(169 days)
The Amia Automated PD System is intended for automatic control of dialysate solution exchanges in the treatment of adult renal failure patients undergoing peritoneal dialysis.
All therapies using the Amia Automated PD System must be prescribed and performed under the responsibility of a physician who is familiar and well informed about peritoneal dialysis.
The Amia Automated PD System is used for automatic control of dialysate solution exchanges in the treatment of adult renal failure patients undergoing peritoneal dialysis therapy. The Amia device automatically cycles peritoneal dialysis fluid in the amounts and time prescribed by a clinician.
The provided text describes the Amia Automated PD System and its substantial equivalence to a predicate device, the Voyager Peritoneal Dialysis System (K103220). The document focuses on regulatory compliance and performance testing to demonstrate safety and effectiveness for a 510(k) submission.
Here's an analysis of the acceptance criteria and the study information based only on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria Category | Stated Method of Evaluation / Standard | Reported Device Performance |
|---|---|---|
| Software Validation & Regression Testing | Software validation and regression testing | "Complete system validation and software regression testing was performed to ensure that the device functions as intended and met all software requirements." |
| Biocompatibility | ISO 10993-1, -4, -5, -7, -10, -11, -12 | "Biocompatibility testing to ISO 10993-1; -4, -5, -7, 10, -11 and -12 . […Standards testing results demonstrated that all applicable sections of the identified standards were in conformance to pre-determined acceptance criteria.]" |
| Sterilization | Sterilization Testing | "Sterilization Testing […Standards testing results demonstrated that all applicable sections of the identified standards were in conformance to pre-determined acceptance criteria.]" |
| Ethylene Oxide Sterilization Residuals | ISO 10993-7 | "Ethylene Oxide Sterilization Residual testing to ISO 10993-7 […Standards testing results demonstrated that all applicable sections of the identified standards were in conformance to pre-determined acceptance criteria.]" |
| Electromagnetic Compatibility (EMC) | IEC 60601-1-2 | "Electromagnetic compatibility (EMC) testing to IEC 60601-1-2 . […Standards testing results demonstrated that all applicable sections of the identified standards were in conformance to pre-determined acceptance criteria.]" |
| Electrical Safety | IEC 60601-1 | "Electrical safety testing to IEC 60601-1 […Standards testing results demonstrated that all applicable sections of the identified standards were in conformance to pre-determined acceptance criteria.]" |
| General Requirements for Safety (PEMS) | IEC 60601-1-4 (Programmable electrical medical system) | "General requirements for safety, Programmable electrical medical system-IEC 60601-1-4 […Standards testing results demonstrated that all applicable sections of the identified standards were in conformance to pre-determined acceptance criteria.]" |
| Usability | Medical electrical equipment General requirements for safety Collateral Standard: Usability | "Medical electrical equipment General requirements for safety Collateral Standard: . Usability […Standards testing results demonstrated that all applicable sections of the identified standards were in conformance to pre-determined acceptance criteria.]" |
| Degrees of Protection Provided by Enclosures | IEC 60529 | "Degrees of Protection Provided by Enclosures - IEC 60529 […Standards testing results demonstrated that all applicable sections of the identified standards were in conformance to pre-determined acceptance criteria.]" |
| Assessment of Hemolytic Properties | ASTM F756-08 (Standard Practice for Assessment of Hemolytic Properties of Materials) | "Standard Practice for Assessment of Hemolytic Properties of Materials ASTM F756-08 . […Standards testing results demonstrated that all applicable sections of the identified standards were in conformance to pre-determined acceptance criteria.]" |
| Performance Testing of Shipping Containers | ASTM D4169 (Standard Practice for Performance Testing of Shipping Containers and Systems) | "Standard Practice for Performance Testing of Shipping Containers and Systems ASTM D4169 […Standards testing results demonstrated that all applicable sections of the identified standards were in conformance to pre-determined acceptance criteria.]" |
| Packaged-Products Basic Requirements | ISTA 2A (Packaged-Products 150 1b (68 kg) or Less Basic Requirements) | "Packaged-Products 150 1b (68 kg) or Less Basic Requirements ISTA 2A . […Standards testing results demonstrated that all applicable sections of the identified standards were in conformance to pre-determined acceptance criteria.]" |
| Pyrogen Test | USP 32 (USP Rabbit Test) | "Pyrogen test (USP Rabbit Test) USP 32 . . […Standards testing results demonstrated that all applicable sections of the identified standards were in conformance to pre-determined acceptance criteria.]" |
| Functional Performance | Design specifications | "It is in conformance with the design specifications and applicable industry standards for software development. […]. Complete system validation and software regression testing was performed to ensure that the device functions as intended and met all software requirements. Performance testing - All performance requirements were tested under simulated and actual environmental conditions using worst case scenarios to confirm compliance to the stated requirements." "Based on demonstrable evidence, the device modifications described within this submission do not affect the intended use, the fundamental technology or operating principles of the device, nor do any material changes raise safety or effectiveness issues with regard to the Amia Automated PD System; therefore, DEKA finds it to be substantially equivalent to the predicate device." |
| System Compatibility | "It was further verified for system compatibility with the devices with which it communicates." | |
| Risk Analysis | Internal risk assessment process | "Risk analysis has been completed and potential hazards associated with the modifications have been identified and mitigated. All potential risks were deemed acceptable after mitigation." |
Based on the provided text, the following information is NOT available:
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- The document mentions "worst case scenarios" for performance testing but does not provide specific sample sizes for any test sets, nor does it specify data provenance (country, retrospective/prospective).
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
- There is no mention of experts or ground truth establishment for any test sets. The testing described is primarily engineering and regulatory compliance, not clinical performance requiring expert consensus.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- No adjudication methods are mentioned as this type of study was not conducted.
5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
- No MRMC study was conducted or mentioned. This device is an automated cycler, not an AI-assisted diagnostic tool for human readers.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
- The tests described ("system validation and software regression testing", "performance testing") represent standalone algorithm/device performance, ensuring the device functions as intended based on its design specifications and relevant standards. However, it's not "algorithm only" in the sense of a medical AI diagnostic algorithm, but rather the functional performance of the APD cycler.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- For the engineering and regulatory tests performed, the "ground truth" is implied by adherence to established industry standards (e.g., ISO, IEC, ASTM, USP) and the device's own design specifications. There's no clinical "ground truth" like pathology or outcomes data discussed for the validation of the device itself, as this is a device for fluid exchange, not diagnosis or clinical outcome prediction.
8. The sample size for the training set
- The document does not describe a "training set" in the context of machine learning. The device is an automated cycler, not a machine learning model that requires training data.
9. How the ground truth for the training set was established
- Not applicable, as no machine learning training set is discussed.
§ 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.