DHF 0.2 HEMOCONCENTRATOR: DIDECO NEWBORN-INFANT HEMONCENTRATION; DHR 0.6 HEMOCONCENTRATOR: DIDECO PEDIATRIC/SMALL ADULT

K021732 · Dideco S.P.A. · KDI · Nov 4, 2002 · Gastroenterology, Urology

Device Facts

• Record ID: K021732
• Device Name: DHF 0.2 HEMOCONCENTRATOR: DIDECO NEWBORN-INFANT HEMONCENTRATION; DHR 0.6 HEMOCONCENTRATOR: DIDECO PEDIATRIC/SMALL ADULT
• Applicant: Dideco S.P.A.
• Product Code: KDI · Gastroenterology, Urology
• Decision Date: Nov 4, 2002
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 876.5860
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Dideco DHF Hemoconcentrator is intended for use in cardiopulmonary bypass circuits for hemoconcentration and consequent restoring of patient's physiological hematocrit. The choice of hemconcentrator depends on the protocol being used and required filtration speed. The device is intended to be used for six hours or less.

Device Story

DHF Hemoconcentrator is a hollow fiber device used during cardiopulmonary bypass; removes excess fluid from patient blood to restore physiological hematocrit. Device consists of external transparent housing, fiber bundle, and blood header caps. During bypass, diluted blood flows through internal fibers; plasma water is removed across semi-permeable fibers to filtrate side. Used in clinical settings by medical professionals. Benefits include fluid management and hematocrit restoration. Single-use, ethylene oxide sterilized.

Clinical Evidence

No clinical data. Bench testing only. In vitro testing performed per ISO 10993-1 and EN 1283 standards, including priming volume, pressure drop, ultrafiltration rate, sieving coefficient, mechanical integrity, and blood trauma (plasma free hemoglobin, index of hemolysis). Testing conducted on devices aged to 5 years; results met all specifications.

Technological Characteristics

Hollow fiber hemoconcentrator; polyurethane fiber bonding; transparent housing; male Pos-Lock ports. Ethylene oxide sterilized; nonpyrogenic. Complies with ISO 10993-1 and EN 1283. Single-use.

Indications for Use

Indicated for patients undergoing cardiopulmonary bypass procedures requiring hemoconcentration to restore physiological hematocrit levels. Intended for use for up to six hours.

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

• Cobe HC 700 Midi Hemoconcentrator (K003023)
• Hemocor HPH 400 Hemoconcentrator (K923139)

Submission Summary (Full Text)

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KO21732

Page 1 of 2

DHF Hemoconcentrator Dideco S.p.A.

Abbreviated 510(k) May 24, 2002

#### 4 2002 NOV

| SUBMITTER: | Dideco S.p.A.<br>86. Via Statale 12 Nord<br>41037 Mirandola (MO) Italy |
|----------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| CONTACT PERSON: | Luigi Vecchi<br>Phone: [phone]<br>Fax: [phone] |
| DATE PREPARED: | May 24, 2002 |
| DEVICE TRADE NAME: | DHF Hemoconcentrator<br>available in the DHF Series:<br>DHF 0,2 Hemoconcentrator: Dideco Newborn-Infant<br>Hemoconcentrator<br>DHF 0.6 Hemoconcentrator: Dideco Pediatric/Small Adult<br>Hemoconcentrator |
| COMMON NAME: | Hemoconcentrator |
| CLASSIFICATION NAME: | Dialyzer, High permeability With or Without Sealed<br>Dialysate System |
| PREDICATE DEVICE: | Cobe HC 700 Midi Hemoconcentrator (K003023)<br>Hemocor HPH 400 Hemoconcentrator (K923139) |

510(k) SUMMARY

## DEVICE DESCRIPTION:

The Dideco DHF Hemoconcentrator is a hollow fiber type hemoconcentrator consisting of an external transparent housing with two filtrate ports on the cylindrical body and a fiber bundle. These fibers are bonded within the housing with polyurethane. A transparent blood header cap with a male Pos-Lock port is bonded to each end of the housing.

## INDICATION FOR USE:

The Dideco DHF Hemoconcentrator is intended for use in cardiopulmonary bypass circuits for hemoconcentration and consequent restoring of patient's physiological hematocrit. The choice of hemconcentrator depends on the protocol being used and required filtration speed. The device is intended to be used for six hours or less.

# TECHNOLOGICAL CHARACTERISTICS:

The design, operating principles and control mechanisms are exactly the Same for the DHF 0.2 Hemoconcentrator and for the Hemoconcentrator (K923139) predicate device. The design, operating principles and control mechanisms are exactly the same for the DHF 0.6 Hemoconcentrator and for the Cobe HC 700 Midi Hemoconcentrator (K003023) predicate device. The

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K021732

Iqs 201-2

DHF Hemoconcentrator Dideco S.p.A.

Abbreviated 510(k) May 24, 2002

basic function of all the above mentioned hemoconcentrators is the removal of excess from patient's blood during or after cardiopulmonary bypass procedures resulting in fluid hemoconcentration and restoring of patient's physiological hematocrit. Diluted blood is drawn, from the patient, inside the fibers of the device while plasma water is removed across the semi-permeable hollow fibers from the blood pathway to the filtrate side. The DHF hemoconcentrators are ethylene oxide sterilized and have a nonpyrogenic fluid path. They are for single use only.

#### NONCLINICAL TEST RESULTS:

Applicable tests were carried out in accordance with the requirements of ISO 10993-1:1997 and the FDA May 1, 1995 Memorandum on the use of the ISO 10993 standard for biocompatibility testing of raw materials. Tests were performed on devices accelerated aged to an equivalent of five years real time aging. Sterility, pyrogenicity, ETO residuals and package integrity testing were also conducted. The results of this testing met established specifications.

#### IN VITRO TEST RESULTS:

In vitro testing was carried out in accordance with the requirements of the "Guidance for the Content of Premarket Notifications for Conventional and High permeability Hemodialyzers" Guidance for industry and CDRH reviewers issued on August 7, 1998 by CDRH and on the EN 1283 "Haemodialysers, haemodiafilters, haemofilters, haemoconcentrators and their extracorporeal circuits" issued on April 1996 when applicable. The following tests were performed to demonstrate the compliance of the DHF hemoconcentrators with safety and effectiveness requirements: priming volume, pressure drop, ultrafiltration rate, sieving coefficient, mechanical integrity, blood trauma, including measurement of plasma free hemoglobin and index of hemolysis. The results of these tests carried out on the DHF 0.6 and DHF 0.2 Hemoconcentrators aged to 5 years met established specifications. Data collected show that functional and biocompatibility parameters exhibited by the currently marketed Cobe HC 700 Midi and HPH 400 apply to the DHF 0.6 and DHF 0.2 hemoconcentrators.

#### CONCLUSION:

The new series of DHF hemoconcentrators show comparable or even better performances with respect to their related predicate devices as demonstrated by the in vitro test results presented in the submission. Biocompatibility studies demonstrate that the device is biocompatible according to its intended use. Additional testing has also demonstrated the effectiveness of production techniques to assure that the hemoconcentrator is sterile and non-pyrogenic. Therefore the DHF 0.2 hemoconcentrator are substantially equivalent to the predicate devices Cobe HC 700 Midi and Hemocor HPH 400 respectively.

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# DEPARTMENT OF HEALTH & HUMAN SERVICES

Public Health Service

od and Drug Administratio 9200 Corporate Boulevard Rockville MD 20850

Dideco S.p.A. c/o Barry Sall, RAC Senior Regulatory Consultant PAREXEL International Corp. 195 West Street WALTHAM MA 02451-1163

# Re: K021732

Trade/Device Name: Dideco DHF Hemoconcentrator Regulation Number: 21 CFR §876.5860 Regulation Name: High permeability hemodialysis system Regulatory Class: II Product Code: 78 KDI Dated: September 18, 2002 Received: September 19, 2002

Dear Mr. Sall:

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 (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.

Image /page/2/Picture/11 description: The image shows a partial view of a seal or emblem. The visible portion includes the words "DEPARTMENT OF HEALTH & HUMAN SERVICES" arranged in a circular pattern around the edge. The central part of the emblem features a stylized design, possibly representing a symbol or logo associated with the department.

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This letter will allow you to begin marketing your device as described in your 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:

| 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" (21 CFR Part 807.97). 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

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DHF Hemoconcentrator Dideco S.p.A.

510(k) Number (if known):

Device Name. Dideco DHF Hemoconcentrator

Indications For Use:

The Dideco DHF Hemoconcentrator is intended for use in cardiopulmonary bypass circuits for hemoconcentration and consequent restoring of patient's physiological hematocrit. The choice of hemconcentrator depends on the protocol being used and required filtration speed. The device is intended. to be used for six hours or less.

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use
(Per 21 CFR 801.109) ✓

OR Over-The-Counter Use _

David h. Symon

(Division Sign-Off) Division of Reproductive, Abdominal, and Radiological Devices 510(k) Number