Indicated for use with the Prisma Control Unit in providing continuous fluid management and renal replacement therapies for patients who have acute renal failure, fluid overload, or both.

Device Description

The Prisma Disposable Sets are sterile disposable extracorporeal circuits containing an AN 69 HF hemofilter/dialyzer and fluid circuit for use with the Prisma Control Unit. These Prisma Disposable Sets allow the following fluid management and renal replacement therapies to be performed: SCUF - Slow Continuous Ultrafiltration CVVH - Continuous Venovenous Hemofiltration CVVHD - Continuous Venovenous Hemodialysis CVVHDF - Continuous Venovenous Hemodiafiltration

AI/ML Overview

The provided text is a 510(k) summary for the Gambro Prisma M60/M100 Sets, a medical device. This document focuses on demonstrating substantial equivalence to predicate devices rather than providing detailed acceptance criteria and a study to prove performance against those criteria in the context of advanced AI/ML device evaluations.

Therefore, many of the requested categories are not applicable or cannot be extracted from this document, as the submission predates the common methodologies and requirements for AI/ML device evaluations.

Here's the information that can be extracted or deduced from the provided document, with notes on what is not applicable:

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

The document does not explicitly state quantitative acceptance criteria in a dedicated table format, nor does it present specific performance metrics like sensitivity, specificity, or AUC as would be found in an AI/ML device study. Instead, it relies on demonstrating "substantial equivalence" through "in vitro testing" to predicate devices.

Acceptance Criteria (Implied)	Reported Device Performance
Maintain performance comparable to predicate devices in design, function, composition, and operation.	"The results of the in vitro testing demonstrate that the proposed configurations are substantially equivalent to the predicate configurations and are suitable for the intended use."

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

Sample Size (Test Set): Not specified. The document only mentions "in vitro testing" without details on the number of tests or specific test runs.
Data Provenance (e.g. country of origin of the data, retrospective or prospective): Not specified. The testing was "in vitro," implying laboratory-based testing rather than patient data.

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

Number of Experts: Not applicable. The "ground truth" for this type of device (hemofilter and blood tubing set) would be established through engineering specifications, material properties, and functional performance benchmarks rather than expert clinical consensus on diagnostic images or patient outcomes.
Qualifications of Experts: Not applicable.

4. Adjudication method for the test set

Adjudication Method: Not applicable. Adjudication methods like 2+1 or 3+1 are used for human-reviewed data, typically in diagnostic imaging or clinical assessment, to establish a consensus ground truth. This is not relevant for in vitro functional performance testing of a physical medical 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

MRMC Study: No, this type of study was not done. MRMC studies are specific to evaluating AI's impact on human diagnostic performance, which is not relevant for a hemofilter and blood tubing set.
Effect Size of Human Reader Improvement: Not applicable.

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

Standalone Performance: Not applicable. The device is not an algorithm and does not have a "standalone" performance in the sense of AI/ML evaluation. Its performance is inherent to its physical design and function. The "in vitro testing" assesses the physical device's performance directly.

7. The type of ground truth used

Type of Ground Truth: For "in vitro testing" of a physical device like this, the 'ground truth' would be defined by established engineering and medical standards, performance specifications for flow rates, filtration efficiency, material compatibility, and sterility, as measured by standard laboratory equipment and protocols. It is not expert consensus, pathology, or outcomes data in the usual sense.

8. The sample size for the training set

Sample Size (Training Set): Not applicable. This document describes a physical medical device, not an AI/ML algorithm that requires a "training set."

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

Ground Truth for Training Set: Not applicable, as there is no training set for this device.

Summary

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510(K) SUMMARY FOR THE GAMBRO PRISMA M60/M100 SETS 510(k) Number: Ko32431

SEP 1 5 2003

A. Submitter's Information

Name:	Gambro Renal Products
Address:	10810 West Collins AvenueLakewood, Colorado 80215USA
Phone:	303-542-5075
Fax:	303-542-5138
Contact Person:	Rod J. Rylands, Director Regulatory Affairs
B. Device Information
Classification name:	High Permeability Hemodialysis System Accessory[21 CFR 876.5860]
Common or usual name:	Hemofilter and Blood Tubing Set
Proprietary Name(s):	Prisma M60 Post-dilutionPrisma M60 Pre-dilutionPrisma M60 Pre-Pump InfusionPrisma M100 Post-dilutionPrisma M100 Pre-dilutionPrisma M100 Pre-Pump Infusion
Product Code Classification Panel:	KDI/Gastroenterology-Urology
Classification:	Class II per 21 CFR 876.5860
C. Predicate Device Information
The predicate devices cleared under 510(k)'s - K946279, K981681, and K980386 are:

Prisma M60 Post-dilution Prisma M60 Pre-dilution Prisma M60 Pre-Pump Infusion Prisma M100 Post-dilution Prisma M100 Pre-dilution Prisma M100 Pre-Pump Infusion

D. Substantial Equivalence

The proposed Prisma M60/M100 sets are substantially equivalent to the Prisma M60/M100 sets currently on the market. The modifications in the proposed Prisma M60/M100 sets are substantially equivalent in design, function, composition, and operation, to the Prisma M60/M100 sets that have FDA clearance under 510(k)'s - K946279, K980386, and K981681.

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510(K) SUMMARY FOR THE GAMBRO PRISMA M60/M100 SETS 510(k) Number: KO3243

E. Device Description

SCUF - Slow Continuous Ultrafiltration CVVH - Continuous Venovenous Hemofiltration CVVHD - Continuous Venovenous Hemodialysis CVVHDF - Continuous Venovenous Hemodiafiltration

F. Indications For Use

Indicated for use with the Prisma Control Unit in providing continuous fluid management and renal replacement therapies for patients who have acute renal failure, fluid overload, or both.

G. Technological Characteristics

The proposed device configurations have the same technological characteristics and are similar in design, function, composition, and operation, to the currently marketed configurations.

H. Summary of Non-Clinical Tests Submitted and Conclusion

In vitro testing was conducted to compare the performance of the proposed device configurations to the predicate configurations. The results of the in vitro testing demonstrate that the proposed configurations are substantially equivalent to the predicate configurations and are suitable for the intended use.

I. Summary of Clinical Tests Submitted - Not Applicable

5 August 2003

Rod J. Rylands

Director Regulatory Affairs Gambro Renal Products

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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

SEP 1 5 2003

Mr. Rod J. Rylands Director Regulatory Affairs Gambro Renal Products 10810 W. Collins Avenue LAKEWOOD CO 80215

Re: K032431

Trade/Device Name: Prisma M60 and M100 Post-dilution, Pre-dilution and Pre-pump Infusion Sets Regulation Number: 21 CFR §876.5860 Regulation Name: High permeability hemodialysis system Regulatory Class: II Product Code: 78 KDI Dated: August 5, 2003 Received: August 16, 2003

Dear Mr. Rylands:

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 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.

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.

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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 the letter

8xx.1xxx	(301) 594-4591
876.2xxx, 3xxx, 4xxx, 5xxx	(301) 594-4616
884.2xxx, 3xxx, 4xxx, 5xxx, 6xxx	(301) 594-4616
892.2xxx, 3xxx, 4xxx, 5xxx	(301) 594-4654
Other	(301) 594-4692

Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. 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 may be obtained 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/dsma/dsmamain.html.

Sincerely yours,

Nancy C. Brogdon

Nancy C. Brogdon Director, Division of Reproductive, Abdominal and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

Page 2

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Indications for Use Statement

510(k) Number (if known)	K032431
Device Name	Prisma M60/M100 Disposable Sets
Indications for Use	Indicated for use with the Prisma Control Unit in providing continuous fluid management and renal replacement therapies for patients who have acute renal failure, fluid overload, or both.

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use	✓ (Per 21 CFR 801. 109)
	OR Over-The-Counter Use ______

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

K032431
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.”