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.

Device Description

The Edwards Aqualine Tubing Sets are designed for use with the Baxter Accura System (K021615). 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 AqualineS Tubing Set is different from the Edwards Aqualine Tubing Set in total volume, length, and inner and outer diameters. 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 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.

AI/ML Overview

The provided text describes a 510(k) premarket notification for the "Edwards Aqualine Sterile Tubing Set" and its accessories. This is a medical device submission, and the content focuses on establishing substantial equivalence to predicate devices rather than proving performance against specific quantitative acceptance criteria through a clinical or algorithmic study.

Therefore, many of the requested elements for describing an acceptance criteria study (like sample sizes for test sets, expert ground truth, adjudication methods, MRMC studies, standalone algorithm performance, and training set details) are not applicable (N/A) in this context. The submission's goal is to demonstrate that the new device is as safe and effective as existing legally marketed devices, primarily through comparison of design, materials, and intended use, along with functional bench testing.

Here's a breakdown of the information as it relates to the provided document:

Acceptance Criteria and Device Performance (Based on Substantial Equivalence)

The acceptance criteria are implicitly met by demonstrating substantial equivalence to predicate devices. The device performance is assessed through bench testing to ensure basic functionality and equivalence in critical parameters.

Acceptance Criteria (Implicit from Substantial Equivalence Claim)	Reported Device Performance (Bench Testing)
Material Equivalence: Same materials as predicate devices.	The Edwards Aqualine Tubing Sets are made of the same materials as the Baxter Accura Tubing Set (K021615), with the exception of one pressure transducer membrane (EPDM rubber instead of butyl rubber).
Process Equivalence: Same manufacturing processes.	The Edwards Aqualine Tubing Sets are manufactured by the same processes and sterilized under the same conditions as the Baxter Accura Tubing Set (K021615).
Design Equivalence: Similar design to predicate devices.	Similar design, with differences noted for the "S" version (total volume, length, diameters) to allow for lower flow rates/priming volumes.
Intended Use Equivalence: Same intended use as predicate devices.	Indicated for use with Baxter Accura System for continuous solute/fluid removal in acute renal failure/fluid overload, and TPE, similar to predicate devices.
Functional Equivalence: Performs like predicate devices.	Functional testing conducted on the Baxter Accura System.
Mechanical Resistance: Withstands pump action.	Rolling tests conducted on Edwards Aqualine, AqualineS, and Baxter Accura (K021615) Tubing Sets.
Shelf-Life/Sterility Maintenance: Maintains integrity over time.	Expiration date established by real-time tests over a 5-year period. Tensile Strength Testing conducted as part of expiration date tests.
Safety - Pressure Transducer: Safe material for pressure sensing.	Use of EPDM rubber for all pressure transducer membranes, which is a material also used in the predicate device (Baxter Accura K021615).

Study Details

Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective):
- Sample Size: Not specified. The "test set" for this type of submission refers to the physical devices undergoing bench testing. The document states "Functional testing has been conducted with the Edwards Aqualine Tubing Sets" and "Rolling tests (mechanical resistance during the rolling pump action) have been conducted with the Edwards Aqualine, Edwards AqualineS and Baxter Accura (K021615) Tubing Sets." No specific number of units tested is provided.
- Data Provenance: Not explicitly stated, but assumed to be internal laboratory testing by the manufacturer or a contracted lab. The manufacturing entity, Haemotronic S.p.A., is in Italy, and the applicant is in Germany. It would be prospective testing on manufactured devices.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience):
- N/A. The "ground truth" for this device comes from engineering specifications and performance standards for hemodialysis tubing sets, established by the manufacturer and validated through the testing performed. There is no mention of external human experts establishing ground truth in the context of a diagnostic or interpretative study.
Adjudication method (e.g. 2+1, 3+1, none) for the test set:
- N/A. Adjudication methods are relevant for studies involving human interpretation or uncertain outcomes. Bench testing for medical device functionality typically relies on objective measurements against predetermined engineering specifications, not expert adjudication.
If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:
- N/A. This device is a sterile tubing set, not an AI-powered diagnostic tool. Therefore, MRMC studies are not applicable.
If a standalone (i.e. algorithm only without human-in-the loop performance) was done:
- N/A. This device is a physical medical tubing set, not an algorithm.
The type of ground truth used (expert consensus, pathology, outcomes data, etc):
- For the bench testing, the "ground truth" is defined by engineering specifications and established performance standards for hemodialysis tubing sets. This includes parameters like material properties (tensile strength), mechanical resistance to pumping, and sterile shelf-life. The predicate device's performance also serves as a de facto benchmark for substantial equivalence.
The sample size for the training set:
- N/A. This is a hardware medical device, not a machine learning algorithm. There is no concept of a "training set."
How the ground truth for the training set was established:
- N/A. Not applicable, as there is no training set for this type of device.

Summary

{0}------------------------------------------------

K063293

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

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}------------------------------------------------

K063293

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:

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

Regulation Number and Section

§ 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.