(84 days)
Not Found
No
The summary describes a simple fluid detection system using a sensor and tray, with no mention of AI or ML terms or concepts.
No
The device is a leak detection sensor and tray, designed to detect fluid leaks. It does not treat or diagnose any medical condition, but rather acts as an accessory to another medical system.
No
The device is a leak detection sensor and tray designed to detect fluid leaks from the NxStage System One, not to diagnose a medical condition in a patient.
No
The device description explicitly states that the device includes a "plastic tray and leak detection sensor," which are physical 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 detect fluid leaks when used as an accessory to a hemodialysis system (NxStage System One). This is a functional accessory for a medical device, not a test performed on biological samples to diagnose or monitor a medical condition.
- Device Description: The description clearly states it's an external device that detects fluid leaks in a tray placed under the cycler. It doesn't interact with biological samples.
- Lack of IVD Characteristics: The document does not mention any of the typical characteristics of an IVD, such as:
- Analyzing biological samples (blood, urine, tissue, etc.)
- Providing diagnostic or monitoring information about a patient's health status
- Using reagents or assays
The device's function is purely to detect the presence of fluid outside of the main medical device, which is a safety and operational function, not an in vitro diagnostic test.
N/A
Intended Use / Indications for Use
The leak detection sensor and tray provide a means of detecting fluid leaks when used as an accessory to the NxStage System One.
Product codes (comma separated list FDA assigned to the subject device)
KOC
Device Description
The NxStage leak detection sensor and tray is designed for use with the NxStage System One. The plastic tray and leak detection sensor are external devices that are not connected to the NxStage System One cycler. The tray fits under the door area of the NxStage System One. The tray includes a molded area on the left-hand side that holds a commercially available leak detection sensor.
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 leak detection sensor and tray. Results of this testing have documented that the proposed leak detection sensor and tray is substantially equivalent to the predicate devices 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
§ 876.5820 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
JUL - 7 2008
K081CY3
Page 1 of 2
NxStage Medical, Inc. Leak Detection Sensor and Tray Traditional 510(k) Premarket Notification
This 510(k) Summary is being submitted in accordance with the requirements of the Safe Medical Device Act (SMDA) of 1990. The content contained in this 510(k) summary has been provided in conformance with 21 CFR §807.92.
| A. Submitter's Information:
| Name: | NxStage Medical, Inc. |
|---|---|
| Address: | 439 South Union Street, 5th Floor |
| Lawrence, MA 01843 | |
| FDA Establishment | |
| Owner/Operator Number: | 9045797 |
| Contact Person: | Mary Lou Stroumbos |
| Regulatory Affairs Associate | |
| Phone: | |
| Fax: | (978) 687-4872 |
| (978) 687-4750 | |
| Manufacturer: | NxStage Medical, Inc. |
| 439 South Union St. 5th Floor | |
| Lawrence, MA 01843 | |
| FDA Establishment | |
| Registration Number: | 3003464075 |
| B. Device Name: | |
| Trade/Proprietary Name: | NxStage Leak Detection Sensor and Tray |
| Common/Usual Name: | Leak Detector |
| Classification Name: | Hemodialysis System and Accessories |
| Regulation Number: | 876.5820 |
| Product Code: | KOC |
| Device Classification: | Class II |
Gastroenterology/Urology
Traditional 510(k) Premarket Notification NxStage Medical, Inc.
Device Panel:
Confidential
1
K08/043
Page 2 of 2
NxStage Medical, Inc. Leak Detection Sensor and Tray Traditional 510(k) Premarket Notification
C. Substantial Equivalence/Predicate Devices:
The NxStage leak detection sensor and tray are substantially equivalent to:
| Device Name | Manufacturer | 510(K) |
|---|---|---|
| PureFlow SL | NxStage Medical, Inc. | K043436 |
| Aksys PHD Personal | ||
| Hemodialysis System | Aksys, LTD | K010131 |
| Nytone Enuretic Alarm | ||
| Bedwetting Device | Nytone Medical | K844866 |
D. Device Description/Indications for Use:
The NxStage leak detection sensor and tray is designed for use with the NxStage System One. The plastic tray and leak detection sensor are external devices that are not connected to the NxStage System One. The tray fits under the door area of the NxStage System One The tray includes a molded area on the left-hand side that holds a commercially cycler. available leak detection sensor.
Indications for use:
The leak detection sensor and tray provide a means of detecting fluid leaks when used as an accessory to the NxStage System One.
E. Technological Characteristics:
The proposed device has similar technological characteristics and design features as compared to the predicate devices.
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 leak detection sensor and tray. Results of this testing have documented that the proposed leak detection sensor and tray is substantially equivalent to the predicate devices and is suitable for the labeled indications for use.
2
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/2/Picture/1 description: The image shows the logo for the Department of Health & Human Services - USA. The logo is a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" written around the perimeter. Inside the circle is a stylized image of a person with their arms outstretched.
Food and Drug Administration 9200 Corporate Blvd. Rockville MD 20850
JUL - 7 2008
Ms. Mary Lou Stroumbos Regulatory Affairs Associate NxStage Medical, Incorporated 439 South Union Street, 5th Floor LAWRENCE MA 01843
Re: K081043
Trade/Device Name; NxStage® System One™ Leak Detection Sensor and Tray Accessory Kit Regulation Number: 21 CFR §876.5820 Regulation Name: Hemodialysis system and accessories Regulatory Class: II Product Code: KOC Dated: April 10, 2008 Received: April 14, 2008
Dear Ms. Stroumbos:
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 I tpp. o an 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" at the top and "Centennial" at the bottom. The letters "FDA" are prominently displayed in the center of the logo. The logo is surrounded by a circular border with small stars and other symbols.
Protecting and Promoting Public Health
3
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 Center for Devices and Radiological Health's (CDRH's) Office of Compliance at one of the following numbers, based on the regulation number at 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" (21CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometric's (OSB's) Division of Postmarket Surveillance at 240-276-3474. For questions regarding the reporting of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at 240-276-3464. 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/cdrb/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
K081043 510(k) Number (if known): NxStage System One Leak Detection Sensor and Tray Device Name: Accessory Kit. Indications for Use: The leak detection sensor and tray provide a means of
NxStage System One.
detecting fluid leaks when used as an accessory to the
Prescription Use (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)
Hulus Lemen
(Division Sign-Off) Division of Reproductive, Abdominal, and Radiological Devices 510(k) Number
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