(74 days)
Not Found
No
The summary explicitly states "Not Found" for mentions of AI, DNN, or ML, and the device description focuses on standard hemofiltration technology.
Yes
The device is indicated for the "treatment of renal failure or fluid overload using hemofiltration and/or ultrafiltration," which directly addresses a medical condition or ailment, classifying it as therapeutic.
No
The device is indicated for treatment (hemofiltration and/or ultrafiltration) of renal failure or fluid overload, not for diagnosis.
No
The device description explicitly states that the LifeMate™ Hemofiltration System consists of hardware, software, and a sterile disposable cartridge, indicating it is not a software-only device.
Based on the provided information, the LifeMate™ Hemofiltration System is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for the treatment of renal failure or fluid overload using hemofiltration and ultrafiltration. This is a therapeutic treatment performed directly on the patient's blood, not a diagnostic test performed on a sample outside the body.
- Device Description: The description reinforces the therapeutic nature of the device, mentioning hardware, software, and a sterile disposable cartridge used for hemofiltration and ultrafiltration.
- Lack of Diagnostic Elements: There is no mention of analyzing biological samples (like blood, urine, etc.) to provide diagnostic information about a patient's condition. The device is used to filter and remove substances from the blood.
IVD devices are specifically designed to examine specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes. The LifeMate™ Hemofiltration System does not fit this description.
N/A
Intended Use / Indications for Use
The LifeMate™ Hemofiltration System is indicated for treatment of renal failure or fluid overload using hemofiltration and/or ultrafiltration. All treatments must be administered by a health care provider, under physician prescription.
Product codes (comma separated list FDA assigned to the subject device)
KDI
Device Description
The LifeMate™ Hemofiltration System, consisting of hardware, software and a sterile disposable cartridge, is indicated for treatment of renal failure or fluid overload using hemofiltration and/or ultrafiltration. All treatments must be administered by a health care provider, under physician prescription.
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
health care provider, under physician prescription.
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)
Design Verification testing has been performed to ensure that the modified device meets design specifications. The modified LifeMate™ System has been compared to the LifeMate™ System as cleared in K001283.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
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.
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.
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
KO12510 p.1/2
OCT 1 9 2001
Section 11
510(K) SUMMARY
Pursuant to §513(i)(3)(A) of the Food, Drug, and Cosmetic Act, NxStage, Inc. is required to submit with this Pre-Market Notification either an "... adequate summary of any information respecting safety and effectiveness or state that such information will be made available upon request of any person." NxStage chooses to submit a summary of information respecting safety and effectiveness.
| Date: | August 3, 2001 |
|---|---|
| Common/Usual Name: | Hemofiltration system |
| Trade/Proprietary Name: | LifeMate™ Hemofiltration System |
| Classification Name & | |
| Device Classification: | Dialyzer, High Permeabilty with or without |
| Dialysate System; Class II | |
| Product Code: | KDI |
| 21 CFR Ref.: | 876.5860 |
| Device Panel: | Gastroenterology-Urology (GU)/Gastro-Renal |
| (GRDB) | |
| 510(k) Sponsor & | |
| Owner/Operator: | NxStage Medical, Inc |
| 439 South Union St, Suite 501 | |
| S. Lawrence, MA 01843 | |
| Owner/Operator No. Not yet assigned | |
| Contact Person: | Karen St.Onge (Contact Person) |
| Director of Quality Assurance |
Device Description:
The LifeMate™ Hemofiltration System, consisting of hardware, software and a sterile disposable cartridge, is indicated for treatment of renal failure or fluid
Confidential
1
overload using hemofiltration and/or ultrafiltration. All treatments must be administered by a health care provider, under physician prescription.
Substantial Equivalence:
This submission is a Special 510(k): Device Modification as described in FDA's guidance document entitled "The New 510(k) Paradigm - Alternate Approaches to Demonstrating Substantial Equivalence in Pre-Market Notifications." In support of this 510(k), NxStage Medical has provided certification of compliance to 21 CFR 820.30 Design Control requirements, and a description of the internal Risk Analysis procedure. Design Verification testing has been performed to ensure that the modified device meets design specifications. The modified LifeMate™ System has been compared to the LifeMate™ System as cleared in K001283.
Conclusion:
Based on the device indications for use, comparison of descriptive and technological characteristics, and design control certification, the modified LifeMate™ Hemofiltration System has been shown to meet the minimum requirements that are considered acceptable for its intended use.
2
Image /page/2/Picture/1 description: The image is a black and white circular logo. The logo features the emblem of the U.S. Department of Health and Human Services. The emblem is a stylized image of an eagle with three lines representing its wings. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged around the upper half of the circle.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
OCT 1 9 2001
Ms. Karen St.Onge Director, Quality Assurance/ Regulatory Affairs NxSTAGE Medical, Inc. 439 South Union Street, Suite 501 Lawrence, Massachusetts 01843
Re: K012510
Trade/Device Name: LifeMate™ Hemofiltration System Regulation Number: 21 CFR §876.5860 Regulation Name: High permeability hemodialysis svstem Regulatory Class: II Product Code: 78 KDI Dated: September 18, 2001 Received: September 19, 2001
Dear Ms. St.Onge:
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 (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (sections 531-542 of the Act); 21 CFR 1000-1050.
3
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 | (301) 594-4591 |
|---|---|
| 876.2xxx, 3xxx, 4xxx, 5xxx | (301) 594-4616 |
| 884.2xxx, 3xxx, 4xxx, 5xxx, 6xxx | (301) 594-4616 |
| 892.2xxx, 3xxx, 4xxx, 5xxx | (301) 594-4654 |
| Other | (301) 594-4692 |
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 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 (800) 638-2041 or (301) 443-6597 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
4
SECTION 4
Indications for Use
Page _________________________________________________________________________________________________________________________________________________________________________
510(k) Number (if known): _ KO | 2510
LifeMate Hemofiltration System Device Name:
Indications for Use:
The LifeMate™ Hemofiltration System is indicated for treatment of renal failure or fluid overload using hemofiltration and/or ultrafiltration. All treatments must be administered by a health care provider, under physician prescription.
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
| (Division Sign-Off) |
|---|
| --------------------- |
Division of Reproductive, Abdominal,
and Radiological Devices
| 510(k) Number | K012510 |
|---|---|
| --------------- | --------- |
| Prescription Use | OR | Over-the -Counter Use | ____ | |
|---|---|---|---|---|
| (Per 21 CFR 801.109) |
ﺔ ﺍﻟﺘﺎﺭﻳﺦ ﺍﻟﺘﻲ ﺗﺘﻮﻗﻊ ﺍﻟﺘﻲ ﺗﺘﻮﻗﻊ ﺍﻟﺘﻲ ﺗﺘﻮﻗﻊ ﺍﻟﺘﻲ ﺗﻌﺘﺒﺮ ﺍﻟﻤﺪﻳﻨﺔ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ