The MEDOS HILITE MVC 4030 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 at flow rates of one (1.0) to seven (7.0) liters per minute for periods up to six hours (6.0) hours.

Device Description

The MEDOS HILITE MVC 4030 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 4030 has a clear polycarbonate shell and an internal defoamer filter cartridge. Venous drainage enters the 1/2' venous inlet at the center top section of the lid. 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 7 lpm. The maximum cardiotomy flow rate is 4 lpm.

AI/ML Overview

The provided text describes a medical device submission (K083131) for the Medos Hilite MVC 4030 Hardshell Venous Reservoir. This is a conventional 510(k) submission for a Class II medical device, which typically relies on demonstrating substantial equivalence to a predicate device rather than conducting extensive clinical studies with specific acceptance criteria in the manner of AI/software devices. The submission focuses on device characteristics, intended use, and performance tests related to its manufacturing quality and functional requirements.

Therefore, many of the requested points, especially those related to AI/algorithm performance (e.g., sample sizes for test sets, ground truth establishment, MRMC studies, standalone performance, training set details), are not applicable to this type of traditional medical device submission.

Here's the information that can be extracted and inferred from the provided text, addressing the applicable points:

1. Acceptance Criteria and Reported Device Performance

The submission states that the device was "subjected to extensive safety, performance, and validations prior to release." It also mentions "various performance tests designed to ensure that the device meets all of its functional requirements and performance specifications" and "Safety tests have further been performed to ensure the device complies with applicable industry and safety standards."

While specific quantitative acceptance criteria are not detailed in the summary, the general areas of performance and safety are highlighted. The reported "performance" is that the device meets these functional requirements and specifications.

Acceptance Criteria Area	Reported Device Performance
Functional Requirements	The device meets all of its functional requirements and performance specifications, including: - Collection, storage, and filtration of blood during cardiopulmonary bypass. - Filtering and defoaming intrathoracic suctioned blood. - Operation at venous flow rates of 1.0 to 7.0 liters per minute. - Operation at cardiotomy flow rates of up to 4.0 liters per minute. - Use for periods up to 6.0 hours.
Safety Standards Compliance	The device complies with applicable industry and safety standards. Implicitly, this includes being sterile, non-pyrogenic, and single-use, as stated in the description.
Equivalence to Predicate	The device is considered equivalent in safety and effectiveness to the predicate device (Gish CAPVRF45 Hardshell Venous Reservoir, K964973) based on being able to perform the same indications for use and having similar technological characteristics. The FDA's substantial equivalence determination implies it meets sufficient standards comparable to the predicate.

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

This is not applicable as this is not a study evaluating an algorithm on a "test set" of data in the AI sense. Performance testing would have involved physical units of the device. The text does not provide details on the number of physical units tested.

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

This is not applicable. Ground truth in this context refers to established functional parameters and safety standards for the device's physical operation. It does not involve expert review or consensus of interpretable data like medical images.

4. Adjudication method for the test set

This is not applicable. Regular engineering testing and validation procedures would have been followed, not adjudication in the context of expert review.

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. This device is a hardware component for cardiopulmonary bypass and does not involve AI or human-in-the-loop performance for image reading or diagnosis.

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

This is not applicable. This is a physical medical device, not a software algorithm.

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

The "ground truth" for this device's performance would be derived from:

Engineering specifications and design requirements: These define what the device should do (e.g., flow rates, filtration efficiency).
Established industry standards: Pertaining to biocompatibility, sterilization, materials, and mechanical integrity for blood-contacting devices.
Comparability to the predicate device: The predicate device (Gish CAPVRF45 Hardshell Venous Reservoir, K964973) serves as a benchmark for performance and safety.

8. The sample size for the training set

This is not applicable. This is a physical medical device, not an AI algorithm requiring a training set.

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

This is not applicable. No training set exists for this type of device.

Summary

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Gish Biomedical, Inc.

1083131/

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.

1. Company making the submission:

JUL 8 0 2009

Name:	Gish BioMedical, Inc.A member of the MEDOS group
Address:	22942 Arroyo VistaRancho Santa Margarita, CA 92688-2600
Telephone:	949-635-6200 voice949-635-6294 faxjanetp@gishbiomedical.com
Contact:	Janet PeetsRegulatory & Clinical AffairsSpecialist

2. Device:

Proprietary Name:	Medos Hilite MVC 4030 Hardshell Venous Reservoir
Common Name:	Cardiopulmonary Blood Reservoir
Classification Name:	Extracorpeal Circuit Blood DefoamerCardiopulmonary Bypass Blood Reservoir

3. Predicate Devices:

Gish CAPVRF45 Hardshell Venous Reservoir, K964973, manufactured by Gish Biomedical, Inc.

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:

Section 5 510(k) Submission Page #

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6. Indications for use:

7. Contra-indications:

No contra-indications have been noted.

8. Comparison:

The Medos Hilite MVC 4030 Hardshell Venous Reservoir has the same device characteristics as the predicate devices.

9. Test Data:

The MEDOS HILITE MVC 4030 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 4030 Hardshell Venous Reservoir.

11. Conclusions:

Based upon the testing and comparison to the predicate device the Medos Hilite MVC 4030 Hardshell Venous Reservoir has the same intended use, with similar technological characteristics. Gish Biomedical, Inc., therefore posits that its device is equivalent in safety and effectiveness to predicate devices.

Confidential Summary.doc

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Image /page/2/Picture/0 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized eagle with its wings spread, and the words "DEPARTMENT OF HEALTH & HUMAN SERVICES · USA" are arranged in a circular pattern around the eagle. The logo is black and white.

DEPARTMENT OF HEALTH & HUMAN SERVICES

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

JUL 3 0 2009

Gish Biomedical, Inc. c/o Ms. Janet Peets 22942 Arroyo Vista Rancho Santa Margarita, CA 92688

Re: K083131

Medos Hilite MVC 4030 Reservoir Regulation Number: 21 CFR 870.4400 Regulation Name: Reservoir, blood, cardiopulmonary bypass Regulatory Class: Class II (two) Product Code: DTN Dated: June 10, 2009 Received: June 11, 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 (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,

R. D. Anderson, M.D.

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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Gish Biomedical, Inc.

510(k) Number K_083/3 |

Device Name: MEDOS HILITE MVC 4030 Hardshell Venous Reservoir

Indications for use:

The MEDOS HILITE MVC 4030 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 the extracorporeal circuit at flow rates of one (1.0) to seven (7.0) liters per minute for periods up to six hours (6.0) hours.

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)

HOH L'Avision of Wardlovascular Devices iki Number

Section 4 510(k) Submission Page

Confidential Indications forUso.dov

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.