(50 days)
Not Found
No
The document describes a catheter extension set, which is a physical device used for peritoneal dialysis. There is no mention of any software, AI, or data processing capabilities within the device description or performance studies.
Yes
The device is used to connect components for peritoneal dialysis, which is a medical treatment for end-stage renal disease, thereby supporting the therapeutic process.
No
The device description indicates that the catheter extension sets are used to connect a PD catheter to PD systems. They are accessories for peritoneal dialysis, not devices intended for diagnostic purposes.
No
The device is a physical catheter extension set and adapter, used to connect dialysis catheters to PD systems. The description details physical attributes, sterilization methods, and performance studies related to physical properties and biocompatibility, clearly indicating it is a hardware device and not software-only.
No
The device is a catheter extension set used for peritoneal dialysis, which is a physical connection component and does not involve in vitro examination of specimens derived from the human body.
N/A
Intended Use / Indications for Use
stay•safe® catheter extension set with Safe-Lock, 12 inch:
The stay•safe catheter extension set with Safe-Lock is indicated for use in patients with acute and chronic end-stage renal disease undergoing peritoneal dialysis (PD) in a healthcare facility or at home. The stay•safe catheter extension set with Safe-Lock is used to connect a PD catheter with Safe-Lock compatible catheter adapter to PD systems that use stay•safe PIN technology.
stay•safe® catheter extension set with Luer-Lock, 6 inch;
stay•safe® catheter extension set with Luer-Lock, 12 inch;
and stay•safe® catheter extension set with Luer-Lock, 18 inch:
The stay•safe catheter extension set with Luer-Lock is indicated for use in patients with acute and chronic end-stage renal disease undergoing peritoneal dialysis (PD) in a healthcare facility or at home. The stay•safe catheter extension set with Luer-Lock is used to connect a PD catheter with Luer-Lock catheter adapter to PD systems that use stay•safe PIN technology.
stay•safe® to Luer-Lock Adapter, 4 inch:
The stay•safe to Luer-Lock adapter is indicated for use in patients with acute and chronic end-stage renal disease undergoing peritoneal dialysis (PD) in a healthcare facility or at home. The stay•safe to Luer-Lock adapter is used to connect a stay•safe catheter extension set to medical devices with a Luer-Lock connection.
Product codes (comma separated list FDA assigned to the subject device)
KDJ
Device Description
The stay•safe® catheter extension set with Safe-Lock, 12 inch (Safe-Lock extension set) stay•safe® catheter extension set with Luer-Lock, 6 inch, stay•safe® catheter extension set with Luer-Lock, 12 inch, and stay•safe® catheter extension set with Luer-Lock, 18 inch (Luer-Lock extension sets), and stay•safe® to Luer-Lock adapter, 4 inch (Luer-Lock adapter), hereinafter collectively referred to as the "Catheter Extension Sets" are the subject devices of this 510(k).
The Safe-Lock extension set is a single-use device designed to connect a PD catheter to PD systems that use the stay•safe PIN technology. The Safe-Lock extension set is provided sterile and non-pyrogenic. The Safe-Lock extension set is sterilized using ethylene oxide (EO).
The Luer-Lock extension sets are single-use devices designed to connect a PD catheter to PD systems that use the stay•safe PIN technology. The Luer-Lock extension sets are provided sterile and non-pyrogenic. The Luer-Lock extension sets are sterilized using EO.
The Luer-Lock adapter is a single-use device designed to connect a stay•safe catheter extension set to a medical device with a Luer lock connector. The Luer-Lock adapter is provided sterile and non-pyrogenic. The Luer-Lock adapter is sterilized using EO.
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
Used by patients with acute and chronic end-stage renal disease undergoing peritoneal dialysis (PD) in a healthcare facility or at home.
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)
The following performance tests were conducted on the Catheter Extension Sets to support the determination of substantial equivalence:
- Weight Verification
- Length Verification
- Clamp Occlusion
- Clamp Compression
- Visual Inspection after Challenge Condition
- Leak Test
- Bond/Tensile Strength
- Shipping and Packaging
- Tubing Verification – Dimensional
Biocompatibility Testing:
The Catheter Extensions Sets were evaluated for biocompatibility in accordance with ISO 10993-1:2018, Biological evaluation of medical devices – Part 1: Evaluation and testing within a risk management process" and FDA guidance Use of International Standard ISO 10993-1, "Biological evaluation of medical devices – Part 1: Evaluation and testing within a risk management process" (September 2023).
The following endpoints were evaluated to support the biological safety of the Catheter Extension Sets:
- Chemical Characterization
- Cytotoxicity
- Sensitization
- Irritation
- Systemic Toxicity (acute to chronic)
- Pyrogenicity
- Genotoxicity
- Hemocompatibility
- Carcinogenicity
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
§ 876.5630 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.
FDA 510(k) Clearance Letter - K250404
Page 1
U.S. Food & Drug Administration
10903 New Hampshire Avenue
Silver Spring, MD 20993
www.fda.gov
Doc ID # 04017.07.05
April 3, 2025
Fresenius Medical Care Renal Therapies Group, LLC
Caitlin Kalda
Senior Lead - RA Home
920 Winter Street
Waltham, MA 02451
Re: K250404
Trade/Device Name: stay•safe® catheter extension set with Safe-Lock, 12 inch; stay•safe® catheter extension set with Luer-Lock, 6 inch; stay•safe® catheter extension set with Luer-Lock, 12 inch; stay•safe® catheter extension set with Luer-Lock, 18 inch; stay•safe® to Luer-Lock Adapter, 4 inch
Regulation Number: 21 CFR § 876.5630
Regulation Name: Peritoneal Dialysis System and Accessories
Regulatory Class: II
Product Code: KDJ
Dated: February 12, 2025
Received: February 12, 2025
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.
Page 2
K250404 - Caitlin Kalda
Page 2
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" (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 QS 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 (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-reporting-combination-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.
All medical devices, including Class I and unclassified devices and combination product device constituent parts are required to be in compliance with the final Unique Device Identification System rule ("UDI Rule"). The UDI Rule requires, among other things, that a device bear a unique device identifier (UDI) on its label and package (21 CFR 801.20(a)) unless an exception or alternative applies (21 CFR 801.20(b)) and that the dates on the device label be formatted in accordance with 21 CFR 801.18. The UDI Rule (21 CFR 830.300(a) and 830.320(b)) also requires that certain information be submitted to the Global Unique Device Identification Database (GUDID) (21 CFR Part 830 Subpart E). For additional information on these requirements, please see the UDI System webpage at https://www.fda.gov/medical-devices/device-advice-comprehensive-regulatory-assistance/unique-device-identification-system-udi-system.
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-devices/medical-device-safety/medical-device-reporting-mdr-how-report-medical-device-problems.
Page 3
K250404 - Caitlin Kalda
Page 3
For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medical-devices/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. See the DICE website (https://www.fda.gov/medical-devices/device-advice-comprehensive-regulatory-assistance/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,
Maura Rooney -S
Maura Rooney
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
Page 4
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
Form Approved: OMB No. 0910-0120
Expiration Date: 07/31/2026
See PRA Statement below.
Indications for Use
Submission Number (if known)
K250404
Device Name
stay•safe® catheter extension set with Safe-Lock, 12 inch;
stay•safe® catheter extension set with Luer-Lock, 6 inch;
stay•safe® catheter extension set with Luer-Lock, 12 inch;
stay•safe® catheter extension set with Luer-Lock, 18 inch;
stay•safe® to Luer-Lock Adapter, 4 inch
Indications for Use (Describe)
stay•safe® catheter extension set with Safe-Lock, 12 inch:
The stay•safe catheter extension set with Safe-Lock is indicated for use in patients with acute and chronic end-stage renal disease undergoing peritoneal dialysis (PD) in a healthcare facility or at home. The stay•safe catheter extension set with Safe-Lock is used to connect a PD catheter with Safe-Lock compatible catheter adapter to PD systems that use stay•safe PIN technology.
stay•safe® catheter extension set with Luer-Lock, 6 inch;
stay•safe® catheter extension set with Luer-Lock, 12 inch;
and stay•safe® catheter extension set with Luer-Lock, 18 inch:
The stay•safe catheter extension set with Luer-Lock is indicated for use in patients with acute and chronic end-stage renal disease undergoing peritoneal dialysis (PD) in a healthcare facility or at home. The stay•safe catheter extension set with Luer-Lock is used to connect a PD catheter with Luer-Lock catheter adapter to PD systems that use stay•safe PIN technology.
stay•safe® to Luer-Lock Adapter, 4 inch:
The stay•safe to Luer-Lock adapter is indicated for use in patients with acute and chronic end-stage renal disease undergoing peritoneal dialysis (PD) in a healthcare facility or at home. The stay•safe to Luer-Lock adapter is used to connect a stay•safe catheter extension set to medical devices with a Luer-Lock connection.
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)
CONTINUE ON A SEPARATE PAGE IF NEEDED.
This section applies only to requirements of the Paperwork Reduction Act of 1995.
DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.
The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:
Department of Health and Human Services
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Office of Chief Information Officer
Paperwork Reduction Act (PRA) Staff
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"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."
Page 5
K250404
stay•safe Catheter Extension Sets
Page 1 of 7
1. 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.
1.1. Submitter's Information
Name: Fresenius Medical Care Renal Therapies Group, LLC
Address: 920 Winter Street
Waltham, MA 02451-1457
Contact Person: Caitlin Kalda, Senior Lead RA – Home
Phone: (857) 291-0009
Alternate Contact: Denise Oppermann, Vice President Regulatory Affairs – North America
Phone: (781) 996-9103
Preparation Date: 12 February 2025
1.2. Device Name
Trade Name:
- stay•safe® catheter extension set with Safe-Lock, 12 inch
- stay•safe® catheter extension set with Luer-Lock, 6 inch
- stay•safe® catheter extension set with Luer-Lock, 12 inch
- stay•safe® catheter extension set with Luer-Lock, 18 inch
- stay•safe® to Luer-Lock Adapter, 4 inch
Common Name:
- Safe-Lock Extension Set
- Luer-Lock Extension Sets
- Luer-Lock Adapter
Regulation Name: Peritoneal Dialysis System and Accessories
Regulatory Class: Class II per 21 CFR §876.5630
Product Code: KDJ
Product Code Name: Set, Administration, For Peritoneal Dialysis, Disposable
FDA Review Panel: Gastroenterology/Urology
1.3. Legally Marketed Predicate Devices
A medical device correction letter was issued for the predicate devices. No removal of the product was required.
1.3.1. Predicate Devices
The stay•safe® catheter extension set with Safe-Lock, 12 inch, stay•safe® catheter extension set with Luer-Lock, 6 inch, stay•safe® catheter extension set with Luer-Lock, 12 inch, stay•safe® catheter extension set with Luer-Lock, 18 inch, and stay•safe® to Luer-Lock adapter, 4 inch (K173593) are the legally marketed predicate devices.
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stay•safe Catheter Extension Sets
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1.4. Device Description
1.4.1. Device Identification
The stay•safe® catheter extension set with Safe-Lock, 12 inch (Safe-Lock extension set) stay•safe® catheter extension set with Luer-Lock, 6 inch, stay•safe® catheter extension set with Luer-Lock, 12 inch, and stay•safe® catheter extension set with Luer-Lock, 18 inch (Luer-Lock extension sets), and stay•safe® to Luer-Lock adapter, 4 inch (Luer-Lock adapter), hereinafter collectively referred to as the "Catheter Extension Sets" are the subject devices of this 510(k).
1.4.2. Device Characteristics
The Safe-Lock extension set is a single-use device designed to connect a PD catheter to PD systems that use the stay•safe PIN technology. The Safe-Lock extension set is provided sterile and non-pyrogenic. The Safe-Lock extension set is sterilized using ethylene oxide (EO).
The Luer-Lock extension sets are single-use devices designed to connect a PD catheter to PD systems that use the stay•safe PIN technology. The Luer-Lock extension sets are provided sterile and non-pyrogenic. The Luer-Lock extension sets are sterilized using EO.
The Luer-Lock adapter is a single-use device designed to connect a stay•safe catheter extension set to a medical device with a Luer lock connector. The Luer-Lock adapter is provided sterile and non-pyrogenic. The Luer-Lock adapter is sterilized using EO.
1.4.3. Environment of Use
The Catheter Extension Sets are used in both healthcare and home environments.
1.4.4. Brief Written Description of the Device
The stay•safe catheter extension set with Safe-Lock, 12 inch is a single-use, sterile (EO), non-pyrogenic disposable accessory. The Safe-Lock extension set is used to connect a PD catheter with a Safe-Lock-compatible catheter adapter to PD systems that use the stay•safe PIN technology. The Safe-Lock extension set is connected to the patient's Safe-Lock-compatible catheter adapter in a hospital or clinic setting by a healthcare professional and is routinely monitored during patient follow-up visits. The extension set is intended to be connected to the patient's Safe-Lock-compatible catheter adapter for up to six (6) months and then replaced with a new one with treatment lasting up to 10 years. The extension set is used in patients for up to 10 years.
The stay•safe catheter extension set with Luer-Lock is a single-use, sterile (EO), non-pyrogenic disposable accessory. It is available in three (3) lengths: 6 inch, 12 inch, and 18 inch. The Luer-Lock extension sets are used to connect a PD catheter with a Luer-Lock catheter adapter to PD systems that use the stay•safe PIN technology. The Luer-Lock extension sets are connected to the patient catheter adapter in a hospital or clinic setting by a healthcare professional and are routinely monitored during patient follow-up visits. The Luer-Lock extension set is intended to be connected to the patient's catheter adapter for up to 6 months and then replaced with a new
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K250404
stay•safe Catheter Extension Sets
Page 3 of 7
one with treatment lasting up to 10 years. The Luer-Lock extension set is used in patients for up to 10 years.
The stay•safe to Luer-Lock adapter is a single-use, sterile (EO), non-pyrogenic disposable accessory that is used to connect a stay•safe catheter extension set to a medical device with a Luer lock connection (e.g., transfer set or syringe). The Luer-Lock adapter consists of a stay•safe connector, tubing, and a Luer lock connector. The Luer-Lock adapter is connected to the stay•safe catheter extension set in a hospital or clinic setting by a healthcare professional. The Luer-Lock adapter is intended to be connected for up to 6 months and then replaced with a new one with treatment lasting up to 10 years. The Luer-Lock adapter is used in patients for up to 10 years.
1.4.5. Materials of Use
The Catheter Extensions Sets are classified as externally communicating blood path indirect, permanent contact (> 30 day) duration devices in accordance with FDA guidance Use of International Standard ISO 10993-1, "Biological evaluation of medical devices – Part 1: Evaluation and testing within a risk management process" (September 2023).
The materials used in the Safe-Lock extension set, Luer-Lock extension set, and Luer-Lock adapter are provided in Table 1.
Table 1: Materials Used in Catheter Extension Sets
| Component | Material |
|---|---|
| Safe-Lock Extension Set | |
| Protective cap | Polypropylene |
| Silicone | |
| Male stay•safe connector | Polyvinylidene fluoride |
| Tubing | Silicone |
| Clamp | Polyoxymethylene |
| Male Safe-Lock connector | Polycarbonate |
| Blue cap | Polyether block amide |
| Luer-Lock Extension Set | |
| Protective cap | Polypropylene |
| Silicone | |
| Male stay•safe connector | Polyvinylidene fluoride |
| Tubing | Silicone |
| Clamp | Polyoxymethylene |
| Male Luer-Lock connector | Thermoplastic elastomer |
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stay•safe Catheter Extension Sets
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Table 1: Materials Used in Catheter Extension Sets
| Component | Material |
|---|---|
| Blue cap | Low-density polyethylene |
| Luer-Lock Adapter | |
| Closure Cap | Polyamide block ether |
| Female Luer-Lock connector | Polyvinylidene fluoride |
| Tubing | Silicone |
| Female stay•safe adapter | Polyvinylidene fluoride |
| stay•safe cap | Polypropylene |
| Silicone |
1.4.6. Key Performance Specifications/Characteristics
The Safe-Lock and Luer-Lock extension sets provide additional length to the patient's catheter and allow for connection to the stay•safe system for PD treatment. The Safe-Lock and Luer-Lock extension sets enable effluent to drain out of, and dialysate to flow into, the patient's peritoneum during PD treatment.
The stay•safe to Luer-Lock adapter converts the stay•safe end of the patient's catheter extension set into a Luer lock to make it compatible with medical devices that have a Luer lock connection.
1.5. Intended Use/Indications for Use
1.5.1. stay•safe catheter extension set with Safe-Lock (Safe-Lock extension set)
Intended Use
The stay•safe catheter extension set with Safe-Lock is intended for use by patients with acute and chronic end-stage renal disease undergoing peritoneal dialysis (PD).
Indications for Use
The stay•safe catheter extension set with Safe-Lock is indicated for use in patients with acute and chronic end-stage renal disease undergoing peritoneal dialysis (PD) in a healthcare facility or at home. The stay•safe catheter extension set with Safe-Lock is used to connect a PD catheter with Safe-Lock compatible catheter adapter to PD systems that use stay•safe PIN technology.
1.5.2. stay•safe catheter extension sets with Luer-Lock (Luer-Lock extension sets)
Intended Use
The stay•safe catheter extension set with Luer-Lock is intended for use by patients with acute and chronic end-stage renal disease undergoing peritoneal dialysis (PD).
Indications for Use
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K250404
stay•safe Catheter Extension Sets
Page 5 of 7
The stay•safe catheter extension set with Luer-Lock is indicated for use in patients with acute and chronic end-stage renal disease undergoing peritoneal dialysis (PD) in a healthcare facility or at home. The stay•safe catheter extension set with Luer-Lock is used to connect a PD catheter with a Luer-Lock catheter adapter to PD systems that use stay•safe PIN technology.
1.5.3. stay•safe to Luer-Lock adapter (Luer-Lock adapter)
Intended Use
The stay•safe to Luer-Lock adapter is intended for use by patients with acute and chronic end-stage renal disease undergoing peritoneal dialysis (PD).
Indications for Use
The stay•safe to Luer-Lock adapter is indicated for use in patients with acute and chronic end-stage renal disease undergoing peritoneal dialysis (PD) in a healthcare facility or at home. The stay•safe to Luer-Lock adapter is used to connect a stay•safe catheter extension set to medical devices with a Luer-Lock connection.
1.6. Comparison of Technological Characteristics with the Predicate Device
The following technological characteristics of the Catheter Extension Sets are substantially equivalent to those of the predicate devices (K173593):
- Intended Use
- Indications for Use
- Design Specifications
- Technological Characteristics
- Principle of Operation
- Performance Requirements
1.7. Performance Data
The following performance tests were conducted on the Catheter Extension Sets to support the determination of substantial equivalence:
- Weight Verification
- Length Verification
- Clamp Occlusion
- Clamp Compression
- Visual Inspection after Challenge Condition
- Leak Test
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stay•safe Catheter Extension Sets
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- Bond/Tensile Strength
- Shipping and Packaging
- Tubing Verification – Dimensional
1.7.1. Biocompatibility Testing
The Catheter Extensions Sets were evaluated for biocompatibility in accordance with ISO 10993-1:2018, Biological evaluation of medical devices – Part 1: Evaluation and testing within a risk management process" and FDA guidance Use of International Standard ISO 10993-1, "Biological evaluation of medical devices – Part 1: Evaluation and testing within a risk management process" (September 2023).
The following endpoints were evaluated to support the biological safety of the Catheter Extension Sets:
- Chemical Characterization
- Cytotoxicity
- Sensitization
- Irritation
- Systemic Toxicity (acute to chronic)
- Pyrogenicity
- Genotoxicity
- Hemocompatibility
- Carcinogenicity
1.7.2. Human Factors Validation Testing
Human Factors testing was not required.
1.7.3. Electrical Safety and Electromagnetic Compatibility (EMC)
Not applicable. The Catheter Extension Sets are not electrical mechanical devices.
1.7.4. Software Verification and Validation Testing
Not applicable. The Catheter Extension Sets do not contain software.
1.7.5. Animal Studies
No animal studies were performed for the Catheter Extension Sets.
1.7.6. Clinical Studies
No clinical studies were performed for the Catheter Extension Sets.
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stay•safe Catheter Extension Sets
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1.8. Conclusion
The indications for use, design, principle of operation, and technological characteristics of the Catheter Extension Sets are substantially equivalent to those of the predicate devices. Test results demonstrate that the differences between the Catheter Extension Sets and the predicate devices do not raise new concerns with regard to safety or efficacy. FMCRTG concludes that within the meaning of the Medical Device Amendments Act of 1976, the stay•safe® catheter extension set with Safe-Lock, 12 inch, stay•safe® catheter extension set with Luer-Lock, 6 inch, stay•safe® catheter extension set with Luer-Lock, 12 inch, stay•safe® catheter extension set with Luer-Lock, 18 inch, and stay•safe® to Luer-Lock adapter, 4 inch are substantially equivalent to the selected predicates.