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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
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
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.
More Information

K993000, K082094, Pre-amendment

Not Found

No
The device description focuses on the physical construction and materials of the guidewires, and there is no mention of AI, ML, or any software-based decision-making or analysis.

No.
The Sunmed Guidewires are used for the "introduction and placement of diagnostic or interventional devices," indicating they facilitate other procedures rather than directly providing therapy themselves.

No

Explanation: The "Intended Use / Indications for Use" and "Device Description" sections clearly state that Sunmed Guidewires are used for the introduction and placement of diagnostic or interventional devices, not as diagnostic devices themselves. They facilitate the use of other devices that may be diagnostic.

No

The device description explicitly details physical components made of stainless steel, PTFE, and mentions coatings, indicating it is a hardware device.

No, this device is not an IVD (In Vitro Diagnostic).

Here's why:

  • IVD Definition: In Vitro Diagnostics are medical devices used to perform tests on samples taken from the human body (like blood, urine, tissue) to provide information about a person's health. These tests are performed outside of the body.
  • Device Description and Intended Use: The description clearly states that Sunmed Guidewires are used for the introduction and placement of devices within the coronary and peripheral vasculature. This is an invasive procedure performed inside the body.
  • No Mention of Samples or Testing: The description does not mention collecting or testing any biological samples.
  • Function: The function of the guidewire is to facilitate the delivery of other devices, not to perform a diagnostic test on a sample.

Therefore, based on the provided information, the Sunmed Guidewire is a medical device used for interventional procedures within the body, not an In Vitro Diagnostic.

N/A

Intended Use / 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.

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

DQX

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.

Mentions image processing

Not Found

Mentions AI, DNN, or ML

Not Found

Input Imaging Modality

Not Found

Anatomical Site

coronary and peripheral vasculature

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)

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

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.

K993000, K082094, Pre-amendment

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.

Not Found

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

§ 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.

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
1
K993000Bard Hydrophilic Coated Guide WiresC.R. Bard Inc.
2
K082094PTFE (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 Stainless
SteelSM-GW-3S32040N-TPPre-amendment
0.025453 mm J302 Stainless
SteelSM-GW-3J25045N-TPPre-amendment
0.03545Straight302 Stainless
SteelSM-GW-3S35045N-TPPre-amendment
0.035453 mm J302 Stainless
SteelSM-GW-3J35045N-TPPre-amendment
0.03845Straight302 Stainless
SteelSM-GW-3S38045N-TPPre-amendment
0.038503 mm J302 Stainless
SteelSM-GW-3J38050N-TPPre-amendment
0.03280Straight302 Stainless
SteelSM-GW-3S32080N-TPPre-amendment
0.035803 mm J302 Stainless
SteelSM-GW-3J35080N-TPPre-amendment
0.035100Straight302 Stainless
SteelSM-GW-3S35100N-TPPre-amendment
DIAMETERLENGTHTIPCOATINGSUNNY CATALOG #BARD K #
0.0351003 mm J302 Stainless
SteelSM-GW-3J35100N-TPPre-
amendment
0.038100Straight302 Stainless
SteelSM-GW-3S38100N-TPPre-
amendment
0.0381003 mm J302 Stainless
SteelSM-GW-3J38100N-TPPre-
amendment
0.045100Straight302 Stainless
SteelSM-GW-3S45100N-TPPre-
amendment
0.035120Straight302 Stainless
SteelSM-GW-3S35120N-TPPre-
amendment
0.0351203 mm J302 Stainless
SteelSM-GW-3J35120N-TPPre-
amendment
0.038120Straight302 Stainless
SteelSM-GW-3S38120N-TPPre-
amendment
0.0381203 mm J302 Stainless
SteelSM-GW-3J38120N-TPPre-
amendment
0.045120Straight302 Stainless
SteelSM-GW-3S45120N-TPPre-
amendment
0.035145Straight302 Stainless
SteelSM-GW-3S35145N-TPPre-
amendment
0.0351453 mm J302 Stainless
SteelSM-GW-3J35145N-TPPre-
amendment
0.038145Straight302 Stainless
SteelSM-GW-3S38145N-TPPre-
amendment
0.0381453 mm J302 Stainless
SteelSM-GW-3J38145N-TPPre-
amendment
0.035250Straight302 Stainless
SteelSM-GW-3S35250N-TPPre-
amendment
0.038260Straight302 Stainless
SteelSM-GW-3S38260N-TPPre-
amendment
0.038300Straight302 Stainless
SteelSM-GW-3S38300N-TPPre-
amendment
0.035400Straight302 Stainless
SteelSM-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

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