(89 days)
The Transonic Syringe Warmer (Model SYR1000) is indicated for use with the Transonic HD01 (HD01PMS and HD02) systems to make Cardiac output measurements. The Transonic Syringe Warmer (Model SYR1000) is an accessory to our HD01-CO Hemodialysis Monitor for Cardiac Output (K980906) which are currently marketed as the HD01046 and HD02 systems. The HD01-CO Hemodialysis Monitor for Cardiac Output (HD01P05 and HD02 systems) requires the user to make a 30cc injection of approximately body temperature saline into the hemodialysis blood circuit for the CO measurement. The syringe warmer provides the user a convenient source of the 30cc injection of approximately body temperature saline for this injection.
In accordance with section 510(k) for the Federal Food, Drug, and Cosmetic Act, Transonic Systems Inc. intends to introduce into interstate commerce the Transonic Syringe Warmer as an accessory to our HD01-CO Hemodialysis Monitor for Cardiac Output (K980906). The HD01-CO Hemodialysis Monitor for Cardiac Output requires the user to make a 30cc injection of ~ body temperature saline into the hemodialysis blood circuit for the CO measurement. The syringe warmer will provide the user a convenient source of the 30cc injection of ~ body temperature saline for this injection.
The provided text describes a 510(k) premarket notification for the Transonic Syringe Warmer, an accessory device. The information primarily focuses on establishing substantial equivalence to a predicate device and does not contain detailed acceptance criteria, specific study designs, or performance metrics in a quantitative manner typical for AI/ML device submissions.
Based on the provided text, I can infer the general nature of the "acceptance criteria" and "study" as implied by the FDA's "Safety and Effectiveness" section, but there are no specific numerical thresholds or detailed study results. The submission relies on demonstrating the device is similar to a predicate device and meets general quality control requirements.
Here's an analysis based on the provided text, attempting to address your points as much as possible, while noting where information is absent for this type of submission:
Acceptance Criteria and Study for the Transonic Syringe Warmer
The Transonic Syringe Warmer is an accessory device intended to warm a 30cc syringe of saline to approximately body temperature for injection into a hemodialysis blood circuit. The acceptance criteria and supporting "study" described are focused on demonstrating the device's safety and effectiveness and its substantial equivalence to a predicate device, rather than a quantifiable performance study against specific metrics for AI/ML devices.
1. A table of acceptance criteria and the reported device performance
Based on the document, the acceptance criteria are implicitly tied to "release specifications" and "product design specifications." The "reported device performance" is essentially that the device functions as intended to warm saline.
| Acceptance Criteria (Implied) | Reported Device Performance (Implied) |
|---|---|
| Designed for intended use | Suitable for warming a 30cc syringe of saline to ~body temperature for CO measurement. |
| Made of suitable materials | Bench tested materials suitable for intended use. |
| Meets required release specifications | All finished products are tested and meet all required release specifications before distribution. |
| Conforms to product design specifications | Established testing procedures ensure performance parameters conform to specifications. |
| No new issues of safety or effectiveness | The use difference (warming saline vs. dental anesthetic) does not raise any new safety or effectiveness issues. |
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 does not specify a "test set" in the context of a typical AI/ML study with data points. Instead, it refers to "all finished products" being tested.
- Sample Size: "All finished products" are tested. This implies a 100% inspection or testing of manufactured units.
- Data Provenance: Not applicable in the context of clinical data. The tests are bench tests performed by the manufacturer, Transonic Systems Inc. (located in Ithaca, NY, USA).
- Retrospective/Prospective: Not applicable. These are manufacturing quality control tests, not clinical studies.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
This information is not applicable to the type of device and submission described. There is no mention of experts establishing ground truth for a test set, as this is a hardware device undergoing manufacturing quality control rather than a diagnostic AI/ML algorithm.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable. There is no "test set" requiring adjudication in the context of clinical or diagnostic performance. The testing described is internal quality control.
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, a multi-reader multi-case (MRMC) comparative effectiveness study was not done. This type of study is relevant for diagnostic imaging AI/ML devices, not for a syringe warmer. There is no AI component mentioned in this device.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
No, a standalone algorithm-only performance study was not done. This device is a hardware accessory and does not contain an AI algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
The "ground truth" for this device's performance is based on its adherence to manufacturing specifications and its ability to perform its stated function (warming saline to ~body temperature). This would be validated through engineering measurements and quality control checks, not expert consensus, pathology, or outcomes data in a clinical sense.
8. The sample size for the training set
Not applicable. This device does not use machine learning or have a "training set."
9. How the ground truth for the training set was established
Not applicable. This device does not use machine learning or have a "training set."
Summary of the "Study" Described:
The "study" demonstrating the Transonic Syringe Warmer meets its acceptance criteria is best described as a comprehensive quality control and manufacturing testing process rather than a clinical trial or AI performance study.
- Process: "All finished products are tested and must meet all required release specifications before distribution."
- Testing Types: "physical testing, visual examination (in process and finished product)."
- Methodology: "The physical testing is defined by Quality Control Test Procedure documents. These tests are established testing procedures that ensure the products performance parameters conform to the product design specifications."
- Documentation: "The testing instruction records for each of the individually required procedures are approved, released, distributed and revised in accordance with document control cGMP's."
The submission primarily relies on demonstrating substantial equivalence to a predicate device (Vista Dental Anesthetic Syringe Warmer) and asserting that the modified intended use (warming saline for hemodialysis monitoring) "does not raise any new issues of safety or effectiveness." This approach underscores that the primary evidence for this particular 510(k) submission is related to manufacturing quality and equivalence, not advanced performance metrics or clinical study data.
§ 876.5820 Hemodialysis system and accessories.
(a)
Identification. A hemodialysis 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 an extracorporeal blood system, a conventional dialyzer, a dialysate delivery system, and accessories. Blood from a patient flows through the tubing of the extracorporeal blood system and accessories to the blood compartment of the dialyzer, then returns through further tubing of the extracorporeal blood system to the patient. The dialyzer has two compartments that are separated by a semipermeable membrane. While the blood is in the blood compartment, undesirable substances in the blood pass through the semipermeable membrane into the dialysate in the dialysate compartment. The dialysate delivery system controls and monitors the dialysate circulating through the dialysate compartment of the dialyzer.(1) The extracorporeal blood system and accessories consists of tubing, pumps, pressure monitors, air foam or bubble detectors, and alarms to keep blood moving safely from the blood access device and accessories for hemodialysis (§ 876.5540) to the blood compartment of the dialyzer and back to the patient.
(2) The conventional dialyzer allows a transfer of water and solutes between the blood and the dialysate through the semipermeable membrane. The semipermeable membrane of the conventional dialyzer has a sufficiently low permeability to water that an ultrafiltration controller is not required to prevent excessive loss of water from the patient's blood. This conventional dialyzer does not include hemodialyzers with the disposable inserts (Kiil type) (§ 876.5830) or dialyzers of high permeability (§ 876.5860).
(3) The dialysate delivery system consists of mechanisms that monitor and control the temperature, conductivity, flow rate, and pressure of the dialysate and circulates dialysate through the dialysate compartment of the dialyzer. The dialysate delivery system includes the dialysate concentrate for hemodialysis (liquid or powder) and alarms to indicate abnormal dialysate conditions. This dialysate delivery system does not include the sorbent regenerated dialysate delivery system for hemodialysis (§ 876.5600), the dialysate delivery system of the peritoneal dialysis system and accessories (§ 876.5630), or the controlled dialysate delivery system of the high permeability hemodialysis system § 876.5860).
(4) Remote accessories to the hemodialysis system include the unpowered dialysis chair without a scale, the powered dialysis chair without a scale, the dialyzer holder set, dialysis tie gun and ties, and hemodialysis start/stop tray.
(b)
Classification. (1) Class II (performance standards) for hemodialysis systems and all accessories directly associated with the extracorporeal blood system and the dialysate delivery system.(2) Class I for other accessories of the hemodialysis system remote from the extracorporeal blood system and the dialysate delivery system, such as the unpowered dialysis chair, hemodialysis start/stop tray, dialyzer holder set, and dialysis tie gun and ties. The devices subject to this paragraph (b)(2) are exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 876.9.