PCI Guide Wires are intended to facilitate the placement of balloon dilatation catheters during percutaneous coronary intervention (PCI) and percutaneous transluminal angioplasty (PTA). The PCI Guide Wires are not to be used in the neurovasculature.

Device Description

SION blue PLUS is steerable guide wire with a maximum diameter of 0.36mm (0.014 inches) and available in 190cm and 300cm lengths. The guide wire is constructed from stainless-steel core wire with platinum-nickel and stainless-steel coils. The coils assembly consists of an inner coil and an outer coil, as well as a safety wire which is soldered to the inner and outer coils and the core wire. The distal end of the guide wire has a 3cm radiopaque tip to achieve visibility and is available in a straight, Pre-shape and J-shape to bend with the vessel curve. A silicone and hydrophilic coatings are applied to the distal portion of SION blue PLUS. The proximal sections of the SION blue PLUS are coated with PTFE. The extension wire is connected to the end of the guide wire outside of the body for 190cm model.

AI/ML Overview

This FDA 510(k) clearance letter pertains to a conventional medical device (a guide wire), not an AI/ML-enabled device. Therefore, the information requested about acceptance criteria, study data, ground truth establishment, expert adjudication, and MRMC studies, which are typical for AI/ML device clearances, is not present in this document.

The document details non-clinical bench testing for the SION blue PLUS guide wire to demonstrate its substantial equivalence to a predicate device.

Here's a breakdown of the available information based on your request, highlighting what is included and what is not applicable to this type of device submission:

1. A table of acceptance criteria and the reported device performance

The document states that "The in vitro bench tests demonstrated the SION blue PLUS met all acceptance criteria and performed similarly to the predicate/reference devices." However, it does not provide a specific table of acceptance criteria with corresponding performance data. It lists the types of tests performed:

Dimensional Verification
Visual Inspection
Simulated Use/Human body Phantom
Tensile Strength (including Tip Pull test)
Torque Strength
Torqueability
Coating Integrity
Particulate Evaluation
Lubricity/Catheter Compatibility
Corrosion Resistance
Kink Resistance
Tip Flexibility
Radiopacity

2. Sample sizes used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

Sample Sizes: Not specified. For physical device bench testing, sample sizes are typically determined by engineering standards and statistical power analysis for the specific tests (e.g., n=3, n=5, n=10 per test) but are not typically detailed in 510(k) summaries as they are for clinical or AI/ML studies.
Data Provenance: Not applicable in the sense of clinical study data provenance (country, retrospective/prospective). The data comes from in vitro bench testing conducted by the manufacturer, ASAHI INTECC CO., LTD. (Global Headquarters and R&D Center in Seto, Aichi, Japan).

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

Not applicable. This information is relevant for AI/ML device evaluations where human experts establish ground truth for image interpretation or diagnosis. For a physical device like a guide wire, performance is measured against engineering specifications and industry standards, not against "expert ground truth" in a clinical diagnostic sense.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

Not applicable. Adjudication methods are typically used in clinical or AI/ML studies where multiple human readers might disagree on a diagnosis or interpretation, requiring a consensus mechanism. This is not relevant for bench testing of a physical medical device.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

Not applicable. An MRMC study is a type of clinical study used to evaluate the diagnostic performance of a device (often AI-enabled) by comparing multiple readers' interpretations across multiple cases, sometimes with and without AI assistance. This device is a physical catheter guide wire, not a diagnostic or AI-assisted device.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

Not applicable. This refers to the evaluation of an AI algorithm's performance independent of human interaction. Since SION blue PLUS is a physical guide wire, this concept does not apply.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

Not applicable in the clinical sense. For this device, "ground truth" equates to the pre-defined engineering specifications, performance standards, and material properties that the device must meet during bench testing. For example, a tensile strength test would have an acceptance criterion (e.g., withstand X Newtons of force), and the device's measured performance against this criterion is the "truth."

8. The sample size for the training set

Not applicable. This concept pertains to AI/ML devices where a "training set" is used to develop the algorithm. This device is a physical instrument, not an AI.

9. How the ground truth for the training set was established

Not applicable. See point 8.

In summary, the provided 510(k) clearance letter is for a physical medical device. The types of detailed information requested regarding AI/ML study design, ground truth, expert adjudication, and sample sizes for training/test sets are not relevant to this specific device submission and therefore are not present in the document. The document focuses on demonstrating substantial equivalence through non-clinical bench testing of the device's physical and material properties.

Summary

FDA 510(k) Clearance Letter - SION blue PLUS

Page 1

U.S. Food & Drug Administration
10903 New Hampshire Avenue
Silver Spring, MD 20993
www.fda.gov

Doc ID # 04017.07.05

April 2, 2025

Asahi Intecc Co., Ltd.
Cynthia Valenzuela
Director, Quality Systems, Regulatory Affairs/Compliance
Asahi Intecc Usa, Inc.
3002 Dow Avenue
Suite 212
Tustin, California 92780

Re: K243733
Trade/Device Name: SION blue PLUS
Regulation Number: 21 CFR 870.1330
Regulation Name: Catheter Guide Wire
Regulatory Class: Class II
Product Code: DQX
Dated: December 24, 2024
Received: March 3, 2025

Dear Cynthia Valenzuela:

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.

April 2, 2025

Asahi Intecc Co., Ltd.
Cynthia Valenzuela
Director, Quality Systems, Regulatory Affairs/Compliance
Asahi Intecc Usa, Inc.
3002 Dow Avenue
Suite 212
Tustin, California 92780

Dear Cynthia Valenzuela:

U.S. Food and Drug Administration
10903 New Hampshire Avenue
Silver Spring, MD 20993
www.fda.gov

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K243733 - Cynthia Valenzuela Page 2

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 (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-reporting-combination-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-advice-comprehensive-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-devices/medical-device-safety/medical-device-reporting-mdr-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/medical-devices/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-devices/device-advice-comprehensive-regulatory-

Page 3

K243733 - Cynthia Valenzuela Page 3

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,

Jenny R. Katsnelson -S Digitally signed by Jenny R. Katsnelson -S Date: 2025.04.02 17:29:39 -04'00'

for Lydia Glaw
Assistant Director
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

Page 4

FORM FDA 3881 (6/20) Page 1 of 1 PSC Publishing Services (301) 443-6740 EF

DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration

Indications for Use

Form Approved: OMB No. 0910-0120
Expiration Date: 06/30/2023
See PRA Statement below.

510(k) Number (if known)
K243733

Device Name
SION blue PLUS

Indications for Use (Describe)
PCI Guide Wires are intended to facilitate the placement of balloon dilatation catheters during percutaneous coronary intervention (PCI) and percutaneous transluminal angioplasty (PTA). The PCI Guide Wires are not to be used in the neurovasculature.

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."

DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration

Form Approved: OMB No. 0910-0120
Expiration Date: 06/30/2023
See PRA Statement below.

Indications for Use

510(k) Number (if known)
K243733

Device Name
SION blue PLUS

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.

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."

FORM FDA 3881 (6/20) Page 1 of 1 PSC Publishing Services (301) 443-6740 EF

Page 5

510(k) Summary

(as required by 21 CFR § 807.92)

Global Headquarters and R&D Center
3-100 Akatsuki-cho, Seto-shi, Aichi 489-0071 Japan
TEL : +81-561-48-5551 FAX : +81-561-48-5552
http://www.asahi-intecc.co.jp/

SION blue PLUS
510(k) K243733

Date Prepared	03DEC2024
Applicant	ASAHI INTECC CO., LTD.3-100 Akatsuki-cho,Seto, Aichi 489-0071 Japan
Contact	C. Cynthia ValenzuelaDirector, Quality and Regulatory AffairsASAHI INTECC USA, Inc.3002 Dow Avenue, Suite 212Tustin, CA 92780Office: (714) 442 0575Mobile: (949) 745-1617e-mail: cynthiav@asahi-intecc-us-.com
Trade/Device Name	SION blue PLUS
Device Classification	Class II 21 CFR § 870.1330
Classification Name	Catheter, Guide, Wire
Product Code	DQX – Catheter Guide Wire
Predicate Device	ASAHI PTCA Guide Wire ASAHI SION blue *(K122468, K163426, K191464)
Reference Device	MINAMO blue; MINAMO viola ** (K240387)

*Referred to as SION blue
** Referred to as MINAMO blue/viola

INDICATIONS FOR USE

The indications and Intended Use of SION blue PLUS is as follows:

PCI Guide Wires are intended to facilitate the placement of balloon dilatation catheters during percutaneous coronary intervention (PCI) and percutaneous transluminal angioplasty (PTA).

The PCI Guide Wires are not to be used in the neurovasculature.

K243733
Page 1 of 5

Page 6

K243733
Page 1 of 5

510(k) Summary

(as required by 21 CFR § 807.92)

Global Headquarters and R&D Center
3-100 Akatsuki-cho, Seto-shi, Aichi 489-0071 Japan
TEL : +81-561-48-5551 FAX : +81-561-48-5552
http://www.asahi-intecc.co.jp/

SION blue PLUS

510(k) K243733

Date Prepared	03DEC2024
Applicant	ASAHI INTECC CO., LTD.3-100 Akatsuki-cho,Seto, Aichi 489-0071 Japan
Contact	C. Cynthia ValenzuelaDirector, Quality and Regulatory AffairsASAHI INTECC USA, Inc.3002 Dow Avenue, Suite 212Tustin, CA 92780Office: (714) 442 0575Mobile: (949) 745-1617e-mail: cynthiav@asahi-intecc-us-.com
Trade/Device Name	SION blue PLUS
Device Classification	Class II 21 CFR § 870.1330
Classification Name	Catheter, Guide, Wire
Product Code	DQX – Catheter Guide Wire
Predicate Device	ASAHI PTCA Guide Wire ASAHI SION blue *(K122468, K163426, K191464)
Reference Device	MINAMO blue; MINAMO viola ** (K240387)

*Referred to as SION blue
** Referred to as MINAMO blue/viola

INDICATIONS FOR USE

The indications and Intended Use of SION blue PLUS is as follows:

PCI Guide Wires are intended to facilitate the placement of balloon dilatation catheters during percutaneous coronary intervention (PCI) and percutaneous transluminal angioplasty (PTA).

The PCI Guide Wires are not to be used in the neurovasculature.

Page 7

DEVICE DESCRIPTION

COMPARISON WITH THE PREDICATE/REFERENCE

A comparison of the SION blue PLUS and the predicate/reference devices shows that the technological characteristics of the subject device such as components, design, materials, sterilization method, shelf life and operating principle are identical or similar to the currently marketed predicate/reference devices.

The table below provides details of similarities between the subject and predicate/reference devices.

The following technological differences exist between the subject and predicate device:

Exclusion of 180cm length model
Outer coil length
Hydrophilic coating length
PTFE coating length
All solder of the outer coil is changed to Au-Sn

K243733
Page 2 of 5

Page 8

K243733
Page 2 of 5

DEVICE DESCRIPTION

COMPARISON WITH THE PREDICATE/REFERENCE

The table below provides details of similarities between the subject and predicate/reference devices.

The following technological differences exist between the subject and predicate device:

Exclusion of 180cm length model
Outer coil length
Hydrophilic coating length
PTFE coating length
All solder of the outer coil is changed to Au-Sn

Page 9

Table 1: Comparison with predicate/reference devices

Name of Devices	SION blue PLUS	SION blue	MINAMO blue/viola
Device Identifier	Subject	Predicate	Reference
510(k)	TBD	K122468, K163426, K191464	K240387
Manufacturer	ASAHI INTECC	ASAHI INTECC	ASAHI INTECC
Regulation Number	21 CFR§ 870.1330	21 CFR§ 870.1330	21 CFR§ 870.1330
Regulation Name	Catheter, Guide Wire	Catheter, Guide Wire	Catheter, Guide Wire
Regulatory Class	II	II	II
Product Code	DQX	DQX	DQX
Intended Use and Indications	PCI Guide Wires are intended to facilitate the placement of balloon dilatation catheters during percutaneous coronary intervention (PCI) and percutaneous transluminal angioplasty (PTA). The PCI Guide Wires are not to be used in the neurovasculature.	ASAHI PTCA Guide Wires are intended to facilitate the placement of balloon dilatation catheters during percutaneous transluminal coronary angioplasty (PTCA) and percutaneous transluminal angioplasty (PTA).The ASAHI PTCA Guide Wires are not to be used in the neurovasculature.	PCI Guide Wires are intended to facilitate the placement of balloon dilatation catheter during percutaneous coronary intervention (PCI) and percutaneous transluminal angioplasty (PTA). The PCI Guide Wires are not intended for use in the neurovasculature.
Total Length	190cm, 300cm	180cm, 190cm, 300cm	190cm, 235cm, 300cm
Tip Shape	Straight, Pre-shape, J-shape	Straight, Pre-shape, J-Shape	Straight, Pre-shape, J-shape
Nominal O.D.	0.36mm (0.014")	0.36mm (0.014")	0.36mm (0.014")
Taper Core wire	Austenitic stainless Steel	Austenitic stainless Steel	Austenitic Stainless-SteelNi-Ti Alloy
Safety Wire	Austenitic stainless Steel	Austenitic stainless Steel	N/A
Inner Coil	Austenitic stainless Steel	Austenitic stainless Steel	Austenitic Stainless-Steel
Outer Coil	Austenitic stainless SteelPt-Ni Alloy	Austenitic stainless SteelPt-Ni Alloy	Austenitic Stainless-SteelPt-Ni Alloy
Solder	Ag-SnAu-Sn	Ag-SnAu-Sn	Ag-SnAu-Sn
Coating	HydrophilicSiliconePTFE	HydrophilicSiliconePTFE	HydrophilicSiliconePTFEPFA
Sterilization	Ethylene oxideSAL 10-6	Ethylene oxideSAL 10-6	Ethylene oxideSAL 10-6

K243733
Page 3 of 5

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K243733
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Table 1: Comparison with predicate/reference devices

Name of Devices	SION blue PLUS	SION blue	MINAMO blue/viola
Device Identifier	Subject	Predicate	Reference
510(k)	TBD	K122468, K163426, K191464	K240387
Manufacturer	ASAHI INTECC	ASAHI INTECC	ASAHI INTECC
Regulation Number	21 CFR§ 870.1330	21 CFR§ 870.1330	21 CFR§ 870.1330
Regulation Name	Catheter, Guide Wire	Catheter, Guide Wire	Catheter, Guide Wire
Regulatory Class	II	II	II
Product Code	DQX	DQX	DQX
Intended Use and Indications	PCI Guide Wires are intended to facilitate the placement of balloon dilatation catheters during percutaneous coronary intervention (PCI) and percutaneous transluminal angioplasty (PTA). The PCI Guide Wires are not to be used in the neurovasculature.	ASAHI PTCA Guide Wires are intended to facilitate the placement of balloon dilatation catheters during percutaneous transluminal coronary angioplasty (PTCA) and percutaneous transluminal angioplasty (PTA).The ASAHI PTCA Guide Wires are not to be used in the neurovasculature.	PCI Guide Wires are intended to facilitate the placement of balloon dilatation catheter during percutaneous coronary intervention (PCI) and percutaneous transluminal angioplasty (PTA). The PCI Guide Wires are not intended for use in the neurovasculature.
Total Length	190cm, 300cm	180cm, 190cm, 300cm	190cm, 235cm, 300cm
Tip Shape	Straight, Pre-shape, J-shape	Straight, Pre-shape, J-Shape	Straight, Pre-shape, J-shape
Nominal O.D.	0.36mm (0.014")	0.36mm (0.014")	0.36mm (0.014")
Taper Core wire	Austenitic stainless Steel	Austenitic stainless Steel	Austenitic Stainless-SteelNi-Ti Alloy
Safety Wire	Austenitic stainless Steel	Austenitic stainless Steel	N/A
Inner Coil	Austenitic stainless Steel	Austenitic stainless Steel	Austenitic Stainless-Steel
Outer Coil	Austenitic stainless SteelPt-Ni Alloy	Austenitic stainless SteelPt-Ni Alloy	Austenitic Stainless-SteelPt-Ni Alloy
Solder	Ag-SnAu-Sn	Ag-SnAu-Sn	Ag-SnAu-Sn
Coating	HydrophilicSiliconePTFE	HydrophilicSiliconePTFE	HydrophilicSiliconePTFEPFA
Sterilization	Ethylene oxideSAL 10-6	Ethylene oxideSAL 10-6	Ethylene oxideSAL 10-6

Page 11

Non-Clinical Bench Testing/Performance Data

The following non-clinical bench testing / performance data for SION blue PLUS provided in support of the substantial equivalence determination. The following testing/assessments were performed:

Dimensional Verification
Visual Inspection
Simulated Use/Human body Phantom
Tensile Strength (including Tip Pull test)
Torque Strength
Torqueability
Coating Integrity
Particulate Evaluation
Lubricity/Catheter Compatibility
Corrosion Resistance
Kink Resistance
Tip Flexibility
Radiopacity

The in vitro bench tests demonstrated the SION blue PLUS met all acceptance criteria and performed similarly to the predicate/reference devices. Performance data demonstrates the device functions as intended and has a safety and effectiveness profile that is similar to the predicate device.

Biocompatibility Testing

To ensure that SION blue PLUS is biocompatible, desk study was conducted leveraging the results of the predicate device; SION blue (K122468, K163426, K191464) and tested articles.

Testing on predicate device and test articles was conducted in accordance with the FDA Guidance "Use of International Standard ISO-10993, 'Biological Evaluation of Medical Devices Part 1: Evaluation and Testing within a Risk Management Process'," 08SEP2023, and International Standard ISO 10993-1 "Biological Evaluation of Medical Devices − Part 1: Evaluation and Testing within a Risk Management Process," as recognized by FDA. The biocompatibility testing included the following tests:

Physical and/or chemical information
Cytotoxicity
Sensitization
Irritation / Intracutaneous Reactivity

K243733
Page 4 of 5

Page 12

K243733
Page 4 of 5

Non-Clinical Bench Testing/Performance Data

The following non-clinical bench testing / performance data for SION blue PLUS provided in support of the substantial equivalence determination. The following testing/assessments were performed:

Dimensional Verification
Visual Inspection
Simulated Use/Human body Phantom
Tensile Strength (including Tip Pull test)
Torque Strength
Torqueability
Coating Integrity
Particulate Evaluation
Lubricity/Catheter Compatibility
Corrosion Resistance
Kink Resistance
Tip Flexibility
Radiopacity

Biocompatibility Testing

To ensure that SION blue PLUS is biocompatible, desk study was conducted leveraging the results of the predicate device; SION blue (K122468, K163426, K191464) and tested articles.

Physical and/or chemical information
Cytotoxicity
Sensitization
Irritation / Intracutaneous Reactivity

Page 13

Acute systemic Toxicity
Material-mediated pyrogenicity
Hemocompatibility
in vivo thrombogenicity testing

Conclusion

The SION blue PLUS has the same intended use and the same or similar technological characteristics such as components, design, materials, sterilization method and operating principles as the predicate/reference devices. Performance data demonstrates that the device functions as intended.

Therefore, the SION blue PLUS is substantially equivalent to the predicate SION blue (K122468, K163426, K191464).

K243733
Page 5 of 5

Regulation Number and Section

§ 870.1330 Catheter guide wire.

(a)
Identification. A catheter guide wire is a coiled wire that is designed to fit inside a percutaneous catheter for the purpose of directing the catheter through a blood vessel.(b)
Classification. Class II (special controls). The device, when it is a torque device that is manually operated, non-patient contacting, and intended to manipulate non-cerebral vascular guide wires, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 870.9.