JOWIRE ASAHI PTCA CATHETER GUIDE WIRES, MODELS AG145300,141300,142300,132200,14M350,14M345,14M360,143390,141002

K031277 · Jomed, Inc. · DQX · May 14, 2003 · Cardiovascular

Device Facts

• Record ID: K031277
• Device Name: JOWIRE ASAHI PTCA CATHETER GUIDE WIRES, MODELS AG145300,141300,142300,132200,14M350,14M345,14M360,143390,141002
• Applicant: Jomed, Inc.
• Product Code: DQX · Cardiovascular
• Decision Date: May 14, 2003
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 870.1330
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The JoWire 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 JoWire Asahi PTCA Guide Wires are not to be in the cerebral blood vessel.

Device Story

Steerable guide wire; 0.014" diameter; 300 cm length. Stainless steel core wire; soldered core; radiopaque distal tip; hydrophilic or silicone distal coating; PTFE proximal coating. Used by physicians in clinical settings to navigate vasculature and facilitate balloon dilatation catheter placement during PTCA/PTA. Manual operation; provides mechanical support and guidance for interventional devices. Benefits patient by enabling precise catheter positioning during coronary and peripheral angioplasty.

Clinical Evidence

Bench testing and biocompatibility testing conducted. No clinical data provided. Testing demonstrated device met acceptance criteria and performed similarly to predicate devices.

Technological Characteristics

Stainless steel core wire; radiopaque distal tip; hydrophilic/silicone distal coating; PTFE proximal coating. 0.014" diameter; 300 cm length. Manual mechanical device.

Indications for Use

Indicated for facilitating placement of balloon dilatation catheters during PTCA and PTA procedures. Contraindicated for use in cerebral blood vessels.

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

• JoWire Asahi PTCA Guide Wire (K022762)

Submission Summary (Full Text)

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| April 2002 | MAY 14 2003 | Special 510(k) | K031277 |
|-------------------------------------------|------------------------------------------------------------|----------------|---------|
| 510K) Summary of Safety and Effectiveness | | | |
| Date Prepared: | April 21, 2003 | | |
| Submitted by: | Jomed Inc.<br>2870 Kilgore Rd.<br>Rancho Cordova, CA 95670 | | |
| Contact Person: | Terry Schultz<br>Regulatory Affairs Manager | | |
| Phone Number: | [phone] Ext. 286 | | |
| Fax Number: | [phone] | | |
| Device Trade Name: | JoWire Asahi PTCA Guide Wire | | |
| Device Classification<br>Name and Class: | Catheter Guide Wire, Class II (21 CFR 870.1330) | | |
| Predicate Devices: | JoWire Asahi PTCA Guide Wire (K022762) | | |

MAY 1 4 2003

JoWire Asahi PTCA Guide Wires

Special 510(k)

#### Device Description:

Jomed Inc.

April 2002

The JoWire Asahi PTCA Guide Wires are steerable guide wires with a maximum diameter of 0.014" and available in a 300 cm length. The extension wire is connected to the end of the guide wire outside the body. The wire is constructed from stainless steel core wire with varying core lengths and diameters for each design. The core wire and core are soldered. The distal end of the guide wire has a radiopaque tip that is available straight and is made soft to easily bend with the vessel curve. The coating (hydrophilic or silicone) is applied to the distal portion of the wire guide wire. The proximal section of the guide wire is coated with PTFE.

#### Intended Use:

The JoWire 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 JoWire Asahi PTCA Guide Wires are not to be in the cerebral blood vessel.

#### Device Technological Characteristics and Comparison to Predicate Device:

The JoWire Asahi PTCA Guide Wires are made of the same materials, available in the same diameters, have a similar design, and have the same indications for use as the predicate devices and other currently marketed PTCA Guide Wires.

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## 510(k) Summary (cont'd)

### Performance Data:

Bench and biocompatibility testing were conducted according to the recommendations from relevant guidances to demonstrate that the JoWire Asahi PTCA Guide Wires met the acceptance criteria and performed similarly to the predicate devices. No new safety or effectiveness issues were raised during the testing.

#### Conclusion:

The JoWire Asahi PTCA Guide Wires are substantially equivalent to the claimed predicate devices and other currently marketed PTCA Guide Wires.

14031277 Premarket Notification [510(k)] Number

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Image /page/2/Picture/1 description: The image shows the seal of the Department of Health & Human Services (HHS) of the United States. The seal features a stylized eagle head facing left, with three parallel lines extending from the back of the head, representing the agency's mission to promote health and well-being. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" are arranged in a circular pattern around the eagle, indicating the department's name and national affiliation.

#### Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

# MAY 1 4 2003

Ms. Terry Schultz Regulatory Affairs Manager JOMED. Inc. 15330 Avenue of Science, Suite 200 San Diego CA 92128

Re: K031277

Trade Name: JoWire Asahi PTCA Guide Wires Regulation Number: 21 CFR 870.1330 Regulation Name: Catheter Guide Wire Regulatory Class: Class II Product Code: DQX Dated: April 21, 2003 Received: April 22, 2003

Dear Ms. Schultz:

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.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such 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.

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); good manufacturing practice requirements as set

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Page 2 - Ms. Terry Schultz

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. This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Office of Compliance at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). 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/cdrh/dsma/dsmamain.html.

Sincerely yours,

.
Bram D. Zuckerman, M.D.

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

Enclosure

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Jomed Inc. April 2003 JoWire Asahi PTCA Guide Wires Special 510(k)

510(k) Number (if known): ___ K 031277

Device Name: JoWire Asahi PTCA Guide Wires

#### Indications for Use:

To facilitate the placement of balloon dilatation catheters during percutaneous transluminal coronary angioplasty (PTCA) and percutaneous transluminal angioplasty (PTA). The JoWire Neo's Guide Wires are not to be used in the cerebral blood vessel.

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------------------------------------------------------------------------------------------------------------------------------------------------------------------------------Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use (Per 21 CFR 801.19)

Over-the Counter Use __________________________________________________________________________________________________________________________________________________________________________

Division Sign-Off) 510(k) N