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The MINISCAV™ waste gas evacuation apparatus is intended to remove patients' exhaled waste gases during procedures where analgesia is administered to a patient via inspiration of mixtures oxide and oxygen from a nitrous oxide / oxygen delivery device. Not intended for use with flammable anesthetic gases.

This device is intended for professional use only in healthcare facilities, clinics, and physician and dentist offices.

The MINISCAV™ is a small, portable, vacuum pump that generates a constant vacuum that can be connected via a standard flexible vacuum hose to nitrous oxide / oxygen delivery equipment. The vacuum hose is connected to the "vacuum / suction" nipple on exemplary equipment.

The MINISCAVIM is a diaphragm hermetically sealed pump with a fixed vacuum flow rate. The inlet line is connected to a flowmeter exhaust port of the nitrous oxide / oxygen delivery equipment which has an exhaust port for scavenging gases.

Here's an analysis of the acceptance criteria and study information for the MINISCAV™ device, based on the provided document:

The document describes a 510(k) premarket notification for the MINISCAV™ waste gas evacuation apparatus. This type of submission focuses on demonstrating substantial equivalence to a legally marketed predicate device rather than providing extensive clinical efficacy studies in the same way a PMA would. Therefore, the "study" mentioned here refers primarily to the non-clinical testing performed to show the device meets its performance specifications and is as safe and effective as the predicate.

1. Table of Acceptance Criteria and Reported Device Performance

The document doesn't explicitly state "acceptance criteria" in a tabulated format for each performance aspect. Instead, it describes various tests and what they demonstrated. I've extracted the implied criteria and the reported performance from the "Non-Clinical Testing Summary" and "Technology, Construction, Performance" sections.

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

• Sample Size: The document does not specify a "sample size" in terms of a number of devices tested for each non-clinical test. It mentions "continuous running," "real-time testing of the complete unit," and "testing demonstrates" but doesn't give precise quantities like "n=X devices were tested." This is common for this type of non-clinical device testing, where the focus is on design verification and validation rather than statistical sampling of many units.
• Data Provenance: Not explicitly stated, but given it's a device manufactured by Sedation Systems LLC in Florida, the non-clinical testing was likely conducted in the USA or by a contracted lab. The document does not indicate if the data is retrospective or prospective; for non-clinical lab testing, this distinction is less relevant than for clinical studies. It's direct testing data.

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

This information is not applicable and not provided in the document.

The "test set" here refers to the physical MINISCAV™ devices (or prototypes/components) undergoing non-clinical validation. There isn't a "ground truth" established by experts in the context of an AI/human-in-the-loop study. The "ground truth" for the performance specifications is determined by established engineering standards (e.g., AAMI/ANSI/ES60601-1, IEC 60601-1-2) and the manufacturer's own design specifications, which are then validated through objective measurements (e.g., pressure gauges, flow meters, electrical testers, timers).

4. Adjudication Method for the Test Set

This information is not applicable and not provided.

Adjudication methods (like 2+1, 3+1 consensus) are typically used in clinical studies or expert review processes, especially for establishing ground truth for diagnostic AI, which is not the nature of this submission. The non-clinical tests involve objective measurements against predefined specifications.

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

No, an MRMC comparative effectiveness study was not done.

This type of study is relevant for diagnostic medical devices, especially those using AI, to compare the performance of human readers with and without AI assistance on a set of clinical cases. The MINISCAV™ is a waste gas evacuation apparatus, a piece of mechanical/electrical equipment, not a diagnostic device.

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

Not applicable.

The MINISCAV™ is a physical medical device (vacuum pump), not an algorithm or AI system. Therefore, there is no "algorithm only" performance to evaluate. Its operation is standalone in the sense that it mechanically performs its function without a human intervening in its internal mechanism once activated, but it is operated by a human in a clinical setting.

7. Type of Ground Truth Used

As discussed in point 3, the "ground truth" here is based on engineering and performance specifications derived from international standards (AAMI/ANSI/ES60601-1, IEC 60601-1-2) and the functional requirements for waste gas scavenging. This is objectively measurable data from physical testing, not expert consensus on clinical cases, pathology, or outcomes data.

8. Sample Size for the Training Set

Not applicable.

This device does not involve a "training set" in the context of machine learning or AI. The MINISCAV™ is a designed and engineered product, not a system that is "trained" on data.

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

Not applicable.

As there is no training set for an AI/ML algorithm, there is no ground truth established for it.

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The PREMIO 10 moxa is a non-invasive infrared lamp intended to provide topical heating. The PREMIO 10 moxa is indicated for temporary relief of minor muscle and joint pain, arthritis and muscle spasm, relieving stiffness, promoting relaxation of muscle tissue, and to temporarily increase local blood circulation where heat is indicated.

The PREMIO 10 moxa is a non-invasive infrared lamp intended to provide topical heating.

I am sorry, but the provided text does not contain the information required to answer your request. The document is an FDA 510(k) clearance letter for a medical device called "PREMIO 10 moxa," which is an infrared lamp. This type of document typically confirms that a device has been cleared for market based on substantial equivalence to a predicate device, but it does not include detailed information about the acceptance criteria, study design, or performance metrics that would be found in a clinical study report or a detailed premarket submission.

Specifically, the document does not provide any information on:

1. Acceptance criteria or reported device performance
2. Sample size, data provenance, number of experts, adjudication method, MRMC studies, standalone performance, or type of ground truth used for a test set.
3. Sample size or ground truth establishment for a training set.

The letter focuses on regulatory compliance and substantial equivalence, not on the results of a performance study with detailed acceptance criteria and study methodologies.

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The Sedat Flamingo is indicated for use during cardiovascular procedures to create, maintain and monitor pressure in the balloon catheter.

The Sedat Flamingo inflation device is a single-use, sterile, and ergonomically designed inflation device used in cardiovascular procedures to pressurize (inflate) and depressurize (deflate) balloon catheters. The device itself consists of two components - the inflation device and large volume syringe (30 cc). The manually operation of the FLAMINGO is achieved by the manipulation of a grip handle to drive a piston housed within the body of the device. Careful and controlled inflation is achieved by rotating the handle clockwise. During inflation a unique cam locking mechanism maintains pressure even if the user lets go of the device. Instantaneous deflation, regardless of balloon size, is made possible by the release of the button locks located on device.

The provided text is a 510(k) summary for the Sedat Flamingo Angiographic injector/syringe. The document explicitly states: "H. Summary of Clinical Tests (Not Applicable)." and lists "G. Summary of Non-Clinical Tests Mechanical testing was presented."

Therefore, a study demonstrating the device meets acceptance criteria via clinical tests, multi-reader multi-case studies, independent standalone algorithm performance, or using experts to establish ground truth is not applicable based on this document. The device's substantial equivalence was established through non-clinical mechanical testing and comparison to a predicate device.

Here's an breakdown of the requested information based on the provided text:

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

The document does not specify quantified acceptance criteria or reported device performance in terms of clinical outcomes or diagnostic accuracy. Instead, it relies on substantial equivalence to a predicate device and mechanical testing.

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 clinical test set or data provenance from clinical data is mentioned for this 510(k) submission.

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

Not applicable. No clinical ground truth or experts were used for this 510(k) submission.

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

Not applicable. No clinical test set or adjudication method is mentioned for this 510(k) submission.

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 mechanical inflation device, not an AI-assisted diagnostic tool.

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

Not applicable. This device is a mechanical inflation device, not an algorithm.

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

Not applicable in a clinical sense. The "ground truth" for this device's performance was established through mechanical testing and comparison to a predicate device's design, materials, and function.

8. The sample size for the training set

Not applicable. No training set is mentioned for this 510(k) submission.

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

Not applicable. No training set is mentioned for this 510(k) submission.

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The SEDAT MYSHELL LITE is indicated for assisting, manipulating, and maintaining a seal around diagnostic/interventional devices with an outside diameter <9F (<.098") used in interventional angioplasty procedures.

The Sedat Myshell Lite consists of a variety of Y-connectors with a double silicone haemostatic valve within a reduce volume, well fitted for handling interventional procedures. The valve opening/closure mechanism could be activated by the thumb like a control button transforming the resilient valve in a variable geometry permitting to enlarge the valve opening of the silicone membrane. The interventionists make better adjustments for the seal introduction point and the size of the vascular instruments able to be introduced or removed to suit the individual pathology and anatomical conditions of the patient.

Here's an analysis of the provided text regarding the Sedat Myshell Lite device's acceptance criteria and the study used to demonstrate it:

Disclaimer: This device is a medical device (Y-connector with a double silicone haemostatic valve) and NOT an AI/algorithm-powered device. Therefore, many of the requested categories related to AI performance, ground truth, expert review, and training sets are not applicable or cannot be extracted from the provided 510(k) summary. I will highlight what information is present and what is missing based on the nature of this particular device approval.

Acceptance Criteria and Device Performance

Note: The primary "acceptance criteria" for a 510(k) device like this is demonstrating substantial equivalence to a previously cleared predicate device. The performance is assessed against the predicate's known safety and effectiveness through comparisons of intended use, design, materials, and function, often supported by bench testing. Specific quantitative clinical performance metrics (like sensitivity, specificity, accuracy) are typically not required or reported for Class II devices gaining clearance via substantial equivalence if their function is well-understood and similar to existing devices.

Study Details (Applicability to AI/Algorithm-Powered Devices)

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

   • N/A (Not an AI Device): There is no "test set" in the context of an algorithm or AI model for this physical medical device. The evaluation relied on a comparison to a predicate device and bench testing.
   • Data Provenance: Bench testing would likely be performed in a laboratory setting by the manufacturer (Sedat, France).

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

   • N/A (Not an AI Device): No expert-established ground truth for an algorithm's test set. The "ground truth" for this device's performance would be its functional performance against engineering specifications and its ability to perform its intended mechanical function (maintaining a seal) during bench testing.

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

   • N/A (Not an AI Device): Not applicable as there is no human adjudication of an AI output for this device.

4. 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 (Not an AI Device): This is a physical Y-connector; it does not involve human readers or AI assistance.

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

   • N/A (Not an AI Device): Not applicable.

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

   • Technical Specifications/Bench Test Results (for mechanical device): The "ground truth" for this device would be its ability to mechanically meet its design specifications and functional requirements (e.g., integrity of the seal, valve opening/closure mechanism, material compatibility, pressure resistance, etc.) demonstrated through bench testing. It's not a diagnostic device requiring a clinical ground truth like pathology or expert consensus on patient conditions.

7. The sample size for the training set:

   • N/A (Not an AI Device): There is no training set for a physical medical device.

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

   • N/A (Not an AI Device): Not applicable.

Summary for this specific device:

The Sedat Myshell Lite is a physical medical device, not an AI or algorithm-powered one. Its regulatory clearance (510(k)) focuses on demonstrating substantial equivalence to an already legally marketed predicate device (Myshell device cleared under K040498).

The study that "proves the device meets the acceptance criteria" is outlined as "Bench performance testing." This testing would have confirmed that the device functions as intended and safely, similar to its predicate. The summary explicitly states: "Summary of Clinical Tests (Not Applicable)." This means that no human clinical trials were required or performed to demonstrate the device's safety and effectiveness for this 510(k) clearance, as its function is well-established through the predicate device and bench testing.

Therefore, questions pertaining to AI-specific evaluation metrics, training/test sets, expert adjudication, or MRMC studies are not relevant to this submission.

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Nautiflux is recommended for use in angiographic and coronarographic procedures to inject contrast media and to allow the physician to monitor the blood pressure.

Nautiflux is a universal and compact automatic set consisting of an injection handle and a fluid delivery system for use in angiographic and coronarographic procedures.

The provided text describes the 510(k) summary for the Nautiflux device. However, it explicitly states "Summary of Clinical Tests (Not Applicable)" and does not include any information about detailed performance testing with acceptance criteria, sample sizes, or specific performance metrics.

Therefore, I cannot provide the requested information from the given text. The document indicates that the device's substantial equivalence was based on non-clinical performance testing and equivalence in indications for use, design, material, and function to previously cleared devices, rather than a clinical study with detailed acceptance criteria and reported performance.

Based on the provided text, the answer is that the document does not contain the information requested regarding acceptance criteria and the study that proves the device meets them.

The sections that would typically contain this information (like performance data, clinical trial results, or detailed non-clinical testing outcomes with pass/fail criteria) are either explicitly stated as "Not Applicable" for clinical tests or are summarized with a general statement that "Performance testing was presented" without specifying the criteria or results.

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The acupuncture needle is a device intended to pierce the skin in the practice of acupuncture by qualified practitioners as determined by the states. The device consists of a solid, titanium needle.

The device consists of a solid, titanium needle.

This document is an FDA 510(k) clearance letter for acupuncture needles. It does not contain information about acceptance criteria or a study proving device performance in the context of an AI/ML medical device. The letter confirms that the device is substantially equivalent to legally marketed predicate devices and can therefore be marketed.

Therefore, I cannot provide the requested information based on the given input. The categories in your request are relevant to the evaluation of AI/ML-driven medical devices, which this document is not about.

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DOLPHIN Inflation Device is intended for use during cardiovascular procedures to create, maintain and monitor pressure in the balloon catheter.

DOLPHIN is a single-use, sterile, and ergonomically designed inflation device used in cardiovascular procedures to pressurize (inflate) and depressurize (deflate) balloon catheters. The device itself consists of two components - the inflation device and large volume syringe (30 cc).

The manually operation of the DOLPHIN is achieved by the manipulation of a large handle to drive a piston housed within the body of the device. Careful and controlled inflation is achieved by rotating the handle clockwise. During inflation a unique cam locking mechanism maintains pressure even if the user lets go of the device.

Instantaneous deflation, regardless of balloon size, is made possible by the release of the dual locks located on device as well as a large, 30 cc syringe that is sold with each Dolphin Inflation Device.

All the while during inflation or deflation pressure is displayed and can be monitored on a large analog gauge mounted on top of the device.

The provided document is a 510(k) summary for the "DOLPHIN Inflation Device". It is a premarket notification for a medical device and describes its indications for use, technological characteristics, and how its substantial equivalence to predicate devices was demonstrated. However, this document does not contain acceptance criteria or detailed study data to prove device performance against such criteria in the way typically expected for an AI/ML device or a device requiring specific performance metrics like sensitivity/specificity for a diagnostic tool.

Instead, it focuses on demonstrating substantial equivalence to a legally marketed predicate device (Indeflator 20/30) based on intended use, conditions of use, design, materials, packaging, sterilization, and location. The "Performance Data" section briefly states that "The safety and efficacy of DOLPHIN has been demonstrated through a variety of preclinical tests and analyses, as well as non-clinical comparisons to the Indeflator 20/30." It does not provide specific numerical acceptance criteria or detailed results of these tests.

Therefore, I cannot populate the requested table and answer the study-specific questions as the detailed information on acceptance criteria, reported performance, sample sizes for test/training sets, expert qualifications, adjudication methods, MRMC studies, or standalone performance for an AI/ML device are not present in this 510(k) summary.

The questions you've asked are typical for the evaluation of AI/ML-based diagnostic or prognostic devices, which often require extensive clinical performance studies with specific statistical endpoints. The "DOLPHIN Inflation Device" is a manual, mechanical device (an angiographic injector and syringe) used to inflate and deflate balloon catheters during cardiovascular procedures. Its evaluation for 510(k) clearance primarily focuses on demonstrating its functional equivalence and safety compared to existing devices, rather than establishing diagnostic accuracy metrics.

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MYSHELL is indicated for maintaining a seal around diagnostic/interventional devices with an outside diameter <9F (<.098") during interventional procedures.

The 3-way stopcock, Alligatork and guidewire introducer are accessories used in conjunction with MYSHELL to facilitate interventional procedures.

MYSHELL and its accessories are indicated for assisting, manipulating and maintaining a seal around diagnostic/interventional devices with an outside diameter <9F (.098") used in interventional procedures.

MYSHELL is an ergonomically designed y-connector/hemostatic valve that accepts materials up to 9F in size (<.098").

The watertight double hemostatic silicone valve is manipulated by a valve opening mechanism on the external body of MYSHELL. The opening mechanism allows for precise control of the internal valve: press gradually on the mechanism for a controlled opening, push the mechanism entirely in for a complete and locked opening, or completely close the valve by depressing on the mechanism in its locked position.

The provided text states that "The safety and efficacy of MYSHELL and its accessories... have been demonstrated," but it does not provide any specific acceptance criteria or details of a study verifying those criteria.

Therefore, I cannot populate the table or answer the specific questions about the study from the provided document. The submission is a 510(k) summary for a medical device (Y-Connector/Hemostatic Valve), which typically focuses on demonstrating substantial equivalence to a predicate device rather than providing detailed performance study results with acceptance criteria.

Information not found in the provided document:

• A table of acceptance criteria and reported device performance.
• Sample size used for the test set.
• Data provenance for the test set.
• Number of experts used to establish ground truth for the test set.
• Qualifications of experts.
• Adjudication method for the test set.
• Whether a multi-reader multi-case (MRMC) comparative effectiveness study was done.
• Effect size (if MRMC was done).
• Whether a standalone performance study was done.
• Type of ground truth used (e.g., expert consensus, pathology, outcomes data).
• Sample size for the training set.
• How ground truth for the training set was established.

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To pierce the skin in the practice of acupuncture by qualified practitioners as determined by the states.

ASP Type needles consists of a short "tack-like" solid stainless steel needle contained in a plastic injector to introduce the needle in the epidermis, to facilitate the delivery of acupuncture treatment. ASP needles are sterile devices for single use only. The "ASP Gold needle" is an "ASP needle" which has been gold plated (an intermediate laver of copper is added between stainless steel and gold). The ASP needles are offered in a single size.

The provided text is a 510(k) premarket notification for the SEDATELEC ASP Acupuncture Needles. It does not describe an acceptance criteria study or report device performance against specific criteria in the way typically expected for an AI/CADe device. Instead, it demonstrates substantial equivalence to a predicate device, which is a common regulatory pathway for medical devices.

Therefore, many of your requested points are not directly applicable or cannot be extracted from this document, as the focus is on demonstrating similarity to an already approved device rather than proving novel performance against predefined criteria through a clinical study.

Here's an analysis based on the provided document:

1. Table of acceptance criteria and the reported device performance

This document does not present acceptance criteria or reported device performance for the ASP Acupuncture Needles in terms of specific metrics like sensitivity, specificity, or accuracy. The demonstration of safety and effectiveness relies on substantial equivalence to a legally marketed predicate device (Seirin - S & Seirin - Pionex acupuncture needles).

Substantial Equivalence Comparison (Excerpted from the document):

The core "acceptance criteria" here is that the device is "substantially equivalent" to the predicate, meaning it is as safe and effective.

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

This information is not applicable to a 510(k) submission based on substantial equivalence for a physical device like an acupuncture needle. There isn't a "test set" of data in the context of an AI/CADe algorithm. The evaluation is based on manufacturing processes, materials, intended use, and general device characteristics compared to a known safe and effective predicate.

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

Not applicable. This type of expert review for ground truth is associated with AI/CADe performance studies.

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

Not applicable. This is not an AI/CADe device.

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

Not applicable. This is not an AI/CADe device.

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

For this type of 510(k) submission, the "ground truth" for safety and effectiveness is established by the legally marketed predicate device. The fundamental premise is that if the new device is sufficiently similar in design, materials, and intended use to an existing device, it can be presumed to be equally safe and effective without requiring a full de novo approval process.

8. The sample size for the training set

Not applicable. This is not an AI/CADe device.

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

Not applicable. This is not an AI/CADe device.

Summary based on the document:

The SEDATELEC ASP Acupuncture Needles were approved based on substantial equivalence to existing legally marketed acupuncture needles (Seirin - S & Seirin - Pionex). The FDA determined that the device is as safe and effective as the predicate device because it shares similar technological characteristics (materials, intended use, sterilization method (though different, it is validated), and basic design). There was no need for a clinical "acceptance criteria" study in the context of AI/CADe performance, as the device is a simple, physical medical instrument.

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To pierce the skin in the practice of acupuncture by qualified practitioners as determined by the states.

The DN needle consists of a solid stainless steel needle with a copper wire wrapped around the stainless steel needle shaft. The copper wire acts as a handle which facilitates the delivery of acupuncture treatment by making the needles easier to manipulate and place. DN needles are sterile devices for single use only. The needles are made from 302 grade stainless steel meeting ASTM F899-84 standards. No lubricant is used on the needles.

The provided document describes a 510(k) premarket notification for the SEDATELEC DN Acupuncture Needles (K983800). This submission aims to demonstrate substantial equivalence to a predicate device, the CARBO MicroClean acupuncture needle (K961339), rather than presenting a performance study against specific acceptance criteria. Therefore, the information requested in the prompt regarding acceptance criteria, device performance, and a study proving said performance is largely not applicable in the context of this 510(k) submission.

Here's an breakdown based on the available information:

1. Table of Acceptance Criteria and Reported Device Performance:

Not applicable in this 510(k) submission. The submission's goal is to establish substantial equivalence to a predicate device, implying that if the DN Acupuncture Needles are sufficiently similar to the legally marketed CARBO MicroClean acupuncture needle, they are presumed to be safe and effective. There are no specific performance criteria or a study demonstrating achievement of those criteria detailed in this document.

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

Not applicable. This is not a performance study involving a test set. The submission relies on a comparison table of device features to demonstrate equivalence.

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

Not applicable. No ground truth establishment by experts for a test set is described.

4. Adjudication Method for the Test Set:

Not applicable. No test set requiring adjudication is described.

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

Not applicable. This is not a comparative effectiveness study involving human readers or AI assistance.

6. Standalone (i.e., algorithm only without human-in-the-loop performance) Study:

Not applicable. This device is an acupuncture needle, not an algorithm or AI system.

7. The type of ground truth used:

Not applicable. No ground truth in the context of a performance study is mentioned. The "ground truth" in a 510(k) submission is effectively the established safety and effectiveness of the predicate device.

8. The Sample Size for the Training Set:

Not applicable. There is no training set mentioned as this is not a study involving machine learning or similar methodologies.

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

Not applicable. As there is no training set, there is no corresponding ground truth establishment process.

Summary of Relevant Information from the Document (if interpreted for "equivalence" as the "criterion"):

The submission argues for substantial equivalence to the CARBO MicroClean acupuncture needle (K961339) based on the following:

• Identical Intended Use: Both devices are "Intended to pierce the skin in the practice of acupuncture by qualified practitioners of acupuncture as determined by the states."
• Similar Design Features:
  • Device Type: Both are considered "DN Type" (DN Equivalent for the predicate).
  • Needle Tip Shape: Both are "Taper."
  • Needle Shape: Both are "Stylet."
  • Biocompatibility: Both use "ASTM 302 surgical stainless steel" (Standard specifications for stainless steel billet, bar, and wire for surgical instruments F899-84).
• Similar Materials: The needle material is surgical stainless steel for both. The handle material differs (copper for the SEDATELEC device vs. silver-plated metal for the CARBO device), but this difference is not presented as affecting equivalence for the intended use.
• Labeling: Both have comparable labeling requirements for identification and statements (e.g., sterile, single use, lot number, manufacturer, gauge, length, quantity).
• Sterilization: Both are sterilized devices. The SEDATELEC needles are sterilized by Gamma radiation at a validated dose level of 25kGy to achieve a sterility assurance level of 10^-6, in accordance with ISO 11737-1, EN552, and ISO 11137 standards. The predicate's sterilization method is listed as "Ethylene oxide gas sterilization" in its labeling, which is a different method but both are acceptable for sterilization.
• Dimensions: While there are differences in the range of invasive lengths (SEDATELEC: 18-47mm; CARBO: 13-75mm) and diameters (SEDATELEC: 0.25-0.40mm; CARBO: 0.20-0.30mm), these variations are considered within acceptable limits for acupuncture needles and do not preclude substantial equivalence.

Conclusion stated in the document: "Based on the design, function, intended use and materials of the DN Needles, substantial equivalence is evident. The referenced CARBO brand needles are functionally identical. The anticipated safety and effectiveness of both devices is or may be expected to be the same."

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