(181 days)
No
The device description and performance studies focus on the physical and material properties of the extension sets and adapter, with no mention of software, AI, or ML. The "Software Verification and Validation Testing" section is explicitly marked as "Not applicable".
Yes.
The device is used to connect a peritoneal dialysis catheter to PD systems, which is a therapeutic process for patients with end-stage renal disease.
No
The device description and intended use clearly state that this device is designed to connect a PD catheter to PD systems, facilitating peritoneal dialysis treatment. It does not perform any diagnostic function.
No
The device description and performance studies clearly indicate that this is a physical medical device (catheter extension sets and adapters) made of materials, requiring sterilization, and undergoing biocompatibility and mechanical testing. It explicitly states "Software Verification and Validation Testing: Not applicable."
Based on the provided text, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states the device is used to connect components for peritoneal dialysis, a treatment for end-stage renal disease. This is a therapeutic procedure, not a diagnostic test performed on samples taken from the body.
- Device Description: The description details the physical components and their function in connecting parts of a peritoneal dialysis system. There is no mention of analyzing biological samples or providing diagnostic information.
- Lack of IVD Characteristics: The text does not mention any of the typical characteristics of an IVD, such as:
- Analyzing biological samples (blood, urine, tissue, etc.)
- Detecting or measuring substances in samples
- Providing information for diagnosis, monitoring, or screening
- Using reagents or calibrators
The device is a medical device used in the delivery of a treatment, not for diagnostic purposes.
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; 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 a 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
stay safe® catheter extension set with Safe-Lock: The Safe-Lock extension set is a single-use, sterile (EO), non-pyrogenic disposable accessory. The Safe-Lock extension set is used to connect a PD catheter that has a Safe-Lock-compatible catheter adapter to PD systems that use 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.
stay safe® catheter extension set with Luer-Lock: The Luer-Lock extension set is a single-use, sterile (EO), non-pyrogenic disposable accessory. It is available in three (3) lengths: 6 inch (050-95013), 12 inch (050-95004), and 18 inch (050-95005). The Luer-Lock extension sets are used to connect a PD catheter that has a Luer-Lock catheter adapter to PD systems that use 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.
stay safe® to Luer-Lock adapter, 4 inch: The 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.
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. The extension sets and adapter are connected by a healthcare professional.
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 Studies conducted to support substantial equivalence:
- Tubing verification
- Clamp performance (for Safe-Lock and Luer-Lock extension sets)
- Connectology (stay safe, Safe-Lock/Luer-Lock)
- Package verification
- Engagements bond/tensile strength
- Device weight verification
- Cleaning agents compatibility
- Latex content verification
- Particulate visual inspection
- Shipping and packaging
- Maintenance of sterility
- Biological safety (biocompatibility)
- Usability
- ISO 594-2 (for Luer-Lock extension sets and Luer-Lock adapter)
Biocompatibility Testing:
Testing was conducted to support the biological safety. This included:
- Simulated Use Leachables Testing
- Cytotoxicity, ISO Elution Method with MEM
- Sensitization, Guinea Pig Maximization
- Intracutaneous Irritation
- Acute Systemic Toxicity
- Systemic Toxicity, Short-Term Repeated Exposure
- Material-Mediated Pyrogenicity
- Genotoxicity, Bacterial Review Mutation Assay
- Genotoxicity, in vitro Mouse Lymphoma Gene Mutation Assay
- Genotoxicity, Mouse Micronucleus in vivo Assay
- Hemocompatibility, ASTM Hemolysis (Indirect) - Extract
A toxicological risk assessment was also performed.
Human Factors Validation Testing:
The devices were validated for their safe and effective use in accordance with FDA guidance Applying Human Factors and Usability Engineering to Medical Devices (03 February 2016).
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.
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.
0
Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
May 21, 2018
Fresenius Medical Care Renal Therapies Group, LLC Denise Oppermann Senior Director, Regulatory Affairs 920 Winter Street Waltham, MA 02451
Re: K173593
Trade/Device Name: stay safe® catheter extension set with Safe-Lock, 12 inch; staysafe® 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: April 23, 2018 Received: April 24, 2018
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.
1
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 of 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.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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.
For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). 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 (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
Joyce M. Whang -S
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
2
Indications for Use
510(k) Number (if known)
K173593
Device Name
stay · safe® catheter extension set with Safe-Lock, 12 inch
Indications for Use (Describe)
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.
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)
Form Approved: OMB No. 0910-0120
Expiration Date: 06/30/2020
See PRA Statement below.
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 Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov
"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."
EF
PSC Publishing Services (301) 443-6740
3
DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration
Indications for Use
510(k) Number (if known)
K173593
Device Name
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
Indications for Use (Describe)
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 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.
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)
Form Approved: OMB No. 0910-0120
Expiration Date: 06/30/2020
See PRA Statement below.
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 Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff@fda.hhs.gov
"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."
PSC Publishing Services (301) 443-6740 EF
4
Indications for Use
510(k) Number (if known)
Device Name stay . safe® to Luer-Lock adapter. 4 inch
Indications for Use (Describe)
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)
X Prescription Use (Part 21 CFR 801 Subpart D)
Over-The-Counter Use (21 CFR 801 Subpart C)
Form Approved: OMB No. 0910-0120
Expiration Date: 06/30/2020
See PRA Statement below.
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 Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff@fda.hhs.gov
"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."
5
Image /page/5/Picture/0 description: The image shows the logo for Fresenius Medical Care. On the left is a blue symbol that looks like three downward pointing arrows stacked on top of each other. To the right of the symbol is the text "FRESENIUS MEDICAL CARE" in blue, with "FRESENIUS" on the top line and "MEDICAL CARE" on the bottom line.
K173593 Page 1 of 14
5. 510(k) SUMMARY
A 510(k) summary for the each device is provided in Section 5.1 (staysafe® catheter extension set with Safe-Lock), Section 5.2 (stay safe® catheter extension sets with Luer-Lock), and Section 5.3 (stay.safe® to Luer-Lock adapter).
510(k) Summary for staysafe® catheter extension set with Safe-Lock 5.1.
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 8807.92.
5.1.1. Submitter's Information
| Name: | Fresenius Medical Care Renal Therapies Group, LLC |
|---|---|
| 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: | 20 November 2017 |
5.1.2. Device Name
| Trade Name: | stay safe® catheter extension set with Safe-Lock, 12 inch |
|---|---|
| Common Name: | Safe-Lock extension set |
| Classification Name: | Peritoneal Dialysis System and Accessories |
| Regulatory Class: | Class II per 21 CFR §876.5630 |
| Product Code: | KDJ |
| Classification Panel: | Gastroenterology/Urology |
5.1.3. Legally Marketed Predicate Device
The legally marketed predicate device is the Dextrolyte II Peritoneal Dialysis Catheter Extension Set with Roller Clamp (K920697). This predicate has not been subject to a design-related recall.
The Fresenius CAPD stay safe® Disposable Administration Sets with stay safe® Connector (K022412) and the Fresenius stay safe Patient Connectors (K041792) are used as reference devices.
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Image /page/6/Picture/0 description: The image contains the logo for Fresenius Medical Care. The logo consists of a blue emblem on the left and the company name on the right. The emblem is made up of three downward-pointing chevron shapes stacked on top of each other. The text "FRESENIUS MEDICAL CARE" is in blue, with "FRESENIUS" on the top line and "MEDICAL CARE" on the bottom line.
5.1.4. Device Description
Device Identification 5.1.4.1.
The stay safe® catheter extension set with Safe-Lock (hereinafter referred to as "Safe-Lock extension set") is the subject of this 510(k).
5.1.4.2. Device Characteristics
The Safe-Lock extension set is a single-use device designed to connect a PD catheter to PD systems that use staysafe PIN technology. The Safe-Lock extension set is provided sterile and non-pyrogenic. The Safe-Lock extension set is sterilized using ethylene oxide (EO).
5.1.4.3. Environment of Use
The Safe-Lock extension set is used in both healthcare and home environments.
5.1.4.4. Brief Written Description of the Device
The Safe-Lock extension set is a single-use, sterile (EO), non-pyrogenic disposable accessory. The Safe-Lock extension set is used to connect a PD catheter that has a Safe-Lock-compatible catheter adapter to PD systems that use 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.
5.1.4.5. Materials of Use
The Safe-Lock extension set is classified as an externally communicating, blood path indirect, permanent contact (> 30 days) duration, Class II (Category C) device 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" (16 June 2016).
| Component | Material |
|---|---|
| Protective cap | Polypropylene |
| Silicone | |
| Male stay•safe connector | Polyvinylidene fluoride |
| Tubing | Silicone |
| Clamp | Polyoxomethylene |
| Male Safe-Lock connector | Polycarbonate |
| Blue cap | Polyether block amide |
The Safe-Lock extension sets are composed of the following materials:
7
Peritoneal Dialysis (PD) Accessories Extension Sets and Adapter Traditional 510(k)
5.1.4.6. Key Performance Characteristics
The Safe-Lock extension set provides additional length to the patient's catheter and allows for connection to the stay safe system for PD treatment. The Safe-Lock extension set enables effluent to drain out of, and dialysate to flow into, the patient's peritoneum during PD treatment.
5.1.5. 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.
5.1.6. 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.
5.1.7. Comparison of Technological Characteristics with the Predicate Device
The following technological characteristics of the Safe-Lock extension set are equivalent to the predicate Dextrolyte II Peritoneal Dialysis Catheter Extension Set with Roller Clamp (K920697).
- Intended use
- Principle of operation ●
- Design characteristics
- o Sterilization method
5.1.8. Performance Data
Testing was conducted to support the determination of substantial equivalence.
- Performance 0
- Tubing verification -
- Clamp performance -
- Connectology (stay safe, Safe-Lock) -
- Package verification -
- -Engagements bond/tensile strength
- Device weight verification -
- -Cleaning agents compatibility
- Latex content verification ।
- Particulate visual inspection
8
Image /page/8/Picture/1 description: The image shows the Fresenius Medical Care logo. The logo consists of a blue symbol on the left and the text "FRESENIUS MEDICAL CARE" on the right, also in blue. The symbol is made up of three chevron shapes stacked on top of each other, pointing downwards.
- Shipping and packaging -
- Maintenance of sterility o
- o Biological safety (biocompatibility)
- o Usability
Biocompatibility Testing 5.1.8.1.
Testing was conducted to support the biological safety of the Safe-Lock extension set.
- Simulated Use Leachables Testing ●
- Cytotoxicity, ISO Elution Method with MEM
- Sensitization, Guinea Pig Maximization
- Intracutaneous Irritation
- o Acute Systemic Toxicity
- Systemic Toxicity, Short-Term Repeated Exposure
- o Material-Mediated Pyrogenicity
- o Genotoxicity, Bacterial Review Mutation Assay
- Genotoxicity, in vitro Mouse Lymphoma Gene Mutation Assay
- Genotoxicity, Mouse Micronucleus in vivo Assay
- Hemocompatibility, ASTM Hemolysis (Indirect) - Extract
A toxicological risk assessment was also performed.
5.1.8.2. Human Factors Validation Testing
The Safe-Lock extension set was validated for its safe and effective use in accordance with FDA guidance Applying Human Factors and Usability Engineering to Medical Devices (03 February 2016).
5.1.8.3. Electrical Safety and Electromagnetic Compatibility
Not applicable. The Safe-Lock extension set is not an electrical mechanical device.
Software Verification and Validation Testing 5.1.8.4.
Not applicable. The Safe-Lock extension set does not contain software.
5.1.8.5. Mechanical and Acoustic Testing
No mechanical or acoustic tests were performed.
9
Image /page/9/Picture/0 description: The image contains the logo for Fresenius Medical Care. The logo consists of a blue emblem on the left and the text "FRESENIUS MEDICAL CARE" on the right. The emblem is made up of three downward-pointing chevron shapes stacked on top of each other. The text is in a bold, sans-serif font, with "FRESENIUS" on the top line and "MEDICAL CARE" on the bottom line.
5.1.8.6. Animal Studies
No animal studies were performed.
Clinical Studies 5.1.8.7.
No clinical studies were performed.
5.1.9. Conclusion
The intended use, principle of operation, design characteristics, and sterilization method of the Safe-Lock extension set is substantially equivalent to that of the predicate device. FMCRTG concludes that within the meaning of the Medical Device Amendments Act of 1976, the Safe-Lock extension set is safe and effective for its intended use.
10
Image /page/10/Picture/1 description: The image contains the logo for Fresenius Medical Care. The logo consists of a blue geometric shape on the left, resembling three downward-pointing chevrons stacked on top of each other. To the right of the geometric shape, the text "FRESENIUS MEDICAL CARE" is displayed in a bold, sans-serif font, also in blue. The text is arranged in two lines, with "FRESENIUS" on the top line and "MEDICAL CARE" on the bottom line.
5.2. 510(k) Summary for stay safe® catheter extension sets with Luer-Lock
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 8807.92.
5.2.1. Submitter's Information
| Name: | Fresenius Medical Care Renal Therapies Group, LLC |
|---|---|
| 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: | 20 November 2017 |
5.2.2. Device Name
| Trade Name: | stay•safe® catheter extension sets with Luer-Lock, 6 inch |
|---|---|
| stay•safe® catheter extension sets with Luer-Lock, 12 inch | |
| stay•safe® catheter extension sets with Luer-Lock, 18 inch | |
| Common Name: | Luer-Lock extension sets |
| Classification Name: | Peritoneal Dialysis System and Accessories |
| Regulatory Class: | Class II per 21 CFR §876.5630 |
| Product Code: | KDJ |
| Classification Panel: | Gastroenterology/Urology |
5.2.3. Legally Marketed Predicate Device
The legally marketed predicate device is the Dextrolyte II Peritoneal Dialysis Catheter Extension Set with Roller Clamp (K920697). This predicate has not been subject to a design-related recall.
The Fresenius CAPD staysafe® Disposable Administration Sets with staysafe® Connector (K022412) and the Fresenius stay safe Patient Connectors (K041792) are used as reference devices.
5.2.4. Device Description
5.2.4.1. Device Identification
The stay safe® catheter extension sets with Luer-Lock (hereinafter referred to as "Luer-Lock extension sets") are the subject of this 510(k).
11
Image /page/11/Picture/1 description: The image shows the Fresenius Medical Care logo. The logo consists of a blue 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 a bold, sans-serif font, with "FRESENIUS" on the top line and "MEDICAL CARE" on the bottom line.
5.2.4.2. Device Characteristics
The Luer-Lock extension sets are single-use devices designed to connect a PD catheter to PD systems that use stay safe PIN technology. The Luer-Lock extension sets are provided sterile and non-pyrogenic. The Luer-Lock extension sets are sterilized using EO.
5.2.4.3. Environment of Use
The Luer-Lock extension set is used in both healthcare and home environments.
Brief Written Description of the Device 5.2.4.4.
The Luer-Lock extension set is a single-use, sterile (EO), non-pyrogenic disposable accessory. It is available in three (3) lengths: 6 inch (050-95013), 12 inch (050-95004), and 18 inch (050-95005). The Luer-Lock extension sets are used to connect a PD catheter that has a Luer-Lock catheter adapter to PD systems that use 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.
5.2.4.5. Materials of Use
The Luer-Lock extension sets are classified as externally communicating, blood path indirect, permanent contact (> 30 days) duration. Class II (Category C) 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" (16 June 2016).
| Component | Material |
|---|---|
| Protective cap | Polypropylene |
| Silicone | |
| Male stay•safe connector | Polyvinylidene fluoride |
| Tubing | Silicone |
| Clamp | Polyoxomethylene |
| Male LuerLock connector | Thermoplastic elastomer |
| Blue cap | Low-density polyethylene |
The Luer-Lock extension sets are composed of the following materials:
Key Performance Characteristics 5.2.4.6.
The Luer-Lock extension sets provide additional length to the patient's catheter and allows for connection to the stay safe system for PD treatment. The Luer-Lock extension sets enable effluent to drain out of, and dialysate to flow into, the patient's peritoneum during PD treatment.
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Image /page/12/Picture/1 description: The image shows the Fresenius Medical Care logo. The logo consists of a blue 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 a bold, sans-serif font, with "FRESENIUS" on the top line and "MEDICAL CARE" on the bottom line.
5.2.5. 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.
5.2.6. Indications for Use
The staysafe 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.
5.2.7. Comparison of Technological Characteristics with the Predicate Device
The following technological characteristics of the Luer-Lock extension sets are equivalent to the predicate Dextrolyte II Peritoneal Dialysis Catheter Extension Set with Roller Clamp (K920697).
- . Intended use
- o Principle of operation
- Design characteristics
- Sterilization method
5.2.8. Performance Data
Testing was conducted to support the determination of substantial equivalence.
- Performance
- -Tubing verification
- -Clamp performance
- Connectology (stay safe, Luer-Lock) -
- Package verification -
- Engagements bond/tensile strength -
- Device weight verification -
- ISO 594-2 -
- Cleaning agents compatibility -
- Latex content verification -
- -Particulate visual inspection
- Shipping and packaging |
- Maintenance of sterility ●
- Biological safety (biocompatibility) ●
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Image /page/13/Picture/1 description: The image shows the logo for Fresenius Medical Care. The logo consists of a blue 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 a bold, sans-serif font, with "FRESENIUS" on the top line and "MEDICAL CARE" on the bottom line.
- Usability
Biocompatibility Testing 5.2.8.1.
Testing was conducted to support the biological safety of the Luer-Lock extension set.
- Simulated Use Leachables Testing
- Cytotoxicity, ISO Elution Method with MEM
- Sensitization, Guinea Pig Maximization
- o Intracutaneous Irritation
- Acute Systemic Toxicity
- Systemic Toxicity, Short-Term Repeated Exposure
- Material-Mediated Pyrogenicity ●
- Genotoxicity, Bacterial Review Mutation Assay ●
- Genotoxicity, in vitro Mouse Lymphoma Gene Mutation Assay ●
- Genotoxicity, Mouse Micronucleus in vivo Assay ●
- Hemocompatibility, ASTM Hemolysis (Indirect) Extract ●
A toxicological risk assessment was also performed.
5.2.8.2. Human Factors Validation Testing
The Luer-Lock extension sets were validated for their safe and effective use in accordance with FDA guidance Applying Human Factors and Usability Engineering to Medical Devices (03 February 2016).
Electrical Safety and Electromagnetic Compatibility 5.2.8.3.
Not applicable. The Luer-Lock extension sets are not electrical mechanical devices.
5.2.8.4. Software Verification and Validation Testing
Not applicable. The Luer-Lock extension sets do not contain software.
5.2.8.5. Mechanical and Acoustic Testing
No mechanical or acoustic tests were performed.
5.2.8.6. Animal Studies
No animal studies were performed.
Clinical Studies 5.2.8.7.
No clinical studies were performed.
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Image /page/14/Picture/1 description: The image shows the logo for Fresenius Medical Care. The logo consists of a blue symbol on the left and the text "FRESENIUS MEDICAL CARE" on the right, also in blue. The symbol is made up of three downward-pointing chevrons stacked on top of each other.
5.2.9. Conclusion
The intended use, principle of operation, design characteristics, and sterilization method of the Luer-Lock extension sets are substantially equivalent to those of the predicate device. FMCRTG concludes that within the meaning of the Medical Device Amendments Act of 1976, the Luer-Lock extension sets are safe and effective for their intended use.
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Image /page/15/Picture/1 description: The image shows the Fresenius Medical Care logo. The logo consists of a blue symbol on the left and the text "FRESENIUS MEDICAL CARE" on the right. The symbol is made up of three downward-pointing chevrons. The text is in a bold, sans-serif font and is also blue.
510(K) Summary for stay safe® to Luer-Lock adapter 5.3.
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 ട്ലു807.92.
5.3.1. Submitter's Information
| Name: | Fresenius Medical Care Renal Therapies Group, LLC |
|---|---|
| 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: | 20 November 2017 |
5.3.2. Device Name
| Trade Name: | stay•safe® to Luer-Lock Adapter, 4 inch |
|---|---|
| Common Name: | Luer-Lock adapter |
| Classification Name: | Peritoneal Dialysis System and Accessories |
| Regulatory Class: | Class II per 21 CFR §876.5630 |
| Product Code: | KDJ |
| Classification Panel: | Gastroenterology/Urology |
5.3.3. Legally Marketed Predicate Device
The legally marketed predicate device is the Universal Connector (K896764). This predicate has not been subject to a design-related recall.
The Fresenius CAPD stay safe® Disposable Administration Sets with stay safe® Connector (K022412) and the Fresenius stay safe Patient Connectors (K041792) are used as reference devices.
5.3.4. Device Description
5.3.4.1. Device Identification
The stay safe® to Luer-Lock adapter (hereinafter referred to as "Luer-Lock adapter") is the subject of this 510(k).
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Image /page/16/Picture/0 description: The image shows the Fresenius Medical Care logo. The logo consists of a blue 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 a bold, sans-serif font, with "FRESENIUS" on the top line and "MEDICAL CARE" on the bottom line.
5.3.4.2. Device Characteristics
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.
5.3.4.3. Environment of Use
The Luer-Lock adapter is used in both healthcare and home environments.
Brief Written Description of the Device 5.3.4.4.
The 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 staysafe 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.
5.3.4.5. Materials of Use
The Luer-Lock adapter is classified as an externally communicating, blood path indirect, permanent contact (> 30 days) duration, Class II (Category C) device 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" (16 June 2016).
| Component | Material |
|---|---|
| Closure Cap | Polyamide block ether |
| Female Luer lock connector | Polyvinylidene fluoride |
| Tubing | Silicone |
| Female stay•safe adapter | Polyvinylidene fluoride |
| stay•safe cap | Polypropylene |
| Silicone |
The Luer-Lock adapter is composed of the following materials:
5.3.4.6. Kev Performance Characteristics
The 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.
5.3.5. Intended Use
The stay safe to Luer-Lock adapter is intended for use by patients with acute and chronic endstage renal disease undergoing peritoneal dialysis.
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Image /page/17/Picture/0 description: The image contains the logo for Fresenius Medical Care. On the left side of the logo, there are three downward-pointing triangles stacked on top of each other. To the right of the triangles, the text "FRESENIUS MEDICAL CARE" is written in a bold, sans-serif font. The text is arranged in two lines, with "FRESENIUS" on the top line and "MEDICAL CARE" on the bottom line.
5.3.6. Indications for Use
The stay safe to Luer-Lock adapter is indicated for use in patients with acute and chronic endstage 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.
5.3.7. Comparison of Technological Characteristics with the Predicate Device
The following technological characteristics of the Luer-Lock adapter are equivalent to the predicate Universal Connector (K896764).
- Intended use
- o Principle of operation
- Design characteristics
- Sterilization method
5.3.8. Performance Data
Testing was conducted to support the determination of substantial equivalence.
- Performance ●
- Tubing verification -
- Connectology (stay safe, Luer-Lock) -
- Package verification -
- Engagements bond/tensile strength -
- -Device weight verification
- ISO 594-2 -
- Cleaning agents compatibility -
- Latex content verification -
- -Shipping and packaging
- Maintenance of sterility
- Biological safety (biocompatibility)
- Usability
5.3.8.1. Biocompatibility Testing
Testing was conducted to support the biological safety of the Luer-Lock adapter.
- o Simulated-use Leachables Testing
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Image /page/18/Picture/1 description: The image shows the Fresenius Medical Care logo. The logo consists of a blue abstract symbol on the left and the text "FRESENIUS MEDICAL CARE" on the right. The abstract symbol is made up of three downward-pointing chevron shapes stacked on top of each other. The text is in a bold, sans-serif font, with "FRESENIUS" on the top line and "MEDICAL CARE" on the bottom line.
- Cytotoxicity, ISO Elution Method with MEM
- Sensitization, Guinea Pig Maximization
- Intracutaneous Irritation
- o Acute Systemic Toxicity
- Systemic Toxicity, Short-Term Repeated Exposure
- Material-Mediated Pyrogenicity
- Genotoxicity, Bacterial Review Mutation Assay
- Genotoxicity, in vitro Mouse Lymphoma Gene Mutation Assay
- Genotoxicity, Mouse Micronucleus in vivo Assay
- Hemocompatibility, ASTM Hemolysis (Indirect) - Extract
5.3.8.2. Human Factors Validation Testing
The Luer-Lock adapter was validated for its safe and effective use in accordance with FDA guidance Applying Human Factors and Usability Engineering to Medical Devices (03 February 2016).
5.3.8.3. Electrical Safety and Electromagnetic Compatibility
Not applicable. The Luer-Lock adapter is not an electrical mechanical device.
5.3.8.4. Software Verification and Validation Testing
Not applicable. The Luer-Lock adapter does not contain software.
5.3.8.5. Mechanical and Acoustic Testing
No mechanical or acoustic tests were performed.
5.3.8.6. Animal Studies
No animal studies were performed.
Clinical Studies 5.3.8.7.
No clinical studies were performed.
5.3.9. Conclusion
The intended use, principle of operation, design characteristics, and sterilization method of the Luer-Lock adapter are substantially equivalent to that of the predicate device. FMCRTG concludes that within the meaning of the Medical Device Amendments Act of 1976, the Luer-Lock adapter is safe and effective for its intended use.