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

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.

AI/ML Overview

The provided text describes a 510(k) premarket notification for Datascope's 10 Fr. FlexiSheath™ Percutaneous Introducer. In the context of 510(k) submissions, the concept of "acceptance criteria" and a "study that proves the device meets the acceptance criteria" in the traditional sense of a clinical trial with predefined performance metrics and statistical endpoints is generally not applicable for devices seeking substantial equivalence.

Instead, the submission aims to demonstrate that the new device is "substantially equivalent" to predicate devices already on the market. This is done by showing that the new device has similar technological characteristics and performance, and does not raise different questions of safety and effectiveness.

Here's an analysis of the provided text based on your request, interpreting "acceptance criteria" as the demonstration of substantial equivalence and "study" as the non-clinical testing performed:

1. Table of Acceptance Criteria (Substantial Equivalence Pillars) and Reported Device Performance

Acceptance Criteria (Demonstration of Substantial Equivalence)	Reported Device Performance
Intended Use Equivalence: The new device has the same intended use as legally marketed predicate devices.	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." This is stated as being substantially equivalent to the intended use of the listed predicate devices (K820834, K902674, K924607, K940092, K940178, K940231, K943896, K964987).
Technological Characteristics Equivalence (no new questions of safety/effectiveness): Any differences in technological characteristics do not raise different questions of safety or effectiveness.	Technological Characteristics: "The difference in material grade and chemical composition has been demonstrated not to effect safety or efficacy of the device." This directly addresses the point of technological differences.
Performance Equivalence (demonstrated through testing): Non-clinical tests demonstrate that the functionality and performance characteristics are comparable to currently marketed devices.	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." This is the core "study" proving equivalence.

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

Sample Size for Test Set: The document mentions "in-vitro tests" but does not specify the sample size used for these tests.
Data Provenance: The document does not specify the country of origin of the data or whether the tests were retrospective or prospective. Given that this is an in-vitro study for a US submission, it's highly likely the tests were conducted in a US-based lab, but this is not explicitly stated. The tests are prospective in nature as they evaluate the device's characteristics.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

This information is not applicable or provided in the context of this 510(k) submission. For in-vitro tests demonstrating substantial equivalence, "ground truth" is typically established by engineering specifications, validated test methods, and comparison against the performance of predicate devices, not by expert consensus on clinical data. No human experts evaluating test results for "ground truth" are mentioned.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

This information is not applicable or provided. Adjudication methods are typically used in clinical studies involving interpretation of medical images or patient outcomes, not for in-vitro engineering tests.

5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

No, an MRMC comparative effectiveness study was not done. This type of study is relevant for AI-powered diagnostic devices, which is not the nature of Datascope's 10 Fr. FlexiSheath™ Percutaneous Introducer.
The device is a medical introducer sheath, a physical medical device, not an AI or imaging diagnostic tool. Therefore, the concept of human readers improving with AI assistance is not applicable.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

No, a standalone (algorithm only) study was not done. As mentioned, this is a physical medical device, not an algorithm or software. Its performance is evaluated through physical and material properties, and functionality in a lab setting.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)

For the non-clinical tests, the "ground truth" would be established by engineering specifications, validated test methods, and direct comparison of performance metrics (e.g., tensile strength, flexibility, lubricity, burst pressure, flow rates, etc.) against the established performance of the predicate devices. It is not based on expert consensus, pathology, or outcomes data.

8. The sample size for the training set

This information is not applicable or provided. The concept of a "training set" and "validation set" is relevant for machine learning algorithms. This submission is for a physical medical device and relies on engineering and material characteristic tests rather than data-driven model training.

9. How the ground truth for the training set was established

This information is not applicable or provided as there is no "training set" in the context of this device and its substantial equivalence submission.

Summary

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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.Cardiac Assist Division
Address:	15 Law DriveFairfield, NJ 07004
Contact Person:	Whitney TorningSupervisor, 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 (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

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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)

(Optional Format 1-2-96)

Regulation Number and Section

§ 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).