Predicate Devices

Reference Devices

AI/ML (Artificial Intelligence / Machine Learning)

No
The device description focuses solely on the mechanical structure and physical characteristics of a balloon dilatation catheter. There is no mention of software, algorithms, data processing, or any terms related to AI or ML. The performance studies described are non-clinical tests verifying physical specifications and substantial equivalence to predicate devices, not evaluating algorithmic performance.

Therapeutic

Yes.
The device is used to dilate strictures of the gastrointestinal tract and Sphincter of Oddi, which directly addresses a medical condition, making it a therapeutic device.

Diagnostic

No
The device is a balloon dilatation catheter used to treat strictures, not diagnose them. Its purpose is interventional (therapeutic), not diagnostic.

SaMD (Software as a Medical Device)

No

The device description clearly details physical components like balloons, shafts, and hubs, indicating it is a hardware device, not software-only.

IVD (In Vitro Diagnostic)

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

Here's why:

IVD Definition: In Vitro Diagnostic devices are used to examine specimens taken from the human body (like blood, urine, tissue) to provide information about a person's health.
Device Function: This device is a balloon dilatation catheter used within the body to physically dilate strictures in the gastrointestinal tract and the Sphincter of Oddi. It is a therapeutic device, not a diagnostic one that analyzes samples.
Intended Use: The intended use clearly states it is for endoscopically dilating strictures, which is a physical intervention, not a diagnostic test.
Device Description: The description focuses on the physical components and structure of a catheter designed for insertion and inflation within the body.
Lack of Diagnostic Elements: There is no mention of analyzing biological samples, detecting biomarkers, or providing diagnostic information based on laboratory tests.

Therefore, this device falls under the category of a therapeutic medical device used for interventional procedures, not an In Vitro Diagnostic device.

PCCP (Predetermined Change Control Plan) Authorized

N/A

Overview

Intended Use / Indications for Use

This device is indicated for use in adult and adolescent populations to endoscopically dilate strictures of the gastrointestinal tract. It is also indicated in adults for endoscopic dilatation of Sphincter of Oddi with or without prior sphincterotomy.

Product codes

FGE

Device Description

According to the structure of the device, it can be divided into three types, RX type, OTW type and OTW with Stainless Wire-guided type. The Rx proposed device mainly consists of tip, balloon, marker band, shaft, sleeve, stress diffusion tube and hub. The OTW proposed device mainly consists of tip, balloon, marker band, shaft, stress diffusion tube and hub. The structure of the OTW with Stainless Wire-guided model same with the structure of OTW model. The difference between OTW with Stainless Wire-guided type catheter and OTW type catheter is that OTW with Stainless Wire-guided type catheter is preloaded with a guide wire and a guide wire locking component. The difference between the RX type catheter and the OTW series catheter is that the guidewire exit position is different. The guide wire of OTW series catheter passed through the guide wire lumen of the catheter. The guidewire of the Rx type catheter will pass through the guidewire exchange port on the shaft.

Single-use Balloon Dilatation Catheter is divided into different specifications. Shafts are available in two different diameters. The effective length of the catheter is 180cm and 240cm. Balloon diameters are available in six different diameters 6-7-8mm, 8-9-10 mm, 12-13.5-15 mm, 15-16.5-18 mm, 18-19-20 mm, and the balloon lengths are available in 30 mm,55 mm and 80 mm three different length.

Mentions image processing

Not Found

Mentions AI, DNN, or ML

Not Found

Input Imaging Modality

Not Found

Anatomical Site

gastrointestinal tract, Sphincter of Oddi

Indicated Patient Age Range

adult and adolescent populations

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)

Non clinical tests were conducted to verify that the proposed device met all design specifications as was Substantially Equivalent (SE) to the predicate device. The test results demonstrated that the proposed device complies with the following standards:

ISO 10993-7:2008 Biological Evaluation Of Medical Devices-Part 7: Ethylene Oxide Sterilization Residuals
ISO 10993-5:2009 Biological Evaluation of Medical Devices-Part 5: Tests for In Vitro Cytotoxicity
ISO 10993-10:2021 Biological Evaluation of Medical Devices-Part 10: Tests for Irritation and Skin Sensitization
ISO 10993-11:2017 Biological Evaluation of Medical Devices-Part 11: Tests for systemic toxicity
ISO 10993-23:2021 Biological evaluation of medical devices — Part 23: Tests for irritation.
ASTM F88/F88M-21 Standard test method for seal strength of flexible barrier materials
ASTM F1929-15 Standard Test Method for Detecting Seal Leaks in Porous Medical Packaging by Dve Penetration
ASTM D4169-22 Standard Practice for Performance Testing of Shipping Containers and Systems
USP Pyrogen Test
ISO10555-4:2013 Intravascular catheters -- Sterile and single-use catheters -- Part 4: Balloon dilatation catheters.
ISO 10555-1:2013/A1:2017 Intravascular catheters -Sterile and single-use catheters -Part 1: General requirements.
ISO20696:2018(E) Sterile urethral catheters for single-use.
ASTM F640-20 Standard Test Methods for Determining Radiopacity for Medical Use
ASTM F1886/F1886M-16, Standard Test Method for Determining Integrity of Seals for Flexible Packaging by Visual Inspection
USP Bacterial Endotoxins Test
ISO 80369-7:2023 Small-bore connectors for liguids and gases in healthcare applications — Part 7: Connectors for intravascular or hypodermic applications
ISO 80369-20:2023 Small-bore connectors for liquids and gases in healthcare applications - Part 20: Common test methods
ASTM F3172 Standard Guide for Design Verification Device Size and Sample Size Selection for Endovascular Devices

The performance testing conducted on subject device and predicate device are listed below. All the test results demonstrate proposed device meet the requirements of its pre-defined acceptance criteria and intended uses.

Dimension Test
Appearance
Compatibility Test
Delivery and Retrieval Force
Peak Tensile Force
Burst Pressure
Kink Stability
Corrosion Resistance Test
Air Leakage
Liquid Leakage
Luer connector
Radiopacity
Balloon Burst Pressure
Balloon Compliance
Balloon Deflation Time
Balloon Fatigue

The proposed device sterilization process using Ethylene Oxide (EO) has been validated in accordance with ISO 11135:2014 to achieve a sterility assurance level (SAL) of 10-6. EO and Ethylene Chlorohydrin (ECH) residuals were below the limits specified in ISO 10993-7:2008. Bacterial Endotoxin Levels were below the level of 20 EU/device in accordance with USP . Both baseline and accelerated shelf life testing were conducted demonstrating the device will perform as intended to support the proposed 3-year shelf-life.

Package Integrity Test after environmental conditioning, simulated transportation testing in accordance to ASTM D4169-22 on final, packaged, and sterile device.
Sterile Barrier Packaging performed on the proposed device:
- Visual Inspection per ASTM F1886/F1886M-16
- Seal Strength per ASTM F88/F88-21
- Dye Penetration per ASTM F1929-15
Shelf-life of 3 years is validated using FDA recognized standard ASTM F1980-16 Standard Guide for Accelerated Aging of Sterile Barrier Systems for Medical Devices.

The biocompatibility evaluations were conducted in accordance with the 2020 FDA Guidance document Use of International Standard ISO-10993-1, 'Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process". The cytotoxicity, sensitization, intracutaneous irritation, system toxicity and pyrogen tests were performed to demonstrate the biocompatibility of the device.

No clinical study is included in this submission.

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

Not Found

Predicate Device(s)

K112994, K172520

Reference Device(s)

K122924

Predetermined Change Control Plan (PCCP) - All Relevant Information

Not Found

Regulation Number and Section

§ 876.5010 Biliary catheter and accessories.

(a)
Identification. A biliary catheter and accessories is a tubular flexible device used for temporary or prolonged drainage of the biliary tract, for splinting of the bile duct during healing, or for preventing stricture of the bile duct. This generic type of device may include a bile collecting bag that is attached to the biliary catheter by a connector and fastened to the patient with a strap.(b)
Classification. Class II (special controls). The device, when it is a bile collecting bag or a surgical biliary catheter that does not include a balloon component, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 876.9.

Summary

0

Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, with the letters "FDA" in a blue square. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.

December 20, 2024

Leo Medical Co., Ltd. % Diana Hong Official Correspondent Mid-Link Consulting Co., Ltd. P.O. Box 120-119 Shanghai, Shanghai 200120 China

Re: K241888

Trade/Device Name: Single-use Balloon Dilatation Catheter Regulation Number: 21 CFR 876.5010 Regulation Name: Biliary Catheter And Accessories Regulatory Class: Class II Product Code: FGE Dated: November 25, 2024 Received: November 25, 2024

Dear Diana Hong:

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

1

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-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 mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatory

2

assistance/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,

Anthony Lee -S

Anthony Lee, Ph.D. Assistant Director DHT3A: Division of Renal, Gastrointestinal, Obesity, and Transplant Devices OHT3: Office of Gastrorenal, ObGyn, General Hospital, and Urology Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health

Enclosure

3

Indications for Use

Submission Number (if known)

K241888

Device Name

Single-use Balloon Dilatation Catheter

Indications for Use (Describe)

This device is indicated for use in adult and adolescent populations to endoscopically dilate strictures of the gastrointestinal tract. It is also indicated in adults for endoscopic dilatation of Sphincter of Oddi with or without prior sphincterotomy.

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

510(k) Summary

This 510(k) Summary is being submitted in accordance with requirements of Title 21, CFR Section 807.92.

The assigned 510(k) Number: K241888

1. Date of Preparation: 06/21/2024
Sponsor Identification 2.

Leo Medical Co., Ltd.

No.10 Building, 23 Middle Huashan Road, Xinbei District, 213022, Changzhou City, Jiangsu Province, PEOPLE'S REPUBLIC OF CHINA

Contact Person: Guojun Zhang Position: Senior RA Manager Tel: +86-15961165897 Email: gjzhang@leomed.cn

1. Designated Submission Correspondent
  Ms. Diana Hong (Primary Contact Person) Ms. Tingting Su (Alternative Contact Person)

Mid-Link Consulting Co., Ltd

P.O. Box 120-119, Shanghai, 200120, China

Tel: +86-21-22815850, Fax: 360-925-3199 Email: info@mid-link.net

1. Identification of Proposed Device
  Trade Name: Single-use Balloon Dilatation Catheter Common Name: Biliary catheter and accessories

Regulatory Information Classification Name: stents, drains and dilators for the biliary ducts Classification: II,

5

Product Code: FGE, Regulation Number: 21 CFR 876.5010. Review Panel: Gastroenterology/Urology

Indications for Use

This device is indicated for use in adult and adolescent populations to endoscopically dilate strictures of the gastrointestinal tract. It is also indicated in adults for endoscopic dilatation of Oddi with or without prior sphincterotomy.

Device Description

According to the structure of the device, it can be divided into three types, RX type, OTW type and OTW with Stainless Wire-guided type. The Rx proposed device mainly consists of tip, balloon, marker band, shaft, sleeve, stress diffusion tube and hub. The OTW proposed device mainly consists of tip, balloon, marker band, shaft, stress diffusion tube and hub. The structure of the OTW with Stainless Wire-guided model same with the structure of OTW model. The difference between OTW with Stainless Wire-guided type catheter and OTW type catheter is that OTW with Stainless Wire-guided type catheter is preloaded with a guide wire and a guide wire locking component. The difference between the RX type catheter and the OTW series catheter is that the guidewire exit position is different. The guide wire of OTW series catheter passed through the guide wire lumen of the catheter. The guidewire of the Rx type catheter will pass through the guidewire exchange port on the shaft.

Single-use Balloon Dilatation Catheter is divided into different specifications. Shafts are available in two different diameters. The effective length of the catheter is 180cm and 240cm. Balloon diameters are available in six different diameters 6-7-8mm, 8-9-10 mm, 12-13.5-15 mm, 15-16.5-18 mm, 18-19-20 mm, and the balloon lengths are available in 30 mm,55 mm and 80 mm three different length.

Identification of Predicate Devices and Reference Device న.
Predicate Device 1 510K Number: K112994 Trade Name: CRE Dilatation Balloon

Predicate Device 2 510K Number: K172520 Trade Name: CRE™ RX Biliary Balloon Dilatation Catheter

Reference device 510K Number: K122924 Trade Name: CRE Fixed Wire Balloon Dilatation Catheter

6

1. Non-Clinical Test Conclusion
  Non clinical tests were conducted to verify that the proposed device met all design specifications as was Substantially Equivalent (SE) to the predicate device. The test results demonstrated that the proposed device complies with the following standards:
A ISO 10993-7:2008 Biological Evaluation Of Medical Devices-Part 7: Ethylene Oxide Sterilization Residuals
A ISO 10993-5:2009 Biological Evaluation of Medical Devices-Part 5: Tests for In Vitro Cytotoxicity
A ISO 10993-10:2021 Biological Evaluation of Medical Devices-Part 10: Tests for Irritation and Skin Sensitization
A ISO 10993-11:2017 Biological Evaluation of Medical Devices-Part 11: Tests for systemic toxicity
ISO 10993-23:2021 Biological evaluation of medical devices — Part 23: Tests for irritation.
ASTM F88/F88M-21 Standard test method for seal strength of flexible barrier materials
A ASTM F1929-15 Standard Test Method for Detecting Seal Leaks in Porous Medical Packaging by Dve Penetration
A ASTM D4169-22 Standard Practice for Performance Testing of Shipping Containers and Systems
USP Pyrogen Test
ISO10555-4:2013 Intravascular catheters -- Sterile and single-use catheters -- Part 4: Balloon dilatation catheters.
A ISO 10555-1:2013/A1:2017 Intravascular catheters -Sterile and single-use catheters -Part 1: General requirements.
ISO20696:2018(E) Sterile urethral catheters for single-use.
ASTM F640-20 Standard Test Methods for Determining Radiopacity for Medical Use A
A ASTM F1886/F1886M-16, Standard Test Method for Determining Integrity of Seals for Flexible Packaging by Visual Inspection
A USP Bacterial Endotoxins Test
ISO 80369-7:2023 Small-bore connectors for liguids and gases in healthcare applications — Part 7: Connectors for intravascular or hypodermic applications
ISO 80369-20:2023 Small-bore connectors for liquids and gases in healthcare applications - Part 20: Common test methods
A ASTM F3172 Standard Guide for Design Verification Device Size and Sample Size Selection for Endovascular Devices

The performance testing conducted on subject device and predicate device are listed below. All the test results demonstrate proposed device meet the requirements of its pre-defined acceptance criteria and intended uses.

. Dimension Test
o Appearance
o Compatibility Test
o Delivery and Retrieval Force

7

Peak Tensile Force
. Burst Pressure
. Kink Stability
Corrosion Resistance Test ●
Air Leakage
Liquid Leakage
. Luer connector
Radiopacity
o Balloon Burst Pressure
. Balloon Compliance
. Balloon Deflation Time
. Balloon Fatigue

The proposed device sterilization process using Ethylene Oxide (EO) has been validated in accordance with ISO 11135:2014 to achieve a sterility assurance level (SAL) of 10 6). EO and Ethylene Chlorohydrin (ECH) residuals were below the limits specified in ISO 10993-7:2008. Bacterial Endotoxin Levels were below the level of 20 EU/device in accordance with USP . Both baseline and accelerated shelf life testing were conducted demonstrating the device will perform as intended to support the proposed 3-year shelf-life.

Package Integrity Test after environmental conditioning, simulated transportation testing in ● accordance to ASTM D4169-22 on final, packaged, and sterile device.
. Sterile Barrier Packaging performed on the proposed device:
- o Visual Inspection per ASTM F1886/F1886M-16
- 0 Seal Strength per ASTM F88/F88-21
- o Dye Penetration per ASTM F1929-15
Shelf-life of 3 years is validated using FDA recognized standard ASTM F1980-16 Standard Guide for ● Accelerated Aging of Sterile Barrier Systems for Medical Devices.

The biocompatibility evaluations were conducted in accordance with the 2020 FDA Guidance document Use of International Standard ISO-10993-1, 'Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process". The cytotoxicity, sensitization, intracutaneous irritation, system toxicity and pyrogen tests were performed to demonstrate the biocompatibility of the device.

1. Clinical Test Conclusion
  No clinical study is included in this submission.

8

8. Substantially Equivalent (SE) Comparison

Table 1. General Comparison
Item	Proposed Device	Predicate Device 1
K112994	Predicate Device 2
K172520	Reference Device
K122924	Remark
Device Name	Single-use Balloon
Dilatation Catheter	GRE Dilatation Balloon	CRE™ RX Biliary Balloon
Dilatation Catheter	CRE Fixed Wire Balloon
Dilatation Catheter	/
Product Code	FGE	FGE	FGE	KNQ	Same
Regulation No.	21 CFR 876.5010	21 CFR 876.5010	21 CFR 876.5010	21 CFR 876.5365	Same
Class	II	II	II	II	Same
Indications for
Use	This device is indicated for use in adult and adolescent populations to endoscopically dilate strictures of the gastrointestinal tract. It is also indicated in adults for endoscopic dilatation of Sphincter of Oddi with or without prior sphincterotomy.	The CRE™ Wireguided
Balloon Dilatation Catheter
is indicated for use in adult
and adolescent populations
to endoscopically dilate
strictures of the alimentary
tract.
It is also indicated in adults
for endoscopic dilatation of
Sphincter of Oddi with or
without prior
sphincterotomy.	CRE™ RX Biliary Balloon
Dilatation Catheter is
indicated for use in adults
for endoscopic dilatation of
the Sphincter of Oddi with
or without prior
sphincterotomy.
The CRE™ RX Biliary Balloon
Dilatation Catheters may
be used for injection of
contrast medium for
fluoroscopic visualization
of the bile ducts.	The CRE™ Balloon
Dilatation Catheter is
intended for use in adult and
adolescent populations to
endoscopically dilate
strictures of the esophagus.	Similar
Catheter Type	Rx, OTW,
OTW
(Stainless Wire-guided)	OTW(Stainless
Wire-guided)	RX	OTW (Fixed wire)	Different
Components	Rx: Tip, Balloon, Marker
band, Shaft, Sleeve, Stress
diffusion tube, Hub	Tip, balloon, marker band,
handle junction, and
guidewire	Tip, balloon, marker band
and handle junction	Tip, balloon, marker band,
tube and handle junction.	Different

Table 1.	General Comparison
----------	--------------------

9

| | OTW(Stainless
Wire-guided):
Tip,
balloon, marker band,
Shaft, Sleeve, Stress
diffusion tube , Hub,
Guide wire locking
device, Stainless Guide
wire

OTW: Tip, balloon,
marker band, Shaft, Stress
diffusion tube, Hub, | | | | |
|----------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------|-------------|-------------|-----------|
| Marker
Bands
Present | Yes | Yes | Yes | Yes | Same |
| Single Use | Single Use | Single Use | Single Use | Single Use | Same |
| | 6-7-8, | 6-7-8, | 6-7-8, | 6-7-8, | |
| | 8-9-10, | 8-9-10, | 8-9-10, | 8-9-10, | |
| Balloon
Diameter(mm) | 10-11-12, | 10-11-12, | 10-11-12, | 10-11-12, | Same |
| | 12-13.5-15, | 12-13.5-15, | 12-13.5-15, | 12-13.5-15, | |
| | 15-16.5-18, | 15-16.5-18, | 15-16.5-18, | 15-16.5-18, | |
| | 18-19-20 | 18-19-20 | 18-19-20 | 18-19-20 | |
| Balloon
length(mm) | 30, 55, 80 | 55 | 30,55 | 80 | Different |
| Working
length(mm) | 1800,2400 | 1800,2400 | 1800 | 1800 | Same |
| Patient-contact Material | | | | | |
| Tip | Pebax 3533 SA01 Med | Guide head (Pebax) | Unknown | Unknown | Different |

10

Shaft	Pebax 7233 SA01 Med	Catheter (Pebax)
Balloon	Nylon 12 ML21	Balloon (Pebax)
Stainless Guide
wire (OTW with
Stainless
Wire-guided)	SUS 304	Guidewire (stainless steel)
Sterilization
Sterile/non-sterile:	Sterile	Sterile	Sterile	Sterile	Same
Method	EO sterilized	EO sterilized	EO sterilized	EO sterilized	Same
SAL	10-6	10-6	10-6	10-6	Same
Biocompatibility
Cytotoxicity	No cytotoxicity
Intracutaneous
Reactivity	No intracutaneous
reactivity
Sensitization	No sensitization	Conform with ISO 10993
standards	Conform with ISO 10993
standards	Conform with ISO 10993
standards	Same
Acute System
Toxicity	No acute system Toxicity
Pyrogen	No pyrogen

11

Similar - Indications for Use

The indication for use of the proposed device and the indication for use of the predicate device 1 are exactly the same. The indication for use of the proposed device 2 are slightly different, but the intend use "indicated in adults for endoscopic dilatation of Sphincter of Oddi with or without prior sphincterotomy." can be covered by predicate device 2. The clinical application site and applicable population of the proposed device can be completely covered by two predicate devices. Therefore, the similar indication for use will not affect the safety and effectiveness of the proposed device.

Different - Catheter Type

The catheter type of the proposed device is different to that of the predicate device 1 and predicate device 2. The proposed device includes Rx, OTW and OTW (Stainless Wire-guided). The Rx type catheter and OTW (Stainless Wire-guided) type catheter can be covered by the predicate device 1 and predicate device 2. The OTW type catheter is very similar to OTW (Stainless Wire-guided) catheter, and the difference with OTW (Stainless Wire-guided) catheter is only the lack of preinstalled guide wire and the structure of OTW (Stainless Wire-guided) catheter same with OTW catheter. Therefore, this difference will not affect the safety and effectiveness of the proposed device.

Different – Components

The component of the proposed device is different to that of the predicate device 1 and predicate device 2. Different manufacturers have different claims on the name of the device components, the difference in the component is only the difference in the name. Therefore, this difference will not affect the safety and effectiveness of the proposed device.

Different - Balloon length

The balloon length of the predicate device 1 is 55mm, the balloon length of the predicate device 2 is 30mm and 55mm, the 30mm and 50mm balloon length of the proposed device is same as the balloon length of the predicate device 2. The 80 mm balloon length of proposed device can be covered by the reference device. Besides, the 80 mm balloon length proposed device was tested for performance and the test results meet the acceptance criteria. Therefore, this difference will not affectiveness of the proposed device.

Different - Material

The materials of the proposed device are different from those of the predicate device. The biocompatibility tests were also performed on the proposed device and the test results showed that there was no adverse effect. Therefore, this difference does not raise new safety and efficacy issues.

9. Substantially Equivalent (SE) Conclusion

The conclusions drawn from the nonclinical tests demonstrate that the proposed device is as safe, as effective, and perform as well as or better than the legally marketed predicate device 1 K112994 and

12

predicate device 2 K172520.