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The PercuTx - Injection /Aspiration Needle device is indicated for use as an accessory for currently marketed endoscopes to provide for delivery of injectable materials into tissues during endoscopic procedures.

As with currently marketed endoscopic injection needles, the PercuTx Endoscopic Injection needle device may be used in a variety of endoscopic procedures for the delivery of a variety of injectable materials which have received approval for use by the FDA. The type of material to be injected will be dependent on the nature of the endoscopic procedure, but such materials may include for example: delivery of collagen during cystoscopic procedures; delivery of sclerosing agents during esophagoscopic, and gastroscopic procedures; delivery of local anesthetics during cystoscopic or laryngoscopic procedures; or delivery of saline or contrast media during colonoscopic.

PercuTxTM Injection/Aspiration Needle Probes with Control Handpiece

It appears the provided document is a 510(k) clearance letter from the FDA for a medical device called "PercuTxTM Injection/Aspiration Needle Probes with Control Handpiece". This type of document does not typically include detailed information about acceptance criteria, study designs, or performance metrics in the way a clinical study report or a premarket approval (PMA) application would.

510(k) clearance is based on demonstrating "substantial equivalence" to a legally marketed predicate device, not necessarily on new clinical performance data that would involve detailed acceptance criteria and studies as requested in the prompt. While some 510(k) submissions might include performance testing, the provided letter itself does not contain that information.

Therefore, I cannot provide the requested information based on the given text. The text only states that the device is "substantially equivalent" to predicate devices and provides its intended use.

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The Injection/ Aspiration probes and devices are to be used independently or with commercially available rigid and flexible endoscopes, including laparoscopes, hysteroscopes, cystoscopes, resectoscopes, and suction/irrigation systems. These devices can be used for laparoscopic, hysteroscopic, cystoscopic, and other endoscopic and open surgical procedures designed for injection and aspiration of fluids and solutions in the tissue or body. This device is not intended for injection of drugs.

Injection/Aspiration Needles Probes/Devices

The provided text is a decision letter from the FDA regarding a 510(k) premarket notification for "Injection/Aspiration Needle Probes/Devices." It states that the devices are substantially equivalent to legally marketed predicate devices.

However, the document does not contain any information regarding acceptance criteria, device performance, sample sizes used for testing, data provenance, expert qualifications, adjudication methods, MRMC studies, standalone performance, types of ground truth used, or training set details.

Therefore, I cannot extract the requested information from the provided text. The document's purpose is to grant market clearance based on substantial equivalence, not to detail the performance study results.

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The TUNIS™ probes and devices are to be used independently or with commercially available rigid and flexible endoscopes, including laparoscopes, hysteroscopes, cystoscopes, resectoscopes for transurethral injection procedures. These devices can be used for laparoscopic, hysteroscopic, cystoscopic, and other endoscopic & open surgical procedures designed for interstitial injection/aspiration of biomaterials, fluids and solutions in the urinary bladder and lower urinary tract.

TUNIS™ - Transurethral Injection System Probe/Device

This document is a 510(k) clearance letter from the FDA for a medical device called the "Tunis™ Transurethral Injection/Aspiration System Probe Device." It signifies that the device has been found substantially equivalent to a predicate device and can be marketed.

Crucially, this document does not contain information about acceptance criteria, device performance details, or any study results proving the device meets acceptance criteria.

The 510(k) clearance process focuses on substantial equivalence to a legally marketed predicate device, ensuring similar safety and effectiveness. It does not typically require the submission of detailed performance studies against specific acceptance criteria in the same way a pre-market approval (PMA) would for novel, high-risk devices.

Therefore, I cannot extract the requested information from the provided text. To answer your questions, one would need access to the original 510(k) submission document (K983765) itself, which might contain summaries of performance testing, albeit less rigorous than what's typically expected for a PMA.

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electrosurgical probes and devices are to be used with The commercially available R.F. generators, endoscopes including laparoscopes, hysteroscopes, resectoscopes, cystoscopes and suction/irrigation systems. These devices can be used for lappeoscopic. hysteroscopic, cystoscopic, resectoscopic and other endoscopic and open surgical procedures including TURP, BPH, prostate surgery, and other soft tissue removal using cutting/coagulation/ablation mode of R.F. energy.

Isolated Electrosurgical Probes & Devices-Salinetrode™M (cutting loops, roller balls, roller bars/barrels, and needles/blades)

I am sorry, but the provided text does not contain any information about acceptance criteria, device performance, study details, sample sizes, ground truth establishment, or expert qualifications. The document is an FDA 510(k) clearance letter for an electrosurgical device, confirming its substantial equivalence to a predicate device and outlining regulatory information. It does not include data from a clinical or performance study.

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The electrosurgical probes and devices are to be used with commercially availbale R.F. Generators, endoscopes, and suction/irrigation sytems. These devices can be used for laparoscopic, hysteroscopic, endoscopic and open surgical procedures designed for soft tissue removal using coagulation/ablation/vaporization mode of R.F. energy.

Isolated Electrosurgical Probe/Device-Salinetrode

The provided document is a 510(k) clearance letter from the FDA for an electrosurgical device (Salinetrode™) from February 1998. It primarily addresses the regulatory status (substantial equivalence) of the device to previously marketed predicate devices.

This type of document (a 510(k) clearance letter) does not contain the detailed technical study information you are asking for.

Specifically, a 510(k) clearance letter:

• Does not include acceptance criteria for device performance. It confirms that the device is "substantially equivalent" to a predicate device, meaning it has the same intended use and technological characteristics, or different characteristics that do not raise new questions of safety and effectiveness.
• Does not include specific study data, sample sizes, expert qualifications, or ground truth methodologies. These details would be found in the 510(k) submission itself, which is typically a much more extensive document that includes performance data, bench testing, and potentially clinical studies, depending on the device and its risk profile.
• Does not discuss multi-reader multi-case (MRMC) studies or standalone algorithm performance, as this device is a physical electrosurgical probe, not an AI/software device.

Therefore, I cannot provide the requested information based on the input text. The document only confirms the device's regulatory clearance based on substantial equivalence, not its specific performance metrics or the studies backing them up.

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The electrosurgical probes and devices are to be used with commercially available R.F. generators, endoscopes including hysteroscopes, resectoscopes, cystoscopes and laparoscopes, suction/irrigation systems. These devices can be used for laparoscopic, hysteroscopic, cystoscopic, resectoscopic and other endoscopic and open surgical procedures including TURP, BPH, prostate surgery, and other soft tissue removal using cutting/coagulation/ablation mode of R.F. energy.

Electrodes/Probes/Devices

This is a 510(k) premarket notification letter from the FDA to Ximed Medical/ProSurg, Inc. regarding their "Electrodes/Probes/Devices."

The document states that the FDA has reviewed the 510(k) notification and determined that the device is "substantially equivalent" to predicate devices. This letter approves the device for marketing.

However, this document does not contain any information about acceptance criteria, performance studies, sample sizes, expert qualifications, adjudication methods, MRMC studies, standalone performance, or training set details.

The information provided (K974637) is a regulatory approval document, not a clinical study report or a performance specification document. Therefore, I cannot extract the requested information from the provided text.

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Ask a specific question about this device