The Omni System, which consists of the Omni-DL™ Control Unit, Omni-DL™ CVVHDF Kit, and 5 Liter Effluent Bag, is intended for use in renal replacement therapies in a hospital or clinical setting where CRRT is administered. Four different solute and fluid management therapies are available:

SCUF (Slow Continuous Ultrafiltration)
CVVH (Continuous Veno-venous Hemofiltration)
CVVHD (Continuous Veno-venous Hemodialysis)
CVVHDF (Continuous Veno-venous Hemodiafiltration)

Device Description

The Omni-DLTM System (Omni System) provides continuous renal replacement therapies (hemodialysis, hemofiltration, hemodiafiltration, and ultrafiltration) in an intensive care setting for patients with acute renal failure and/or fluid overload. The Omni System consists of the Omni-DLTM Control Unit (Control Unit), the Omni-DLTM CVVHDF Kit (Omni Kit); a dedicated disposable tubing set which does not incorporate a hemofilter, and a separately packaged 5 Liter Effluent Bag.

The Omni System is a continuous renal replacement therapy (CRRT) system intended for patients with acute renal failure and/or fluid overload. The Omni is indicated for continuous solute and or fluid removal in patients with acute renal failure and/or fluid overload. Blood access for therapy with the Omni System is via established methods of vascular access. The Omni System is designed for use on patients in a hospital setting to provide the following treatments: SCUF (Slow Continuous Ultrafiltration), CVVH (Continuous Veno-Venous Hemofiltration), CVVHD (Continuous Veno-Venous Hemodialysis), and CVVHDF (Continuous Veno-Venous Hemodiafiltration).

AI/ML Overview

The provided document, K080650, describes the Transvivo Omni-DL™ system, a high permeability hemodialysis system. The submission focuses on substantial equivalence to a predicate device rather than presenting a detailed study with acceptance criteria met by specific performance metrics. Therefore, explicit "acceptance criteria" and "reported device performance" in a quantitative sense, as typically seen for novelAI-driven diagnostic tools, are not provided.

Instead, the document asserts that the device met its functional and performance specifications through "extensive safety, software, and performance testing." The conclusion is based on the device having the "same intended use, with similar technological characteristics" as the predicate device (Prisma CFM System [K946279]).

Here's an attempt to structure the information based on the request, acknowledging the limitations of the provided text:

Acceptance Criteria and Study for Transvivo Omni-DL™ System

The provided 510(k) summary for the Transvivo Omni-DL™ device focuses on demonstrating substantial equivalence to a predicate device. It does not present specific quantitative acceptance criteria or a detailed clinical study report proving the device meets such criteria as would be expected for a novel AI-driven diagnostic system. Instead, it relies on non-clinical testing to demonstrate functional and performance specifications.

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criterion (Inferred from "Spec. Compliance")	Reported Device Performance (Inferred from "Extensive Testing")
Functional Specifications	Met
Performance Specifications	Met
Safety	Extensive safety testing performed; deemed equivalent to predicate
Software Functionality	Extensive software testing performed; deemed equivalent to predicate
Technological Characteristics	Similar to predicate device
Intended Use	Same as predicate device

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

The document does not specify a "test set" in the context of clinical data or patient samples for performance evaluation. The testing described is "non-clinical testing" for functional and performance specifications, likely involving laboratory or bench testing of the device hardware and software. No patient-specific data, country of origin, or retrospective/prospective nature is mentioned as this was likely not a clinical study.

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

Not applicable. This was a non-clinical evaluation of a medical device's functional and performance specifications, not an AI model requiring expert-established ground truth.

4. Adjudication Method for the Test Set

Not applicable. No "test set" requiring adjudication by experts is described.

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

No. An MRMC comparative effectiveness study was not performed. The device is a high permeability hemodialysis system, not an AI-assisted diagnostic tool that would typically involve human reader performance evaluation.

6. Standalone (Algorithm Only) Performance Study

No. Since this device is a physical system for renal replacement therapies and not an AI algorithm, a standalone algorithm performance study is not applicable. The "software" referred to in the document relates to the control unit's operation, not a diagnostic algorithm.

7. Type of Ground Truth Used

Not applicable. The evaluation was based on functional and performance specifications for a medical device, which would involve engineering and physical measurements against predefined requirements, rather than clinical ground truth (e.g., pathology, outcomes data, or expert consensus).

8. Sample Size for the Training Set

Not applicable. There is no mention of a "training set" as the device is not an AI/ML model that undergoes a training phase.

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

Not applicable for the same reasons as above.

Summary

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K080650
Page 1 of 3

NOV 2 6 2008

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

Transvivo

N C O R P O R A T E D

3067 Research Drive Richmond, CA 94806

Summary

This Summary of 510(k) safety and effectiveness information is being submitted in accordance with the requirements of 21 CFR Part 807.92 for the Omni-DL™ device.

1. Company making the Submission:

Name:	Transvivo, Inc.
Address:	3067 Research Drive
	Richmond, CA 94806 USA
Telephone:	510-223-1054 Voice
	510-785-8073 Fax
Contact:	J. Michael Delmage, Ph.D., MBA
e-mail:	mdelmage@transvivo.com

. 2. Device Name:

Trade/Proprietary Name:	Omni-DL™
Common/Usual Name:	High permeability hemodialysis system
Regulation Number:	876.5860
Product Code:	KDI
Review Panel:	Gastroenterology/Urology
Third Party Reviewed:	No
513g Number:	C060198

3. Predicate Devices:

Omni-DL™ device is substantially equivalent to other Dialyzer High permeability hemodialysis systems in the market such as the Prisma CFM System [K946279].

4. Indications for Use Statement:

Omni-DLTM Control Unit, Omni-DLTM CVVHDF Kit, 5 Liter Effluent Bag

The Omni System, which consists of the Omni-DL™ Control Unit, Omni-DLTM CVVHDF Kit, and 5 Liter Effluent Bag, is intended for use in renal replacement therapies in a hospital or clinical setting where CRRT is administered. Four different solute and fluid management therapies are available:

SCUF (Slow Continuous Ultrafiltration) .
CVVH (Continuous Veno-venous Hemofiltration) t

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KC80650
Page 2 of 3

♥ CVVHD (Continuous Veno-venous Hemodialysis)
. CVVHDF (Continuous Veno-venous Hemodiafiltration)

Description of Device: 5.

Image /page/1/Picture/7 description: The image shows a device with a screen on top and an open compartment below. The screen appears to be blank or displaying a uniform color. The open compartment reveals some internal components, though the details are obscured by shadow. The device has a somewhat boxy shape with rounded edges, and there are some buttons or controls visible on the front panel.

6. Technological Characteristics:

The basic method of construction and materials is very similar. The methods of operation and indications for use are the same for the Omni-DL ™ and the predicate device. Minor modifications were made to the Omni-DLTM System to incorporate current technology.

7. Non-clinical and Clinical Performance Data:

Non-clinical testing was performed on the Omni-DL™ System to demonstrate that the device met its functional and performance specifications. The Omni-DLTM System was subjected to extensive safety, software, and performance testing.

8. Conclusion:

Based on the testing and comparison to the predicate device the Transvivo, Inc., Omni-DLTM System has the same intended use, with similar technological characteristics. Transvivo, Inc., therefore posits that its device is equivalent in safety and effectiveness to the predicate devices.

Summary Section 5 rev2
Delphi Consulting Group
Houston, TX 77071

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KC80650
Page 3 of 3

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

Transvivo, Inc.

Q. Michael Dalmayer, M.D., Ph.D.
Michael Dalmayer, Ph.D., M.D.

J. Michael Delmage, Ph President and CEO

Revised per discussion with FDA. Dated: November 24, 2008

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized abstract design resembling an eagle or bird in flight, composed of three curved lines. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" is arranged in a circular fashion around the emblem.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

NOV 2 6 2008

J. Michael Delmage, Ph.D., M.B.A President and CEO Transvivo, Inc. 3067 Research Drive RICHMOND CA 94806

Re: K080650

Trade/Device Name: Omni-DL™ Control Unit, Omni-DL™ CVVHDF Kit, 5 Liter Effluent Bag Regulation Number: 21 CFR §876.5860 Regulation Name: High permeability hemodialysis system Regulatory Class: II Product Code: KDI Dated: October 27, 2008 Received: October 29, 2008

Dear Dr. Delmage:

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

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 one of the following numbers, based on the regulation number at the top of this letter:

21 CFR 876.xxx	(Gastroenterology/Renal/Urology	240-276-011.
21 CFR 884.xxx	(Obstetrics/Gynecology)	240-276-011.
21 CFR 894.xxx	(Radiology)	240-276-012
Other		240-276-010-

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometrics' (OSB's) Division of Postmarket Surveillance at 240-276-3474. For questions regarding the reporting of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at 240-276-3464. 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,

Joppu M. Whang

Joyce M. Whang, Ph.D. Acting Director, Division of Reproductive, Abdominal, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Indications for Use Statement

510(k) Number : K 80650

Device Name: Omni-DLTM Control Unit, Omni-DL™ CVVHDF Kit, 5 Liter Effluent Bag

The Omni System, which consists of the Omni-DL™ Control Unit, Omni-DL™ CVVHDF Kit, and 5 Liter Effluent Bag, is intended for use in renal replacement therapies in a hospital or clinical setting whee CRRT is administered. Four different solute and fluid management therapies are valiable

SCUF (Slow Continuous Ultrafiltration) .
CVVH (Continuous Veno-venous Hemofiltration) D
CVVHD (Continuous Veno-venous Hemodialysis) .
CVVHDF (Continuous Veno-venous Hemodiafiltration) .

Prescription Use YES (Part 21 CFR 801 Subpart D) AND/OR

Over-The-Counter Use (21 CFR 807 Subpart C)

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

(Division Sign-Off)
Division of Reproductive, Abdominal and
Radiological Devices

2_Indications_for_Use Rev.2 phi Consulting Group

510(k) Number

Regulation Number and Section

§ 876.5860 High permeability hemodialysis system.

(a)
Identification. A high permeability hemodialysis system is a device intended for use as an artificial kidney system for the treatment of patients with renal failure, fluid overload, or toxemic conditions by performing such therapies as hemodialysis, hemofiltration, hemoconcentration, and hemodiafiltration. Using a hemodialyzer with a semipermeable membrane that is more permeable to water than the semipermeable membrane of the conventional hemodialysis system (§ 876.5820), the high permeability hemodialysis system removes toxins or excess fluid from the patient's blood using the principles of convection (via a high ultrafiltration rate) and/or diffusion (via a concentration gradient in dialysate). During treatment, blood is circulated from the patient through the hemodialyzer's blood compartment, while the dialysate solution flows countercurrent through the dialysate compartment. In this process, toxins and/or fluid are transferred across the membrane from the blood to the dialysate compartment. The hemodialysis delivery machine controls and monitors the parameters related to this processing, including the rate at which blood and dialysate are pumped through the system, and the rate at which fluid is removed from the patient. The high permeability hemodialysis system consists of the following devices:(1) The hemodialyzer consists of a semipermeable membrane with an in vitro ultrafiltration coefficient (K
uf ) greater than 8 milliliters per hour per conventional millimeter of mercury, as measured with bovine or expired human blood, and is used with either an automated ultrafiltration controller or anther method of ultrafiltration control to prevent fluid imbalance.(2) The hemodialysis delivery machine is similar to the extracorporeal blood system and dialysate delivery system of the hemodialysis system and accessories (§ 876.5820), with the addition of an ultrafiltration controller and mechanisms that monitor and/or control such parameters as fluid balance, dialysate composition, and patient treatment parameters (e.g., blood pressure, hematocrit, urea, etc.).
(3) The high permeability hemodialysis system accessories include, but are not limited to, tubing lines and various treatment related monitors (e.g., dialysate pH, blood pressure, hematocrit, and blood recirculation monitors).
(b)
Classification. Class II. The special controls for this device are FDA's:(1) “Use of International Standard ISO 10993 ‘Biological Evaluation of Medical Device—Part I: Evaluation and Testing,’ ”
(2) “Guidance for the Content of 510(k)s for Conventional and High Permeability Hemodialyzers,”
(3) “Guidance for Industry and CDRH Reviewers on the Content of Premarket Notifications for Hemodialysis Delivery Systems,”
(4) “Guidance for the Content of Premarket Notifications for Water Purification Components and Systems for Hemodialysis,” and
(5) “Guidance for Hemodialyzer Reuse Labeling.”