(114 days)
The introducer sheath and dilator are intended to be used in percutaneous access for the purpose of facilitating catheter placement by allowing multiple catheter and/or guidewire exchanges.
The Introducer Sheath and Dilator is used for percutaneous introduction of catheters and guide wires.
The introducer set consists of a tapered dilator with a slightly shorter sheath that splits for removal after catheter placement. The sheath is peeled away from the catheter by breaking the handle at the hub.
The provided text describes a 510(k) premarket notification for an "Introducer Sheath and Dilator" (K971165). This type of submission focuses on demonstrating substantial equivalence to a legally marketed predicate device, rather than proving performance against specific acceptance criteria through a clinical study with detailed statistical outcomes.
Therefore, many of the specific details requested regarding acceptance criteria, study design, sample sizes, expert ground truth, and AI performance are not applicable to this 510(k) submission.
Here's an breakdown of the available information:
Description of the Device and its Intended Use:
The introducer sheath and dilator are intended to be used in percutaneous access for the purpose of facilitating catheter placement by allowing multiple catheter and/or guidewire exchanges. The set consists of a tapered dilator with a slightly shorter sheath that splits for removal after catheter placement. The sheath is peeled away from the catheter by breaking the handle at the hub.
1. Table of Acceptance Criteria and Reported Device Performance:
This information is not provided in the submission. 510(k)s for devices like this typically don't include a table of performance metrics and acceptance criteria in the same way a new, high-risk device might. The "performance" is implicitly deemed acceptable if it is substantially equivalent to predicate devices that are already on the market and considered safe and effective.
2. Sample Size Used for the Test Set and Data Provenance:
This information is not provided. Clinical studies with test sets, as understood in the context of performance metrics and AI, were not part of this 510(k) submission. The substantial equivalence was likely based on design comparisons and perhaps bench testing, but specific sample sizes for a "test set" are not mentioned.
3. Number of Experts Used to Establish Ground Truth and Qualifications:
This information is not applicable/not provided. Ground truth in the context of a 510(k) equivalence claim usually refers to the established safety and effectiveness of the predicate devices already on the market, rather than a new "ground truth" being established for the submitted device through expert review of a test set.
4. Adjudication Method for the Test Set:
This information is not applicable/not provided. There is no mention of a formal test set requiring an adjudication method.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:
No, a MRMC comparative effectiveness study was not performed or reported. This type of study is more common for diagnostic imaging AI devices, not for an introducer sheath and dilator.
6. Standalone (Algorithm Only) Performance Study:
No, a standalone performance study as would be conducted for an AI algorithm was not performed or reported. This device is a physical medical instrument, not an algorithm.
7. Type of Ground Truth Used:
The "ground truth" in this context is the established safety and effectiveness of legally marketed predicate devices. The submission states: "The proposed introducer dilator has been shown to be substantially equivalent to Cook's Peel-Away® Introducers and to B. Braun's Tearaway Introducer." This means the predicate devices' historical performance and acceptance served as the benchmark.
8. Sample Size for the Training Set:
This information is not applicable/not provided. This device is not an AI algorithm, so there is no training set in that sense.
9. How the Ground Truth for the Training Set Was Established:
This information is not applicable/not provided for the same reason as above.
In summary: K971165 is a 510(k) premarket notification for an introducer sheath and dilator. Its "acceptance criteria" were met by demonstrating substantial equivalence to existing, legally marketed predicate devices (Cook's Peel-Away® Introducers and B. Braun's Tearaway Introducer). The submission text does not detail specific performance metrics, clinical study results, or AI-related evaluations that would typically include the requested information. The FDA's letter confirms that based on the provided information, the device was found substantially equivalent and could proceed to market.
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SUMMARY OF SAFETY AND EFFECTIVENESS
Pursuant to §513(i)(3)(A) of the Food, Drug, and cosmetic Act, Boston Scientific Corporation submits this summary of safety and effectiveness.
A. GENERAL INFORMATION
| Owner Operator Submitting Boston Scientific Corporationthis Premarket Notification: One Boston Scientific PlaceNatick, MA 01757(508) 650.8174 | JUL 2 3 1997 |
|---|---|
| Contact Person: | Wanda M. CarpinellaRegulatory Affairs Department |
| Device Generic Name: | Introuducer Sheath and Dilator |
| Device Classification: | 74 DYB, Catheter, introducer |
B. INDICATIONS FOR USE
The introducer sheath and dilator are intended to be used in percutaneous access for the purpose of facilitating catheter placement by allowing multiple catheter and/or guidewire exchanges.
C. DESCRIPTIVE CHARACTERISTICS
The introducer set consists of a tapered dilator with a slightly shorter sheath that splits for removal after catheter placement. The sheath is peeled away from the catheter by breaking the handle at the hub.
D. SUBSTANTIAL EQUIVALENCE
The proposed introducer dilator has been shown to be substantially equivalent to Cook's Peel-Away® Introducers and to B. Braun's Tearaway Introducer.
E. PACKAGING, STERILIZATION, AND PYROGENICITY
The introducer sheath and dilator is packaged in a heat-sealed Tyvek/mylar pouch. The product is sterilized using either ethylene oxide gas or gamma radiation . Bacterial endotoxin levels are monitored for sterility release purposes.
F. CONCLUSION
Based on the information presented, Boston Scientific Corporation believes that the proposed introducer sheath and dilator meets the minimum requirements that are considered acceptable for its intended use and is substantially equivalent to other currently marketed introducer sheath and dilators.
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DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/1/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle with three lines forming its body and wings. The eagle is positioned within a circle, and the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged around the upper portion of the circle.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20856
Ms. Wanda M. Carpinella Project Manager, Regulatory Affairs Boston Scientific Corporation One Boston-Scientific Place . . .... . Natick, Massachusetts 01760-1537
JUL 2 3 7997
Re: K971165 Introducer Sheath and Dilator Regulatory Class: II (two) Product Code: LDF Dated: July 9, 1997 Received: July 10, 1997
Dear Ms. Carpinella:
We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to 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, Druq, and Cosmetic Act (Act). 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, qood 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 (Premarket Approval), 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 895. A substantially equivalent determination assumes compliance with the Current Good Manufacturing Practice requirement, as set forth in the Quality System Regulation (QS) for Medical Devices. General regulation (21 CFR Part 820) and that, through periodic QS inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.
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This letter will allow you to begin marketing your device as described in your 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 requlation- (21 CFR Part 801 and additionally 809:10 for in vitre --------------------------------diagnostic devices), please contact the Office of Compliance at (301) 594-4648. 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" (21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its internet address "http://www.fda.gov/cdrh/dsmamain.html".
Sincerely yours,
Thomas J. Callahan
Thomas J. Callahan, Ph.D. Director Division of Cardiovascular, Respiratory, and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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510(k) Number (if known): New Application ------------
Device Name:
Introducer Sheath and Dilator
The Introducer Sheath and Dilator is used for percutaneous introduction Indications for Use: of catheters and guide wires.
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED.)
Concurrence of CDRH, Office of Device Evaluaiton (ODE)
Taua A. Rh
(Division Sign-Off) Division of Cardiovascular. Respiratory, and Neurological Devices x971165 510(k) Number
Prescription Use V (Per 21 CRF 801.109)
OR
Over-The-Counter Use
(Optional Format 1-2-96)
§ 870.3680 Cardiovascular permanent or temporary pacemaker electrode.
(a)
Temporary pacemaker electrode —(1)Identification. A temporary pacemaker electrode is a device consisting of flexible insulated electrical conductors with one end connected to anexternal pacemaker pulse generator and the other end applied to the heart. The device is used to transmit a pacing electrical stimulus from the pulse generator to the heart and/or to transmit the electrical signal of the heart to the pulse generator.(2)
Classification. Class II (performance standards).(b)
Permanent pacemaker electrode —(1)Identification. A permanent pacemaker electrode is a device consisting of flexible insulated electrical conductors with one end connected to an implantable pacemaker pulse generator and the other end applied to the heart. The device is used to transmit a pacing electrical stimulus from the pulse generator to the heart and/or to transmit the electrical signal of the heart to the pulse generator.(2)
Classification. Class III (premarket approval).(c)
Date PMA or notice of completion of PDP is required. A PMA or notice of completion of a PDP is required to be filed with the Food and Drug Administration on or before October 4, 2012, for any permanent pacemaker electrode device that was in commercial distribution before May 28, 1976, or that has, on or before October 4, 2012, been found to be substantially equivalent to any permanent pacemaker electrode device that was in commercial distribution before May 28, 1976. Any other pacemaker repair or replacement material device shall have an approved PMA or declared completed PDP in effect before being placed in commercial distribution.