Ballast 088 Long Sheath
Device Facts
| Record ID | K182918 |
|---|---|
| Device Name | Ballast 088 Long Sheath |
| Applicant | Balt USA, LLC |
| Product Code | DQY · Cardiovascular |
| Decision Date | Mar 21, 2019 |
| Decision | SESE |
| Submission Type | Traditional |
| Regulation | 21 CFR 870.1250 |
| Device Class | Class 2 |
Indications for Use
The Ballast 088 Long Sheath is indicated for the introduction of interventional devices into the peripheral, coronary, and neuro vasculature.
Device Story
Ballast 088 Long Sheath is a sterile, single-lumen, variable-stiffness guide catheter/long sheath; facilitates introduction of interventional devices into peripheral, coronary, and neuro vasculature. Device features lubricous PTFE inner liner, stainless steel coil/braid reinforcement, and thermoplastic outer jacket (TPU, Pebax, polyamide 12). Distal section includes hydrophilic coating and Platinum/Iridium radiopaque marker. Operated by clinicians under radiographic imaging; provides access path for interventional tools. Benefits include improved vessel access and device delivery. Supplied with introducer sheath, hemostasis valves, and dilator. Single-use, sterile, EtO-sterilized.
Clinical Evidence
No human clinical data. Evidence consists of extensive bench testing (dimensional, compatibility, simulated use, coating integrity, lubricity, burst, leakage, tensile, torque, kink resistance, stiffness, fracture resistance, particulate matter) and an acute porcine animal study evaluating trackability, handling, and radiopacity. Biocompatibility testing (ISO 10993) confirmed non-cytotoxic, non-sensitizing, non-irritant, non-toxic, non-pyrogenic, non-mutagenic, and non-hemolytic properties.
Technological Characteristics
Guide catheter/long sheath; 8F proximal/distal OD, 0.088" ID. Materials: PTFE inner liner, stainless steel coil/braid, TPU/Pebax/polyamide 12 jacket. Platinum/Iridium marker. Hydrophilic coating (20 cm). Sterilization: 100% Ethylene Oxide (ISO 11135). Connectivity: None (mechanical device).
Indications for Use
Indicated for introduction of interventional devices into peripheral, coronary, and neuro vasculature.
Regulatory Classification
Identification
A percutaneous catheter is a device that is introduced into a vein or artery through the skin using a dilator and a sheath (introducer) or guide wire.
Predicate Devices
- Neuron MAX System (K111380)
Submission Summary (Full Text)
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March 21, 2019
Balt USA, LLC Charles Yang Senior Vice President, Quality Assurance and Regulatory Affairs 29 Parker Irvine, California 92618
Re: K182918
Device Name: Ballast 088 Long Sheath Regulation Number: 21 CFR 870.1250 Regulation Name: Percutaneous Catheter Regulatory Class: Class II Product Code: DQY Dated: February 15, 2019 Received: February 19, 2019
Dear Charles Yang:
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/CombinationProducts/GuidanceRegulatoryInformation/ucm597488.htm); 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 http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm.
For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). 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 (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely.
Lin Zheng
Digitally signed by
Xiaolin Zheng -S
Date: 2019.03.21
10:11:36 -04'00'
for Carlos L. Peña, PhD, MS Director Division of Neurological and Physical Medicine Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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## Indications for Use
510(k) Number (if known) K182918
Device Name Ballast 088 Long Sheath
Indications for Use (Describe)
The Ballast 088 Long Sheath is indicated for the introduction of interventional devices into the peripheral, coronary, and neuro vasculature.
X Prescription Use (Part 21 CFR 801 Subpart D)
| Over-The-Counter Use (21 CFR 801 Subpart C)
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### Ballast 088 Long Sheath 510(k) Summary
This 510(k) summary for Ballast 088 Long Sheath is submitted in accordance with the requirements of 21 CFR 807.87(h) and 807.92 and following the recommendation outlined in FDA Guidance, The 510(k) Program: Evaluating Substantial Equivalence in Premarket Notification [510(k)], dated 28 July, 2014.
#### SUBMITTER [807.92(a)(1)]
Balt USA, LLC 29 Parker Irvine CA 92618
| Contact Person: | Charles Yang |
|-----------------|-----------------------------------------------------------------|
| | Senior Vice President, Quality Assurance and Regulatory Affairs |
| Telephone: | 949-788-1443 |
| E-mail: | charles.yang@balt-usa.com |
| Date prepared: | March 13, 2019 |
#### DEVICE [807.92(a)(2)]
| Name of Device: | Ballast 088 Long Sheath |
|---------------------------|-----------------------------------------------------------------------------------------------|
| Common or Usual Name: | Guide Catheter / Long Sheath |
| Classification Name: | Catheter, Percutaneous |
| Product Code: | DQY |
| Regulatory Class: | Class II |
| Submission Type: | Traditional 510(k) |
| Regulation Number: | 21 C.F.R. 870.1250 |
| Reviewing Product Branch: | Division of Neurological and Physical Medicine Devices (Office of<br>Device Evaluation. CDRH) |
#### PREDICATE DEVICE [807.92(a)(3)]
Neuron MAX System (K111380)
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### DEVICE DESCRIPTION [807.92(a)(4)]
The Ballast 088 Long Sheath is a sterile, single lumen, variable stiffness Guide Catheter / Long Sheath that is designed for facilitating the introduction of appropriately sized interventional devices into target blood vessels in the peripheral, coronary, and neuro vasculature.
The Ballast 088 Long Sheath consists of a lubricous inner liner made from Polytetrafluoroethylene (PTFE) reinforced by a stainless steel coil over the inner liner and stainless steel braid partially covering the inner coil layer. The outer jacket consists of thermoplastics ranging from thermoplastic polyurethane (TPU), polyether block amide (Pebax), and polyamide 12.
The distal section of the Ballast 088 Long Sheath is coated with hydrophilic coating to provide lubricity during use. A Platinum/Iridium marker band is placed at the distal end of the catheter for maximum radiopacity. An introducer sheath, 9F hemostasis valve, 8F hemostasis valve adapter and a dilator are also provided with the device.
# INDICATIONS FOR USE [807.92(a)(5)]
The Ballast 088 Long Sheath is indicated for the introduction of interventional devices into the peripheral, coronary, and neuro vasculature.
# COMPARISON OF TECHNOLOGICAL CHARACTERISTICS [807.92(a)(6)]
The technological characteristics of the Ballast 088 Long Sheath are highly analogous to the technological characteristics of the Neuron MAX™ System previously cleared (K111380). Substantial equivalence is determined based on the following similarities:
- Same intended use/indications for use
- Same principles of operation ●
- Same fundamental scientific technology ●
- Incorporate similar basic Guide Catheter / Long Sheath design .
- . Incorporate similar Guide Catheter / Long Sheath construction material
Table 1 comprises the comparison between Ballast 088 Long Sheath (Subject Device) and Neuron MAXTM System (Predicate Device, K111380).
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| Feature | Neuron MAX™ System | Ballast 088 Long Sheath |
|--------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------|
| | [PREDICATE DEVICE<br>K111380] | [SUBJECT DEVICE] |
| Product Code | DQY | Same |
| Regulatory Class | Class II | Same |
| Regulation Number | 21 CFR 870.1250 | Same |
| Regulation Name | Catheter, Percutaneous | Same |
| Generic Name | Guide Catheter / Long Sheath | Same |
| Indications for Use<br>Statement | The Neuron MAX™ System is<br>indicated for the introduction of<br>interventional devices into the<br>peripheral, coronary, and neuro<br>vasculature. | Same |
| Function | Guide Catheter / Long Sheath for<br>facilitating the introduction of<br>appropriately sized interventional<br>devices into target blood vessels in<br>the peripheral, coronary, and neuro<br>vasculature | Same |
| Principle of Operation | The steerable Guide Catheter / Long<br>Sheath is used to facilitate the<br>selective placement of interventional<br>devices | Same |
| Anatomical Location | Peripheral, coronary, and neuro<br>vasculature. | Same |
| Visualization | Visible under radiographic imaging | Same |
| Feature | Neuron MAX™ System | Ballast 088 Long Sheath |
| | [PREDICATE DEVICE<br>K111380] | [SUBJECT DEVICE] |
| Configurations | PNML6F088804<br>(Usable Length 80, Straight Tip<br>Shape)<br>PNML6F088804M<br>(Usable Length 80, Multipurpose<br>Tip Shape)<br>PNML6F088904<br>(Usable Length 90, Straight Tip<br>Shape)<br>PNML6F088904M<br>(Usable Length 90, Multipurpose<br>Tip Shape) | Ballast80<br>(Usable Length 80 cm)<br>Ballast90<br>(Usable Length 90 cm)<br>Ballast100<br>(Usable Length 100 cm)<br>Ballast105<br>(Usable Length 105 cm) |
| Tip Shape | Straight,<br>Multipurpose | Straight |
| Overall Length | 80 cm - 90 cm | 80 cm - 105cm |
| Proximal Outer<br>Diameter | 8F | Same |
| Distal Outer Diameter | 8F | Same |
| Internal Diameter | 0.088" | Same |
| Coil Length | Not Listed | 77 cm - 102 cm |
| Length from<br>Radiopaque marker<br>band to distal tip | Not Listed | 0.025" |
| Braided Shaft Length | Not Listed | 9 cm from distal tip |
| Feature | Neuron MAX™ System | Ballast 088 Long Sheath |
| | [PREDICATE DEVICE<br>K111380] | [SUBJECT DEVICE] |
| Coil | Not Listed | Stainless Steel |
| Inner Liner | Not Listed | PTFE |
| Braid | Stainless Steel | Same |
| Radiopaque Marker | Not Listed | Platinum/Iridium |
| Coating | Hydrophilic Coating | Same |
| Hydrophilic Coating<br>Length | Not Listed | 20 cm |
| Method of supply | Sterile and single use | Same |
| Sterilization method | Ethylene oxide gas | Same |
| Accessories | Rotating Hemostasis Valve (RHV) | Introducer sheath |
| | Hemostasis valve adapter (HVA) | 9F rotating hemostasis valve |
| | Dilator | 8F hemostasis valve adapter |
| | | Dilator |
| Package configuration | Placed into a packaging card,<br>Tyvek pouch and Carton box. | Same |
# Table 1: Predicate Device vs. Subject Device Comparison Table
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# PERFORMANCE DATA [807.92(b)]
Performance Bench Testing and Animal Testing: Results of the performance bench testing and animal testing (Table 2) indicate that Ballast 088 Long Sheath (Subject Device) meets established performance requirements and is substantially equivalent for its intended use.
| Performance Bench Testing | | |
|----------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Tests | Test Method Summary | Results |
| Visual and Dimensional<br>Inspection | Inspected dimensions for overall length,<br>total length of proximal hub and strain<br>relief, inner diameter, outer diameter (distal<br>and proximal). | All test samples passed testing. |
| Surface Contamination | A microscope was used to inspect the<br>catheter surface for the presence of<br>particulates. | All test samples passed testing |
| Catheter Compatibility | Verify the compatibility of the Ballast 088<br>Long Sheath with the following:<br>- Accessory devices<br>- Guidewire<br>- 6F dilator and guidewire<br>- Inner guide catheter and guidewire<br>- Inner diagnostic catheter and<br>guidewire | All test samples passed testing. |
| Simulated Use | Verify the <i>in vitro</i> performance of the test<br>article under simulated use conditions<br>using Type III, Bovine Aortic Arch vessel<br>model. | All test samples passed testing. |
| Coating Integrity and<br>Adherence | Test samples were dyed and gone through<br>simulated use testing. The coating quality | All test samples passed testing |
| | of the dyed test articles were inspected<br>under a microscope. | |
| Lubricity/Durability of<br>Hydrophilic Coating | Test samples underwent 25 friction cycles<br>with a maximum friction force of 75 grams<br>to determine the lubricity and durability of<br>the catheter coating. | All test samples passed testing. |
| Dynamic Burst | A MEDRAD Mark V Plus Injection<br>System was used to measure catheter<br>dynamic burst test of the test samples. | All test samples passed testing. |
| Liquid Leakage at 46 psi | Determined whether liquid leaks from the<br>catheter under a pressure of 46 psi per ISO<br>10555-1 and ISO 594-2. | All test samples passed testing. |
| Air Leakage | Determined whether air leaks into the hub<br>assembly during aspiration per EN ISO<br>10555-1 and ISO 594-2. | All test samples passed testing. |
| Catheter Static Burst Test | A hydraulic Burst/Leak tester was used to<br>test the static burst resistance of the test<br>samples per ISO 10555-1. | All test samples passed testing. |
| Tensile Strength | Measured the catheter shaft peak tensile<br>force and the hub to shaft peak tensile<br>force using an Intron tensile tester per the<br>guidelines in ISO 10555-1. | All test samples passed testing. |
| Corrosion Resistance | The test article is immersed in sodium<br>chloride solution before being placed in<br>boiling distilled or deionized water.<br>Subsequently, the test article is examined<br>visually for evidence of corrosion. | All test samples passed testing. |
| Torque Strength | Torque strength was determined by number<br>of turns-to-failures. Torque strength of the<br>subject device was compared to the<br>predicate device. | All test samples passed testing.<br>The Torque Strength of the<br>subject device is comparable to<br>the predicate device. |
| Kink Resistance Test | The kink resistance of the test samples was<br>tested against the predicate device in<br>simulated use. In addition, kink resistance<br>of the test samples was tested against the<br>predicate device by wrapping the device<br>around a pin and examining the device for<br>kinks by using a microscope. | All test samples passed testing.<br>The Kink Resistance of the<br>subject device is comparable to<br>the predicate device. |
| Catheter Stiffness Testing | An Instron tensile tester was used to<br>characterize the stiffness profile of the<br>device. | All test samples passed testing. |
| Fracture Resistance and<br>Flexing Test | Testing was conducted to determine the<br>Guide Catheter's resistance to damage by<br>flexing and resistance to fracture per ISO<br>11070. | All test samples passed testing. |
| Particulate Matter<br>Characterization | Particulate matter in injections of the<br>device were quantified after simulated use. | All test samples passed testing. |
| Luer Dimensional<br>Inspection | Inspected the luer dimensions per ISO<br>80369-7. | All test samples passed testing. |
| Separation Force | Verified mating parts separation force per<br>ISO 594-1 and ISO 594-2. | All test samples passed testing. |
| Unscrewing Torque | Verified that the catheter luer remained<br>attached after applying an unscrewing<br>torque, per ISO 594-1 and ISO 594-2. | All test samples passed testing. |
| Resistance to Overriding | Verified that the catheter luer did not<br>override reference fitting threads, per ISO<br>594-1 and ISO 594-2. | All test samples passed testing. |
| Stress Cracking | Verified that there were no stress cracks on<br>microcatheter hub, per ISO 594-1 and ISO<br>594-2. | All test samples passed testing. |
| Subatmospheric-pressure<br>Air Leakage | ISO 80369-7 | All test samples passed testing. |
| | The fittings were assembled by applying an<br>axial force while rotating the test<br>connector.<br>The test connector and reference connector<br>assembly were secured to the test port on<br>the pressure decay leak tester and the<br>pressure decay rates were recorded. | |
| Separation Force | ISO 80369-7<br>The fittings were assembled by applying an<br>axial force while rotating the test<br>connector. An axial force is applied in the<br>direction away from the test connection. | All test samples passed testing. |
| Stress Cracking | ISO 80369-7<br>The fittings were assembled by applying an<br>axial force while rotating the test<br>connector. The test connector is<br>disconnected from the reference connector<br>and is reassembled again.<br>With the axis of the lock fitting horizontal,<br>the assembly outlet is sealed and the<br>internal water pressure is brought to an<br>effective pressure and maintained for a | All test samples passed testing. |
| Unscrewing Torque | specific time.<br>ISO 80369-7<br>The fittings were assembled by applying an<br>axial force while rotating the test<br>connector. A screwing torque was applied<br>for a certain hold period. | All test samples passed testing. |
| Resistance to Overriding | ISO 80369-7<br>The fittings were assembled by applying an<br>axial force while rotating the test<br>connector. Using a torque watch with no<br>axial load, a torque is applied for a specific<br>hold period. | All test samples passed testing. |
| Packaging Integrity Test | | |
| Visual Inspection<br>(Product carton) | Visually inspected packaging for any signs<br>of damage. | All test samples passed testing. |
| Seal strength | Perform seal strength test per ASTM<br>F88/F88M. | All test samples passed testing. |
| Bubble Immersion | Perform Bubble Immersion test per ASTM<br>F2096-11. No bubbles observed<br>attributable to leaks and no test fluid<br>attributable to leaks inside the device<br>packaging. | All test samples passed testing. |
| Visual Inspection<br>(Seal Integrity) | Visual inspection testing was performed<br>per ASTM F1886/F1886M-16 to visually<br>detect channel defects in package seals. | All test samples passed testing. |
| Performance Animal Testing | | |
| Animal Testing (GLP) | Animal testing is to evaluate the in vivo<br>performance of the device in an acute<br>porcine model. Trackability and handling<br>of the guide catheter, radiopacity, and<br>catheter compatibility were assessed.<br>Subject device was compared to predicate<br>device. | All test samples passed testing.<br>Trackability and handling of<br>the guide catheter, radiopacity,<br>and catheter compatibility with<br>microcatheter were comparable<br>to predicate device. |
| Test | Results | Conclusion |
| Cytotoxicity – MEM Elution Test<br>– 48 hours<br>ISO 10993-5 | Test Article extract showed no evidence of<br>lysed cells or cytotoxicity to L-929 cells,<br>with an average grade of 0 (no reactivity). | Non-cytotoxic |
| Sensitization - ISO Guinea Pig<br>Kligman Maximization Test<br>ISO 10993-10 | The 0.9% Sodium Chloride for injection<br>(NaCl) and Cottonseed Oil (CSO) extracts<br>did not induce delayed sensitization in the<br>guinea pig (0% Sensitization). | Did not elicit sensitization<br>response |
| Irritation or Intracutaneous - ISO<br>Intracutaneous Study in Rabbits -<br>Two Extracts<br>ISO 10993-10 | The difference between the test and the<br>control mean score was 0.0. | Non-irritant…
