(71 days)
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No
The description focuses on the physical components and performance characteristics of a hemoconcentrator, a device for fluid removal. There is no mention of AI, ML, image processing, or any data-driven decision-making processes.
Yes
The device is intended to remove excess fluid during and/or following cardiopulmonary bypass procedures, which is a therapeutic intervention.
No.
The device is described as an "ultrafiltration system to remove excess fluid," not to diagnose a condition. Its function is to filter blood, as indicated by "remove excess fluid" and "determine device effectiveness as a hemoconcentrator."
No
The device description clearly states it is a hardware device made of physical components like membranes, chambers, and tubing.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is to remove excess fluid during and/or following cardiopulmonary bypass procedures. This is a therapeutic procedure performed on a patient's blood outside the body, but it's not for the purpose of diagnosing a condition.
- Device Description: The description details a system for filtering blood, not for analyzing biological samples to provide diagnostic information.
- Lack of Diagnostic Elements: There is no mention of analyzing samples, detecting biomarkers, or providing any kind of diagnostic result.
- Performance Studies: The performance studies focus on the device's ability to filter fluid (ultrafiltration rate, pressure drop, protein rejection), which are related to its function as a hemoconcentrator, not a diagnostic tool.
IVD devices are specifically designed to examine specimens (like blood, urine, tissue) from the human body to provide information for the diagnosis, monitoring, or treatment of a disease or condition. The Hemocor HPH® Hemoconcentrator's function is to physically remove fluid from blood during a medical procedure.
N/A
Intended Use / Indications for Use
The Hemocor HPH® Hemoconcentrator is intended for use as an ultrafiltration system to remove excess fluid during and/or following cardiopulmonary bypass procedures where acute hemodilution has been employed.
Product codes (comma separated list FDA assigned to the subject device)
78 KDI
Device Description
The Minntech I lemocor HPI 700 Hemoconcentrator is made of glycerin-free, microporous, hollow fiber, polysulfone membrane encased in a polycarbonate chamber meroporous, notiow troot, porty and polycarbonate blood port header caps. The FIPE 700 TS device has attached PVC 1/4" tubing and accessory polycarbonate adapters for blood path connection. The no-rinse device feature provides versatility for inscrtion of the hemococentrator into the extracorporeal circuit.
Mentions image processing
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Mentions AI, DNN, or ML
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Input Imaging Modality
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Anatomical Site
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Indicated Patient Age Range
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Intended User / Care Setting
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Description of the training set, sample size, data source, and annotation protocol
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Description of the test set, sample size, data source, and annotation protocol
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Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
The following performance testing was conducted to determine device effectiveness as a hemoconcentrator: Ultrafiltration Rate vs. Transmembrane Pressure, Pressure Drop vs. Blood Flow Rate, Protein Rejection, Minimum Blood Flow Rate & Blood Path Integrity.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
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Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Hemocor HPH® 1000 Hemoconcentrator
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
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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).
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§ 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
K78 3085
Nov 1 3 1998
510(k) SUMMARY
Submitter Information: 1.
| Name: | Minntech Corporation |
|---|---|
| Address: | 14605 28th Avenue North, Minneapolis, Minnesota 55447 |
| Contact Person: | Mark Murphy |
| Date Prepared: | September 1, 1998 |
Device Name: 2.
| Proprietary name: | Minntech Hemocor HPH® 700 Hemoconcentrator and Tubing Set |
|---|---|
| Common name: | Hemoconcentrator |
| Classification name: | Dialyzer, High Permeability per 21 CFR 876.5860 |
3. Predicate Device:
Hemocor HPH® 1000 Hemoconcentrator
4. Device Description:
The Minntech I lemocor HPI 700 Hemoconcentrator is made of glycerin-free, microporous, hollow fiber, polysulfone membrane encased in a polycarbonate chamber meroporous, notiow troot, porty and polycarbonate blood port header caps. The FIPE 700 TS device has attached PVC 1/4" tubing and accessory polycarbonate adapters for blood path connection. The no-rinse device feature provides versatility for inscrtion of the hemococentrator into the extracorporeal circuit.
న్. Indications for Use:
| Device | Indications |
|---|---|
| Minntech HPH® 700 | |
| Hemoconcentrator | The Hemocor HPH® Hemoconcentrator is intended for |
| use as an ultrafiltration system to remove excess fluid | |
| during and/or following cardiopulmonary bypass | |
| procedures where acute hemodilution has been employed. |
DE 1 of 2
1
6. Technological Characteristics:
| Characteristic | Hemocor HPH® 700 | Hemocor HPH® 1000 |
|---|---|---|
| Hemoconcentrator | Hemoconcentrator | |
| Housing | Polycarbonate | Polycarbonate |
| Potting Material | Polyurethane | Polyurethane |
| Membrane | Polysulfone | Polysulfone |
| Membrane Surface Arca | 0.7 m² | 1.06 m² |
| Maximum Transmembrane | ||
| Pressure (mmHg) | 500 | 500 |
| Max. Blood Flow rate (ml/min) | 500 | 500 |
| Min. Blood Flow rate (ml/min) | 50 | 100 |
| Priming volume (ml) | 58 | 70 |
| Molecular weight cut-off | ||
| (daltons) | 65000 | 65000 |
A comparative summary of the Hemocor HPH® 700 and predicate device is as follows:
7. Performance Testing:
The following performance testing was conducted to determine device effectiveness as a hemoconcentrator: Ultrafiltration Rate vs. Transmembranc Pressure, Pressure Drop vs. Blood Flow Rate, Protein Rejection, Minimum Blood Flow Rate & Blood Path Integrity.
2
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Image /page/2/Picture/2 description: The image shows a logo for the Department of Health and Human Services. The logo features a stylized eagle with three lines representing its wings. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES" is arranged in a circular fashion around the eagle.
NOV 1 3 1998
Mr. Mark Murphy Regulatory Affairs Associate MINNTECH®Corporation 14605 28th Avenue North Minneapolis, MN 55447
Re: K983085 Hemocor HPH® 700 Hemoconcentrator and Tubing Set Dated: September 1, 1998 Received: September 3, 1998 Regulatory Class: III 21 CFR 876.5860/Procode: 78 KDI
Dear Mr. Murphy:
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. The general controls provisions of the Act include ಿಗೆ ಮಾಡಿದ್ದಾರೆ.
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 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 Current Good Manufacturing Practice requirements, as set forth in the Quality System Regulation (OS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic QS inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, 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 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 our labeling regulation (21 CFR Part 801 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4613. 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 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/dsmaldsmamain.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
3
Indications for Use
510(k) Number (if known):
Device Name:
Hemocor HPH 700 Hemoconcentrator
Indications for Use:
The Hemocor HPH 700 Hemoconcentrator is intended for use as an ultrafiltration system to remove excess fluid during and/or following cardiopulmonary bypass procedures where acute hemodilution is employed.
(PLEASE DO NOT WRITE BELOW THIS LINE- CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use (Per 21 CFR 801.109)
OR
Over-the -counter-use (Optional Format 1-2-96)
William Yin
(Division Sign-Off)
vision of Reproductive, Abdominal, E nd Radiological Dev 510(k) Number