(85 days)
Integra SL is intended to fragment urinary stones in the kidney (renal pelvis and renal calyces) and upper ureter.
Integra SL is a transportable Electromagnetic (EM) Extracorporeal Shock Wave Lithotripter (ESWL) used for urinary stones treatment. The device consists of a Shock Wave Generator (SWAG), a Urological Table (UT) and the remote controls. Integra SL also contains the necessary interfaces for fluoroscopic and (or) ultrasonic imaging devices. The device has no Software control.
Integra SL includes the following features:
- EM Shockwave generator with parabolic reflector for focusing mechanism
- Swinging reflector (i.e. shockwaves are produced by angularly moving the shockwave while keeping the Therapeutic focus (F2) at the stone such that the shockwaves converge on the stone from multiple orientations).
- A stand alone UT unit
- Modular construction
Here's a summary of the acceptance criteria and study information based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (Set by which standard/guidance) | Reported Device Performance |
|---|---|
| No explicitly stated quantitative acceptance criteria beyond compliance with the listed standards and guidance documents. | Device was tested and found compliant with the following standards and guidance: |
| IEC 60601-1 (1988) +A1 (1991) +A2 (1995) | Met |
| IEC 60601-1-1 (2000) | Met |
| IEC 60601-1-2 (2001) | Met |
| IEC 606001-2-36 (1997) | Met |
| IEC 61846 (1998) | Met |
| IEC 60601-2-46 (1998) | Met |
| ANSI/ AAMI/ ISO 10993– 1 (1998) | Met |
| Guidance for the Content of Premarket Notifications (510(k)s) for Extracorporeal Shock Wave Lithotripters Indicated for the Fragmentation of Kidney and Ureteral Calculi; August 9, 2000 | Met |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size: Not applicable. The document states "No clinical tests were performed." Performance testing was based on compliance with engineering and safety standards.
- Data Provenance: Not applicable, as no clinical tests were performed.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
- Not applicable. No clinical tests were performed, and thus no expert-established ground truth for a test set was required.
4. Adjudication Method for the Test Set
- Not applicable. No clinical tests were performed.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
- No, an MRMC comparative effectiveness study was not done. The document explicitly states "No clinical tests were performed."
6. Standalone (i.e., algorithm only without human-in-the-loop performance) Study
- Not applicable. This device is an Extracorporeal Shock Wave Lithotripter (ESWL), a physical medical device, not an algorithm or software requiring standalone performance evaluation in the context of AI. The device has "no Software control."
7. Type of Ground Truth Used
- Not applicable. No clinical tests were performed. The "ground truth" for this submission refers to compliance with safety and performance standards for a physical device.
8. Sample Size for the Training Set
- Not applicable. This is not an AI/ML device requiring a training set.
9. How the Ground Truth for the Training Set Was Established
- Not applicable. This is not an AI/ML device requiring a training set.
Summary of the Study that Proves the Device Meets Acceptance Criteria:
The Direx Systems Corporation Integra SL device's acceptance criteria are primarily based on its compliance with a series of recognized international and national standards for medical devices, specifically those pertaining to Extracorporeal Shock Wave Lithotripters (ESWLs). The document lists several IEC, ANSI/AAMI/ISO standards, and FDA guidance documents.
The study proving the device meets these criteria is described as "Performance Testing" within the 510(k) submission. This does not involve clinical trials or studies with human subjects. Instead, it refers to in-house engineering and laboratory testing to ensure the device's design and functionality align with the safety, electrical, mechanical, and performance specifications outlined in the referenced standards. The submission asserts that the Integra SL "was tested according to the following standards:" and implicitly states that by meeting these standards, it fulfills the performance requirements.
The submission also leverages a "special 510(k)" pathway, stating that the Integra SL "meets the requirements for a special 510(k) by the virtue of being a minor modification, which does not change the fundamental technology or reduce safety and effectiveness, of the Company's predicate device, Integra." This implies that the safety and effectiveness are largely established through the predicate device's prior clearance and the current device's adherence to the same core technology and performance standards, without new clinical data being necessary for this specific modification.
§ 876.5990 Extracorporeal shock wave lithotripter.
(a)
Identification. An extracorporeal shock wave lithotripter is a device that focuses ultrasonic shock waves into the body to noninvasively fragment urinary calculi within the kidney or ureter. The primary components of the device are a shock wave generator, high voltage generator, control console, imaging/localization system, and patient table. Prior to treatment, the urinary stone is targeted using either an integral or stand-alone localization/imaging system. Shock waves are typically generated using electrostatic spark discharge (spark gap), electromagnetically repelled membranes, or piezoelectric crystal arrays, and focused onto the stone with either a specially designed reflector, dish, or acoustic lens. The shock waves are created under water within the shock wave generator, and are transferred to the patient's body using an appropriate acoustic interface. After the stone has been fragmented by the focused shock waves, the fragments pass out of the body with the patient's urine.(b)
Classification. Class II (special controls) (FDA guidance document: “Guidance for the Content of Premarket Notifications (510(k)'s) for Extracorporeal Shock Wave Lithotripters Indicated for the Fragmentation of Kidney and Ureteral Calculi.”)