(84 days)
Not Found
No
The device description and performance studies focus on the physical properties and mechanical performance of guide wires and extension wires, with no mention of AI or ML technologies.
No.
The document states that the PT2TM Guide Wires are intended to facilitate the placement of "other therapeutic devices," indicating that the guide wires themselves are not considered therapeutic devices.
No
The device, PT2TM Guide Wires and AddWireTM Extension Wire, is intended to facilitate the placement of other therapeutic devices during interventional procedures, not to diagnose a condition.
No
The device description clearly details physical components like wires, coatings, and connectors, indicating it is a hardware medical device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states that the device is used to facilitate the placement of other therapeutic devices during intravascular interventional procedures. This is a procedural device used in vivo (within the body), not a device used in vitro (outside the body) to examine specimens from the human body.
- Device Description: The description details a physical guide wire and extension wire designed for navigating blood vessels. This aligns with an interventional device, not a diagnostic test performed on samples.
- No mention of analyzing biological samples: There is no indication that this device is used to analyze blood, urine, tissue, or any other biological specimen for diagnostic purposes.
Therefore, the PT2TM Guide Wires and AddWireTM Extension Wire are considered medical devices used in interventional procedures, not IVDs.
N/A
Intended Use / Indications for Use
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.
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.
Product codes (comma separated list FDA assigned to the subject device)
74DQX
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.
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not for use in the cerebral 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)
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.
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.
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.
K962572, K021228, K983033, K973494, K971815, K970376, K011968
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
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
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