SEDAT MYSHELL LITE

K080472 · Sedat · DTL · Apr 23, 2008 · Cardiovascular

Device Facts

• Record ID: K080472
• Device Name: SEDAT MYSHELL LITE
• Applicant: Sedat
• Product Code: DTL · Cardiovascular
• Decision Date: Apr 23, 2008
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 870.4290
• Device Class: Class 2

Intended Use

The Sedat Myshell Lite is indicated for assisting, manipulating and maintaining a seal around diagnostic/interventional devices with an outside diameter<9F (<.098'') use in interventional angioplasty procedures.

Device Story

The Sedat Myshell Lite is a Y-connector device featuring a double silicone haemostatic valve within a reduced volume housing. It is designed for use during interventional angioplasty procedures. The device includes a thumb-activated control button that adjusts the geometry of the silicone membrane, allowing the clinician to enlarge the valve opening. This mechanism enables the interventionist to adjust the seal around diagnostic or interventional instruments of varying sizes, facilitating their introduction or removal based on patient-specific pathology and anatomy. The device is operated by a physician in a clinical setting to maintain a haemostatic seal while manipulating vascular instruments.

Clinical Evidence

Bench testing only.

Technological Characteristics

Y-connector with double silicone haemostatic valve. Features a thumb-activated mechanical button to adjust valve geometry. Designed for instruments <9F (<.098").

Indications for Use

Indicated for assisting, manipulating, and maintaining a seal around diagnostic/interventional devices with an outside diameter <9F (<.098") used in interventional angioplasty procedures.

Regulatory Classification

Identification

A cardiopulmonary bypass adaptor, stopcock, manifold, or fitting is a device used in cardiovascular diagnostic, surgical, and therapeutic applications to interconnect tubing, catheters, or other devices.

Special Controls

*Classification.* Class II (special controls). The device 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

• Myshell (K040498)

Submission Summary (Full Text)

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Special 510(k) Premarket Notification Myshell Lite

### VII. 510(k) Summary

## APR 2 3 2008

In accordance with Title 21 of the Code of Federal Regulations, Part 807, and in particular 8807.92, the following summary of information is provided:

### A. Submitted by

Catherine Charles Director of Regulatory Affairs and Quality Assurance Sedat 135, Route Neuve 69540 Irigny - France Telephone: [phone] Fax: [phone]

#### B. Device Name

Trade or Proprietary Name: Sedat Myshell Lite Common or Usual Name: Myshell Lite Y Connector Classification Name: Cardiopulmonary Bypass Adaptor, Stopcock, Mannifold, or Fitting Device Class: Class II Classification: 870.4290 Product Code: DTL

#### C. Predicate Devices

The subject device is substantially equivalent to the Myshell device cleared under K040498.

#### D. Device Description

The Sedat Myshell Lite consists of a variety of Y-connectors with a double silicone haemostatic valve within a reduce volume, well fitted for handling interventional procedures. The valve opening/closure mechanism could be activated by the thumb like a control button transforming the resilient valve in a variable geometry permitting to enlarge the valve opening of the silicone membrane. The interventionists make better adjustments for the seal introduction point and the size of the vascular instruments able to be introduced or removed to suit the individual pathology and anatomical conditions of the patient.

#### E. Intended Use

The Sedat Myshell Lite is indicated for assisting, manipulating and maintaining a seal around diagnostic/interventional devices with an outside diameter<9F (<.098'') use in interventional angioplasty procedures.

#### F. Substantial Equivalence

Data were provided which demonstrated the Sedat Myshell Lite, Y connector with a double silicone haemostaticvalve to be substantially equivalent to previously cleared

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devices. The substantial equivalence is based upon equivalence in indications for use, design, material, and function.

# G. Summary of Non-Clinical Tests

Bench performance testing was presented.

- H. Summary of Clinical Tests (Not Applicable).

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Image /page/2/Picture/2 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized eagle with three curved lines representing its wings. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the eagle.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

APR 2 3 2008

SEDAT c/o Ms. Laetitia Cousin President c/o EXCAELIA™ 8895 Towne Centre Drive, 105-416 San Diego, CA 92122

Re: K080472

SEDAT MYSHELL LITE Regulation Number: 21 CFR 870.4290 Regulation Name: Adapter, stopcock, manifold, fitting, cardiopulmonary bypass Regulatory Class: Class II (two) Product Code: DTL Dated: February 20, 2008 Received: February 21, 2008

Dear Ms. Cousin:

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.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), 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 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

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#### Page 2 - Ms. Laetitia Cousin

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 begin 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), please contact the Office of Compliance at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number [phone] or [phone] or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely yours,

Dma R. Viener

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):

Device Name:__________________________________________________________________________________________________________________________________________________________________

Indications For Use:

The SEDAT MYSHELL LITE is indicated for assisting, manipulating, and maintaining a seal around diagnostic/interventional devices with an outside diameter <9F (<.098") used in interventional angioplasty procedures.

Prescription Use (Part 21 CFR 801 Subpart D) AND/OR

Over-The-Counter Use _________________________________________________________________________________________________________________________________________________________ (21 CFR 807 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

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Duma R. de Mines

(Division Sign-Off) Division of Cardiovascular Devices

510(k) Number K080472