RMI HEMOCONCENTRATOR PREFERENCE PACK

K970739 · Research Medical, Inc. · KDI · Jul 8, 1997 · Gastroenterology, Urology

Device Facts

• Record ID: K970739
• Device Name: RMI HEMOCONCENTRATOR PREFERENCE PACK
• Applicant: Research Medical, Inc.
• Product Code: KDI · Gastroenterology, Urology
• Decision Date: Jul 8, 1997
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 876.5860
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The RMI Hemoconcentrator Preference Pack is a medical device convenience pack that is intended to allow RMI customers to specify their preference for one or more of the following devices that will be provided in their hemoconcentrator pack: - Rinse-Required Hemoconcentrator with tubing set and prime lines, LCH-500-A - Pre-Rinsed BioFilter™ 140 Hemoconcentrator, HEM-001 - 24 inch Hemoconcentrator Tubing Set, TS-024 - 36 inch Hemoconcentrator Tubing Set, TS-036 - Hemoconcentrator Adapter Set, HEM-001 Adapters - Hemoconcentrator Waste Bag, WB-001 - BioFilter™ 140 with Adapter Set, HEM-001-A - BioFilter™ 140 with 24 inch Tubing Set, HEM-024 - BioFilter™ 140 with 36 inch Tubing Set, HEM-036 - BioFilter™ 140 with 24 inch Tubing Set and Waste Bag, HEM-024-B - BioFilter™ 140 with 36 inch Tubing Set and Waste Bag, HEM-036-B - Hemoconcentrator Pole Mount, HEM-01H The hemoconcentrator is intended for relief or mitigation of overhydration in patients undergoing cardiopulmonary bypass procedures and to decrease the concentration of plasma water in blood.

Device Story

Convenience pack containing various hemoconcentrator components, tubing sets, adapters, waste bags, and pole mounts. Used during cardiopulmonary bypass procedures to manage patient fluid balance. Operates by filtering blood to remove excess plasma water, thereby mitigating overhydration. Intended for clinical use by medical professionals in surgical settings. Components are pre-selected by the customer to suit specific procedural needs. Benefits include streamlined setup and availability of necessary hemoconcentration equipment.

Clinical Evidence

No clinical data provided; device is a convenience pack of previously cleared or pre-amendment components.

Technological Characteristics

Convenience pack containing hemoconcentrators, tubing, adapters, and waste collection bags. Components are standard medical-grade materials used in extracorporeal circuits. No electronic or software components. Sterilization is assumed to be consistent with the individual component specifications.

Indications for Use

Indicated for patients undergoing cardiopulmonary bypass procedures requiring relief or mitigation of overhydration and reduction of plasma water concentration in blood.

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 CV Personalized Hemoconcentration Packs (K823338)
• COBE CV 3 Liter Waste Bag For Filtrate Collection
• COBE CV Hemoconcentrator (K823338)
• Baxter Bentley HemoCon 1.3
• ALTREX® 140 Hemodialyzer (K945596)
• RMI Hemoconcentrator, HEM-140 (K951344)
• RMI Hemoconcentrator Tubing Set with adapters, TS-024 (K961927)
• Ultrafiltrate Waste Bag, WB-001 (K961927)

Submission Summary (Full Text)

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K970739
July 8, 1997

# Attachment II.A.

## SMDA Summary of Safety and Effectiveness Information

In compliance with requirements of the Safe Medical Device Act (SMDA) of 1990, the following information is submitted as a summary of safety and effectiveness information for this 510(k) premarket notification:

1. **Predicate Device Identification**: A claim of substantial equivalence of the RMI Hemoconcentrator Preference Pack, or components thereof, is made to the:

- COBE CV *Personalized* Hemoconcentration Packs, 510(k) number unknown [possibly K823338];
- COBE CV 3 Liter Waste Bag For Filtrate Collection, preamendment device;
- COBE CV Hemoconcentrator, K823338;
- Baxter Bentley HemoCon 1.3, 510(k) number unknown;
- ALTREX® 140 Hemodialyzer, K945596;
- RMI Hemoconcentrator, HEM-140, K951344; and
- RMI Hemoconcentrator Tubing Set with adapters, TS-024, and Ultrafiltrate Waste Bag, WB-001, K961927.

These devices were marketed prior to May 28, 1976 or have received FDA clearance to market since that date.

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Public Health Service

Food and Drug Administration
9200 Corporate Boulevard
Rockville MD 20850

Mr. R.D. Hibbert
Director, Clinical and Regulatory Affairs
Research Medical, Inc.
6864 South 300 West
Midvale, Utah 84047

Re: K970739
RMI Hemoconcentrator Preference Pack
Regulatory Class: III
Product Code: 78 KDI
Dated: February 25, 1997
Received: February 28, 1997

JUL - 8 1997

Dear Mr. Hibbert:

We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to 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). You may, therefore, market the device, subject to the general controls provisions of the Act. However, you are responsible to determine that the medical devices you use as components in the kit have either been determined as substantially equivalent under the premarket notification process (Section 510(k) of the act), or were legally on the market prior to May 28, 1976, the enactment date of the Medical Device Amendments. Please note: If you purchase your device components in bulk (i.e., unfinished) and further process (e.g., sterilize) you must submit a new 510(k) before including these components in your kit. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, and labeling, and prohibitions against misbranding and adulteration.

If your device is classified (see above) into either class II (Special Controls) or class III (Premarket Approval) 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 895. A substantially equivalent determination assumes compliance with the Good Manufacturing Practice for Medical Devices: General (GMP) regulation (21 CFR Part 820) and that, through periodic GMP inspections, FDA will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, the Food and Drug Administration (FDA) may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control 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 the labeling regulation (21 CFR Part 801 and additionally 809.10 for in vitro diagnostic devices), please contact 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

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Page 2 - Mr. R.D. Hibbert

general information on your responsibilities under 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,


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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Page ___ of ___

510(k) Number (if known): _______________

Device Name: RMI Hemoconcentrator Preference Pack

## Indications For Use:

The RMI Hemoconcentrator Preference Pack is a medical device convenience pack that is intended to allow RMI customers to specify their preference for one or more of the following devices that will be provided in their hemoconcentrator pack:

- Rinse-Required Hemoconcentrator with tubing set and prime lines, LCH-500-A
- Pre-Rinsed BioFilter™ 140 Hemoconcentrator, HEM-001
- 24 inch Hemoconcentrator Tubing Set, TS-024
- 36 inch Hemoconcentrator Tubing Set, TS-036
- Hemoconcentrator Adapter Set, HEM-001 Adapters
- Hemoconcentrator Waste Bag, WB-001
- BioFilter™ 140 with Adapter Set, HEM-001-A
- BioFilter™ 140 with 24 inch Tubing Set, HEM-024
- BioFilter™ 140 with 36 inch Tubing Set, HEM-036
- BioFilter™ 140 with 24 inch Tubing Set and Waste Bag, HEM-024-B
- BioFilter™ 140 with 36 inch Tubing Set and Waste Bag, HEM-036-B
- Hemoconcentrator Pole Mount, HEM-01H

The hemoconcentrator is intended for relief or mitigation of overhydration in patients undergoing cardiopulmonary bypass procedures and to decrease the concentration of plasma water in blood.

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

(Division Sign-Off)
*Handwritten signature: "Dale D. Selling"*

Division of Reproductive, Abdominal, ENT, and Radiological Devices

510(k) Number: **K97C739**

Prescription Use ☑ (Per 21 CFR 801.109)

OR

Over-The-Counter Use ☐ (Optional Format 1-2-96)

TOTAL P.02
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