CAPIOX HEMOCONCENTRATOR

K973516 · Terumo Medical Corp. · KDI · Jan 30, 1998 · Gastroenterology, Urology

Device Facts

• Record ID: K973516
• Device Name: CAPIOX HEMOCONCENTRATOR
• Applicant: Terumo Medical Corp.
• Product Code: KDI · Gastroenterology, Urology
• Decision Date: Jan 30, 1998
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 876.5860
• Device Class: Class 2
• Attributes: Therapeutic

Indications for Use

The CAPIOX Hemoconcentrator is designed to remove excess fluid from the blood in order to maintain proper hematocrit and protein concentration during cardiopulmonary bypass and to enable reinfusion of blood remaining in the circuit after bypass. It is intended to be used during and after surgical procedures requiring cardiopulmonary bypass (up to 6 hours) when the removal of excess fluid from blood is required. It should not be used as a dialyzer, hemofilter or other device.

Device Story

CAPIOX Hemoconcentrator is a hollow-fiber device used during cardiopulmonary bypass to remove excess fluid from blood while retaining essential plasma proteins. Device consists of glycerin-free polysulfone fibers within a tubular casing. Blood flows inside fibers; hydrostatic pressure differential across membrane drives ultrafiltration of excess fluid. Available in two models (HC05, HC11) with varying surface areas. Operated by perfusionists or clinicians in surgical settings. Transparent ports allow air bubble observation during priming. Device requires no pre-rinse. Benefits include maintenance of hematocrit and protein levels and enabling reinfusion of residual circuit blood post-bypass.

Clinical Evidence

Bench testing only. Device performance validated through comparison of specifications and materials with predicate. Biocompatibility testing conducted per ISO-10993. Sterilization validated to SAL 10^-6. Ethylene oxide residuals meet regulatory limits.

Technological Characteristics

Hollow-fiber membrane technology; glycerin-free polysulfone fibers; tubular casing; blood ports (1/4" slip, 3/16" slip, 3/16" luer lock); filtrate ports (1/2" Hansen quick connect); max blood flow 500 mL/min; max transmembrane pressure 500 mmHg; sterilization via ethylene oxide.

Indications for Use

Indicated for patients undergoing surgical procedures requiring cardiopulmonary bypass where removal of excess fluid is necessary to maintain hematocrit and protein concentration; intended for use during and up to 6 hours after bypass.

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

• Minntech Hemocor HPH (K923139)

Reference Devices

• Baxter HQ-7000
• Cobe Hemofilter
• Bard H-4207

Submission Summary (Full Text)

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# SUMMARY OF SAFETY AND EFFECTIVENESS INFORMATION
SUMMARY OF SEPTEMBER SUPERSANTIAL FOUNVALENCE PERTAINING TO SUBSTANTIAL EQUIVALENCE

K973516

Proprietary Device Name: CAPIOX® Hemoconcentrator

Classification Name: High permeability dialyzer

Reason for Submission:

New device.

### Intended Use:

The CAPIOX Hemoconcentrator is designed to remove excess fluid from the blood in The CAPIOX Hemocorcentrator is accept and protein concentration during cardiopulmonary
order to maintain proper hematocrit and recorpsion in the citization of the bypass. order to maintain proper nematocrit and proceen could after bypass.

It is intended to be used during and after surgical procedures required. It should It is intended to be used during and arter survey of excess fluid from blood is required. It should
bypass (up to 6 hours) when the removal of excess fluide not be used as a dialyzer, hemofilter or other device.

### Description

CAPIOX® Hemoconcentrator consists of Glycerin-free polysulfone fibers, casing, blood port, O-ring and adhesives.

The hemoconcentrator is available in two model has a total membrane area I he nemoconcentrator is a valuable in a 1.08 m² surface area.

Three types of blood ports are available in each model: ¼" slip, 3/16" slip, and 3/16" Three types of blood ports are available in oden model.
The ports are transparent allowing easy observation of air bubbles passing through the ports when priming.

Dimensions of filtrate ports meet the requirements specified in ISO 8637 which permits connection of fast couplings.

The CAPIOX Hemoconcentuator provides high ultra filtration rates which permits the The CAPIOX Hemoval of excess fluid by a slight hydrostatic pressure differential across the membrane without loss of essential plasma proteins

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II - Summary and Certification Summary and Cectiveness

The CAPIOX Hemoconcentrator provides high ultration rates which permits the The CAPIOX Hemoconcentrator provides mgr differentic pressure differential across the sufficient removal of excess that plasma proteins.

..

Pre-rinse is not needed. Priming with blood is acceptable.

## Substantial Equivalence

. . .

The CAPIOX® Hemoconcentrator is substantially equivalent to the Minntech Hemocor HPH
anting of the concerners and as follows The CAI 101&ator (510(k) K923139).as follows:

### Intended use: same

## Design and Materials

Both devices consist of a tubular casing which contains glycerine-free polysulfone bollow
wall and the contraction for for first while execuse fluid passes through the membr Both devices consist of a fibers while excess fibid passes through the membrane walls
fibers. Blood flows inside the fibers while excess through the membrane walls
to the sam fibers. Blood flows inside the fibers withe excess nun-passes and exist of the casing.

# Technology and Principles of Operation

Both devices use hollow fiber membrane technology. Some form of punping mechanism is Both devices use hollow fiber memoratie technology. Some to may be and thus through the hemoconcentrator.

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II - Summary and Certification Summary of Safety and Effectiveness

## Specifications

1

The specifications for both devices are substantially equivalent. The table below summarizes the The specifications for bour devices are centrator with the Minntech Hemocor Hemoconcentrator.

| Table | - |
|-------|---|
|-------|---|

| | CAPIOX Hemoconcenterator | Minnetch Hemocor |
|-----------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------|
| Intended Use | Used during and after surgical<br>procedures requiring<br>cardiopulmonary bypass when<br>the removal of excess fluid is<br>required. (Should not be used<br>as a dialyzer, hemofilter or for<br>any other function. | Used during and after surgical<br>procedures requiring<br>cardiopulmonary bypass when<br>the removal of excess fluid is<br>required. |
| Membrane technology | Hollow Fiber | Hollow Fiber |
| Membrane material | Glycerin-free polysulfone | Glycerin-free polysulfone |
| Blood flow relative to fiber | Inside | Inside |
| Effective surface area | HC11: 1.08m2<br>HC05: 0.5 m2 | HPH1000: 1.1m2<br>HPH400 : 0.3m2 |
| Blood Ports | 1/4" slip<br>3/16" slip<br>3/16"luer lock | 1/4" slip |
| Filtrate ports (*see note) | ½" Hansen quick connect | ¼" slip |
| Maximum Blood Flow | 500 mL/min | 500 mL/min |
| Maximum transmembrane<br>pressure | 500 mmHg | 500 mmHg |
| Priming volume | HC11:70 mL<br>HC05: 35 mL | HPH1000: 88 mL<br>HPH400 : 34 mL |
| Priming | No rinse required | No rinse required |
| Sterilization method | Ethylene oxide | Ethylene oxide |

*1/2" Hansen quick connect is the most commonly used filtrate port which is also used in the Baxter HQ-7000, Cobe Hemofilter, and Bard H-4207.

p. 3/4

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Summary and Certification II -Summary of Safety and Effectiveness

In summary, the CAPIOX® and the Minntech Hemocor HPH Hemoconcentrator are substantially equivalent in intended use, design and materials, technology/principles of operation, specifications and performance. Differences as described above do not raise new issues of safety or effectiveness.

Terumo's statement that this device is substantially equivalent to any other device is Foreme of stocomply with the requirements of the Federal Food, Drug and Cosmetic Act and is not intended whatsoever to be the basis for a patent infringement action.

### Additional Safety Information

- ·Pyrogen Testing
- · Sterilization conditions have been validated to provide a Sterility Assurance Level (SAL) of 10-6.
- · Ethylene oxide residuals will not exceed the maximum residue limits proposed for Part 821 of Title 21 in the Federal Register of June 23, 1978 (or as finalized or amended).
- · Manufacturing control testing
- · Blood contacting materials were tested in accordance with the FDA General Program Memorandum #G95-1 (5/1/95): Use of International Standard ISO-10993, " Biological Evaluation of Medical Devices Part 1: Evaluation and Testing (External communicating devices/Circulating Blood/Limited contact duration).

Date Prepared September 3, 1997

- Prepared by: Sandi Hartka, Manager Regulatory Affairs
- for: Terumo Medical Corporation 2100 Cottontail Lane Somerset, NJ 08873

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Image /page/4/Picture/1 description: The image shows a seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" arranged in a circular pattern around the edge. Inside the circle is a stylized graphic of an eagle with three stripes representing its wings. The eagle is facing to the right.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Ms. Sandi Hartka Manager Regulatory Affairs TERUMO.Medical Corporation 125 Blue Ball Road Elkton, MD 21921

Re. K973516

CAPIOX® Hemoconcentrator Models CX*HC05, CX*HC11 Dated: December 17, 1997 Received: December 19, 1997 Regulatory Class: III 21 CFR 876.5860/Procode: 78 KDI JAN 3 0 1998

Dear Ms. Hartka:

We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have are memor We have reviewed your Security from and of on use stated in the enclosure) to devices marketed in internet commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been recitasified in pror to may 26, 1970, the enabilied and on the medical of (Act). You may, therefore, market the ceries, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements of a column to the general controls provisions of the same of the sense and prohibitions against misbranding and additions of

If your device is classified (see above) into either class III (Prematet Approval) in may be subject to If your device is classified (see above) and the could in the Cound in the Coast of Essent Regulations. The 21, Parts 800 to 895. A substantially equivalent determination assumes compliance with the Current Crook Post COST Postice 21, Falls 800 to 693. A substition (QS) for Medical Devices: General regulation (21 CFR Part 20) and requirement, as set to ut in the Quality System (V) its ) vill verify such assumptions. Filing on one oncerners assessming volu with the GMP regulation may results are action. In addition, FDA may publish further announcements concerning Viour device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections \$31 through \$42 of the Act for devices under the Electronic Provisions, or other Federal laws or regulations.

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 and additionally 809.10 for in yitte if you done opening and the Office of Compliance at [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 807 97) Other general information on your resons (200) the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number [phone] or [phone] or at its Internet address http://www.fda.gov/cdrh/dsmamain.html".

Sincerely yours.

h.7liau
Lillian Yiu, Ph.D.

Lillian Yin, Ph.D. Director, Division of Reproductive, Abdominal, Ear, Nose and Throat, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health

.. . ..

Enclosure

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K973516 510(k) Number (if known):

CAPIOX® Hemoconcentrator Device Name:

## Indications For Use:

The CAPIOX Hemoconcentrator is designed to remove excess fluid from the I the CAYION Tiemoconoomiator is estages
blood in order to maintain proper hematocrit and protein concentration during cardiopulmonary bypass and to enable reinfusion of blood remaining in the circuit after bypass.

It is intended to be used during and after surgical procedures requiring it is michede to or or or 6 hours) when the removal of excess fluid from blood is required. It should not be used as a dialyzer, hemofilter or other device.

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

Over-The-Counter Use_ Prescription Use OR (Per 21 CFR 801.109) (Division Sign-Off) Division of Reproductive, Abduminal, ENT, (Optional Format 1-2-96) and Radiological Devices 510(k) Number

Concurrence of CDRH, Office of Device Evaluation (ODE)