MODEL 3100 SERIES SHEATH INTRODUCER KITS, MODELS 3110, 3130

K040552 · Cryocor, Inc. · DYB · May 28, 2004 · Cardiovascular

Device Facts

• Record ID: K040552
• Device Name: MODEL 3100 SERIES SHEATH INTRODUCER KITS, MODELS 3110, 3130
• Applicant: Cryocor, Inc.
• Product Code: DYB · Cardiovascular
• Decision Date: May 28, 2004
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 870.1340
• Device Class: Class 2

Intended Use

The CryoCor Model 3100 Series Sheath Kits are intended to facilitate the perculaneous introduction of cardiovascular catheters into the heart, while preventing backflow of blood.

Device Story

Model 3100 Series Sheath Kits facilitate percutaneous cardiovascular catheter introduction into heart; prevent blood backflow. Kit includes sheath introducer, dilator, introducer catheter, guide wire. Sheath features hemostasis valve to minimize blood loss; side port with three-way stopcock for air aspiration, fluid infusion, blood sampling, pressure monitoring; radioopaque tip marker for fluoroscopic guidance; distal side holes for contrast media injection. Dilator tapered for trans-septal procedures; accommodates up to 0.038" guide wire. Introducer catheter tapered for gradual vascular entry. Guide wire 0.038" diameter, 150 cm length, J-tip configuration. Used by clinicians in clinical settings. Output is physical access to vasculature for catheter placement; aids clinical decision-making by enabling diagnostic or therapeutic cardiovascular procedures.

Clinical Evidence

Bench testing only. Performance testing confirmed design requirements met. Pre-clinical comparison testing showed performance equivalent to predicate devices. Biocompatibility testing performed on blood-contacting materials per ISO 10993-1; all materials found biocompatible.

Technological Characteristics

Kit includes sheath, dilator, introducer catheter, guide wire. Features hemostasis valve, side port with three-way stopcock, radioopaque tip marker. Materials are blood-contacting and biocompatible per ISO 10993-1. Sterilization via E-beam radiation. No software or electronic components.

Indications for Use

Indicated for patients requiring percutaneous introduction of cardiovascular catheters into the heart. No specific age or gender restrictions noted. Contraindications not specified.

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

• Daig Fast-Cath Intra-Cardiac Introducer (K973840)
• Daig Fast-Cath Transseptal Introducer (K964518)

Submission Summary (Full Text)

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# MAY 2 8 2004

## 510(k) Summary of Substantial Equivalence

K040552

| Date Prepared | March 01, 2004 |
|----------------------------------|--------------------------------------------------------------------|
| Submitter<br>Address | CryoCor, Inc.<br>9717 Pacific Heights Blvd.<br>San Diego, Ca 92121 |
| Contact | Jami Miller<br>Regulatory Affairs Specialist |
| Phone | 858-909-2231 |
| Fax<br>E-Mail Address | 858-909-2350<br>[e-mail] |
| Device Trade Name/ Model Numbers | Model 3100 Series Sheath Kits<br>Model 3110<br>Model 3130 |
| Device Common Name | Catheter Introducer |
| Device Classification Name | Catheter Introducer |
| Classification Regulation | Class II, C.F.R. Section 870.1340 |
| Product Code | DYB |

## Device Description

The Model 3100 Series Sheath Introducer Kit consists of various sheath introducers, each packaged in a kit together with a dilator, introducer catheter and guide wire.

The sheath introducer is fitted with a hemostasis valve to minimize blood loss during catheter introduction and/or exchange. A side port with three-way stopcock is provided for air aspiration, fluid infusion, blood sampling and pressure monitoring. A radioopaque marker at the tip of the sheath will aid during placement while utilizing fluoroscopic guidance. There are side holes at the distal end to allow for injection of contrast media.

The dilator is tapered at the distal tip to allow for use of standard needles for trans-septal procedures, and will accommodate a guide wire or needle no larger than 0.038".

The introducer catheter is gradually tapered distally to allow for gradual dilation of entry into vasculature without producing damage.

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The guide wire is 0.038" in diameter, 150 cm in length with a "I"-tip configuration. It is supplied in a hoop dispenser with a "J" straightener attached to the distal end. The proximal end of the hoop dispenser has a luer hub to facilitate flushing of the wire.

## Intended Use

The CryoCor Model 3100 Series Sheath Kits are intended to facilitate the perculaneous introduction of cardiovascular catheters into the heart, while preventing backflow of blood.

## Substantially Equivalent Devices

The Model 3100 Series Sheath Kits are substantially equivalent to the Daig Fast-Cath Intra-Cardiac Introducer cleared under K973840 and the Daig Fast-Cath Transseptal Introducer cleared under K964518.

The physical characteristics, the intended use, and the mode of use of the Model 3100 Series Sheath Kits are similar to the predicate device.

### Test Summarv

#### Performance Testing

Bench testing confirmed that the Model 3100 Series Sheath Kits met all of its design and performance requirements.

#### Pre-Clinical Studies

Comparison testing found that the Model 3100 Series Sheath Kits performed at least as well as the predicate device.

#### Biocompatibility Information

Biocompatibility testing was performed on the materials which are blood contacting according to ISO 10993-1. All materials were found to be biocompatible.

#### Sterilization Validation

The Model 3100 Series Sheath Kits are sterilized using a validated E-beam radiation sterilization cycle.

#### Conclusion

CryoCor, Inc. considers the Model 3100 Series Sheath Kits to be substantially equivalent to their legally marketed predicate device based on the data and information presented within this application.

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Public Health Service

Image /page/2/Picture/2 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an abstract symbol that resembles a stylized caduceus or a bird-like figure with three wing-like shapes.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

MAY 2 8 2004

CryoCor, Inc. c/o Ms. Jami Miller Regulatory Affairs Specialist 9717 Pacific Heights Blvd. San Diego, CA 92121

K040552 Re: Model 3100 Series Sheath Kits Regulation Number: 21 CFR 870.1340 Regulation Name: Catheter Introducer Regulatory Class: Class II Product Code: DYB Dated: March 1, 2004 Received: March 2, 2004

Dear Ms. Miller:

We have reviewed your Section 510(k) premarket notification of intent to market the device we nave reviewed your betermined 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 I ou may, arorely manns 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 may or dayses to de 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. Jami Miller

Please be advised that FDA's issuance of a substantial equivalence determination does not mean Please be advised that I DA 3 issualite of a verse complies with other requirements of the Act that FDA has made a decertifications administered by other Federal agencies. You must or any Federal statutes and regulations damands. but not limited to: registration and listing (21 Comply with an the Fiel 31 cquinements, 110, good manufacturing practice requirements as set CFR Fart 807), adoning (21 OF R Part 820); and if applicable, the electronic form in the quality systems (Sections 531-542 of the Act); 21 CFR 1000-1050. product radiation oom or provision arketing your device as described in your Section 510(k) This letter will anow you to begin maxicong your antial equivalence of your device to a legally premarket notheation. The PDF intelling sizes cation 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 11 you desire specific acries 101 ) 594-4648. Also, please note the regulation entitled, Connact the Office or Comparket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the Division of Small other general mionnational 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,

R. Vachner

Br
Di

Bram D. Zuckerman, M.D. Director Office of Device Evaluation

Division of Cardiovascular Devices Center for Devices and Radiological Health

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# Indications for Use

510(k) Number: K (140557

Device Name: Model 3100 Series Sheath Kits

Indications for Use:

The CryoCor Model 3100 Series Sheath Kits are intended to facilitate the percutaneous introduction of cardiovascular catheters into the heart, while preventing backflow of blood.

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 OF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Duna R. Vachner
(Division Sign

(Division Sign-Off) Statution Olgh-Oll)
Division of Cardiovascular Devices

510(k) Number_K040552