(20 days)
The FATHOM -16 Steerable Guidewire is intended for general intravascular use in the peripheral vasculature. It can be used to selectively introduce and position catheters and other interventional devices within the peripheral vasculature. This device should be used only by physicians trained in percutaneous, intravascular techniques and procedures.
Fathom™-16 Steerable Guidewires are hydrophilic coated, steerable guidewires intended to facilitate the placement of balloon dilatation catheters, and/or other therapeutic devices during peripheral vascular procedures. They are not intended for use in the cerebral or coronary vasculatures. The devices provided are non-pyrogenic, sterile, and intended for one procedure only. The device shaft is coated with a thin hydrophilic coating over the distal section to provide lubricity, which aids in the navigation of distal, tortuous vasculature. Accessories include a torque device, guidewire introducer and torque device. They are not intended to enter the body and have no patient contact.
The provided document is a 510(k) summary for the Boston Scientific Fathom™-16 Steerable Guidewire. This type of submission is for medical devices, specifically guidewires, not for AI/ML-driven diagnostic or assistive software. Therefore, the document does not contain information related to acceptance criteria, ground truth, expert consensus, or study designs like MRMC or standalone performance evaluations as they would apply to an AI device.
The "Performance Data" section in the document indicates that the testing was conducted to demonstrate equivalence to a predicate device, focusing on physical and mechanical properties of the guidewire. The tests listed are:
- Total Length
- Particulate
- Tip Shape Retention
- Torsional Strength
- Pre-Shape Tips
The document states, "The Fathom™-16 Steerable Guidewires met the predetermined acceptance criteria ensuring substantial equivalence to the predicate device. No new safety or performance issues were raised during testing." However, it does not provide the specific "acceptance criteria" values or the "reported device performance" values for these tests.
Therefore, I cannot populate the requested table or answer the questions related to AI/ML device study methodologies using the provided text. The information is simply not present in this type of regulatory submission for a physical medical device like a guidewire.
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Public Health Service
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March 22, 2017
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
Boston Scientific Corporation Mr. Keith Neligan Senior Regulatory Affairs Specialist Three Scimed Place Maple Grove, MN 55311
Re: K170636
Trade/Device Name: Fathom-16 Steerable Guidewires Regulation Number: 21 CFR 870.1330 Regulation Name: Catheter Guide Wire Regulatory Class: Class II Product Code: DQX Dated: March 1, 2017 Received: March 2, 2017
Dear Mr. Neligan:
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.
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
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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 contact the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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 Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely,
Fernando
Aguel-S
for 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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Indications for Use
510(k) Number (if known) K170636
Device Name Fathom™-16 Steerable Guidewire
Indications for Use (Describe)
The FATHOM -16 Steerable Guidewire is intended for general intravascular use in the
peripheral vasculature. It can be used to selectively introduce and position catheters and other interventional devices within the peripheral vasculature. This device should be used only by physicians trained in percutaneous, intravascular techniques and procedures.
Type of Use (Select one or both, as applicable):
| ☑ Prescription Use (Part 21 CFR 801 Subpart D) | ☐ Over-The-Counter Use (21 CFR 801 Subpart C) |
|---|---|
| ---------------------------------------------------------------------------------------------------------- | --------------------------------------------------------------------------------------------------------- |
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510(k) Summary
Per 21 CFR 807.92
| Submitter's Name and Address | Boston Scientific CorporationThree Scimed PlaceMaple Grove, MN 55311USA | ||
|---|---|---|---|
| Contract Information | Keith NeliganSenior Regulatory Affairs SpecialistPhone: 353 21 4531786Fax: 353 21 4343354Email: keith.neligan@bsci.com | ||
| Date Prepared | 01 March 2017 | ||
| Proprietary Name | Fathom™ -16 Steerable Guidewire | ||
| Common Name | Catheter Guidewire | ||
| Classification | Class II per CFR 870.1330 | ||
| Predicate Device(s) | Boston Scientific Fathom™ -16 Steerable Guidewire• K111485, DQX, Jun 30, 2011 |
Device Description
Fathom™-16 Steerable Guidewires are hydrophilic coated, steerable guidewires intended to facilitate the placement of balloon dilatation catheters, and/or other therapeutic devices during peripheral vascular procedures. They are not intended for use in the cerebral or coronary vasculatures. The devices provided are non-pyrogenic, sterile, and intended for one procedure only.
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The device shaft is coated with a thin hydrophilic coating over the distal section to provide lubricity, which aids in the navigation of distal, tortuous vasculature.
Accessories include a torque device, guidewire introducer and torque device. They are not intended to enter the body and have no patient contact.
Intended Use / Indications for Use
The Fathom™-16 Steerable Guidewire is intended for general intravascular use in the peripheral vasculature. It can be used to selectively introduce and position catheters and other interventional devices within the peripheral vasculature. This device should be used only by physicians trained in percutaneous, intravascular techniques and procedures.
Comparison of Technological Characteristics
The Fathom™-16 Steerable Guidewires are similar in fundamental design, function, materials, packaging, sterilization, operating principle, intended use / indication for use and fundamental technology as the predicate device. Modifications were made to the guidewire length and tips (inclusion of angled tip) and associated packaging of the Fathom™-16 Steerable Guidewire.
Performance Data
The following testing was conducted for design elements and performance characteristics deemed appropriate to demonstrate equivalence to the predicate device. The Fathom™-16 Steerable Guidewires met the predetermined acceptance criteria ensuring substantial equivalence to the predicate device. No new safety or performance issues were raised during testing.
- . Total Length
- Particulate ●
- Tip Shape Retention
- Torsional Strength ●
- Pre-Shape Tips 0
Conclusion
Boston Scientific has demonstrated that the modifications to the Fathom™-16 Steerable Guidewires are substantially equivalent in fundamental design, technology, function, materials, packaging, operating principle, and intended use / indication for use as the predicate device.
§ 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.