MODIFICATION TO: X-SEPT TRANSSEPTAL SHEALTH AND TRANSITION CATHETER (WITH DILATOR), MODELS PL-12-12-09, PL-12-12-10

K012489 · Appriva Medical, Inc. · DYB · Aug 30, 2001 · Cardiovascular

Device Facts

• Record ID: K012489
• Device Name: MODIFICATION TO: X-SEPT TRANSSEPTAL SHEALTH AND TRANSITION CATHETER (WITH DILATOR), MODELS PL-12-12-09, PL-12-12-10
• Applicant: Appriva Medical, Inc.
• Product Code: DYB · Cardiovascular
• Decision Date: Aug 30, 2001
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 870.1340
• Device Class: Class 2

Intended Use

The X-Sept Transseptal Sheath and Transition Catheter is indicated for percutaneous introduction of various cardiovascular devices into the left side of the heart through the atrial septum.

Device Story

The X-Sept Transseptal Sheath and Transition Catheter (with Dilator) is a catheter introducer designed to facilitate the percutaneous placement of cardiovascular devices into the left heart via the atrial septum. The device consists of a sheath and a dilator. It is used by clinicians in a cardiovascular clinical setting. By providing a pathway through the atrial septum, the device enables the delivery of therapeutic or diagnostic cardiovascular instruments, assisting in procedures requiring left-sided heart access.

Clinical Evidence

Bench testing only; no clinical data provided.

Technological Characteristics

Catheter introducer (21 CFR 870.1340). Consists of a sheath and dilator. Mechanical device; no energy source or software. Sterilized via external service.

Indications for Use

Indicated for percutaneous introduction of various cardiovascular devices into the left side of the heart through the atrial septum in patients requiring such access.

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

• X-Sept Transseptal Sheath and Transition Catheter (with Dilator) (K002054)

Submission Summary (Full Text)

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Image /page/0/Picture/0 description: The image shows the logo for Appriva Medical. The logo consists of a stylized image on the left and the text "Appriva Medical" on the right. The stylized image appears to be a medical symbol. The text "Appriva" is in a larger font than "Medical".

## AUG 3 0 2001

Special 510(k): Device Notification August, 2001

Ko12489

## Attachment 4 510 (k) Summary

| Sponsor: | Appriva Medical, Inc.<br>777 North Pastroia Ave.<br>Sunnyvale, CA 94043 | |
|-----------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------|
| Device Name: | X-Sept Transseptal Sheath and Transition Catheter (with Dilator) | |
| Contact Person: | Michael Kolber<br>Vice President, Regulatory Affairs and Quality Assurance<br>Telephone: [phone]<br>Fax: [phone]<br>Email: [e-mail] | |
| Trade Name | X-Sept Transseptal Sheath and Transition Catheter | |
| Common/Classification Name | Catheter Introducer | |
| Establishment Registration: | 2954914 | |
| Address of Manufacturing Facility<br>and Sterilization Site | Manufacturing Facility<br>Appriva Medical,<br>777 North Pastoria Ave<br>Sunnyvale, CA 94043<br>and/or<br>MedSource Technologies<br>3310 Montgomery Drive<br>Santa Clara, CA 95054 | Sterilization Site<br>Centurion Sterilization Services<br>301 Catrell Drive<br>Howell, MI 48843 |
| Classification | The FDA has classified devices of this type as Class II devices (21CFR<br>870.1340, Catheter Introducer). | |
| Reason for Pre-market Notification<br>(Substantial Equivalence) | The intended use for the X-Sept Transseptal Sheath and Transition<br>Catheter (with Dilator) is substantially equivalent to the X-Sept<br>Transseptal Sheath and Transition Catheter marketed by Appriva<br>Medical, Inc. The intended use is also consistent with the identification<br>in 21CFR870.1340, which states that a catheter introducer is a sheath<br>used to facilitate placing a catheter through the skin into a vein or artery.<br><br>The X-Sept Transseptal Sheath and Transition Catheter (with Dilator) is<br>substantially equivalent in materials and design parameters to the<br>Appriva Medical, Inc, X-Sept Transseptal Sheath and Transition<br>Catheter. In instances where technological characteristics are different, it<br>has been demonstrated through biocompatibility and in-vitro (functional)<br>testing that there are no questions raised regarding safety or efficacy of<br>the device. | |
| Identification of Predicate Device | Manufacturer and Device Name<br>Appriva Medical, Inc., X-Sept<br>Transseptal Sheath and Transition<br>Catheter (with Dilator) | 510(k) Number<br>K002054 |
| Compliance with Performance<br>Standards | None are established under Section 514, | |

Date

Michael Kolber Vice President, Regulatory Affairs and Quality Assurance

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Image /page/1/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized eagle with three lines forming its body and 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

## AUG 3 0 2001

Mr. Michael Kolber Vice President, Regulatory Affairs and Quality Assurance Appriva Medical, Inc. 777 North Pastroia Ave. Sunnyvale, CA 94043

K012489 Re:

> X-Sept Transseptal Sheath and Transition Catheter Regulation Number: 870.1340 Regulatory Class: II (two) Product Code: DYB Dated: August 2, 2001 Received: August 3, 2001

Dear Mr. Kolber:

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

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Page 2 - Mr. Michael Kolber

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 our 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" (21CFR 807.97). 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.

r

Sincerely yours.

,

James E. Dillard III Director Division of Cardiovascular and Respiratory Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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## Attachment 2 Indications for Use Statement

| 510(k) Number: | K002054 K012489 |
|----------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Device Name: | X-Sept Transseptal Sheath and Transition Catheter (with Dilator) |
| Indications for use: | The X-Sept Transseptal Sheath and Transition Catheter is indicated<br>for percutaneous introduction of various cardiovascular devices into<br>the left side of the heart through the atrial septum. |

**Division of Cardiovascular & Respiratory Devices**

510(k) Number Kel 2489

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