(130 days)
No
The provided text describes a medical device convenience pack containing various hemoconcentrator components and accessories. There is no mention of any software, algorithms, or capabilities that would suggest the use of AI or ML. The device's function is purely mechanical/filtration based.
Yes
The hemoconcentrator is intended for "relief or mitigation of overhydration in patients undergoing cardiopulmonary bypass procedures," which is a therapeutic purpose.
No
The description states 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," which indicates a therapeutic rather than diagnostic function.
No
The device description and intended use clearly list multiple physical components (hemoconcentrators, tubing sets, waste bags, pole mounts) which are hardware, not software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use describes the device's function in relieving or mitigating overhydration and decreasing plasma water concentration in blood during cardiopulmonary bypass procedures. This is a therapeutic intervention performed directly on the patient's blood outside the body, but it's not for the purpose of diagnosing a condition.
- Lack of Diagnostic Purpose: The description does not mention any use for analyzing samples (blood, urine, etc.) to provide information for diagnosis, monitoring, or screening.
- Device Type: Hemoconcentrators are devices used in extracorporeal circulation to remove excess fluid from blood. This is a treatment, not a diagnostic test.
IVD devices are specifically designed to examine specimens derived from the human body to provide information for diagnostic purposes. This device's function falls outside of that definition.
N/A
Intended Use / 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 BioFilterTM 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
- BioFilterTM 140 with Adapter Set, HEM-001-A -
- BioFilterTM 140 with 24 inch Tubing Set, HEM-024 (
- BioFilter TM 140 with 36 inch Tubing Set, HEM-036 I
- BioFilterTM 140 with 24 inch Tubing Set and Maste Bag, HEM-O24-B
- Biofilter TM 140 with 36 inch Tubing Set and Waste Bag, HEM-024-B
- Hemoconcentrator Pole Mount, WEW OV
- Hemoconcentrator Pole Mount, HEM-OIH
The hemoconcentrator is intended for relief or mitigation of overhadration in patients undergoing cardiopulmonary bypass procedures and to decrease the concentration of plasma water in blood.
Product codes
78 KDI
Device Description
Not Found
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Not Found
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
COBE CV Personalized Hemoconcentration Packs, 510(k) number unknown; 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; RMI Hemoconcentrator Tubing Set with adapters, TS-024, and Ultrafiltrate Waste Bag, WB-001, K961927
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc)
Not Found
§ 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.”
0
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:
- Predicate Device Identification: A claim of substantial equivalence of the RMI 1. 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; t
- 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.
1
Image /page/1/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized eagle with outstretched wings, symbolizing protection and care. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular fashion around the eagle. The logo is printed in black and white.
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 84047 ··· Midvale, Utah
K970739 Re: RMI Hemoconcentrator Preference Pack Requlatory 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 However, you are responsible to determine that the medical devices you use Act. 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 leqally 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 notitication 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 ictter 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 (301) 594-4616. 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" (21 CFR 807.97). Other
2
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 (800) 638-2041 or (301) 443-6597, or at its internet address "http://www.fda.gov/cdrh/dsmamain.html".
Sincerely yours,
Robert R. Ratliff
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
3
510(k) Number (if known):
RMI Hemoconcentrator Preference Pack Device Name:
dications 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 :
દર તુવુદ
- Rinse-Required Hemoconcentrator with tubing set and prime lines, LCH-500-A
- Pre-Rinsed BioFilterTM 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
- BioFilterTM 140 with Adapter Set, HEM-001-A -
- BioFilterTM 140 with 24 inch Tubing Set, HEM-024 (
- BioFilter™ 140 with 36 inch Tubing Set, HEM-036 I
- BioFilterTM 140 with 24 inch Tubing Set and Maste Bag, HEM-O24-B
- Biofilter TM 140 with 36 inch Tubing Set and Waste Bag, HEM-024-B
Hemoconcentrator Pole Mount, WEW OV - Hemoconcentrator Pole Mount, HEM-OIH
The hemoconcentrator is intended for relief or mitigation of overhadration 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)
Daker D. Rethmel
Division of Reproductive, Abdominal, ENT, and Radiological Devices
Prescription Use
(Per 21 CFR 801.109)
OR
Over-The-Counter Use
(Optional Format 1-2-96)