(94 days)
The NxStage Dialysate Preparation Module is an optional accessory to the NxStage System One that prepares dialysate for use during hemodialysis, as prescribed by the physician.
Device Booonproniment and optional accessory to the NxStage System The NAGtage Dialyone in that mixes with concentrate to produce One that pro treats crequirements of the ANSI/AAMI Standards, RD52:2004 and The dialysate is to be used with the NxStage System One during RD62:2001. hemodialysis therapies.
The provided text describes a 510(k) premarket notification for the NxStage Dialysate Preparation Module, not a study evaluating acceptance criteria or device performance in the typical sense of a clinical or algorithmic study.
Therefore, most of the requested information cannot be extracted from this document, as it pertains to a regulatory submission demonstrating substantial equivalence to predicate devices, rather than a detailed performance study with quantifiable acceptance criteria and results.
However, based on the document, I can provide the following:
1. A table of acceptance criteria and the reported device performance
The document does not specify quantitative acceptance criteria. Instead, it states that the device's performance was characterized to enable comparison to predicate devices, focusing on demonstrating substantial equivalence.
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| Adherence to ANSI/AAMI Standards (RD52:2004 and RD62:2001) | The device "pro treats requirements of the ANSI/AAMI Standards, RD52:2004 and RD62:2001." |
| Produces AAMI dialysate from purified AAMI water and AAMI concentrate | The device "uses purified AAMI water that mixes with AAMI concentrate to produce AAMI dialysate." |
| Incorporates proper safety features (conductivity measurement, automatic safety clamp, mix to use timer, ultrafilters and I.V. sterilization filters to insure dialysate purity) | The device "incorporates the proper safety features, such as conductivity measurement, automatic safety clamp, mix to use timer, and ultrafilters and I.V. sterilization filters to insure dialysate purity." |
| Safe for intended use as an optional accessory to the NxStage System One during hemodialysis | "Verification and Validation testing, which includes simulated use testing, sufficiently demonstrates that the Prep Module can be used safely as intended." |
| Substantially equivalent to predicate devices | "Results of the testing presented in this 510(k) have demonstrated that the NxStage Prep Module is substantially equivalent to the predicate devices and is suitable for the labeled indication for use." |
2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
This information is not provided in the document. The submission references "Verification and Validation testing" and "simulated use testing," but does not specify sample sizes, specific test sets, or data provenance.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
This information is not provided as the submission does not detail ground truth establishment by experts. The "ground truth" here is regulatory compliance and functional performance against standards.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
This information is not provided.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
This is not applicable. The device is a medical accessory (Dialysate Preparation Module), not an AI or imaging device that would typically involve human readers or MRMC studies.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
This is not applicable. The device is a hardware accessory; there is no "algorithm only" performance concept in this context.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
The "ground truth" indirectly used here is adherence to industry performance standards (ANSI/AAMI RD52:2004 and RD62:2001) for dialysate quality and the successful functioning of safety features, as well as comparison to legally marketed predicate devices. It is based on engineering and functional testing rather than clinical outcomes or expert consensus on diagnostic interpretations.
8. The sample size for the training set
This information is not provided. This is not an AI/machine learning device, so the concept of a "training set" is not applicable.
9. How the ground truth for the training set was established
This is not applicable as there is no training set for this device.
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NxStage Medical, Inc. NxStage Dialysate Prep Module MAR 1 7 2005 510(k) Premarket Notification
K043436
Page 1 of 2
Section VIII: 510(k) Summary of Safety & 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 501Lawrence, MA 01843 |
| Phone: | (978) 687-4700 |
| Fax: | (978) 687-4800 |
| Contact Person: | Norma LeMayManager, Regulatory Affairs |
| Date of Preparation: | December 10, 2004 |
B. Device Name:
| Trade Name: | NxStage Dialysate Preparation Module |
|---|---|
| Common/Usual Name: | Subsystem, proportioning |
| Classification Name: | Hemodialysis System & Accessories (Class Imedical device under 21 CFR 875.5820, (ProductCode 78 FKR) |
C. Substantial Equivalence/Predicate Devices:
The NxStage Dialysate Prep Module is substantially equivalent to the following legally marketed predicate devices previously cleared by FDA:
- Aksys PHD System, K010131 (cleared on 03/26/02) .
- Fresenius 2008K Hemodialysis System, K994267 (cleared on 03/16/00) .
- Gambro Bicarbonate Module BCM-10, K810127 (cleared on 02/25/81) .
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NxStage Medical, Inc. NxStage Dialysate Prep Module 510(k) Premarket Notification
K043436
Page 2 of 2
Section VIII: 510(k) Summary of Safety & Effectiveness
D. Device Description/Indications for Use:
Device Booonproniment and optional accessory to the NxStage System The NAGtage Dialyone in that mixes with concentrate to produce One that pro treats crequirements of the ANSI/AAMI Standards, RD52:2004 and The dialysate is to be used with the NxStage System One during RD62:2001. hemodialysis therapies.
Indications for use:
The NxStage Dialysate Preparation Module is an optional accessory to the NxStage rne NAGtago Dialysate for use during hemodialysis, as prescribed by the physician.
There are no known contraindications with the use of the NxStage Dialysate Preparation Module.
E. Technological Characteristics:
The proposed Prep Module has the same technological characteristics and is similar in design and configuration as compared to the predicate devices. It uses purified AAMI water that mixes with AAMI concentrate to produce AAMI dialysate. The proposed device is designed and assembled with components commonly found in the predicate devices. Importantly, the NxStage Prep Module incorporates the proper safety features, such as conductivity measurement, automatic safety clamp, mix to use timer, and ultrafilters and I.V. sterilization filters to insure dialysate purity.
F. Summary of Non-Clinical Test/Performance Testing
NxStage believes that the information and data provided in this submission clearly describes the proposed device and demonstrates that the device is adequately designed for the labeled indication for use.
As there is no technological differences as compared to the predicate devices, performance testing was deemed appropriate and was conducted to characterize the performance of the proposed Prep Module to provide a basis of comparison to the predicate devices. The Prep Module utilizes FDA cleared devices with minor modifications, and additional components which are simple to operate using the Verification and Validation testing, which includes provided device labeling. simulated use testing, sufficiently demonstrates that the Prep Module can be used safely as intended. All testing performed is summarized in Section V of this 510(k) submission. Results of the testing presented in this 510(k) have demonstrated that the NxStage Prep Module is substantially equivalent to the predicate devices and is suitable for the labeled indication for use.
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Image /page/2/Picture/1 description: The image shows a circular seal or logo. The seal features an abstract image of a bird in flight, composed of three curved lines. Encircling the bird is text that reads "DEPARTMENT OF HEALTH & HUMAN SERVICES U.S.A."
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
MAR 1 7 2005
Ms. Norma LeMay Manager, Regulatory Affairs NxStage® Medical, Inc. 439 South Union Street, 5th Floor LAWRENCE MA 01843
Re: K043436
K043430
Trade/Device Name: NxStage® Dialysate Preparation Module Regulation Number: 21 CFR §876.5820 Regulation Name: Hemodialysis system and accessories Regulatory Class: II Product Code: 78 KPO and FKR Dated: March 3, 2005 Received: March 4, 2005
Dear Ms. LeMay:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced we have review of your better of substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to the cholosate) to regary mantowa of the Medical Device Amendments, or to devices that have been ready 20, 1776, the chance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that recrassition in accercation in premarket approval application (PMA). You may, therefore, market the do not require upproval er a ve visions of the Act. The general controls provisions of the Act de fice, subjoct to the general 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 (Premarket It your devise is elective (t to such additional controls. Existing major regulations affecting your Applorary, the lia) 00 bely works 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 I reast of advised that 127 i our 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 I carral statues and regulations association and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set forth in the quality systems (QS) (21 CFR Part 801); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
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This letter will allow you to begin marketing your device as described in your Section 510(k) This letter will allow you to begin marketing your actrice of your device of your device to a legally
premarket notification. The FDA finding of substantial equipand this pe premarket notification. The FDA Imaling of substantial equivalent of your device to proceed to the market.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please If you desire specific advice for your device on our labering regarantists.
contact the Office of Compliance at one of the following numbers, based on the regulation number a the top of this letter:
| 21 CFR 876.xxxx | (Gastroenterology/Renal/Urology) | 240-276-0115 |
|---|---|---|
| 21 CFR 884.xxxx | (Obstetrics/Gynecology) | 240-276-0115 |
| 21 CFR 892.xxxx | (Radiology) | 240-276-0120 |
| Other | 240-276-0100 |
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Also, please note the regulation entitled, "onsonmants" of the sunder the Act from the 807.97). You may obtain other gelleral intornation on your respeared its toll-free number (800)
Division of Small Manufacturers, International and Consumer Assistance at its Division of Small 1143-6597 or at its Internet address 056-2041 or (2019/01/2019/11/industry/support/index.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
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Indications for Use
| 510(k) Number (if known): | K043436 |
|---|---|
| Device Name: | NxStage Dialysate Preparation Module |
| Indications for Use: | The NxStage Dialysate Preparation Module is an optionalaccessory to the NxStage System One that preparesdialysate for use during hemodialysis, as prescribed by thephysician. |
Prescription Use _____________________________________________________________________________________________________________________________________________________________ Use (Part 21 CFR 801 Subpart D)
Over-The-Counter AND/OR
(21 CFR 807 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Nancy C. Brogdon
(Division Sign-Off)
Division of Reproductive, Abdominal, and Radiological Devices 510(k) Number _
Page 1 of 1
§ 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.