Predicate Devices

Reference Devices

AI/ML (Artificial Intelligence / Machine Learning)

No
The 510(k) summary describes a mechanical introducer sheath and dilator, with no mention of AI/ML capabilities, image processing, or data-driven performance metrics.

Therapeutic

No
The document states that the Introducer Sheath is intended for the "introduction of diagnostic and therapeutic devices," meaning it facilitates the use of other devices, rather than being a therapeutic device itself.

Diagnostic

No

The device description clearly states "The Introducer Sheath is intended for establishing a percutaneous access that facilitates the introduction of intravascular devices." This indicates it's an access tool, not a device that directly diagnoses conditions. Its use is for "introduction of diagnostic and therapeutic devices," meaning it aids other devices that might be diagnostic, but it is not diagnostic itself.

SaMD (Software as a Medical Device)

No

The device description clearly states it is a physical Introducer Sheath composed of a Guiding Sheath and a Dilator, which are hardware components.

IVD (In Vitro Diagnostic)

Based on the provided information, this device is not an IVD (In Vitro Diagnostic).

Here's why:

Intended Use: The intended use clearly states the device is for the "introduction of diagnostic and therapeutic devices into the human vasculature." This describes a tool used during a medical procedure to facilitate the use of other devices, not a device that performs a diagnostic test on a sample taken from the body.
Device Description: The description reinforces this by stating it "facilitates the introduction of intravascular devices."
Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue, etc.), detecting analytes, or providing diagnostic information based on in vitro testing.

IVD devices are specifically designed to perform tests on samples taken from the human body to provide information for diagnosis, monitoring, or screening. This device is a procedural tool used within the body.

PCCP (Predetermined Change Control Plan) Authorized

N/A

Overview

Intended Use / Indications for Use

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.

Product codes (comma separated list FDA assigned to the subject device)

DYB

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.

Mentions image processing

Not Found

Mentions AI, DNN, or ML

Not Found

Input Imaging Modality

Not Found

Anatomical Site

human vasculature, including but not limited to intracardiac, renal or other peripheral placements

Indicated Patient Age Range

Not Found

Intended User / Care Setting

Not Found

Description of the training set, sample size, data source, and annotation protocol

Not Found

Description of the test set, sample size, data source, and annotation protocol

Not Found

Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)

Performance tests were conducted to ensure that the Introducer Sheath met the applicable design and performance requirements throughout its shelf life. The physical properties (including particulate matter), chemical properties, microbial properties, sterile barrier properties, biocompatibility, shelf-life, packaging, simulated transportation and labeling and identification of the Introducer Sheath products were tested to ensure the design output meets the requirements of the design inputs. The tests results indicate that the Introducer Sheath passed all the tests and it conforms to 150 11070:2014 Sterile single-use intravascular introducers, dilators and guidewires.

Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)

Not Found

Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.

K210627

Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.

K172995

Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).

Not Found

Regulation Number and Section

§ 870.1340 Catheter introducer.

(a)
Identification. A catheter introducer is a sheath used to facilitate placing a catheter through the skin into a vein or artery.(b)
Classification. Class II (performance standards).

Summary

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 (DICE@fda.hhs.gov) or phone (1-800-638-2041 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)
-------------------------------------------------

Prescription Use (Part 21 CFR 801 Subpart D)
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: anlan.zhang@ap-healthcare.com

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.: +86-18906178526 E-mail: ra@pulnovomed.com

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
name	Introducer Sheath	Breezeway II	Destination®
Guiding
Sheath (Carotid, Peripheral
and Renal)
Regulatory
Decision		K210627	K172995
Product
Code	DYB	DYB	DYB
Regulation
Number	870.1340	870.1340	870.1340
Intended
Use/Indicati
ons 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.	The Breezeway II
products are 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.	The Destination® Carotid
Guiding Sheath is designed
to be used for the
introduction of interventional
and diagnostic devices into
the human vasculature,
including but not limited to
the carotid arteries.
The Destination® Peripheral
Guiding Sheath is designed
to be used for the
introduction of
interventional and diagnostic
devices into the human
vasculature, including but
not limited to lower
extremity access via a
contralateral approach.
The Destination® Renal
Guiding Sheath is intended
for the introduction of
interventional and diagnostic
devices into the human
vasculature including but
not limited to
			the renal arteries.
Operation
Principle	Operated manually
or by a manual
process	Operated manually or by
a manual process	Operated manually or by a
manual process
Design /
Construction	Sheath, Dilator,
Hemostatic Valve
with side tube and
three-way stopcock	Sheath, Dilator,
Hemostatic Valve with
side tube and three-way
stopcock	Sheath, Dilator, Hemostatic
Valve with side tube and
three-way stopcock, and
Dilator Retaining Clip
Materials	Sheath Assembly
Tubing: PTFE-SSL
braided-Pebax,
BaSO4
Tip: Pebax, BaSO4
Hydrophilic Coating:
NA
Radiopaque Band:
Platinum-Iridium
alloy
Dilator Assembly
Tubing: HDPE,
BaSO4
Hub: HDPE
Hemostatic Valve
Assembly
Valve assembly:
Nylon, silicone
rubber, Polyurethane
Side Tube/3-Way
Stopcock Assembly:
Polyvinyl chloride,
Polycarbonate,
Polyethylene	Sheath
Liner (Inner): PA12
Distal Tip (Outer): Pebax
45D
Proximal Shaft (Outer):
Pebax 63D
Sheath Hub Cap:
Polycarbonate
Sheath Coating:
Hydrophobic
Hemostatic Valve:
Silicone
Marker Band: Gold
Dilator
6F to 12F: HDPE (Body
and Hub)
14F: LDPE (Body),
HDPE (Hub)	Sheath Assembly
Tubing: PTFE-SSL
coil-Nylon
Tip: Nylon
Hydrophilic Coating:
Polyvinylpyrrolidone-based
Coating
Hub: Nylon
Radiopaque Band: Gold
Dilator Assembly

Table 1 Comparison of technological characteristics with the predicate device

7

8

9

VII Performance Data

Non-Clinical Bench Performance Testing

Performance tests were conducted to ensure that the Introducer Sheath met the applicable design and performance requirements throughout its shelf life. The physical properties (including particulate matter), chemical properties, microbial properties, sterile barrier properties, biocompatibility, shelf-life, packaging, simulated transportation and labeling and identification of the Introducer Sheath products were tested to ensure the design output meets the requirements of the design inputs. The tests results indicate that the Introducer Sheath passed all the tests and it conforms to 150 11070:2014 Sterile single-use intravascular introducers, dilators and guidewires. The basis for a determination of substantial equivalence of the device is demonstrated by the following:

Physical properties

Dilator: 1.
- . Appearance,
- Dimensional (including OD/ID, working length), .
- Luer compatibility, ●
- Guidewire compatibility, .
- . Tensile strength.

Introducer sheath: 2.

. Appearance,
Dimensional (including OD/ID, working length, curve geometry), .
Luer compatibility, .
Guidewire compatibility. .
Valve liquid/air leak test. ●
Tensile strength, ●
Torque strength, ●
Simulated use,
Kink resistance, .
Particulate matter, .
. Radiopacity.

Biocompatibility

The Introducer Sheath was evaluated for biological safety based on its body contact and duration per ISO 10993-1 and FDA Guidance on Use of International Standard ISO 10993-1.

The Introducer Sheath is classified as an Externally Communicating Medical Device with limited (