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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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Used to excise target tissue, perform biopsies and control bleeding through a standard Monopolar Electrosurgical Generator.

The Wallach LOOP Electrode is a Sterile, Disposable, Single Use Electrode. Used in conjunction with an ESU (electrosurtical unit or generator) to CUT or COAG during an electorsurgical procedure.

The provided text describes a 510(k) premarket notification for the "Wallach LOOP Electrode." This type of submission focuses on demonstrating substantial equivalence to a legally marketed predicate device, rather than proving novel effectiveness through controlled studies with detailed acceptance criteria and performance metrics typically seen for AI/ML or complex diagnostics.

Therefore, the information you've requested regarding acceptance criteria, specific study details, sample sizes, expert involvement, and ground truth establishment, is largely not applicable (N/A) or explicitly detailed in this document. The purpose of this 510(k) is to show that the new device is as safe and effective as existing ones, primarily through comparison of design, materials, and intended use.

Here's a breakdown based on the provided text, indicating where information is not present:

1. Table of Acceptance Criteria and Reported Device Performance

Note: Specific quantitative acceptance criteria (e.g., minimum tensile strength, maximum power output, specific coagulation times) are not provided in this summary document. The "acceptance criteria" here are inferred from the demonstrated equivalence to predicate devices.

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

• Sample Size for Test Set: N/A. No specific "test set" in the context of an independent clinical study is described. The evaluation is based on design, materials, and a hazard analysis, along with "testing" whose specifics are not detailed.
• Data Provenance: N/A. No geographical origin or retrospective/prospective nature of data is provided. The testing mentioned is likely in-house engineering and bench testing.

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

• N/A. This 510(k) does not describe a study involving expert-established ground truth as would be relevant for diagnostic devices or those requiring expert interpretation.

4. Adjudication Method for the Test Set

• N/A. Not applicable as no expert-reviewed test set is described.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done

• No. This is an electrosurgical electrode, not a diagnostic imaging device or AI system, so an MRMC study is not relevant or described.

6. If a Standalone Performance Study (algorithm only without human-in-the-loop) was done

• N/A. This device is a physical electrode, not an algorithm. Standalone performance data, if relevant (e.g., specific electrical resistance, thermal properties), is not detailed in this summary.

7. The Type of Ground Truth Used

• N/A. The "ground truth" for this device is its physical and functional characteristics matching specified engineering standards and performing equivalently to predicate devices. It does not involve "expert consensus, pathology, or outcomes data" in the typical sense of a diagnostic or therapeutic clinical outcome study for general medical devices. The ground truth essentially relies on established performance characteristics of the predicate devices and conformity to relevant standards (e.g., ANSI/AMMI HF18-1993).

8. The Sample Size for the Training Set

• N/A. This is not an AI/ML device, so there is no training set.

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

• N/A. Not applicable, as there is no training set.

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The Wallach Ultimate Reusable, Plastic Vaginal Speculum is intended to be used for general gynecologic and electrosurgical procedures and is inserted into the vagina to expose the cervix. It is supplied non-sterile and is intended to be autoclavable for 100+ cycles.

The Ultimate Reusable, Plastic Vaginal Speculum is a device used to expose the interior of the vagina during general gynecologic and electrosurgical procedures. The non-conductive, specialized plastic stops dangerous grounding of the electrical current that a metal would not. The stainless steel metal parts will not rust and are away from the operating area. The three main parts are injection molded from a plastic called ULTEM, a General Electric Company product used for many years in the manufacturing of medical devices, where high temperature and chemical interaction is a concern. The speculum has been autoclaved and cold soak sterilized for many hours to be sure of its usability after repeated cycles and there is no coating to breakdown, crack, chip, or peel. The color is pink to stop light reflection (as opposed to white) and still light enough to show any surface damage that might happen in use. The surfaces are polished and all sharp edges are removed for the protection of the patient.

The provided documents describe a 510(k) premarket notification for a medical device, the "Wallach Ultimate Reusable, Plastic Vaginal Speculum." This type of submission focuses on establishing substantial equivalence to previously approved predicate devices, rather than conducting a de novo study to prove safety and effectiveness against specific acceptance criteria using a novel methodology.

Therefore, many of the typical acceptance criteria and study elements often found in submissions for AI/ML-driven diagnostic devices or more complex therapeutic devices are not applicable or explicitly detailed in this document. The device is a physical medical instrument, not a software or AI-based system.

Here's a breakdown based on the information provided, highlighting what is applicable and what is not:

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

For this device, the "acceptance criteria" are essentially defined by its substantial equivalence to predicate devices in terms of materials, sterilization, design, intended use, and where it is used. There are no quantitative performance metrics (like sensitivity, specificity, accuracy) typically associated with AI/ML devices.

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

Not applicable. This is a physical device, and the demonstration of substantial equivalence does not involve a "test set" of data in the manner of AI/ML or diagnostic devices. Performance is assessed through comparison of characteristics and safety evaluations, not data analysis.

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. Ground truth establishment with experts is relevant for diagnostic or AI/ML devices where interpretation is involved. For this physical speculum, its function is directly observable and its safety/equivalence is assessed by regulatory bodies against defined characteristics.

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

Not applicable, as there is no "test set" or diagnostic interpretation requiring adjudication.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

Not applicable. This type of study is for AI/ML diagnostic tools. The speculum is an instrument used by a physician, not an AI-assisted diagnostic.

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

Not applicable. This is not an algorithm or software.

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

Not applicable. The "ground truth" for this submission is the established safety and effectiveness of the predicate devices. The new device demonstrates "substantial equivalence" to this established standard based on its physical and functional characteristics.

8. The sample size for the training set

Not applicable. There is no training set as this is not an AI/ML device.

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

Not applicable. There is no training set.

Summary of the Study/Evidence:

The study proving the device meets the "acceptance criteria" (defined as substantial equivalence to predicate devices) is primarily a comparative analysis of device characteristics and a hazard analysis.

• Design and Materials Comparison: The Wallach Ultimate Reusable, Plastic Vaginal Speculum was directly compared to two predicate devices:
  • Adept-Med's Gravespec Reusable Nonmetal, Vaginal Speculum (K935636)
  • CooperSurgical's Prima Series, Vaginal LEEP Plastic Reusable Specula (K951898)
    The comparison covered materials (Ultem Plastic), sterilization methods (Autoclavable/Reusable), design features (plastic injection molded, non-conductive, no coating to breakdown), intended use, and user (physician). The Wallach device was found to be "Equivalent" or "Similar" to the predicate devices across these categories.
• Safety Evaluation: "Hazard analysis evaluations performed on the Ultimate Reusable, Plastic Vaginal Speculum indicated that there were no new hazards presented with the use of the Ultimate Reusable, Plastic Vaginal Speculum as compared to the predicate device."
• Performance Claim: The document states that "Testing that was performed on the Ultimate Reusable, Plastic Vaginal Speculum indicates that the devices are substantially equivalent in their performance and design of operation." While specific test details (e.g., details of autoclaving for 100+ cycles) are mentioned in the product description (e.g., "autoclaved and cold soak sterilized for many hours to be sure of its usability after repeated cycles"), the detailed results of these tests are not provided in this summary.

In essence, the "study" is a demonstration of equivalence based on documented technical specifications, material properties, and a safety assessment, rather than a clinical trial or performance study requiring patient data or expert interpretation.

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The PMS750 Fingerswitch is intended to be used in general electrosurgical applications for cutting and coagulating during surgical procedures. It is provided non-sterile and is intended for limited reuse.

The PMS750 Reusable (Autoclavable) Fingerswitch Pencil is intended to be used in general electrosurgical applications for cutting and coagulating during electrosurgical procedures. It is provided non-sterile and is intended to be autoclavable for 100+ cycles.

The PMS750 Fingerswitch Pencil is a non-sterile, limited reusable electrosurgical handcontrol pencil. It utilizes an insert-molded body that houses a printed circuit board; depression of the yellow button will activate the CUT circuit and depression of the blue button will activate the COAG circuit. It is an accessory to an ESU (electrosurgical unit or generator).

The provided document (K991669) does not contain information about acceptance criteria or a study proving the device meets acceptance criteria in the way typically seen for AI/ML-driven medical devices. Instead, it is a 510(k) premarket notification for a traditional medical device (an electrosurgical handcontrol pencil).

The core of this submission is demonstrating substantial equivalence to predicate devices already on the market, rather than a clinical study with specific performance metrics and acceptance criteria for a novel technology.

Therefore, many of the requested fields regarding AI/ML device evaluation are not applicable to this document. I will fill in the relevant available information and state "Not Applicable" where the information is not present or relevant to this type of device submission.

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

1. Table of Acceptance Criteria and Reported Device Performance

This 510(k) summary focuses on demonstrating substantial equivalence rather than meeting specific quantifiable performance criteria compared to an absolute standard. The "performance" assessment is comparative to predicate devices.

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

• Sample Size: Not explicitly stated as a "test set" in the context of an AI/ML algorithm. The document mentions "Testing that was performed on the PMS750 Fingerswitch," but no specific number of units tested is provided for performance validation.
• Data Provenance: Not applicable. This is a conventional medical device, not an AI/ML system.

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

• Not Applicable: This type of assessment (expert-established ground truth) is for AI/ML devices or diagnostic outputs. This submission for an electrosurgical pencil would typically involve engineering testing, material compatibility, and electrical safety assessments, not expert image review or diagnosis.

4. Adjudication Method for the Test Set

• Not Applicable: There is no "test set" for expert adjudication in this type of submission. Performance is assessed through engineering testing and comparison to predicates.

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/ML device.

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

• Not Applicable: This is not an AI/ML device.

7. The Type of Ground Truth Used

• Not Applicable: For a device like an electrosurgical pencil, "ground truth" generally refers to established engineering standards, electrical safety standards (e.g., IEC standards), biocompatibility standards, and the functional performance of existing, legally marketed predicate devices. The "truth" is that the device performs its intended function safely and effectively, and is substantially equivalent to known safe and effective devices.

8. The Sample Size for the Training Set

• Not Applicable: This is not an AI/ML device, so there is no training set.

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

• Not Applicable: This is not an AI/ML device.

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Indications for use: The intended use of the Quantum 500 Electrosurgical Generator is for in-office high frequency, electrosurgical OB/GYN procedures. Some OB/GYN indications for applications include:

1. Cervical Conization.
2. Large Loop Excision of the Transformation Zone (LLETZ) in the diagnosis and treatment of some Cervical Intraepithelial Neoplasias (CIN) and Dysplasias.
3. External Anogenital Lesions.
4. Large Vaginal Intraepithelial Neoplastic (VAIN) Lesions.
5. Bipolar pinpoint, precise coagulation. Pinpoint hemostasis in any field, wet or dry.

Not Found

This is a 510(k) clearance letter for the Wallach Quantum 500 Electrosurgical Generator. This document does not contain the information requested regarding acceptance criteria and a study proving device performance.

The provided text is a regulatory clearance document from the FDA, indicating that the device is substantially equivalent to legally marketed predicate devices. It outlines the intended use and regulatory classification but does not include details about device performance studies, acceptance criteria, or the methodology of such studies.

Therefore, I cannot provide the requested table and details based on the given input.

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The 'Inseminator' is used for intrauterine artificial insemination procedures utilizing washed spermatozoa or semen. The 'Inseminator' is not intended for intrafallopian tube or in vitro fertilization (IVF) procedures.

The malleable catheter of Wallach's 'Inseminator' includes the fine, smoothed tip, with a flared proximal end. Insemination fluid (washed sperm) is introduced into the uterine cavity using a syringe attached to the proximal luer.

The provided text describes a 510(k) premarket notification for a medical device called 'The Inseminator' by Wallach Surgical Devices, Inc. This submission focuses on establishing substantial equivalence to previously marketed predicate devices rather than presenting new clinical study data.

Therefore, the requested information regarding acceptance criteria, device performance studies, sample sizes, expert qualifications, adjudication methods, MRMC studies, standalone performance, ground truth establishment, and training set details cannot be extracted from the provided text.

The document explicitly states:

"Substantial equivalence for this device is based solely on design and performance characteristics; no performance or safety data is included in this premarket notification. The materials, performance specifications and essential design characteristics of the Wallach's Insemination Catheter are equivalent to those of the predicate devices."

The submission relies on a comparison of design, materials, sterilization, and intended use with existing predicate devices to demonstrate safety and effectiveness.

Here's what can be provided based on the available information:

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

Since no performance data or specific acceptance criteria for performance were included in the submission beyond showing equivalence to predicate devices, this table cannot be fully populated as requested. The criteria for acceptance in this context refer to the characteristics being compared for substantial equivalence.

2. Sample size used for the test set and the data provenance: Not applicable. No test set data was provided.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. No ground truth establishment from experts was described for performance.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable. No test set requiring adjudication was 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 an intrauterine insemination catheter, not an AI-assisted diagnostic device, and no MRMC study was performed.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. This device is not an algorithm.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc): Not applicable. No ground truth for performance was established within this submission; substantial equivalence was based on design and characteristic comparison to predicate devices.

8. The sample size for the training set: Not applicable. This device is not an AI-based system and does not have a training set in the context of machine learning.

9. How the ground truth for the training set was established: Not applicable.

In summary, this 510(k) submission leverages the "substantial equivalence" pathway, which allows a new device to be marketed without new clinical trials if it can be shown to be as safe and effective as a legally marketed predicate device. The information provided focuses on demonstrating this equivalence through comparative tables of device characteristics, not through new performance studies.

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Indications for use: The intended use of the Quantum 500 Electrosurgical Generator is for all General & Plastic Surgery related in-office high frequency, electrosurgical procedures. Some indications for applications include:

• 1. Cutting skin incisions, biopsy, cysts, abscesses, tumors, cosmetic repairs, development of skin flaps, skin tags, nevi, keratosis, oculoplastic procedures, blepharoplasty, aponeurotic repair, and levator resection.
• 2. Blended Cutting and Coagulation skin tags, papilloma keloids, keratosis, verrucae, basal cell carcinoma, nevi, skin tags, fistulas, epithelioma, cosmetic repairs, cysts, abscesses, development of skin flaps, and oculoplastic procedures.
• 3. Hemostasis control of bleeding, epilation, and telangiectasia.
• 4. Fulguration basal cell carcinoma, papilloma, cyst destruction, tumors, verrucae, and hemostasis.
• 5. Bipolar pinpoint, precise coagulation. Pinpoint hemostasis in any field; wet or dry.

Not Found

I am sorry, but the provided text does not contain the detailed information required to answer your request about the acceptance criteria and the study that proves the device meets them. The text is a 510(k) clearance letter from the FDA for the "Wallach Quantum 500 Electrosurgical Generator."

While it lists the indications for use of the device, it does not include any information about:

• Specific acceptance criteria (e.g., performance metrics, thresholds).
• Any study design, data, or results that demonstrate the device meets acceptance criteria.
• Sample sizes, data provenance, expert qualifications, or ground truth methodologies.
• Whether MRMC or standalone performance studies were conducted.

The letter primarily communicates the FDA's finding of substantial equivalence based on a submission (K983208), but the details of that submission, including performance studies, are not present in the provided document.

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The intended use of the Quantum 2000 System is for in-office electrosurgical OB/GYN procedures. Some OB/GYN indications for applications include:

1. Cervical Conization.
2. Large Loop Excision of the Transformation Zone (LLETZ) in the diagnosis and treatment of some Cervical Intraepithelial Neoplasias (CIN) and Dysplasias.
3. External Anogenital Lesions.
4. Large Vaginal Intraepithelial Neoplastic (VAIN) Lesions.

WALLACH QUNATUM 2000 ELECTROSURGICAL SYSTEM

This document is a 510(k) premarket notification decision letter from the FDA to Wallach Surgical Devices, Inc. regarding their Quantum 2000 Electrosurgical System. It states that the device is substantially equivalent to legally marketed predicate devices and can be marketed.

The provided text does NOT contain information about acceptance criteria or a study proving the device meets acceptance criteria. It is a regulatory clearance document, not a clinical study report. It indicates that the device is substantially equivalent to devices marketed prior to May 28, 1976, which is the basis for its clearance, not performance against specific acceptance criteria.

Therefore, I cannot answer the questions regarding acceptance criteria and a study that proves the device meets the acceptance criteria from the provided text.

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