Phenom 27 Catheter

K180959 · Cathera, Inc. · DQY · Jun 11, 2018 · Cardiovascular

Device Facts

• Record ID: K180959
• Device Name: Phenom 27 Catheter
• Applicant: Cathera, Inc.
• Product Code: DQY · Cardiovascular
• Decision Date: Jun 11, 2018
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 870.1250
• Device Class: Class 2

Intended Use

Phenom® Catheters are intended for the introduction of interventional devices and infusion of diagnostic or therapeutic agents into the neuro, peripheral, and coronary vasculatures.

Device Story

Phenom 27 Catheter is a variable stiffness, single-lumen catheter for accessing small, tortuous vasculature. Device features PTFE composite polymeric shaft with stainless steel reinforcement, polyamide hub, thermoplastic elastomer strain relief, and platinum/iridium radiopaque markers. Outer surface has hydrophilic coating to aid navigation; liner facilitates introduction device movement. Used by physicians in clinical settings (neuro, peripheral, coronary procedures) under fluoroscopy. Device is introduced into vasculature to deliver interventional devices or diagnostic/therapeutic agents. Modification increases proximal shaft length (up to 160cm) to assist physician set-up; distal working shaft remains identical to predicate. Benefits include improved procedural set-up flexibility while maintaining established trackability and accessibility performance.

Clinical Evidence

Bench testing only. No clinical data. Testing included flow rate, dead space volume, accessibility/tractability in tortuous neurovascular models, dimensional verification, material verification, compatibility (guide catheter, guidewire, RHV), shaft stiffness, chemical compatibility, shaping mandrel compatibility, kink resistance, hub conical fitting, corrosion resistance, tensile strength, leakage (liquid/air), rupture pressure, particulate levels, coating lubricity/durability, and flexural fatigue. All tests met specifications and demonstrated equivalence to the predicate.

Technological Characteristics

Variable stiffness, single-lumen catheter. Materials: PTFE composite polymer, stainless steel reinforcement, polyamide hub, thermoplastic elastomer strain relief, platinum/iridium alloy markers, polymeric hydrophilic coating. Dimensions: 3.1F proximal OD, 2.8F distal OD, 0.027" ID. Sterilization: Ethylene Oxide (ISO 11135). Connectivity: None. Software: None.

Indications for Use

Indicated for introduction of interventional devices and infusion of diagnostic or therapeutic agents into neuro, peripheral, and coronary vasculatures.

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

• Phenom® 27 Catheter (K151638)

Submission Summary (Full Text)

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June 11, 2018

Cathera, Inc. Victor Ham Chief Regulatory & Quality Officer 627 National Avenue Mountain View, California 94043

Re: K180959

Trade/Device Name: Phenom 27 Catheter Regulation Number: 21 CFR 870.1250 Regulation Name: Percutaneous Catheter Regulatory Class: Class II Product Code: DQY, KRA Dated: May 30, 2018 Received: May 31, 2018

Dear Victor Ham:

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. Iisting 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 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); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820);

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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 ([e-mail]) or phone [phone] or 301-796-7100).

Sincerely,

# Xiaolin Zheng -S

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) K180959

Device Name Phenom 27 Catheter

#### Indications for Use (Describe)

Phenom® Catheters are intended for the introduction of interventional devices and infusion of diagnostic or therapeutic agents into the neuro, peripheral, and coronary vasculatures.

Type of Use (Select one or both, as applicable)

| <span style="font-size:16px">☒</span> Prescription Use (Part 21 CFR 801 Subpart D) | <span style="font-size:16px">☐</span> Over-The-Counter Use (21 CFR 801 Subpart C) |
|------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------|
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# 510(k) Summary - K180959

This 510(k) summary is being submitted in accordance with the requirements of 21 CFR 807.92(c).

# Submitted by:

Cathera, Inc. 627 National Ave. Mountain View, CA 94043 Tel.: [phone] Fax: [phone]

Contact Person: Victor Ham

Date summary prepared: April 22, 2018

Trade Name: Phenom® 27 Catheter

Common Name: Catheter

# Classification Name & Product Codes:

Percutaneous Catheter (21 CFR 870.1250, Product Code DOY) Continuous Flush Catheter (21 CFR 870.1210, Product Code KRA)

Predicate Devices: Phenom® 27 Catheter (510K # K151638)

#### Device Description:

The Phenom® 27 Catheters are variable stiffness, single lumen catheters designed to access small, tortuous vasculature. They are available in a variety of lengths, stiffness and inner and outer diameters. The outer surface of the catheter is coated to aid in navigation in the vessel. The catheter also incorporates a liner to facilitate movement of introduction devices passing through its lumen. The distal tip has radiopaque marker(s) to aid visualization and positioning under fluoroscopy.

# Indications for Use:

Phenom® Catheters are intended for the introduction of interventional devices and infusion of diagnostic or therapeutic agents into the neuro, peripheral, and coronary vasculatures.

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# Device Comparison of Technological Characteristics

Table A provides a comparison of the technological characteristics of the Phenom® 27 Catheter and the modified Phenom® 27 Catheter with additional effective length.

| Technological<br>Characteristic | Phenom® 27, predicate<br>(510k # K151638) | Phenom® 27, modified<br>(510k # K180959) | Rationale for<br>Difference (if present) |
|------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Indication for Use | Phenom® Catheters are intended<br>for the introduction of<br>interventional devices and infusion<br>of diagnostic or therapeutic agents<br>into the neuro, peripheral, and<br>coronary vasculatures. | Identical | N/A-No difference |
| Composite Shaft | PTFE composite polymeric<br>catheter | Identical | N/A-No difference |
| Composite Shaft<br>support | Stainless Steel Reinforcement | Identical | N/A-No difference |
| Hub | Polyamide | Identical | N/A-No difference |
| Stain Relief | Thermoplastic elastomer | Identical | N/A-No difference |
| Marker(s) | Platinum/Iridium Alloy | Identical | N/A-No difference |
| Coating | Polymeric hydrophilic coating | Identical | N/A-No difference |
| Proximal OD | 3.1F (1.02mm) | Identical | N/A-No difference |
| Distal OD | 2.8F (0.91mm) | Identical | N/A-No difference |
| Proximal ID | 0.027 inches (0.69 mm) | Identical | N/A-No difference |
| Distal ID | 0.027 inches (0.69 mm) | Identical | N/A-No difference |
| Effective Length Range<br>(cm) | 75 to 150 | 75 to 160 | Increasing the length of the<br>proximal shaft provide the<br>physicians extra length for set-<br>up. Working (distal) shaft of<br>catheter is the same therefore<br>equivalent. |
| Tip Configurations | Steam shapeable straight tip | Identical | N/A-No difference |
| Accessories | | | |
| Steam shaping mandrel | Stainless Steel | Identical | N/A-No difference |
| Packaging & Sterilization | | | |
| Packaging materials<br>and configuration | Catheter package inside<br>dispensing coil; inside Tyvek®<br>pouch; inside cardboard box | Identical | N/A-No difference |
| Sterilization | Ethylene Oxide | Identical | N/A-No difference |

# Table A-Summary of Technological Characteristics, Components and Materials

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Conclusion- Based on the comparison shown in Table A (above), the technological characteristic of the modified Phenom® 27 and the predicate Phenom® 27 are equivalent. The only design modification was to increase the effective length from 150 cm to 160 cm. This provides the user with additional length during the set-up procedure which does not alter the intended use or the fundamental scientific technology of the device as originally cleared for the predicate device and therefore substantially equivalent.

# Performance Testing - Bench

As identified in the risk analysis, the increased length would require testing of the flow rate and dead space volume. Testing was conducted according to the same method used for the original predicate device. Accessibility and tractability testing was performed to verify that modified catheter can reach M1 region of tortuous neurovascular model. The modification to add extra length to the catheter did not affect the design or function of the distal shaft of the catheter that enters the body. All other tests performed on the predicate device apply to the modified version. A summary of the pre-clinical bench testing performed for the Phenom® 27 Catheter and the modified Phenom® 27 Catheter is presented in the Table B below:

| Test Description | Test Method Summary | Results |
|-------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Catheter Flow Rate | The purpose of the testing is to<br>provide the user with a flow rate<br>reference when using various<br>contrast media and pressure<br>conditions. Similar to the<br>predicate device, 2 pressure<br>conditions and 3 commonly<br>used contrast media are used for<br>the testing. High pressure vessel<br>and tank, timer and scale are<br>used to determine flow rate. | Flow rate data was collected for the<br>modified (160cm) device and the<br>predicate device (150cm). As expected,<br>the new geometry result in slightly<br>different fluid dynamics (i.e., lower flow<br>rates). The results are within the expected<br>range and therefore are equivalent. |
| Flow rate for each<br>lumen, according to<br>ISO 10555-1 | Test method is to verify<br>compliance to catheter standard<br>BS EN ISO 10555-1: 2013.<br>Conditions, method and<br>equipment as prescribed in the<br>standard. | Flow rate data was collected for the<br>modified (160 cm) device and the<br>predicate device (150 cm). As expected,<br>the new geometry result in slightly<br>different fluid dynamics (i.e., lower flow<br>rates). The passing results are within the<br>expected range and therefore are<br>equivalent. |
| Dead Space Volume | The purpose of the testing is to<br>provide the user with the dead<br>space volume (fill volume) of<br>the catheters. | Data was collected for the modified (160<br>cm) device and the predicate device (150<br>cm). As expected, the new geometry<br>result in slightly larger dead space<br>volume. The passing results within the<br>expected range and therefore are<br>equivalent. |
| Test Description | Test Method Summary | Results |
| Accessibility/<br>Tractability Test | The purpose is to verify that the<br>modified Catheter can reach M1<br>region of tortuous neurovascular<br>model. Test were conducted at<br>body temperature, using the<br>appropriate guidewires, guide<br>catheters, RHV and continuous<br>flushing conditions to mimic<br>actual use. | Data was collected for the modified (160<br>cm) device and the predicate device (150<br>cm). Similar to the predicate device, all<br>tested articles were able to reach M1<br>region of model neurovasculature. All<br>samples passed. This confirms functional<br>equivalence between the predicate and the<br>modified device. The added length to the<br>proximal shaft does not affect the working<br>(distal) shaft of the catheter. |
| Dimensional<br>Verification | Purpose is to verify that all<br>dimensional requirements will<br>meet the specified attributes.<br>Performed visual and<br>dimensional inspection on pre-<br>and post-sterile. | Test samples were inspected and passed<br>the specified attributes as specified. All<br>test articles met the visual and<br>dimensional specifications pre-<br>sterilization and post-sterilization.<br>Modified and predicate device meet the<br>same equivalent requirements. |
| Material verification | The purpose is to verify that all<br>materials are as specified in raw<br>material, final assembly,<br>subassembly specifications and<br>vendor certifications. | The results verified that all materials are<br>as specified and confirms that all material<br>of the modified device and the predicate<br>are identical therefore equivalent. |
| Catheter/ Guide<br>Catheter<br>Compatibility | The purpose is to verify that the<br>catheter can track through a<br>guiding catheter with an I.D.<br>≥ 0.0445". | The added length to the proximal shaft<br>does not affect the working (distal) shaft<br>of the catheter that goes through the<br>guide catheter. The passing test results of<br>the predicate device apply to the<br>modified device and therefore equivalent.<br>Results are also confirmed with<br>Accessibility/Tractability Test (above). |
| Catheter/Guide Wire<br>Compatibility | Catheter is able to track over the<br>guide wire that is ≤ 0.025" in<br>diameter. | The added length to the proximal shaft<br>does not affect the working (distal) shaft<br>of the catheter that goes through the<br>guide catheter. The passing test results of<br>the predicate device apply to the<br>modified device and therefore equivalent.<br>Results are also confirmed with<br>Accessibility/Tractability Test (above). |
| Catheter/ RHV<br>Compatibility and<br>Leakage<br>Verification | Catheter is compatible with<br>rotating hemostasis value (RHV)<br>in dimension and RHV will not<br>leak during use. | The added length to the catheter shaft<br>does not affect the RHV connection. It is<br>the identical RHV. The passing test<br>results of the predicate device apply to<br>the modified device and therefore<br>equivalent. |
| Test Description | Test Method Summary | Results |
| Shaft Stiffness | Catheter shaft to meet<br>specification on stiffness. | The added length to the proximal shaft<br>does not affect the shaft stiffness of the<br>working (distal) shaft of the catheter that<br>goes into the body. The passing test<br>results of the predicate device apply to the<br>modified device and therefore equivalent.<br>Results are also confirmed with<br>Accessibility/ Tractability Test (above). |
| Chemical<br>Compatibility | Catheter should show no damage<br>when exposed to saline and<br>contrast medium. | Materials are all identical. The passing<br>test results of the predicate device apply<br>to the modified device and therefore<br>equivalent. |
| Shaping Mandrel<br>compatibility &<br>shapeability | The purpose is to verify that the<br>steam shaping mandrel fits the<br>distal lumen of the catheter; the<br>tip meets retention specification<br>and dimensional shrinkage OD<br>and ID requirements. | The added length to the proximal shaft<br>does not affect the working (distal) shaft<br>of the catheter is subjected to tip shaping.<br>The passing test results of the predicate<br>device apply to the modified device and<br>therefore equivalent. |
| Kink Resistance | The purpose of the test is to<br>verify that the catheter distal<br>shaft will not kink when tested<br>in accordance with BS EN<br>13868:2002 Annex A; and<br>lumen integrity when catheter is<br>looped to predetermine diameter.<br>Method, equipment and<br>conditions as prescribed in<br>standard. | The added length to the proximal shaft<br>does not affect the working (distal) shaft<br>of the catheter is subjected to kinking.<br>The passing test results of the predicate<br>device apply to the modified device and<br>therefore equivalent. |
| Conical Fitting for<br>Hub | The purpose of the test is to<br>verify that the catheter hub will<br>meet the testing requirements as<br>specified in BS EN 1707:1997.<br>Method, equipment and<br>conditions as prescribed in<br>standard. | The added length to the catheter proximal<br>shaft does not affect the hub connection.<br>It is the identical hub. The passing test<br>results of the predicate device apply to<br>the modified device and therefore<br>equivalent. |
| Corrosion<br>Resistance | Catheter shall show no sign of<br>corrosion per ISO10555-1:2013<br>Annex A.<br>(material characterization only) | Materials are all identical. The passing<br>test results of the predicate device apply<br>to the modified device and therefore<br>equivalent. |
| Test Description | Test Method Summary | Results |
| Tensile Strength of<br>catheter body, hub<br>attachment, distal<br>attachment | The tip, distal, mid, proximal and<br>hub junctions should meet the<br>tensile strength requirement per<br>EN ISO-10555-1: Annex B.<br>Method, equipment and<br>conditions as prescribed in<br>standard. | The added length to the proximal shaft<br>does not affect the various catheter<br>segments, hub or distal attachments of the<br>catheter. The passing test results of the<br>predicate device apply to the modified<br>device and therefore equivalent. |
| Liquid Leakage at<br>Hub | No liquid leakage detected per<br>BS EN ISO 10555-1:2013<br>Annex C. Method, equipment<br>and conditions as prescribed<br>in standard. | The added length modification does not<br>affect the hub attachments to the catheter.<br>The passing test results of the predicate<br>device apply to the modified device and<br>therefore equivalent. |
| Air Leakage During<br>Aspiration | No leak detected when tested BS<br>EN ISO 10555-1:2013 Annex D.<br>Method, equipment and<br>conditions as prescribed in<br>standard. | The added length does not affect the<br>various catheter segments and joints of<br>the catheter. The passing test results of<br>the predicate device apply to the<br>modified device and therefore equivalent. |
| Rupture Pressure | Verify that the catheter can<br>withstand predetermined static<br>and dynamic rupture pressure<br>testing. | The added length does not affect the<br>various catheter segments, joints or<br>methods of fabrication of the catheter.<br>The passing test results of the predicate<br>device apply to the modified device and<br>therefore equivalent. |
| Particulate | Verify particulate levels<br>catheter. | The added length does not affect the<br>material, method and environment of<br>fabrication of the catheter that affects<br>particulates. The passing test results of<br>the predicate device apply to the<br>modified device and therefore equivalent. |
| Outer Surface<br>Coating Lubricity<br>and Durability | Test is to verify predetermine<br>friction force of the coating. | The added length to the proximal shaft<br>does not affect the working (distal) shaft<br>of the catheter which is coated. The<br>passing test results of the predicate<br>device apply to the modified device and<br>therefore equivalent. |
| Flexural Fatigue | The test method is to verify that<br>the catheter structure will remain<br>intact after predetermined<br>number of cycles when used to<br>accessing in a simulated<br>torturous path model. | The added length does not affect the<br>design of the shaft segments or joints of<br>the catheter which affect flexural fatigue.<br>The passing test results of the predicate<br>device apply to the modified device and<br>therefore equivalent. |

Table B- Summary of Pre-Clinical Bench Testing

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# Conclusion of the Pre-Clinical Bench Testing

Based on the non-clinical testing provided above in Table B, the proposed modified device is as safe, as effective, and performs as well or better than the legally marketed device. The additional length will assist the user in the set-up procedures without affecting the performance or safety of the device. The accessibility, trackability, high pressure flow rate testing show that the modified device is substantially equivalent to the predicate device.

# Substantial Equivalence Determination

The information presented in the 510k shows that the modified Phenom® 27 Catheters are substantially equivalent to predicate Phenom® 27 catheters regarding the following aspects:

| Design: | The subject and predicate devices are substantially equivalent with respect to design characteristics. The modified devices provide the user with additional effective length on the proximal shaft of the catheter which remain outside the patient. The working (distal) shaft of the catheter that enters the body is identical. |
|----------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Function: | The subject and predicate devices are substantially equivalent with respect to functional characteristics. The modified devices provide the user with additional length on the proximal shaft of the catheter to assist in the procedural set-up. The working (distal) portion of the catheter that enters the body is identical. Trackability and accessibility testing was performed to verify that the modified catheter can reach the MI region of the neurovascular model. |
| Manufacturing: | The subject and predicate devices are the same with respect to technological manufacturing processes. |
| Materials: | The subject and predicate devices are composed of identical materials, all of which have an extensive clinical history of safe use in medical devices. |
| Indications: | The subject and predicate devices have identical indications. |
| Packaging: | The subject and predicate devices utilize same packaging configurations. |
| Sterilization: | The subject and predicate devices are both sterilized utilizing an Ethylene Oxide sterilization cycle validated in accordance with ISO 11135 - Medical Devices - Validation and Routine Control of Ethylene Oxide Sterilization. |
| Labeling: | Both the subject and predicate devices have similar labeling. |

# Conclusion for Substantial Equivalence Determination

Based on the comparison of the technological characteristics and the non-clinical testing provided in Table A & Table B (respectively, above), the proposed modified device is as safe, as effective, and performs as well or better than the legally marketed Phenom ® 27. The additional length of the proximal shaft will assist the user in the set-up procedures without affecting the safety performance of the device.

Testing was conducted to show that no new risks were identified, and that the performance and risk profile is the same as the predicate devices cleared for the market. Additional testing as identified in the risk analysis was performed to show that the modified Phenom® 27device is substantially equivalent to the predicate Phenom® 27 device.