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Intended for use in patients requiring endoscopic surgery for general urological tissue resection, ablation, and excision and hemostasis of blood vessels. These procedures include Bladder Tumor Diagnosis and Resection, Transurethral Prostatic and Bladder Biopsy, Transurethral Prostatic Resection, and Treatment of Vesical Neck Constriction.

The USA Elite Bipolar Resectoscope consists of a Telescope, Sheath, Bipolar Working Element, and Obturator. The USA Elite Bipolar Resectoscope is designed to work with currently marketed Electrosurgery Systems consisting of a electrosurqical generator called the Controller, a disposable Bipolar Loop, and a reusable or disposable Loop Cable or Cord.

Here's an analysis of the provided text regarding the ACMI Bipolar Resectoscope, focusing on acceptance criteria and study details.

Important Note: The provided document is a 510(k) summary for a modification to an existing device, not a de novo clearance or a 510(k) for a completely new device. This means the primary evidence presented is for substantial equivalence to a predicate device, rather than extensive clinical efficacy or performance studies with specific numerical acceptance criteria. Therefore, many of the requested data points (like sample sizes for test/training sets, expert ground truth details, MRMC studies, standalone performance studies with quantitative metrics) are not typically present or required in a 510(k) of this nature and are absent from this document.

The "acceptance criteria" here refer to demonstrating that the modified device remains as safe and effective as the predicate device.

1. Table of Acceptance Criteria and Reported Device Performance

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

• Not Applicable / Not Provided. This 510(k) is for a modification to a mechanical/electrical surgical instrument, not an AI/software device that typically uses "test sets" of data. The "test" here refers to demonstrating safety and performance equivalence through engineering verification and validation, rather than data-driven clinical prediction on a patient cohort. The document emphasizes that the modifications do not significantly affect safety or efficacy, implying internal company testing (e.g., bench testing, biocompatibility for material changes) rather than clinical studies on patient data.

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

• Not Applicable / Not Provided. See point 2. Ground truth in this context would likely refer to engineering specifications or validated performance characteristics rather than expert consensus on medical images or patient outcomes.

4. Adjudication Method for the Test Set

• Not Applicable / Not Provided. See point 2 and 3.

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

• No. This is not an AI/software device; it's a surgical instrument. An MRMC study is not relevant here.

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

• Not Applicable. This is a physical medical device, not a standalone algorithm.

7. The Type of Ground Truth Used

• Not Applicable (in the context of clinical data/AI). For this device, "ground truth" generally refers to:
  • Engineering Specifications: Design tolerances, material properties, electrical output specifications, etc.
  • Performance Benchmarks: Comparison against the predicate device's known performance characteristics (e.g., cutting efficacy, coagulation properties, structural integrity, electrical safety).
  • Regulatory Standards: Adherence to relevant national and international standards for medical devices.
    The document states the modifications are "not substantial changes or modifications, and do not significantly affect the safety or efficacy of the devices," implying that internal testing (bench, possibly animal) was performed to show that the modified device performs comparably to the predicate.

8. The Sample Size for the Training Set

• Not Applicable / Not Provided. This is not a machine learning or AI device.

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

• Not Applicable. There is no training set mentioned or implied for this type of device.

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Circon's Rigid Operative Culdoscopy Accessories are intended to be used with Circon's Rigid Culdoscope and Accessories for viewing pelvic organs endoscopically via a posterior vaginal fornix entry for the purpose of performing diagnostic and operative procedures on the female genital organs. Indications for use are:

• Unexplained pelvic pain (acute, chronic)
• Menstrual abnormalities
• Infertility and sterility
• Indefinite pelvic mass
• Ectopic pregnancy
• Pelvic endometriosis
• Polycystic ovaries
• Pelvic inflammatory disease (PID)
• Pain mapping
• Congenital anomalies of the pelvic organs
• Lysis of adhesions
• Cytology sampling
• Biopsy

Circon's Rigid Operative Culdoscopy Accessories consist of several tubular stainless steel components. During culdoscopy, light from a high intensity light source is transmitted to a rigid culdoscope by a fiber optic light guide that is detachably connected to a light post on the body of the scope. The light is carried by the illumination fibers to the target. A distal lens focuses an image of the target onto the rod lens train. The image is transmitted to the proximal end of the scope, where it is magnified and focused by an eyepiece ocular. The image may be viewed directly through the evepiece, or the scope may be connected to a video system via a standard endoscopic video coupler. In order to perform operative procedures, the operative cannula of the subject system replaces the smaller diagnostic cannula of the predicate system, and an operative sheath replaces the smaller diagnostic sheath of the predicate system. A channel is formed between the culdoscope and the operative sheath, thereby allowing passage of small instruments for a variety of operative procedures.

The provided text is a 510(k) Summary for "Circon's Rigid Operative Culdoscopy Accessories". The document describes the device, its intended use, and compares it to predicate devices. However, it does not contain information on acceptance criteria, a study proving device performance, sample sizes, expert qualifications, adjudication methods, MRMC studies, standalone performance, or ground truth details.

The 510(k) submission process for this type of device (medical instruments) primarily focuses on demonstrating substantial equivalence to a legally marketed predicate device, rather than requiring extensive clinical trials with specific performance metrics and acceptance criteria as might be expected for novel diagnostic algorithms or AI-driven systems.

Therefore, I cannot populate the requested information from the provided text.

Here's the structure of the answer I would provide if the information were available:

1. Table of Acceptance Criteria and Reported Device Performance

2. Sample Size and Data Provenance for Test Set

• Sample Size for Test Set: [Number]
• Data Provenance: [e.g., Country(ies) of origin, Retrospective/Prospective, (if applicable) specific institutions/databases]

3. Number and Qualifications of Experts for Ground Truth (Test Set)

• Number of Experts: [Number]
• Qualifications of Experts: [e.g., Board-certified Radiologist with X years of experience in Y subspecialty, Pathologist, etc.]

4. Adjudication Method for Test Set

• [e.g., 2+1 (two experts, third for tie-breaking), 3+1 (three experts, fourth for tie-breaking), Majority vote, Consensus meeting without formal tie-breaker, None (single expert review)]

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

• Was an MRMC study done? [Yes/No]
• If Yes:
  • Effect size (improvement with AI vs. without AI assistance): [e.g., increase in AUC, sensitivity, specificity, reduction in reading time, etc., with specific values or ranges]

6. Standalone (Algorithm Only) Performance Study

• Was a standalone performance study done? [Yes/No]
• If Yes:
  • Performance metrics: [e.g., Accuracy, Sensitivity, Specificity, AUC, F1-Score, etc., with specific values]

7. Type of Ground Truth Used

• [e.g., Expert Consensus (as described above), Histopathology/Pathology, Long-term patient outcomes, Clinical follow-up, Surgical findings, Reference standard device output]

8. Sample Size for Training Set

• Sample Size for Training Set: [Number]

9. How Ground Truth for Training Set Was Established

• [e.g., Expert annotation (similar to test set, or different process/number of experts), Pathology reports linked to images, Pre-existing clinical labels, etc., describe the process in detail]

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Circon Corporation's Tsunami™ Battery-Powered Irrigation Pump is intended to be used in conjunction with Circon's Surgiflex® WAVE® Tsunami™ Suction-Irrigation System to provide controlled, powered delivery of sterile irrigation fluids to surgical sites and to evacuate blood, tissue debris and smoke from the operative field to aid in visualization during laparoscopic and open surgical procedures. The system may also be used for resection of filmy adhesions and for peritoneal lavage.

The Circon Surgiflex® WAVE® Tsunami™ Suction-Irrigation System is comprised of a Tsunami™ Battery-Powered Pump that may be attached to a source of irrigation tubing connected to a Surgiflex WAVE suction-irrigation handpiece, and a length of suction tubing connected between the handpiece and a vacuum source (usually a suction canister that is connected to a wall suction outlet). Irrigation solution is introduced to the surgical site and fluids, debris and smoke are evacuated from the site via a disposable suction-irrigation probe. All components of the system are supplied sterile, disposable in a sealed plastic tray for single patient use.

This 510(k) summary (K992126) for the Circon Surgiflex® WAVE® Tsunami™ Suction-Irrigation System does not contain specific acceptance criteria or the details of a study proving the device meets acceptance criteria in the way typically expected for performance claims of AI/ML-enabled devices.

This document is for a traditional medical device (a battery-powered irrigation pump) and focuses on demonstrating substantial equivalence to predicate devices, rather than establishing numerical performance metrics against predefined acceptance criteria for a new clinical function or AI algorithm.

Therefore, most of the requested information cannot be extracted from this document as it pertains to AI/ML device evaluations, which is not applicable here.

Here's an explanation based on the provided text, highlighting why certain information is absent and what is available:

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

• Not Applicable/Not Provided: This document does not present acceptance criteria in a quantitative, measurable format (e.g., sensitivity, specificity, accuracy thresholds) for a specific clinical outcome or an algorithm's performance. The "performance" assessment here is focused on demonstrating that the device functions similarly to legally marketed predicate devices for its intended use, without raising new questions of safety or effectiveness. The comparison is primarily around design, operating principles, materials, sterility, and method of delivery/evacuation.

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/Not Provided: There is no "test set" in the context of an AI/ML device evaluation. This device is a hardware component. Any testing conducted would likely involve engineering verification and validation (e.g., flow rate, pressure, battery life, material compatibility, sterility) rather than a clinical study with a patient data 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 Applicable/Not Provided: Since there's no test set requiring ground truth labeling (e.g., image annotation, diagnosis), there's no mention of experts for ground truth establishment.

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

• Not Applicable/Not Provided: No test set, no ground truth adjudication method.

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/Not Provided: This is not an AI-assisted device, so an MRMC study is irrelevant.

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

• Not Applicable/Not Provided: This is a hardware device; there is no standalone algorithm.

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

• Not Applicable/Not Provided: No ground truth in the AI/ML sense is mentioned. Any "ground truth" equivalent for this device would be established through engineering specifications, standards, and possibly bench testing against known values (e.g., measuring actual fluid flow against specified flow rates).

8. The sample size for the training set

• Not Applicable/Not Provided: There is no AI/ML model, hence no training set.

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

• Not Applicable/Not Provided: No training set, no ground truth for it.

Summary of what is described in the document relevant to device acceptance (though not in the requested AI/ML format):

The primary "acceptance criteria" and "study" for this device are framed around substantial equivalence to predicate devices already on the market.

• Intended Use: The device is intended to "provide controlled, powered delivery of sterile irrigation fluids to surgical sites and to evacuate blood, tissue debris and smoke from the operative field to aid in visualization during laparoscopic and open surgical procedures. The system may also be used for resection of filmy adhesions and for peritoneal lavage." This intended use is compared directly to predicate devices.
• Technological Characteristics Comparison: The document states that "Circon's Surgiflex® WAVE® Tsunami™ Suction-Irrigation System is substantially equivalent to Cabot's Surgiflex® Suction-Irrigation Probes, Davol's Hydro-Surgi Laparoscopic Irrigator and Stryker's Laparoscopic Suction Irrigator."
  • Basis for Substantial Equivalence: "All of these devices employ substantially equivalent design considerations and operating principles, and their materials of construction are safe for the intended uses. All of these devices are supplied sterile for single-use only, and none actively delivers any form of electrical energy to the patient."
  • Conclusion: "Any differences between the various devices do not raise new questions regarding safety or effectiveness."

In essence, the "study" is a comparison with predicate devices, showing that the new device shares fundamental technological characteristics and intended use with already cleared devices, and any differences do not negatively impact safety or effectiveness. This comparison is the method for demonstrating that the device meets the (implied) regulatory acceptance criteria for market clearance via the 510(k) pathway.

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CIRCON SURGITEK's Snap-N-Pee!™ Introducers are intended to be used to permit direct passage of catheters or other devices for the purpose of performing diagnostic and surgical procedures (e.g., nephrostomy, cystoscopy, ureteroscopy, etc.) in the urinary tract.

The CIRCON SURGITEK Snap-N-Peel7M Introducer consists of a stepped dilator (with proximal Luer hub) that fits within an external sheath (with rotating locking collar). The dilator may be straight or curved and has a lumen to allow passage of fluids or a guidewire.

The provided document is a 510(k) summary for the CIRCON SURGITEK Snap-N-Peel™ Introducer, seeking market clearance from the FDA. This type of submission focuses on demonstrating substantial equivalence to a legally marketed predicate device, rather than providing extensive clinical study data with specific acceptance criteria and performance metrics typically found for novel or high-risk devices.

Therefore, many of the requested elements for describing acceptance criteria and a study proving device performance are not applicable or not explicitly detailed in this 510(k) summary.

Here's an analysis based on the available information:

Acceptance Criteria and Device Performance

• Acceptance Criteria: The primary "acceptance criterion" for this 510(k) submission is demonstrating substantial equivalence to existing predicate devices (Cook Peel-Away® Introducer and Microvasive® Banana Peel™ Sheath) in terms of design, materials, operating principles, lengths, diameters, and smoothly finished contours. The document explicitly states that "Any differences between the CIRCON SURGITEK and Cook or Microvasive devices do not raise new questions regarding safety or effectiveness."
• Reported Device Performance: The document does not report specific quantitative performance metrics against pre-defined acceptance criteria in a tabular format as would be expected from a device study. Instead, it asserts that the device is substantially equivalent to the predicate devices, implying similar performance.

Detailed Information Request (where applicable from the document):

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

   Acceptance Criteria (Inferred from 510(k) process)	Reported "Device Performance" (Based on Substantial Equivalence Claim)
   Design Considerations: Similar to predicate devices.	CIRCON SURGITEK devices "employ the same design considerations" as predicate devices.
   Materials of Construction: Similar to predicate devices.	CIRCON SURGITEK devices "employ the same... materials of construction" as predicate devices.
   Operating Principles: Similar to predicate devices.	CIRCON SURGITEK devices "employ the same... operating principles" as predicate devices.
   Physical Characteristics (Lengths, Diameters, Smoothly Finished Contours): Similar to predicate devices.	CIRCON SURGITEK devices "also employ lengths, diameters, and smoothly finished contours similar to those of the predicate devices."
   Safety and Effectiveness: Differences should not raise new questions regarding safety or effectiveness. (Implied for substantial equivalence).	"Any differences between the CIRCON SURGITEK and Cook or Microvasive devices do not raise new questions regarding safety or effectiveness."
   Sterility: Supplied sterile, for single use. (This is a common requirement for such devices, though not explicitly compared to predicates for equivalence).	CIRCON SURGITEK devices "are supplied sterile, for single use."
   Energy Delivery: No active energy delivery. (Important for safety classification).	"None of the devices actively delivers any form of energy to the patient."

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

   • N/A: The document does not describe a "test set" in the context of a clinical study or performance evaluation with a specified sample size. The substantial equivalence claim is based on comparison of technological characteristics with predicate devices.

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: No ground truth establishment by experts for a test set is mentioned.

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

   • N/A: No test set or adjudication method 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

   • N/A: This device is an introducer sheath and dilator, not an AI or imaging device. 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

   • N/A: This is a physical medical device, not an algorithm, so this concept is not applicable.

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

   • N/A: No "ground truth" in the typical sense of a clinical study is established or used for this 510(k) submission. The "truth" for substantial equivalence is based on engineering design, material characteristics, and operational principles as compared to legally marketed predicate devices.

8. The sample size for the training set

   • N/A: No training set is mentioned as this is not an AI/machine learning device.

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

   • N/A: Not applicable.

In summary, this 510(k) filing demonstrates substantial equivalence to predicate devices, which is a regulatory pathway that typically relies on bench testing, material characterization, and comparison of design and intended use, rather than extensive clinical efficacy studies with ground truth establishment. The document does not provide the detailed performance study information requested because it falls outside the scope of a typical 510(k) summary for this type of device.

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Circon's Rigid Culdoscopes and Accessories are intended for viewing pelvic organs endoscopically via a posterior vaginal fornix entry. Culdoscopy is indicated for: Unexplained pelvic pain (acute, chronic), Menstrual abnormalities, Infertility and sterility, Indefinite pelvic mass, Ectopic pregnancy, Pelvic endometriosis, Polycystic ovaries, Pelvic inflammatory disease, Pain mapping, Congenital anomalies of the pelvic organs.

CIRCON's Rigid Culdoscopes and Accessories are rod lens-type endoscopes which consist of imaging optics and fiber optic illumination fibers contained within a stainless steel sleeve. Light from a high intensity light source is transmitted to the scope by a fiber optic light guide that is detachably connected to a light post on the body of the scope. The light is carried by the illumination fibers to the target. A distal lens focuses an image of the target onto the rod lens train. The image is transmitted to the proximal end of the scope, where it is magnified and focused by an eyepiece ocular. The image may be viewed directly through the eyepiece, or the scope may be connected to a video system via a standard endoscopic video coupler.

The provided document is a 510(k) summary for the CIRCON Rigid Culdoscope and Accessories (K980972). This type of submission is for demonstrating substantial equivalence to a legally marketed predicate device, rather than proving a device meets specific performance acceptance criteria through clinical trials or performance studies with detailed statistical analysis.

Therefore, the document does not contain the information requested in your prompt regarding acceptance criteria, device performance, study details, sample sizes, ground truth establishment, or expert involvement.

Here's why and what the document does provide:

• Acceptance Criteria and Reported Device Performance (1): This information is not present. The 510(k) process for this device relies on demonstrating that the new device is "substantially equivalent" to predicate devices already on the market prior to May 28, 1976. This typically involves comparing design, materials, intended use, and operating principles, rather than presenting new performance data against specific acceptance criteria.
• Sample Size for Test Set and Data Provenance (2): Not applicable, as no performance study data is presented.
• Number of Experts and Qualifications for Ground Truth (3): Not applicable, as no ground truth establishment for a test set is described.
• Adjudication Method (4): Not applicable.
• Multi-reader Multi-case (MRMC) Comparative Effectiveness Study (5): This is not a study type relevant to a 510(k) submission for a culdoscope in 1998, which is focused on physical and functional equivalence to existing devices. Therefore, no such study is described, nor is any effect size for human readers with or without AI assistance.
• Standalone Performance Study (6): No standalone performance study (algorithm only) is mentioned, as this device is a physical medical instrument, not an AI or software-only device.
• Type of Ground Truth Used (7): Not applicable, as no performance evaluations against a ground truth are described.
• Sample Size for Training Set (8): Not applicable, as no machine learning model or training set is involved.
• How Ground Truth for Training Set was Established (9): Not applicable.

What the document does provide in lieu of performance data:

The core of this 510(k) submission is the demonstration of substantial equivalence to predicate devices.

• Name of Device: Rigid Culdoscope and Accessories
• Intended Use: "CIRCON's Rigid Culdoscopes and Accessories are intended to be used for direct viewing of the organs within the peritoneal cavity for the purpose of performing diagnostic and surgical procedures. The system is introduced into the pelvic cavity through the posterior vaginal fornix."
• Indications for Use: Unexplained pelvic pain, menstrual abnormalities, infertility and sterility, indefinite pelvic mass, ectopic pregnancy, pelvic endometriosis, polycystic ovaries, pelvic inflammatory disease, pain mapping, congenital anomalies of the pelvic organs.
• Predicate Devices: ACMI's Decker Culdoscope and Decker Operating Culdoscope, Karl Storz Endoscopy America, Inc.'s Culdoscopes, and Richard Wolf Medical Instrument Corp.'s Fiber Light Culdoscopes. All were marketed prior to May 28, 1976.
• Comparison of Technical Characteristics: "CIRCON's scopes employ the same design considerations and operating principles as the legally marketed predicate devices, and each can be sterilized and reused. Any differences between these culdoscopes do not raise new questions regarding safety or effectiveness."

In summary, this document is a regulatory submission focused on demonstrating equivalence in design and intended use to pre-existing devices, rather than presenting a study proving performance against specific acceptance criteria.

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Circon ACMI's USA Elite System™ VaporTrode™ Vaporization Electrodes and VaporTome Resection Electrodes are indicated for use in urology for cutting, coagulation, and vaporization of soft tissue, including prostatic and bladder tissue and the treatment of benign prostatic hyperplasia (BPH) and bladder cancer.

CIRCON ACMI's USA Elite System™ VaporTrode™ Vaporization Electrodes and VaporTome™ Resection Electrodes are electrosurgical electrodes used in CIRCON ACMI's resectoscopes utilizing a direct connection between the electrode and the active cord of the electrosurgical generator.

This document, K973820, is a 510(k) Summary for the CIRCON ACMI USA Elite System™ VaporTrode™ Vaporization Electrode and VaporTome™ Resection Electrode. It asserts substantial equivalence to predicate devices and does not present data from a study demonstrating the device meets specific acceptance criteria in the typical contemporary sense of clinical or performance metrics. Instead, "acceptance criteria" here implicitly refer to the regulatory requirements for establishing substantial equivalence.

Here's an analysis based on the provided text, addressing your points where possible:

1. Table of Acceptance Criteria and Reported Device Performance

Study Details:

This 510(k) summary is based on a claim of substantial equivalence, not a performance study in the sense of demonstrating a device meets quantifiable metrics through a clinical trial or extensive bench testing against predefined acceptance criteria (apart from regulatory compliance). The "study" here is the regulatory comparison to predicate devices.

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

No explicit "test set" or sample size is mentioned in the context of a performance study. The evaluation is a comparative review of design, intended use, and technological characteristics against predicate devices. The data provenance is implied to be from the manufacturer's internal assessment comparing their new device to their own previously marketed (preamendments) devices.

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

Not applicable. There was no specific "test set" and thus no ground truth established by experts in the context of a performance study. The ground truth for the comparison is the established regulatory status and characteristics of the predicate devices.

4. Adjudication Method for the Test Set:

Not applicable. No performance test set or adjudication method is described.

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

No, an MRMC comparative effectiveness study was not done. This document is a 510(k) summary for establishing substantial equivalence, not a clinical effectiveness study. There is no mention of human readers or AI assistance.

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

Not applicable. This device is an electrosurgical electrode, not an algorithm or AI system. Its performance is directly tied to its physical interaction with tissue and operation by a medical professional.

7. The Type of Ground Truth Used:

The "ground truth" implicitly used for this submission is the regulatory status and established safety/effectiveness profile of the predicate devices (preamendments devices: Grooved Roller Electrodes and Resectoscope Cutting Loops by American Cystoscope Makers, Inc.). The argument is that the new device is fundamentally the same and therefore equally safe and effective.

8. The 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.

Summary of the "Study" and "Acceptance Criteria" in this context:

The "study" presented in this 510(k) is a comparative analysis of the new device against predicate devices based on:

• Intended Use: Identical.
• Technological Characteristics: Similar design considerations and operating principles.
• Performance: Implied to be equivalent due to similar characteristics, with no new questions of safety or effectiveness.

The "acceptance criteria" are the regulatory requirements for substantial equivalence under 21 CFR §876.4300 and the general provisions of the Federal Food, Drug, and Cosmetic Act. The device "meets the acceptance criteria" by demonstrating that it is substantially equivalent to legally marketed predicate devices, thereby allowing it to proceed to market without premarket approval. The FDA's letter explicitly states, "We have reviewed your Section 510(k) notification... and we have determined the device is substantially equivalent..." This regulatory determination constitutes the fulfillment of the "acceptance criteria" for marketing.

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The primary indications for use are abnormal uterine bleeding with or without pain, and infertility. Vaporization electrodes intended uses in gynecology, along with other resectoscopic electrodes and instruments, are: transuterine resection of fibroids, endometrial ablation, resectoscopic management of Müllerian fusion defects, resectoscopic management of intrauterine lesions, resectoscopic management of intractable uterine bleeding.

VaporTrode™ Vaporization Electrodes in Gynecology

This document is a 510(k) clearance letter from the FDA, and it does not contain the detailed information about acceptance criteria or a study proving device performance as requested. The letter confirms that Circon Corporation's VaporTrode™ Vaporization Electrodes in Gynecology are "substantially equivalent" to legally marketed predicate devices, allowing them to be marketed.

Therefore, I cannot extract the requested information regarding acceptance criteria and device performance studies from the provided text. The document is primarily a regulatory approval notification and does not delve into the technical study details.

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