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The ambIT PCA*PIB Pump is used to infuse medicines and/or fluids into patients primarily for pain management.

The routes of administration are generally intravenous, epidural and/or regional.

The ambIT PCA*PIB Pump is not intended to supersede, augment, or replace any other medical device or drug indications for use or intended uses.

The ambIT PCA*PIB Pump is intended to be used in the home and in healthcare facilities.

The new ambIT PCA*PIB is an electro-mechanically controlled, rotary-peristaltic, infusion pump that consists of two components: (1) the reusable pump driver; and (2) the sterile, single-use cassette (tubing set).

The ambIT PCAPIB Pump has a microprocessor-controlled motor that turns the rollers in the cassette at a set frequency to provide the desired infusion rate/therapy. The ambIT PCAPIB Pump is powered by two (2) standard 1.5-volt "AA" batteries, and cannot be powered by electrical mains. The batteries are replaceable but cannot be recharged inside the pump.

The controls consist of two buttons and an OFF/ON switch. One button toggles the pump between pause and infusing. The other button (BOLUS button) is used to request a bolus. An LCD display shows the pump status, alarms, and history. The pump monitors downstream occlusions, pump malfunctions, and other pump error conditions. The materials of construction are all medical grade plastics. Specifically, the materials are ABS, polycarbonate, nylon, and glass-filled nylon.

The part of the pump that comes into indirect contact with the body is the cassette or tubing set. The medications flow through the tubing into a catheter and then into the body. The tubing set is classified to be used for less than 30 days. The length of time the pump is used is based on the therapy requirements.

The ambIT PCA*PIB product has been validated and verified to meet healthcare providers', lay users', and patients' needs for pain management infusions. The pump meets all applicable national and international consensus standards.

The provided text does not describe acceptance criteria for a medical device in terms of performance metrics or a study designed to prove the device meets those criteria. Instead, it is a 510(k) premarket notification for infusion pumps (ambIT PCAPIB, ambIT PIB, ambIT PIBPCA, ambIT PIEB, and ambIT Programmable Intermittent Pump).

The document focuses on demonstrating substantial equivalence to a previously cleared predicate device (ambIT PCA Pump, K002434) and a reference device (CADD-Solis Ambulatory Infusion Pump, K130394), rather than presenting a study against specific acceptance criteria for performance.

Therefore, I cannot fulfill the request to provide a table of acceptance criteria, reported performance, or details about a study proving the device meets acceptance criteria, as this information is not present in the provided text.

Specifically, the document states:

• "Non-Clinical Performance Data: Both the predicate ambIT PCA Pump and the new ambIT PCAPIB Pump meet the same non-clinical performance data. The bench testing on the ambIT PCAPIB Pump demonstrates that the new pump meets the same volumetric accuracy requirements (when delivering high, low, and median flow rates and bolus volumes), the same usability requirements, and the same downstream occlusion alarm specifications. The volumetric accuracy and occlusion alarm were tested and the results show that the new pump meets the same specifications as the predicate pumps."
• "Clinical Performance Data: Clinical Performance Data was not relied on to show substantial equivalence."

This indicates that while performance testing was done (e.g., volumetric accuracy, usability, occlusion alarm), the purpose was to show the new device meets the same specifications as the predicate, not to meet pre-defined acceptance criteria for a new clinical performance study. The exact numerical specifications for these tests are not provided, nor is a detailed study report.

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The Direct Antibiotic Infusion Kit is intended for direct administration of mediation and/or fluids into the body. The Direct Antibiotic Infusion kit is intended for use by a physician or by a trained individual under the supervision of a physician. Any drug(s) used with this kit is (are) at the discretion of the physician and the indications for the drug should be verified and followed.

The Direct Antibiotic Infusion kit product line is a convenience kit for doctors. The Direct Antibiotic Infusion kit is designed to allow a physician or heath care provider to have the devices needed to administer antibiotics. The Direct Antibiotic Infusion kit consists of the following components: 1. Short or long term in-dwelling Catheter. 2. Suture. 3. Tubing anchor. 4. Tegaderm dressing. 5. Providone Iodine 10% ointment

The provided text describes a 510(k) premarket notification for a medical device called the "Direct Antibiotic Infusion Kit" by Summit Medical Products, Inc. However, it does not contain any information about acceptance criteria, device performance studies, sample sizes, expert involvement, ground truth establishment, or specific study designs (like MRMC or standalone performance).

The document is a communication from the FDA regarding the "substantial equivalence" of the device to existing predicate devices. It focuses on regulatory aspects, classification, and general controls, noting that there is "no substantial equivalence for the Direct Antibiotic Infusion kit" but then states the FDA has reviewed the 510(k) and "determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices." This apparent contradiction might be explained if components of the kit are individually substantially equivalent, even if the kit as a whole has no direct equivalent.

Crucially, the FDA's letter states: "Our substantially equivalent determination does not apply to the drug component of your device. We recommend you first contact the Center for Drug Evaluation and Research before marketing your device with the drug component." This indicates that the Povidone Iodine 10% Ointment, a drug component, falls under a different regulatory pathway.

Therefore, I cannot provide the requested information regarding acceptance criteria and performance studies because this document does not contain that level of detail about device testing. The 510(k) process often relies on demonstrating substantial equivalence to existing devices rather than requiring new, extensive performance studies that would typically be described with the requested metrics.

If this were a document about a new algorithm or AI device, it would be expected to include such detailed performance metrics. As it stands, this is a regulatory clearance document for a medical kit.

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The ambIT® Tunneler is a non-sterile, reusable device indicated for use in the percutaneous introduction of catheters into and around the surgical wound site or close to the nerve.
The ambIT Tunnelers are intended for the perculaneous introduction of catheters.

The ambIT® Tunneler is a non-sterile, reusable device indicated for use in the percutaneous introduction of catheters into and around the surgical wound site or close to the nerve. The ambIT® Tunneler is packaged and shipped non-sterile and must be cleaned and autoclaved by the purchaser/facility prior to use.

Summit Medical Products, Inc. is adding a tunneling device to the ambIT® Tunneler product line for use in the placement of catheters. This specification is specifically for a 16 gauge (GA), 12 inch shaft length, re-useable tunneler and single use sterilized peelable sheath.

The ambIT® Tunneler will consist of 2 components:

· The component is a stainless steel shaft (blunt end) with a handle. The diameter of the shaft is 16 GA (S French) and the length of the shaft will accommodate a 12 inch useable length sheath, The end of the shaft will have a rounded blunt tip.

Here's an analysis of the provided text regarding the acceptance criteria and the study that proves the device meets them:

1. Table of Acceptance Criteria and Reported Device Performance:

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

The provided text does not specify a sample size or data provenance (e.g., country of origin, retrospective/prospective) for any specific test set. The submission refers to "Non-Clinical Testing" which met various ISO standards and states "Results of testing demonstrate that the ambIT® Tunneler design meets product specifications and intended uses." This implies that the testing was likely laboratory-based and simulated, rather than involving human subjects or real-world data collection in a clinical setting.

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

The document does not mention the involvement of experts to establish ground truth. The evaluation criteria appear to be based on adherence to established international and national standards (ISO, ASTM) for medical device performance, materials, and sterilization. These standards themselves are developed by expert consensus within their respective fields, but the document doesn't detail specific experts involved in this particular device's ground truth establishment.

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

The document does not describe an adjudication method. Since the testing
primarily references adherence to engineering and material standards, it's unlikely that a human-based adjudication process (like 2+1, 3+1 for clinical endpoints) would be applicable or required. The "results demonstrate" implies meeting predefined thresholds within the standards.

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, an "ambIT® Tunneler" (a catheter tunneler), is a physical medical device, not an AI or imaging software. Therefore, there would be no MRMC study, human readers, or AI assistance involved.

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

This is not applicable. As mentioned above, the device is a physical medical tool, not an algorithm or software. Its performance is evaluated through non-clinical laboratory testing against physical and material standards.

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

The ground truth for this device's performance is primarily based on adherence to recognized engineering, material, and sterilization standards (e.g., ISO, ASTM). This represents a form of pre-defined technical and safety criteria established by expert consensus within the standards bodies themselves. It's not clinical "ground truth" like pathology or outcomes data, but rather a demonstration of inherent device properties and manufacturing processes meeting established benchmarks.

8. The sample size for the training set:

This is not applicable. As a physical medical device, there is no "training set" in the context of machine learning or AI. The design and manufacturing processes are validated against standards.

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

This is not applicable for the same reasons as above.

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The ambIT™ Introducer products are intended allow for the percutaneous placement of catheters in close proximity to nerves and around or into surgical wound or non-surgical wound sites. It may be used to inject or aspirate the introduction area via the luer hub of the needle.

The ambIT Introducer product line is intended for use by a physician or by a trained individual under direct supervision of a physician.

The ambIT™ Introducer is intended for the percutaneous introduction of a catheter

1. A stainless steel shaft with a sharp tip.
   a. Stainless steel shafts with sharp tips (various configurations such as beveled or touhy) may or may not be solid (may be hollow).. The diameter of the stainless steel shaft ranges from 11 to 17 GA and the length is from 3.25 to 12 inches.
2. A plastic peelable sheath (split T-handle) on the outside of the stainless steel shaft and/or a plastic/metal inserts inside hollow stainless steel shafts.
   a. Introducers that have a plastic sheath will allow the catheter to be inserted after the stainless steel shaft has been withdrawn. The tips of the stainless steel shaft will be blunt or sharp.
   b. Introducers that do not have a plastic sheath will allow the catheter to be inserted through the stainless steel shaft, after the plastic/metal insert has been withdrawn.
   The ambiT Introducers may have a handle or luer hub connected to the stainless steel shaft.

The following are the configurations and names for the amblT Introducers:

1. amblT Introducer Sheath
   a. Sterile single use product
   b. Made for use with ambIT Tunneler (without sheath) reusable product.
2. amblT Introducer Needle
   a. Sterile single use product
   b. Stainless steel shaft with sharp tip and insert inside stainless steel shaft.

The provided document is a 510(k) summary for the ambIT Introducer, seeking substantial equivalence to a predicate device, the On-Q Introducer.

Here's an analysis of the acceptance criteria and the study that proves the device meets them, based solely on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance:

The document states that the ambIT Introducers meet the requirements of several FDA-recognized consensus standards. It also claims substantial equivalence to the predicate device based on material, intended use, and similar testing to applicable ISO standards. The "reported device performance" is implicitly that the device passed all applicable testing requirements of these standards.

2. Sample Size Used for the Test Set and Data Provenance:

The document does not specify the sample sizes used for the testing conducted against the ISO standards. It generally states that "The product passed all applicable testing requirements."

The data provenance is from testing conducted by Summit Medical Products, Inc. as part of their 510(k) submission. It refers to a "comparison of the proposed and predicate device is provided" in Section 2, but this detailed comparison is not fully contained within the provided excerpts regarding the actual results of the testing. The nature of these tests (e.g., bench testing, animal studies) suggests they are prospective in the sense that they were performed specifically for this submission. The origin of any specific data (e.g., patient data) if applicable for performance claims, is not mentioned, as this device primarily relies on engineering and biocompatibility standards.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts:

This information is not applicable in the context of this 510(k) submission. The "ground truth" for this device revolves around meeting established engineering and biocompatibility standards (e.g., ISO standards) and demonstrating substantial equivalence to a legally marketed predicate device. The assessment relies on technical testing and regulatory review rather than expert consensus on diagnostic or clinical outcomes.

4. Adjudication Method for the Test Set:

This information is not applicable. As mentioned above, the evaluation is based on objective testing against established standards, not on human interpretation or adjudication of outputs.

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 information is not applicable. This document describes a medical device (catheter introducer) for which an MRMC study for AI assistance would not be relevant. AI is not mentioned as part of the device's function.

6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) Was Done:

This information is not applicable. This device is a physical medical instrument, not an algorithm or AI system.

7. The Type of Ground Truth Used:

The "ground truth" for this device is based on:

• Predetermined engineering and performance specifications defined by recognized international standards (ISO 594-2, ISO 10555-1).
• Biocompatibility requirements as outlined in ISO 10993-1.
• The characteristics and performance of a legally marketed predicate device (On-Q Introducer K063234) for demonstrating substantial equivalence.

8. The Sample Size for the Training Set:

This information is not applicable. There is no mention of a "training set" as this device is not an AI/ML product. The submission refers to a comparison with a predicate device and testing against established standards, not a machine learning model.

9. How the Ground Truth for the Training Set Was Established:

This information is not applicable as there is no training set for an AI/ML algorithm.

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