(85 days)
No
The device description and intended use are for a simple percutaneous introducer sheath, a mechanical device. There is no mention of any software, algorithms, or data processing that would suggest the use of AI/ML.
No
The device is an introducer sheath and is intended for the introduction of a therapeutic device (Intra-Aortic Balloon Catheters), but it is not a therapeutic device itself.
No
The device is described as an introducer for intra-aortic balloon catheters, which is an interventional/therapeutic purpose rather than diagnostic.
No
The device description clearly states it is a "Percutaneous Introducer," which is a physical medical device used for introducing catheters into the body. There is no mention of software as the primary or sole component.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for the "percutaneous introduction of Datascope's 9.5Fr. Intra-Aortic Balloon Catheters." This describes a device used in vivo (within the body) for a medical procedure.
- Device Description: The description reiterates the intended use, confirming its role in introducing a catheter into the body.
- Lack of IVD Characteristics: The document does not mention any of the typical characteristics of an IVD, such as:
- Analyzing samples (blood, urine, tissue, etc.)
- Detecting or measuring substances in samples
- Providing information for diagnosis, monitoring, or screening based on sample analysis
IVDs are used to perform tests on samples taken from the body to provide information about a person's health. This device is a tool used to facilitate a medical procedure within the body.
N/A
Intended Use / Indications for Use
Datascope's 10 Fr. FlexiSheath™ Percutaneous Introducer is intended for the percutaneous introduction of Datascope's 9.5 Fr. Intra-Aortic Balloon Catheters.
Product codes
DYB
Device Description
Datascope's 10 Fr. FlexiSheath™ Percutaneous Introducer is intended for the percutaneous introduction of Datascope's 9.5 Fr. Intra-Aortic Balloon Catheters.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies
The results of in-vitro tests conducted demonstrate that the functionality and performance characteristics of the device are comparable to the currently marketed devices.
There has been no clinical evaluation of the new device in the U.S.
Key Metrics
Not Found
Predicate Device(s)
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, 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.
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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).
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Image /page/0/Picture/0 description: The image shows a large, block-style letter "D" in black ink. The letter has a slightly distressed appearance, with some areas of the ink appearing faded or broken. The background has a grid-like pattern of small dots, which gives the image a textured feel.
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.
Cardiac Assist Division |
|-----------------|---------------------------------------------------|
| Address: | 15 Law Drive
Fairfield, NJ 07004 |
| Contact Person: | Whitney Torning
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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Image /page/1/Picture/0 description: The image shows a close-up of the letter 'D' in a bold, serif typeface. The letter is black and stands out against a background of small dots. There are also some diagonal lines that intersect the letter, adding a textured effect to the image.
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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.
2
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.
3
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 (301) 594-4648. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. 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 (800) 638-2041 or (301) 443-6597 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
4
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)