(90 days)
Not Found
No
The device description and intended use are for a chemical concentrate used to create dialysate, with no mention of software, algorithms, or any computational processing that would involve AI/ML. The "Mentions AI, DNN, or ML" field is explicitly "Not Found".
No.
The device is a concentrate that, when diluted, forms dialysate for renal replacement therapy, which is a supportive treatment rather than a therapeutic device that directly treats, cures, or prevents disease.
No
Explanation: The device is a concentrate that, when diluted, creates a dialysate for use in renal replacement therapy. It is a therapeutic agent and not used for diagnosing medical conditions.
No
The device description clearly states it is a physical concentrate provided in vials, which is a hardware component, not software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for "renal replacement therapy systems that utilize sterile premixed dialysate." This describes a therapeutic use, not a diagnostic one.
- Device Description: The device is a concentrate that is diluted to create a dialysate. Dialysate is a solution used in dialysis to remove waste products and excess fluid from the blood. This is a treatment, not a diagnostic test.
- Lack of Diagnostic Elements: There is no mention of analyzing samples (blood, urine, etc.) to provide information about a patient's health status or disease. The device itself is a component used in a therapeutic process.
IVD devices are used to examine specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes. This device does not fit that description.
N/A
Intended Use / Indications for Use
NxStage Dialysate Concentrate, after dilution, is indicated for use with renal replacement therapy systems that utilize sterile premixed dialysate.
Product codes
78 KPO
Device Description
NxStage Dialysate Concentrate is a clear, sterile, non-pyrogenic concentrate, provided in 150 ml unit-dose vials, which, when diluted with sterile water in the required proportions, creates a dialysate for use in renal replacement therapy. When diluted, NxStage Dialysate Concentrate yields a dialysate with the following composition: Sodium 140.0 mEq/L; Calcium 3.0 mEq/L; Potassium 2.0 mEq/L; Magnesium 1,0 mEq/L; Chloride 111.0 mEq/L; L-Lactate 35.0 mEq/L.
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)
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
K013655 pgΣ 1 of 3
NxStage Medical, Inc. Dialysate Concentrate 510(k) Premarket Notification
FEB 0 4 2002
Section VI: Summary of Safety and Effectiveness
This 510(k) Summary of Safety and Effectiveness is being submitted in accordance with the requirements of SMDA 1990.
A. Submitter's Information:
| Name: | NxStage Medical, Inc. |
|---|---|
| Address: | 439 South Union Street, Suite 501 |
| Lawrence, MA 01843 | |
| Phone: | 1-978-687-4700 |
| Fax: | (978) 687-4800 |
| Contact Person: | Karen St. Onge, |
| Director, Quality Assurance/Regulatory Affairs | |
| Date of Preparation: | 1 February 2002 |
B. Device Name:
| Trade Name: | NxStage Dialysate Concentrate |
|---|---|
| Common/Usual Name: | Dialysate Concentrate for Hemodialysis |
| (Liquid or Powder) | |
| Classification Name: | Dialysate Concentrate for Hemodialysis |
| (Liquid or Powder) |
C. Predicate Device Name:
The predicate devices for the NxStage Dialysate Concentrate are:
- NormoCarb Sterile Bicarbonate Concentrate (#K001059, 6/30/2000); ●
- Baxter Premixed Dialysate for Hemodiafiltration (#K910270, 4/18/1991). .
D. Device Description/Indications for Use:
NxStage Dialysate Concentrate is a clear, sterile, non-pyrogenic concentrate, provided in 150 ml unit-dose vials, which, when diluted with sterile water in the required proportions, creates a dialysate for use in renal replacement therapy. When diluted, NxStage Dialysate Concentrate yields a dialysate with the following composition:
- Sodium 140.0 mEq/L; �
- Calcium 3.0 mEq/L; .
- Potassium 2.0 mEq/L ; ●
- Magnesium 1,0 mEq/L; .
- Chloride 111.0 mEq/L; .
- L-Lactate 35.0 mEq/L.
1
KO19655
NxStage Medical. Inc. Dialysate Concentrate 510/k) Premarket Notification
Section VI: Summary of Safety and Effectiveness
Intended Use
NxStage Dialysate Concentrate, after dilution, is indicated for use with renal replacement therapy systems that utilize sterile premixed dialysate.
E. Substantial Equivalence:
510(k) Substantial Equivalence Decision Making Process
1. Is the product a device?
YES - NxStage Dialysate Concentrate is a device pursuant to 21 CFR §201 [321] (h).
2. Does the new device have the same intended use?
YES - The intended use for the NxStage Dialysate Concentrate is equivalent to those for the predicate dialysis concentrates.
NxStage Dialysate Concentrate
NxStage Dialysate Concentrate, after dilution, is indicated for use with renal replacement therapy systems that utilize sterile premixed dialysate.
NormoCarb Sterile Bicarbonate Concentrate (#K001059)
Normocarb, after dilution, is indicated for use in Continuous Renal Replacement Therapy (CRRT).
Baxter Premixed Dialysate for Hemodiafiltration (#K910270)
Baxter Premixed Dialysate is indicated for acute dialysis modalities such as continuous arteriovenous hemodiafiltration (CAVHD), and continuous venousvenous hemodiafiltration (CVVHD), when treating acute renal failure patients with hypervolemia and uremia that requires high solute clearance.
3. Does the device have technological characteristics that raise new types of safety or effectiveness questions?
NO - The composition of the NxStage Dialysate Concentrate is equivalent to that of other commercially available hemodialysis concentrates and raises no new types of safety or effectiveness questions. In addition, the packaging, isterility status and method of preparation are equivalent to those of the NormoCarb Sterile Bicarbonate Concentrate.
2
K013655 page 3 of 3
NxStage Medical, Inc. Dialysate Concentrate 510(k) Premarket Notification
Section VI: Summary of Safety and Effectiveness
4. Does descriptive or performance information demonstrate equivalence?
YES - NxStage Medical, Inc. believes that the information provided in this submission clearly describes the NxStage Dialysate Concentrate and demonstrates that it is substantially equivalent to other commercially available hemodialysis concentrates.
F. Satety Summary
Both the vial label and Instructions for Use include indications for uso, cautions and both the vial labor and motions instructions required for proper use of NxStage Dialysate Concentrate. In addition, "Medication Added" labels are provided for customer use. This information promotes safe and effective use of the device.
3
Image /page/3/Picture/1 description: The image is a black and white logo. The logo is circular in shape and contains text around the perimeter. The text reads "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA". In the center of the circle is a symbol that resembles three curved lines, possibly representing a stylized wing or a similar design.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
FEB 0 4 2002
Ms. Karen St. Onge Director, Quality Assurance NxSTAGE Medical, Inc. 439 S. Union St., 5th Floor LAWRENCE MA 01843
Re: K013655
Trade/Device Name: NxStage Dialysate Concentrate Regulation Number: 21 CFR §876.5820 Regulation Name: Hemodialysis system and accessories Regulatory Class: II Product Code: 78 KPO Dated: November 2, 2001 Received: November 6, 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. Iisting 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.
4
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
5
Indications for Use Statement
Page 1 of 1
510(k) Number (if known): K013655
NxStage Dialysate Concentrate Device Name:
Indications for Use:
NxStage Dialysate Concentrate, after dilution, 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 | |
|---|---|
| Use | |
| (Per 21 CFR 801.109) |
OR
Over-The-Counter
David G. Ferguson
(Division Sign-Off
Division of Reproductive, Abdominal,
and Radiological Devices
510(k) Number
004