(144 days)
The Ultra-Flex Hemostasis Introducers are designed for the introduction of angiographic catheters, closed end catheters, balloon catheters and electrodes into a vessel where minimizing the blood loss is essential.
The Daig Ultra-Flex Hemostasis Introducer is an Introducer designed to provide easy access to the vascular system while providing convenient temporary closure of a standard indwelling introducer access site during introduction of pacing leads, angiographic catheters, closed end catheters, balloon catheters and electrodes into a vessel.
I am sorry, but based on the provided text, there is no information about acceptance criteria or a study proving the device meets acceptance criteria. The document is a 510(k) summary for a medical device (Ultra-Flex Hemostasis Introducer), focusing on its substantial equivalence to a predicate device and its intended use. It does not include details on performance testing, acceptance criteria, sample sizes, expert qualifications, or ground truth establishment.
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99ψ334
510(k) Summary (As required by 21 CFR 807.92)
Submitter Information A.
| Submitter's Name: | Daig Corporation, a St. Jude Medical Company |
|---|---|
| Address: | 14901 DeVeau PlaceMinnetonka, Minnesota 55345-2126 U.S.A. |
| Telephone Number: | (612) 933-4700 |
| Contact Person: | Todd J. Kornmann |
| Date Submission Prepared: | December 22, 1999 |
| B. | Device Information |
| Common or Usual Name: | Ultra-Flex Hemostasis Introducer |
| Classification Name: | Introducer |
| Predicate Device: | Fast-Cath™ Hemostasis Introducer (K910861) |
| Device Description: | The Daig Ultra-Flex Hemostasis Introducer is anIntroducer designed to provide easy access to thevascular system while providing convenienttemporary closure of a standard indwellingintroducer access site during introduction of pacingleads, angiographic catheters, closed end catheters,balloon catheters and electrodes into a vessel. |
| Intended Use: | The Ultra-Flex Hemostasis Introducer is designedfor the introduction of angiographic catheters,closed end catheters, balloon catheters andelectrodes into a vessel where minimizing bloodloss is essential. (same as predicate device) |
C. Comparison of Required Technological Characteristics
All technological characteristics of the Ultra-Flex Hemostasis Introducer are substantially equivalent to the predicate device (K910861) including product design, packaging, sterilization, and labeling.
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8.0 510(k) Summary
Support of the Substantial Equivalence D.
Daig Corporation considers the Ultra-Flex Hemostasis Introducer to be substantially equivalent to the following predicate device: the Fast-Cath™ Hemostasis Introducer which received marketing clearance on May 7, 1991 (K910861).
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Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
MAY 1 5 2000
Mr. Todd Kornmann DAIG Corporation 14901 Deveau Pl. Minnetonka, MN 55345-2126
Re : K994334/S0002 Trade Name: Ultra-Flex Hemostasis Introducer Regulatory Class: II (two) : Product Code: DYB Dated: April 10, 2000 Received: April 11, 2000
Dear Mr. Kornmann:
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 control provisions of the Act. The general control 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 Eederal 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. Todd Kornmann
This letter will allow you to begin marketing your device as described in your 510(k) premarket notification. The FDA finding of substantial in foal oce of your device to a legally marketed predicate device equivales or your device and thus, permits 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 reguracton (Er ces), please contact the Office of Compliance at Graghobere devices), prouse y, for questions on the promotion and (301) 331 1010 hauter, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR 807.97). ffrobrancing by Formation on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its be obseree number (800) 638-2041 or (301) 443-6597 or at its Internet address "http://www.fda.gov/cdrh/dsma/dsmamain.html".
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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Page 1 of
510(k) Number (if known):
Device Name:
Ultra-Flex Hemostasis Introducer
Indications for Use:
The Ultra-Flex Hemostasis Introducers are designed for the introduction of angiographic catheters, closed end catheters, balloon catheters and electrodes into a vessel where minimizing the blood loss is essential.
Bim E. Otum
(Division Sign-Off) Division of Cardiovascular, Respiratory, and Neurological Devices 510(k) Number.
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use
(Per 21 CFR 801.109)
OR
Over-The-Counter Use (Optional Format 1-2-96)
§ 870.1340 Catheter introducer.
(a)
Identification. A catheter introducer is a sheath used to facilitate placing a catheter through the skin into a vein or artery.(b)
Classification. Class II (performance standards).