(78 days)
Multiple Tubing Segment (MTS) Set with stay safe® PIN Connectors: The Multiple Tubing Segment (MTS) Set with stay safe PIN Connectors is indicated for use by patients with acute and chronic end-stage renal disease undergoing peritoneal dialysis (PD) in a healthcare facility or at home. The MTS Set is placed during set-up to make additional connections to the cycler set when an interruption in treatment is necessary. This device is compatible with stay safe Peritoneal Dialysis (PD) connectology system and is to be used only with Fresenius Medical Care (FMCNA) Cyclers and Cycler Sets.
stay·safe® Drain Set: The stay safe Drain Set is indicated for use by patients with acute and chronic end-stage renal disease undergoing peritoneal dialysis (PD) in a healthcare facility or at home. The staysafe Drain Set is used to connect directly to the stay safe catheter extension set to enable drainage and/or effluent sampling as needed. This device is compatible with Fresenius Medical Care (FMCNA) Peritoneal Dialysis (PD) stay safe catheter extension sets.
Multiple Tubing Segment (MTS) Set with stay safe® PIN Connectors: The MTS Set is a single-use device that provides additional connections/disconnections when used with a stay safe compatible cycler set during acute and chronic peritoneal dialysis (PD) treatment. The MTS Set is provided sterile and non-pyrogenic. The MTS Set is sterilized using ethylene oxide (EO). The MTS Set consists of two (2) stay safe PIN Connectors at the proximal end, tubing, and a Safe-Lock connector at the distal end.
stay·safe® Drain Set: The Drain Set is a single-use device that connects directly to the patient's stay safe catheter extension set to enable effluent drainage as needed. The Drain Set is provided sterile and non-pyrogenic. The Drain Set is sterilized using ethylene oxide (EO). The Drain Set consists of an empty three (3) L drain bag, a stay safe PIN connector, a sample port, tubing, and a low force clamp.
The provided text describes two medical devices: the Multiple Tubing Segment (MTS) Set with stay safe® PIN Connectors and the stay safe® Drain Set. Both are accessories for peritoneal dialysis.
Here's an analysis of the acceptance criteria and supporting studies for both devices, structured as requested. Please note that the document focuses on performance testing to demonstrate substantial equivalence to predicate devices, rather than a clinical effectiveness study in the typical sense of AI/reader studies.
Multiple Tubing Segment (MTS) Set with stay safe® PIN Connectors
1. Table of Acceptance Criteria and Reported Device Performance
| Test | Test Method Description | Acceptance Criteria | Reported Device Performance |
|---|---|---|---|
| Tubing verification (ID & OD) | Inner diameter (ID) and outer diameter (OD) of the MTS Set tubing measured using a calibrated non-contact measurement system. | The PVC tubing shall have an ID of 0.158" ± 0.005" and an OD of 0.236" ± 0.005". | Pass, results within acceptance criteria |
| Tubing verification (Hardness) | Hardness of the resin of the MTS Set tubing measured using a durometer. | The resin hardness of the PVC tubing shall be of 70 ± 3 durometer. | Pass, results within acceptance criteria |
| stay•safe PIN connector and male Safe-Lock connector performance | A simulated PD treatment was performed using the MTS Set, Liberty Cycler, and Liberty Cycler Set to verify compatibility. The stay•safe patient connector of the MTS Set was inserted in the blue clip of the stay•safe organizer. | The patient and male Safe-Lock connectors shall be compatible with the stay•safe PD connectology system of the Liberty Cycler Set. No leaks or disconnections. The stay•safe patient connector shall fit with the stay•safe organizer. | Pass, results within acceptance criteria |
| Bond/tensile strength | An Instron machine was used to perform a pull-off test for each bonded engagement. | The test samples shall resist a minimum force of 10 lbs at each bonded engagement. | Pass, results within acceptance criteria |
| Packaging verification (Vents) | The MTS Set packaging (polyethylene bag) was visually inspected to verify the presence of 4 (four) vents. | The device bag (packaging bag) shall have 4 vents according to drawing P134D-A763. | Pass, results within acceptance criteria |
| Packaging verification (Units per bag) | The MTS Set packaging (polyethylene bag) was visually inspected to verify that each bag consisted of one MTS Set device. | The devices shall be packaged individually in a polyethylene bag. | Pass, results within acceptance criteria |
| Weight verification | Cases (corrugated cartons) of MTS Sets were weighed using a calibrated scale to verify the quantity of devices per case. | The outer packaging shall contain 10 individually packaged units. | Pass, results within acceptance criteria |
| Shipping and packaging | A simulated shipping and distribution test was conducted per ASTM D4169-16 Standard Practice for Performance Testing of Shipping Containers and Systems, Distribution Cycle 13, Assurance Level II. | Visual Inspection: No loose or missing caps, no kinks in tubing, no damage to components and/or tubing (cracks, holes, cuts). No damage to bag or case labels. | Pass, results within acceptance criteria |
| Biocompatibility | Evaluation for biocompatibility in accordance with ISO 10993-1:2009/(R)2013, including: Simulated use Leachables, Cytotoxicity (ISO Elution Method with MEM), Sensitization (Guinea Pig Maximization), Intracutaneous Irritation, Acute Systemic Toxicity, Systemic Toxicity (Short-term repeated exposure), Materials-Mediated Pyrogenicity, and Hemocompatibility (ASTM Hemolysis (Indirect) – Extract). A toxicological risk assessment was also performed. | The proposed device is biologically safe for its intended use. | Pass, results within acceptance criteria |
| Human Factors Validation Testing | Validation for safe and effective use in accordance with FDA guidance Applying Human Factors and Usability Engineering to Medical Devices (03 February 2016). | No specific quantitative acceptance criteria are listed, but the implication is that the design was found safe and effective for human use. | Pass |
2. Sample Size and Data Provenance (Test Set)
- The document does not explicitly state exact sample sizes for each test (e.g., number of MTS Sets tested for tubing verification, bond strength, etc.).
- It describes "test samples" for bond/tensile strength, "cases (corrugated cartons) of MTS Sets" for weight verification, and a general reference to methods for tubing, connector, and packaging verification.
- Data provenance is not specified (e.g., country of origin). The studies appear to be performed internally by the manufacturer or a contract lab.
- The studies are retrospective in the sense that they are conducted on manufactured devices as part of the market clearance process.
3. Number of Experts and Qualifications (Ground Truth for Test Set)
- Not applicable. These are engineering and biological performance tests, not AI-based diagnostic studies requiring expert review for ground truth.
4. Adjudication Method (Test Set)
- Not applicable. The tests involve objective measurements and visual inspections against predefined criteria, not expert adjudication.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
- No. This is not an AI-based diagnostic device.
6. Standalone Performance Study (Algorithm Only)
- No. This is not an AI-based diagnostic device.
7. Type of Ground Truth Used
- The ground truth for these tests is based on established engineering standards (e.g., ASTM, ISO), internal design specifications (e.g., tubing dimensions, vent count, force resistance), and standardized biological evaluation methods.
8. Sample Size for Training Set
- Not applicable. This is not an AI-based device requiring a training set.
9. How Ground Truth for Training Set was Established
- Not applicable.
stay safe® Drain Set
1. Table of Acceptance Criteria and Reported Device Performance
| Test | Test Method Description | Acceptance Criteria | Reported Device Performance |
|---|---|---|---|
| Tubing verification (ID & OD) | Inner diameter (ID) and outer diameter (OD) of the Drain Set tubing measured using a calibrated non-contact measurement system. | The PVC tubing shall have an ID of 0.168” ± 0.005” and an OD of 0.265” ± 0.005”. | Pass, results within acceptance criteria |
| Tubing verification (Hardness) | Hardness of the resin of the Drain Set tubing measured using a durometer. | The resin hardness of the PVC tubing shall be of 70 ± 3 durometer. | Pass, results within acceptance criteria |
| stay•safe PIN connector performance | The stay•safe patient connector of the Drain Set was inserted in the blue clip of the stay•safe organizer. | The stay•safe patient connector shall fit with the stay•safe organizer. | Pass, results within acceptance criteria |
| Clamp performance | An Instron machine measured the force required to close the clamps. | Force required must be less than 10 lbf. | Pass, results within acceptance criteria |
| Drop test | The principles of ISO 15747:2010 Plastic Containers for Intravenous Injections were applied: The Drain Set was filled to capacity with water and dropped from a height of 0.375 m. | Acceptance criteria from ISO 15747:2010 were applied: The Drain Bag shall not leak (visual inspection). | Pass, results within acceptance criteria |
| Bond/tensile strength | An Instron machine was used to perform a pull-off test for each bonded engagement. | The test samples shall resist a minimum force of 10 lbs at each bonded engagement. | Pass, results within acceptance criteria |
| Packaging verification (Clear/textured side) | A visual inspection was performed to verify that Drain Set bag has a clear and a textured side. | The Drain Set shall have a clear and a textured side. | Pass, results within acceptance criteria |
| Packaging verification (Vents) | The Drain Set packaging (polyethylene bag) were visually inspected to verify the presence of 4 vents. | The device bag (packaging bag) shall have 4 vents according to drawing P134D-A763. | Pass, results within acceptance criteria |
| Packaging verification (Units per bag) | The Drain Set packaging (polyethylene bag) was visually inspected to verify that each bag consisted of one MTS Set device. (Note: The document mistakenly refers to "MTS Set device" here instead of "Drain Set device".) | The devices shall be packaged individually in a polyethylene bag. | Pass, results within acceptance criteria |
| Weight verification | Cases (corrugated cartons) of Drain Sets were weighed using a calibrated scale to verify the quantity of devices per case. | The outer packaging shall contain 10 individually packaged units. | Pass, results within acceptance criteria |
| Shipping and packaging | A simulated shipping and distribution test was conducted per ASTM D4169-16 Standard Practice for Performance Testing of Shipping Containers and Systems, Distribution Cycle 13, Assurance Level II. | Visual Inspection: No loose or missing caps, no kinks in tubing, no damage to components and/or tubing (cracks, holes, cuts). No damage to bag or case labels. | Pass, results within acceptance criteria |
| Biocompatibility | Evaluation for biocompatibility in accordance with ISO 10993-1:2009/(R)2013, including: Simulated use Leachables, Cytotoxicity (ISO Elution Method with MEM), Sensitization (Guinea Pig Maximization), Intracutaneous Irritation, Acute Systemic Toxicity, Systemic Toxicity (Short-term repeated exposure), Materials-Mediated Pyrogenicity, and Hemocompatibility (ASTM Hemolysis (Indirect) – Extract). A toxicological risk assessment was also performed. | The proposed device is biologically safe for its intended use. | Pass, results within acceptance criteria |
| Human Factors Validation Testing | Validation for safe and effective use in accordance with FDA guidance Applying Human Factors and Usability Engineering to Medical Devices (03 February 2016). | No specific quantitative acceptance criteria are listed, but the implication is that the design was found safe and effective for human use. | Pass |
2. Sample Size and Data Provenance (Test Set)
- The document does not explicitly state exact sample sizes for each test (e.g., number of Drain Sets tested for tubing verification, bond strength, etc.).
- It describes "test samples" for bond/tensile strength, "cases (corrugated cartons) of Drain Sets" for weight verification, and a general reference to methods for tubing, clamp, and packaging verification, and a single "Drain Set" for the drop test.
- Data provenance is not specified (e.g., country of origin). The studies appear to be performed internally by the manufacturer or a contract lab.
- The studies are retrospective as they are conducted on manufactured devices as part of the market clearance process.
3. Number of Experts and Qualifications (Ground Truth for Test Set)
- Not applicable. These are engineering and biological performance tests, not AI-based diagnostic studies requiring expert review for ground truth.
4. Adjudication Method (Test Set)
- Not applicable. The tests involve objective measurements and visual inspections against predefined criteria, not expert adjudication.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
- No. This is not an AI-based diagnostic device.
6. Standalone Performance Study (Algorithm Only)
- No. This is not an AI-based diagnostic device.
7. Type of Ground Truth Used
- The ground truth for these tests is based on established engineering standards (e.g., ASTM, ISO), internal design specifications (e.g., tubing dimensions, vent count, force resistance, no-leak for drop test), and standardized biological evaluation methods.
8. Sample Size for Training Set
- Not applicable. This is not an AI-based device requiring a training set.
9. How Ground Truth for Training Set was Established
- Not applicable.
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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 FDA logo is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
February 14, 2018
Fresenius Medical Care Renal Therapies Group, LLC Denise Oppermann Senior Director, Regulatory Affairs 920 Winter Street Waltham, MA 02451
Re: K173651
Trade/Device Name: Multiple Tubing Segment (MTS) Set with stay safe® PIN Connectors, stay safe® Drain Set Regulation Number: 21 CFR§ 876.5630 Regulation Name: Peritoneal Dialysis System and Accessories Regulatory Class: II Product Code: KDJ Dated: November 24, 2017 Received: November 29, 2017
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.
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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,
Image /page/1/Picture/6 description: The image shows the text "Charles Viviano -S" in a simple, sans-serif font. The text is horizontally aligned and appears to be the main subject of the image. The background is plain and does not distract from the text.
For Benjamin R. Fisher, Ph.D. Director Division of Reproductive, Gastro-Renal, and Urological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known) K173651
Device Name
Multiple Tubing Segment (MTS) Set with stay safe® PIN Connectors stay·safe® Drain Set
Indications for Use (Describe)
Multiple Tubing Segment (MTS) Set with stay safe® PIN Connectors:
The Multiple Tubing Segment (MTS) Set with stay safe PIN Connectors is indicated for use by patients with acute and chronic end-stage renal disease undergoing peritoneal dialysis (PD) in a healthcare facility or at home. The MTS Set is placed during set-up to make additional connections to the cycler set when an interruption in treatment is necessary. This device is compatible with stay safe Peritoneal Dialysis (PD) connectology system and is to be used only with Fresenius Medical Care (FMCNA) Cyclers and Cycler Sets.
stay·safe® Drain Set:
The stay safe Drain Set is indicated for use by patients with acute and chronic end-stage renal disease undergoing peritoneal dialysis (PD) in a healthcare facility or at home. The staysafe Drain Set is used to connect directly to the stay safe catheter extension set to enable drainage and/or effluent sampling as needed. This device is compatible with Fresenius Medical Care (FMCNA) Peritoneal Dialysis (PD) stay safe catheter extension sets.
| 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)
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5. 510(K) SUMMARY
A 510(k) summary for each device is provided in Section 5.1 (Multiple Tubing Segment (MTS) Set with stay safe® PIN connectors), and Section 5.2 (stay safe® Drain Set).
5.1. Multiple Tubing Segment (MTS) Set with stay .safe® PIN Connectors
This 510(k) Summary is in accordance with the requirements of the Safe Medical Device Act (SMDA) of 1990. The content of this 510(k) summary is provided in conformance with 21 CFR §807.92.
Submitter's Information 5.1.1.
| Name: | Fresenius Medical Care Renal Therapies Group, LLC |
|---|---|
| Address: | 920 Winter StreetWaltham, MA02451-1457 |
| Phone: | (781) 699-4479 |
| Fax: | (781) 699-9635 |
| Contact Person: | Denise Oppermann, Senior DirectorRegulatory Affairs – Devices |
| Preparation Date: | 24 November 2017 |
5.1.2. Device Name
| Trade Name: | Multiple Tubing Segment (MTS) Set with stay•safe® PIN Connectors |
|---|---|
| Common Name: | MTS 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 Fresenius stay safe Patient Connectors (K041792). This predicate has not been subject to a design-related recall.
5.1.4. Device Description
Device Identification 5.1.4.1.
The Multiple Tubing Segment (MTS) Set with stay safe® PIN Connectors (hereinafter referred to as "MTS Set") is the subject of this 510(k).
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5.1.4.2. Device Characteristics
The MTS Set is a single-use device that provides additional connections/disconnections when used with a stay safe compatible cycler set during acute and chronic peritoneal dialysis (PD) treatment. The MTS Set is provided sterile and non-pyrogenic. The MTS Set is sterilized using ethylene oxide (EO).
Environment of Use 5.1.4.3.
The MTS Set is used in both healthcare and home environments.
Brief Written Description of the Device 5.1.4.4.
The MTS Set is a single-use, sterile (EO), non-pyrogenic, optional accessory that provides additional connections/disconnections when used with a stay safe compatible cycler set during acute and chronic PD treatment. The MTS Set utilizes the same PIN engagement technology used in Fresenius stay safe Patient Connectors (K041792). The MTS Set consists of two (2) stay safe PIN Connectors at the proximal end, tubing, and a Safe-Lock connector at the distal end. The MTS Set is attached to a cycler set by a patient, care partner, or healthcare professional. The MTS Set is attached during setup to make additional connections to the cycler set when they are prescribed by a physician or when an interruption in treatment is necessary.
Materials of Use 5.1.4.5.
The MTS Set is classified as externally communicating, blood path indirect, prolonged contact (> 24 hours to 30 days) duration, Class II (Category B) 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).
| Components | Material |
|---|---|
| PD filter assembly cap | PolypropyleneAcrylic (Membrane) |
| Male tubing connector (frosted) | Polycarbonate |
| stay•safe assembly (clear body connector) | PolycarbonatePolypropyleneSilicone |
| Tubing | Polyvinyl chloride |
| stay•safe assembly (clear body connector) with clear cap | PolycarbonatePolypropyleneSilicone |
| Male Safe-Lock connector | Polycarbonate |
| Cap, Male connector | Ethylene vinyl acetate |
The MTS Set components are composed of the following materials:
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5.1.4.6. Key Performance Characteristics
The MTS Set is an optional accessory that allows additional connections/disconnections by providing a sterile fluid path with secure connections (stay safe® and Safe-Lock®), when used with a stay.safe compatible cycler set.
5.1.5. Intended Use
The Multiple Tubing Segment (MTS) Set with staysafe PIN Connectors is intended for use by patients with acute and chronic end-stage renal disease undergoing peritoneal dialysis (PD).
5.1.6. Indications for Use
The Multiple Tubing Segment (MTS) Set with stay safe PIN Connectors is indicated for use by patients with acute and chronic end-stage renal disease undergoing peritoneal dialysis (PD) in a healthcare facility or at home. The MTS Set is placed during set-up to make additional connections to the cycler set when prescribed or when an interruption in treatment is necessary. This device is compatible with stay safe Peritoneal Dialysis (PD) connectology system and is to be used only with Fresenius Medical Care (FMCNA) Cyclers and Cycler Sets.
5.1.7. Comparison of Technological Characteristics with the Predicate Device
The following technological characteristics of the MTS Set are equivalent to the predicate Fresenius stay safe Patient Connectors (K041792).
- Intended use
- Principle of operation ●
- Sterilization method ●
- Design characteristics
5.1.8. Performance Data
A summary of testing conducted to support the determination of substantial equivalence is as follows:
| Test | Test Method Description | Acceptance Criteria | Results/Conclusion |
|---|---|---|---|
| Tubing verification | The inner diameter (ID) and outer diameter (OD) of the MTS Set tubing was measured using a calibrated non-contact measurement system. | The PVC tubing shall have an ID of 0.158" ± 0.005" and an OD of 0.236" ± 0.005". | Pass, results within acceptance criteria |
| The hardness of the resin of the MTS Set tubing was measured using a durometer. | The resin hardness of the PVC tubing shall be of 70 ± 3 durometer. | ||
| Test | Test Method Description | Acceptance Criteria | Results/Conclusion |
| stay•safe PINconnector andmale Safe-Lockconnectorperformance | A simulated PD treatmentwas performed using theMTS Set, Liberty Cycler, andLiberty Cycler Set to verifythe compatibility of thestay•safe PIN connector andmale Safe-Lock connector ofthe MTS Set with thestay•safe PD connectologysystem.The stay•safe patientconnector of the MTS Setwas inserted in the blue clipof the stay•safe organizer. | The patient and maleSafe-Lock connectorsshall be compatiblewith the stay•safe PDconnectology systemof the Liberty CyclerSet.No leaks ordisconnections.The stay•safe patientconnector shall fit withthe stay•safe organizer. | Pass, results withinacceptance criteria |
| Bond/tensilestrength | An Instron machine was usedto perform a pull-off test foreach bonded engagement. | The test samples shallresist a minimum forceof 10 lbs at eachbonded engagement. | Pass, results withinacceptance criteria |
| Packagingverification | The MTS Set packaging(polyethylene bag) wasvisually inspected to verifythe presence of 4 (four) vents.The MTS Set packaging(polyethylene bag) wasvisually inspected to verifythat each bag consisted of oneMTS Set device. | The device bag(packaging bag) shallhave 4 vents accordingto drawing P134D-A763.The devices shall bepackaged individuallyin a polyethylene bag. | Pass, results withinacceptance criteria |
| Weightverification | Cases (corrugated cartons) ofMTS Sets were weighedusing a calibrated scale toverify the quantity of devicesper case. | The outer packagingshall contain 10individually packagedunits. | Pass, results withinacceptance criteria |
| Shipping andpackaging | A simulated shipping anddistribution test wasconducted per ASTM D4169-16 Standard Practice forPerformance Testing ofShipping Containers andSystems, Distribution Cycle13, Assurance Level II. | Visual InspectionNo loose or missingcaps, no kinks intubing, no damageto componentsand/or tubing(cracks, holes, cuts).No damage to bagor case labels. | Pass, results withinacceptance criteria |
| Test | Test Method Description | Acceptance Criteria | Results/Conclusion |
| Biocompatibility | The proposed MTS Setdevice was evaluated forbiocompatibility inaccordance with therequirements of ISO 10993-1:2009/(R)2013, Biologicalevaluation of medical devices- Part 1: Evaluation andtesting within a riskmanagement process. | The proposed device isbiologically safe for itsintended use. | Pass, results withinacceptance criteria |
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Results of the design verification tests met the design requirements for the proposed device and demonstrated that, like the predicate device, it is safe and effective for its intended use.
5.1.8.1. Biocompatibility Testing
Testing was performed to support the biological safety of the MTS Set.
- Simulated use Leachables
- Cytotoxicity, ISO Elution Method with MEM ●
- Sensitization, Guinea Pig Maximization
- Intracutaneous Irritation ●
- Acute Systemic Toxicity
- Systemic Toxicity, Short-term repeated exposure ●
- Materials-Mediated Pyrogenicity ●
- Hemocompatibility, ASTM Hemolysis (Indirect) – Extract
A toxicological risk assessment was also performed.
Human Factors Validation Testing 5.1.8.2.
The MTS 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 (EMC)
Not applicable. The MTS Set is not an electrical mechanical device.
5.1.8.4. Software Verification and Validation Testing
Not applicable. The MTS Set does not contain software.
5.1.8.5. Mechanical and Acoustic Testing
No mechanical or acoustic tests were performed.
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5.1.8.6. Animal Studies
No animal studies were performed.
Clinical Studies 5.1.8.7.
No clinical studies were performed.
Conclusion 5.1.9.
The intended use, principle of operation, sterilization method and design of the MTS 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 MTS Set device is safe and effective for its intended use.
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Image /page/9/Picture/0 description: The image shows the logo for Fresenius Medical Care. 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 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. stay.safe® Drain Set
This 510(k) Summary is in accordance with the requirements of the Safe Medical Device Act (SMDA) of 1990. The content of this 510(k) summary is provided in conformance with 21 CFR §807.92.
5.2.1. 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: | 24 November 2017 |
5.2.2. Device Name
| Trade Name: | stay·safe® Drain Set |
|---|---|
| Common Name: | Drain Set |
| Classification Name: | Peritoneal Dialysis System and Accessories |
| Regulatory Class: | Class II per 21 CFR §876.5630 |
| Product Code: | KDJ |
| Classification Panel: | Gastroenterology/Urology |
5.2.3. Legally Marketed Predicate Device
The legally marketed predicate device is the Peritoneal Dialysis Drainage Set (K895991). 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.
5.2.4. Device Description
5.2.4.1. Device Identification
The stay safe® Drain Set (hereinafter referred to as "Drain Set") is the subject of this 510(k).
5.2.4.2. Device Characteristics
The Drain Set is a single-use device that connects directly to the patient's stay safe catheter extension set to enable effluent drainage as needed. The Drain Set is provided sterile and non-pyrogenic. The Drain Set is sterilized using ethylene oxide (EO).
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Image /page/10/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.
5.2.4.3. Environment of Use
The Drain Set is used in both healthcare and home environments.
5.2.4.4. Brief Written Description of the Device
The Drain Set is a single-use, sterile, non-pyrogenic accessory that connects directly to the patient's stay safe catheter extension set. The Drain Set is attached to the patient's stay safe catheter extension set by a patient, care partner, or healthcare professional. The Drain Set is used to enable effluent drainage as needed (e.g., when a patient is feeling full) after concluding Automated Peritoneal Dialysis (APD) or Continuous Ambulatory Peritoneal Dialysis (CAPD) treatment. The Drain Set consists of an empty three (3) L drain bag, a stay safe PIN connector, a sample port, tubing, and a low force clamp. The sample port allows effluent sampling, as needed. Sampling is performed following effluent collection, per facility procedure.
5.2.4.5. Materials of Use
The Drain Set is classified as externally communicating, blood path indirect, prolonged contact (> 24 hours to 30 days) duration, Class II (Category B) 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).
| Components | Material |
|---|---|
| 3 L drain bag | Polyvinyl chloride |
| Sample port | Polyisoprene |
| Clamp, low force,yellow | Polypropylene |
| Tubing | Polyvinyl chloride |
| stay•safe assembly(clear body connector) | PolycarbonatePolypropyleneSilicone |
| PD filter assembly cap | PolypropyleneAcrylic (Membrane) |
The Drain Set components are composed of the following materials:
5.2.4.6. Kev Performance Characteristics
The Drain Set connects directly to the patient's stay safe catheter extension set to enable effluent drainage as needed.
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Image /page/11/Picture/0 description: The image contains the logo for Fresenius Medical Care. On the left side of the logo, there is a blue symbol that consists of three downward-pointing chevrons stacked on top of each other. To the right of the symbol, the text "FRESENIUS MEDICAL CARE" is written in bold, blue letters. The words "FRESENIUS" and "MEDICAL CARE" are stacked on top of each other.
5.2.5. Intended Use
The Drain Set is intended for use by patients with acute and chronic end-stage renal disease undergoing peritoneal dialysis (PD).
5.2.6. Indications for Use
The stay safe Drain Set is indicated for use by patients with acute and chronic end-stage renal disease undergoing peritoneal dialysis (PD) in a healthcare facility or at home. The stay safe Drain Set is used to connect directly to the stay safe catheter extension set to enable drainage and/or effluent sampling as needed. This device is compatible with Fresenius Medical Care (FMCNA) Peritoneal Dialysis (PD) stay safe catheter extension sets.
5.2.7. Comparison of Technological Characteristics with the Predicate Device
The following technological characteristics of the Drain Set are equivalent to the predicate Peritoneal Dialysis Drainage Set (K895991).
- Intended use
- Sterilization method ●
- Principle of operation ●
5.2.8. Performance Data
| Test | Test Method Description | Acceptance Criteria | Results/Conclusion |
|---|---|---|---|
| Tubingverification | The inner diameter (ID) andouter diameter (OD) of theDrain Set tubing was measuredusing a calibrated non-contactmeasurement system.The hardness of the resin of theDrain Set tubing was measuredusing a durometer. | The PVC tubing shallhave an ID of 0.168”$\pm$ 0.005” and an ODof 0.265” $\pm$ 0.005”.The resin hardness ofthe PVC tubing shallbe of 70 $\pm$ 3durometer. | Pass, results withinacceptance criteria |
| stay•safe PINconnectorperformance | The stay•safe patient connectorof the Drain Set was inserted inthe blue clip of the stay•safeorganizer. | The stay•safe patientconnector shall fitwith the stay•safeorganizer. | Pass, results withinacceptance criteria |
| Clampperformance | An Instron machine measuredthe force required to close theclamps. | Force required mustbe less than 10 lbf. | Pass, results withinacceptance criteria |
| Test | Test Method Description | Acceptance Criteria | Results/Conclusion |
| Drop test | The principles of ISO15747:2010 Plastic Containers for Intravenous Injections were applied:The Drain Set was filled to capacity with water and dropped from a height of 0.375 m. | Acceptance criteria from ISO 15747:2010 were applied:The Drain Bag shall not leak (visual inspection). | Pass, results within acceptance criteria |
| Bond/tensilestrength | An Instron machine was used to perform a pull-off test for each bonded engagement. | The test samples shall resist a minimum force of 10 lbs at each bonded engagement. | Pass, results within acceptance criteria |
| Packagingverification | A visual inspection was performed to verify that Drain Set bag has a clear and a textured side.The Drain Set packaging (polyethylene bag) were visually inspected to verify the presence of 4 vents.The Drain Set packaging (polyethylene bag) was visually inspected to verify that each bag consisted of one MTS Set device. | The Drain Set shall have a clear and a textured side.The device bag (packaging bag) shall have 4 vents according to drawing P134D-A763.The devices shall be packaged individually in a polyethylene bag. | Pass, results within acceptance criteria |
| Weightverification | Cases (corrugated cartons) of Drain Sets were weighed using a calibrated scale to verify the quantity of devices per case. | The outer packaging shall contain 10 individually packaged units. | Pass, results within acceptance criteria |
| Shipping andpackaging | A simulated shipping and distribution test was conducted per ASTM D4169-16 Standard Practice for Performance Testing of Shipping Containers and Systems , Distribution Cycle 13, Assurance Level II. | Visual InspectionNo loose or missing caps, no kinks in tubing, no damage to components and/or tubing (cracks, holes, cuts). No damage to bag or case labels | Pass, results within acceptance criteria |
| Test | Test Method Description | Acceptance Criteria | Results/Conclusion |
| Biocompatibility | The proposed Drain Set devicewas evaluated forbiocompatibility in accordancewith the requirements of ISO10993-1:2009/(R)2013,Biological evaluation ofmedical devices – Part 1:Evaluation and testing within arisk management process. | The proposed deviceis biologically safe forits intended use. | Pass, results withinacceptance criteria |
A summary of testing conducted to support the determination of substantial equivalence is as follows:
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Image /page/12/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 blue 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.
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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.
Results of the design verification tests met the design requirements for the proposed device and demonstrated that, like the predicate device, it is safe and effective for its intended use.
5.2.8.1. Biocompatibility Testing
Testing was performed to support the biological safety of the Drain Set.
- Simulated use Leachables ●
- Cytotoxicity, ISO Elution Method with MEM
- . Sensitization, Guinea Pig Maximization
- Intracutaneous Irritation
- Acute Systemic Toxicity ●
- Systemic Toxicity, Short-term repeated exposure ●
- Materials-Mediated Pyrogenicity
- Hemocompatibility, ASTM Hemolysis (Indirect) - Extract
A toxicological risk assessment was also performed.
5.2.8.2. Human Factor Validation Testing
The Drain 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).
5.2.8.3. Electrical Safety and Electromagnetic Compatibility (EMC)
Not applicable. The Drain Set is not an electrical mechanical device.
5.2.8.4. Software Verification and Validation Testing
Not applicable. The Drain Set does not contain software.
5.2.8.5. Mechanical and Acoustic Testing
No mechanical or acoustic tests were performed.
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Image /page/14/Picture/0 description: The image contains the logo for Fresenius Medical Care. On the left side of the logo is a blue symbol that consists of three downward-pointing chevrons stacked on top of each other. To the right of the symbol is the text "FRESENIUS MEDICAL CARE", with "FRESENIUS" on the top line and "MEDICAL CARE" on the bottom line. The text is also in blue.
5.2.8.6. Animal Studies
No animal studies were performed.
5.2.8.7. Clinical Studies
No clinical studies were performed.
5.2.9. Conclusion
The intended use, sterilization method, and principle of operation of the Drain 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 Drain Set device is safe and effective for its intended use.
§ 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.