(145 days)
The NxStage System One is indicated for treatment of renal failure or fluid overload using hemofiltration, hemodialysis and/or ultrafiltration. All treatments must be administered by a health care provider, under physician prescription.
The NxStage System One consists of the NxStage Cycler and the NxStage Cartridge Extracorporeal Blood and Fluid Circuit. The NxStage Cycler is an electro-mechanical device that interfaces with the NxStage Cartridge. The NxStage Cartridge is a single-use extracorporeal blood circuit and fluid management device that mounts integrally within the NxStage Cycler. The system is designed to deliver hemofiltration, hemodialysis and/or ultrafiltration.
The provided FDA 510(k) premarket notification for the NxStage System One does not contain specific acceptance criteria or a detailed study report with performance metrics, sample sizes, ground truth methodologies, or information about human reader studies commonly found in submissions for AI/ML-enabled medical devices.
Instead, this document focuses on demonstrating substantial equivalence to predicate devices through a qualitative comparison of technological characteristics and general performance testing. Therefore, I cannot provide a table of acceptance criteria or a detailed study description as requested for a typical AI/ML medical device submission.
Here's an analysis of what can be extracted from the document based on the provided questions:
1. A table of acceptance criteria and the reported device performance
The document does not specify quantitative acceptance criteria (e.g., sensitivity, specificity, AUC thresholds) or specific performance metrics in a tabular format. The FDA letter states: "We have reviewed your Section 510(k) premarket notification... and have determined the device is substantially equivalent... to legally marketed predicate devices." This implies the "acceptance criteria" were met by demonstrating equivalence, rather than achieving specific performance thresholds.
The "reported device performance" is summarized conceptually: "Results of the performance testing have documented that the proposed NxStage System One is substantially equivalent to the predicate devices and is suitable for the labeled indications for use." No specific performance values are given.
2. Sample size 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 mentions "Performance testing was conducted," but gives no details about the size or nature of any test sets used, the type of data, or its 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 applicable and not provided. The NxStage System One is a hemodialysis system, not an AI/ML diagnostic device requiring expert interpretation for ground truth establishment. The "performance testing" likely involved engineering and clinical functional assessments, not subjective expert reviews of output.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set
Not applicable and not provided, for the same reasons as point 3.
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
Not applicable. The NxStage System One is a standalone medical device for renal failure treatment, not an AI system designed to assist human readers (e.g., radiologists) in interpretation. Therefore, no MRMC study or AI assistance effect size is mentioned or relevant.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
While the device operates without a human-in-the-loop for its core function (delivering hemofiltration, hemodialysis, and/or ultrafiltration), the concept of "standalone performance" as it applies to an algorithm's diagnostic or prognostic capabilities is not relevant here. The device itself is a standalone system, and its performance was evaluated against predicate devices.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
The document does not detail the specific "ground truth" used for performance testing. Given the device type, "ground truth" would likely relate to objective measurements of system function, such as fluid removal rates, solute clearance, pressure monitoring accuracy, and safety parameters, compared to established medical standards and predicate device performance. It would not involve expert consensus on diagnostic images or pathology.
8. The sample size for the training set
Not applicable and not provided. The NxStage System One is not an AI/ML device that requires a "training set" in the conventional sense. Its design and validation would follow traditional engineering and clinical testing methodologies.
9. How the ground truth for the training set was established
Not applicable and not provided, for the same reasons as point 8.
In summary: The provided 510(k) summary focuses on demonstrating substantial equivalence of a hemodialysis system to existing devices through general performance testing and technological comparison. It predates the widespread regulatory focus on AI/ML devices and therefore does not contain the specific details about acceptance criteria, study designs, ground truth, or expert involvement typically associated with such submissions, as requested in your prompt.
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K030470
page 1 of 2
NxStage Medical, Inc. NxStage System One 510(k) Premarket Notification
Section VIII: 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:
JUL 0 7 2003
| Name: | NxStage Medical, Inc. |
|---|---|
| Address: | 439 South Union Street, Suite 50Lawrence, MA 01843 |
| Phone: | (978) 687-4700 |
| Fax: | (978) 687-4800 |
| Contact Person: | Norma LeMaySr. Regulatory Specialist |
| Date of Preparation: | January 30, 2003 |
B. Device Name:
| Trade Name: | NxStage System One |
|---|---|
| Common/Usual Name: | High Permeability Hemodialysis System |
| Classification Name: | System, Dialysate Delivery, Sealed (21 CFR875.5860, Product Code FII) |
C. Substantial Equivalence/Predicate Devices:
The proposed NxStage System One is substantially equivalent to the following legally marketed predicate devices previously cleared by FDA:
- NxStage Therapy System (K020858, cleared 04/17/02)
- B. Braun Diapact CRRT (K973322, cleared 11/10/98) .
- . Baxter (SPS), Model 550 (K872364, cleared 10/13/87)
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NxStage Medical, Inc. NxStage System One 510(k) Premarket Notification
Section VIII: Summary of Safety and Effectiveness
D. Device Description/Indications for Use:
The NxStage System One consists of the NxStage Cycler and the NxStage Cartridge Extracorporeal Blood and Fluid Circuit.
The NxStage Cycler is an electro-mechanical device that interfaces with the NxStage Cartridge. The NxStage Cartridge is a single-use extracorporeal blood circuit and fluid management device that mounts integrally within the NxStage Cycler. The system is designed to deliver hemofiltration, hemodialysis and/or ultrafiltration.
Indications for use:
The NxStage System One is indicated for treatment of renal failure or fluid overload using hemofiltration, hemodialysis and/or ultrafiltration. All treatments must be administered by a health care provider, under physician prescription.
E. Technological Characteristics:
The proposed device has the same technological characteristics and is similar in design and configuration as compared to the predicate devices. The proposed device is designed and assembled with components commonly found in the predicate devices.
F. Summary of Non-Clinical Test/Performance Testing
NxStage Medical 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 indications for use. Performance testing was conducted to characterize performance of the proposed NxStage System One to provide a basis of comparison to the predicate devices. Results of the performance testing have documented that the proposed NxStage System One is substantially equivalent to the predicate devices and is suitable for the labeled indications for use.
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Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized eagle with three stripes forming its body and wings. The eagle faces right and is enclosed within a circle. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged around the upper portion of the circle.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
JUL - 7 2003
NxStage Medical, Inc. c/o Intertek Testing Services Donald James Sherratt 70 Codman Hill Road BOXBOROUGH MA 01719
Re: K030470
Trade/Device Name: NxStage® System One Regulation Number: 21 CFR §876.5860 Regulation Name: High permeability hemodialysis system Product Code: 78 FII Dated: July 3, 2003 Received: July 7, 2003
Dear Mr. Sherratt:
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.
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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
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INDICATIONS FOR USE STATEMENT
Page 1 of 1
510(k) Number (if known):
510(k) Number (if known): `K030470
Device Name:
NxStage System One
Indications for Use:
The NxStage System One is indicated for treatment of renal failure or fluid overload using hemofiltration, hemodialysis 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 Prescription Use Over-The-Counter Use__________________________________________________________________________________________________________________________________________________________ OR (Per 21 CFR 801.109)
§ 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.”