(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.
§ 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.