Introducer Sheath (PFlexi00L065, PFlexi00L070, PFlexi00L075, PFlexi00L080, PFlexi00L090, PFlexi30L065, PFlexi30L070, PFlexi30L075, PFlexi30L080, PFlexi30L090, PFlexi45L065, PFlexi45L070, PFlexi45L075, PFlexi45L080, PFlexi45L090, PFlexi60L065, PFlexi60L070, PFlexi60L075, PFlexi60L080, PFlexi60L090)

K242756 · Pulnovo Medical (Wuxi) Co., Ltd. · DYB · Nov 8, 2024 · Cardiovascular

Device Facts

• Record ID: K242756
• Device Name: Introducer Sheath (PFlexi00L065, PFlexi00L070, PFlexi00L075, PFlexi00L080, PFlexi00L090, PFlexi30L065, PFlexi30L070, PFlexi30L075, PFlexi30L080, PFlexi30L090, PFlexi45L065, PFlexi45L070, PFlexi45L075, PFlexi45L080, PFlexi45L090, PFlexi60L065, PFlexi60L070, PFlexi60L075, PFlexi60L080, PFlexi60L090)
• Applicant: Pulnovo Medical (Wuxi) Co., Ltd.
• Product Code: DYB · Cardiovascular
• Decision Date: Nov 8, 2024
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 870.1340
• Device Class: Class 2

Intended Use

The Introducer Sheath is intended for the introduction of diagnostic and therapeutic devices into the human vasculature, including but not limited to intracardiac, renal or other peripheral placements. Do not use this device for neural placements.

Device Story

Introducer Sheath facilitates percutaneous access for diagnostic/therapeutic instruments (catheters, guidewires) into blood vessels. Device consists of guiding sheath, dilator, hemostatic valve, side tube, and three-way stopcock. Operated manually by clinicians in clinical settings. Sheath inserted into vasculature to provide pathway for intravascular devices; hemostatic valve prevents blood loss during instrument exchange. Benefits include reliable access to target anatomy for interventional procedures. No software or electronic components.

Clinical Evidence

No clinical data. Substantial equivalence supported by non-clinical bench testing including physical properties (tensile strength, kink resistance, torque, radiopacity), biocompatibility (cytotoxicity, sensitization, irritation, systemic toxicity, hemocompatibility), and sterilization validation per ISO 11135:2014.

Technological Characteristics

Sheath assembly: PTFE-SSL braided-Pebax with BaSO4; Tip: Pebax with BaSO4; Radiopaque band: Platinum-Iridium alloy. Dilator: HDPE. Hemostatic valve: Nylon, silicone rubber, polyurethane. Sterilization: Ethylene Oxide (ISO 11135:2014). Manual operation. No software or connectivity.

Indications for Use

Indicated for introduction of diagnostic and therapeutic devices into human vasculature, including intracardiac, renal, or peripheral placements. Contraindicated for neural placements.

Regulatory Classification

Identification

A catheter introducer is a sheath used to facilitate placing a catheter through the skin into a vein or artery.

Predicate Devices

• Breezeway II (K210627)

Reference Devices

• Destination Carotid Guiding Sheath (K172995)
• Destination Peripheral Guiding Sheath (K172995)
• Destination Renal Guiding Sheath (K172995)

Submission Summary (Full Text)

{0}------------------------------------------------

Image /page/0/Picture/0 description: The image shows the logo for the U.S. Food & Drug Administration (FDA). The logo consists of two parts: a symbol on the left and the FDA name on the right. The symbol is a stylized representation of a human figure, while the FDA name is written in blue and includes the words "U.S. Food & Drug Administration".

November 8, 2024

Pulnovo Medical (Wuxi) Co., Ltd Wen Gu Clinical Vice President 3rd Floor, Bldg D 17, No. 1719-17 Huishan Ave, & 3rd Floor, Bldg D 11, No. 1719-11 Huishan Ave, Huishan Economic Dev Zone Wuxi, Jiangsu 214000 China

Re: K242756

Trade/Device Name: Introducer Sheath (PFlexi00L065, PFlexi00L070, PFlexi00L075, PFlexi00L080, PFlexi00L090, PFlexi30L065, PFlexi30L070, PFlexi30L075, PFlexi30L080, PFlexi30L090. PFlexi45L065. PFlexi45L070. PFlexi45L075. PFlexi45L080. PFlexi45L090, PFlexi60L065, PFlexi60L070, PFlexi60L075, PFlexi60L080, PFlexi60L090) Regulation Number: 21 CFR 870.1340 Regulation Name: Catheter introducer Regulatory Class: Class II Product Code: DYB Dated: September 12, 2024 Received: September 12, 2024

Dear Wen Gu:

We have reviewed your section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food. Drug. and Cosmetic Act (the Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database available at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of

{1}------------------------------------------------

Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device" (https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download).

Your device is also subject to, among other requirements, the Quality System (QS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30, Design controls; 21 CFR 820.90, Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review, the QS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181).

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting of medical device-related adverse events) (21 CFR Part 803) for devices or postmarketing safety reporting (21 CFR Part 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050.

All medical devices, including Class I and unclassified devices and combination product device constituent parts are required to be in compliance with the final Unique Device Identification System rule ("UDI Rule"). The UDI Rule requires, among other things, that a device bear a unique device identifier (UDI) on its label and package (21 CFR 801.20(a)) unless an exception or alternative applies (21 CFR 801.20(b)) and that the dates on the device label be formatted in accordance with 21 CFR 801.18. The UDI Rule (21 CFR 830.300(a) and 830.320(b)) also requires that certain information be submitted to the Global Unique Device Identification Database (GUDID) (21 CFR Part 830 Subpart E). For additional information on these requirements, please see the UDI System webpage at https://www.fda.gov/medical-devices/device-advicecomprehensive-regulatory-assistance/unique-device-identification-system-udi-system.

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.

For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the

{2}------------------------------------------------

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

> Sincerely, Sevan R. 2024.11.08 Oungoulian -S 16:59:04 -05'00' For Finn Donaldson Assistant Director (Acting) DHT2C: Division of Coronary and Peripheral Intervention Devices OHT2: Office of Cardiovascular Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health

Enclosure

{3}------------------------------------------------

# Indications for Use

510(k) Number (if known) K242756

### Device Name

Introducer Sheath (PFlexi00L070, PFlexi00L075, PFlexi00L080, PFlexi00L090, PFlexi30L065, PFlexi30L070, PFlexi30L075. PFlexi30L080. PFlexi45L065. PFlexi45L070. PFlexi45L075. PFlexi45L080. PFlexi45L090. PFlexi60L065, PFlexi60L070, PFlexi60L075, PFlexi60L080, PFlexi60L090

## Indications for Use (Describe)

The Introducer Sheath is intended for the introduction of diagnostic devices into the human vasculature, including but not limited to intracardiac, renal or other peripheral placements.

Do not use this device for neural placements.

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

| <input checked="true" type="checkbox"/> Prescription Use (Part 21 CFR 801 Subpart D) |
|--------------------------------------------------------------------------------------|
| <input type="checkbox"/> Over-The-Counter Use (21 CFR 801 Subpart C) |

## CONTINUE ON A SEPARATE PAGE IF NEEDED.

This section applies only to requirements of the Paperwork Reduction Act of 1995.

## *DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.*

The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:

> Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov

"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."

{4}------------------------------------------------

# Summary

## I Submitter

## Prepared by:

Ms. Anlan Zhang APlus Healthcare Technology (Shanghai) Co., Ltd. E-mail: [e-mail]

## Prepared for:

Pulnovo Medical (Wuxi) Co., Ltd.

3rd Floor, Building D 17, No. 1719-17 Huishan Avenue, and 3rd Floor, Building D 11, No. 1719-11, Huishan Avenue, Huishan Economic Development Zone, Wuxi, 214000 Jiangsu Province, China

## Contact person:

Name: Mr. Wen Gu Occupation title: Clinical Vice President Tel.: [phone] E-mail: [e-mail]

# Preparation date: September 12, 2024

# II Proposed Device

| Trade Name of Device: | Introducer Sheath |
|-----------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Models: | PFlexi00L065, PFlexi00L070, PFlexi00L075, PFlexi00L080, PFlexi00L090, PFlexi30L065, PFlexi30L070, PFlexi30L075, PFlexi30L080, PFlexi30L090, PFlexi45L065, PFlexi45L070, PFlexi45L075, PFlexi45L080, PFlexi45L090, PFlexi60L065, PFlexi60L070, PFlexi60L075, PFlexi60L080, PFlexi60L090 |
| Regulation name: | Catheter introducer |
| Regulation Number: | 21 CFR 870.1340 |
| Regulatory Class: | Class II |
| Product code: | DYB |
| Review Panel | Cardiovascular |

## III Predicate Device

## Predicate device

510(k) Number: K210627 Product Code: DYB

{5}------------------------------------------------

Classification: 21 CFR 870.1340 Trade Name: Breezeway II Regulatory Class: II

Reference Device 510(k) Number: K172995 Product Code: DYB Classification: 21 CFR 870.1340 Trade Name: Destination Carotid Guiding Sheath, Destination Peripheral Guiding Sheath, Destination Renal Guiding Sheath Regulatory Class: II

# IV Device description

The Introducer Sheath is intended for establishing a percutaneous access that facilitates the introduction of intravascular devices. The Introducer Sheath is composed of the Guiding Sheath and the Dilator. The Introducer Sheath is available in multiple effective lengths and curve shape configurations.

## Principles of Operation

The Introducer Sheath is used to assist in the insertion of diagnostic/therapeutic instruments such as guide wires, catheters, and other medical devices into blood vessels, or to establish percutaneous access pathways that facilitate the insertion of intravascular instruments.

## V Indications for use

The Introducer Sheath is intended for the introduction of diagnostic and therapeutic devices into the human vasculature, including but not limited to intracardiac, renal or other peripheral placements.

Do not use this device for neural placements.

# VI Comparison of technological characteristics with the predicate device

The comparable properties between the proposed device and the predicate devices are listed in Table 1. Table 1 compares the Introducer Sheath to the predicate devices with respect to intended use, technological characteristics, and principles of operations, providing more detailed information regarding the bases for the determination of substantial equivalence.

{6}------------------------------------------------

| Items | Proposed Device | Predicate Device | Reference Device |
|-----------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Device<br>name | Introducer Sheath | Breezeway II | Destination®<br>Guiding<br>Sheath (Carotid, Peripheral<br>and Renal) |
| Regulatory<br>Decision | | K210627 | K172995 |
| Product<br>Code | DYB | DYB | DYB |
| Regulation<br>Number | 870.1340 | 870.1340 | 870.1340 |
| Intended<br>Use/Indicati<br>ons for use | The Introducer<br>Sheath is intended for<br>the introduction of<br>diagnostic and<br>therapeutic devices<br>into the human<br>vasculature,<br>including but not<br>limited to<br>intracardiac, renal or<br>other peripheral<br>placements.<br>Do not use this<br>device for neural<br>placements. | The Breezeway II<br>products are intended for<br>the introduction of<br>diagnostic and<br>therapeutic devices into<br>the human vasculature,<br>including but not limited<br>to intracardiac, renal or<br>other peripheral<br>placements.<br>Do not use this device<br>for neural placements. | The Destination® Carotid<br>Guiding Sheath is designed<br>to be used for the<br>introduction of interventional<br>and diagnostic devices into<br>the human vasculature,<br>including but not limited to<br>the carotid arteries.<br>The Destination® Peripheral<br>Guiding Sheath is designed<br>to be used for the<br>introduction of<br>interventional and diagnostic<br>devices into the human<br>vasculature, including but<br>not limited to lower<br>extremity access via a<br>contralateral approach.<br>The Destination® Renal<br>Guiding Sheath is intended<br>for the introduction of<br>interventional and diagnostic<br>devices into the human<br>vasculature including but<br>not limited to |
| | | | the renal arteries. |
| Operation<br>Principle | Operated manually<br>or by a manual<br>process | Operated manually or by<br>a manual process | Operated manually or by a<br>manual process |
| Design /<br>Construction | Sheath, Dilator,<br>Hemostatic Valve<br>with side tube and<br>three-way stopcock | Sheath, Dilator,<br>Hemostatic Valve with<br>side tube and three-way<br>stopcock | Sheath, Dilator, Hemostatic<br>Valve with side tube and<br>three-way stopcock, and<br>Dilator Retaining Clip |
| Materials | Sheath Assembly<br>Tubing: PTFE-SSL<br>braided-Pebax,<br>BaSO4<br>Tip: Pebax, BaSO4<br>Hydrophilic Coating:<br>NA<br>Radiopaque Band:<br>Platinum-Iridium<br>alloy<br>Dilator Assembly<br>Tubing: HDPE,<br>BaSO4<br>Hub: HDPE<br>Hemostatic Valve<br>Assembly<br>Valve assembly:<br>Nylon, silicone<br>rubber, Polyurethane<br>Side Tube/3-Way<br>Stopcock Assembly:<br>Polyvinyl chloride,<br>Polycarbonate,<br>Polyethylene | Sheath<br>Liner (Inner): PA12<br>Distal Tip (Outer): Pebax<br>45D<br>Proximal Shaft (Outer):<br>Pebax 63D<br>Sheath Hub Cap:<br>Polycarbonate<br>Sheath Coating:<br>Hydrophobic<br>Hemostatic Valve:<br>Silicone<br>Marker Band: Gold<br>Dilator<br>6F to 12F: HDPE (Body<br>and Hub)<br>14F: LDPE (Body),<br>HDPE (Hub) | Sheath Assembly<br>Tubing: PTFE-SSL<br>coil-Nylon<br>Tip: Nylon<br>Hydrophilic Coating:<br>Polyvinylpyrrolidone-based<br>Coating<br>Hub: Nylon<br>Radiopaque Band: Gold<br>Dilator Assembly<br> |
| | | | Valve assembly: |
| | | | Polypropylene, |
| | | | Polycarbonate, Silicone |
| | | | Rubber, Elastomer, |
| | | | Non-reactive silicone oil |
| | | | 1000cst |
| | | | Side Tube/3-Way Stopcock |
| | | | Assembly: Same as TBV |
| Package | Unit Pouch | Unit Pouch | Unit Pouch |
| | Shelf Box | Shelf Box | Shelf Box |
| | Shipping Carton | Shipping Carton | Shipping Carton |
| | Sheath Size: 9Fr | Sheath Size: 6Fr to 14 Fr | Sheath Size |
| | Sheath Length: | Sheath Length | Carotid: 6-7Fr |
| | 65-90cm | 79 cm (6Fr to 14 Fr) | Peripheral: 5-8Fr |
| | Hydrophilic Coating: | 110 cm (6Fr to 10Fr) | Renal: 5-7Fr |
| | NA | Hydrophilic Coating: | Sheath Length |
| | Curve Shapes: ST, | Hydrophobic | Carotid: 80-110cm |
| | MP | Curve Shapes: Not | Peripheral: 45-110cm |
| | Dilator Extended | reported | Renal: 45-55cm |
| | Length: 2.5cm | | Hydrophilic Coating |
| | | Dilator Extended | Carotid Distal 15 cm |
| Specificatio<br>ns | | Length: Not reported | Peripheral Distal 15-60 |
| | | | cm |
| | | | Renal Distal 5 cm |
| | | | Curve Shapes |
| | | | Carotid: ST, MP |
| | | | Peripheral: ST |
| | | | Renal: ST, HS, MP, RDC, |
| | | | LIMA |
| | | | Dilator Extended Length |
| | | | Carotid: 5cm |
| | | | Peripheral: 2.5 and 5cm |
| | | | Renal: 2cm |
| Sterilization | Ethylene Oxide | Ethylene Oxide | Ethylene Oxide |
| Shelf life…