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For injection of solutions (such as lidocaine with or without 1:100,000 eninephine) into the cervix. This application includes outlines that require local anaesthetics such as loop excision (LEEP), elecro-fulguration, CO2 laser excision and vaporization, and when required, endocervical curettage and cervical biopsies.

For use with 2.2ml glass vials, such as those containing local anaesthetic agents.

CerviNeedle™ Disposable Cartridge Syringe

The provided text is a 510(k) summary for the Rocket Medical plc CerviNeedle™ Disposable Cartridge Syringe. It focuses on demonstrating substantial equivalence to predicate devices rather than providing detailed performance study data against specific acceptance criteria.

Therefore, many of the requested details about acceptance criteria, performance studies, sample sizes, and expert qualifications are not present in this document.

Here's an analysis based on the provided text:

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

No explicit acceptance criteria or detailed performance data against them are provided in the 510(k) summary. The summary states:

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

Not provided. The 510(k) summary does not describe a performance study with a test set.

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 provided. The 510(k) summary does not describe a performance study that involved experts establishing ground truth for a test set.

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

Not applicable. No performance study requiring adjudication is described.

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 manual cartridge syringe, not an AI-powered diagnostic device. Therefore, an MRMC study related to AI assistance for human readers is irrelevant.

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

Not applicable. This is a manual medical device, not an algorithm.

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

Not applicable in the context of a performance study for this device. The "ground truth" for the 510(k) submission is the demonstration of substantial equivalence to existing, legally marketed predicate devices.

8. The sample size for the training set

Not applicable. This device does not use machine learning or require a training set.

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

Not applicable. This device does not use machine learning or require a training set.

Summary of Safety and Effectiveness Information Presented (from the document):

The 510(k) submission for the CerviNeedle™ Disposable Cartridge Syringe relies on demonstrating substantial equivalence to existing predicate devices. The key elements are:

• Substantial Equivalence: The device is deemed substantially equivalent to the CooperSurgical Inc Potocky Needle™ Disposable Injection Needle (#K910252), Wallach Surgical Devices Inc, Endocervical Block Needle (#K021224), and A & A Medical Inc, Endocervical Block Needle (#K973671).
• Basis for Safety and Effectiveness: The conclusion of safety and effectiveness is drawn from "indications for use, technical characteristics and comparison to currently commercial marketed devices." This implies that because the device is technically similar and intended for the same uses as already approved devices, it is considered safe and effective.
• Ongoing Monitoring: Rocket Medical plc states they "continue to search all appropriate sources for information relating to safety and effectiveness and maintains an in-house reporting system to identify adverse safety and effectiveness information." This indicates a post-market surveillance commitment rather than detailed pre-market study data in the 510(k).

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This needle is designed for injection of solutions (such as 2% lidocaine with or without 1:100,000 epinephrine) into the cervix. The application includes local anesthetics such as electro-excision, electro-fulguration, CO2 laser excision, and vaporization, and when required, endocervical curettage and cervical biopsies.

The Wallach Endocervical Block Needle is a Sterile, Disposable, Single Use device. The needle is 27ga., 3 1/2" long. It is used for uterine anesthesia prior to Ob/Gyn procedures. It consists of a metal tube that is sharpened at one end and at the other end joined to a female connector (Luer lock) designed to mate with a male connector (Nozzle) of a piston syringe or an intra-vascular administration set. Over 3 1/4" of its proximal end a 21 gauge metal tube is added to strengthen the shaft.

This document, a 510(k) Premarket Notification Submittal for the "Wallach Endocervical Block Needle," primarily focuses on demonstrating substantial equivalence to predicate devices rather than providing a detailed study that defines and meets specific acceptance criteria based on quantitative performance metrics.

However, based on the provided text, we can infer the implicit acceptance criteria are for the device to be functionally equivalent and safe as compared to existing, legally marketed predicate devices. The study conducted is a comparative analysis, rather than a performance study with defined numerical acceptance thresholds.

Here's an attempt to structure the information based on your request, highlighting what is provided and what is absent:

1. Table of Acceptance Criteria and Reported Device Performance

• Coopersurgical 'Potocky Needle': Described as "Equivalent" in design.
• Avid Medical 'Avid-Nit Cervical Regional Anesthesia Needle': Described as "Equivalent" in design.
• Terumo Medical 'Terumo 30 Ga. Hypodermic Needle': Described as "Similar" in design.
• Nipro Medical Corp 'Nipro Hypodermic Needle': Described as "Similar" in design.
  (The full description of the Wallach needle design is provided, and the predicates are compared against it). |
  | Material Equivalence: Stainless Steel Tubing, Plastic Hub. | Equivalent. All predicate devices are noted as "Equivalent" in material. |
  | Safety: No new hazards presented compared to predicate devices. | Met. "Hazard analysis evaluations performed on the Wallach Endocervical Block Needle indicated that there were no new hazards presented with the use of the Wallach Endocervical Block Needle as compared to the predicated devices." |
  | Performance: Device performance is substantially equivalent to predicate devices. | Met. "Testing that was performed on the Wallach Endocervical Block Needle indicates that the devices are substantially equivalent in the performance and design of operation." (Specific performance metrics or test results are not detailed) |

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

• Sample Size for Test Set: This document does not describe a "test set" in the context of a clinical study or a statistically defined, independent dataset to evaluate a machine learning algorithm. The "testing" mentioned refers to hazard analysis and performance evaluations that deemed it substantially equivalent to existing devices, but no sample sizes for such tests are provided.
• Data Provenance: Not applicable, as there's no defined "test set" of patient data or images. The evaluation is based on a comparison of design, materials, intended use, and a generic statement about performance testing.

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

• Not applicable. This is not a study involving expert-established ground truth for a test set in the context of an AI/ML device. The "ground truth" for substantial equivalence is derived from regulatory classifications, established safety profiles, and intended uses of existing predicate devices.

4. Adjudication Method for the Test Set

• Not applicable, as there is no independent "test set" requiring adjudication by experts.

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 submission is for a physical medical device (needle), not an AI/ML diagnostic or assistive tool.

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

• Not applicable. This is not an AI/ML algorithm.

7. The Type of Ground Truth Used

• The "ground truth" for this 510(k) submission is the established regulatory status, safety, design characteristics, and intended uses of legally marketed predicate devices. The Wallach Endocervical Block Needle's characteristics are compared against these established predicates to demonstrate substantial equivalence.

8. The Sample Size for the Training Set

• Not applicable. This is not an AI/ML device, and thus there is no "training set" in that context.

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

• Not applicable. There is no training set mentioned or implied.

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

The "study" presented here is a substantive equivalence comparison to legally marketed predicate devices as per 510(k) requirements. The manufacturer, Wallach Surgical Devices, Inc., claims that the Endocervical Block Needle is "substantially equivalent" to the following predicates:

• Coopersurgical 'Potocky Needle', K910252
• Avid Medical 'Avid-Nit Cervical Regional Anesthesia Needle', K000117
• Terumo Medical 'Terumo 30 Gauge Hypodermic Needle', K012646
• Nipro Medical Corp 'Nipro Hypodermic Needle', K013293

The comparison is based on:

1. Intended Use: Identical.
2. Technological Characteristics (Design, Materials, Operation): Found to be equivalent or similar.
3. Performance: General statement that "Testing... indicates that the devices are substantially equivalent in the performance and design of operation." No specific test reports or data are included in this summary.
4. Safety: "Hazard analysis evaluations... indicated that there were no new hazards presented with the use of the Wallach Endocervical Block Needle as compared to the predicated devices."

The FDA's letter (K021224 dated July 12, 2002) confirms this and states that the device is "substantially equivalent" to legally marketed predicate devices, allowing it to be marketed. This regulatory finding serves as the "proof" that the device meets the implied acceptance criteria for market entry under a 510(k) pathway.

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The RI. MOS. Cervical and Intracervical Anaesthesia Needles are used to apply cervical and intracervical anesthesia block.

The RI. MOS. s.r.l. cervical and intracervical needles operate with standard medical syringes are are sterile, single-use, disposable devices.

The provided text is a 510(k) summary for a medical device: "RI. MOS. s.r.l. cervical anesthesia needle and intracervical anesthesia needle." This document focuses on demonstrating substantial equivalence to a legally marketed predicate device rather than presenting a study that establishes performance against specific acceptance criteria.

Therefore, most of the requested information regarding acceptance criteria and performance studies is not available in the provided text. The 510(k) process for devices like needles primarily relies on showing that the new device has the same intended use, technological characteristics, and performance as an existing, legally marketed device.

Here's a breakdown of what can be extracted and what cannot:

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

• Not Available. The document does not define specific acceptance criteria (e.g., in terms of mechanical strength, sterility, or anesthesia efficacy) nor does it report the device's performance against such criteria. The submission is a claim of substantial equivalence.

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

• Not Available. No test study or data provenance is mentioned.

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 Available. There is no mention of a test set, experts, or ground truth establishment.

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

• Not Available. No adjudication method is mentioned as there is no test set or study.

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 medical needle, not an AI-assisted diagnostic device. No MRMC study was performed.

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

• Not Applicable. This is a medical needle, not an algorithm.

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

• Not Available. No ground truth is established or mentioned in the context of a performance study. For a 510(k) submission of this type, the "ground truth" for regulatory review is the substantial equivalence to a predicate device based on its intended use and technological characteristics.

8. The sample size for the training set

• Not Applicable. This is not a machine learning or AI device that would require a training set.

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

• Not Applicable. As above, no training set or associated ground truth establishment.

Summary of available information from the document:

• Device Name: RI. MOS. s.r.l. cervical anesthesia needle and intracervical anesthesia needle.
• Intended Use: Applying cervical and intracervical anesthesia block.
• Predicate Device: Potocky Needle® marketed by CooperSurgical.
• Basis for Acceptance: Substantial equivalence to the predicate device, meaning the new device has "the same or similar technological characteristics" and intended use as the predicate. The FDA's letter (FEB 1 1999) explicitly states that the device is "substantially equivalent" for the stated indications for use.
• Device Characteristics: Sterile, single-use, disposable devices that operate with standard medical syringes.

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1. Injection and administration of anesthetic regional blocks (e.g., paracervical, uterosacral, and pudendal) that may be used during labor, delivery, or both.
2. Injection and administration of anesthetic regional blocks (e.q., paracervical, uterosacral, and pudendal) that may be used during minor surgical procedures.

The Gynex Extended Reach Needles are made of 302 instrument grade stainless steel. There are two styles each being 27 gauge and 90mm in length. One is equipped with a standard I hore are the other basing thas a threaded hub. Both are disposable. As is typical for this type of anesthetic needle, the shaft of the needle is dual diameter. That is, the shaft of the needle from the hub to within 5mm of the tip a is larger diameter. This allows for easy estimation of insertion depth during anesthetic administration and prevents over-insertion of needle into deeper tissue levels or spaces.

The provided text is a 510(k) premarket notification for the GYNEX Extended Reach Needle. This document primarily focuses on establishing substantial equivalence to a predicate device and does not contain information on detailed acceptance criteria or a specific study proving the device meets them in the context of performance metrics like sensitivity, specificity, or reader improvement. This type of regulatory submission for a simple medical device like a needle typically demonstrates safety and effectiveness through comparison to existing devices and compliance with relevant standards, rather than complex performance studies.

Therefore, many of the requested sections about study details, sample sizes, expert qualifications, and ground truth cannot be answered from the provided text.

Here's a breakdown of what can be extracted and what cannot:

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

The document does not explicitly present a table of acceptance criteria with corresponding performance metrics like sensitivity, specificity, or accuracy. The "Comparison Table" in the document focuses on features for establishing substantial equivalence to the predicate device, not on quantitative performance against specific acceptance criteria.

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. The document does not describe a clinical performance study with a test set. The validation is based on comparison to an existing predicate device and adherence to manufacturing and materials standards.

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, as no test set requiring expert ground truth is described.

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

Not applicable, as no test set requiring adjudication is described.

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 disposable needle, 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 disposable needle, not an algorithm.

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

Not applicable, as no ground truth is established for performance evaluation of this device type in this submission. The "ground truth" for regulatory approval here is primarily based on the predicate device's established safety and efficacy, and compliance with manufacturing and materials standards.

8. The sample size for the training set

Not applicable, as there is no training set for an AI algorithm described.

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

Not applicable, as there is no training set for an AI algorithm described.

Summary of available information:

The provided document describes the GYNEX Extended Reach Needle as a Class II medical device intended for administering regional anesthetic blocks. The regulatory submission (510(k)) aims to demonstrate substantial equivalence to legally marketed predicate devices, primarily the Potocky Needle (K910252) and preamendment devices.

Acceptance Criteria (Implicit via Substantial Equivalence and Standards):

While not explicitly presented as a "table of acceptance criteria" with numerical performance targets, the document establishes implicit acceptance criteria based on:

• Indications for Use: The Gynex needle must be suitable for administering paracervical-pudendal anesthetic, matching the predicate.
• Design: Leuer lock & threaded hub, comparable to predicate.
• Sterilization Method: Supplied sterile and non-pyrogenic via radiation, with a Sterility Assurance Level (SAL) of at least 10⁻⁶. This is a critical safety criterion.
• Dimensions/Sizes: 90mm with a 5mm 27 gauge tip, matching the Potocky predicate.
• Material: 302 Stainless Steel, matching the predicate.
• Manufacturing Standards: Compliance with voluntary standards such as ASTM, GYNEX Corporation Standard Operating Procedures (SOPs), vendor certification/qualification, Quality Systems Regulations (QSR), ISO materials standards, and ISO 9000 series quality regulations. This implies the device must meet specified mechanical properties, biocompatibility, and manufacturing quality.
• Packaging: Individually packaged and labeled, with instructions for inspection and handling to maintain sterility.

Reported Device Performance (Implicit/Feature Comparison):

The "Comparison Table" provides the "reported device performance" in terms of features relative to the predicate:

Note on Sterilization: The "NO & YES" for sterilization indicates that Gynex's radiation sterilization method differs from "Steam Autoclave - reusable" but is equivalent to "Potocky - Supplied sterile - disposable." The FDA found this acceptable for substantial equivalence.

This document serves as a regulatory submission demonstrating substantial equivalence for a medical device, and as such, does not typically include detailed clinical performance studies often associated with diagnostic or AI-driven devices.

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The intended use for the Worldwide Medical Technologies Intracervical Block Needle is to inject anesthetic in the cervical area.

Worldwide Medical Technologies Intracervical Block Needle

The provided text is a 510(k) clearance letter from the FDA for the "Worldwide Medical Technologies Intracervical Block Needle." This document primarily addresses regulatory approval based on substantial equivalence to a predicate device, rather than presenting a detailed study proving performance against specific acceptance criteria.

As such, none of the requested information (acceptance criteria, device performance, study details, sample sizes, expert qualifications, ground truth methods, MRMC studies, or standalone algorithm performance) is present in the provided document.

The document indicates that the device's substantial equivalence was determined based on its intended use "to inject anesthetic in the cervical area" and comparison to devices marketed before May 28, 1976. This regulatory pathway does not typically require the submission of clinical performance data in the same way that a novel device might.

Therefore, I cannot populate the requested table or answer the questions based on the given text.

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This needle is designed for injection of solutions (such as 2% lidocaine with or without 1:100,000 epinephrine) into the cervix Local anesthetics such as electroexcision, electrofulguration, CO2 laser excision and vaporization, and in some patients, endocervical curettage and cervical blopsies

The needle is 27g, 3 ½ª long. It is used for uterine anesthesia prior to Ob/Gyn procedures. It consists of a metal lube that is sharpened at one end and at the other end joined to a female connector (Luer lock) designed to mate with a male connector (Nozzle) of a piston syringe or an intravascular administration set. Over 3 ¼" of its proximal end a 21 gauge metal tube is added to strengthen the shaft

I am sorry, but I cannot provide a detailed description of acceptance criteria and a study proving device performance based on the provided text. The document is a 510(k) summary for a medical device (Endocervical Block Needle) and focuses on demonstrating substantial equivalence to a predicate device rather than presenting a standalone study with specific performance metrics and acceptance criteria as you've requested.

Here's why I cannot fulfill your request based on the given information, and what I can extract:

What the document does provide:

• Acceptance Criteria (Implicit via Equivalence): The implicit acceptance criterion for the Endocervical Block Needle is substantial equivalence to the Potocky Needle™ Disposable Injection Needle. The device is deemed acceptable if it can be shown to be as safe and effective as the predicate device.
• Study That Proves the Device Meets Acceptance Criteria: The "study" is a comparison of technological characteristics between the Endocervical Block Needle and the Potocky Needle™. This comparison, presented as a table, claims equivalence across multiple attributes.

Why the specific details you requested are not present:

1. Table of Acceptance Criteria and Reported Device Performance: The document does not provide predefined numerical acceptance criteria (e.g., "device must achieve X accuracy" or "Y tensile strength") and then report specific performance results against those. Instead, it states "Equivalent" for various characteristics when compared to the predicate.
2. Sample Size for Test Set and Data Provenance: There is no mention of a test set, statistical sample sizes, or data provenance (e.g., country of origin, retrospective/prospective). The assessment is based on a comparative analysis of specifications, not a new clinical or performance study with a distinct test set.
3. Number of Experts and Qualifications for Ground Truth: Since no new performance study is described, there's no mention of experts establishing ground truth for a test set. The "ground truth" for equivalence is essentially derived from the established safety and efficacy of the predicate device.
4. Adjudication Method: Not applicable as no new performance data requiring adjudication is presented.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study: Not applicable. This type of study is for evaluating human performance, often with and without AI assistance, which is not relevant to a hypodermic needle's 510(k) submission.
6. Standalone Performance Study (Algorithm Only): Not applicable. This is a physical medical device, not an algorithm. Its performance is assessed through equivalence to a physically similar device, not a standalone algorithm.
7. Type of Ground Truth Used: The "ground truth" implicitly used is the established safety and efficacy profile of the predicate device (Potocky Needle™) as accepted by the FDA. There's no pathology, outcomes data, or expert consensus specifically generated for this new device's performance claims, beyond the general understanding that the predicate performs as intended.
8. Sample Size for Training Set: Not applicable. This is a physical device, not an AI/ML algorithm that requires a training set.
9. How Ground Truth for Training Set Was Established: Not applicable for the same reason as above.

In summary, the provided document demonstrates substantial equivalence through a comparative analysis of technological characteristics to a legally marketed predicate device, which is a common pathway for 510(k) clearance. It does not describe a performance study with specific acceptance criteria, test sets, or ground truth establishment in the way you've outlined for a new device's performance validation.

The table showing the comparison is:

Comparison of Technological Characteristics (Predicate vs. New Device)

Acceptance Criteria: For each characteristic, the acceptance criterion is "Equivalent" to the predicate device (Potocky Needle™ Disposable Injection Needle). The reported performance across all relevant characteristics is that the Endocervical Block Needle is "Equivalent" to the predicate.

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