The Jostra Venous Hardshell Cardiotomy Reservoir (non-vacuum-tight model) is designed to collect, store and filter the blood in an extracorporeal circuit during cardiopulmonary bypass procedures up to six hours in adult surgery . It can be integrated into almost all perfusion systems. The Jostra Venous Hardshell Cardiotomy Reservoir is designed and sold for use only as indicated.

The Jostra Venous Hardshell Cardiotomy Reservoir (vacuum-tight model) is designed to collect, store and filter the blood in an extracorporeal circuit during cardiopulmonary bypass procedures with or without vacuum assisted venous return up to six hours in adult surgery . It can be integrated into almost all perfusion systems. The Jostra Venous Hardshell Cardiotomy Reservoir is designed and sold for use only as indicated. This reservoir is also designed to be used postoperatively as a drainage and autotransfusion reservoir (e.g. for chest drainage) to return autologous blood shed from the chest to the patient for volume replacement.

Device Description

The Jostra Venous Hardshell Cardiotomy Reservoirs (vacuum-tight and non-vacuum-tight model) with Safeline Coating are identical to the Jostra Venous Hardshell Cardin tygn Reservoirs with the only exception that the Venous Hardshell Cardiotomy Reservoirs with Safeline Coating have been coated with Safeline. The Safeline Coating is the same as with the Jostra RotaFlow Centrifugal Pump with Safeline Coating. Besides this difference the Venous Hardshell Cardiotomy Reservoirs with Safeline Coating are the same in design. intended use, method of operation, components, packaging, and fundamental scientific technology as compared to the uncoated Venous Hardshell Cardiotomy Reservoirs.

AI/ML Overview

This document describes a 510(k) submission for a medical device modification, not an AI/ML powered device. Therefore, the questions related to AI/ML specific aspects like "test set," "ground truth," "MRMC study," "human readers," and "training set" are not applicable.

The submission focuses on demonstrating substantial equivalence of a modified medical device to existing predicate devices.

Here's an analysis of the provided text in the context of the questions that are applicable:

1. A table of acceptance criteria and the reported device performance

The document does not provide a table with specific acceptance criteria or quantitative performance metrics in the way one would expect for an AI/ML model. Instead, it states that the device was evaluated for "safety and effectiveness" and that the data "demonstrate that the Jostra Venous Hardshell Cardiotomy Reservoirs (sealed and non-sealed model) with Safeline Coating are substantially equivalent to the named predicate devices."

The evaluation areas mentioned are:

Integrity
Performance
Biocompatibility
Sterility

No specific performance thresholds or detailed results are reported in this summary. The "performance" assessment refers to the device's functional integrity and ability to perform its intended purpose (collecting, storing, and filtering blood) without adverse effects compared to the predicate.

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

Not applicable in the context of an AI/ML model's test set. This submission refers to a medical device modification (adding a coating). The "testing" here refers to standard medical device verification and validation activities (e.g., bench testing, biocompatibility studies). The document does not specify sample sizes for these tests, nor their provenance as would be relevant for a data-driven model. The submitter is Maquet Cardiopulmonary AG from Germany.

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)

Not applicable. There is no concept of "ground truth" or "experts" establishing it in the context of this device modification. The evaluation is based on standard engineering and biological testing against established specifications or predicate device performance.

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

Not applicable. This concept is relevant for AI/ML models where human disagreement on ground truth might occur.

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

Not applicable. This is not an AI/ML device.

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

Not applicable. This is not an AI/ML device.

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

Not applicable for an AI/ML model. For this device, "ground truth" would be established specifications, regulatory requirements, and the performance characteristics of the predicate device. For example, "sterility" ground truth would be a validated sterile state, "biocompatibility" would be a state of not causing adverse biological reactions, and "integrity" would be a state of structural soundness.

8. The sample size for the training set

Not applicable. This is not an AI/ML device. There is no "training set."

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

Not applicable. This is not an AI/ML device. There is no "training set" or corresponding ground truth.

Summary for K061743: Device Modification - Venous Hardshell Cardiotomy Reservoirs with Safeline Coating

This 510(k) submission is for a modification to an existing medical device, the Jostra Venous Hardshell Cardiotomy Reservoirs, by adding a "Safeline Coating." The submission aims to demonstrate substantial equivalence to predicate devices. It is not an AI/ML enabled device, therefore many of the requested criteria related to AI/ML performance evaluation are not applicable.

The core of the study is a comparison to predicate devices, showing that the modified device is "the same in design, intended use, method of operation, components, packaging, and fundamental scientific technology as compared to the uncoated Venous Hardshell Cardiotomy Reservoirs," with the only difference being the Safeline coating. The coating itself is also stated as being the same as already cleared for the Jostra RotaFlow Centrifugal Pump (K061072).

The "study" refers to the evaluation and testing conducted to demonstrate safety and effectiveness, leading to the conclusion of substantial equivalence.

Applicable Information:

Acceptance Criteria & Reported Device Performance: General acceptance of "safety and effectiveness" through demonstration of substantial equivalence to predicate devices (Jostra Venous Hardshell Cardiotomy Reservoirs and Jostra RotaFlow Centrifugal Pump with Safeline Coating).
- Evaluation Areas: Integrity, Performance, Biocompatibility, Sterility.
- Reported Performance: The data "demonstrate that the Jostra Venous Hardshell Cardiotomy Reservoirs (sealed and non-sealed model) with Safeline Coating are substantially equivalent to the named predicate devices." No specific quantitative performance metrics are provided in the summary, as the focus is on equivalence.
Sample Size and Data Provenance: Not explicitly detailed in the summary for individual tests (e.g., "N=XX samples tested for biocompatibility"). The device manufacturer is Maquet Cardiopulmonary AG, Germany. The testing would be prospective validation of the modified device.
Ground Truth: For non-AI/ML devices, "ground truth" refers to recognized standards, established specifications, and the performance of legally marketed predicate devices. The modified device's performance across the evaluation areas (integrity, performance, biocompatibility, sterility) would be measured against these benchmarks.

Non-Applicable Information (for this type of device submission):

Test set/Training set sample sizes
Number/Qualifications of experts for ground truth
Adjudication method
MRMC comparative effectiveness study
Standalone (algorithm-only) performance
Specific types of ground truth (e.g., pathology, outcomes data relevant to AI diagnostics)

Summary

{0}------------------------------------------------

K061743
MAQUET

JUL 21 2006

Special 510(k): Device Modification: Venous Hardshell Cardiotomy Reservoirs with Safeline Coating

510(k) SUMMARY

SUBMITTER:

Maquet Cardiopulmonary AG Hechinger Strasse 38 72145 Hirrlingen, Germany

Phone: (011) 49 7478 921- 151

011 49 7478 921- 400

Katrin Schwenkglenks

CONTACT PERSON:

DATE PREPARED:

DEVICE TRADE NAME:

COMMON/USUAL NAME

CLASSIFICATION NAME

June 16, 2006

Fax:

Jostra Venous Hardshell Cardiotomy Reservoirs with Safeline Coating

Venous Reservoirs

Cardiopulmonary bypass blood reservoir Cardiopulmonary bypass defoamer Cardiopulmonary bypass cardiotomy suction line blood filter

PREDICATE DEVICES OR LEGALLY MARKETED DEVICES

Jostra Venous Hardshell Cardiotomy Reservoirs (K982136, K003551) Jostra RotaFlow Centrifugal Pump with Safeline Coating (K061072)

DEVICE DESCRIPTION/INDICATONS FOR USE STATEMENT

{1}------------------------------------------------

MAQUET

STATEMENT OF TECHNICAL CHARACTERISTICS COMPARISON

DETERMINATION OF SUBSTANTIAL EQUIVALENCE

Evaluation and testing on safety and effectiveness was executed to demonstrate that the Jostra Venous Hardshell Cardiotomy Reservoirs with Safeline Coating described in this submission are substantially equivalent to the Jostra Venous Hardshell Cardiotomy Reservoirs as reservoirs and to the RotaFlow Centrifugal Pump with Safeline Coating regarding the Safeline coating.

The following areas have been tested and / or evaluated:

Integrity -
Performance 1
-Biocompatibility
-Sterility

Conclusion

The data given demonstrate that the Jostra Venous Hardshell Cardiotomy Reservoirs (sealed and non-sealed model) with Safeline Coating are substantially equivalent to the named predicate devices which hold currently market clearance.

{2}------------------------------------------------

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

JUL 21 2006

Maquet Cardiopulmonary AG c/o Ms. Katrin Schwenkglenks Regulatory Affairs Manager Hechinger Strasse 38 Hirrling Germany 72145

Re: K061743

Trade Name: Venous Hardshell Cardiotomy Reservoir with Safeline Coating Regulation Number: 21 CFR 870.4400 Regulation Name: Cardiotomy Reservoir Regulatory Class: Class II (two) Product Code: DTN Dated: June 16, 2006 Received: June 21, 2006

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 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 (240) 276-0120. 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 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/industry/support/index.html.

Sincerely yours,

Duna R. Holmes

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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Indications for Use

510(k) Number (if known): K061743

Device Name: Venous Hardshell Cardiotomy Reservoirs with Safeline Coating _____

Prescription Use (Part 21 CFR 801 Subpart D)

AND/OR

Over-The-Counter Use (21 CFR 801 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE

OF NEEDED) ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------

Concurrence of CDRH, Office of Device Evaluation (ODE)

Page Lof I

(Posted November 13, 2003)

uma P. Vorland

(Division Sign-Off) Division of Cardiovascular Devices

510(k) Number K061743

062

Regulation Number and Section

§ 870.4400 Cardiopulmonary bypass blood reservoir.

(a)
Identification. A cardiopulmonary bypass blood reservoir is a device used in conjunction with short-term extracorporeal circulation devices to hold a reserve supply of blood in the bypass circulation.(b)
Classification. Class II (special controls), except that a reservoir that contains a defoamer or filter is classified into the same class as the defoamer or filter. The device, when it is a cardiopulmonary bypass blood reservoir that does not contain defoamers or blood filters, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 870.9.