(34 days)
Not Found
No
The summary describes a sterile dialysis solution and its intended use with renal replacement therapy systems. There is no mention of AI, ML, image processing, or any other technology typically associated with AI/ML in medical devices. The performance studies focus on design validation and substantial equivalence to a predicate device, not on algorithmic performance.
No
The device is a dialysis solution, which is a component used in renal replacement therapy systems, but it is not a therapeutic device itself. Its function is to facilitate the therapeutic process of dialysis by providing the necessary liquid medium.
No
This device is a dialysis solution used in renal replacement therapy systems, not a diagnostic tool for identifying a medical condition. Its purpose is therapeutic, not diagnostic.
No
The device description explicitly states it is provided in "single use flexible PVC bags" and varying sizes, indicating a physical product, not software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use/Indications for Use: The device is indicated for use with renal replacement therapy systems that utilize sterile premixed dialysate. This describes a therapeutic use (dialysis) rather than a diagnostic use (testing samples from the body to diagnose or monitor a condition).
- Device Description: The description focuses on the composition and packaging of a dialysis solution, which is a substance used in a medical procedure, not a test kit or instrument for analyzing samples.
- Lack of IVD Characteristics: The description does not mention any of the typical characteristics of an IVD, such as:
- Analyzing samples (blood, urine, tissue, etc.)
- Detecting or measuring substances in samples
- Providing information for diagnosis, monitoring, or prognosis
The device is a component used in a medical treatment (renal replacement therapy), not a diagnostic tool.
N/A
Intended Use / Indications for Use
The NxStage Pureflow Solution is indicated for use with renal replacement therapy systems that utilize sterile premixed dialysate.
Product codes
78 KPO
Device Description
The NxStage PureFlow Solutions are sterile, non-pyrogenic dialysis solutions provided in single use flexible PVC bags varying in sizes from 1000 to 5000ml. The dialysis solutions are intended for use with renal replacement therapy systems that utilize sterile premixed dialysate.
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)
Design validation testing has been performed to ensure that the modified device meets design specifications.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 876.5820 Hemodialysis system and accessories.
(a)
Identification. A hemodialysis system and accessories is a device that is used as an artificial kidney system for the treatment of patients with renal failure or toxemic conditions and that consists of an extracorporeal blood system, a conventional dialyzer, a dialysate delivery system, and accessories. Blood from a patient flows through the tubing of the extracorporeal blood system and accessories to the blood compartment of the dialyzer, then returns through further tubing of the extracorporeal blood system to the patient. The dialyzer has two compartments that are separated by a semipermeable membrane. While the blood is in the blood compartment, undesirable substances in the blood pass through the semipermeable membrane into the dialysate in the dialysate compartment. The dialysate delivery system controls and monitors the dialysate circulating through the dialysate compartment of the dialyzer.(1) The extracorporeal blood system and accessories consists of tubing, pumps, pressure monitors, air foam or bubble detectors, and alarms to keep blood moving safely from the blood access device and accessories for hemodialysis (§ 876.5540) to the blood compartment of the dialyzer and back to the patient.
(2) The conventional dialyzer allows a transfer of water and solutes between the blood and the dialysate through the semipermeable membrane. The semipermeable membrane of the conventional dialyzer has a sufficiently low permeability to water that an ultrafiltration controller is not required to prevent excessive loss of water from the patient's blood. This conventional dialyzer does not include hemodialyzers with the disposable inserts (Kiil type) (§ 876.5830) or dialyzers of high permeability (§ 876.5860).
(3) The dialysate delivery system consists of mechanisms that monitor and control the temperature, conductivity, flow rate, and pressure of the dialysate and circulates dialysate through the dialysate compartment of the dialyzer. The dialysate delivery system includes the dialysate concentrate for hemodialysis (liquid or powder) and alarms to indicate abnormal dialysate conditions. This dialysate delivery system does not include the sorbent regenerated dialysate delivery system for hemodialysis (§ 876.5600), the dialysate delivery system of the peritoneal dialysis system and accessories (§ 876.5630), or the controlled dialysate delivery system of the high permeability hemodialysis system § 876.5860).
(4) Remote accessories to the hemodialysis system include the unpowered dialysis chair without a scale, the powered dialysis chair without a scale, the dialyzer holder set, dialysis tie gun and ties, and hemodialysis start/stop tray.
(b)
Classification. (1) Class II (performance standards) for hemodialysis systems and all accessories directly associated with the extracorporeal blood system and the dialysate delivery system.(2) Class I for other accessories of the hemodialysis system remote from the extracorporeal blood system and the dialysate delivery system, such as the unpowered dialysis chair, hemodialysis start/stop tray, dialyzer holder set, and dialysis tie gun and ties. The devices subject to this paragraph (b)(2) are exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 876.9.
0
K03386
Page 1 of 2
NOV 26 2003
SECTION 7
510(K) SUMMARY OF SAFETY EFFECTIVENESS
This 510(k) summary of safety and effectiveness information is being submitted in accordance with the requirements of the Safe Medical Device Act (SMDA) of 1990. The contents of this 510(k) summary have been provided in conformance with 21 CFR $807.92.
| Date: | October 22, 2003 |
|---|---|
| Common/Usual Name: | Pre-mixed Dialysate |
| Trade/Proprietary Name: | NxStage PureFlow Solution |
| Classification Name: | Hemodialysis systems and accessories (21 CFR |
| 876.5820) | |
| Device Classification: | |
| Product Code: | Class II |
| 78 KPO - Dialysate Concentrate for Hemodialysis | |
| (Liquid or Powder) | |
| Device Panel: | Gastroenterology-Urology (GU)/Gastro-Renal |
| (GRDB) | |
| 510(k) Sponsor & | |
| Owner/Operator: | NxStage Medical, Inc |
| 439 South Union St, Suite 501 | |
| Lawrence, MA 01843 | |
| Owner/Operator No. 9045797 | |
| Contact Person: | Norma LeMay |
| Regulatory Affairs Manager |
Device Description:
The NxStage PureFlow Solutions are sterile, non-pyrogenic dialysis solutions provided in single use flexible PVC bags varying in sizes from 1000 to 5000ml. The dialysis solutions are intended for use with renal replacement therapy systems that utilize sterile premixed dialysate.
1
Page 2 of 2
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. Design validation testing has been performed to ensure that the modified device meets design specifications. The modified NxStage PureFlow Solution has been compared to the baseline as cleared in K022913 and found to be substantial equivalent.
Conclusion:
Based on the device indications for use, comparison of descriptive and technological characteristics, and design control certification, the modified NxStage PureFlow Solution 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 shows the seal of the Department of Health & Human Services (HHS). The seal features a stylized eagle with three stripes representing the three branches of government. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular pattern around the eagle.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
NOV 26 2003
Ms. Norma LeMay Regulatory Affairs Manager NxStage Medical, Inc. 439 South Union Street, Suite 501 LAWRENCE MA 01843
Re: K033386
Trade/Device Name: NxStage PureFlow Solution Regulation Number: 21 CRR §876.5820 Regulation Name: Hemodialysis system and accessories Regulatory Class: II Product Code: 78 KPO Dated: October 22, 2003 Received: October 27, 2003
Dear Ms. LeMay:
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 Section 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 the 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" (21CFR Part 807.97) you may obtain. 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
Page 2
4
INDICATIONS FOR USE STATEMENT
Page __ 1__ of __ 1__
510(k) Number (if known): Ko3 3386
NxStage PureFlow Solution Device Name:
Indications for Use:
The NxStage Pureflow Solution is indicated for use with renal replacement therapy systems that utilize sterile premixed dialysate.
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use J (Per 21 CFR 801.109) OR
Over-the -Counter Use _
David G. Ingram
Vision of Reproductive
510(k) Number