(265 days)
Not Found
No
The device is a simple mechanical adapter for connecting different types of connectors in a peritoneal dialysis system. There is no mention of any software, algorithms, or data processing that would suggest the use of AI or ML.
No.
The device is an adapter for connecting components of a peritoneal dialysis system, not a device that directly performs a therapeutic function itself. It facilitates the exchange of peritoneal dialysis solution but does not administer or perform the therapy.
No
The device is an adapter for connecting peritoneal dialysis solution bags to a dialysis cycler. Its function is to facilitate the exchange of dialysis solution, which is a treatment process, not a diagnostic one.
No
The device description clearly states it is a physical adapter designed to connect two different types of connectors, indicating it is a hardware device. The performance studies also focus on physical properties like structural integrity, sterility, and leak testing.
Based on the provided text, the Fresenius APD Luer-Lock Adapter is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is to connect components for the exchange of peritoneal dialysis solution within the patient's body. This is a therapeutic procedure, not a diagnostic test performed on samples taken from the body.
- Device Description: The description focuses on connecting a solution bag to a cycler set for peritoneal dialysis, which is a treatment for kidney failure.
- Lack of IVD Characteristics: The document does not mention any of the typical characteristics of an IVD, such as:
- Analyzing samples (blood, urine, tissue, etc.)
- Detecting or measuring substances in samples
- Providing information for diagnosis, monitoring, or screening of diseases
The device is a medical device used in a therapeutic procedure (peritoneal dialysis), not a diagnostic test.
N/A
Intended Use / 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.
Product codes (comma separated list FDA assigned to the subject device)
KDJ
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).
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
Not Found
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 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 .
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.
Universal Connector, Catalog No. 48-1025-5 (K896764)
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
§ 876.5630 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.
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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 Street |
| Waltham, MA 02451-1457 | |
| Phone: | (781) 699-4479 |
| Fax: | (781) 699-9635 |
| Contact Person: | Denise Oppermann, Senior Director |
| Regulatory 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 § 876.5630 |
| Peritoneal dialysis system and accessories |
5.3 Legally Marketed Predicate Device
Universal Connector, Catalog No. 48-1025-5 (K896764)
5.4 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).
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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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Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle or bird-like figure with three swooping lines forming its body and wings. The logo is surrounded by the text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" arranged in a circular fashion around the emblem.
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
3
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:
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.
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)