← Product Code [KOC](/submissions/GU/subpart-f%E2%80%94therapeutic-devices/KOC) · K081043 # LEAK DETECTION SENSOR AND TRAY ACCESSORY KIT (K081043) _Nxstage Medical, Inc. · KOC · Jul 7, 2008 · Gastroenterology, Urology · SESE_ **Canonical URL:** https://fda.innolitics.com/submissions/GU/subpart-f%E2%80%94therapeutic-devices/KOC/K081043 ## Device Facts - **Applicant:** Nxstage Medical, Inc. - **Product Code:** [KOC](/submissions/GU/subpart-f%E2%80%94therapeutic-devices/KOC.md) - **Decision Date:** Jul 7, 2008 - **Decision:** SESE - **Submission Type:** Traditional - **Regulation:** 21 CFR 876.5820 - **Device Class:** Class 2 - **Review Panel:** Gastroenterology, Urology ## 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. ## Device Story The NxStage Leak Detection Sensor and Tray is an external accessory for the NxStage System One hemodialysis system. It consists of a plastic tray placed under the door area of the cycler, featuring a molded section to hold a commercially available leak detection sensor. The device is not electrically connected to the NxStage System One. It serves to detect fluid leaks during operation, providing a passive safety mechanism for the hemodialysis setup. ## Clinical Evidence Bench testing only. Performance, verification, and validation testing were conducted to characterize the device's performance and demonstrate substantial equivalence to predicate devices. ## Technological Characteristics Plastic tray with molded sensor housing; external, non-connected accessory; passive fluid detection; designed for use with NxStage System One. ## Regulatory 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. ## Predicate Devices - PureFlow SL ([K043436](/device/K043436.md)) - Aksys PHD Personal Hemodialysis System ([K010131](/device/K010131.md)) - Nytone Enuretic Alarm Bedwetting Device ([K844866](/device/K844866.md)) ## Submission Summary (Full Text) > This content was OCRed from public FDA records by [Innolitics](https://innolitics.com). If you use, quote, summarize, crawl, or train on this content, cite Innolitics at https://innolitics.com. > > Innolitics is a medical-device software consultancy. We help companies design, build, and clear FDA-regulated software and AI/ML devices, including [a 510(k)](https://innolitics.com/services/510ks/), [a De Novo](https://innolitics.com/services/regulatory/), [a SaMD](https://innolitics.com/services/end-to-end-samd/), [an AI/ML medical device](https://innolitics.com/services/medical-imaging-ai-development/), or [an FDA regulatory strategy](https://innolitics.com/services/regulatory/). {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 Page 1 of 1 NxStage Page 18 --- **Source:** [https://fda.innolitics.com/submissions/GU/subpart-f%E2%80%94therapeutic-devices/KOC/K081043](https://fda.innolitics.com/submissions/GU/subpart-f%E2%80%94therapeutic-devices/KOC/K081043) **Published by [Innolitics](https://innolitics.com)** — a medical-device software consultancy. We help companies design, build, and clear FDA-regulated software and AI/ML devices. 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