Search Results

The PSI TEC III Peristaltic Infiltration Pump indications for use are lipoplasty general tumescent infiltration to include body contouring. The PSI TEC III Peristaltic Infiltration Pump is not intended for intravenous use.

The principles of operation and technology incorporated in the PT-PINF III pump are equivalent to peristaltic irrigation systems, which use peristalsis-type action to move fluid through a tube by alternating mechanical squeezing of fluid-filled tubing with a roller. The PT-PINF III uses a single-cam roller and a grooved channel to squeeze and hold tubing and assist in moving fluid from an I.V. fluid bag to the infiltration site. As with all peristaltic pumps, the PT-PINF III contacts only the tubing/tractor and never directly contacts the fluid, thus fluid sterility cannot be compromised by the pumping action.

This submission (K040149) is a 510(k) premarket notification for a medical device called "The PSI TEC III Peristaltic Infiltration Pump." A 510(k) submission generally focuses on demonstrating substantial equivalence to a legally marketed predicate device, rather than providing extensive clinical study data with detailed acceptance criteria and performance metrics for the new device as would be seen for novel technologies or higher-risk devices.

Based on the provided document, there is no information available about acceptance criteria, a specific study proving the device meets those criteria, or most of the requested details about such a study.

The document states: "We have reviewed your Section 510(k) premarket notification of intent to market the device...and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976..." This confirms that the approval was based on substantial equivalence, not on a standalone performance study with defined acceptance criteria for the new device K040149 itself.

Here's an attempt to answer the questions based on the available text, highlighting what is not present:

1. Table of acceptance criteria and the reported device performance

   • Not provided. The document does not specify performance acceptance criteria for the new device (PSI TEC III Peristaltic Infiltration Pump) or report specific performance metrics against such criteria. The submission is framed around substantial equivalence to existing devices.

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

   • Not applicable/Not provided. This information pertains to a performance study, which is not detailed in this 510(k) summary. The approval is based on substantial equivalence to predicate devices, not on a performance study of the PSI TEC III itself.

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)

   • Not applicable/Not provided. This information pertains to a performance study, which is not detailed in this 510(k) summary.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

   • Not applicable/Not provided. This information pertains to a performance study, which is not detailed in this 510(k) summary.

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

   • Not applicable. This device is an irrigation/infusion pump, not an AI-assisted diagnostic tool. No MRMC study would be relevant here.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

   • Not applicable. This device is a pump, not an algorithm. Standalone performance for a physical device would refer to its functional specifications (e.g., flow rate accuracy, pressure), but these are not detailed as specific performance study results in this summary. The substantial equivalence argument implicitly assumes its performance is comparable to predicates.

7. The type of ground truth used (expert concensus, pathology, outcomes data, etc)

   • Not applicable/Not provided. This information pertains to a performance study, which is not detailed in this 510(k) summary.

8. The sample size for the training set

   • Not applicable/Not provided. This information pertains to a type of performance study (often for AI/ML) that is not described for this device.

9. How the ground truth for the training set was established

   • Not applicable/Not provided. This information pertains to a type of performance study (often for AI/ML) that is not described for this device.

Summary of available information related to equivalence:

The document primarily focuses on demonstrating substantial equivalence to previously cleared predicate devices.

Predicate Devices for Substantial Equivalence Claim:

• Product: Bi-Phasic Infiltrator
  • Manufacturer: Reliance Medical
  • 510(k) Number: K012044
  • Substantial Equivalence Date: August 28th, 2001
• Product: Autofuse V Infiltration Pump
  • Manufacturer: Randolph-Austin
  • 510(k) Number: K980394
  • Substantial Equivalence Date: March 25th, 1998
• Product: Wells-Johnson Infusion System
  • Manufacturer: Wells-Johnson
  • 510(k) Number: K991437
  • Substantial Equivalence Date: August 30th, 1999

The substantial equivalence claim is based on the "principles of operation and technology incorporated" being similar to these predicates, specifically mentioning that the PT-PINF III uses a single-cam roller and a grooved channel to squeeze and hold tubing, similar to other peristaltic irrigation systems. It also mentions that, like all peristaltic pumps, it contacts only the tubing and not the fluid, thus maintaining sterility.

In conclusion, for this specific 510(k) submission, the device did not undergo a study to meet defined acceptance criteria in the way a novel diagnostic or therapeutic device might. Its approval was based on demonstrating substantial equivalence to pre-existing, legally marketed predicate devices.

Ask a specific question about this device

The Accelerator Reciprocating Cannula indications for use are the removal of tissue or fluid from the body during general surgical procedures including suction lipoplasty for the purpose of aesthetic body contouring.

Not Found

The provided documents pertain to the FDA 510(k) clearance for the Accelerator Reciprocating Cannula by Byron Medical. This is a medical device submission, specifically a predicate comparison, not a study that proves a device meets acceptance criteria in the typical sense of a clinical trial or performance study against specific metrics.

Therefore, I cannot provide the information requested in the format of acceptance criteria and the study that proves the device meets them, as this document type does not contain such a study or detailed performance metrics.

However, I can extract the information that is present, focusing on the comparative effectiveness study (which is a comparison to predicate devices for substantial equivalence, not a clinical trial proving new acceptance criteria).

Here's a breakdown of what can be extracted or inferred from the provided FDA 510(k) summary regarding the requested points:

1. A table of acceptance criteria and the reported device performance

The document does not establish explicit "acceptance criteria" for the Accelerator Reciprocating Cannula in the way a clinical performance study would. Instead, it demonstrates substantial equivalence to legally marketed predicate devices. The "performance" is reported within a comparative table against these predicates on certain functional attributes.

2. Sample size used for the test set and the data provenance

• Sample Size: Not applicable in the context of a clinical test set. The submission focuses on a comparison of device specifications and operational characteristics to predicate devices. No human subject testing data (test set) is provided or referenced here.
• Data Provenance: The data is a comparison of technical specifications and operating parameters, likely derived from engineering testing, functional analysis, and manufacturer specifications of the Byron Medical device and its predicate devices. No country of origin for a "test set" or information about retrospective/prospective collection is relevant here.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

• This is not applicable. There was no "test set" in the sense of patient data or images requiring expert adjudication. The "ground truth" for this type of submission is the documented performance characteristics of the devices and their equivalence.

4. Adjudication method for the test set

• Not applicable, as there was no test set requiring adjudication.

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

• This is not applicable. The device (Accelerator Reciprocating Cannula) is a surgical instrument (a cannula for liposuction), not an AI-powered diagnostic imaging device. Therefore, no MRMC study involving human readers or AI assistance was performed or is relevant to this submission.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

• Not applicable, as this is a physical surgical instrument, not an algorithm or AI system.

7. The type of ground truth used

• For this 510(k) submission, the "ground truth" for demonstrating substantial equivalence is based on the technical specifications, functional performance characteristics, and intended use comparison of the proposed device against legally marketed predicate devices. This includes physical measurements, operational parameters (e.g., cpm, travel distance, force), and safety features, substantiated through engineering and non-clinical testing data (not provided in detail in this summary) and comparison with predicate device information.

8. The sample size for the training set

• Not applicable. This is not an AI/ML device, so there is no concept of a "training set" for an algorithm.

9. How the ground truth for the training set was established

• Not applicable. No training set exists for this type of device.

Ask a specific question about this device

The PSI-TEC Liposuction Aspirator(s) indications for use is for esthetic body contouring.
Aesthetic Body Contouring.

Powered Suction Pump(s)/Aspirator(s) which use an electrically (AC) driven vacuum pump generating a negative pressure for the removal of fat/adipose, soft tissue, and general surgical waste. The Psi-Tec Aspirator 2 also has the capability to capture the waste air "exhaust" (that creates the negative pressure) in an enclosed container. This now, contained and pressurized air, can then be utilized for driving other devices requiring the use of pressurized air.

This document is a 510(k) premarket notification for a medical device (Psi-Tec Liposuction Aspirator), which means it focuses on demonstrating substantial equivalence to a legally marketed predicate device rather than presenting new clinical study data with acceptance criteria.

Therefore, the provided text does not contain the information requested in your prompt regarding acceptance criteria and a study proving the device meets them.

Here's why and what kind of information you would typically find in a document that does address your request:

• 510(k) Notifications: These submissions aim to show that a new device is as safe and effective as another legally marketed device (the predicate device). This is usually done by demonstrating similar technological characteristics and indications for use, often through performance testing that is not a full-blown clinical study with acceptance criteria as you've described.
• Premarket Approval (PMA) Applications (or De Novo submissions for novel devices): These types of FDA submissions would typically include detailed clinical study data, acceptance criteria, and comprehensive reports proving the device's safety and effectiveness.

Based only on the provided text, I can infer the following, but cannot provide the detailed information you requested:

• Device Name: Psi-Tec Liposuction Aspirator
• Indications for Use: Aesthetic Body Contouring (stated on page 3 and 5)
• Predicate Device: Psi-Tec Aspirator(s) (K880392, Substantial Equivalence Date: 05 March 1998)
• Nature of the Submission: 510(k) summary, aiming to demonstrate substantial equivalence, not to present novel clinical trial data.

To answer your specific questions, I would need a different type of document, such as a summary of a clinical trial report or a performance data section from a PMA application.

Ask a specific question about this device

The Aspiration and Infusion Cannulae and Needles indications for use are for Aesthetic Body Contouring.

The principles of operation and technology incorporated in the Cannulae and Needles are equivalent to fluid, soft tissue, and exudate removal and infusion instruments generally used for aspiration and infusion, utilizing a hollow Stainless Steal tube with multiple tip, handle and attachment connectors that are in a reusable and disposable configuration.

I am sorry, but the provided text does not contain information about the acceptance criteria or a study proving that a device meets such criteria. The document is a 510(k) premarket notification for Lipoplasty/Liposuction Aspiration and Tumescent Infusion Cannulae and Needles, indicating that the device is substantially equivalent to a previously marketed device. It does not include performance data, study designs, sample sizes, expert qualifications, or ground truth establishment.

Therefore, I cannot fulfill your request for the specific information regarding acceptance criteria and a study's results based on the provided text.

Ask a specific question about this device

General surgical fluid irrigation and infiltration.
The Psi-Tec Syringe Infusion Pump and accessories indications for use are for General Fluid Irrigation/Infiltration.

The principles of operation and technology incorporated in the Psi-Tec Svringe Infusion Pump and accessories are to provide controlled fluid delivery by utilizing a disposable, pneumatically driven syringe cartridge attached to tubing, that can propel and monitor fluid volumes delivered into a surgical site by the system.

This document is a 510(k) summary for the Byron Medical Psi-Tec Syringe Infusion Pump. It does not contain information about acceptance criteria or a study proving the device meets said criteria.

Therefore, I cannot provide the requested information. The document focuses on establishing substantial equivalence to previously cleared devices for the purpose of market clearance, rather than presenting performance study data against specific acceptance criteria.

Ask a specific question about this device

General surgical fluids, exudate, soft tissue, and general tissue removal from surgical sites.

General aspirator(s), which use an electrically (AC) driven vacuum pump generating a negative pressure for evacuating surgical waste. The Psi-Tec Aspirator 2 also has the capability to capture the waste air "exhaust" (that creates the negative pressure) in an enclosed container. This now, contained and pressurized air, can then be utilized for driving other devices requiring the use of pressurized air.

This document is a 510(k) summary for a medical device called the "Psi-Tec Aspirator," submitted by Byron Medical, Inc. The purpose of a 510(k) summary is to demonstrate substantial equivalence to legally marketed predicate devices, not to provide detailed performance study results against specific acceptance criteria.

Therefore, the provided text does not contain the information requested regarding acceptance criteria, study details, sample sizes, ground truth establishment, expert qualifications, adjudication methods, or direct performance results.

The document primarily focuses on:

• Identification of the device: Psi-Tec Aspirator
• Manufacturer information: Byron Medical, Inc.
• Classification: Aspirator, Apparatus, Suction, Ward Use and Aspirator, Apparatus, Suction, Operating Room, Wall Vacuum Powered (Class II)
• Intended Use/Indications for Use: General surgical fluids, exudate, soft tissue, and general tissue removal from surgical sites.
• Device Description: Electrically (AC) driven vacuum pump generating negative pressure for evacuating surgical waste, with the Psi-Tec Aspirator 2 also capturing and pressurizing exhaust air for other devices.
• Substantial Equivalence Claim: Lists several predicate devices (General Aspirator by Kolster Methods, Grams Aspirator by Grams Medical, Aspirator and Aspirator II by Wells Johnson Company, General Aspirator by Mentor Corporation) to which the Psi-Tec Aspirator is claimed to be substantially equivalent.
• Approval Letter: A letter from the FDA indicating that the device is substantially equivalent and can be marketed.

In summary, none of the requested information regarding acceptance criteria or the specific study details (sample size, ground truth, experts, adjudication, MRMC, standalone performance) is present in the provided text. The 510(k) process for this type of device typically relies on demonstrating equivalence to predicate devices, often through performance testing that shows similar functional characteristics, rather than establishing de novo acceptance criteria and conducting extensive clinical efficacy trials with detailed statistical reporting as would be expected for a novel device or a device requiring de novo authorization.

Ask a specific question about this device

The Tubing Indications for use are general surgical fluid, exudate, rne Tubing me aspiration and general surgical fluid irrigation/infiltration.

The principles of operation and technology incorporated in the Tubing are equivalent to other standard surgical tubing that acts as a pathway between the operative site and either an aspiration or irrigation source for fluid or soft tissue removal and fluid delivery.

This document, K974295, describes a 510(k) submission for the Byron Medical Aspiration and Infiltration/Irrigation Tubing. The submission focuses on demonstrating substantial equivalence to predicate devices rather than proving performance against specific acceptance criteria through a clinical study. Therefore, most of the requested information regarding acceptance criteria, study details, and performance metrics is not applicable or not provided in this type of regulatory submission.

Here's a breakdown of what can be gleaned from the provided text in relation to your request:

Acceptance Criteria and Reported Device Performance

Not Applicable. This 510(k) submission does not present specific acceptance criteria or performance data for the Byron Medical Tubing. Its primary goal is to establish "substantial equivalence" to existing, legally marketed devices. This means that instead of proving specific performance metrics, the device is asserted to be safe and effective because its operational principles, technology, and intended use are similar to predicate devices that have already been cleared by the FDA.

Study Details

Since this is a substantial equivalence claim, it does not involve the type of clinical or performance study you are asking about. Therefore, the following information is not provided in the document:

• Sample size used for the test set and the data provenance: No test set is described.
• Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable, as there's no test set requiring ground truth establishment.
• Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable.
• If a multi-reader multi-case (MRMC) comparative effectiveness study was done: No.
• If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: No.
• The type of ground truth used (expert consensus, pathology, outcomes data, etc.): Not applicable.
• The sample size for the training set: Not applicable.
• How the ground truth for the training set was established: Not applicable.

Summary of Substantial Equivalence Claim

The document explicitly states:

• Device Description: "The principles of operation and technology incorporated in the Tubing are equivalent to other standard surgical tubing that acts as a pathway between the operative site and either an aspiration or irrigation source for fluid or soft tissue removal and fluid delivery."
• Substantial Equivalence Claim: "The principles of operation and technology incorporated in the Tubing are similar to other tubing devices with the function to deliver fluids or remove soft tissue and general aspirate which the FDA has founded to be substantially equivalent to pre-amendment devices..."

The submission lists several predicate devices to which the Byron Medical Tubing claims substantial equivalence:

• VCI Suction and Irrigation Tubing Sets (Vital Concepts, K93482, 01 February 1994)
• Irrigation and Aspiration Tubing (ARMM. Inc., K923201, Substantial Equivalence Date: Unknown)
• Ackrad Fluid Connecting Set (Ackrad Laboratories, Inc., K820937, 26 April 1982)
• Disposable Tubing (Wells Johnson Company., 510(k) Number: Unknown, Substantial Equivalence Date: Unknown)

Conclusion:

This 510(k) submission for the Byron Medical Aspiration and Infiltration/Irrigation Tubing relies on demonstrating substantial equivalence to previously cleared devices rather than providing detailed performance data against pre-defined acceptance criteria from a specific study. Therefore, the detailed information requested about study design, sample sizes, ground truth establishment, and expert involvement is not present in this document, as it is generally not required for this type of regulatory pathway.

Ask a specific question about this device

The Big Bag 3000 Pressure Infusor indications for use are general surgical fluid irrigation and infiltration.

The principles of operation and technology incorporated in the Big Bag 3000 Pressure Infusor are equivalent to pressurized irrigation systems, which use compressed nonflammable gases within a closed bladder (inflatable cuff) to apply direct pressure externally to a bag of fluid for infusion of fluids.

The provided text is a 510(k) summary for the Byron Medical Big Bag 3000 Pressure Infusor, which is a device used for general surgical fluid irrigation and infiltration. This document focuses on demonstrating substantial equivalence to existing predicate devices, rather than presenting a performance study with specific acceptance criteria and detailed study results as one might find for a novel or entirely new class of medical device.

Therefore, the document does not contain the requested information regarding:

• A table of acceptance criteria and reported device performance.
• Sample sizes, data provenance, number of experts, adjudication method for a test set.
• Multi-reader multi-case (MRMC) comparative effectiveness study or related effect sizes.
• Standalone algorithm performance.
• Type of ground truth used for performance validation.
• Sample size for the training set or how ground truth for the training set was established.

Explanation of document content:

The core of this 510(k) submission is to establish that the Big Bag 3000 Pressure Infusor is "substantially equivalent" to legally marketed predicate devices. This means that its fundamental technology, principles of operation, and indications for use are similar enough to existing devices that it does not raise new questions of safety or effectiveness.

The document explicitly states:

• "The principles of operation and technology incorporated in the Big Bag 3000 Pressure Infusor are equivalent to pressurized irrigation systems, which use compressed nonflammable gases within a closed bladder (inflatable cuff) to apply direct pressure externally to a bag of fluid for infusion of fluids." (Page 1)
• "The principles of operation and technology Substantial Equivalence Claim: incorporated in the Byron Medical Big Bag 3000 are similar to other irrigation devices with the function to pressurizing bags of fluid which the FDA has founded to be substantially equivalent to pre-amendment devices as outlined below." (Page 1)

It then lists several predicate devices (e.g., Medex. Inc. Pressure Infusor, Davol, Inc. Nezhat-Dorsey Hydro-Dissection Universal Bag Squeezer) with their 510(k) numbers and substantial equivalence dates. This is the primary "proof" provided – a comparison to devices already cleared by the FDA.

In summary, this document is a regulatory submission for substantial equivalence based on technological similarity to existing devices, not a detailed clinical or performance study with specific quantitative acceptance criteria.

Ask a specific question about this device