(114 days)
The Arcadia ™ Steerable and Straight Balloon Catheters are intended to be used for the reduction and fixation of fractures and/or creation of a void in cancellous bone in the spine. This includes use during percutaneous vertebral augmentation. These balloon catheters are to be used with cleared spinal polymethylmethacrylate (PMMA) bone cement for use during percutaneous vertebral augmentation, such as kyphoplasty.
The Arcadia Balloon Catheters consist of a Y-Adapter with a dual-lumen catheter shaft and a balloon. The inner shaft lumen contains a stylet (either straight or articulating). The outer lumen is an inflation conduit for the balloon. A valved luer port on the Y-adapter allows for connecting an inflation device to inflate and deflate the balloon. Two marker bands are printed on the shaft and serve as indicators of when the distal tip of the balloon catheter has reached the distal end of the working cannula of the StabiliT® Introducer. Radiopaque markers are located on the proximal and distal end of the balloon to aid in balloon placement prior to inflation. The exterior surface of balloon is covered by a lubricant which ease access through the introducer cannula. The Arcadia Steerable Balloon Catheter features a mechanism that enables steering of the device. The Arcadia Straight Balloon Catheter has a removable stylet.
The Arcadia™ Balloon Catheter underwent non-clinical performance testing to demonstrate substantial equivalence to predicate devices.
1. Table of Acceptance Criteria and Reported Device Performance:
| Test Performed | Acceptance Criteria | Reported Device Performance (Implied from "met the requirements") |
|---|---|---|
| Biocompatibility Testing | Device meets applicable ISO 10993-1:2018 requirements (including Cytotoxicity, Sensitization, Irritation, Acute Systemic Toxicity, and Pyrogenicity). | All biocompatibility testing met the requirements of the respective test methods, thus supporting the biocompatibility of the subject device. |
| Insertion and Withdrawal Force | Insertion and withdrawal of the device through the introducer do not create forces that would damage the balloon catheter. | Design validation testing confirmed that the subject device conforms to user needs and intended uses. Performance testing demonstrates equivalence between the subject device and the predicate device. (This implies the force criteria were met, though specific values are not provided). |
| Inflated Balloon Dimensions (Unconstrained) | Inflated balloon dimensions are similar to similarly labeled predicate devices. | Performance testing demonstrates equivalence between the subject device and the predicate device. (This implies the balloon dimensions were similar to predicates). |
| Articulated Angle and Radius (for Steerable device) | Articulation profile of steerable devices matches that of tools used to create channels in the bone for balloon placement. | Performance testing demonstrates equivalence between the subject device and the predicate device. (This implies the articulation profile met the criteria). |
| Deflation Time with Contrast Solution | Deflation time is similar to predicate devices of the same size and volume profile. | Performance testing demonstrates equivalence between the subject device and the predicate device. (This implies the deflation time was similar to predicates). |
| Constrained Max Pressure Testing | Device is capable of sustaining its maximum rated pressure when the balloon is constrained. | Performance testing demonstrates equivalence between the subject device and the predicate device. (This implies the device sustained its maximum rated pressure). |
| Unconstrained Burst Volume | Device exceeds its maximum volume rating before burst failure. | Performance testing demonstrates equivalence between the subject device and the predicate device. (This implies the device exceeded its maximum volume rating before burst). |
| Tensile Force Testing | Device material and bond strengths exceed forces that may be applied during normal clinical use. | Performance testing demonstrates equivalence between the subject device and the predicate device. (This implies the material and bond strengths exceeded anticipated clinical forces). |
| Shelf-life | N/A (implied from the statement). | The Arcadia Balloon Catheter is qualified and labeled as a sterile, single-use device with the 6-month shelf-life at this time. |
2. Sample size(s) used for the test set and the data provenance:
The document does not specify the exact sample sizes for each non-clinical test.
No clinical studies were conducted, so there is no patient data or data provenance (e.g., country of origin, retrospective/prospective). The tests performed are all in-vitro or benchtop tests.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
Not applicable. This device underwent non-clinical (benchtop) testing, not studies involving human interpretation or expert ground truth establishment.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set:
Not applicable. This device underwent non-clinical (benchtop) testing.
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 is a medical device (balloon catheter), not an AI-powered diagnostic or assistive technology for human readers.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:
Not applicable. This is a medical device (balloon catheter), not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
The "ground truth" for the non-clinical tests was established by defined engineering specifications, industry standards (e.g., ISO, ASTM, USP), and comparison to predicate device characteristics. For example, for "Inflated Balloon Dimensions," the ground truth was that the dimensions should be "similar to similarly labeled predicate devices."
8. The sample size for the training set:
Not applicable. This is a medical device that underwent non-clinical testing, not a machine learning algorithm requiring a training set.
9. How the ground truth for the training set was established:
Not applicable.
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Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
Merit Medical Systems, Inc. Shamsa Karimi Principal Regulatory Affairs Specialist 1600 West Merit Parkway South Jordan, Utah 84095
Re: K191596
Trade/Device Name: Arcadia™ Balloon Catheter Regulation Number: 21 CFR 888.1100 Regulation Name: Arthroscope Regulatory Class: Class II Product Code: HRX, HXG, NDN Dated: September 11, 2019 Received: September 12, 2019
Dear Ms. Karimi:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's
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requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
Laurence D. Coyne, Ph.D. Assistant Director DHT6C: Division of Restorative, Repair and Trauma Devices OHT6: Office of Orthopedic 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: 06/30/2020 See PRA Statement below.
510(k) Number (if known) K191596
Device Name Arcadia TM Balloon Catheter
Indications for Use (Describe)
The Arcadia ™ Steerable and Straight Balloon Catheters are intended to be used for the reduction and fixation of fractures and/or creation of a void in cancellous bone in the spine. This includes use during percutaneous vertebral augmentation. These balloon catheters are to be used with cleared spinal polymethylmethacrylate (PMMA) bone cement for use during percutaneous vertebral augmentation, such as kyphoplasty.
| Type of Use (Select one or both, as applicable) |
|---|
X Prescription Use (Part 21 CFR 801 Subpart D)
Over-The-Counter Use (21 CFR 801 Subpart C)
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| GeneralProvisions | Submitter Name:Address:Telephone Number:Contact Person:Registration Number: | Merit Medical Systems, Inc.1600 West Merit ParkwaySouth Jordan, UT 84095(408) 770-1115Shamsa Karimi1721504 |
|---|---|---|
| Subject Device | Trade Name:Common/Usual Name:Classification Name:Regulatory Class:Product Code:21 CFR §:Review Panel: | Arcadia™ Balloon CatheterInflatable Balloon TampArthroscope, Orthopedic Manual SurgicalInstrument, Polymethylmethacrylate (PMMA)bone cementIIHRX, HXG, NDN888.1100, and 888.4540, 888.3027Orthopedics |
| PredicateDevice | Predicate #1:Trade Name:Classification Name:Premarket Notification:Manufacturer:Predicate#2:Trade Name:Classification Name:Premarket Notification:Manufacturer: | Kyphon® Express II™ Inflatable Bone TampArthroscope, Orthopedic Manual SurgicalInstrument, Polymethylmethacrylate (PMMA)Bone CementK123771Medtronic Sofamor Danek USAOsseoflex® SBArthroscope, Polymethylmethacrylate (PMMA)Bone CementK141930Osseon LLCThis predicate device has not been subject to a design-related recall. |
| DeviceDescription | The Arcadia Balloon Catheters consist of a Y-Adapter with a dual-lumen catheter shaft and a balloon. The inner shaft lumen contains astylet (either straight or articulating). The outer lumen is an inflation conduit for the balloon. A valved luer port on the Y-adapter allows for | |
| marker bands are printed on the shaft and serve as indicators of when the distal tip of the balloon catheter has reached the distal end of the working cannula of the StabiliT® Introducer. Radiopaque markers are located on the proximal and distal end of the balloon to aid in balloon placement prior to inflation. The exterior surface of balloon is covered by a lubricant which ease access through the introducer cannula. | ||
| The Arcadia Steerable Balloon Catheter features a mechanism that enables steering of the device. The Arcadia Straight Balloon Catheter has a removable stylet. | ||
| Indications forUse | The ArcadiaTM Steerable and Straight Balloon Catheters are intended to be used for the reduction and fixation of fractures and/or creation of a void in cancellous bone in the spine. This includes use during percutaneous vertebral augmentation. These balloon catheters are to be used with cleared spinal polymethylmethacrylate (PMMA) bone cement for use during percutaneous vertebral augmentation, such as kyphoplasty. |
connecting an inflation device to inflate and deflate the balloon. Two
510(k) Summarv
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The design and technological characteristics of the subject Arcadia Balloon Catheter are substantially equivalent to the predicate devices. Kyphon® Express II™ Inflatable Bone Tamp and Osseoflex® SB. The comparison between the subject and the predicate devices were based on the following: ● Intended Use Indications for Use ● ● Labeling Basic Design and Material ● Principle of Operation/Fundamental Technology ● Performance ● Sterilization ● Biocompatibility ● Comparison to Predicate Devices Summary of Technological Characteristics of the Subject Device to the Predicate Devices Attribute Predicate Device Predicate Device Subject Device Osseoflex® SB Kyphon® Express II™ Arcadia Balloon Catheter (Steerable) Inflatable Bone Tamp (Steerable and Straight) (Straight) Balloon Inflation Medium 60% Contrast 60% Contrast 60% Contrast Polyurethane Device Balloon Polyurethane Polyurethane Materials Catheter Polyurethane Polyurethane Polyurethane Marker Platinum/Iridium Platinum/Iridium Platinum/Iridium Bands Balloon Length (pre-10mm/(2mL), 10mm/(3mL), 15mm/(4mL), 10mm/(3mL), 15mm/(4mL), (inflation)/Maximum 20mm/(5mL) 20mm/(5mL), 25mm/(7mL), 20mm/(4mL) 30mm/(8mL) Balloon Volume Max Inflation Pressure 400 psi 700 psi 700 psi
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| Summary of Non-Clinical Tests Conducted for Determination of Substantial Equivalence | |
|---|---|
| Performance Test Summary | |
| Test Performed | Acceptance Criteria |
| Biocompatibility Testing | Device meets applicable ISO 10993-1:2018 requirements |
| Insertion and Withdrawal Force | Insertion and withdrawal of the device through theintroducer do not create forces that would damage theballoon catheter. |
| Inflated Balloon Dimensions(Unconstrained) | Inflated balloon dimensions are similar to similarly labeledpredicate devices. |
| Articulated Angle and Radius | Articulation profile of steerable devices matches that oftools used to create channels in the bone for balloonplacement. |
| Deflation Time with Contrast Solution | Deflation time is similar to predicate devices of the samesize and volume profile. |
| Constrained Max Pressure Testing | Device is capable of sustaining its maximum rated pressurewhen the balloon is constrained. |
| Unconstrained Burst Volume | Device exceeds its maximum volume rating before burstfailure |
| Tensile Force Testing | Device material and bond strengths exceed forces that maybe applied during normal clinical use. |
| Summary of Clinical Tests for Determination of Substantial Equivalence | |
| N/A- No clinical test was conducted for this submission. | |
| Substantial Equivalence Conclusion | |
| Based on the indications for use, intended use, design, safety and performance testing, the subjectArcadia Balloon Catheter meets the requirements that are considered essential for its intended use and issubstantially equivalent to the Predicate Devices, Kyphon® Express II™ Inflatable Bone Tamp [K123771]and Osseoflex® SB [K141930]. |
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| No performance standards have been established under Section 514 ofthe Food, Drug and Cosmetic Act for these devices. Performancetesting of the subject device, Arcadia Balloon Catheter was conductedbased on the risk assessment and based on the requirements of thefollowing international standards: | |
|---|---|
| PerformanceData | FDA Guidance Document: Use of International Standard ISO10993-1, Biological evaluation of medical devices - Part 1:Evaluation and testing within a risk management process. ISO 10993-1:2018, Biological evaluation of medical devices -Part 1: Evaluation and testing within a risk management process ISO 10993-5:2009: Biological evaluation of medical devices-Tests for in vitro cytotoxicity. ISO 10993-10:2010: Biological evaluation of medical devices-Tests for irritation and skin sensitization ISO 10993-11:2017: Biological evaluation of medical devices-Tests for systemic toxicity. USP 41- NF 36: 2018, <151>, Pyrogen Test (USP Rabbit Test) ASTM D 4169-16: Standard practice for performance testing ofshipping and systems. ASTM F88M/F88M-15: Standard test method for seal strengthof flexible barrier materials. ASTM F1140/F1140M-13: Standard test method for internalpressurization failure resistance of unrestrained packages. ASTM F1929-15: Standard test method for detecting seal leaksin porous medical packaging by dye penetration. ASTM F1980-16: Standard Guide for accelerated aging ofsterile barrier systems for medical devices. ASTM F2096-11: Standard test method for detecting grossleaks in packaging by internal pressurization (bubble test). EN ISO 2233:2000: Packaging—Complete filled transportpackages and unit loads—Conditioning for testing. ISO 11607-1:2006: Packaging for terminally sterilized medicaldevices-Part 1: Requirements for materials, sterile barriersystems and packaging systems [Including: Amendment 1(2014)]. ISO 11607-2: 2006: Packaging for terminally sterilized medicaldevices - Part 2: Validation requirements for forming, sealingand assembly processes [Including: Amendment 1 (2014)] ISO 11137-2:2013: Sterilization of health care products –Radiation - Part 2 Establishing the sterilization dose. |
| PerformanceData cont. | Pre-Inflation Dimensional Analysis Insertion and Withdrawal Force Inflated Balloon Dimensions (Unconstrained) Articulated Angle and Radius Deflation Time with Contrast Solution Constrained Max Pressure Testing Unconstrained Burst Volume Tensile Force Testing |
| Design validation testing confirmed that the subject de |
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The following performance data were provided in support of the substantial equivalence determination.
Biocompatibility testing
The biocompatibility evaluation and testing for the subject Arcadia Balloon Catheter was conducted in accordance with ISO 10993-1:2018, Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process and 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" (2016)". The battery of testing included the following tests:
- Cytotoxicity ●
- Sensitization ●
- Irritation .
- Acute Systemic Toxicity
- Pyrogenicity
The Arcadia Balloon Catheter is categorized as an externally communicating device with tissue/bone/dentin contact for a limited (< 24 hours) duration. All biocompatibility testing met the requirements of the respective test methods, thus supporting the biocompatibility of the subject device, Arcadia Balloon Catheter.
Performance Testing
Design verification and validation testing were completed to establish the performance of the subject device, Arcadia Balloon Catheter and substantial equivalence to the predicate device.
Design Verification Testing:
ice, Arcadia Balloon Catheter conforms to user needs and intended uses.
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| Performance testing demonstrates equivalence between the subjectdevice and the predicate device. A risk management assessment wasperformed and found that the subject device does not introduce anynew risk related to its safety or effectiveness. | |
|---|---|
| Summary ofSubstantialEquivalence | Based on the indications for use, intended use, design, safety andperformance testing, the subject Arcadia Balloon Catheter meets therequirements that are considered essential for its intended use and issubstantially equivalent to the Predicate Devices, Kyphon® ExpressIIT™ Inflatable Bone Tamp [K123771] and Osseoflex® SB [K141930]. |
| PerformanceData | No performance standards have been established under Section 514 ofthe Food, Drug and Cosmetic Act for these devices. Performancetesting of the subject device, Arcadia Balloon Catheter was conductedbased on the risk assessment and based on the requirements of thefollowing international standards:FDA Guidance Document: Use of International Standard ISO10993-1, Biological evaluation of medical devices - Part 1:Evaluation and testing within a risk management process. ISO 10993-1:2018, Biological evaluation of medical devices -Part 1: Evaluation and testing within a risk management process ISO 10993-5:2009: Biological evaluation of medical devices—Tests for in vitro cytotoxicity. ISO 10993-10:2010: Biological evaluation of medical devices—Tests for irritation and skin sensitization ISO 10993-11:2017: Biological evaluation of medical devices—Tests for systemic toxicity. USP 41- NF 36: 2018, <151>, Pyrogen Test (USP Rabbit Test) ASTM D 4169-16: Standard practice for performance testing ofshipping and systems. ASTM F88M/F88M-15: Standard test method for seal strengthof flexible barrier materials. ASTM F1140/F1140M-13: Standard test method for internalpressurization failure resistance of unrestrained packages. ASTM F1929-15: Standard test method for detecting seal leaksin porous medical packaging by dye penetration. ASTM F1980-16: Standard Guide for accelerated aging ofsterile barrier systems for medical devices. ASTM F2096-11: Standard test method for detecting grossleaks in packaging by internal pressurization (bubble test). EN ISO 2233:2000: Packaging—Complete filled transportpackages and unit loads—Conditioning for testing. ISO 11607-1:2006: Packaging for terminally sterilized medicaldevices—Part 1: Requirements for materials, sterile barriersystems and packaging systems [Including: Amendment 1(2014)]. ISO 11607-2: 2006: Packaging for terminally sterilized medicaldevices - Part 2: Validation requirements for forming, sealingand assembly processes [Including: Amendment 1 (2014)] ISO 11137-2:2013: Sterilization of health care products –Radiation - Part 2 Establishing the sterilization dose. |
| PerformanceData cont. | • Pre-Inflation Dimensional Analysis• Insertion and Withdrawal Force• Inflated Balloon Dimensions (Unconstrained)• Articulated Angle and Radius• Deflation Time with Contrast Solution• Constrained Max Pressure Testing• Unconstrained Burst Volume• Tensile Force Testing |
| Design validation testing confirmed that the subject de |
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The following performance data were provided in support of the substantial equivalence determination.
Biocompatibility testing
The biocompatibility evaluation and testing for the subject Arcadia Balloon Catheter was conducted in accordance with ISO 10993-1:2018, Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process and 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" (2016)". The battery of testing included the following tests:
- Cytotoxicity ●
- Sensitization ●
- Irritation .
- Acute Systemic Toxicity
- Pyrogenicity
The Arcadia Balloon Catheter is categorized as an externally communicating device with tissue/bone/dentin contact for a limited (< 24 hours) duration. All biocompatibility testing met the requirements of the respective test methods, thus supporting the biocompatibility of the subject device, Arcadia Balloon Catheter.
Performance Testing
Design verification and validation testing were completed to establish the performance of the subject device, Arcadia Balloon Catheter and substantial equivalence to the predicate device.
Design Verification Testing:
vice, Arcadia Balloon Catheter conforms to user needs and intended uses.
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| Performance testing demonstrates equivalence between the subject device and the predicate device. A risk management assessment was performed and found that the subject device does not introduce any new risk related to its safety or effectiveness. | |
|---|---|
| The Arcadia Balloon Catheter is qualified and labeled as a sterile, single-use device with the 6-month shelf-life at this time. | |
| Summary ofSubstantialEquivalence | Based on the indications for use, intended use, design, safety and performance testing, the subject Arcadia Balloon Catheter meets the requirements that are considered essential for its intended use and is substantially equivalent to the Predicate Device, Kyphon® Express II™ Inflatable Bone Tamp [K123771]. |
§ 888.1100 Arthroscope.
(a)
Identification. An arthroscope is an electrically powered endoscope intended to make visible the interior of a joint. The arthroscope and accessories also is intended to perform surgery within a joint.(b)
Classification. (1) Class II (performance standards).(2) Class I for the following manual arthroscopic instruments: cannulas, currettes, drill guides, forceps, gouges, graspers, knives, obturators, osteotomes, probes, punches, rasps, retractors, rongeurs, suture passers, suture knotpushers, suture punches, switching rods, and trocars. The devices subject to this paragraph (b)(2) are exempt from the premarket notification procedures in subpart E of part 807 of this chapter, subject to the limitations in § 888.9.