The Jostra Mecc System is a finished, sterile device for single use only and not to be restenlized by the user. The Jostra Mecc System is an extracorporeal circuit including circulatory and gas exchange support devices for use during extracorporeal circulation lasting 6 hours or less.

AI/ML Overview

This is a 510(k) premarket notification for a medical device called the "Jostra Mecc System". This type of submission relies on demonstrating substantial equivalence to a legally marketed predicate device, rather than proving novel safety and effectiveness through clinical trials with defined acceptance criteria and performance metrics.

Therefore, the requested information about acceptance criteria, study details, human reader improvement with AI assistance, standalone algorithm performance, ground truth, and training set information is not applicable to this 510(k) submission.

Here's why and what can be inferred from the document:

Acceptance Criteria and Reported Device Performance: In a 510(k), the primary "acceptance criterion" is demonstrating substantial equivalence to a predicate device in terms of intended use, technological characteristics, and safety and effectiveness. There isn't a table of specific performance metrics against pre-defined acceptance thresholds as you'd find in a clinical trial for a new therapeutic or diagnostic device. The document states: "The Jostra Mecc System is substantially equivalent to the currently marketed predicate devices for the stated intended use."
Study That Proves the Device Meets Acceptance Criteria: The "study" here is a comparison to a predicate device, not a typical clinical trial. The document explicitly states: "All devices have previous 510(K) market clearance, have the same intended use, and have been validated for assembly into an extracorporeal circuit." This implies bench testing and possibly animal studies pertinent to the predicate device's clearance, but no specific study details are provided for the Jostra Mecc System in this summary.
Sample Size for Test Set and Data Provenance: Not applicable. The submission relies on equivalence.
Number of Experts and Qualifications: Not applicable. Ground truth establishment by experts is not described for this type of submission.
Adjudication Method: Not applicable.
Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study: Not applicable. This type of study is for evaluating diagnostic performance, often with human readers. This device is an extracorporeal circuit.
Standalone (Algorithm Only) Performance: Not applicable. This is a physical medical device, not an AI/algorithm-based diagnostic tool.
Type of Ground Truth Used: Not applicable in the context of demonstrating performance against a ground truth. The "ground truth" for a 510(k) of this nature is that the predicate device is safe and effective when used as intended.
Sample Size for the Training Set: Not applicable. This is not a machine learning device.
How the Ground Truth for the Training Set Was Established: Not applicable.

Summary of Relevant Information from the Document:

While the direct answers to your questions are "not applicable" due to the nature of a 510(k) submission for this device, here's what the document does provide:

Predicate Device: Bentley Duraflo Treated Extracorporeal Circuit
Comparison Basis: The Jostra Mecc System provides the same components as the Bentley Duraflo system, assembled to the manufacturer's specifications. All components of both systems have previous 510(k) market clearance, have the same intended use, and have been validated for assembly into an extracorporeal circuit.
Intended Use: For use in surgical procedures requiring extracorporeal circulation and gas exchange support for 6 hours or less.
Conclusion: The FDA determined that the Jostra Mecc System is substantially equivalent to the predicate devices.

Summary

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DEC 1 7 2002

510 (K) Summary

Submitter:	Jostra AGHechinger Straße 3872145 HirrlingenGermany
Contact Person:	Kathleen JohnsonPhone: (302) 521-9469Fax: (281) 292-7930
Date Prepared:	September 16, 2002
Device Trade Name:	Jostra Mecc System
Common/Usual Name:	Extracorporeal Circuit
Classification Names:	Cardiopulmonary bypass vascular catheter, cannula, ortubingCardiopulmonary bypass adaptor, stopcock, manifold, orfittingCardiopulmonary bypass blood reservoirNon-roller-type cardiopulmonary bypass blood pumpCardiopulmonary bypass pump speed controlCardiopulmonary bypass oxygenatorCardiopulmonary bypass arterial line blood filter
Predicate Device:	Bentley Duraflo Treated Extracorporeal Circuit

Device Description:

Indications for use:

The Jostra Mecc System is intended for use in surgical procedures requiring extracorporeal circulation and gas exchange support for 6 hours or less.

Statement of Technical Characteristics Comparison:

The Bentley Duraflo Extracorporeal circuit provides a user defined tubing circuit and may provide other user specified components such as pump, gas exchange device, reservoir and filter packaged together as a "custom tubing pack". The Jostra Mecc

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System provides the same components assembled to the manufacturer's specifications.

All devices have previous 510(K) market clearance, have the same intended use, and have been validated for assembly into an extracorporeal circuit. The instructions for the Jostra Mecc System address safety issues regarding the use of a closed loop extracorporeal circuit.

Conclusion:

The Jostra Mecc System is substantially equivalent to the currently marketed predicate devices for the stated intended use.

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

DEC 17 2002

Jostra AG c/o Ms. Kathleen Johnson Jostra-Bentley Corp. 2828 N. Crescent Ridge Drive The Woodlands, TX 77381

Re: K023132

Jostra Mecc System Regulation Number: 870.4360 Regulation Name: Non-roller type CPB pump Regulatory Class: Class III (three) Product Code: KFM Dated: September 16, 2002 Received: September 20, 2002

Dear Ms. Johnson:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and 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) that do not require approval of a premarket approval application (PMA). 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 (PMA), 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 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act

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Page 2 - Ms. Kathleen Johnson

or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050. This letter will allow you to begin marketing your device as described in your Section 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), please contact the Office of Compliance at (301) 594-4646. 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 regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 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 (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.qov/cdrh/dsma/dsmamain.html

Sincerely yours,

Kallstrom

Bram D. Zuckerman, M.D. Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Page 1 of 1

510(k) Number:

Device Name: JOSTRA MECC SYSTEM

Indications for Use

Indications for ose THE - oosta - MOSC - Systems gas exchange support for 6 hours or less.

(Please do not WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

(Optional Format 3-10-98)

X Prescription Use

Odetten

(Division Sign-Off) Division of Cardiovascular Devices

510(k) Number K023132

003

Regulation Number and Section

§ 870.4360 Nonroller-type blood pump.

(a)
Nonroller-type cardiopulmonary and circulatory bypass blood pump —(1)Identification. A nonroller-type cardiopulmonary and circulatory bypass blood pump is a prescription device that uses a method other than revolving rollers to pump the blood through an extracorporeal circuit for periods lasting less than 6 hours for the purpose of providing either:(i) Full or partial cardiopulmonary bypass (
i.e., circuit includes an oxygenator) during open surgical procedures on the heart or great vessels; or(ii) Temporary circulatory bypass for diversion of flow around a planned disruption of the circulatory pathway necessary for open surgical procedures on the aorta or vena cava.
(2)
Classification —Class II (special controls). The special controls for this device are:(i) Non-clinical performance testing must perform as intended over the intended duration of use and demonstrate the following: Operating parameters, dynamic blood damage, heat generation, air entrapment, mechanical integrity, and durability/reliability;
(ii) The patient-contacting components of the device must be demonstrated to be biocompatible;
(iii) Sterility and shelf life testing must demonstrate the sterility of patient-contacting components and the shelf life of these components; and
(iv) Labeling must include information regarding the duration of use, and a detailed summary of the device- and procedure-related complications pertinent to use of the device.
(b)
Nonroller-type temporary ventricular support blood pump —(1)Identification. A nonroller-type temporary ventricular support blood pump is a prescription device that uses any method resulting in blood propulsion to provide the temporary ventricular assistance required for support of the systemic and/or pulmonary circulations during periods when there is ongoing or anticipated hemodynamic instability due to immediately reversible alterations in ventricular myocardial function resulting from mechanical or physiologic causes. Duration of use would be less than 6 hours.(2)
Classification. Class III (premarket approval).(c)
Date premarket approval application (PMA) or notice of completion of product development protocol (PDP) is required. A PMA or notice of completion of a PDP is required to be filed with FDA on or before September 8, 2015, for any nonroller-type temporary ventricular support blood pump that was in commercial distribution before May 28, 1976, or that has, on or before September 8, 2015, been found to be substantially equivalent to any nonroller-type temporary ventricular support blood pump that was in commercial distribution before May 28, 1976. Any other nonroller-type temporary ventricular support blood pump shall have an approved PMA or declared completed PDP in effect before being placed in commercial distribution.