staysafe catheter extension set with Safe-Lock, 12 inch, staysafe catheter extension set with Luer-Lock, 6 inch, staysafe catheter extension set with Luer-Lock, 12 inch, staysafe catheter extension set with Luer-Lock, 18 inch, staysafe to Luer-Lock adapter, 4 inch

Q: Who is the manufacturer of staysafe catheter extension set with Safe-Lock, 12 inch, staysafe catheter extension set with Luer-Lock, 6 inch, staysafe catheter extension set with Luer-Lock, 12 inch, staysafe catheter extension set with Luer-Lock, 18 inch, staysafe to Luer-Lock adapter, 4 inch?

Fresenius Medical Care Renal Therapies Group, LLC filed the 510(k) submission for staysafe catheter extension set with Safe-Lock, 12 inch, staysafe catheter extension set with Luer-Lock, 6 inch, staysafe catheter extension set with Luer-Lock, 12 inch, staysafe catheter extension set with Luer-Lock, 18 inch, staysafe to Luer-Lock adapter, 4 inch (K173593).

Q: What is the FDA product code for staysafe catheter extension set with Safe-Lock, 12 inch, staysafe catheter extension set with Luer-Lock, 6 inch, staysafe catheter extension set with Luer-Lock, 12 inch, staysafe catheter extension set with Luer-Lock, 18 inch, staysafe to Luer-Lock adapter, 4 inch?

KDJ. It is classified under 21 CFR 876.5630 as a Class 2 device in the Gastroenterology, Urology panel.

Q: What is the regulatory pathway for staysafe catheter extension set with Safe-Lock, 12 inch, staysafe catheter extension set with Luer-Lock, 6 inch, staysafe catheter extension set with Luer-Lock, 12 inch, staysafe catheter extension set with Luer-Lock, 18 inch, staysafe to Luer-Lock adapter, 4 inch?

510(k) clearance (submission type: Traditional).

Q: Who can help prepare an FDA 510(k) submission like staysafe catheter extension set with Safe-Lock, 12 inch, staysafe catheter extension set with Luer-Lock, 6 inch, staysafe catheter extension set with Luer-Lock, 12 inch, staysafe catheter extension set with Luer-Lock, 18 inch, staysafe to Luer-Lock adapter, 4 inch?

Innolitics — a medical-device software consultancy — provides regulatory and engineering support for FDA 510(k) submissions. See https://innolitics.com/services/510ks/ or contact https://innolitics.com/contact.

K173593 · Fresenius Medical Care Renal Therapies Group, LLC · KDJ · May 21, 2018 · Gastroenterology, Urology

Device Facts

Record ID	K173593
Device Name	staysafe catheter extension set with Safe-Lock, 12 inch, staysafe catheter extension set with Luer-Lock, 6 inch, staysafe catheter extension set with Luer-Lock, 12 inch, staysafe catheter extension set with Luer-Lock, 18 inch, staysafe to Luer-Lock adapter, 4 inch
Applicant	Fresenius Medical Care Renal Therapies Group, LLC
Product Code	KDJ · Gastroenterology, Urology
Decision Date	May 21, 2018
Decision	SESE
Submission Type	Traditional
Regulation	21 CFR 876.5630
Device Class	Class 2

Intended 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. 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. 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.

Device Story

Single-use, sterile, non-pyrogenic accessories for peritoneal dialysis (PD). Devices include catheter extension sets (Safe-Lock or Luer-Lock) and a Luer-Lock adapter. Extension sets connect PD catheters to PD systems using stay safe PIN technology; adapter converts stay safe extension set ends to Luer-Lock for compatibility with other medical devices (e.g., transfer sets, syringes). Used in clinics or home settings; connected by healthcare professionals and monitored during follow-up. Devices provide additional catheter length and facilitate dialysate flow/effluent drainage. Intended for permanent contact (>30 days, up to 6 months). Benefits include system compatibility and extended reach for PD treatment.

Clinical Evidence

No clinical studies were performed. Evidence is based on bench testing, including tubing verification, clamp performance, connectology, package verification, bond/tensile strength, device weight, cleaning agent compatibility, latex content, particulate inspection, shipping/packaging, sterility maintenance, and biocompatibility (cytotoxicity, sensitization, irritation, systemic toxicity, pyrogenicity, genotoxicity, hemocompatibility). Human factors validation was conducted per FDA guidance.

Technological Characteristics

Single-use, EO-sterilized accessories. Materials: Polypropylene, silicone, polyvinylidene fluoride, polyoxomethylene, polycarbonate, polyether block amide, thermoplastic elastomer, low-density polyethylene, polyamide block ether. Externally communicating, blood path indirect, permanent contact (>30 days). No electrical/mechanical components. No software.

Indications for Use

Indicated for patients with acute and chronic end-stage renal disease undergoing peritoneal dialysis in healthcare facilities or at home.

Regulatory Classification

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.

Special Controls

*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.

Predicate Devices

Dextrolyte II Peritoneal Dialysis Catheter Extension Set with Roller Clamp (K920697)
Universal Connector (K896764)

Reference Devices

Fresenius CAPD stay safe Disposable Administration Sets with stay safe Connector (K022412)
Fresenius stay safe Patient Connectors (K041792)

Related Devices

K250404 — staysafe® catheter extension set with Safe- Lock, 12 inch; staysafe® catheter extension set with Luer-Lock, 6 inch; staysafe® catheter extension set with Luer-Lock, 12 inch; staysafe® catheter extension set with Luer-Lock, 18 inch; staysafe® to Luer-Lock Adapter, 4 inch · Fresenius Medical Care Renal Therapies Group, LLC · Apr 3, 2025
K152675 — EXTENDED LIFE CAPD TRANSFER SET, PERITONEAL DIALYSIS TITANIUM CATHETER ADAPTER AND LOCKING CAP FOR TITANIUM CATHETER ADAPTER · Baxter Healthcare · Oct 29, 2015
K041792 — FRESENIUS STAYSAFE PATIENT CONNECTORS, MODEL 050-87211 · Fresenius Medical Care North America · Sep 24, 2004
K231849 — MiniCap Extended Life PD Transfer Set with Twist Clamp - Code 5C4482A; MiniCap Extended Life PD Transfer Set with Twist Clamp - Extra Short - Code 5C4483 · Baxter Healthcare · Mar 12, 2024
K173651 — Multiple Tubing Segment Set with stay safe PIN Connectors, stay safe Drain Set · Fresenius Medical Care Renal Therapies Group, LLC · Feb 14, 2018

Submission Summary (Full Text)

{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) K173593 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. {6}------------------------------------------------ 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. {12}------------------------------------------------ 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) ● {13}------------------------------------------------ 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. {14}------------------------------------------------ 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. {15}------------------------------------------------ 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). {16}------------------------------------------------ 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. {17}------------------------------------------------ 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 {18}------------------------------------------------ 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.