The Fresenius APD Luer-Lock Adapter is intended for use with an Automated Peritoneal Dialysis cycler for the exchange of peritoneal dialysis solution. The single-use device is designed to connect any Fresenius cycler set with a Safe-Lock® connector to a peritoneal dialysis solution bag equipped with a standard luer-lock connector.

Device Description

The Fresenius APD Luer-Lock Adapter, Catalog number 050-95018, is designed to connect a peritoneal dialysis bag equipped with a luer-lock connector to a Fresenius Automated Peritoneal Dialysis (APD) cycler set that uses the Fresenius Safe-Lock® connector (e.g., Liberty® cycler, Newton IQ® cycler).

AI/ML Overview

The provided document is a 510(k) summary for the Fresenius APD Luer-Lock Adapter. It describes the device, its intended use, and indicates that performance testing was conducted to demonstrate substantial equivalence to a predicate device. However, it does not contain specific acceptance criteria, detailed study results, or the methodological details typically associated with studies proving a device meets acceptance criteria, particularly for AI/ML-based medical devices.

The document pertains to a physical medical device (an adapter) and its performance evaluation through standard engineering and biocompatibility tests, not an AI/ML diagnostic or prognostic algorithm. Therefore, many of the requested categories (e.g., sample size for test set, number of experts, MRMC studies, standalone performance, training set details) are not applicable to this type of device and submission.

Here's a breakdown of what can be extracted or inferred from the provided text, and where information is missing or not applicable:

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria Category	Acceptance Criteria (Specific Values/Thresholds)	Reported Device Performance / Evaluation
Biological Safety	Not specified (implied to meet relevant standards)	Material characterization and biocompatibility testing performed.
Sterility	Not specified (implied to meet relevant standards)	Sterility and nonpyrogenicity testing performed.
Nonpyrogenicity	Not specified (implied to meet relevant standards)	Sterility and nonpyrogenicity testing performed.
Structural Integrity	Not specified (implied to meet relevant standards)	Bond strength tensile testing performed.
Performance (Leak Test)	Not specified (implied to meet relevant standards)	Connector underwater leak test performed.
Performance (ISO 594-1 & 594-2)	ISO 594-1 and 594-2 requirements	Complete ISO 594-1 and 594-2 testing performed.
Functional Testing	Not specified (implied functional equivalence to predicate)	Simulated use testing performed.
Overall Equivalence	Performance is "substantially equivalent" to predicate.	"Based on a cumulative review of the verification testing, the performance of the APD Luer-Lock Adapter is substantially equivalent to the predicate Universal Connector..."

Missing Information: The document states what types of tests were performed but does not provide the specific quantitative acceptance criteria (e.g., minimum tensile strength, maximum leakage rate) or the exact numerical results obtained from these tests. It only reports that the testing "provided a sound basis for comparison" and demonstrated substantial equivalence.

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

Not Applicable / Not Provided for this Device Type: This information is typically relevant for studies evaluating the performance of diagnostic algorithms or imaging devices with clinical data. For a physical adapter, testing involves bench-top engineering tests (e.g., tensile strength, leak tests) and biocompatibility studies, not clinical "test sets" in the sense of patient data. The document does not specify the number of adapters tested for each performance criterion. Data provenance like "country of origin" or "retrospective/prospective" is also not applicable to this type of engineering and biocompatibility testing.

3. 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)

Not Applicable: This is relevant for AI/ML devices where human expert consensus often establishes ground truth for diagnosis/prognosis. For a physical adapter, "ground truth" is established by adherence to engineering specifications, physical integrity, and biological safety standards, evaluated by laboratory methods and qualified technicians/scientists, not by clinical experts reviewing cases for a diagnosis.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

Not Applicable: Adjudication methods are used in clinical studies, particularly for diagnostic accuracy, where disagreements between experts need to be resolved to establish a definitive ground truth. This concept does not apply to the performance testing of a physical medical device like an adapter.

5. 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

Not Applicable: MRMC studies are specifically designed to evaluate the performance of diagnostic imaging aids (often AI-powered) by comparing human reader performance with and without the aid. This is entirely irrelevant to an APD Luer-Lock adapter.

6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done

Not Applicable: This question pertains to the performance of an AI algorithm in isolation. Since the device is a physical adapter, there is no AI algorithm to evaluate.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

Engineering/Physical Standards & Biological Safety Standards: For this device, "ground truth" refers to meeting established engineering specifications for structural integrity (e.g., bond strength, leak-proof nature), functional compatibility (connecting Luer-Lock to Safe-Lock), and adherence to biological safety standards (biocompatibility, sterility, nonpyrogenicity). This is confirmed through laboratory testing against predefined criteria, not clinical outcomes or expert consensus on diagnosis.

8. The sample size for the training set

Not Applicable: "Training set" refers to data used to train an AI/ML model. This device is a physical adapter and does not involve AI/ML.

9. How the ground truth for the training set was established

Not Applicable: As there is no AI/ML model or training set, this question is not applicable.

Conclusion:

The provided document is a 510(k) summary for a physical medical device (an adapter). The "study" mentioned refers to a series of engineering, biological safety, and functional tests conducted to demonstrate substantial equivalence to a predicate device, as required for 510(k) clearance. The focus of these tests is on the device's physical properties, safety, and functional compatibility.

Many of the questions posed (especially those related to sample sizes for test/training sets, experts, adjudication, MRMC studies, and AI/ML performance) are highly specific to the evaluation of AI/ML-based diagnostic or prognostic medical devices and are not relevant to the type of device and submission described in this document. The document confirms that testing was done and that the device meets equivalence criteria based on those tests, but it does not provide the granular detail of a clinical trial or algorithm validation study.

Summary

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APD Luer-Lock Adapter Traditional 510(k) Notification

Image /page/0/Picture/2 description: The image contains the logo for Fresenius Medical Care. The logo consists of a stylized symbol on the left, resembling three downward-pointing chevrons stacked on top of each other. To the right of the symbol are the words "FRESENIUS" and "MEDICAL CARE" stacked vertically, with "FRESENIUS" on top and "MEDICAL CARE" below.

Section 5 510(k) Summary

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:	Fresenius Medical Care North America (FMCNA)
Address:	920 Winter StreetWaltham, MA 02451-1457
Phone:	(781) 699-4479
Fax:	(781) 699-9635
Contact Person:	Denise Oppermann, Senior DirectorRegulatory Affairs – Devices
Preparation Date:	12/27/2012

5.2 Device Name

Trade Name:	APD Luer-Lock Adapter
Common Name:	Peritoneal Dialysis Adapter
Product Code/Classification Panel:	KDJ / Gastroenterology-Urology
Classification Name:	21 CFR § 876.5630Peritoneal dialysis system and accessories

5.3 Legally Marketed Predicate Device

Universal Connector, Catalog No. 48-1025-5 (K896764)

5.4 Device Description

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Image /page/1/Picture/1 description: The image shows the Fresenius Medical Care logo. The logo consists of a stylized symbol on the left and the text "FRESENIUS MEDICAL CARE" on the right. The symbol is made up of three chevron-like shapes stacked vertically, with the top two pointing upwards and the bottom one pointing downwards. The text is in bold, sans-serif font, with "FRESENIUS" on the top line and "MEDICAL CARE" on the bottom line.

APD Luer-Lock Adapter Traditional 510(k) Notification

5.5 Indications for Use

The Fresenius APD Luer-Lock Adapter is intended for use with an Automated Peritoneal Dialysis cycler for the exchange of peritoneal dialysis solution. The singleuse device is designed to connect any Fresenius cycler set with a Safe-Lock® connector to a peritoneal dialysis solution bag equipped with a standard luer-lock connector.

5.6 Technological Characteristics

The APD Luer-Lock Adapter and the Universal Connector, Catalog No. 48-1025-5 (K896764) have equivalent technological characteristics. The APD Luer-Lock Adapter and Universal Connector share equivalent:

Indications for Use For use in Automated Peritoneal Dialysis (APD) . Design/Configuration – Adapts a luer-lock connection to a friction-fit connection.
Basic Scientific Technology Used in delivery of peritoneal dialysis solution . to the patient
Sterility - single use, nonpyrogenic

5.7 Performance Data

Performance testing was selected through the application of a risk management process, appropriate guidance documents and relevant standards. Results of testing have provided a sound basis for comparison to the predicate connector. Testing performed to support the determination of substantial equivalence included the following:

Biological safety material characterization and biocompatibility testing .
. Sterility and nonpyrogenicity testing
. Structural integrity - bond strength tensile testing
Performance testing of connector underwater leak test and complete ISO . 594 -1 and 594-2 testing
Functional testing simulated use .

5.8 Conclusion

Based on a cumulative review of the verification testing, the performance of the APD Luer-Lock Adapter is substantially equivalent to the predicate Universal Connector, Catalog No. 48-1025-5 (K896764). The differences between the APD Adapter and the predicate device do not raise any new concerns with regard to safety or effectiveness.

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Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

September 19, 2013

Fresenius Medical Care North America % Denise Oppermann Senior Director Regulatory Affairs, Devices 920 Winter Street Waltham, MA 02451

Re: K124024

Trade/Device Name: APD Luer-Lock Adapter Regulation Number: 21 CFR§ 876.5630 Regulation Name: Peritoneal dialysis system and accessories Regulatory Class: II Product Code: KDJ Dated: August 26, 2013 Received: August 28, 2013

Dear Denise Oppermann,

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. 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.

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 (reporting of

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medical device-related adverse events) (21 CFR 803); 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.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to

http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

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) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely yours,

Image /page/3/Figure/6 description: The image shows the name "Herbert P. Lerner -S" in a simple, sans-serif font. The letters "P" and "L" are stylized with a maze-like pattern, adding a unique visual element to the text. The overall impression is clean and professional, with a touch of creativity in the letter design. The text is horizontally aligned and appears to be a title or heading.

FOR

Benjamin R. Fisher, Ph.D. Director Division of Reproductive, Gastro-Renal, and Urological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Image /page/4/Picture/0 description: The image shows the logo for Fresenius Medical Care. The logo consists of a stylized 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 bold, sans-serif font, with "FRESENIUS" on the top line and "MEDICAL CARE" on the bottom line.

Indications for Use Statement Section 4

510(k) Number: K124024

Device Name: APD Luer-Lock Adapter

Indications for Use:

Note: A copy of this section is also provided in Appendix 1.

X Prescription Use (Per 21 CFR 801 Subpart D)

AND/OR

Over-the-Counter Use (21 CFR 801 Subpart C)

PLEASE DO NOT WRITE BELOW THIS LINE- CONTINUE ON ANOTHER PAGE IF NEEDED

Concurrence of CDRH, Office of Device Evaluation (ODE)

Herbert 22 Merner -S

Regulation Number and Section

§ 876.5630 Peritoneal dialysis system and accessories.

(a)
Identification. (1) A peritoneal dialysis 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 a peritoneal access device, an administration set for peritoneal dialysis, a source of dialysate, and, in some cases, a water purification mechanism. After the dialysate is instilled into the patient's peritoneal cavity, it is allowed to dwell there so that undesirable substances from the patient's blood pass through the lining membrane of the peritoneal cavity into this dialysate. These substances are then removed when the dialysate is drained from the patient. The peritoneal dialysis system may regulate and monitor the dialysate temperature, volume, and delivery rate together with the time course of each cycle of filling, dwell time, and draining of the peritoneal cavity or manual controls may be used. This generic device includes the semiautomatic and the automatic peritoneal delivery system.(2) The peritoneal access device is a flexible tube that is implanted through the abdominal wall into the peritoneal cavity and that may have attached cuffs to provide anchoring and a skin seal. The device is either a single use peritioneal catheter, intended to remain in the peritoneal cavity for less than 30 days, or a long term peritoneal catheter. Accessories include stylets and trocars to aid in the insertion of the catheter and an obturator to maintain the patency of the surgical fistula in the abdominal wall between treatments.
(3) The disposable administration set for peritoneal dialysis consists of tubing, an optional reservoir bag, and appropriate connectors. It may include a peritoneal dialysate filter to trap and remove contaminating particles.
(4) The source of dialysate may be sterile prepackaged dialysate (for semiautomatic peritoneal dialysate delivery systems or “cycler systems”) or dialysate prepared from dialysate concentrate and sterile purified water (for automatic peritoneal dialysate delivery systems or “reverse osmosis” systems). Prepackaged dialysate intended for use with either of the peritoneal dialysate delivery systems is regulated by FDA as a drug.
(b)
Classification. Class II (special controls). The following accessories are exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 876.9: A catheter finger grip that is non-patient contacting and intended for single use with a peritoneal catheter; a continuous ambulatory peritoneal dialysis (CAPD) belt; and a catheter stand that does not include weigh scales.