(112 days)
Not Found
No
The device description and performance studies focus on the physical and chemical properties of a premixed dialysate solution and its container, with no mention of AI or ML.
Yes.
The device is a premixed dialysate solution used in renal replacement therapy for chronic care patients, which is a therapeutic treatment.
No
Explanation: The device is a premixed dialysate solution used in conjunction with renal replacement therapy systems (hemodialysis), not for diagnosing a condition.
No
The device description explicitly states it is a "family of premixed dialysate solution formulations which are sterile, non-pyrogenic, fully constituted dialysate solutions provided in 5L single use flexible bags," indicating a physical product (liquid solution and bags), not software. The "Software Verification and Validation Testing" section is marked as "Not Applicable."
Based on the provided information, the NxStage PureFlow Solution is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for "use with NxStage renal replacement therapy systems that utilize sterile premixed dialysate during hemodialysis for chronic care patients." This describes a therapeutic use (hemodialysis) and not a diagnostic use (testing samples from the body to diagnose or monitor a condition).
- Device Description: The device is a "premixed dialysate solution formulations." Dialysate is a fluid used in dialysis to remove waste products and excess fluid from the blood. This is a treatment, not a diagnostic test.
- Lack of Diagnostic Activities: The description does not mention any activities related to analyzing samples from the body (like blood, urine, etc.) to provide diagnostic information.
- Performance Studies: The performance studies focus on the physical and chemical properties of the solution, container integrity, stability, biocompatibility, and human factors related to its use in dialysis. There are no studies related to diagnostic accuracy, sensitivity, specificity, etc.
Therefore, the NxStage PureFlow Solution is a therapeutic device used in hemodialysis, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
NxStage PureFlow Solution is indicated for use with NxStage renal replacement therapy systems that utilize sterile premixed dialysate during hemodialysis for chronic care patients.
Product codes (comma separated list FDA assigned to the subject device)
KPO
Device Description
The NxStage PureFlow Solution is a family of premixed dialysate solution formulations which are sterile, non-pyrogenic, fully constituted dialysate solutions provided in 5L single use flexible bags. The NxStage PureFlow Solution is a sterile, nonpyrogenic, single-use device provided in a single chamber flexible bag. The device is sterilized using moist steam sterilization and SAL=10° using a validated sterilization cycle per ISO 17665-1:2006/(R)2013, Sterilization of health care products – Moist heat – Part 1: Requirements for the development, validation and routine control of a sterilization process for medical devices. The NxStage PureFlow Solution is a product family of fully constituted, sterile, non-pyrogenic dialysate solutions that are provided in single use, single chamber 5L flexible bags. The solutions are intended for use with renal replacement therapy systems that utilize sterile premixed dialysate. A range of formulations is offered which allows the physician to prescribe the electrolyte compositions that meet the specific needs of individual patients. The solutions are not designed for use with proportioning hemodialysis systems and are not intended for direct infusion into the patient.
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
Dialysis Clinics
Health Care Facilities
Home
Community at Large (e.g. travel/hotel)
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 testing has been conducted to support the determination of substantial equivalence with regards to design, safety, and efficacy. The testing is summarized in Table 3.
Test Conducted: Analytical testing; Test Method Description: Per device specifications and applicable sections of USP and EP
Test Conducted: Physical testing of container (bag); Test Method Description: Per device specifications
Test Conducted: Container closure integrity testing; Test Method Description: Per ISO 11607-1
Test Conducted: Temperature excursion testing; Test Method Description: Per device specifications
Test Conducted: Stability/Shelf-life testing; Test Method Description: Per ICH Q1A to support 24-month shelf life
Test Conducted: Ship testing; Test Method Description: Per ASTM D4169-22
Biocompatibility Testing: The NxStage PureFlow Solution has been evaluated for biological safety in accordance with ISO 10993 -1 and the FDA guidance document Use of International Standard ISO 10993-1, "Biological evaluation of medical devices - Part 1 : Evaluation and testing within a risk management process", published Sept 4, 2020. The following testing was performed:
Chemical characterization
Toxicological Risk Assessment
Cytotoxicity
Sensitization
Irritation
Pyrogenicity
Hemocompatibility
Systemic toxicity
Human Factors Validation Testing: The NxStage PurceFlow Solution is found to be safe and effective for its intended user, use, and use environments in accordance with the FDA guidance document "Applying Human Factors and Usability Engineering to Medical Devices (Feb 3, 2016) and applicable sections of AAMI/ANSI/EC 62366-1.
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.
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Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health & Human Services logo on the left and the FDA acronym with the full name of the agency on the right. The FDA part of the logo is in blue, with the acronym in a square and the full name written out to the right of the square.
January 18, 2024
NxStage Medical, Inc. Caitlin Kalda Senior Lead, Regulatory Affairs North America 350 Merrimack Street Lawrence, Massachusetts 01843
Re: K233213
Trade/Device Name: NxStage PureFlow Solution Regulation Number: 21 CFR 876.5820 Regulation Name: Hemodialysis system and accessories Regulatory Class: Class II Product Code: KPO Dated: December 19, 2023 Received: December 19, 2023
Dear Caitlin Kalda:
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 (the 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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database available at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
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.
Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device"
1
(https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download).
Your device is also subject to, among other requirements, the Quality System (QS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30. Design controls; 21 CFR 820.90. Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review. the OS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181).
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); medical device reporting of medical device-related adverse events) (21 CFR Part 803) for devices or postmarketing safety reporting (21 CFR Part 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic.
2
See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
Gema Gonzalez -S
Maura Rooney, MS Assistant Director DHT3A: Division of Renal, Gastrointestinal, Obesity and Transplant Devices OHT3: Office of Gastrorenal, ObGyn, General Hospital, and Urology Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
3
Indications for Use
510(k) Number (if known) K233213
Device Name NxStage PureFlow Solution
Indications for Use (Describe)
NxStage PureFlow Solution is indicated for use with NxStage renal replacement therapy systems that utilize sterile premixed dialysate during hemodialysis for chronic care patients.
Type of Use (Select one or both, as applicable)
| Prescription Use (Part 21 CFR 801 Subpart D) |
|---|
| Over-The-Counter Use (21 CFR 801 Subpart C) |
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Image /page/4/Picture/2 description: The image shows the Fresenius Medical Care logo. The logo consists of a blue chevron-like symbol on the left and the text "FRESENIUS MEDICAL CARE" on the right. The text is also in blue, with "FRESENIUS" on the top line and "MEDICAL CARE" on the bottom line.
NxStage PureFlow Solution Traditional 510(k)
510(K) SUMMARY 5.
This 510(k) Summary is in accordance with the requirements of the Safe Medical Device Act (SMDA) of 1990. The content of this 510(k) summary is provided in conformance with 21 CFR § 807.92.
5.1. Submitter's Information
| Name: | NxStage Medical, Inc. |
|---|---|
| Address: | 350 Merrimack Street |
| Lawrence MA 01843 USA | |
| Phone: | (617) 831-3469 |
| Fax: | (781) 699-9635 |
| Contact Person: | Caitlin Kalda, Senior Lead |
| Preparation Date: | 28 September 2023 |
5.2. Device Name
| Trade Name: | NxStage PureFlow Solution |
|---|---|
| Common Name: | Premixed Dialysate |
| Regulation Name: | Hemodialysis Systems and Accessories |
| Regulatory Class: | Class II per 21 CFR § 876.5820 |
| Product Code: | 78 KPO |
| Product Code Name: | Dialysate Concentrate for Hemodialysis |
| (Liquid of Powder) | |
| FDA Review Panel: | Gastroenterology/Urology |
5.3. Legally Marketed Predicate Device
The legally marketed predicate for the proposed device is the NxStage PureFlow Solution, as cleared through K033386 (November 26, 2003). This predicate has not been subject to a design-related recall.
5.4. Device Description
Device Identification: 5.4.1.
The NxStage PureFlow Solution is a family of premixed dialysate solution formulations which are sterile, non-pyrogenic, fully constituted dialysate solutions provided in 5L single use flexible bags.
| Catalog Number | Description |
|---|---|
| RFP-204-A* | 5000mL, 40 Lactate, 1K |
| RFP-204-B* | |
| RFP-204-C* |
Table 1: Device Identification
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Image /page/5/Picture/1 description: The image contains the logo for Fresenius Medical Care. The logo consists of a blue symbol on the left and the text "FRESENIUS MEDICAL CARE" on the right. The symbol is made up of three downward-pointing chevrons stacked on top of each other. The text is in a bold, sans-serif font, with "FRESENIUS" on the top line and "MEDICAL CARE" on the bottom line.
| RFP-205-A | 5000mL, 35 Lactate, 3K |
|---|---|
| RFP-205-B | |
| RFP-205-C | |
| RFP-207-A | 5000mL, 45 Lactate, 1K |
| RFP-207-B | |
| RFP-207-C | |
| RFP-209-A | 5000mL, 45 Lactate, 2K |
| RFP-209-B | |
| RFP-209-C | |
| RFP-211-A | 5000mL, 40 Lactate, 2K |
| RFP-211-B | |
| RFP-211-C | |
| RFP-220-A | 5000mL, 40 Lactate, 2K |
| RFP-220-B | |
| RFP-220-C | |
| RFP-221-A | 5000mL, 40 Lactate, 3K |
| RFP-221-B | |
| RFP-221-C | |
| RFP-222-A | 5000mL, 45 Lactate, 3K |
| RFP-222-B | |
| RFP-222-C | |
| RFP-223-A | 5000mL, 35 Lactate, 2K |
| RFP-223-B | |
| RFP-223-C | |
| RFP-224-A | 5000mL, 35 Lactate, 4K |
| RFP-224-B | |
| RFP-224-C |
Table 1: Device Identification
- suffix of A, B, or C indicates country or region specific labeling content and language translations for the same dialysate formulation.
Device Characteristics 5.4.2.
The NxStage PureFlow Solution is a sterile, nonpyrogenic, single-use device provided in a single chamber flexible bag. The device is sterilized using moist steam sterilization and SAL=10° using a validated sterilization cycle per ISO 17665-1:2006/(R)2013, Sterilization of health care products – Moist heat – Part 1: Requirements for the development, validation and routine control of a sterilization process for medical devices.
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Image /page/6/Picture/0 description: The image shows the Fresenius Medical Care logo. The logo consists of a blue symbol on the left and the text "FRESENIUS MEDICAL CARE" on the right, also in blue. The symbol is made up of three downward-pointing chevrons stacked on top of each other. The text is in a bold, sans-serif font, with "FRESENIUS" on the top line and "MEDICAL CARE" on the bottom line.
5.4.3. Environment of Use
The intended environments of use are:
- Dialysis Clinics ●
- Health Care Facilities
- Home
- Community at Large (e.g. travel/hotel) ●
Brief Written Description of the Device 5.4.4.
The NxStage PureFlow Solution is a product family of fully constituted, sterile, non-pyrogenic dialysate solutions that are provided in single use, single chamber 5L flexible bags. The solutions are intended for use with renal replacement therapy systems that utilize sterile premixed dialysate.
A range of formulations is offered which allows the physician to prescribe the electrolyte compositions that meet the specific needs of individual patients. The solutions are not designed for use with proportioning hemodialysis systems and are not intended for direct infusion into the patient.
| 5.4.5. | Materials of Use |
|---|---|
| -------- | ------------------ |
Table 2: Materials
| Where Used | Materials |
|---|---|
| Dialysate Fluid | Sodium chloride |
| Potassium chloride dihydrate | |
| Calcium chloride dihydrate | |
| Magnesium chloride hexahydrate | |
| Sodium lactate | |
| Dextrose monohydrate | |
| Hydrochloric acid | |
| Water for injection | |
| Container Materials | Polypropylene (PP) |
| Styrene ethylene butylene styrene (SEBS) | |
| Styrene-isoprene-rubber (SIS) | |
| Polycarbonate (PC) |
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Image /page/7/Picture/0 description: The image contains the logo for Fresenius Medical Care. On the left is a blue symbol that looks like three chevrons stacked on top of each other. To the right of the symbol is the text "FRESENIUS MEDICAL CARE" in blue, with "FRESENIUS" on top of "MEDICAL CARE".
Duration and type of contact:
- Per ISO 10993-1 NxStage PureFlow Solution is categorized as: o
- External communicating device —
- -Blood path, indirect
- । Long term (>30 d)
Key Performance Specifications/Characteristic 5.4.6.
The NxStage PureFlow Solution is used as dialysate during hemodialysis therapy.
5.5. Intended Use
The NxStage PureFlow Solution is intended for use with renal replacement therapy systems that utilize sterile premixed dialysate. The solutions are not designed for use with intermittent proportioning hemodialysis systems. The NxStage offering of premixed dialysate solutions allows the physician to prescribe different electrolyte compositions that meet the specific needs of individual patients.
Indications for Use 5.6.
NxStage PureFlow Solution is indicated for use with NxStage renal replacement therapy systems that utilize sterile premixed dialysate during hemodialysis for chronic care patients.
5.7. Comparison of Technological Characteristics with the Predicate Device
The proposed device has the same intended use, technological characteristics, and principle of operation as the predicate. The proposed device is similar in container design and configuration as compared to the predicate device and has similar performance specifications.
5.8. Performance Data
Performance testing has been conducted to support the determination of substantial equivalence with regards to design, safety, and efficacy. The testing is summarized in Table 3.
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Image /page/8/Picture/0 description: The image contains the logo for Fresenius Medical Care. On the left side of the logo is a blue symbol that consists of three downward-pointing chevrons stacked on top of each other. To the right of the symbol is the text "FRESENIUS MEDICAL CARE" in a bold, blue sans-serif font. The text is arranged in two lines, with "FRESENIUS" on the top line and "MEDICAL CARE" on the bottom line.
| Test Conducted | Test Method Description |
|---|---|
| Analytical testing | Per device specifications and applicable sections of USP and EP |
| Physical testing of container (bag) | Per device specifications |
| Container closure integrity testing | Per ISO 11607-1 |
| Temperature excursion testing | Per device specifications |
| Stability/Shelf-life testing | Per ICH Q1A to support 24-month shelf life |
| Ship testing | Per ASTM D4169-22 |
Table 3: Performance Testing Summary
Biocompatibility Testing 5.8.1.
The NxStage PureFlow Solution has been evaluated for biological safety in accordance with ISO 10993 -1 and the FDA guidance document Use of International Standard ISO 10993-1, "Biological evaluation of medical devices - Part 1 : Evaluation and testing within a risk management process", published Sept 4, 2020. The following testing was performed:
- Chemical characterization
- Toxicological Risk Assessment ●
- Cytotoxicity ●
- Sensitization ●
- Irritation
- Pyrogenicity ●
- Hemocompatibility ●
- Systemic toxicity
Human Factors Validation Testing 5.8.2.
The NxStage PurceFlow Solution is found to be safe and effective for its intended user, use, and use environments in accordance with the FDA guidance document "Applying Human Factors and Usability Engineering to Medical Devices (Feb 3, 2016) and applicable sections of AAMI/ANSI/EC 62366-1.
5.8.3. Electrical Safety and Electromagnetic Compatibility (EMC)
Not Applicable - The device subject of this submission does not have any electronic features
Software Verification and Validation Testing 5.8.4.
Not Applicable - The device subject of this submission does not have any software features.
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Image /page/9/Picture/0 description: The image contains the logo for Fresenius Medical Care. On the left side of the logo is a blue symbol that consists of three downward-pointing chevrons stacked on top of each other. To the right of the symbol is the text "FRESENIUS" in a bold, blue font, with the words "MEDICAL CARE" stacked below it in the same font.
Animal Studies 5.8.5.
Not Applicable – The device subject of this submission did not use any animal studies
5.8.6. Clinical Studies
Not Applicable - The device subject of this submission did not require clinical studies
5.9. Conclusion
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. Verification and validation was conducted to characterize the proposed device and the predetermined acceptance criteria were met. Results of this testing have documented that the proposed NxStage PureFlow Solution is suitable for the labeled indications for use.
The proposed modifications to the NxStage PureFlow Solution are substantially equivalent to the predicate device with regards to design, intended use, principle of operation and materials of construction. Differences between the proposed device and the predicate device do not introduce any new concerns regarding the safety of efficacy of the device. NxStage Medical, Inc. concludes that within the meaning of the Medical Device Amendments Act of 1976, the NxStage PureFlow Solution product family is safe and effective for its intended use.