DOLPHIN INFLATION DEVICE

K042449 · Sedat S.A. · MAV · Apr 18, 2005 · Cardiovascular

Device Facts

• Record ID: K042449
• Device Name: DOLPHIN INFLATION DEVICE
• Applicant: Sedat S.A.
• Product Code: MAV · Cardiovascular
• Decision Date: Apr 18, 2005
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 870.1650
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

DOLPHIN Inflation Device is intended for use during cardiovascular procedures to create, maintain and monitor pressure in the balloon catheter.

Device Story

Dolphin Inflation Device is a single-use, sterile, manual device used in cardiovascular procedures to pressurize and depressurize balloon catheters. Operated by a clinician, the device features a large handle that drives an internal piston; clockwise rotation increases pressure. A cam locking mechanism maintains pressure up to 30 ATM, allowing the user to release the device. Dual locks and a 30 cc syringe enable instantaneous deflation. An integrated analog gauge displays pressure for real-time monitoring. The device is designed for ergonomic handling, stability on operating drapes, and suitability for both right- and left-handed users. Clear materials allow for air bubble detection and debubbling. The device assists clinicians in controlled balloon inflation/deflation, facilitating cardiovascular interventions.

Clinical Evidence

No clinical data. Safety and efficacy demonstrated through preclinical tests, analyses, and non-clinical comparisons to the predicate device.

Technological Characteristics

Manual inflation device; cam locking mechanism; 30 cc syringe; analog pressure gauge; ergonomic design with grained side panels; clear materials for bubble detection; supports pressures up to 30 ATM; sterile, single-use.

Indications for Use

Indicated for use during cardiovascular procedures to create, maintain, and monitor pressure in balloon catheters for patients undergoing such procedures.

Regulatory Classification

Special Controls

*Classification.* Class II (special controls). The device, when it is a non-patient contacting balloon inflation syringe intended only to inflate/deflate balloon catheters and monitor pressure within the balloon, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 870.9.

Predicate Devices

• Indeflator 20/30 (K961471)

Reference Devices

• Myshell (K040498)

Submission Summary (Full Text)

{0}------------------------------------------------

Image /page/0/Picture/1 description: The image shows the seal of the U.S. Department of Health & Human Services. The seal is circular and contains the department's name around the perimeter. In the center of the seal is an abstract image of an eagle with its wings spread.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

MAY 20 2005

Sedat c/o Excaelia™ Ms. Laetitia Bernard President 45900 Parsippany Court Temecula, CA 92592

K042449 Re: Dolphin Inflation Device Regulation Number: 21 CFR 870.1650 Regulation Name: Angiographic injector and syringe Regulatory Class: II (two) Product Code: MAV Dated: March 10,2005 Received: March 14,2005

Dear Ms. Bernard:

This letter corrects our substantially equivalent letter of April 18, 2005 regarding the address change.

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 (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 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.

{1}------------------------------------------------

Page 2 - Ms. Laetitia Bernard

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 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 continue 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 and additionally Part 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]. Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers, International and Consumer Assistance at their toll free number [phone] or at [phone] or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html.

Sincerely yours,

Blummore for

Bram D. Zuckerman, M.D. Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health

{2}------------------------------------------------

9/7/2004

## Indications for Use

510(k) Number (if known):

Device Name: DOLPHIN INFLATION DEVICE

Indications for Use: DOLPHIN Inflation Device is intended for use during cardiovascular procedures to create, maintain and monitor pressure in the balloon catheter.

AND/OR Prescription Use Over-The-Counter Use X (21 CFK 807 Subpart C) (Part 21 CFR 801 Subpart D) (PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUEON ANOTHER PAGE OF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

viva R. Lochner
(Division Sign Off)

Division of Cardiovascular Devices

510(k) Number_K Q 4

Sedat Inc.

Indications for Usc

{3}------------------------------------------------

9/7/2004

## APR 1 g 2005

## 510(k) Summary

| Applicant | Sedat, Inc.<br>76 Bedford Street, #33<br>Lexington, MA 02420 | Contact: Jean-Pierre Desseignes<br>Telephone: [phone]<br>Facsimile: 781/674-3115<br>Email: [e-mail] |
|------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------|
| Manufacturer | Sedat<br>135, Route Neuve<br>69540 Irigny<br>FRANCE | Contact: Jean-Pierre Desseignes<br>Telephone: [phone]<br>Facsimile: 33(0) 4 78 51 89 67<br>Email: [e-mail] |
| Date | August 26, 2004 | |
| Device Name | DOLPHIN Inflation Device | |
| Common Name | Angiographic injector/syringe | |
| Summary of<br>Substantial<br>Equivalence | DOLPHIN is substantially equivalent, with respect to the intended use, conditions<br>of use, and design, of the currently marketed Indeflator 20/30 (K961471, Product<br>Code: MAX, Regulation: 870.1650).<br><br>The DOLPHIN is substantial equivalent, with respect to materials, packaging<br>process and location, as well as sterilization and location, to the Myshell (K040498,<br>Product Code: DTL, Regulation: 870.4290). | |
| Device Description | DOLPHIN is a single-use, sterile, and ergonomically designed inflation device used<br>in cardiovascular procedures to pressurize (inflate) and depressurize (deflate)<br>balloon catheters. The device itself consists of two components - the inflation<br>device and large volume syringe (30 cc).<br><br>The manually operation of the DOLPHIN is achieved by the manipulation of a<br>large handle to drive a piston housed within the body of the device. Careful and<br>controlled inflation is achieved by rotating the handle clockwise. During inflation a<br>unique cam locking mechanism maintains pressure even if the user lets go of the<br>device.<br><br>Instantaneous deflation, regardless of balloon size, is made possible by the release<br>of the dual locks located on device as well as a large, 30 cc syringe that is sold with<br>each Dolphin Inflation Device.<br><br>All the while during inflation or deflation pressure is displayed and can be<br>monitored on a large analog gauge mounted on top of the device. | |
| Intended Use | DOLPHIN Inflation Device is intended for use during cardiovascular procedures to<br>create, maintain and monitor pressure in the balloon catheter. | |
| Technological<br>Characteristics | Ergonomic design of the DOLPHIN permits easy holding (grained side panels) and handling (slip-free buttons). A unique cam locking mechanism maintains high pressure (up to 30 ATM) and allows for a fast and easy release of pressure. The 30 cc syringe allows rapid deflation, regardless of balloon size. Very stable on the operating drape with an easy to read pressure gauge. Suitable for right and left-handed personnel. Precise pressure increase with a simple wrist movement. Clear materials facilitate the detection of air bubbles and debubbling. | |
| Performance Data | The safety and efficacy of DOLPHIN has been demonstrated through a variety of<br>preclinical tests and analyses, as well as non-clinical comparisons to the Indeflator<br>20/30. | |