PRISMA M60/M100 SETS

K032431 · Gambro, Inc. · KDI · Sep 15, 2003 · Gastroenterology, Urology

Device Facts

• Record ID: K032431
• Device Name: PRISMA M60/M100 SETS
• Applicant: Gambro, Inc.
• Product Code: KDI · Gastroenterology, Urology
• Decision Date: Sep 15, 2003
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 876.5860
• Device Class: Class 2
• Attributes: Therapeutic

Intended 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.

Device Story

Prisma Disposable Sets are sterile extracorporeal circuits comprising an AN 69 HF hemofilter/dialyzer and fluid tubing; designed for use with the Prisma Control Unit. The system facilitates continuous renal replacement therapies (CRRT) including SCUF, CVVH, CVVHD, and CVVHDF. The device manages blood flow and fluid exchange extracorporeally to treat acute renal failure and fluid overload. Operated by clinical staff in a hospital setting, the sets provide the physical interface for blood purification and fluid management. The output is the processed blood returned to the patient and the removal of excess fluid/solutes, directly supporting clinical decision-making in critical care renal management.

Clinical Evidence

No clinical data. Substantial equivalence was established through in vitro bench testing comparing the performance of the proposed device configurations to the predicate configurations.

Technological Characteristics

Sterile disposable extracorporeal circuit; includes AN 69 HF hemofilter/dialyzer and fluid tubing. Designed for use with the Prisma Control Unit. No electronic or software components within the disposable set itself; mechanical fluid management interface.

Indications for Use

Indicated for patients with acute renal failure, fluid overload, or both requiring continuous fluid management and renal replacement therapies.

Regulatory Classification

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).

Special Controls

*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.”

Predicate Devices

• Prisma M60/M100 sets (K946279)
• Prisma M60/M100 sets (K981681)
• Prisma M60/M100 sets (K980386)

Submission Summary (Full Text)

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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 Avenue<br>Lakewood, Colorado 80215<br>USA |
| Phone: | 303-542-5075 |
| Fax: | 303-542-5138 |
| Contact Person: | Rod J. Rylands, Director Regulatory Affairs |
| <b>B. Device Information</b> | |
| Classification name: | High Permeability Hemodialysis System Accessory<br>[21 CFR 876.5860] |
| Common or usual name: | Hemofilter and Blood Tubing Set |
| Proprietary Name(s): | Prisma M60 Post-dilution<br>Prisma M60 Pre-dilution<br>Prisma M60 Pre-Pump Infusion<br>Prisma M100 Post-dilution<br>Prisma M100 Pre-dilution<br>Prisma M100 Pre-Pump Infusion |
| Product Code Classification Panel: | KDI/Gastroenterology-Urology |
| Classification: | Class II per 21 CFR 876.5860 |
| <b>C. Predicate Device Information</b> | |
| 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

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

#### 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 | [phone] |
|----------------------------------|----------------|
| 876.2xxx, 3xxx, 4xxx, 5xxx | [phone] |
| 884.2xxx, 3xxx, 4xxx, 5xxx, 6xxx | [phone] |
| 892.2xxx, 3xxx, 4xxx, 5xxx | [phone] |
| Other | [phone] |

Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at [phone]. 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 [phone] or [phone] 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 | <div>✓</div> <div>(Per 21 CFR 801. 109)</div> |
|------------------|-----------------------------------------------|
| | OR Over-The-Counter Use ______ |

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

K032431
510(k) Number