The MEDOS HILITE MVC 0730 Hardshell Venous Reservoir is indicated for use during cardiopulmonary bypass surgery as a storage reservoir for gravity and augmented venous return blood and to filter and defoam intrathoracic suctioned blood prior to its return to the extracorporeal circuit. The MVC 0730 is a neonate, infant reservoir intended for use in procedures at a maximum flow rate of 1.2 liters per minute for periods up to six hours (6.0) hours.

Device Description

The MEDOS HILITE MVC 0730 Hardshell Venous Reservoirs are sterile, non-pyrogenic, single use, disposable, device designed for collection, storage and filtration of blood during cardiopulmonary bypass. The MEDOS HILITE MVC 0730 has a clear polycarbonate shell and an internal defoamer filter cartridge. Venous drainage enters the 1/4" venous inlet at the bottom section of the reservoir. Venous suctioned blood enters the top section of the defoamer/filter cartridge and passed through a defoamer sponge and 30 micron filter. The maximum venous flow rate is 1.2 lpm. The maximum cardiotomy flow rate is 0.9 lpm.

AI/ML Overview

The provided text is a 510(k) summary for the MEDOS HILITE MVC 0730 Hardshell Venous Reservoir, a medical device, not an AI/ML-driven device. Therefore, many of the requested categories related to AI/ML device evaluation, such as sample sizes for test/training sets, data provenance, ground truth establishment, expert adjudication, and MRMC studies, are not applicable to this submission.

The document describes a traditional medical device and its predicate comparison, focusing on safety, performance, and validation for its intended use.

Here's the information that can be extracted relevant to the acceptance criteria and study:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly present a table of "acceptance criteria" with specific numerical targets. Instead, it broadly states that "the device meets all of its functional requirements and performance specifications" and "complies with applicable industry and safety standards."

Acceptance Criteria Category	Reported Device Performance (Summary)
Functional Requirements	Device meets all functional requirements and specifications
Performance Specifications	Device meets all performance specifications
Safety Standards	Device complies with applicable industry and safety standards
Intended Use	Same intended use as the predicate device
Technological Characteristics	Similar technological characteristics as the predicate device
Equivalence	Equivalent in safety and effectiveness to predicate devices

2. Sample size used for the test set and the data provenance

The document states, "The MEDOS HILITE MVC 0730 Hardshell Venous Reservoir has been subjected to extensive safety, performance, and validations prior to release. Final testing for the system includes various performance tests..."

However, specific sample sizes for testing (e.g., number of units tested, number of in-vitro or in-vivo trials) are NOT provided. The text does not mention data provenance in terms of country of origin or whether the studies were retrospective or prospective, which are typical considerations for clinical trials, not necessarily for engineering performance validation of a mechanical device like this.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

This section is not applicable as the ground truth concept (e.g., for diagnostic accuracy) is not relevant to the performance validation of a mechanical device like a blood reservoir. The device's performance is assessed against engineering specifications, not clinical interpretations by experts.

4. Adjudication method for the test set

This is not applicable for the same reasons as #3. Adjudication is typically used to resolve discrepancies in expert interpretations or assessments, which is not relevant for the functional and safety testing of this mechanical device.

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 is not applicable. The device is a hardshell venous reservoir, a mechanical component of a cardiopulmonary bypass circuit. It is not an AI-driven diagnostic or assistive technology, and therefore, human reader improvement or MRMC studies are entirely irrelevant.

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

This is not applicable. The device is a mechanical blood reservoir, not an algorithm.

7. The type of ground truth used

For a mechanical device like this, the "ground truth" is typically defined by engineering specifications, design requirements, and applicable industry or regulatory standards. Performance tests verify if the device meets these pre-defined physical and functional parameters (e.g., flow rates, filtration efficiency, defoaming capability, material compatibility, sterile barrier integrity). There is no "expert consensus," "pathology," or "outcomes data" in the sense of clinical diagnostic accuracy for this type of device's core validation.

8. The sample size for the training set

This is not applicable as the device is not an AI/ML algorithm that requires a training set.

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

This is not applicable as the device is not an AI/ML algorithm.

Summary

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K09/062

MEDOS Medizintechnik AG

Traditional 510(k) Section 5, 510(k) Summary

Summary

This summary of 510(k)-safety and effectiveness information is being submitted in accordance with the requirements of 21 CFR § 807.92.

AUG 0 4 2009

Company making the submission: 1.

Name:	GISH Biomedical, Inc.
	A member of the MEDOS group
Address:	22942 Arroyo Vista
	Rancho Santa Margarita, CA 92688-2600
Telephone:	949-635-6200 voice
	949-635-6299 fax
Contact:	janetp@gishbiomedical.com
	Janet Peets
	Regulatory & Clinical Affairs

2. Device:

Proprietary Name:	MEDOS HILITE MVC 0730 Hardshell Venous Reservoir
Common Name:	Cardiopulmonary Blood Reservoir
Classification Name:	Extracorpeal Circuit Blood Defoamer
	Cardiopulmonary Bypass Blood Reservoir

3. Predicate Devices:

CAPIOX® RX05 Hollow Fiber Oxygenator with Hardshell Reservoir, K022115, manufactured by Terumo Cardiovascular Systems Corporation.

Classifications Names & Citations: 4.

21 CFR 870.4230, 21 CFR 870.4400, Extracorpeal circuit blood defoamers, Cardiopulmonary bypass blood reservoir. Cardiopulmonary Bypass, Class II, DTN, Cardiovascular.

5. Description:

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6. Indications for use:

7. Contra-indications:

No contra-indications have been noted.

8. Comparison:

The MEDOS HILITE MVC 0730 Hardshell Venous Reservoir has the same device characteristics as the predicate device.

9. Test Data:

The MEDOS HILITE MVC 0730 Hardshell Venous Reservoir has been subjected to extensive safety, performance, and validations prior to release. Final testing for the system includes various performance tests designed to ensure that the device meets all of its functional requirements and performance specifications. Safety tests have further been performed to ensure the device complies with applicable industry and safety standards.

10. Literature Review:

A review of literature pertaining to the safety and effectiveness has been conducted. Appropriate safeguards have been incorporated in the design of MEDOS HILITE MVC 0730 Hardshell Venous Reservoir.

11. Conclusions:

Based upon the testing and comparison to the predicate device, the MEDOS HILITE MVC 0730 Hardshell Venous Reservoir has the same intended use, with similar technological characteristics. MEDOS Medizintechnik AG therefore posits that its device is equivalent in safety and effectiveness to predicate devices.

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo is a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" around the perimeter. Inside the circle is an abstract image of an eagle.

Public Health Service

Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-0609 Silver Spring, MD 20993-0002

AUG 0 4 2009

GISH Biomedical, Inc. c/o Ms. Janet Peets Regulatory and Clinical Affairs 22942 Arroyo Vista Rancho Santa Margarita, CA 92688-2600 Lansing. MI 48917

K091062 Re:

Medos Hilite MVC 0730 Reservoir Regulation Number: 21 CFR 870.4400 Regulation Name: Cardiopulmonary Bypass Blood Reservoir Regulatory Class: Class II (two) Product Code: DTN Dated: June 24, 2009 Received: June 25, 2009

Dear Ms. Peets:

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. Janet Peets

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 (OS) 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/odrh/industry/support/index.html.

Sincerely yours,

ina R. bulmer.

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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MEDOS Medizintechnik AG

510(k) Number KL)91062

Device Name: MEDOS HILITE MVC 0730 Reservoir

Indications for use:

Prescription Device:

Federal Law (US) restricts this device to sale by or on the order of a physician.

Prescription Use :	Yes
OR
Over-The-Counter Use:	No

PLEASE DO NOT WRITE BELOW THIS LINE- CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Dwna R. La Lune

ivision Sian-Off Division of Cardiovascular Devices

510(k) Number Ko 9 10 6 2

Section 4 510(k) Submission Page

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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.