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GIMMI ALPHA® Gastro-Urology and Laparoscopic Endoscopes, Endoscopic Accessories and GIMMI devices for minimally invasive gastrointestinal (GI), genitourinary (GU), and laparoscopic diagnostic and/or therapeutic indications are intended to be used by qualified physicians to provide access, illumination and visualization of internal structures and for manipulating soft tissue (grasping, cutting, coagulating, dissecting and suturing) in a wide variety of diagnostic and therapeutic laparoscopic/urologic and minimally invasive procedures.

GIMMI ALPHA Endoscopes are comprised of rigid, panoramic telescopes using rod lens technology. The body contact portions are composed of surgical grade stainless steel, which is commonly used in medical devices for a wide range of applications and has a long history of biocompatibility for human use.

Laparoscopic and urological-gastroenterologic and related accessories are composed of reusable handle and shaft assemblies and removable, reusable tip assemblies. Needle holders and other Class I devices included in the endoscopic catalogs may be onepiece. The instruments are designed and manufactured specifically for the purpose of manipulating soft tissue structures (grasping, cutting, dissecting, coagulating and suturing).

Minimally Invasive Gl and GU Devices are design specific for short term use in diagnostic and/or therapeutic procedures

This document is a 510(k) premarket notification for the GIMMI ALPHA® Endoscopic Instruments & Accessories. It establishes substantial equivalence to various predicate devices and describes the general characteristics of the device. However, it does not contain a detailed study with specific acceptance criteria and performance results directly comparable to those criteria in a quantitative manner.

Instead, the document states general compliance and conformance without providing numerical performance metrics or detailed study designs.

Therefore, many of the requested sections regarding specific acceptance criteria, performance data, sample sizes, ground truth establishment, and expert involvement cannot be extracted from this document based on the provided text.

Here's what can be inferred and what cannot:

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

• Acceptance Criteria: Not explicitly stated with quantifiable thresholds in the provided text. The document broadly states "safety, effectiveness, and reliability."
• Reported Device Performance: Not reported numerically. The document states, "All results were in conformance with the cited harmonized device standards" and "The results of design validation raise no new issues of safety and effectiveness."

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

• Sample Size: Not specified.
• Data Provenance: Not specified, but likely from GIMMI GmbH's internal testing.

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

• This information is not provided as the document does not detail specific clinical or performance studies involving "ground truth" established by experts. The "ground truth" in this context would typically refer to definitive diagnoses or outcomes for a clinical study comparing the device's output to reality, which is not described.

4. Adjudication method for the test set

• Not applicable/not provided, as no expert-adjudicated test set 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

• This is not applicable. The device is described as "Endoscopic Instruments & Accessories" and devices "for minimally invasive GI, GU, and laparoscopic diagnostic and/or therapeutic indications." It is a physical medical device, not an AI-powered diagnostic tool, and therefore, an MRMC study with AI assistance is not relevant to this submission.

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

• This is not applicable as the device is a physical instrument, not a standalone algorithm.

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

• Not applicable/not specified for a clinical performance study involving "ground truth." The "performance and physical tests" would likely rely on engineering standards and measurements rather than medical ground truth.

8. The sample size for the training set

• Not applicable, as this is a physical medical device, not a machine learning algorithm requiring a "training set."

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

• Not applicable for the same reason as above.

Summary based on the provided text:

The document serves as a regulatory submission confirming that the GIMMI ALPHA® Endoscopic Instruments & Accessories are "substantially equivalent" to predicate devices. It states that:

• The devices have the same intended use.
• They are made of the same materials.
• They are produced to the same international and FDA-recognized standards.
• "All materials used... were subjected to performance and physical tests to evaluate safety, effectiveness, and reliability of the devices."
• "All results were in conformance with the cited harmonized device standards."
• "The results of design validation raise no new issues of safety and effectiveness."

However, it refrains from providing detailed study protocols, quantitative performance data, or specific acceptance criteria with reported numerical results. The substantiation relies on adherence to general standards and comparison to existing, cleared predicate devices rather than a new, detailed clinical performance study with defined acceptance criteria.

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Resectoscope and Laser Resectoscope Working Elements are intended to be used in urological procedures to endoscopically remove, cut, coagulate, and/or transect tissue in the bladder, prostate, and/or urethra. The surgeon performs the examination through the urethra. The working elements are devices that house and control the various electrodes and lasers used to remove, cut, coagulate, and transect tissue. The doctor controls the back and forth movement of the electrode using finger controls. The working elements also house a cystoscope for visualization. The high frequency cable transmits electrical current.

Albarran deflectors are intended for use in urological procedures to control the flexible instrumentation that is passed through the COMEG cystoscope sheaths.

Urethrotomes are intended to be used in urological procedures to endoscopically cut and or transect tissue(strictures) in the urethra. The surgeon performs this function through the urethra and will visually (cystoscope) find the location of the stricture in the urethra. Once the stricture is located a urethrotome knife will be extended an the entire urethrotome will be extracted cutting the affected area.

Electrodes are intended to be used endoscopically im conjunction with COMEG resectoscopes, urethrotomes, or cystoscope sheaths. The purpose of the electrodes is for cutting, tissue removal, tissue vaporization, coagulation, and/or transection of tissue. Electrodes are connected to either a resectoscope working element or a high frequency cable. The electrodes are reusable.

The COMEG devices that we intend to market include the following endoscopic electrosurgical instruments and accessories: resectoscope and laser-resectoscope working elements; Albarran deflectors; urethrotomes (urethrotome bridges, obturators, and knives); high frequency cable; and, electrodes. A "Quick-Connection" feature is used to attach the device to the sheath or working element.

Endoscopic electrosurgical instruments and accessories are described in endoscope and accessories 21 CFR 8876.1500, urethrotomes are described in 21 CFR §876.4770, and endoscope ESU unit and accessories are described in 21 CFR §876.4300.

The Resectoscope and Laser Resectoscope Working Elements are intended to be used in urological procedures to endoscopically remove, cut, coagulate, and/or transect tissue in the bladder, prostate, and/or urethra. The surgeon performs the examination through the urethra. The working elements are devices that house and control the various electrodes and lasers used to remove, cut, coagulate, and transect tissue. The doctor controls the back and forth movement of the electrode using finger controls. The working elements also house a cystoscope for visualization. The high frequency cable transmits electrical current.

These devices are composed of stainless steel chrome plated, plastic, and brass chrome plated. The high frequency cable is composed of silicone.

Albarran deflectors are intended for use in urological procedures to control the flexible instrumentation that is passed through the COMEG cystoscope sheaths.

These devices are composed of stainless steel chrome plated and brass chrome plated.

The intended use for the urethrotomes is in urological procedures to endoscopically cut and/or transect tissue (strictures) in the urethra. The surgeon performs this function through the urethra and will visually (cystoscope) find the location of the stricture in the urethra. Once the stricture is located a urethrotome will be extracted, cutting the affected area.

These devices are composed of stainless steel chrome plated, plastic, and brass chrome plated. The complete working unit is comprised of each of the models below plus a cystoscope.

The electrodes are intended to be used endoscopically in conjunction with COMEG resectoscopes, urethrotomes, or cystoscope sheaths. The purpose of the electrodes is for cutting, tissue removal, tissue vaporization, coagulation, and/or transection of tissue. Electrodes are connected to either a resectoscope working element or a high frequency cable. The electrodes are reusable.

These electrodes are composed of stainless steel, teflon, silicone, ultem (black plastic), tungsten, and silver.

The provided document is a 510(k) summary for COMEG Endoscopy Resectoscope and Laser-Resectoscope Working Elements, Albarran Deflectors, Urethrotomes, and Electrodes. This document focuses on demonstrating substantial equivalence to legally marketed predicate devices, not on proving device performance against specific acceptance criteria through a clinical study.

Therefore, the document does not contain the information requested in your prompt regarding acceptance criteria, study details, sample sizes, expert qualifications, adjudication methods, MRMC studies, standalone performance, or ground truth establishment.

Instead, the document primarily focuses on:

• Device Description: What the devices are and their components.
• Intended Use: The medical procedures and purposes for which the devices are designed.
• Comparison of Technical Characteristics: A statement that the subject devices are similar to predicate devices (Karl Storz and Circon ACMI) in terms of intended uses, materials, operational principles, and mode of action.

The FDA's review and approval letter (K971881) confirms that the device is "substantially equivalent" to predicate devices, which is the standard for 510(k) clearance. This process typically relies on demonstrating that the new device has the same intended use and similar technological characteristics as a predicate device, or that any differences do not raise new questions of safety and effectiveness. It does not usually require new clinical studies with detailed safety and effectiveness acceptance criteria if substantial equivalence can be demonstrated through other means (e.g., comparison to existing devices, bench testing, non-clinical performance data).

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