INTRODUCER SHEATH, VESSEL DILATOR

K992309 · Boston Scientific Corp · DYB · Oct 7, 1999 · Cardiovascular

Device Facts

• Record ID: K992309
• Device Name: INTRODUCER SHEATH, VESSEL DILATOR
• Applicant: Boston Scientific Corp
• Product Code: DYB · Cardiovascular
• Decision Date: Oct 7, 1999
• Decision: SESK
• Submission Type: Traditional
• Regulation: 21 CFR 870.1340
• Device Class: Class 2

Intended Use

The Boston Scientific/EP Technologies sheaths and accessories are designed to facilitate the intracardiac placement of interventional devices. The Introducing sheath may be exchanged and used in a transseptal position after transseptal puncture has been obtained by another sheath.

Device Story

Intracardiac introducing sheath and accessories (sheath, vessel dilator, guidewire) facilitate placement of interventional devices within the heart. Sheath features braided shaft, soft distal tip, and marker band; available with hemostasis valve or luer fitting in various diameters (8.5F, 9.5F) and curve configurations. Used by physicians in clinical settings to provide a conduit for interventional devices, fluid infusion, blood sampling, or air aspiration. Device provides a stable pathway for cardiac interventions; benefits include improved access and maneuverability during procedures.

Clinical Evidence

Bench testing only. Testing included biocompatibility, sterilization validation (ISO 11135), reliability (shipping, accelerated aging), tensile testing of bond joints, rotational testing, and in vitro leak, friction, and insertion force testing.

Technological Characteristics

Braided shaft construction with soft distal tip and marker band. Available with hemostasis valve or luer fitting. Diameters: 8.5F and 9.5F. Angles: 0° - 180°. Sterilization: Validated per ISO 11135. Mechanical device; no software or energy source.

Indications for Use

Indicated for facilitating the intracardiac placement of interventional devices in patients requiring such procedures. The sheath may be used in a transseptal position following transseptal puncture.

Regulatory Classification

Identification

A catheter introducer is a sheath used to facilitate placing a catheter through the skin into a vein or artery.

Predicate Devices

• Percutaneous Introducer Set
• Long Length Percutaneous Introducer Set
• EPT Constellation Outer Guiding Catheters
• Fast-Cath™ Intracardiac Introducer
• Cook Toughy-Borst Introducer set

Submission Summary (Full Text)

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## E. 510(k) Summary [as required by 21 CFR 807.87(h)] Date Prepared: July 1, 1999 Sponsor: Boston Scientific Corporation 2710 Orchard Parkway San Jose, CA 95134 Telephone: [phone] Contact: Susan Pool Title: Manager, Regulatory Affairs Trade Name: n/a Common Name: Intracardiac Introducing Sheath and Accessories Classification Name: Catheter, Introducer Classification: Class II-21 CFR 870.1310 Class II-21 CFR 870.1340 Predicate Devices: Percutaneous Introducer Set, Long Length Percutaneous Introducer Set; EPT Constellation Outer Guiding Catheters, Fast-Cath™ Intracardiac Introducer, Cook Toughy-Borst Introducer set * Device Description: The intracardiac introducing sheath and accessories consists of: (1) a disposable introducer sheath, (2) a vessel dilator and (3) guidewire. The intracardiac introducing sheath consists of a braided shaft a soft distal tip and marker band. The sheath comes with either a Hemostasis valve or a luer fitting. The introducer sheaths are constructed in a range of curve reach configurations, diameters and lengths to respond to physician preferences. The introducer sheath configurations covered under the subject 510(k) Premarket Notification include 8.5F and 9.5F diameter, angles ranging form 0° - 180 Intended Use: The Boston Scientific/EP Technologies intracardiac introducing sheaths and accessories are designed to facilitate the intracardiac placement of interventional devices. Technical Features: The intracardiac introducer sheath combines design features of marketed predicate devices. The design features of the subject devices of fall within ranges specified by the predicate devices. All the devices are Further oll madicate which other medical devices can be passed. Further, all predicate devices allow for sideports through which air can be aspirated, fluids can be infused, blood can be sampled, etc. Performance Data: In vitro testing qualified the equivalence between the subject device and the predicate devices for the intracardiac deployment of devices and

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verified that no new safety or effectiveness issues. The type of testing is summarized below:

1. Biocompatibility testing on manufactured sheaths and dilators;

2. Sterilization validation of packaged units per ISO 11135 guidelines;

3. Reliability testing such as shiping, and accelerated aging of packaged units:

4. Tensile testing of the critical bond joints;

5. Rotational testing on the sheath to luer bond;

6. Leak, friction forces and insertions tests of the subject device in an in vitro setup;

Conclusions: The results of the performance tests indicate that the intracardiac introducing sheath and accessories perform as well as the predicate devices. Any differences in testing outcome are not significant. Therefore, Boston Scientific Corporation/ EP Technologies concludes that the intracardiac introducing sheath and accessories is substantially equivalent to the predicate devices, Percutaneous Introducer Set, Long Length Percutaneous Introducer Set; EPT Constellation Outer Guiding Catheters, Fast-Cath™ Intracardiac Introducer, Cook Toughy-Borst Introducer set. な

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Image /page/2/Picture/1 description: The image shows the logo for the Department of Health & Human Services - USA. The logo is a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an abstract image of a bird-like figure with three lines forming the body and wings.

Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

OCT 7 1999

Ms. Susan Pool Manager, Regulatory Affairs Boston Scientific Corporation 2710 Orchard Parkway San Jose, CA 95134

Re : K992309 Intracardiac Introducing Sheath and Accessories Trade Name: Regulatory Class: II Product Code: DYB July 8, 1999 Dated: Received: July 9, 1999

Dear Ms. Pool:

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 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). You may, therefore, market the device, subject to the general controls provisions of the Act. However, you are responsible to determine that the medical devices you use as components in the kit have either been determined as substantially equivalent under the premarket notification process (Section 510(k) of the act), or were legally on the market prior to May 28, 1976, the enactment date of the Medical Device Amendments. Please note: If you purchase your device components in bulk (i.e., unfinished) and further process (e.g., sterilize) you must submit a new 510(k) before including these components in your kit. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, and 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 requirements, as set forth in

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Page 2 - Ms. Susan Pool

the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic QS inspections, FDA will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, the Food and Drug Administration (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.

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 the labeling regulation (21 CFR Part 801 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at [phone]. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at [phone]. 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 [phone] or [phone], or at its internet address "http://www.fda.gov/cdrh/dsma/dsmamain.html".

Sincerely yours,

Thomas J. O'Keefe

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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## D. Indications For Use Statement

510(k) Number (if known):

Intracardiac Introducing Sheath and accessories Device Name: __

Indication For Use:

发

The Boston Scientific/EP Technologies sheaths and accessories are designed to facilitate the intracardiac placement of interventional devices. The Introducing sheath may be exchanged and used in a transseptal position after transseptal puncture has been obtained by another sheath.

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Concurrence of CDRH, Office of Device Evaluation (ODE)

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(Division Sign-Off) Division of Cardiovascular, Respiratory, and Neurological Devices K492309 510(k) Number

Prescription Use

.OR

Over-The-Counter Use

(Per 21 CFR 801.109)

(Optional Format 1-2-96)