(114 days)
Not Found
Not Found
No
The device description and intended use are purely mechanical, and there are no mentions of AI, ML, or image processing.
No
The device is an introducer sheath and dilator, used to facilitate the placement of other catheters or guidewires. It does not perform a therapeutic function itself.
No
This device is an introducer sheath and dilator, used for facilitating catheter placement by creating percutaneous access. Its function is to assist in the physical insertion of other medical devices, not to diagnose a condition or disease.
No
The device description clearly describes physical components (introducer sheath, dilator, handle) and their mechanical function (splitting, peeling), 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 describes a device used for percutaneous access and facilitating catheter placement within the body. This is an in vivo procedure, meaning it's performed on a living organism.
- Device Description: The description of the introducer sheath and dilator, and how it's used to introduce catheters and guidewires, aligns with a surgical or interventional medical device used directly on a patient.
- Lack of IVD Characteristics: There is no mention of the device being used to examine specimens derived from the human body (like blood, urine, tissue, etc.) to provide information for diagnosis, monitoring, or screening.
IVD devices are specifically designed to be used outside the body to analyze biological samples. This device is designed to be used inside the body to facilitate medical procedures.
N/A
Intended Use / 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.
Product codes
LDF
Device Description
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
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
Not Found
Key Metrics
Not Found
Predicate Device(s)
Cook's Peel-Away® Introducers, B. Braun's Tearaway Introducer
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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.
0
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 Corporation
this Premarket Notification: One Boston Scientific Place
Natick, MA 01757
| (508) 650.8174 | JUL 2 3 1997 |
|---|---|
| Contact Person: | Wanda M. Carpinella |
| Regulatory 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.
1
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.
2
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
3
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)