(109 days)
Not Found
No
The summary describes a simple electro-mechanical warming unit and disposable set, with no mention of AI, ML, or related concepts.
No.
The device's intended use is to warm dialysate, which is an accessory function to a therapeutic system (NxStage System One) but not a therapeutic action itself. It does not directly treat or diagnose a medical condition.
No
The device is described as an accessory to warm dialysate prior to administration, which is a treatment function, not a diagnostic one. It does not perform any analysis or detection of medical conditions.
No
The device description explicitly states that the device consists of an "electro-mechanical warming unit" and a "single-use disposable," indicating the presence of hardware components.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is to "warm dialysate prior to administration." Dialysate is a fluid used in dialysis to remove waste products from the blood. This is a therapeutic process, not a diagnostic one.
- Device Description: The description reinforces that it warms dialysate and is not used to warm blood or blood products. IVDs typically involve testing biological samples like blood, urine, or tissue to diagnose or monitor a condition.
- Lack of Diagnostic Elements: There is no mention of analyzing biological samples, detecting analytes, or providing diagnostic information.
Therefore, the NxStage Travel Warmer and Travel Warmer Disposable Set are accessories used in a therapeutic procedure (dialysis) and do not fit the definition of an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The NxStage Travel Warmer and Travel Warmer Disposable Set are accessories to the NxStage System One used to warm dialysate prior to administration.
Product codes (comma separated list FDA assigned to the subject device)
78 FLA
Device Description
The NxStage Travel Warmer and Travel Warmer Disposable Set are accessories to the NxStage System One used to warm dialysate. The Travel Warmer is for use with the NxStage System One only and is not used to warm blood or blood products. The Travel Warmer consists of an electro-mechanical warming unit and a single-use disposable.
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)
Performance, verification and validation testing was conducted to characterize performance of the proposed NxStage Travel Warmer to provide a basis of comparison to the predicate device as all features are not identical. Results of the all testing have documented that the proposed NxStage Travel Warmer is substantially equivalent to the predicate device and is suitable for the labeled indications for use.
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.”
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K071263
PAGE 1 OF 2
NxStage Medical, Inc. NxStage Travel Warmer 510(k) Premarket Notification
AUG 2 4 2007
Section 5 - 510(k) Summary
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: | (978) 687-4700 |
| Fax: | (978) 687-4800 |
| Contact Person: | Norma LeMay |
| Manager, Regulatory Affairs | |
| Date of Preparation: | May 4, 2007 |
| B. Device Name: | |
| Trade Name: | NxStage Travel Warmer |
| Common/Usual Name: | Monitor, Temperature, Dialysis |
| Classification Name: | Hemodialysis System and Accessories (876.5820) |
| Product Code: 78 FLA |
C. Substantial Equivalence/Predicate Devices:
The proposed NxStage Travel Warmer is substantially equivalent to the NxStage Warmer cleared through K012832 on 10/24/2001 and K020858 on 4/17/2002.
D. Device Description/Indications for Use:
The NxStage Travel Warmer and Travel Warmer Disposable Set are accessories to the NxStage System One used to warm dialysate. The Travel Warmer is for use with the NxStage System One only and is not used to warm blood or blood products. The Travel Warmer consists of an electro-mechanical warming unit and a
1
NxStage Medical, Inc. NxStage Travel Warmer 510(k) Premarket Notification
XC71263
Section 5 - 510(k) Summary
single-use disposable.
Indications for use:
The NxStage Travel Warmer and Travel Warmer Disposable Set are accessories to the NxStage System One used to warm dialysate prior to administration.
- E. Technological Characteristics:
The proposed device has the same technological characteristics and is similar in design and configuration as compared to the predicate device. The proposed device is designed with similar software, components and features also used in the predicate device.
F. Summary of Non-Clinical Test/Performance Testing - Bench
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 indications for use. Performance, verification and validation testing was conducted to characterize performance of the proposed NxStage Travel Warmer to provide a basis of comparison to the predicate device as all features are not identical. Results of the all testing have documented that the proposed NxStage Travel Warmer is substantially equivalent to the predicate device and is suitable for the labeled indications for use.
2
Image /page/2/Picture/0 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized caduceus symbol, which is a staff with two snakes entwined around it, and the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged in a circular pattern around the symbol. The logo is black and white.
DEPARTMENT OF HEALTH & HUMAN SERVICES
Food and Drug Administration 9200 Corporate Blvd. Rockville MD 20850
AUG 2 4 2007
Mr. Paul Clark Director of Clinical and Regulatory Affairs NxStage Medical, Inc. 439 South Union Street, 5th Floor LAWRENCE MA 01843-2800
Re: K071263
Trade/Device Name: NxStage Travel Warmer Regulation Number: 21 CFR §876.5860 Regulation Name: High permeability hemodialysis system Regulatory Class: II Dated: August 6, 2007 Received: August 8, 2007
Dear Mr. Clark:
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 (Premarket Approval), it may be subject to such 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.
Image /page/2/Picture/10 description: The image shows a circular logo with the text "1906-2006 FDA Centennial" in the center. The letters "FDA" are prominently displayed in a bold, stylized font. Three stars are arranged below the word "Centennial". The logo is surrounded by a decorative border with repeating patterns.
Protecting and Promoting Public Health
3
Page 2 -
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.
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 this letter:
| 21 CFR 876.xxx | (Gastroenterology/Renal/Urology) | 240-276-0115 |
|---|---|---|
| 21 CFR 884.xxx | (Obstetrics/Gynecology) | 240-276-0115 |
| 21 CFR 894.xxx | (Radiology) | 240-276-0120 |
| Other | 240-276-0100 |
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 from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (240) 276-3150
or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely vours.
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
Indications for Use
510(k) Number (if known):
Device Name:
NxStage Travel Warmer
Indications for Use:
The NxStage Travel Warmer and Travel Warmer Disposable Set are accessories to the NxStage System One used to warm dialysate prior to administration.
Prescription Use __ X (Part 21 CFR 801 Subpart D) AND/OR
Over-The-Counter Use (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)
Dwhary
Division Sign-Off
Division of Reproductive, Abdominal, and Radiological Devi 510(k) Number
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