Who is the manufacturer of PT2 GUIDE WIRE AND ADDWIRE EXTENSION WIRE?

Boston Scientific Scimed, Inc. filed the 510(k) submission for PT2 GUIDE WIRE AND ADDWIRE EXTENSION WIRE (K030617).

What is the FDA product code for PT2 GUIDE WIRE AND ADDWIRE EXTENSION WIRE?

DQX. It is classified under 21 CFR 870.1330 as a Class 2 device in the Cardiovascular panel.

What is the regulatory pathway for PT2 GUIDE WIRE AND ADDWIRE EXTENSION WIRE?

510(k) clearance (submission type: Abbreviated).

What are the predicate devices for PT2 GUIDE WIRE AND ADDWIRE EXTENSION WIRE?

PT Graphix (K962572); Balance MiddleWeight (K021228); BMW (K983033, K973494, K971815); Extension Wire (K970376); Steerable PTCA GW (K011968, K970376).

Who can help prepare an FDA 510(k) submission like PT2 GUIDE WIRE AND ADDWIRE EXTENSION WIRE?

Innolitics — a medical-device software consultancy — provides regulatory and engineering support for FDA 510(k) submissions. See https://innolitics.com/services/510ks/ or contact https://innolitics.com/contact.

PT2 GUIDE WIRE AND ADDWIRE EXTENSION WIRE

K030617 · Boston Scientific Scimed, Inc. · DQX · May 21, 2003 · Cardiovascular

Device Facts

Record ID	K030617
Device Name	PT2 GUIDE WIRE AND ADDWIRE EXTENSION WIRE
Applicant	Boston Scientific Scimed, Inc.
Product Code	DQX · Cardiovascular
Decision Date	May 21, 2003
Decision	SESE
Submission Type	Abbreviated
Regulation	21 CFR 870.1330
Device Class	Class 2

Intended Use

The PT2TM Guide Wires are intended to facilitate the placement of balloon dilatation catheters or other therapeutic devices during PTCA, PTA, or other intravascular interventional procedures. The PT2TM Guide Wires are not intended for use in the cerebral vasculature. The AddWireTM Extension Wire creates an extended guide wire that can be used to exchange out a therapeutic device without removing the original guide wire from the anatomy. When the exchange is complete, the Extension Wire can be detached and the original guide wire can be used in a conventional manner.

Device Story

PT2 Guide Wire: steerable, polymer-tipped wire; 0.014-inch diameter; Light/Moderate support models; 185/300 cm lengths; radiopaque distal tip (straight or J-tip). Construction: PTFE-coated stainless steel core coupled to tapered Nitinol core; stainless steel coupler; distal stainless steel ribbon; Tungsten-loaded polyurethane sleeve; ICE hydrophilic coating. AddWire Extension Wire: 145 cm length; 0.014-inch diameter; PTFE-coated stainless steel wire with distal connector. Used in clinical interventional settings (PTCA/PTA) by physicians to navigate vasculature and exchange therapeutic devices without removing the primary guide wire. Benefits include procedural efficiency during catheter exchanges. Non-clinical bench testing confirms mechanical integrity and compatibility.

Clinical Evidence

Bench testing only. Evaluations included tensile strength, combined load, coupler fatigue, torque response, tip prolapse, coating adherence, polymer peel, PTCA catheter compatibility, and biocompatibility. Results verified device meets all minimum requirements.

Technological Characteristics

Materials: PTFE-coated stainless steel, Nitinol, Tungsten-loaded polyurethane, stainless steel coupler. Design: 0.014-inch diameter, steerable, hydrophilic coating. Extendable proximal section on 185-cm models. Sterilized, single-use.

Indications for Use

Indicated for facilitating placement/exchange of balloon dilatation catheters or therapeutic devices during PTCA, PTA, or intravascular interventional procedures. Contraindicated for use in cerebral vasculature.

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

PT Graphix (K962572)
Balance MiddleWeight (K021228)
BMW (K983033, K973494, K971815)
Extension Wire (K970376)
Steerable PTCA GW (K011968, K970376)

Related Devices

K970244 — SCIMED CHOICE FAMILY OF PTCA GUIDE WIRES · Scimed Life Systems, Inc. · Mar 28, 1997
K032183 — IQ HYDROPHILIC GUIDE WIRE · Boston Scientific Corp · Aug 1, 2003
K143587 — ChoICE Guide Wire, Mailman Guide Wire, Luge Guide Wire, ChoICE PT Guide Wire, PT Graphix Wire · Boston Scientific Corporation · Jan 15, 2015
K020340 — MODIFICATION TO HI-TORQUE WHISPER LS AND MS GUIDE WIRES WITH HYDROCOAT HYDROPHILIC COATING · Guidant Corp. · Mar 1, 2002
K980294 — ACS HI-TORQUE SUPER SPORT GUIDE WIRE WITH HYDROCOAT HYDROPHILIC COATING · Guidant Corp. · Apr 24, 1998

Submission Summary (Full Text)

{0}------------------------------------------------ K030617 MAY 21 2003 Abbreviated 510(k) BSC PT2TM Guide Wire BSC AddWire™ Extension Wire February 25, 2003 ## 510(k) Summary per 21 CFR §807.92 | Submitter's Name and Address | Boston Scientific Corporation (BSC) One Scimed Place Maple Grove, MN 55311 | |---------------------------------|----------------------------------------------------------------------------------------------------------------------------| | Contact Name and Information | Anne V. Rossi Specialist, Regulatory Affairs Phone: 763-494-2827 Fax: 763-494-2323 e-mail: Anne.Rossi@bsci.com | | Date Prepared | February 25, 2003 | | Proprietary Name(s) | PT2TM Guide Wire AddWireTM Extension Wire | | Common Name | Catheter Guide Wire | | Product Code | 74DQX | | Classification of Device | Class II, 21 CFR Part 870.1330 | | Predicate Devices | | | BSC Scimed | | | | PT GraphixTM K962572 (Clearance Date December 17, 1996) | | | Advanced Cardiovascular Systems, Inc. (ACS) | | | Balance MiddleWeightTM K021228 May 15, 2002 | | | (BMW) K983033 November 10, 1998 | | | K973494 December 12, 1997 | | | K971815 July 9, 1997 | | | Lake Region Manufacturing, Inc. (LRM) | | | Extension Wire1 K970376 June 6, 1997 | | | Steerable PTCA GW2 K011968 July 25, 2001 | | | K970376 June 6, 1997 | 1 The LRM Extension Wire is currently marketed by Boston Scientific under the trade name Trooper™/Patriot™ Extension Wire. 2 The LRM Steerable PTCA Guide Wire is currently marketed by Boston Scientific under the trade name Forté™ Guide Wire. {1}------------------------------------------------ K030617 Abbreviated 510(k) BSC AddWire™ BSC PT2TM Guide Wire BSC AddWire™™ Extension Wire BSC AddWire™™ Extension Wire February 25, 2013 | | February 2 | |--------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | Device Description - Guide Wire | The PT2TM Guide Wires with ICE® hydrophilic coating are steerable, polymer-tipped guide wires. The PT2TM is available in a nominal diameter of 0.014 inches, two rail support models, Light Support and Moderate Support, and nominal lengths of 185 and 300 centimeters with Brachial and Femoral marks at 90cm and 100cm respectively. The distal two centimeters of all models are radiopaque and available in either a straight shapeable or a pre-formed J-Tip. The 185-centimeter version of the PT2TM is designed with a proximal extension section. This proximal extension section allows connection to the AddWireTM Extension Wire or the similarly designed TrooperTM/PatriotTM Extension Wire. The PT2TM corewire consists of a PTFE coated SS corewire segment coupled to a tapered Nitinol corewire segment. The PT2TM coupler is a stainless steel material. The distal most end of the PT2TM corewire is a SS ribbon. The distal tapered Nitinol corewire segment of the PT2TM is coated with an adhesive pre-coat. The pre-coated corewire is then jacketed with a Tungsten loaded polyurethane sleeve. The entire polymer sleeve of the PT2TM Guide Wire is coated with ICE® Hydrophilic coating. | | Intended Use of Device - Guide Wire | The PT2TM Guide Wires are intended to facilitate the placement and exchange of balloon dilatation catheters or other therapeutic devices during PTCA or PTA or other intravascular interventional procedures. The PT2TM Guide Wires are not intended for use in the cerebral vasculature. The devices are provided non-pyrogenic, sterile, and intended for one procedure only. | | Technological Characteristics - Guide Wire | The PT2TM Guide Wires utilize similar materials and methods of construction as the currently marketed PT GraphixTM family of guide wires. The differences in construction are a minor change to the polymer sleeve formulation and the addition of a 2-part core wire. The 185-cm models also incorporate an extendable proximal section similar in construction to the BSC FortéTM extendable guide wires. | | Non-Clinical Test Summary - Guide Wire | Testing and evaluation of the PT2TM Guide Wires included tensile, combined load, coupler fatigue, torque response, tip prolapse, coating adherence, visual inspection, polymer peel, PTCA catheter compatibility, and biocompatibility. Test results verified that the PT2TM Guide Wires met all of the minimum requirements and are adequate for their intended use. The PT2TM Guide Wires are considered to be substantially equivalent to guide wires currently marketed by Boston Scientific and ACS based on a comparison of intended use, design and the results of in vitro testing and evaluation. | {2}------------------------------------------------ KO30617 Abbreviated 510(k) BSC PT2T" GSC PT2T" Guide Wire BSC AddWire™ Extension Wire BSC AddWire™ Extension Wire February 25, 2005 | Device Description - Extension Wire | The AddWireTM Extension Wire is a PTFE coated SS wire with a connector at the distal end that connects to the proximal end of BSC extendable guide wires. The nominal length is 145 cm and the nominal diameter is 0.014 inches. The AddWireTM Extension Wire is similar in design and materials to the LRM Extension Wire that is currently marketed by BSC as the TrooperTM/PatriotTM Extension Wire. | |------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | Intended Use of Device - Extension Wire | The AddWireTM Extension Wire creates an extended guide wire that can be used to exchange out a therapeutic device without removing the original guide wire from the anatomy. When the exchange is complete, the Extension Wire can be detached and the original guide wire can be used in a conventional manner. | | Technological Characteristics - Extension Wire | The AddWireTM Extension Wires utilize similar materials and methods of construction as the LRM Extension Wire that is currently marketed by BSC as the TrooperTM/PatriotTM Extension Wire. | | Non-Clinical Test Summary - Extension Wire | Testing and evaluation of the AddWireTM Extension Wires included tensile, coating adherence, visual inspection, PTCA catheter compatibility, exchange system connectability, and biocompatibility. Test results verified that the AddWireTM Extension Wire met all of the minimum requirements and are adequate for their intended use. The AddWireTM Extension Wire is considered to be substantially equivalent to the currently marketed BSC TrooperTM/PatriotTM Extension wire based on a comparison of intended use, design and the results of in vitro testing and evaluation. | {3}------------------------------------------------ Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized eagle with three curved lines representing its wings. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" are arranged in a circular pattern around the eagle. Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850 MAY 21 2003 Ms. Anne V. Rossi Specialist, Regulatory Affairs Boston Scientific Corporation One Scimed Place Maple Grove, MN 55311 K030617 Re: > Trade/Device Name: PT2TM Guide Wire and AddWire™ Extension Wire Regulation Number: 21 CFR 870.1330 Regulation Name: Catheter guide wire. Regulatory Class: II Product Code: DQX Dated: February 25, 2003 Received: February 26, 2003 Dear Ms. Rossi: 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 {4}------------------------------------------------ Page 2 - Ms. Anne V. Rossi 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 (301) 594-4646. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. 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 may be obtained from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html Sincerely yours. laatu Bram D. Zuckerman, M.D. Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health Enclosure {5}------------------------------------------------ KO 30617 ## Indications for Use Statement | 510(k) Number (if known) | Unknown | |-----------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | Device Name(s) | PT2TM Guide Wire AddWireTM Extension Wire | | Indications For Use | The PT2TM Guide Wires are intended to facilitate the placement of balloon dilatation catheters or other therapeutic devices during PTCA, PTA, or other intravascular interventional procedures. The PT2TM Guide Wires are not intended for use in the cerebral vasculature. The AddWireTM Extension Wire creates an extended guide wire that can be used to exchange out a therapeutic device without removing the original guide wire from the anatomy. When the exchange is complete, the Extension Wire can be detached and the original guide wire can be used in a conventional manner. | (PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED) Concurrence of CDRH, Office of Device Evaluation (ODE) Prescription Use (Per 21 CFR §801.109) Confidential and Proprietary to Boston Scientific Corporation