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K Number
K120119
Device Name
SUNMED GUIDE WIRE
Manufacturer
SUNNY MEDICAL DEVICE (SHENZHEN) CO., LTD
Date Cleared
2012-05-11

(115 days)

Product Code
DQX
Regulation Number
870.1330
Type
Traditional
Panel
Cardiovascular
Reference & Predicate Devices
K993000,K082094
Predicate For
N/A
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
Intended Use

Sunmed Guidewires are used for the introduction and placement of diagnostic or interventional devices in the coronary and peripheral vasculature and may be used to reach and cross a target lesion.

Device Description

Sunmed Guidewires are used for the introduction and placement of diagnostic or interventional devices in the coronary and peripheral vasculature and mav be used to reach and cross a target lesion.

The Sunmed Guide Wires are available in three versions with a variety of tips:

Stainless steel guide wire Hydrophilic coated quide wire PTFE (Teflon®) coated guide wires

The Seldinger technique is used with these quidewires.

The stainless steel guide wires are standard wires with various tip configurations. The guide wire construction consists of a safety wire, a core wire, and a wound spring for flexibility. The features that distinguish individual wires consist of the core type (fixed or moveable), a straight or "J" tip configuration, diameters and lengths.

The Hydrophilic coated guide wires are constructed from the stainless steel core wire, with varying core lengths and diameters for each design.

The PTFE (Teflon®) coated guide wires are also manufactured from stainless steel wire, with PTFE (Teflon®) coating, or Benzalkonium Heparin (BH) coating applied over the PTFE (Teflon®) coating.

These guide wires are radiodetectable and fluoroscopy may be used to confirm position.

These medical devices are single use and supplied sterile by EQ.

AI/ML Overview

The Sunny Medical Device (Shenzhen) Co., Ltd. (K120119) describes the performance testing and technological characteristics of its Sunmed Guide Wires to establish substantial equivalence to predicate devices.

1. Table of Acceptance Criteria and Reported Device Performance:

The provided 510(k) summary does not explicitly list quantitative acceptance criteria with corresponding performance metrics in a direct table format. Instead, it lists various tests performed and states that the device was found to have "identical technological characteristics and to be equivalent" to the predicate devices. This implies that the acceptance criteria for each test were met sufficiently to demonstrate equivalence.

Here's a breakdown of the tests performed, which inherently serve as the areas where the device needed to perform comparably to its predicates:

Acceptance Criteria (Inferred from Tests)Reported Device Performance (Summary Statement)
Degradation Test on Disposable Guide Wire"found to have identical technological characteristics and to be equivalent"
Physical Performance (General)"found to have identical technological characteristics and to be equivalent"
Appearance"found to have identical technological characteristics and to be equivalent"
Radiodetectability"found to have identical technological characteristics and to be equivalent"
Eroding Resistance"found to have identical technological characteristics and to be equivalent"
Breakage Resistance"found to have identical technological characteristics and to be equivalent"
Deformation Resistance"found to have identical technological characteristics and to be equivalent"
Connection Strength"found to have identical technological characteristics and to be equivalent"
Package Performance"found to have identical technological characteristics and to be equivalent"
Sterility"found to have identical technological characteristics and to be equivalent"
ETO Residue"found to have identical technological characteristics and to be equivalent"
ECH Residue"found to have identical technological characteristics and to be equivalent"
Indications for Use (Match)"identical technological characteristics" and "equivalent"
Target Population (Match)"identical technological characteristics" and "equivalent"
Design Technique (Match)"identical technological characteristics" and "equivalent"
Biocompatibility (Match)"identical technological characteristics" and "equivalent"
Anatomical Sites (Match)"identical technological characteristics" and "equivalent"

2. Sample Size for Test Set and Data Provenance:

The document does not explicitly state the sample sizes used for the "Performance Testing." It broadly lists the types of tests conducted. As this is a 510(k) submission for a Class II medical device, the studies would primarily be bench and material testing rather than clinical trials with human subjects. The data provenance is not specified, but it's assumed to be from internal testing conducted by Sunny Medical Device (Shenzhen) Co., Ltd. or its contracted laboratories, likely in China (given the company's address). The studies are retrospective in the sense that they are conducted on manufactured devices as part of the submission process, not prospective clinical trials.

3. Number of Experts Used to Establish Ground Truth and Qualifications:

This information is not applicable in the context of this 510(k) submission. The performance testing described consists of objective, quantifiable physical and chemical tests (e.g., degradation, resistance, sterility) rather than diagnostic accuracy studies requiring expert interpretation of results to establish ground truth.

4. Adjudication Method for the Test Set:

Not applicable. As described above, the tests are objective and do not involve human interpretation or adjudication for ground truth establishment.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done:

No, an MRMC comparative effectiveness study was not done. These types of studies are typically for diagnostic imaging devices where human readers interpret medical images with and without AI assistance. The Sunmed Guide Wires are interventional devices, and their evaluation focuses on physical and material properties, not diagnostic interpretation.

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

Not applicable. This device is not an algorithm or an AI-enabled device. Its performance is hardware-based and evaluated through physical and chemical testing.

7. Type of Ground Truth Used:

The "ground truth" for the performance tests would be defined by established engineering standards, material specifications, and regulatory requirements for guide wires. For example:

  • Physical Performance: Mechanical properties (e.g., tensile strength, flexibility, lubricity) would be compared against predetermined specifications or the properties of the predicate devices.
  • Sterility: Absence of viable microorganisms, confirmed by validated sterilization methods and sterility testing.
  • Chemical Residues: Levels of ETO and ECH residues within acceptable regulatory limits.
  • Biocompatibility: Demonstrated compliance with ISO 10993 standards.

The comparison is primarily against the performance of the legally marketed predicate devices, K993000 (Bard Hydrophilic Coated Guide Wires) and K082094 (PTFE (Teflon) Coated Guide Wires), as well as pre-amendment devices for the stainless steel versions. The statement "found to have identical technological characteristics and to be equivalent" suggests that the Sunmed Guide Wires met or exceeded the performance characteristics of these predicates.

8. Sample Size for the Training Set:

Not applicable. This device is a physical medical instrument, not an AI or machine learning algorithm that requires a training set.

9. How the Ground Truth for the Training Set was Established:

Not applicable for the same reason as above.

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

5. 510(k) Summary

MAY 1 1 2012

K120119

Sunny Medical Device (Shenzhen) Co., Ltd.

Suite 401 Dongpingxin Creative Science Park, Zhongxincheng Longcheng Street, Longgang District, Shenzhen, Guangdong Province P.R. China 518172

Tel: +86 755 3383-1052 Fax: +86 755 2893-8097, +852 3171-6516, +1 949 423-0168 Email: sunnymedical_cn@139.com, jamesqizhang@gmail.com Website: www.sunnymedical.com.cn

SUMMARY

K Reference #K120119
Submitter's name:Sunny Medical Device (Shenzhen) Co., Ltd.
Address:Suite 401 Dongpingxin Creative Science

Address. Park, Zhongxincheng Longcheng Street, Longgang District, Shenzhen, Guangdong Province, P.R. China 518172 Phone: +86-755 3383-1052 Fax number: +86 755 2893-8097/+1 949 423-0168

Name of contact person:

Greg Holland Regulatory Specialists, Inc. 3722 Ave. Sausalito Irvine, CA 92606 Phone: 949-262-0411 Fax: 949-552-2821

May 8, 2012 Date the summary was revised:

Name of the device:Sunmed Guide Wires
Trade or proprietary nameSunmed Guide Wires
Common or usual nameGuide wires
Product CodeClassification RegulationClassification Name
DQX870.1330Catheter guide wire

The legally marketed devices to which we are claiming equivalence [807.92(a)(3)]:

510(k)Trade or Proprietary or Model NameManufacturer
1K993000Bard Hydrophilic Coated Guide WiresC.R. Bard Inc.
2K082094PTFE (Teflon) Coated Guide WiresC.R. Bard Inc.

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

Description of the device:

K120119 D. Doff

Sunmed Guidewires are used for the introduction and placement of diagnostic or interventional devices in the coronary and peripheral vasculature and mav be used to reach and cross a target lesion.

The Sunmed Guide Wires are available in three versions with a variety of tips:

Stainless steel guide wire Hydrophilic coated quide wire PTFE (Teflon®) coated guide wires

The Seldinger technique is used with these quidewires.

The stainless steel guide wires are standard wires with various tip configurations. The guide wire construction consists of a safety wire, a core wire, and a wound spring for flexibility. The features that distinguish individual wires consist of the core type (fixed or moveable), a straight or "J" tip configuration, diameters and lengths.

The Hydrophilic coated guide wires are constructed from the stainless steel core wire, with varying core lengths and diameters for each design.

The PTFE (Teflon®) coated guide wires are also manufactured from stainless steel wire, with PTFE (Teflon®) coating, or Benzalkonium Heparin (BH) coating applied over the PTFE (Teflon®) coating.

These guide wires are radiodetectable and fluoroscopy may be used to confirm position.

These medical devices are single use and supplied sterile by EQ.

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

List of devices and predicate K reference numbers:

120119

DIAMETERLENGTHTIPCOATINGSUNNY CATALOG #BARD K #
0.035453 mm JPTFESM-GW-3J35045P-TPK082094
0.035501.5 mm JPTFESM-GW-1J35050P-TPK082094
0.02580StraightPTFESM-GW-3S25080P-TPK082094
0.03280StraightPTFESM-GW-3S32080P-TPK082094
0.03580StraightPTFESM-GW-3S35080P-TPK082094
0.035803 mm JPTFESM-GW-3J35080P-TPK082094
0.03880StraightPTFESM-GW-3S38080P-TPK082094
0.025100StraightPTFESM-GW-3S25100P-TPK082094
0.0251003 mm JPTFESM-GW-3J25100P-TPK082094
0.035100StraightPTFESM-GW-3S35100P-TPK082094
0.0351003 mm JPTFESM-GW-3J35100P-TPK082094
0.038100StraightPTFESM-GW-3S38100P-TPK082094
0.0381003 mm JPTFESM-GW-3J38100P-TPK082094
0.025120StraightPTFESM-GW-3S25120P-TPK082094
0.0251203mm JPTFESM-GW-3J25120P-TPK082094
0.032120StraightPTFESM-GW-3S32120P-TPK082094
0.0321203 mm JPTFESM-GW-3J32120P-TPK082094
0.035120StraightPTFESM-GW-3S35120P-TPK082094
0.0351201.5 mm JPTFESM-GW-1J35120P-TPK082094
0.0351203 mm JPTFESM-GW-3J35120P-TPK082094
0.0351206 mm JPTFESM-GW-6J35120P-TPK082094
0.038120StraightPTFESM-GW-3S38120P-TPK082094
0.0381203 mm JPTFESM-GW-3J38120P-TPK082094
0.045120StraightPTFESM-GW-3S45120P-TPK082094
0.018145StraightPTFESM-GW-3S18145P-TPK082094
0.0241453 mm JPTFESM-GW-3J24145P-TPK082094
0.025145StraightPTFESM-GW-3S25145P-TPK082094
0.0251451.5 mm JPTFESM-GW-1J25145P-TPK082094
0.028145StraightPTFESM-GW-3S28145P-TPK082094
0.0281451.5 mm JPTFESM-GW-1J28145P-TPK082094
0.0281453 mm JPTFESM-GW-3J28145P-TPK082094
0.032145StraightPTFESM-GW-3S32145P-TPK082094
0.0321451.5 mm JPTFESM-GW-1J32145P-TPK082094
0.0321453 mm JPTFESM-GW-3J32145P-TPK082094
0.035145StraightPTFESM-GW-3S35145P-TPK082094
0.0351451.5 mm JPTFESM-GW-1J35145P-TPK082094
0.0351453 mm JHeparinSM-GW-3J35145E-TPK082094
0.0351453 mm JPTFESM-GW-3J35145P-TPK082094
0.0351456 mm JPTFESM-GW-6J35145P-TPK082094
0.038145StraightPTFESM-GW-3S38145P-TPK082094
0.0381453 mm JHeparinSM-GW-3J38145E-TPK082094
P. 4 of
DIAMETERLENGTHTIPCOATINGSUNNY CATALOG #BARD K #
0.0381453 mm JPTFESM-GW-3J38145P-TPK082094
0.0381456 mm JPTFESM-GW-6J38145P-TPK082094
0.045145StraightPTFESM-GW-3S45145P-TPK082094
0.065145StraightPTFESM-GW-3S65145P-TPK082094
0.038150StraightPTFESM-GW-3S38150P-TPK082094
0.0381503 mm JPTFESM-GW-3J38150P-TPK082094
0.0351753 mm JPTFESM-GW-3J35175P-TPK082094
0.0252001.5 mm JPTFESM-GW-1J25200P-TPK082094
0.032200StraightPTFESM-GW-3S32200P-TPK082094
0.0322001.5 mm JPTFESM-GW-1J32200P-TPK082094
0.035200StraightPTFESM-GW-3S35200P-TPK082094
0.0352001.5 mm JPTFESM-GW-1J35200P-TPK082094
0.0352003 mm JPTFESM-GW-3J35200P-TPK082094
0.038200StraightPTFESM-GW-3S38200P-TPK082094
0.025220StraightPTFESM-GW-3S25220P-TPK082094
0.035220StraightPTFESM-GW-3S35220P-TPK082094
0.0352203 mm JPTFESM-GW-3J35220P-TPK082094
0.038220StraightPTFESM-GW-3S38220P-TPK082094
0.035260StraightPTFESM-GW-3S35260P-TPK082094
0.0352603 mm JPTFESM-GW-3J35260P-TPK082094
0.038260StraightPTFESM-GW-3S38260P-TPK082094
0.035300StraightPTFESM-GW-3S35300P-TPK082094
0.035400StraightPTFESM-GW-3S35400P-TPK082094
0.025145StraightHydrophilicSM-GW-3S25145H-TPK993000
0.035145StraightHydrophilicSM-GW-3S35145H-TPK993000
0.038145StraightHydrophilicSM-GW-3S38145H-TPK993000
0.03240Straight302 StainlessSteelSM-GW-3S32040N-TPPre-amendment
0.025453 mm J302 StainlessSteelSM-GW-3J25045N-TPPre-amendment
0.03545Straight302 StainlessSteelSM-GW-3S35045N-TPPre-amendment
0.035453 mm J302 StainlessSteelSM-GW-3J35045N-TPPre-amendment
0.03845Straight302 StainlessSteelSM-GW-3S38045N-TPPre-amendment
0.038503 mm J302 StainlessSteelSM-GW-3J38050N-TPPre-amendment
0.03280Straight302 StainlessSteelSM-GW-3S32080N-TPPre-amendment
0.035803 mm J302 StainlessSteelSM-GW-3J35080N-TPPre-amendment
0.035100Straight302 StainlessSteelSM-GW-3S35100N-TPPre-amendment
DIAMETERLENGTHTIPCOATINGSUNNY CATALOG #BARD K #
0.0351003 mm J302 StainlessSteelSM-GW-3J35100N-TPPre-amendment
0.038100Straight302 StainlessSteelSM-GW-3S38100N-TPPre-amendment
0.0381003 mm J302 StainlessSteelSM-GW-3J38100N-TPPre-amendment
0.045100Straight302 StainlessSteelSM-GW-3S45100N-TPPre-amendment
0.035120Straight302 StainlessSteelSM-GW-3S35120N-TPPre-amendment
0.0351203 mm J302 StainlessSteelSM-GW-3J35120N-TPPre-amendment
0.038120Straight302 StainlessSteelSM-GW-3S38120N-TPPre-amendment
0.0381203 mm J302 StainlessSteelSM-GW-3J38120N-TPPre-amendment
0.045120Straight302 StainlessSteelSM-GW-3S45120N-TPPre-amendment
0.035145Straight302 StainlessSteelSM-GW-3S35145N-TPPre-amendment
0.0351453 mm J302 StainlessSteelSM-GW-3J35145N-TPPre-amendment
0.038145Straight302 StainlessSteelSM-GW-3S38145N-TPPre-amendment
0.0381453 mm J302 StainlessSteelSM-GW-3J38145N-TPPre-amendment
0.035250Straight302 StainlessSteelSM-GW-3S35250N-TPPre-amendment
0.038260Straight302 StainlessSteelSM-GW-3S38260N-TPPre-amendment
0.038300Straight302 StainlessSteelSM-GW-3S38300N-TPPre-amendment
0.035400Straight302 StainlessSteelSM-GW-3S35400N-TPPre-amendment

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

K120119 14

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

20119 CC

Package:

Material No.1: DuPont Tyvek package for medical use. Material No.2: Multiple-layer compound film made from of PE and PA.

Indications:

Sunmed Guidewires are used for the introduction and placement of diagnostic or interventional devices in the coronary and peripheral vasculature and may be used to reach and cross a target lesion.

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

Performance Testing:

K120119 P- 6 of 6

The following tests were performed on the Sunmed Guide Wires:

Degradation Test on Disposable Guide Wire Physical Performance Appearance Radiodetectability Eroding resistance Breakage resistance Deformation resistance Connection strength Package Performance Sterility ETO Residue ECH Residue

Technological Characteristics:

Summary of the technological characteristics of our device compared to the predicate device:

The predicates were compared in the following areas and found to have identical technological characteristics and to be equivalent because they are the identical products.

  • Indications for Use Target Population Design Technique Sterility Biocompatibility Anatomical Sites

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

DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/6/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized caduceus symbol, which is a staff with two snakes coiled around it, and the text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" arranged in a circular fashion around the symbol. The caduceus is depicted in black, and the text is also in black, creating a monochrome design.

Public Health Service

Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002

MAY 1 1 . 2012

Sunny Medical Device (Shenzhen) Co., Ltd. c/o Mr. Greg Holland Regulatory Specialists, Inc. 3722 Ave. Sausalito Irvine, CA 92606

Re: K120119

Sunmed Guide Wire Regulation Number: 21 CFR 870.1330 Regulation Name: Catheter Guide Wire Regulatory Class: Class II Product Code: DQX Dated: April 20, 2012 Received: May 10, 2012

Dear Mr. Holland:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, 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.

{7}------------------------------------------------

Page 2 – Mr. Greg Holland

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 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to

http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.

Sincerely yours,

W. G. Hillen

Bram D. Zuckerman, M.D. Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

{8}------------------------------------------------

4. Indications for Use Statement

Indications for Use

510(k) Number (if known): K120119

Device Name: Sunmed Guide Wires

Indications for Use:

Sunmed Guidewires are used for the introduction and placement of diagnostic or interventional devices in the coronary and peripheral vasculature and may be used to reach and cross a target lesion.

Prescription Use >>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>> (Part 21 CFR 801 Subpart D) AND/OR Over-The-Counter Use (21 CFR 801 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED) ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------

Concurrence of CDRH, Office of Device Evaluation (ODE)

M. A. Kildeer

diovascular Devices

510(k) Number K120119

Page 1 of 1

§ 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.