Part 17: Establishment of allowable limits for leachable substances
Sterilization Standards
4
- · NF EN 556-1:2002, Sterilization of medical devices -Requirements for medical devices to be designated "STERILE" - Part 1: Requirements for terminally sterilized medical devices
- · NF EN ISO 11137-1:2006, Medical Sterilization of care products - Radiation - Part 1: health Requirements for development, validation and routine control of a sterilization process for medical devices
Safety & Performance Tests
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| Safety & PerformanceTests,Cont'd | Packaging and Aging Standards |
|---|---|
| ASTM F88:2009, Standard Test Method for SealStrength of Flexible Barrier Methods ASTM F2096:2011, Standard Test Method forDetecting Gross Leaks in Packaging by InternalPressurization (Bubble Test) ASTM D4169-09:2009, Standard Practice forPerformance Testing of Shipping Containers andsystems ISO 2233:2000, Packaging – Complete, filledtransport packaging and unit loads – Conditioning fortesting BS EN ISO 11607:2010, Packaging for terminallysterilized medical devices – Part 1: Requirements formaterials, sterile barrier systems and packagingsystems ASTM F1140-07:2012, Standard Test Methods forInternal Pressurization Failure Resistance ofUnrestrained Packages | |
| The following is a list of all significant testing that wassuccessfully completed: | |
| Polyvinyl Alcohol (PVA) Particle Testing Chemical Analysis of the Final Sterilized Device Removal of Formaldehyde and/or otherProcessing Materials Particle Size Ranges (granulometry) Assessment of Particle Size Compatibility withRecommended Delivery Catheter(s) Evaluation of the Uniform Dispersion andSuspension of Particles within a Catheter (when |
5
mixed with the recommended contrast
labeled instructions.
agents/interactive material(s) according to the
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Section 5 510(k) Summary
Packaging Performance - Packaging Qualification for 5-up Cartons for Merit Bearing™ nsPVA Sterile Pouches/Vials
- . Primary Packaging Performance
- Visual Inspection Bubble Emission Testing .
- Peel Strenath Testing .
- Sterile Barrier Maintenance After Exposure to Simulated Transportation and Storage Conditions
Accelerated Aging
- . Product
- Visual Inspection ಂ
- Granulometric Analysis O
- Residual Formaldehyde O
- IR Analysis o
- Primary Packaging
- Visual Inspection ರ
- Seal width o
- Label Inspection 0
- Burst Test 0
- Seal Strength Test O
Endotoxins:
Endotoxin testing is performed on each batch of Bearing TM nsPVA Embolization particles as they are labeled nonpyrogenic. The limit per device is 20 EU. Labeling indicates that the device is non pvrogenic. Each lot is tested for endotoxin prior to finished product release.
Safety & Performance Tests. Cont'd
Sterility Assurance Level: 10-6.
Clinical Data Review:
Clinical testing was not conducted on the Bearing nsPVA embolization particles due to the large amount of existing data on the use of PVA in embolotherapy for the last 30 years, and according to the evidence of equivalency between the Bearing nsPVA and the Contour Embolization Particles manufactured by Boston Scientific Corporation, and Cook PVA Particles manufactured by Cook Medical.
A literature based clinical data review was completed to analyze the available clinical data concerning polyvinyl alcohol (PVA) particles that are currently on the market. The search was conducted on medical/scientific databases, PubMed, and of Systematic Reviews (CDSR). Cochrane Database The literature review took into account the safety of the Embolization Particles. The data completed and collected by previously conducted clinical trials, applications of the product, and the absence of materovigilance reports concerning similar PVA embolic devices are sufficient to establish the efficacy and safety of the Merit Bearing TM nsPVA Embolization Particles.
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Summary of Substantial Equivalence
Based on the same indications for use, design, scientific technology and results of safety and comparative bench testing, the subject device Bearing™ nsPVA Embolization Particles meets the requirements that are considered essential for its intended use and is substantially equivalent to the predicate device, the Contour™ Embolization Particles, manufactured by Boston Scientific Corporation.
Section 5 510(k) Summary
7
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DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/7/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized depiction of an eagle or bird-like figure with three curved lines forming its body and wings. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the bird symbol.
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
June 7, 2013
Merit Medical Systems, Inc. % Ms. Linda Varroso Director, Global Regulatory Affairs 1050 Hingham St ROCKLAND MA 02370 US
Re: K130259
Trade/Device Name: Bearing™ nsPVA Embolization Particles Regulation Number: 21 CFR 870.3330 Regulation Name: Vascular Embolization Device Regulatory Class: Class II Product Code: KRD, NAJ . Dated: May 13, 2013 Received: May 15, 2013
Dear Ms. Varroso:
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 affècting 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
{8}------------------------------------------------
CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) 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 n 10 http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, Misbranding by reference to premarket notification (21CFR 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.htmfor 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 Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638 2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.
Sincerely yours,
Benjamin R. Fisher -S
Benjamin R. Fisher, Ph.D. Director Division of Reproductive, Gastro-Renal, and-Urological-Devices-Office of Device Evaluation Center for Devices and Radiological Health
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Section 4 Indications for Use Statement
INDICATIONS FOR USE STATEMENT
510(k) Number (if known):
Device Name: Bearing™ nsPVA Embolization Particles
Indications for Use:
Bearing™ nsPVA Embolization Particles are used for the embolization of peripheral hypervascularized turnors, including leiomyoma uteri and peripheral arteriovenous malformations (AVMs).
Do not use particles smaller than 355 microns for the treatment of leiomyoma uteri.
Prescription Use _ × (Part 21 CFR 801 Subpart D) AND/OR
Over-The-Counter Use (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Benjamin F 2013.06.07
(Division Sign-Off) Division of Reproductive, Gastro-Renal, and Urological Devices K130259 510(k) Number
§ 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).