(84 days)
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.
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.
The Boston Scientific Corporation (BSC) PT2™ Guide Wire and AddWire™ Extension Wire, covered by K030617, received 510(k) clearance based on substantial equivalence to existing predicate devices.
1. A table of acceptance criteria and the reported device performance
The submission does not explicitly list acceptance criteria in a quantitative table format. Instead, it states that "Test results verified that the PT2TM Guide Wires met all of the minimum requirements and are adequate for their intended use" and similarly for the AddWire™ Extension Wire. The performance is summarized qualitatively by confirming that both devices met their respective minimum requirements and are adequate for their intended use.
However, based on the non-clinical tests conducted, the implicit acceptance criteria would have been successful completion of these tests without failure, demonstrating performance comparable to the predicate devices.
| Acceptance Criteria (Inferred from tests) | Reported Device Performance (Summary) |
|---|---|
| PT2™ Guide Wire: | |
| Tensile Strength | Met minimum requirements, adequate for intended use. |
| Combined Load | Met minimum requirements, adequate for intended use. |
| Coupler Fatigue | Met minimum requirements, adequate for intended use. |
| Torque Response | Met minimum requirements, adequate for intended use. |
| Tip Prolapse | Met minimum requirements, adequate for intended use. |
| Coating Adherence | Met minimum requirements, adequate for intended use. |
| Visual Inspection | Met minimum requirements, adequate for intended use. |
| Polymer Peel | Met minimum requirements, adequate for intended use. |
| PTCA Catheter Compatibility | Met minimum requirements, adequate for intended use. |
| Biocompatibility | Met minimum requirements, adequate for intended use. |
| AddWire™ Extension Wire: | |
| Tensile Strength | Met minimum requirements, adequate for intended use. |
| Coating Adherence | Met minimum requirements, adequate for intended use. |
| Visual Inspection | Met minimum requirements, adequate for intended use. |
| PTCA Catheter Compatibility | Met minimum requirements, adequate for intended use. |
| Exchange System Connectability | Met minimum requirements, adequate for intended use. |
| Biocompatibility | Met minimum requirements, adequate for intended use. |
2. Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective)
The document does not specify the sample sizes used for the non-clinical tests (tensile, fatigue, etc.) for either the PT2™ Guide Wire or the AddWire™ Extension Wire. The data provenance is not explicitly stated but is implicitly from in-vitro laboratory testing conducted by Boston Scientific Corporation. This would be considered prospective testing as it was performed specifically for this submission.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g., radiologist with 10 years of experience)
This submission relies on non-clinical (bench) testing and comparison to predicate devices, not on clinical data involving human subjects or expert ground truth determination from images/patient data. Therefore, the concept of "experts establishing ground truth" as typically seen in AI/diagnostic studies is not applicable here. The "experts" would be the engineers and scientists at Boston Scientific Corporation who designed and performed the tests, verifying the device's physical and functional properties. Their qualifications are not provided.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set
As this is a non-clinical, bench testing submission, there was no adjudication method as typically applied to clinical data or subjective assessments by multiple experts. The tests performed are objective, measurable physical and mechanical tests.
5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
No MRMC comparative effectiveness study was performed or is relevant for this type of medical device (guide wire and extension wire). This is a submission for a physical, interventional device, not an AI or diagnostic imaging device that involves human readers interpreting cases.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
No standalone algorithm performance study was done. This device is a physical medical instrument, not an algorithm or AI.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
For this type of device, the "ground truth" for non-clinical testing is established by objective engineering specifications, material standards, and benchmark performance of predicate devices. Biocompatibility testing relies on established and accepted biological and chemical assays. The performance is compared against these predetermined specifications and the known performance characteristics of the predicate devices.
8. The sample size for the training set
Not applicable. This submission is for a physical medical device and does not involve a "training set" in the context of an AI or machine learning model.
9. How the ground truth for the training set was established
Not applicable. As stated above, there is no "training set" for this device.
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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 Nameand Address | Boston Scientific Corporation (BSC)One Scimed PlaceMaple Grove, MN 55311 |
|---|---|
| Contact Name andInformation | Anne V. RossiSpecialist, Regulatory AffairsPhone: 763-494-2827Fax: 763-494-2323e-mail: Anne.Rossi@bsci.com |
| Date Prepared | February 25, 2003 |
| ProprietaryName(s) | PT2TM Guide WireAddWireTM Extension Wire |
| Common Name | Catheter Guide Wire |
| Product Code | 74DQX |
| Classification ofDevice | Class II, 21 CFR Part 870.1330 |
| Predicate Devices | |
| BSC Scimed | |
| PT GraphixTM K962572 (Clearance Date December 17, 1996) | |
| Advanced Cardiovascular Systems, Inc. (ACS) | |
| BalanceMiddleWeightTM 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.
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Abbreviated 510(k)
BSC AddWire™ BSC PT2TM Guide Wire
BSC AddWire™™ Extension Wire
BSC AddWire™™ Extension Wire
February 25, 2013
| February 2 | |
|---|---|
| DeviceDescription -Guide Wire | The PT2TM Guide Wires with ICE® hydrophilic coating are steerable,polymer-tipped guide wires. The PT2TM is available in a nominaldiameter of 0.014 inches, two rail support models, Light Support andModerate Support, and nominal lengths of 185 and 300 centimeterswith Brachial and Femoral marks at 90cm and 100cm respectively.The distal two centimeters of all models are radiopaque and availablein either a straight shapeable or a pre-formed J-Tip.The 185-centimeter version of the PT2TM is designed with a proximalextension section. This proximal extension section allows connectionto the AddWireTM Extension Wire or the similarly designedTrooperTM/PatriotTM Extension Wire.The PT2TM corewire consists of a PTFE coated SS corewire segmentcoupled to a tapered Nitinol corewire segment. The PT2TM coupler isa stainless steel material. The distal most end of the PT2TM corewire isa SS ribbon.The distal tapered Nitinol corewire segment of the PT2TM is coatedwith an adhesive pre-coat. The pre-coated corewire is then jacketedwith a Tungsten loaded polyurethane sleeve. The entire polymersleeve of the PT2TM Guide Wire is coated with ICE® Hydrophiliccoating. |
| Intended Use ofDevice - GuideWire | The PT2TM Guide Wires are intended to facilitate the placement andexchange of balloon dilatation catheters or other therapeutic devicesduring PTCA or PTA or other intravascular interventional procedures.The PT2TM Guide Wires are not intended for use in the cerebralvasculature. The devices are provided non-pyrogenic, sterile, andintended for one procedure only. |
| TechnologicalCharacteristics -Guide Wire | The PT2TM Guide Wires utilize similar materials and methods ofconstruction as the currently marketed PT GraphixTM family of guidewires. The differences in construction are a minor change to thepolymer sleeve formulation and the addition of a 2-part core wire.The 185-cm models also incorporate an extendable proximal sectionsimilar in construction to the BSC FortéTM extendable guide wires. |
| Non-Clinical TestSummary - GuideWire | Testing and evaluation of the PT2TM Guide Wires included tensile,combined load, coupler fatigue, torque response, tip prolapse, coatingadherence, visual inspection, polymer peel, PTCA cathetercompatibility, and biocompatibility.Test results verified that the PT2TM Guide Wires met all of theminimum requirements and are adequate for their intended use.The PT2TM Guide Wires are considered to be substantially equivalentto guide wires currently marketed by Boston Scientific and ACS basedon a comparison of intended use, design and the results of in vitrotesting and evaluation. |
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KO30617
Abbreviated 510(k)
BSC PT2T" GSC PT2T" Guide Wire
BSC AddWire™ Extension Wire
BSC AddWire™ Extension Wire
February 25, 2005
| DeviceDescription -Extension Wire | The AddWireTM Extension Wire is a PTFE coated SS wire with aconnector at the distal end that connects to the proximal end of BSCextendable guide wires. The nominal length is 145 cm and thenominal diameter is 0.014 inches. The AddWireTM Extension Wire issimilar in design and materials to the LRM Extension Wire that iscurrently marketed by BSC as the TrooperTM/PatriotTM ExtensionWire. |
|---|---|
| Intended Use ofDevice -Extension Wire | The AddWireTM Extension Wire creates an extended guide wire thatcan be used to exchange out a therapeutic device without removing theoriginal guide wire from the anatomy. When the exchange iscomplete, the Extension Wire can be detached and the original guidewire can be used in a conventional manner. |
| TechnologicalCharacteristics -Extension Wire | The AddWireTM Extension Wires utilize similar materials and methodsof construction as the LRM Extension Wire that is currently marketedby BSC as the TrooperTM/PatriotTM Extension Wire. |
| Non-Clinical TestSummary -Extension Wire | Testing and evaluation of the AddWireTM Extension Wires includedtensile, coating adherence, visual inspection, PTCA cathetercompatibility, exchange system connectability, and biocompatibility.Test results verified that the AddWireTM Extension Wire met all of theminimum requirements and are adequate for their intended use.The AddWireTM Extension Wire is considered to be substantiallyequivalent to the currently marketed BSC TrooperTM/PatriotTMExtension wire based on a comparison of intended use, design and theresults of in vitro testing and evaluation. |
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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
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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
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KO 30617
Indications for Use Statement
| 510(k) Number(if known) | Unknown |
|---|---|
| Device Name(s) | PT2TM Guide WireAddWireTM Extension Wire |
| Indications ForUse | The PT2TM Guide Wires are intended to facilitate theplacement of balloon dilatation catheters or othertherapeutic devices during PTCA, PTA, or otherintravascular interventional procedures. The PT2TM GuideWires are not intended for use in the cerebral vasculature.The AddWireTM Extension Wire creates an extended guidewire that can be used to exchange out a therapeuticdevice without removing the original guide wire from theanatomy. When the exchange is complete, the ExtensionWire can be detached and the original guide wire can beused 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
§ 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.