DATASCOPE'S 10 FR. FLEXISHEATH PERCUTANEOUS INTRODUCER

K973007 · Datascope Corp. · DYB · Nov 6, 1997 · Cardiovascular

Device Facts

• Record ID: K973007
• Device Name: DATASCOPE'S 10 FR. FLEXISHEATH PERCUTANEOUS INTRODUCER
• Applicant: Datascope Corp.
• Product Code: DYB · Cardiovascular
• Decision Date: Nov 6, 1997
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 870.1340
• Device Class: Class 2

Intended Use

Datascope's 10 Fr. FlexiSheath™ Percutaneous Introducer is intended for the percutaneous introduction of Datascope's 9.5Fr. Intra-Aortic Balloon Catheters.

Device Story

The 10 Fr. FlexiSheath Percutaneous Introducer is a catheter introducer used to facilitate the percutaneous insertion of 9.5 Fr. Intra-Aortic Balloon Catheters. It is a mechanical device used in a clinical setting by healthcare professionals. The device functions as a conduit for the balloon catheter, allowing for safe vascular access. It does not involve electronic, software, or algorithmic components.

Clinical Evidence

No clinical data. Bench testing only.

Technological Characteristics

Catheter introducer, 10 Fr. size. Mechanical device. Materials of construction differ in grade/composition from predicates but demonstrated equivalent safety/efficacy via in-vitro testing.

Indications for Use

Indicated for percutaneous introduction of 9.5 Fr. Intra-Aortic Balloon Catheters in patients requiring such therapy.

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

• Datascope's 10 Fr. Percor Percutaneous Introducer with Hemostasis Valve (K820834)
• Datascope's Arterial cannula with Access Port (K902674)
• Super Arrow-Flex Percutaneous Sheath Introducer (Arrow Fischell Corp.) (K924607)
• Bard's Input Percutaneous Arterial/Venous Catheter Introducer (K940092)

Reference Devices

• Datascope's Percor STAT-DL 9.5 Fr. 34cc and 40cc & 10.5 Fr. 40cc and 50cc IABs with Alternate Inner Lumen (K940178)
• Datascope's Percor STAT-DL 40cc IAB with Alternate Membrane Material (K940231)
• Datascope's Staged Guide Wire for use with Datascope's Percor STAT-IABs (K943896)
• Datascope's Percor STAT-DL 9.5 Fr. 25 and 40cc IAB (K964987)

Submission Summary (Full Text)

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K973007

NOV - 6 1997

## SUMMARY OF SAFETY AND EFFECTIVENESS FOR

# DATASCOPE'S 10 Fr. FLEXISHEATH™ PERCUTANEOUS INTRODUCER

(Prepared in accordance with 21 CFR Part 807.92)

- GENERAL INFORMATION A.

| Submitter: | Datascope Corp.<br>Cardiac Assist Division |
|-----------------|---------------------------------------------------|
| Address: | 15 Law Drive<br>Fairfield, NJ 07004 |
| Contact Person: | Whitney Torning<br>Supervisor, Regulatory Affairs |

#### B. DEVICE INFORMATION

Generic Name: Catheter Introducer Datascope's FlexiSheath Percutaneous Introducer Trade Name: Classification Name: Introducer, Catheters are classified under 21 CFR 870.1340

#### C. PREDICATE DEVICE INFORMATION

Datascope's FlexiSheath Percutaneous Introducer is substantially equivalent to the following marketed devices:

- K820834 Datascope's 10 Fr. Percor Percutaneous Introducer with Hemostasis Valve
- K902674 Datascope's Arterial cannula with Access Port
- K924607 Super Arrow-Flex Percutaneous Sheath Introducer (Arrow Fischell Corp.)
- K940092 Bard's Input Percutaneous Arterial/Venous Catheter Introducer

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Summary of Safety & Effectiveness/Datascope's 10 Fr. FlexiSheath TM Percutaneous Introducer Page 2

- K940178 Datascope's Percor STAT-DL 9.5 Fr. 34cc and 40cc & 10.5 Fr. 40cc and 50cc IABs with Alternate Inner Lumen
- K940231 Datascope's Percor STAT-DL 40cc IAB with Alternate Membrane Material
- K943896 Datascope's Staged Guide Wire for use with Datascope's Percor STAT-IABs.
- K964987 Datascope's Percor STAT-DL 9.5 Fr. 25 and 40cc IAB.

#### D. DEVICE DESCRIPTION/INTENDED USE

Datascope's 10 Fr. FlexiSheath™ Percutaneous Introducer is intended for the percutaneous introduction of Datascope's 9.5 Fr. Intra-Aortic Balloon Catheters.

#### E. TECHNOLOGICAL CHARACTERISTICS

The difference in material grade and chemical composition has been demonstrated not to effect safety or efficacy of the device.

#### F. NON-CLINICAL TESTS

The results of in-vitro tests conducted demonstrate that the functionality and performance characteristics of the device are comparable to the currently marketed devices.

#### CLINICAL TESTS G.

There has been no clinical evaluation of the new device in the U.S.

#### H. CONCLUSIONS

Based on the information presented in this 510(k) premarket notification, Datascope's 10 Fr. FlexiSheath percutaneous introducer is considered substantially equivalent to Datascope's currently marketed catheter introducer.

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### DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/2/Picture/2 description: The image shows the logo for the Department of Health & Human Services USA. The logo is a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the top half of the circle. The bottom half of the circle contains a stylized image of an eagle with three human profiles incorporated into its design. The eagle's head and neck are formed by the silhouettes of the human profiles.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Ms. Whitney Torning Supervisor, Regulatory Affairs Datascope Corporation Cardiac Assist Division 15 Law Drive CN 40011 Fairfield, New Jersey 07004

NOV - 6 1997

K973007 Re: 10 Fr. Flexisheath™ Percutaneous Introducer Regulatory Class: II (Two) Product Code: DYB Dated: August 11, 1997 Received: August 13, 1997

Dear Ms. Torning:

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 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 Requlations, 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 requlatory 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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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 leqally 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 requlation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number [phone] or [phone] or at its internet address "http://www.fda.gov/cdrh/dsmamain.html."

Sincerely yours,

Thomas J. Callahan

Thomas J. Callahan Director Division of Cardiovascular, Respiratory, and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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there aucer 370, 1340 Catheter II --DYB

510(k) Number (if known):_____________________________________________________________________________________________________________________________________________________

Device Name: Datascope's 10 Fr. FlexiSheath™ Percutaneous Introducer

Indications for Use:

Datascope's 10 Fr. FlexiSheath™ Percutaneous Introducer is intended for the percutaneous introduction of Datascope's 9.5Fr. Intra-Aortic Balloon Catheters.

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Bette R. Cooper Co.

Over-the-Counter Use

Prescription Use_X (Per 21 CFR 801.109)

OR

(Optional Format 1-2-96)