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The Kendall Curity Iodoform Packing Strip is intended for wet to dry packing of deep wounds including nasal and sinus passages. It helps control/prevent bleeding, encourages drainage and assists in removing necrotic tissue. It is indicated for general wound packing.

The proposed Kendall Curity Iodoform Packing Strip is a sterile, single-use, wound dressing consisting of a cotton gauze strip impregnated with a formulated Iodoform solution. It is packaged in HDPE amber colored bottles and is available in 14" x 5yd, 1/2" x 5yd, 1" x 5yd and 2" x 5yd sizes.

The provided text is related to a 510(k) submission for a medical device called the "Kendall Curity Iodoform Packing Strip." This document focuses on demonstrating substantial equivalence to a predicate device based on material, function, and intended use, rather than presenting a performance study with specific acceptance criteria and performance metrics.

Therefore, the requested information regarding acceptance criteria, device performance, sample sizes, ground truth establishment, expert adjudication, or MRMC studies for AI performance is not available in the provided text.

The document states that "Biocompatibility testing of the Kendall Curity Iodoform Packing Strip has demonstrated that it contains no bioactive components. Testing performed on the product was based upon guidelines presented in the 10993 ISO Standard, Part 1, with the FDA modified matrix presented in memorandum G95-1."

This indicates that some non-clinical testing was performed for biocompatibility, but the details of acceptance criteria and reported performance for this testing are not provided in a format that would allow for a table similar to what's expected for a diagnostic device's performance study.

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It is intended for use as a primary layer in dressing wounds such as minor burns, skin grafts, skin donor sites, as an initial layer in surgical dressings, as protective layer for injured body sites, as a seal around tubes and drains leading from the body.

The proposed Kendall Curity Petrolatum Gauze Dressing is a sterile, single-use, non-adherent dressing consisting of absorbent gauze impregnated with white petrolatum. It is packaged in metalized chevron pouches and is available in ½" x 72", 1" x 36", 3" x 9", 3" x 18", 3" x 36", 6" x 36" and 1" x 8" sizes.

The provided document is a 510(k) premarket notification for a medical device, specifically a "Petrolatum Gauze Dressing." This type of submission focuses on demonstrating substantial equivalence to a legally marketed predicate device rather than fulfilling acceptance criteria through clinical studies. Therefore, many of the requested categories are not applicable or cannot be extracted from this document.

Here's an analysis based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

This information is Not Applicable to this 510(k) submission. A 510(k) largely relies on demonstrating substantial equivalence to a predicate device, not on meeting specific performance acceptance criteria from novel clinical trials. The document focuses on material comparison, function, and intended use as defined by the predicate.

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

This information is Not Applicable. No test set based on patient data is described for performance evaluation in this 510(k) submission. The nonclinical testing mentioned (Biocompatibility) would involve laboratory samples, not a "test set" in the context of clinical performance data.

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

This information is Not Applicable. No clinical test set requiring expert ground truth establishment for performance evaluation is described.

4. Adjudication Method for the Test Set

This information is Not Applicable. No test set (clinical or performance-based) requiring adjudication is described.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done

No, an MRMC comparative effectiveness study was Not Done as described in this 510(k) submission. The focus is on demonstrating substantial equivalence to a predicate device based on material, function, and intended use, not on a comparative effectiveness study involving human readers and AI assistance.

6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Was Done

This information is Not Applicable. The device is a petrolatum gauze dressing, not a software algorithm or AI-powered diagnostic tool. Therefore, the concept of "standalone algorithm performance" is not relevant.

7. The Type of Ground Truth Used

This information is Not Applicable. No clinical "ground truth" (expert consensus, pathology, outcomes data) is discussed in the context of device performance evaluation in this 510(k) submission. The ground for comparison is the "legally marketed device" (predicate device).

8. The Sample Size for the Training Set

This information is Not Applicable. The device is a physical dressing, not an AI or machine learning model that requires a training set.

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

This information is Not Applicable for the same reasons as #8.

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The Kendall Xeroform Petrolatum Wound Dressing is intended for use as a primary contact layer in dressing wounds such as lacerations, skin graft recipient sites, newly sutured wounds, abrasions, and minor or partial thickness burns. It may also be used as an initial layer in dressing surgical wounds with light exudate where mild medication and deodorization are desired.

The proposed Kendall Xeroform Petrolatum Wound Dressing is a sterile, singleuse, non-adherent dressing consisting of absorbent gauze impregnated with Xeroform in a petrolatum blend. It is packaged in metalized chevron pouches and is available in 4" x 3yd roll, 1" x 8", 5" x 9", 2" x 2" and 4" x 4" sizes.

The provided document is a 510(k) summary for the Kendall Xeroform Petrolatum Wound Dressing. This document focuses on demonstrating substantial equivalence to a legally marketed predicate device rather than detailing specific device performance against acceptance criteria from a clinical study.

Therefore, the requested information regarding acceptance criteria and a study proving the device meets them cannot be fully extracted as it pertains to a traditional clinical performance study for an AI/CADe device. The provided text describes the device's characteristics and its equivalence to a predicate device based on material, function, and indication for use, alongside biocompatibility testing. It is not a document describing the results of a controlled clinical trial with performance metrics.

I can, however, extract the relevant information that is present regarding non-clinical testing and the comparison method:

1. Table of acceptance criteria and the reported device performance:

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

• Sample Size for Test Set: Not applicable. The document discusses device characteristics and performance in terms of biocompatibility and equivalence, not a test set of data points for an algorithm.
• Data Provenance: Not applicable.

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

• Not applicable. This is not a study involving expert-established ground truth for a test set.

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

• Not applicable.

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:

• No MRMC comparative effectiveness study was done. This document does not describe an AI/CADe device.

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

• No standalone algorithm performance study was done. This is not an algorithmic device.

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

• Not applicable in the context of an algorithm's ground truth. However, the ground for the device's safety and effectiveness relies on biocompatibility testing standards and demonstration of substantial equivalence to a previously marketed device (Sherwood Medical Xeroform Petrolatum Dressing) which was already deemed safe and effective.

8. The 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.

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Theae dressings are intended for use as a primary dressing in the management of medium to heavy draining wounds such as minor burne, abrasions and lacerations. These dressings may also be used under the care of a health tare professional for wounds such as surgical incisions, skin grafts, and dermal ulcers.

The proposed Kendall Curity Non-Adhering Dressing is a sterile, single-use, dressing consisting of cellulose acetate fabric impregnated with a specially formulated petrolatum emulsion. It is packaged in clear polyester pouches and is available in 3" x 3", 3" x 8", 3" x 16" and 14" x 4 yds sizes.

Here's an analysis of the provided text regarding the Kendall Curity Non-Adhering Dressing, focusing on the absence of acceptance criteria and a study proving their fulfillment:

1. Table of Acceptance Criteria and Reported Device Performance:

There is no table of acceptance criteria or reported device performance in the provided document. The submission is a 510(k) summary, which focuses on demonstrating substantial equivalence to a predicate device rather than presenting specific quantitative performance metrics against pre-defined acceptance criteria.

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

No information regarding a "test set" in the context of evaluating performance against acceptance criteria is provided. The document refers to "Biocompatibility testing," but doesn't specify sample sizes, data provenance (e.g., country of origin), or whether it was retrospective or prospective.

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

This information is not applicable or available in the provided document. The submission type (510(k) for a non-adhering wound dressing) does not typically involve the establishment of ground truth by clinical experts in the way AI or diagnostic device studies would. The assessment revolves around material composition and intended use equivalence.

4. Adjudication Method for the Test Set:

This information is not applicable or available as there is no described test set or clinical performance evaluation involving adjudication.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done:

No MRMC comparative effectiveness study was done or reported. The 510(k) submission for this type of device does not typically require an MRMC study. The focus is on product comparison to a predicate device.

6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Was Done:

This information is not applicable as the device is not an algorithm or AI-driven system. It is a physical wound dressing.

7. The Type of Ground Truth Used:

Ground truth in the typical sense (expert consensus, pathology, outcomes data) is not applicable for this device submission. The primary "truth" being established is the safety and effectiveness through substantial equivalence to a legally marketed predicate device, based on material composition and intended use. The biocompatibility testing implies adherence to established safety standards, which can be seen as a form of "ground truth" derived from scientific principles, but not clinical outcomes in the same way.

8. The Sample Size for the Training Set:

This information is not applicable as the device is not an AI/ML algorithm that requires a training set.

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

This information is not applicable for the same reason as above.

Summary of Device Submission Type and Relevance:

The provided document is a 510(k) Pre-Market Notification for a wound dressing. This regulatory pathway primarily focuses on demonstrating that a new device is "substantially equivalent" to a legally marketed predicate device. This typically involves:

• Comparison of Technical Characteristics: Showing similar materials, design, energy (if applicable), and intended use.
• Performance Data (often non-clinical): Such as biocompatibility, sterility, and physical properties, to ensure the new device performs as safely and effectively as the predicate.
• Clinical Data (rarely required for 510(k)s for simple devices like dressings): Unless the device has novel technology, a new intended use, or raises new safety/effectiveness questions not addressed by a predicate.

In this specific case, the submission relies on:

• Substantial Equivalence: To the Johnson & Johnson Medical, Inc., Adaptic® Non-Adhering Dressing based on similar materials and intended use.
• Biocompatibility Testing: Based on ISO 10993 standards and FDA guidelines (memorandum G95-1). This testing aims to ensure the materials used are not toxic or irritating to the human body, which is a key safety aspect.

The absence of detailed quantitative acceptance criteria and a "study that proves the device meets the acceptance criteria" in the way one might expect for an AI or diagnostic device is consistent with the nature of a 510(k) submission for a non-adhering wound dressing in 1997. The "proof" lies in the demonstration of substantial equivalence and adherence to general safety standards (like biocompatibility).

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The proposed device is for use in the management of wounds which present moderate to heavy wound exudate such as dermal ulcers (i.e., venous stasis, pressure, arterial, diabetic); traumatic wounds (i.e., lacerations, punctures, abrasions or incisions); donor sites; and second-degree burns.

The Kendall CURASORB® Zn+Mg Alginate Wound Dressings are sterile, single-use, nonwoven, absorptive dressings. The off-white alginate fibers are composed of calcium, sodium, zinc and magnesium. As the dressing absorbs wound exudate it converts to a firm gel/fiber mat. This gel cushions the wound and forms a moist environment at the wound interface. The product is available in 2" x 2", 4" x 4", and 4" x 8" , 6" x 10", 12" x 24" pads, as well as 12", 24" and 36" long wound packing rope.

This submission for K973509 is a 510(k) for a wound dressing, which typically relies on demonstrating substantial equivalence to a predicate device rather than presenting specific performance metrics against pre-defined acceptance criteria in the same way a diagnostic or therapeutic device might. Therefore, the requested information in the prompt, particularly points 1, 5, 6, and details about sample sizes, experts, and ground truth for training/test sets, is not included in the provided 510(k) summary.

Here's a breakdown of the available information:

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

This information is not provided in the 510(k) summary. For wound dressings in a 510(k), acceptance criteria are typically met by demonstrating substantial equivalence in composition, function, and intended use to a predicate device, along with biocompatibility and other regulatory requirements. Specific quantitative performance metrics (e.g., absorption rate, healing time improvement) against pre-defined acceptance criteria are generally not part of a 510(k) for this type of device unless specific claims are being made that necessitate such testing.

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

No specific test set or data provenance details are provided as this is not a study presenting clinical performance data from human subjects or a diagnostic algorithm. The "testing" mentioned refers to biocompatibility.

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. This is not a study involving expert-established ground truth for a test set.

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

Not applicable. This is not a study involving expert adjudication of a test set.

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 is a wound dressing, not an AI-assisted diagnostic or therapeutic device. No MRMC study was performed or required.

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

Not applicable. This is a medical device (wound dressing), not an algorithm.

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

Not applicable. No ground truth in this context is relevant for a wound dressing 510(k) submission.

8. The sample size for the training set:

Not applicable. There is no training set for a wound dressing.

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

Not applicable. There is no training set or ground truth in this context.

Summary of what is provided in the K973509 510(k) for the Kendall CURASORB® Zn+Mg Alginate Wound Dressing:

The device's acceptability is based on substantial equivalence to existing predicate devices (Kendall CURASORB® Calcium Alginate Dressing and Kendall CURASORB® Zn Alginate Wound Dressing).

Study/Evidence that proves the device meets the acceptance criteria (substantial equivalence):

• Product Comparison: The submission states that the Kendall CURASORB® Zn+Mg Alginate Wound Dressings are equivalent to the referenced predicate devices because "they are fabricated from similar materials, have a similar function and equivalent indications for use."
• Biocompatibility Testing: "Biocompatibility testing of the Kendall CURASORB® Zn+Mg Alginate Wound Dressing has demonstrated that it contains no bioactive components. Testing performed on the product was based upon guidelines presented in the 10993 ISO Standard, Part I, with the FDA modified matrix presented in memorandum G95-1." This demonstrates that the materials used are safe for their intended purpose in contact with the body.

The FDA's letter concurs with the finding of substantial equivalence, allowing the device to be marketed, with specific limitations on labeling claims related to third-degree burns, accelerated healing, long-term use, or explicit claims of treatment/cure.

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The Kendall FAST-CATH Pre-Lubricated Urethral Catheter is intended for sterile intermittent catherization for urine drainage from the bladder.

The Kendall FAST-CATH Pro-Lubricated Urethral Catheter is a sterile, single use system designed for the sterile intermittent cathererization for urine drainage from the bladder. The system is designed for use in both male and female patients. The system consists of a 1200cc plastic collection bag. A 14 Fr rubber or vinyl urological catheler is self contained within the collection bag. A pre-lubricated introducer up allows the catheter to be advanced through the top of the collection bag to perform wrinary cathelestization. A removable cover guards the introducer tip prior to use to maintain sterility.

The Kendall FAST-CATH Pre-Lubricated Urethral Catheter is a sterile, single-use system designed for intermittent catheterization for urine drainage. The provided documentation does not include explicit acceptance criteria with numerical targets. Instead, the testing focuses on demonstrating equivalence to predicate devices and adherence to general medical device standards.

Here's an analysis of the provided information:

1. Table of Acceptance Criteria and Reported Device Performance

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

The document does not specify the sample sizes used for the biocompatibility or functional testing in terms of the number of individual devices or tests performed. The data provenance is not explicitly stated "country of origin" or "retrospective/prospective," but given the nature of the tests (biocompatibility and functional testing), they would typically be prospective laboratory studies conducted by the manufacturer.

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

This type of information is not applicable to this submission. The tests described (biocompatibility and functional performance) are objective laboratory measurements, not subjective evaluations requiring expert consensus for ground truth.

4. Adjudication Method for the Test Set

This is not applicable. Adjudication methods like 2+1 or 3+1 are used for resolving discrepancies in expert opinions on subjective data, which is not the case here.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and Effect Size

No, a multi-reader multi-case (MRMC) comparative effectiveness study was not done. This type of study is relevant for diagnostic imaging or interpretation tasks involving human readers, which is not the function of a urinary catheter.

6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Was Done

This is not applicable. "Standalone" performance generally refers to AI algorithms performing a task without human intervention. The Kendall FAST-CATH is a medical device, not an AI algorithm.

7. The Type of Ground Truth Used

The ground truth for the non-clinical testing was based on:

• Biocompatibility Standards: Compliance with ISO-10993, which defines acceptable biological responses of medical devices.
• Predicate Device Performance: Performance metrics (like flow rates, shaft stiffness) observed from commercially available predicate urinary catheterization systems. This implies that the 'ground truth' for functional performance was defined by the established performance of existing equivalent devices.

8. The Sample Size for the Training Set

This information is not applicable. The Kendall FAST-CATH is a physical medical device, not a machine learning model, and therefore does not have a "training set" in the computational sense. The design and manufacturing processes are informed by engineering principles and standards, not data training.

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

This is not applicable, as there is no "training set" for this type of device.

Summary of the Study that Proves the Device Meets Acceptance Criteria:

The study proving the device meets the (implicit) acceptance criteria is described under "7. Nonclinical Testing":

• Biocompatibility Testing: Performed on the catheter system following ISO-10993 Biological Evaluation of Medical Devices. The results "found the materials contained no toxic diffusible substances." This demonstrates compliance with established safety standards.
• Functional Testing: Performed to determine parameters such as "flow rates, shaft stiffness and other attributes." The results "demonstrated equivalence between the proposed catheter system and commercially available intermittent urological catheterization systems." This establishes that the device performs functionally comparably to legally marketed predicate devices.

The acceptance criteria are implicitly met by demonstrating compliance with international biocompatibility standards and functional equivalence to predicate devices, rather than through specific numerical thresholds. The submission relies on the concept of substantial equivalence under 510(k) regulations, where a new device is found to be as safe and effective as a legally marketed predicate device.

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Like the predicate device, the Kendall Hydrophilic Powder Wound Dressing is indicated for the management of exudating wounds such as dermal ulcers (e.g., venous stasis, pressure, arterial, diabetic), surgical incisions, traumatic wounds (e.g., lacerations, abrasions).

The proposed Kendall Hydrophilic Powder Wound Dressing is a sterile composition of maltodextrin, sodium alginate and chitosan chloride. As the powder absorbs wound exudate It converts to a gel. This gel forms a moist environment at the wound interface conducive to healing The product is available in 6 gram, 12 gram and 25 gram packets.

The provided text is a 510(k) summary for the Kendall Hydrophilic Powder Wound Dressing and subsequent FDA correspondence. It focuses on establishing substantial equivalence to a predicate device, rather than presenting a study demonstrating the device meets specific performance acceptance criteria.

Therefore, the document does not contain the information requested for acceptance criteria and a study proving the device meets those criteria. The provided text primarily addresses:

• Device identification and contact information.
• Classification and legal marketing identification of a predicate device.
• Device description and intended use.
• Product comparison to the predicate device (similar materials, function, indications).
• Nonclinical testing for biocompatibility.
• FDA's substantial equivalence determination letter with labeling limitations.

Specifically, regarding the requested information:

1. A table of acceptance criteria and the reported device performance: Not present. The submission focuses on equivalence, not performance against specific criteria.
2. Sample size used for the test set and the data provenance: Not applicable, as no performance study is described. Biocompatibility testing is mentioned, but details on sample size or provenance are not provided.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable.
4. Adjudication method for the test set: Not applicable.
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 a wound dressing, not an AI-assisted diagnostic tool.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc): Not applicable.
8. The sample size for the training set: Not applicable.
9. How the ground truth for the training set was established: Not applicable.

The "Nonclinical Testing" section mentions "Biocompatibility testing... based upon guidelines presented in the 10993 ISO Standard, Part 1, with the FDA modified matrix presented in memorandum G95-1." While this indicates testing was performed according to established standards, it does not specify performance acceptance criteria (e.g., cytotoxicity levels, irritation scores) or the specific results of these tests. It only states that the testing "demonstrated that it contains no bioactive components."

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The Kendal! Dual Lumen Catheters are intended for use as short-term vascular access for hemodialysis. The catheters can be inserted in the femoral, subclavian or jugular vein as required.

The Kendall Dual Lumen Catheters are single use, sterile devices. The single radiopaque cannula catheters have two distinct lumina which provide simultaneous "arterial" outflow and "venous" return. The catheters have two extension tubes, sach with a color-coded in-line clamp (red for arterial outflow, blue for venous return) and luer lock adapter. The catheters are sold in 8.5, 10.0 and 11.0 Fr sizes.

This document only provides information about a 510(k) submission for a medical device (Kendall CURITY Dual Lumen Subclavian Catheters) and does not describe acceptance criteria or a study proving the device meets those criteria in the context of diagnostic performance (e.g., sensitivity, specificity for image analysis).

The provided text focuses on demonstrating substantial equivalence to a predicate device, which is a different type of regulatory submission than one requiring a clinical performance study with defined acceptance criteria for diagnostic output.

Here's a breakdown based on the information provided, highlighting why most of your requested points cannot be answered:

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

• Not applicable / Not provided. The document describes non-clinical performance (flow rate, hemolysis, recirculation, biocompatibility) and notes these were "similar" to the predicate device. It does not define specific quantitative acceptance criteria for these tests nor does it provide a table of performance against such criteria. Crucially, there are no diagnostic performance metrics (e.g., sensitivity, specificity, AUC) because this is not a diagnostic device.

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. No diagnostic test set was used. The non-clinical comparative testing would have involved lab-based samples for flow rate, hemolysis, and recirculation, but specific sample sizes, provenance, or study types (retrospective/prospective) are not detailed.

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. No ground truth was established for a diagnostic test set.

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

• Not applicable. No diagnostic test set was used.

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

• No. This device is a vascular access catheter, not an AI-powered diagnostic tool. Therefore, an MRMC study is not relevant and was not performed.

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

• Not applicable. This is a medical device (catheter), not an algorithm or AI.

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

• Not applicable. No ground truth for diagnostic purposes was established. The "truth" for the non-clinical tests would be the measured physical and functional properties of the catheters.

8. The sample size for the training set

• Not applicable. This is a medical device, not an AI model, so there is no training set in the context you're asking about.

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

• Not applicable. As above, no training set for an AI model.

Summary of Relevant Information from the Provided Text:

• Device Type: Hemodialysis System and Accessories, specifically Kendall CURITY Dual Lumen Subclavian Catheters.
• Intended Use: Short-term vascular access for hemodialysis.
• Regulatory Pathway: 510(k) submission, demonstrating substantial equivalence to a predicate device (Neostar Dual Lumen Catheters, K941851).
• Performance Data Provided:
  • Non-Clinical Tests: Comparative testing with the predicate device.
    • Criteria included: flow rate, hemolysis, recirculation studies.
    • Results: Found "similar physical and functional properties" to the predicate.
    • Biocompatibility testing was also performed and demonstrated no bioactive components.
  • Clinical Tests: "No clinical testing was performed."
• Conclusion: The device is similar in design, physical, and functional attributes to the predicate device.

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The Kendall Curity Ureteral Catheter is intended to be used to inject contrast medium for fluoroscopic ureteral visualization, to direct a guidewire into the ureter and for urinary drainage.

The proposed Kendall Curity Ureteral Catheter is a sterile, single use device which facilitates preliminary procedural components of ureteroscopy. The catheter is a single lumen extrusion fabricated from nylon resin. Graduated placement markers on the catheter shaft will allow the urologist to determine the extent of catheter advancement. The proximal end of the catheter has a friction fitted luer lock adapter. The distal catheter tip will be manufactured in a cone tip, open tip or whistle tip configuration. The catheter will be sold in a standard 70 cm working length in French sizes ranging from 4.0 Fr. to 7.0 Fr.

The provided text describes a 510(k) summary for a medical device, the Kendall Curity® Ureteral Catheter. This type of submission is for demonstrating substantial equivalence to a legally marketed predicate device, not typically for reporting on a study with acceptance criteria in the manner requested (e.g., diagnostic accuracy, sensitivity, specificity).

Therefore, many of the requested sections about acceptance criteria and study design are not applicable (N/A) because the provided document details a non-clinical testing approach focused on material biocompatibility and functional/mechanical equivalence to predicate devices, rather than a clinical study evaluating diagnostic or therapeutic efficacy against specific performance metrics for human perception.

Here's an attempt to answer the questions based on the available information, noting when information is N/A:

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

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

• Sample Size: Not specified for nonclinical testing. This typically refers to the number of catheters or material samples tested.
• Data Provenance: Not applicable. The testing is described as nonclinical/laboratory-based.

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)

• N/A. Ground truth in this context refers to the expected physical/chemical properties or performance of the device itself, not a diagnostic interpretation by experts. Standard laboratory methods and predicate device performance serve as the "ground truth" for these tests.

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

• N/A. This refers to clinical expert adjudication of ambiguous cases, which is not relevant for nonclinical device performance testing.

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

• N/A. This document describes a medical device (catheter), not an AI algorithm or a diagnostic tool that involves human readers for interpretation.

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

• N/A. This describes a physical medical device, not an algorithm.

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

• For biocompatibility: Adherence to ISO-10993 standards and absence of toxic diffusible substances.
• For functional/mechanical testing: Performance comparable to or equivalent to legally marketed predicate devices, established using standard material and mechanical testing methodologies.

8. The sample size for the training set

• N/A. This is a physical device, not an algorithm that requires a "training set."

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

• N/A. Not applicable, as there is no "training set" for this type of device.

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The Kendall Curity Thoracentesis Tray is intended to be used to drain fluid from the pleural cavity.

The proposed Kendall Curity Thoracentesis Tray is a sterile, single use procedural tray containing the components required to perform a thoracentesis. This submission covers proposed changes to the aspirating needle and thoracentesis catheter. An ergonomically designed polycarbonate hub will be insert molded onto the needle cannula and a polyurethane hub insert molded onto the catheter shaft. In addition, the catheter shaft material will change from Teflon® to polyurethane. There will be no changes to the current dimensions or performance specifications.

In addition, a new product code will incorporate Kendall's thoracentesis catheter-over-needle with an automatic valve that acts to occlude the proximal end of the catheter lumen. The valve is an integral part of the catheter. Once the needle is withdrawn from the valve, a spring mechanism occludes the catheter lumen.

This document describes a 510(k) submission for the Kendall Curity Thoracentesis Tray. It is a pre-amendment device, therefore much of the information you have requested about acceptance criteria and study design is not applicable or not provided. Here's a breakdown of the available information:

1. Table of Acceptance Criteria and Reported Device Performance

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

• Sample Size: Not specified for any of the functional or biocompatibility tests.
• Data Provenance: Not specified, but implied to be from internal Kendall Healthcare Products Company testing. The document is silent on country of origin or whether it's retrospective/prospective.

3. Number of Experts Used to Establish Ground Truth and Qualifications

• Not Applicable. This device is a medical instrument (thoracentesis tray), not an AI/diagnostic tool. "Ground truth" in the context of expert consensus, pathology, or outcomes data is not relevant for this type of submission. The performance is assessed through material and functional testing against specified engineering parameters.

4. Adjudication Method

• Not Applicable. See point 3.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

• No. This is not a diagnostic device or imaging modality that would involve human readers.

6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study

• Not Applicable. This is a physical medical device, not an algorithm or AI.

7. Type of Ground Truth Used

• Engineering Specifications/Standards: The "ground truth" for this device's performance is adherence to established engineering specifications, safety standards (like ISO-10993 for biocompatibility), and functional requirements (e.g., no leakage, sufficient pull-off force for the hub).

8. Sample Size for the Training Set

• Not Applicable. This is not an AI/machine learning device that requires a training set.

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

• Not Applicable. See point 8.

Summary of Device and Evidence:

The Kendall Curity Thoracentesis Tray is seeking 510(k) clearance based on substantial equivalence to existing predicate devices. The submission focuses on changes to the aspirating needle and thoracentesis catheter (material change and hub design) and the incorporation of a new automatic valve. The evidence provided is primarily from nonclinical testing:

• Biocompatibility testing to ISO-10993 standards confirmed no toxic diffusible substances.
• Functional/Mechanical testing was performed for hub pull-off force, potential for leakage, and siphoning capability of the automatic valve.

The document explicitly states that there will be "no changes to the current dimensions or performance specifications" for the existing components, implying that the new or modified components also meet the established performance levels of the predicate devices. The 510(k) pathway relies on demonstrating that the new device is as safe and effective as a legally marketed predicate device, often by showing similar technological characteristics and performance.

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