The Jostra Venous Softbag Reservoirs are indicated for use in extracorporeal circuits during cardiopulmonary bypass procedures in the field of open-heart-surgery. The utilization period of this device is restricted to six hours. Blood contact longer than 6 hours is not recommended. Application and use of the softbag reservoir is in the sole responsibility of the respective physician.

Device Description

The Venous Softbag Reservoir is used in extracorporeal circuits during cardiopulmonary bypass surgery and serves as container for a certain blood volume. It consists of plastic foils which are welded together and between which tubes of different diameters and a polyester mesh are sandwiched. The polyester mesh serves for an improved air removal. Application duration: The utilization period of this device is restricted to six hours. The softbag reservoir is delivered sterile and is determined for single use only.

The group of Venous Softbag Reservoirs consists of a variety of models which differ in size (filling volume) and in the port sizes. The filling volumes of the reservoirs range from 650 ml to 1900 ml depending on the model and the ports are either 3/8" or ½" in size.

AI/ML Overview

The provided text describes a 510(k) submission for the Jostra Venous Softbag Reservoirs. Based on the document, here's a breakdown of the requested information, focusing on what is explicitly stated:

1. Table of Acceptance Criteria and Reported Device Performance

Test Area	Acceptance Criteria (Implied)	Reported Device Performance
Integrity	Not explicitly stated, but implies the device should maintain structural integrity and prevent leaks or breakage during the intended six-hour use.	In-vitro testing on safety and effectiveness was executed to demonstrate that the Jostra Venous Softbag Reservoirs... are substantially equivalent to the named predicate devices. (This implies it met the integrity performance of the predicates, though no specific results are given.)
Performance	Not explicitly stated, but implies the device should perform its intended function as a venous reservoir in extracorporeal circuits for six hours.	In-vitro testing on safety and effectiveness was executed to demonstrate that the Jostra Venous Softbag Reservoirs... are substantially equivalent to the named predicate devices. (This implies it met the functional performance of the predicates, though no specific results are given.)
Stability of the Coating	Not explicitly stated, but implies the Safeline Coating (when present) should remain stable and effective throughout the six-hour use.	In-vitro testing on safety and effectiveness was executed to demonstrate that the Jostra Venous Softbag Reservoirs... are substantially equivalent to the named predicate devices. (This implies the coating stability was comparable to predicates or met industry standards, though no specific results are given.)
Biocompatibility	Not explicitly stated, but implies the device materials should be safe for blood contact for six hours, without adverse biological reactions.	In-vitro testing on safety and effectiveness was executed to demonstrate that the Jostra Venous Softbag Reservoirs... are substantially equivalent to the named predicate devices. (This implies it met biocompatibility standards, though no specific results are given.)
Sterility	Not explicitly stated, but implies the device should be delivered sterile.	In-vitro testing on safety and effectiveness was executed to demonstrate that the Jostra Venous Softbag Reservoirs... are substantially equivalent to the named predicate devices. (This implies it met sterility standards, though no specific results are given.) The device is described as "delivered sterile."

Note: The document states that "In-vitro testing on safety and effectiveness was executed to demonstrate that the Jostra Venous Softbag Reservoirs with and without Safeline Coating described in this submission are substantially equivalent to the named predicate devices." This is the primary "proof" of meeting acceptance criteria, meaning the new device performed comparably to already cleared devices in these areas. Specific quantitative acceptance criteria and detailed test results are not provided in this summary.

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: Not specified in the provided text.
Data Provenance: Not specified. The testing was "in-vitro," meaning in a controlled laboratory environment rather than on human or animal subjects. The company is based in Germany, so it's plausible the testing was conducted there, but this is not explicitly stated.
Retrospective or Prospective: Not applicable, as the document refers to "in-vitro testing" which typically refers to lab experiments rather than patient data.

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 section is not applicable to this document. The device is a physical medical device (venous reservoir bag) and the testing described is primarily mechanical and material characterization ("Integrity," "Performance," "Stability of the coating," "Biocompatibility," "Sterility"). There is no mention of an "AI device," "image analysis," or "ground truth" derived from human interpretation in the context of diagnostic or clinical assessment.

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

This section is not applicable to this document. As mentioned above, this is not an AI/diagnostic device that would involve human review and adjudication of findings against a "ground truth." The testing methods would have followed established protocols for medical device performance and safety testing.

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

This section is not applicable to this document. This is not an AI-assisted diagnostic device.

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

This section is not applicable to this document. This is not an AI algorithm.

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

This section is not applicable in the AI/diagnostic sense. For the in-vitro testing, the "ground truth" would be established by the predefined specifications, standards, and performance characteristics of the predicate devices, against which the new device was compared for substantial equivalence. For example, for "sterility," the ground truth is "no microbial growth." For "integrity," the ground truth is "no leaks under specified pressure." These are objective measurements rather than subjective expert consensus.

8. The sample size for the training set

This section is not applicable to this document. There is no mention of machine learning or an AI training set.

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

This section is not applicable to this document for the reasons stated above.

Summary

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

JAN - 4 2008

K070605 MAQUET

510 (K) Summary Jas required by 21 CFR 807.92(c) 1

Submitter:	Maquet Cardiopulmonary AGHechinger Strasse 3872145 HirrlingenGermany
Contact Person:	Katrin SchwenkglenksPhone: +49 7478 921-151Fax: +49 7478 921-400E-mail: katrin.schwenkglenks@maquet-cp.com
Date Prepared:Device Trade Name:	February 28, 2007Jostra Venous Softbag Reservoirs with and withoutSafeline Coating
Common/Usual Name:	Venous Reservoir Bag
Classification Names:	Reservoir, Blood, Cardiopulmonary Bypass(21 CFR 870.4400, product code: DTN)
Predicate Devices:	BMR 1900 Soft-Shell Venous Reservoir, CobeCardiovascular Inc. (K050111),MVR 800 Collapsible Venous Reservoir Bag,Medtronic Inc. (K920774)RotaFlow Centrifugal Pump with Safeline Coating(K061072)

Device Description

Statement of Indications for Use

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

MAQUET

Statement of Technical Characteristics Comparison

Maquet Cardiopulmonary AG has compared indications for use, design, specifications, performance characteristics and safety of the Jostra Venous Softbag Reservoirs with and without Safeline Coating and of the predicate devices.

In-vitro testing on safety and effectiveness was executed to demonstrate that the Jostra Venous Softbag Reservoirs with and without Safeline Coating described in this submission are substantially equivalent to the named predicate devices.

The following areas have been tested:

Integrity .
Performance -
Stability of the coating -
Biocompatibility ・
-Sterility

Conclusion

The Jostra Venous Softbag Reservoirs with and without Safeline Coating are substantially equivalent to the named predicate devices that currently hold market clearance.

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

Public Health Service

Image /page/2/Picture/2 description: The image shows the logo for the Department of Health & Human Services - USA. The logo consists of a circular border with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the circumference. Inside the circle is a stylized emblem featuring three abstract human profiles or faces, stacked vertically and connected by flowing lines, creating a sense of unity and movement.

JAN - 4 2008

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

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

Re: K070605

Jostra Venous Softbag Reservoirs with and without Safeline Regulation Number: 21 CFR 870.4400 Regulation Name: Cardiopulmonary bypass blood reservoir Regulatory Class: Class II (two) Product Code: DTN Dated: December 20, 2007 Received: December 26, 2007

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.

{3}------------------------------------------------

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 (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely yours.

Bfommamourh

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

Enclosure

{4}------------------------------------------------

Indications for Use

510(k) Number (if known): Ko 70605

Device Name: Jostra Venous Softbag Reservoir with and without Safeline Coating

Indications for Use:

Prescription Use Over-The-Counter Use X AND/OR (Part 21 CFR 801 Subpart D) (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)

Bhammana

San-Off second Cardiovascular De

Page ___ of __________________________________________________________________________________________________________________________________________________________________

(Posted November 13, 2003)

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.