MYSHELL

K040498 · Sedat S.A. · DTL · Jul 2, 2004 · Cardiovascular

Device Facts

• Record ID: K040498
• Device Name: MYSHELL
• Applicant: Sedat S.A.
• Product Code: DTL · Cardiovascular
• Decision Date: Jul 2, 2004
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 870.4290
• Device Class: Class 2

Intended Use

MYSHELL is indicated for maintaining a seal around diagnostic/interventional devices with an outside diameter <9F (<.098") during interventional procedures. The 3-way stopcock, Alligatork and guidewire introducer are accessories used in conjunction with MYSHELL to facilitate interventional procedures.

Device Story

MYSHELL is an ergonomic y-connector/hemostatic valve used during interventional procedures. It accepts diagnostic/interventional devices up to 9F in diameter. The device features a watertight double hemostatic silicone valve controlled by an external mechanism; the mechanism allows for gradual opening, complete/locked opening, or complete closure. The device is transparent to ensure visibility. It is used by clinicians in interventional settings to maintain a seal around inserted devices, preventing blood loss while allowing device manipulation. Accessories include a 3-way stopcock, Alligatork, and guidewire introducer.

Clinical Evidence

No clinical data. Safety and efficacy were demonstrated through bench testing of the device and its accessories (3-way stopcock, guidewire introducer, and Alligatork).

Technological Characteristics

Ergonomic y-connector/hemostatic valve; accepts catheters up to 9F; internal double hemostatic silicone valve; transparent body; mechanical valve opening/closing mechanism. No energy source or software.

Indications for Use

Indicated for patients undergoing interventional procedures requiring the use of diagnostic or interventional devices with an outside diameter less than 9F (0.098").

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

• Copilot™ Bleedback Control Valve (K991102)

Submission Summary (Full Text)

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K040498

2/24/2004

JUL 0 2 2004

## 510(k) Summary C.

| Applicant | Sedat, Inc.<br>76 Bedford Street, #33<br>Lexington, MA 02420<br>Contact: Jean-Pierre Desseignes<br>Telephone: [phone]<br>Facsimile: 781/674-3115<br>Email: [e-mail] |
|------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Manufacturer | Sedat<br>France Address<br>Contact |
| Date | February 24, 2004 |
| Device Name | MYSHELL |
| Common Name | Y-Connector/Hemostatic Valve<br>(per 21 CFR 870.4290) |
| Summary of<br>Substantial<br>Equivalence | MYSHELL is substantially equivalent in respect to the intended use, design and method of operation of the Copilot™ Bleedback Control Valve manufactured by Guidant Corporation (K991102). |
| Device Description | MYSHELL is an ergonomically designed y-connector/hemostatic valve that accepts materials up to 9F in size (<.098").<br><br>The watertight double hemostatic silicone valve is manipulated by a valve opening mechanism on the external body of MYSHELL. The opening mechanism allows for precise control of the internal valve: press gradually on the mechanism for a controlled opening, push the mechanism entirely in for a complete and locked opening, or completely close the valve by depressing on the mechanism in its locked position. |
| Intended Use | MYSHELL is indicated for maintaining a seal around diagnostic/interventional devices with an outside diameter <9F (<.098") during interventional procedures.<br><br>The 3-way stopcock, Alligatork and guidewire introducer are accessories used in conjunction with MYSHELL to facilitate interventional procedures. |
| Indications<br>Statement | MYSHELL is indicated for maintaining a seal around diagnostic/interventional devices with an outside diameter <9F (.098") during interventional procedures. |
| Technological<br>Characteristics | - Ergonomic design fits entirely and comfortable into the hand.<br>- MYSHELL accepts catheters up to 9F in size.<br>- Internal double hemostatic silicone valve is watertight.<br>- Transparency ensures total visibility<br>- The valve opening mechanism allows for gradual or complete opening/closing. |
| Performance Data | The safety and efficacy of MYSHELL and its accessories, the 3-way stopcock, guidewire introducer and Alligatork, have been demonstrated |

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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

JUL 0 2 2004

Sedat, Inc. c/o Mr. Peter C. Wood Regulatory Affairs Counsel 4 Harvard Place, #1 Charlestown, MA 01960

Re: K040498

MYSHELL Regulation Number: 21 CFR 870.4290 Regulation Name: Cardiopulmonary Bypass Adaptor, Stopcock, Manifold, or Fitting Regulatory Class: Class II (two) Product Code: DTL Dated: June 16, 2004 Received: June 17, 2004

Dear Mr. Wood:

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 legs!ly marketed predicate devices marketed in interstate for the enaturior 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 - Mr. Peter C. Wood

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]. 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" (21CFR Part 807.97) you may obtain. Other general information on your responsibilities under the Act may be obtained 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/dsma/dsmamain.html

Sincerely yours,

Diana R. Holmes

(for 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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040498

2/24/2004

## Indications for Use B.

510(k) Number (if known):

K040 J98

Device Name:

MYSHELL

Indications for Use:

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

Prescription Use X (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 OF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Duna R. Ladner

(Division Sign-Off) Division of Cardiovascular Devices

510(k) Number_