(28 days)
The COOK- Swartz Doppler Flow Probe and Monitor System is intended for monitoring blood flow in vessels intraoperatively, and following reconstructive micro-vascular procedures, re-implantation, and free flap transfers. The COOK-Swartz Doppler Flow Probe is supplied sterile and intended for one time use
The Modified COOK-Swartz Doppler Flow Probe is intended for monitoring blood flow through vessels in patients intraoperatively and during reconstructive vascular procedures. The COOK-Swartz Doppler Flow Probe is supplied sterile, and nonpyroqenic and is intended for one-time use. Reasonable assurance of biocompatibility of the body fluid/tissue contacting materials comprising the device is provided by their established history of use in medical product manufacturing.
The provided document is a 510(k) summary for a Special 510(k) Device Modification for the COOK-Swartz Doppler Flow Probe. This type of submission is for modifications to a legally marketed device and primarily focuses on demonstrating substantial equivalence to the predicate device, rather than providing extensive de novo clinical study data to demonstrate novel performance against acceptance criteria.
Therefore, the document does not contain the detailed information typically found in a clinical study report that establishes acceptance criteria and then proves the device meets those criteria.
Here's a breakdown of what can be extracted and what is missing, based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
This information is not present in the document. The 510(k) summary focuses on demonstrating substantial equivalence to a predicate device (COOK-Swartz Doppler Flow Probe D.C. #K964001) based on intended use, material composition, and method of operation. It does not provide specific performance metrics or acceptance criteria for the modified device.
2. Sample Size Used for the Test Set and Data Provenance
This information is not present in the document. Since it's a 510(k) for a device modification showing substantial equivalence, a formal "test set" with a specified sample size for performance evaluation in the way a de novo clinical study would isn't typically included in this summary.
3. Number of Experts Used to Establish Ground Truth and Qualifications
This information is not present. The document doesn't describe a study involving expert panels for ground truth establishment.
4. Adjudication Method
This information is not present. No adjudication method is mentioned as there is no description of a study involving multiple readers or complex diagnostic interpretations requiring consensus.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
This information is not present. There is no mention of an MRMC study or any comparison of human readers with and without AI assistance. The device in question is a Doppler flow probe, which is a diagnostic tool, not an AI-assisted diagnostic software.
6. Standalone (Algorithm Only) Performance Study
This information is not present. The device is hardware (a probe), not a standalone algorithm. Therefore, "algorithm-only" performance is not applicable.
7. Type of Ground Truth Used
This information is not present. Given that the submission is for a device modification demonstrating substantial equivalence to a predicate, a new "ground truth" establishment for performance validation is not usually required or detailed in this type of submission summary.
8. Sample Size for the Training Set
This information is not present. The document does not describe the development of an algorithm that would require a "training set."
9. How the Ground Truth for the Training Set Was Established
This information is not present, as no training set or ground truth for an algorithm is mentioned.
Summary of the Document's Approach:
The provided document (K022649) is a Special 510(k) Device Modification for the COOK-Swartz Doppler Flow Probe. The core of this submission is to demonstrate substantial equivalence to a previously cleared predicate device (COOK-Swartz Doppler Flow Probe D.C. #K964001).
The argument for equivalence is based on:
- Intended Use: "monitoring blood flow through vessels in patients intraoperatively and during reconstructive vascular procedures." (The modified device also adds "and following reconstructive micro-vascular procedures, re-implantation, and free flap transfers" which is also aligned with the predicate's expanded indications as K964001's indications include "monitor blood flow intraoperatively, during intraoperative neuro-vascular procedures, and following reconstructive micro-vascular procedures, re-implantation and free flap transfer.")
- Material Composition: "biocompatibility of the body fluid/tissue contacting materials comprising the device is provided by their established history of use in medical product manufacturing."
- Method of Operation: Implied to be similar as it's a modification to an existing device.
- Manufacturing: "manufactured according to specified process controls and a Quality Assurance Program, undergoing packaging and sterilization procedures similar to the currently marketed and distributed COOK-Swartz Doppler Flow Probe D.C. #K964001."
No new clinical data, performance criteria, or "proof of meeting acceptance criteria" in the sense of a novel functional claim are presented in this summary. The FDA's letter explicitly states: "We have determined the device is substantially equivalent... You may, therefore, market the device, subject to the general controls provisions of the Act." This confirms that the modification was deemed equivalent without requiring new, extensive performance studies detailed in this summary.
§ 892.1570 Diagnostic ultrasonic transducer.
(a)
Identification. A diagnostic ultrasonic transducer is a device made of a piezoelectric material that converts electrical signals into acoustic signals and acoustic signals into electrical signals and intended for use in diagnostic ultrasonic medical devices. Accessories of this generic type of device may include transmission media for acoustically coupling the transducer to the body surface, such as acoustic gel, paste, or a flexible fluid container.(b)
Classification. Class II.