SUNMED GUIDE WIRE

K120119 · Sunny Medical Device (Shenzhen) Co., Ltd. · DQX · May 11, 2012 · Cardiovascular

Device Facts

• Record ID: K120119
• Device Name: SUNMED GUIDE WIRE
• Applicant: Sunny Medical Device (Shenzhen) Co., Ltd.
• Product Code: DQX · Cardiovascular
• Decision Date: May 11, 2012
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 870.1330
• Device Class: Class 2

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 Story

Sunmed Guide Wires are single-use, sterile, radiodetectable guide wires used for coronary and peripheral vascular procedures. They facilitate the introduction and placement of diagnostic or interventional devices and assist in crossing target lesions. The device is operated by clinicians using the Seldinger technique; fluoroscopy is used to confirm wire position. Construction includes a safety wire, core wire, and wound spring for flexibility. Available in three versions: stainless steel, hydrophilic-coated, and PTFE (Teflon)-coated (some with Benzalkonium Heparin coating). Variations include fixed or moveable cores, straight or 'J' tip configurations, and various diameters and lengths. The device provides a track for interventional tools, potentially benefiting patients by enabling minimally invasive access to vascular lesions.

Clinical Evidence

Bench testing only. Testing included degradation, physical performance (appearance, radiodetectability, eroding resistance, breakage resistance, deformation resistance, connection strength), package performance, sterility, and ETO/ECH residue analysis.

Technological Characteristics

Materials: 302 stainless steel, PTFE (Teflon) coating, hydrophilic coating, Benzalkonium Heparin coating. Construction: safety wire, core wire, wound spring. Radiodetectable. Single-use. Sterile (ETO).

Indications for Use

Indicated for introduction and placement of diagnostic or interventional devices in coronary and peripheral vasculature; may be used to reach and cross target lesions.

Regulatory Classification

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.

Special Controls

*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.

Predicate Devices

• Bard Hydrophilic Coated Guide Wires (K993000)
• PTFE (Teflon) Coated Guide Wires (K082094)

Submission Summary (Full Text)

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# 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: [phone] Fax: [phone] Email: [e-mail], [e-mail] 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: [phone] Fax number: [phone]/[phone]

Name of contact person:

Greg Holland Regulatory Specialists, Inc. 3722 Ave. Sausalito Irvine, CA 92606 Phone: [phone] Fax: [phone]

May 8, 2012 Date the summary was revised:

| Name of the device: | Sunmed Guide Wires |
|---------------------------|--------------------|
| Trade or proprietary name | Sunmed Guide Wires |
| Common or usual name | Guide wires |

| Product Code | Classification Regulation | Classification Name |
|--------------|---------------------------|---------------------|
| DQX | 870.1330 | Catheter guide wire |

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

| 510(k) | Trade or Proprietary or Model Name | Manufacturer |
|--------------|-------------------------------------|----------------|
| 1<br>K993000 | Bard Hydrophilic Coated Guide Wires | C.R. Bard Inc. |
| 2<br>K082094 | PTFE (Teflon) Coated Guide Wires | C.R. Bard Inc. |

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#### 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.

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# List of devices and predicate K reference numbers:

# 120119

| DIAMETER | LENGTH | TIP | COATING | SUNNY CATALOG # | BARD K # |
|----------|--------|----------|------------------------|-------------------|-------------------|
| 0.035 | 45 | 3 mm J | PTFE | SM-GW-3J35045P-TP | K082094 |
| 0.035 | 50 | 1.5 mm J | PTFE | SM-GW-1J35050P-TP | K082094 |
| 0.025 | 80 | Straight | PTFE | SM-GW-3S25080P-TP | K082094 |
| 0.032 | 80 | Straight | PTFE | SM-GW-3S32080P-TP | K082094 |
| 0.035 | 80 | Straight | PTFE | SM-GW-3S35080P-TP | K082094 |
| 0.035 | 80 | 3 mm J | PTFE | SM-GW-3J35080P-TP | K082094 |
| 0.038 | 80 | Straight | PTFE | SM-GW-3S38080P-TP | K082094 |
| 0.025 | 100 | Straight | PTFE | SM-GW-3S25100P-TP | K082094 |
| 0.025 | 100 | 3 mm J | PTFE | SM-GW-3J25100P-TP | K082094 |
| 0.035 | 100 | Straight | PTFE | SM-GW-3S35100P-TP | K082094 |
| 0.035 | 100 | 3 mm J | PTFE | SM-GW-3J35100P-TP | K082094 |
| 0.038 | 100 | Straight | PTFE | SM-GW-3S38100P-TP | K082094 |
| 0.038 | 100 | 3 mm J | PTFE | SM-GW-3J38100P-TP | K082094 |
| 0.025 | 120 | Straight | PTFE | SM-GW-3S25120P-TP | K082094 |
| 0.025 | 120 | 3mm J | PTFE | SM-GW-3J25120P-TP | K082094 |
| 0.032 | 120 | Straight | PTFE | SM-GW-3S32120P-TP | K082094 |
| 0.032 | 120 | 3 mm J | PTFE | SM-GW-3J32120P-TP | K082094 |
| 0.035 | 120 | Straight | PTFE | SM-GW-3S35120P-TP | K082094 |
| 0.035 | 120 | 1.5 mm J | PTFE | SM-GW-1J35120P-TP | K082094 |
| 0.035 | 120 | 3 mm J | PTFE | SM-GW-3J35120P-TP | K082094 |
| 0.035 | 120 | 6 mm J | PTFE | SM-GW-6J35120P-TP | K082094 |
| 0.038 | 120 | Straight | PTFE | SM-GW-3S38120P-TP | K082094 |
| 0.038 | 120 | 3 mm J | PTFE | SM-GW-3J38120P-TP | K082094 |
| 0.045 | 120 | Straight | PTFE | SM-GW-3S45120P-TP | K082094 |
| 0.018 | 145 | Straight | PTFE | SM-GW-3S18145P-TP | K082094 |
| 0.024 | 145 | 3 mm J | PTFE | SM-GW-3J24145P-TP | K082094 |
| 0.025 | 145 | Straight | PTFE | SM-GW-3S25145P-TP | K082094 |
| 0.025 | 145 | 1.5 mm J | PTFE | SM-GW-1J25145P-TP | K082094 |
| 0.028 | 145 | Straight | PTFE | SM-GW-3S28145P-TP | K082094 |
| 0.028 | 145 | 1.5 mm J | PTFE | SM-GW-1J28145P-TP | K082094 |
| 0.028 | 145 | 3 mm J | PTFE | SM-GW-3J28145P-TP | K082094 |
| 0.032 | 145 | Straight | PTFE | SM-GW-3S32145P-TP | K082094 |
| 0.032 | 145 | 1.5 mm J | PTFE | SM-GW-1J32145P-TP | K082094 |
| 0.032 | 145 | 3 mm J | PTFE | SM-GW-3J32145P-TP | K082094 |
| 0.035 | 145 | Straight | PTFE | SM-GW-3S35145P-TP | K082094 |
| 0.035 | 145 | 1.5 mm J | PTFE | SM-GW-1J35145P-TP | K082094 |
| 0.035 | 145 | 3 mm J | Heparin | SM-GW-3J35145E-TP | K082094 |
| 0.035 | 145 | 3 mm J | PTFE | SM-GW-3J35145P-TP | K082094 |
| 0.035 | 145 | 6 mm J | PTFE | SM-GW-6J35145P-TP | K082094 |
| 0.038 | 145 | Straight | PTFE | SM-GW-3S38145P-TP | K082094 |
| 0.038 | 145 | 3 mm J | Heparin | SM-GW-3J38145E-TP | K082094 |
| P. 4 of | | | | | |
| DIAMETER | LENGTH | TIP | COATING | SUNNY CATALOG # | BARD K # |
| 0.038 | 145 | 3 mm J | PTFE | SM-GW-3J38145P-TP | K082094 |
| 0.038 | 145 | 6 mm J | PTFE | SM-GW-6J38145P-TP | K082094 |
| 0.045 | 145 | Straight | PTFE | SM-GW-3S45145P-TP | K082094 |
| 0.065 | 145 | Straight | PTFE | SM-GW-3S65145P-TP | K082094 |
| 0.038 | 150 | Straight | PTFE | SM-GW-3S38150P-TP | K082094 |
| 0.038 | 150 | 3 mm J | PTFE | SM-GW-3J38150P-TP | K082094 |
| 0.035 | 175 | 3 mm J | PTFE | SM-GW-3J35175P-TP | K082094 |
| 0.025 | 200 | 1.5 mm J | PTFE | SM-GW-1J25200P-TP | K082094 |
| 0.032 | 200 | Straight | PTFE | SM-GW-3S32200P-TP | K082094 |
| 0.032 | 200 | 1.5 mm J | PTFE | SM-GW-1J32200P-TP | K082094 |
| 0.035 | 200 | Straight | PTFE | SM-GW-3S35200P-TP | K082094 |
| 0.035 | 200 | 1.5 mm J | PTFE | SM-GW-1J35200P-TP | K082094 |
| 0.035 | 200 | 3 mm J | PTFE | SM-GW-3J35200P-TP | K082094 |
| 0.038 | 200 | Straight | PTFE | SM-GW-3S38200P-TP | K082094 |
| 0.025 | 220 | Straight | PTFE | SM-GW-3S25220P-TP | K082094 |
| 0.035 | 220 | Straight | PTFE | SM-GW-3S35220P-TP | K082094 |
| 0.035 | 220 | 3 mm J | PTFE | SM-GW-3J35220P-TP | K082094 |
| 0.038 | 220 | Straight | PTFE | SM-GW-3S38220P-TP | K082094 |
| 0.035 | 260 | Straight | PTFE | SM-GW-3S35260P-TP | K082094 |
| 0.035 | 260 | 3 mm J | PTFE | SM-GW-3J35260P-TP | K082094 |
| 0.038 | 260 | Straight | PTFE | SM-GW-3S38260P-TP | K082094 |
| 0.035 | 300 | Straight | PTFE | SM-GW-3S35300P-TP | K082094 |
| 0.035 | 400 | Straight | PTFE | SM-GW-3S35400P-TP | K082094 |
| 0.025 | 145 | Straight | Hydrophilic | SM-GW-3S25145H-TP | K993000 |
| 0.035 | 145 | Straight | Hydrophilic | SM-GW-3S35145H-TP | K993000 |
| 0.038 | 145 | Straight | Hydrophilic | SM-GW-3S38145H-TP | K993000 |
| 0.032 | 40 | Straight | 302 Stainless<br>Steel | SM-GW-3S32040N-TP | Pre-amendment |
| 0.025 | 45 | 3 mm J | 302 Stainless<br>Steel | SM-GW-3J25045N-TP | Pre-amendment |
| 0.035 | 45 | Straight | 302 Stainless<br>Steel | SM-GW-3S35045N-TP | Pre-amendment |
| 0.035 | 45 | 3 mm J | 302 Stainless<br>Steel | SM-GW-3J35045N-TP | Pre-amendment |
| 0.038 | 45 | Straight | 302 Stainless<br>Steel | SM-GW-3S38045N-TP | Pre-amendment |
| 0.038 | 50 | 3 mm J | 302 Stainless<br>Steel | SM-GW-3J38050N-TP | Pre-amendment |
| 0.032 | 80 | Straight | 302 Stainless<br>Steel | SM-GW-3S32080N-TP | Pre-amendment |
| 0.035 | 80 | 3 mm J | 302 Stainless<br>Steel | SM-GW-3J35080N-TP | Pre-amendment |
| 0.035 | 100 | Straight | 302 Stainless<br>Steel | SM-GW-3S35100N-TP | Pre-amendment |
| DIAMETER | LENGTH | TIP | COATING | SUNNY CATALOG # | BARD K # |
| 0.035 | 100 | 3 mm J | 302 Stainless<br>Steel | SM-GW-3J35100N-TP | Pre-<br>amendment |
| 0.038 | 100 | Straight | 302 Stainless<br>Steel | SM-GW-3S38100N-TP | Pre-<br>amendment |
| 0.038 | 100 | 3 mm J | 302 Stainless<br>Steel | SM-GW-3J38100N-TP | Pre-<br>amendment |
| 0.045 | 100 | Straight | 302 Stainless<br>Steel | SM-GW-3S45100N-TP | Pre-<br>amendment |
| 0.035 | 120 | Straight | 302 Stainless<br>Steel | SM-GW-3S35120N-TP | Pre-<br>amendment |
| 0.035 | 120 | 3 mm J | 302 Stainless<br>Steel | SM-GW-3J35120N-TP | Pre-<br>amendment |
| 0.038 | 120 | Straight | 302 Stainless<br>Steel | SM-GW-3S38120N-TP | Pre-<br>amendment |
| 0.038 | 120 | 3 mm J | 302 Stainless<br>Steel | SM-GW-3J38120N-TP | Pre-<br>amendment |
| 0.045 | 120 | Straight | 302 Stainless<br>Steel | SM-GW-3S45120N-TP | Pre-<br>amendment |
| 0.035 | 145 | Straight | 302 Stainless<br>Steel | SM-GW-3S35145N-TP | Pre-<br>amendment |
| 0.035 | 145 | 3 mm J | 302 Stainless<br>Steel | SM-GW-3J35145N-TP | Pre-<br>amendment |
| 0.038 | 145 | Straight | 302 Stainless<br>Steel | SM-GW-3S38145N-TP | Pre-<br>amendment |
| 0.038 | 145 | 3 mm J | 302 Stainless<br>Steel | SM-GW-3J38145N-TP | Pre-<br>amendment |
| 0.035 | 250 | Straight | 302 Stainless<br>Steel | SM-GW-3S35250N-TP | Pre-<br>amendment |
| 0.038 | 260 | Straight | 302 Stainless<br>Steel | SM-GW-3S38260N-TP | Pre-<br>amendment |
| 0.038 | 300 | Straight | 302 Stainless<br>Steel | SM-GW-3S38300N-TP | Pre-<br>amendment |
| 0.035 | 400 | Straight | 302 Stainless<br>Steel | SM-GW-3S35400N-TP | Pre-<br>amendment |

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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 [phone] or [phone] 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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