The Jostra Suction Devices are designed to aspirate blood and other fluids from the operative field and return it to the extracorporeal circuit during open heart surgery lasting 6 hours or less.

Device Description

The Jostra Suction Devices are single, sterile devices for single use only and not to be resterilized by the user. The Jostra Suction Devices are designed to aspirate blood and other fluids from the operative field and return it to the extracorporeal circuit during open-heart surgery. The suction devices include rigid, flexible and pericardial suckers.

AI/ML Overview

The provided text describes a 510(k) summary for Jostra Suction Devices, focusing on establishing substantial equivalence to a predicate device. This type of regulatory submission does not typically involve the kind of detailed clinical study with acceptance criteria, sample sizes, expert ground truth, or MRMC studies that would be associated with AI/ML-based medical devices or devices requiring extensive clinical trials for efficacy.

The document primarily discusses non-clinical testing to demonstrate performance and biocompatibility. Therefore, much of the requested information regarding AI/ML study methodologies is not applicable.

Here's an analysis based on the provided text, highlighting what is present and what is absent:

Acceptance Criteria and Study to Prove Device Meets Acceptance Criteria for Jostra Suction Devices

The Jostra Suction Devices underwent non-clinical testing to demonstrate substantial equivalence to a predicate device (Medtronic DLP Suction Devices), rather than a clinical study with detailed acceptance criteria for a new clinical outcome.

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria (from predicate comparison)	Reported Device Performance (Jostra Suction Devices)
Intended Use: Aspirate blood and fluids from operative field and return to extracorporeal circuit during open-heart surgery lasting ≤ 6 hours.	Meets: Same intended use as the predicate device.
Principles of Operation: Similar design and function for aspiration.	Meets: Substantially equivalent to predicate.
Materials: Biocompatible materials suitable for blood contact and surgical use.	Meets: Biocompatibility testing performed.
Design: Rigid, flexible, and pericardial suckers for aspiration.	Meets: Devices include rigid, flexible, and pericardial suckers, similar to predicate.
Performance: Effective aspiration, no leakage, no adverse effects on cellular components, suitable for single-use, sterile.	Meets: Performance testing (Bond Strength, Leakage Test) and in-vitro testing (effects on cellular components) performed and demonstrated substantial equivalence.

Note: The document states, "Comparative testing has demonstrated that these differences do not affect safety and effectiveness." This implies that the acceptance criteria were based on demonstrating comparable safety and effectiveness to the predicate device through these non-clinical tests.

2. Sample Size Used for the Test Set and Data Provenance

Sample Size: The document does not specify exact sample sizes for the performance or in-vitro tests conducted. It only generically mentions "performance testing" and "in-vitro testing."
Data Provenance: The testing was non-clinical (laboratory/bench testing and in-vitro). The country of origin for the testing is not specified, but the submitter is based in Germany. The data is retrospective in the sense that it's a review of non-clinical tests performed, not a prospective clinical trial.

3. Number of Experts Used to Establish Ground Truth and Qualifications

This information is not applicable to this submission. The ground truth was established through engineering and laboratory testing protocols designed to assess physical performance characteristics and biocompatibility against established standards and the characteristics of the predicate device. There was no "ground truth" established by human expert consensus in the clinical sense for this type of device.

4. Adjudication Method for the Test Set

This information is not applicable. As there were no human expert evaluations for clinical "ground truth," there was no need for an adjudication method like 2+1 or 3+1. Performance was assessed through objective measurements from non-clinical tests.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

No, an MRMC comparative effectiveness study was not conducted for this device. This type of study is typically done for diagnostic imaging devices or AI-assisted diagnostic tools, which is not the nature of the Jostra Suction Devices.

6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study

Not applicable. The device is a physical medical instrument (suction device), not an algorithm or AI system.

7. Type of Ground Truth Used

The "ground truth" for this device's evaluation was based on:

Engineering specifications and performance standards.
Biocompatibility test results.
Direct comparison to the Medtronic DLP Suction Devices (predicate device) specifications and known performance.
Objective measurements from performance tests like bond strength and leakage tests, and in-vitro cellular component analysis.

8. Sample Size for the Training Set

Not applicable. This device is not an AI/ML system, so there is no concept of a "training set" for an algorithm.

9. How the Ground Truth for the Training Set Was Established

Not applicable. As there is no training set, there is no ground truth to be established for it.

Summary

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510 (K) Summary
Submitter:	Jostra AGHechinger Straße 3872145 HirrlingenGermany
Contact Person:	Kathleen JohnsonPhone: (610) 932-7738Fax: (610) 932-7366
Date Prepared:	March 11, 2002
Device Trade Name:	Jostra Suction Devices
Common/Usual Name:	Suction Devices
Classification Names:	Cardiopulmonary Bypass Vascular CannulaCardiopulmonary-Bypass Cardiotomy Return SuckerCardiopulmonary Bypass Adaptor, Stopcock, Manifold, orFitting
Predicate Device:	Medtronic DLP Suction Devices

Device Description:

Indications for use:

The Jostra Suction Devices are designed to aspirate blood and other fluids from the operative field and return it to the extracorporeal circuit during open-heart surgery lasting 6 hours or less.

Statement of Technical Characteristics Comparison;

The Jostra Suction Devices have the same intended use as the Medtronic DLP Suction Devices. Comparative testing has demonstrated that these differences do not affect safety and effectiveness.

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Non-Clinical Testing:

Biocompatibility and performance testing were performed to demonstrate substantial equivalency to the predicate device.

Performance testing included:

Bond Strength Leakage Test

Additionally, in-vitro testing was performed to determine the effects on cellular components.

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Conclusion:

Section of the couple

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Performance, and in-vitro testing demonstrate that the Jostra Suction Devices are "substantially equivalent" to the predicate devices in intended use, principles of operation, materials, design, and performance.

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Public Health Service

Image /page/2/Picture/2 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle with three stripes forming its body and wings. The eagle is encircled by the text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" in a circular arrangement. The text is in all capital letters and is evenly spaced around the circle.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

JAN 3 0 2004

Jostra AG c/o Ms. Katrin Schwenkglenks Regulatory Affairs Hechinger Strasse 38 72145 Hirrlingen Germany

Re: K020983

Suction Devices Regulation Number: 21 CFR 870.4210 Regulation Name: Cardiopulmonary Bypass Catheter, Cannula and Tubing Regulatory Class: Class II (two) Product Code: DWF Dated: November 11, 2003 Received: November 14, 2003

Dear Ms. Schwenkglenks:

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.

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Page 2 - Ms. Katrin Schwenkglenks

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 or any Federal statutes and regulations administered by other Federal agencies. You must or any I 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 Of It 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 prarketed 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) you may obtain. 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.gov/cdrh/dsma/dsmamain.html

Sincerely yours,

Duna R. Willines

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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020983

Page 1 of 1

510(k) Number:

1988 - 1999

. . .

Device Name: Suction Devices

Indications for Use

The Jostra Suction Devices are designed to aspirate blood and other fluids from the operative field and return it to the extracorporeal circuit during open heart surgery lasting 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)

Prescription use X

Dolma, R. builting Division of Cardiovascular & Respiratory Devices 510(k) Number K620983

Regulation Number and Section

§ 870.4210 Cardiopulmonary bypass vascular catheter, cannula, or tubing.

(a)
Identification. A cardiopulmonary bypass vascular catheter, cannula, or tubing is a device used in cardiopulmonary surgery to cannulate the vessels, perfuse the coronary arteries, and to interconnect the catheters and cannulas with an oxygenator. The device includes accessory bypass equipment.(b)
Classification. Class II (performance standards).