(185 days)
The probes kits are intended for extravascular monitoring of microcirculation blood flow in buried tissues, specifically, in monitoring cerebral blood flow in patients at risk of cerebral ischemia.
The Model BPM2 is a Laser Doppler Blood Perfusion Monitor, which is used to measure microcirculatory blood flow in a variety of clinical applications. Permission to market the BPM2 was granted by FDA on February 13, 1990 (Ref. K896515). The Model SUPR-434 Blunt Needle Probe is a single use fiber optic probe designed for use with the BPM2. These probes are labeled so as to be used for monitoring buried tissue, such as brain parenchyma during and following neurosurgical procedures. Permission to market the Model SUPR-434 ( Note: the SUPR-434 Blunt needle probes model names have since been changed to Trimflo 4314, 4316, 4364 and 4366) was granted on March 21, 1996 (Ref. K951832).
The provided text K961368 is a 510(k) summary for a medical device (Single Use Laser Doppler Probe Kits). It describes the device, its intended use, and argues for substantial equivalence to a predicate device. However, it does not contain any information about a study proving the device meets acceptance criteria, nor does it mention specific acceptance criteria with corresponding performance metrics.
Therefore, I cannot fulfill your request for:
- A table of acceptance criteria and reported device performance.
- Sample size used for the test set or data provenance.
- Number of experts used to establish ground truth or their qualifications.
- Adjudication method.
- MRMC comparative effectiveness study results.
- Standalone performance.
- Type of ground truth used.
- Sample size for the training set.
- How ground truth for the training set was established.
The document focuses on establishing substantial equivalence based on the device being largely the same as existing, cleared devices (the probes themselves) with minor changes (addition of accessories, packaging as a kit, and ETO sterilization). It highlights biocompatibility and sterilization processes, but these are described as general adherence to standards (e.g., AAMI guidelines for sterilization, FDA guidelines for residual levels) rather than a specific study with measured performance against predefined acceptance criteria for the device's primary function.
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4/8/96
Vasamedics 510(k)
Single Use Laser Doppler Probe Kits
Section [2] 510(k) Summary
OCT 11 1996
Device Name:
Trimflo Parenchymal Blood Flow Monitoring Probe Kit
Predicate Device:
The Vasamedics' model SUPR-434 Single use Blunt Needle Probe, K951832 and for kit accessories the Codman disposable ICP system (believed to be a pre-amendment device).
Device Description:
The Model BPM2 is a Laser Doppler Blood Perfusion Monitor, which is used to measure microcirculatory blood flow in a variety of clinical applications. Permission to market the BPM2 was granted by FDA on February 13, 1990 (Ref. K896515). The Model SUPR-434 Blunt Needle Probe is a single use fiber optic probe designed for use with the BPM2. These probes are labeled so as to be used for monitoring buried tissue, such as brain parenchyma during and following neurosurgical procedures. Permission to market the Model SUPR-434 ( Note: the SUPR-434 Blunt needle probes model names have since been changed to Trimflo 4314, 4316, 4364 and 4366) was granted on March 21, 1996 (Ref. K951832).
Intended Use:
The probes kits are intended for extravascular monitoring of microcirculation blood flow in buried tissues, specifically, in monitoring cerebral blood flow in patients at risk of cerebral ischemia.
Biocompatibility:
Materials used in the Probe kits that may come in contact with tissue are all biocompatible. The probes used in the kits are the same devices as the SUPR-434 (Trimflo) probes outlined in K951832. All accessories contained in the kit are standard items used in neurosurgery and ICP monitoring.
The Probe kits will be sterilized by gas ( ETO ) sterilization methods. The cycle used will be validated in accordance with AAMI guidelines using the overkill method to a sterility assurance level (SAL) of at least 1 x 10 4. Process release will be a combination of biological testing by methods at least as stringent as those described in the USP XXII monograph for sterility testing, combined with process documents review assuring that validating conditions are met. At the time of release all residual levels will be at or below those issued in the 1978 FDA guidelines for invasive devices:
- EO 25ppm ECH - 25ppm EG - 250ppm
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Substantial Equivalence:
The probes used in the Single Use Probe kits are substantially equivalent to products currently in commercial distribution, specifically the Model SUPR-434 (Trimflo) Single use Blunt Needle Probes. The only changes made to the product are the addition of probe accessories and the use of a tray for kit packaging. The single use probe kits will be packaged and ETO sterilized prior to shipment and will be labeled for single use only . All other kit components are equivalent to the Codman ICP monitoring kit.
Douglas G. Tomasko
Dalston
Director of Operations Vasamedics April 8, 1996
§ 870.2120 Extravascular blood flow probe.
(a)
Identification. An extravascular blood flow probe is an extravascular ultrasonic or electromagnetic probe used in conjunction with a blood flowmeter to measure blood flow in a chamber or vessel.(b)
Classification. Class II (performance standards).