(142 days)
Not Found
No
The description focuses on the physical components and intended use of tubing sets and accessories for a renal therapy system, with no mention of AI or ML capabilities.
Yes
The device is indicated for "continuous solute and/or fluid removal in patients with acute renal failure or fluid overload" and "Therapeutic Plasma Exchange (TPE) therapies," which are therapeutic interventions.
No
The device is described as a tubing set and accessory for continuous solute and/or fluid removal and Therapeutic Plasma Exchange (TPE) therapies. Its function is to facilitate the removal of substances from the body, which is a therapeutic process, not a diagnostic one.
No
The device description clearly outlines physical components such as tubing sets, spikes, and bags, indicating it is a hardware device.
Based on the provided text, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use describes the device as being used for "continuous solute and/or fluid removal in patients with acute renal failure or fluid overload" and "Therapeutic Plasma Exchange (TPE) therapies." These are therapeutic procedures performed directly on the patient's blood, not diagnostic tests performed on samples in vitro (outside the body).
- Device Description: The description details tubing sets designed to connect to a system for blood processing and fluid management. This aligns with a therapeutic device, not a diagnostic one.
- Lack of Diagnostic Language: There is no mention of analyzing samples, detecting biomarkers, or providing diagnostic information.
Therefore, the Edwards Aqualine Tubing Set and its accessories are therapeutic devices used in clinical settings for blood processing and fluid management, not IVDs.
N/A
Intended Use / Indications for Use
The Edwards Aqualine Tubing Set is indicated for use with the Baxter Accura System for continuous solute and/or fluid removal in patients with acute renal failure or fluid overload. The Edwards Aqualine Tubing Set may also be used in Therapeutic Plasma Exchange (TPE) therapies. The Edwards Aqualine Tubing Sets are indicated for use in a clinical setting and not for home use. The Edwards Aqualine S Tubing Set is indicated for use where a lower flow rate and lower priming volume are desired.
The Edwards Aquaspike tubing set is indicated for use with the Edwards Aqualine Tubing Set and the infusion bags used for continuous solute and for fluid removal in patients with acute failure or fluid overload. Aquaspike is used to connect up to four infusion bags with the Aqualine Tubing
The Edwards Aquasafe is an Aqualine accessory (a three 25ml-empty-sterile bags disposable device) and it is used when it is necessary to decrease the pressure level inside Aqualine, prior its removal from the machine.
Product codes (comma separated list FDA assigned to the subject device)
FJK
Device Description
The Edwards Aqualine Tubing Sets are designed for use with the Baxter Accura System (K021615).
The Edwards AqualineSTubing Set is different from the Edwards Aqualine Tubing Set in total volume, length, and inner and outer diameters.
The tubing pathway can be split up in to five separate sections:
- Access Blood path (Red) .
- . Return Blood path ( Dark Blue)
- . Filtrate (Effluent) path ( Yellow)
- . Dialysate Solution path (Green)
- . Replacement (Substitution) path (Light Blue)
The Edwards Lifesciences Services GmbH Edwards Aqualine Sterile Tubing Set will be packaged in a sterile pack. An expiration date has been determined based on real time tests.
The Edwards Aquaspike tubing set is indicated for use with the Edwards Aqualine Tubing Set and the infusion bags used for continuous solute and /or fluid removal in patients with acute failure or fluid overload. Aquaspike is used to connect up to four infusion bags with the Aqualine Tubinq
The Edwards Aquasafe is an Aqualine accessory (a three 25ml-empty-sterile bags disposable device) and it is used when it is necessary to decrease the pressure level inside Aqualine, prior its removal from the machine.
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
clinical setting
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)
Functional testing has been conducted with the Edwards Aqualine Tubing Sets on the Baxter Accura System (K021615).
Rolling tests (mechanical resistance during the rolling pump action) have been conducted with the Edwards Aqualine, Edwards AqualineS and Baxter Accura (K021615) Tubing Sets.
The expiration date has been established by a series of real-time tests conducted over a 5 year period.
Tensile Strength Testing was conducted as part of the expiration date tests.
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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510(k) Summary Page 1 of 5
Owner's Name:
MAR 2 3 2007 Edwards Lifesciences Services GmbH Address: Edisonstrasse 6 Unterschleissheim 85716 Germany +49 89 95475 203 Telephone Number: Fax Number: +49 89 95475 301 Director RA/QA Robert Madjno Contact Person: March 23, 2007 Summary Prepared:
Classification Name:
Regulatory Name: Regulation Number: Panel number: Product Code:
High Permeability Hemodialysis System 21 CFR 876.5860 78 KDI
Common/Usual Name:
Hemofiltration Line.
Proprietary Name:
Edwards Aqualine Sterile Tubing Set, Edwards AqualineS Sterile Tubing Set, and accessories:
Edwards Aquaspike, and
Edwards Aquasafe
Establishment Registration Number:
The device will be manufactured and packed for: Edwards Lifesciences Services GmbH Edisonstrasse 6
Unterschleissheim 85716 Germany
by
Haemotronic S.p.A. 16, Via Carreri Mirandola Modena 41037 Italy Establishment Registration Number 9611157
1
510(k) Summary Page 2 of 5
and
Haemotronic, S.P.A. Advanced Medical Technologies Via Ugo Roncada 83/e Carbonara Di Po Mantova 46020 Italy Establishment Registration Number 9614854
and sterilized by:
BioSter S.p.A. 9, Via Einaudi Calcinate Bergamo 24050 Italy Establishment Registration Number 3002806603
Substantial Equivalence:
The Edwards Lifesciences Services GmbH Edwards Aqualine Tubing Sets are substantially equivalent in design, use and materials to the:
| Baxter Helathcare Corp.
- K021615 | Baxter Accura Disposable Tubing Set |
|----------------------------------------|-------------------------------------|
| Baxter Helathcare Corp. - K911315/A | Baxter BM 11 Disposable Tubing Set |
| Gambro Inc. - K032431 | Prisma M100 and M60 Tubing Sets |
The Edwards Aqualine Tubing Sets are made of the same materials, by the same processes and contains many of the same components as the Baxter Accura Tubing Set (K021615), which is also manufactured by Haemotronic S.p.A. The significant exception is one of the pressure transducer membranes: this is made of EPDM rubber instead of the butyl rubber used in the Baxter Accura Tubing Set (K021615). The Edwards Aqualine Tubing Sets uses only EPDM rubber for the pressure transducer membranes, whereas the Baxter Accura Tubing Set (K021615) uses both EPDM and butyl rubber for the pressure tranducer membranes.
The Edwards Aqualine Tubing Sets, the Baxter Accura Tubing Set (K021615), the Baxter BM11 Tubing Set (K911315/A) and the Gambro Prisma M100 and M60 Tubing Sets (K032431) are all single use and intended for disposal after each session.
2
510(k) Summary Page 3 of 5
The Edwards AqualineS Tubing Set is indicated for use where a lower flow rate and lower priming volume are desired than with the Edwards Aqualine Tubing Set. Other manufacturers offer a tubing set with a lower volume as an alternative, for example: Gambro Prisma M100 and M60 Tubing Sets (K032431).
The Edwards Aqualine Tubing Sets are sterilized under the same conditions as the Baxter Accura Tubing Set (K021615).
Description of Product:
The Edwards Aqualine Tubing Sets are designed for use with the Baxter Accura System (K021615),
The Edwards Aqualine Tubing Sets are indicated for use with the Baxter Accura System (K021615) for continuous solute and/or fluid removal in patients with acute renal failure or fluid overload. The Edwards Aqualine Tubing Sets may also be used in Therapeutic Plasma Exchange (TPE) therapies.
The Edwards Aqualine Tubing Sets and the Baxter Accura System (K021615) are indicated for use in a clinical setting and not for home use.
The Edwards AqualineS Tubing Set is indicated for use where a lower flow rate and lower priming volume are desired than with the Edwards Aqualine Tubing Set. The Edwards AqualineS Tubing Set is particularly suitable for therapies in which a low blood flow or a low priming blood volume is desired, such as SCUF or low volume for congestive heart failure therapy. The selection of the Edwards Aqualine Tubing Set or the Edwards AqualineS Tubing Set is to be determined by clinical preference.
The Edwards AqualineS Tubing Set is different from the Edwards Aqualine Tubing Set in total volume, length, and inner and outer diameters.
The differences between the Edwards Aqualine Tubing Sets and the Baxter Accura Tubing Set (K021615) are not significant for their intended use, and do not involve any potential risk related to the use of the Edwards Aqualine Tubing Sets with the Baxter Accura System (K021615).
3
510(k) Summary Page 4 of 5
The tubing pathway can be split up in to five separate sections:
- Access Blood path (Red) .
- . Return Blood path ( Dark Blue)
- . Filtrate (Effluent) path ( Yellow)
- . Dialysate Solution path (Green)
- . Replacement (Substitution) path (Light Blue)
The Edwards Lifesciences Services GmbH Edwards Aqualine Sterile Tubing Set is used with the Baxter Accura System for the following therapies:
SCUF (Slow continuous ultrafiltration) CVVH (Continuous veno-venous hemofiltration) CVVHD (Continuous veno-venous hemodialysis) CVVHDF (Continuous veno-venous hemodiafiltration) TPE (Therapeutic plasma-exchange)
The Edwards Lifesciences Services GmbH Edwards Aqualine Sterile Tubing Set will be packaged in a sterile pack. An expiration date has been determined based on real time tests.
Intended Use:
The Edwards Aqualine Tubing Set is indicated for use with the Baxter Accura System for continuous solute and/or fluid removal in patients with acute renal failure or fluid overload. The Edwards Aqualine Tubing Set may also be used in Therapeutic Plasma Exchange (TPE) therapies. The Edwards Aqualine Tubing Set and the Baxter Accura System are indicated for use in a clinical setting and not for home use. The Edwards AqualineS Tubing Set is indicated for use where a lower flow rate and lower priming volume are desired.
The Edwards Aquaspike tubing set is indicated for use with the Edwards Aqualine Tubing Set and the infusion bags used for continuous solute and /or fluid removal in patients with acute failure or fluid overload. Aquaspike is used to connect up to four infusion bags with the Aqualine Tubinq
4
Kc63293
510(k) Summary Page 5 of 5
The Edwards Aquasafe is an Aqualine accessory (a three 25ml-emptysterile bags disposable device) and it is used when it is necessary to decrease the pressure level inside Aqualine, prior its removal from the machine.
Bench Testing:
Functional testing has been conducted with the Edwards Aqualine Tubing Sets on the Baxter Accura System (K021615).
Rolling tests (mechanical resistance during the rolling pump action) have been conducted with the Edwards Aqualine, Edwards AqualineS and Baxter Accura (K021615) Tubing Sets.
The expiration date has been established by a series of real-time tests conducted over a 5 year period.
Tensile Strength Testing was conducted as part of the expiration date tests.
Conclusions:
Based on the numerous common features and comparative testing, Edwards Lifesciences Services GmbH believes the Edwards Aqualine Tubing Sets are substantially equivalent to the predicate products.
5
Image /page/5/Picture/1 description: The image is a black and white logo for the Department of Health & Human Services USA. The logo features a stylized eagle with its wings spread, symbolizing strength and protection. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" are arranged in a circular fashion around the eagle, indicating the organization's name and national affiliation.
Food and Drug Administration 9200 Corporate Blvd. Rockville MD 20850
Edwards Lifesciences Services GmbH c/o Mr. Neil R. Armstrong Regulatory Affairs Advisor Meddiquest Limited Business & Technology Center Bessemer Drive Stevenage, Hertsfordshire UNITED KINGDOM SG1 2DX
MAR 2 3 2007
Re: K063293
Trade/Device Name: Edwards Aqualine Sterile Tubing Set; Edwards AqualineS Sterile Tubing Set; Edwards Aquaspike; and, Edwards Aquasafe Regulation Number: 21 CFR §876.5820 Regulation Name: Hemodialysis system and accessories Regulatory Class: II Product Code: FJK Dated: February 28, 2007 Received: March 7, 2007
Dear Mr. Armstrong:
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/5/Picture/10 description: The image shows a circular logo with the letters "FDA" in large, bold font in the center. Above the letters, the years "1906-2006" are printed. Below the letters, the word "Centennial" is printed in a smaller font, followed by three stars. The logo is surrounded by text that reads "A Century of Commitment & Leadership in Advancing Regulatory Science & Service on Behalf of Public Health."
Protesting and Promoting Public Health
6
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.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" (21 CFR 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 (301) 443-6597 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
7
Center for Devices and Radiological Health 10/13/2006 revised 02/17/2007
510(k) Number (if known): K063293
Device Name: Edwards Aqualine Sterile Tubing Set, Edwards AqualineS Sterile Tubing Set, Edwards Aquaspike and Edwards Aquasafe
Indications for Use:
The Edwards Aqualine Tubing Set is indicated for use with the Baxter Accura System for continuous solute and/or fluid removal in patients with acute renal failure or fluid overload. The Edwards Aqualine Tubing Set may also be used in Therapeutic Plasma Exchange (TPE) therapies. The Edwards Aqualine Tubing Sets are indicated for use in a clinical setting and not for home use. The Edwards Aqualine S Tubing Set is indicated for use where a lower flow rate and lower priming volume are desired.
The Edwards Aquaspike tubing set is indicated for use with the Edwards Aqualine Tubing Set and the infusion bags used for continuous solute and for fluid removal in patients with acute failure or fluid overload. Aquaspike is used to connect up to four infusion bags with the Aqualine Tubing
The Edwards Aquasafe is an Aqualine accessory (a three 25ml-empty-sterile bags disposable device) and it is used when it is necessary to decrease the pressure level inside Aqualine, prior its removal from the machine.
Prescription Use X Over-The-Counter Use Prescription Use Subpart D) AND/OR (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Page _1_of _1
(Posted November 13, 2003)
David A. Syverson
(Division Sign-Off) Division of Reproductive, Abdominal. and Radiological Devices 510(k) Number
4 Indications for Use Statement