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The LAP-WAVE 3000 (P07) is an irrigation pump for minimally invasive surgery. It is used to facilitate the removal of debris and fluids during laparoscopic procedures by irrigation.

The LAP-WAVE 3000 (P07) (K990732) is an irrigation pump for minimally invasive surgery. It is used to facilitate the removal of debris and fluids during laparoscopic procedures by irrigation. Irrigation fluid is transported from the fluid container to the instrument inserted in the patient by means of a roller-wheel pump at the device and a disposable PVC tubing set. A trumpet valve instrument (not provided with device) is used to manipulate the flow of fluid into the patient. A pressure sensor at the device is used to regulate pressure at the instrument (trumpet valve). Irrigation is initiated by opening the instrument and discontinued by closing the instrument. Also, a tubing set for connection to a central suction system is provided with the device to allow for removal of the fluid from the patient.

The provided text describes a 510(k) premarket notification for the LAP-WAVE 3000 (P07) laparoscopic irrigation pump. It establishes substantial equivalence to a predicate device, the Surgipump (K935763). However, the document does not contain specific acceptance criteria or details of a study that proves the device meets such criteria in the way a modern medical device submission would.

Instead, the summary for this device relies on historical experience with similar devices and a literature review to assert safety and effectiveness.

Here's an attempt to answer your questions based on the provided text, highlighting what is
and isn't present:

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

The document does not specify formal acceptance criteria in a quantitative, measurable way that would typically be presented in a table for a performance study. It states qualitative performance characteristics.

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

• No specific test set or clinical study data is provided for the LAP-WAVE 3000 (P07).
• The justification for safety and effectiveness is based on "extensive experience with suction/irrigation systems in operative laparoscopy without complications" and a review of medical literature. This implies a large, retrospective summation of real-world usage from various sources over many years, rather than a controlled, prospectively collected dataset for this specific device.
• The provenance would be general clinical practice of laparoscopic irrigation/suction systems, likely international, given the references include German publications.

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. There was no specific test set requiring expert ground truth establishment for this device in the provided submission.

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

• Not applicable. No test set or expert adjudication process 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. The LAP-WAVE 3000 (P07) is a mechanical irrigation pump, not an AI-assisted diagnostic or decision-support tool. Therefore, an MRMC study and AI assistance metrics are irrelevant.

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

• Not applicable. This is a hardware device; the concept of a "standalone algorithm" is not relevant.

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

• The "ground truth" used is essentially historical clinical outcomes data (absence of reported complications over many years of use of similar devices) combined with expert consensus/established clinical practice as documented in relevant medical literature. The document argues that the procedure (laparoscopic irrigation/suction) is safe and effective based on widespread acceptance and lack of reported complications, and since the device's performance specifications align with these established requirements, the device itself is also safe and effective.

8. The sample size for the training set

• Not applicable. This device's approval is based on substantial equivalence to a predicate and general clinical experience with the procedure, not a machine learning model requiring a training set.

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

• Not applicable. (See point 8).

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The Arthro-Surgimat-2000 ECU is a high flow arthroscopic pump intended for fluid distention of the knee, shoulder, elbow, ankle and wrist joint cavities under optional voice-activation control during arthroscopic procedures. (21 C.F.R. & 888.1100).

The ARTHRO-SURGIMAT-2000 ECU is a high flow arthroscopic pump intended to distend joint cavities. The ARTHRO-SURGIMAT-2000 ECU is a modified version of and substantially equivalent to the device Arthro-Surgimat-1500 (K983910) manufactured by W.O.M. GmbH. W.O.M. also claims substantial equivalence to the Surgiflator-20 ECU (K981859) and the Linvatec Apex Universal Inrigation System (K933873).

With the exception of the following modifications, the ARTHRO-SURGIMAT-2000 ECU incorporates the same design features and accessories as the Arthro-Surgimat-1500 (K983910):

• A serial interface has been incorporated in the device to allow for surgeon selection of device settings ● utilizing the HERMES Operating Room Control Center (K980787). The external adjustment capability of the ARTHRO-SURGIMAT-2000 ECU is substantially equivalent to the device Surgiflator-20 ECU (K981859) manufactured by W.O.M. GmbH
• The maximum flow performance of the device has been increased from 1,5 Vmin. to 2 Vmin. The . flow performance of the ARTHRO-SURGIMAT-2000 ECU is substantially equivalent to the device Apex Universal Irrigation System (K933873) manufactured by Linvatec Corp.

The provided text is a 510(k) Summary for a medical device (arthroscopic pump) and does not contain the specific information required to complete the detailed table and answer the questions related to acceptance criteria, study design, and performance metrics typically associated with AI/software-as-a-medical-device (SaMD) clearances.

This document is for a hardware device, the ARTHRO-SURGIMAT-2000 ECU, an arthroscopic pump. The review process for such a device primarily focuses on demonstrating substantial equivalence to predicate devices in terms of design, materials, and intended use, rather than rigorous performance metric studies or AI algorithm validation.

Therefore, most of the requested information, such as "acceptance criteria and reported device performance" in the context of diagnostic accuracy, "sample sizes used for the test set," "number of experts," "adjudication method," "MRMC comparative effectiveness study," "standalone performance," "type of ground truth," and "training set details," is not applicable to this type of device submission and is not present in the provided text.

The document states:

• The ARTHRO-SURGIMAT-2000 ECU is a modified version of and substantially equivalent to the Arthro-Surgimat-1500 (K983910).
• Modifications include:
  • A serial interface for surgeon selection of device settings via the HERMES Operating Room Control Center (K980787).
  • Maximum flow performance increased from 1.5 l/min to 2 l/min, claimed to be substantially equivalent to the Apex Universal Irrigation System (K933873).

Essentially, the "study" proving the device meets acceptance criteria is the demonstration of substantial equivalence to predicate devices based on design and performance specifications (flow rate) for a physical pump, along with literature references describing the utility and safety of arthroscopic techniques.

Here's a breakdown of why the requested information is absent and what is available:

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

• Acceptance Criteria: Not explicitly stated as diagnostic performance metrics. The implicit acceptance criteria are that the device performs its intended function (fluid distention up to 2 l/min) safely and effectively, and is substantially equivalent to predicate devices.
• Reported Device Performance:
  • Maximum flow performance: 2 l/min (increased from 1.5 l/min of the previous version).
  • Integration with HERMES Operating Room Control Center for remote setting selection.

2. Sample sized 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 hardware device. No "test set" of data for diagnostic performance was used. The substantial equivalence relies on engineering specifications and comparison to existing 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)

• Not applicable. No ground truth for a diagnostic test was established.

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

• Not applicable.

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/SaMD device.

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

• Not applicable. This is a hardware device, not an algorithm.

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

• Not applicable.

8. The sample size for the training set

• Not applicable.

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

• Not applicable.

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The HYS-Surgiflator 150P is a hysteroscopic insufflator intended to distend the uterus by fillng the uterine cavity with a gas to facilitate viewing with a hysteroscope (21 C.F.R. § 884.1700).

The HYS-Surgiflator 150P is a hysteroscopic insufflator. It is substantially equivalent to the Hysteroflator OP, K922632/B, manufactured by W.O.M. GmbH. Differences include: reduced max. intrauterine pressure (150 mm Hg), preselection of desired pressure (15 - 150 mm Hg), incorporation of a venting valve for automatic pressure regulation, incorporation of an audible and visible overpressure alarm, and required use of a hydrophobic filter.

The provided text is a 510(k) premarket notification letter for the HYS-Surgiflator 150P, a hysteroscopic insufflator. This document focuses on establishing substantial equivalence to a predicate device, rather than presenting a detailed study with acceptance criteria, performance metrics, and sample sizes for a new, independent performance study of the HYS-Surgiflator 150P.

Therefore, many of the requested details about acceptance criteria, specific study designs (like MRMC or standalone), sample sizes, and ground truth establishment are not present in the provided text. The document primarily relies on the established safety and effectiveness of the predicate device and literature review to support the new device's substantial equivalence.

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

1. Table of Acceptance Criteria and Reported Device Performance:

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

• Not applicable/Not provided. This document is a 510(k) submission for substantial equivalence based on design comparison and literature review, not a new performance study requiring a test set of data samples. The comparison is against a legally marketed predicate device (Hysteroflator OP, K922632/B).

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

• Not applicable/Not provided. No new test set requiring expert ground truth establishment is described. The device's safety and effectiveness are supported by existing literature and the predicate device's history.

4. Adjudication method for the test set:

• Not applicable/Not provided. No test set requiring adjudication is mentioned.

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:

• No. This is a medical device (hysteroscopic insufflator), not an AI-driven image analysis or diagnostic tool. Therefore, an MRMC study and AI-related metrics are irrelevant and not performed.

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

• No. This is a medical device, not an algorithm. Standalone performance as described (algorithm only without human-in-the-loop) is not relevant.

7. The type of ground truth used:

• Existing literature and the performance of the legally marketed predicate device (Hysteroflator OP, K922632/B). The 510(k) submission states, "The utility and safety of hysteroscopic techniques using modern electronic hysteroscopic insufflators is thoroughly reported in the literature..." and details specific references for this.

8. The sample size for the training set:

• Not applicable/Not provided. This is not a machine learning model, so there is no training set.

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

• Not applicable/Not provided. As there is no training set, this question is not relevant.

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The Arthro-Surgimat-1500 is a high flow arthroscopic pump intended for fluid distention of the knee, shoulder, elbow, ankle, and wrist joint cavities during arthroscopic procedures.

The Arthro-Surgimat-1500 is a high flow arthroscopic pump intended to distend joint cavities. The Arthro-Surgimat-1500 is a modified version of and substantially equivalent to the device Arthro-Surgimat (K962114) manufactured by W.O.M. GmbH. The Arthro-Surgimat-1500 incorporates the same design features and accessories as the Arthro-Surgimat (K962114). The following modifications have been performed: 1. The device Arthro-Surgimat-1500 incorporates a software filter function referred to as the instrument recognition feature. The instrument recognition feature of the device measures the resistance of the tubing set and instrument being used and regulates the actual pressure accordingly. The instrument recognition feature of the device allows for a more accurate attainment of the desired intraarticular pressure. 2. The device Arthro-Surgimat-1500 incorporates an optional cable remote control for the adjustment of device parameters. Only those parameter which may be adjusted utilizing the user-interface (front panel) and the foot pedal may be adjusted utilizing the cable remote control.

The provided text is a 510(k) Summary for a medical device (Arthro-Surgimat-1500 arthroscopic pump) seeking substantial equivalence to a predicate device. It primarily discusses the device's function, modifications, and references existing literature on arthroscopic techniques. It does not contain information about acceptance criteria, specific device performance studies, sample sizes, expert involvement, or ground truth establishment.

Therefore, I cannot fulfill the request for a table of acceptance criteria and reported device performance or details about a study demonstrating the device meets those criteria, as this information is not present in the provided document.

The document states:

• The Arthro-Surgimat-1500 is a modified version of and substantially equivalent to the device Arthro-Surgimat (K962114).
• Modifications include a software filter for instrument recognition and an optional cable remote control.
• The utility and safety of arthroscopic techniques using modern electronic high flow pumps are discussed in referenced literature.

The 510(k) submission process for this type of device typically relies on demonstrating substantial equivalence to a predicate device through comparison of technological characteristics and indications for use, rather than conducting new performance studies that would involve acceptance criteria, test sets, experts, or ground truth as described in your request. Clinical performance studies with defined endpoints and statistical analyses are generally reserved for Pre-Market Approval (PMA) applications or when substantial equivalence cannot be demonstrated through non-clinical means.

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intraperitoneal high flow introduction of CO2 gas, under voice-activation control, for abdominal distention to facilitate laparoscopic vísualization

The Surgiflator-20 ECU described in this notification is a modified version of and substantially equivalent to the Surgiflator 20-PIM (K955791) which is manufactured by W.O.M. GmbH. The Surgiflator-20 ECU incorporates the same design features as the Surgiflator-20 PIM. The only difference is that the function adjustment feature of the Surgiflator-20 ECU has been modified. The modification consists of a serial interface to allow for surgeon selection of device settings utilizing the HERMES Operating Room Control Center (K980787).

The provided text is a 510(k) summary for the SURGIFLATOR-20 ECU, a laparoscopic insufflator. This document focuses on demonstrating substantial equivalence to a predicate device (Surgiflator 20-PIM) and does not contain the kind of detailed study data, acceptance criteria, or performance metrics typically found in clinical trial reports or academic papers for devices that rely on complex algorithms or diagnostic capabilities.

Instead, the submission leverages existing literature and the substantial equivalence pathway for a modified version of an already cleared device. Therefore, the requested information regarding acceptance criteria, study details, sample sizes, ground truth, and expert involvement is not available within this document.

Here's how the provided information relates to your request:

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

   • Not available. The document states the device "incorporates the same design features" as the predicate and the "only difference" is a modification to a function adjustment feature (serial interface for surgeon selection of device settings via the HERMES Operating Room Control Center). This suggests that the acceptance criteria for performance would implicitly be the same as the predicate, but these are not explicitly stated or quantified in this 510(k) summary. No specific performance data for the modified device is reported.

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. There is no mention of a dedicated test set or clinical study for the SURGIFLATOR-20 ECU in this document. The submission relies on existing literature and the equivalence to a previously cleared device.

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. No ground truth establishment is described as there's no test set or clinical study.

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

   • Not available. No test set or related adjudication process 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 laparoscopic insufflator, not an AI-powered diagnostic or assistive tool for human readers. Therefore, an MRMC study related to AI assistance is irrelevant.

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

   • Not applicable. This is a hardware device; no standalone algorithm performance is relevant or described.

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

   • Not available. No ground truth is described. The safety and effectiveness are supported by referencing existing literature on laparoscopic techniques and the substantial equivalence to a predicate device.

8. The sample size for the training set:

   • Not applicable. This device does not involve machine learning or a training set.

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

   • Not applicable. This device does not involve machine learning or a training set.

Summary of Device Rationale provided in the document:

The argument for safety and effectiveness is based on:

• Substantial Equivalence: The SURGIFLATOR-20 ECU is a modified version of the SURGIFLATOR 20-PIM (K955791), with the only difference being a modified function adjustment feature (serial interface to allow surgeon selection of device settings utilizing the HERMES Operating Room Control Center).
• Existing Literature: The submission references several books detailing the utility and safety of laparoscopic techniques and the use of high-flow insufflators. This literature serves as general background and support for the established safety and efficacy of the procedure and device type, rather than presenting specific study data for the new device. The provided references are:
  • "Operative Laparoscopy" by M.-A. Bruhat, 1992.
  • "Laparoscopy in gynecology, surgery and pediatrics" by H. Frongenheim, 1977.
  • "Minimal Invasive Surgery" by John G. Hunter and Jonathan M. Sackier, 1993.

In conclusion, this 510(k) summary uses the substantial equivalence pathway and reliance on established medical literature for the device type, rather than presenting a de novo study with specific acceptance criteria, performance metrics, or ground truth data for the modified device itself.

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To facilitate the use of the laparoscope by filling the peritoneal cavity with gas to distend it.

The Surgiflator-30 is a laparoscopic high flow insufflator intended to facilitate the use of the laparoscope by filling the peritoneal cavity with gas to distend it. The Surgifiator-30 incorporates the same design features as the W.O.M. Surgifiator 20-PIM. The only differences lie in the following: Surgiflator-30 offers an increased flow rate of max. 30 Vmin. The device will also be available as a 25 Vmin version. The Surgifiator-30 does not offer optional simultaneous pressure monitoring.

The provided text is a 510(k) summary for a medical device called the SURGIFLATOR 30, a laparoscopic insufflator. This type of regulatory submission historically focused on demonstrating substantial equivalence to a predicate device already on the market, rather than conducting new clinical trials with detailed acceptance criteria and performance data as might be seen for novel devices today.

Therefore, the document does not contain the typical information requested regarding acceptance criteria, a specific study proving it, sample sizes, expert involvement for ground truth, or an MRMC comparative effectiveness study. The basis for clearance is demonstrating substantial equivalence to existing devices.

Here's an analysis of what can be extracted or inferred based on the document's nature:

Acceptance Criteria and Device Performance

Since this is a 510(k) submission from 1997, the "acceptance criteria" are broad and relate to demonstrating substantial equivalence to predicate devices already on the market. The primary "performance" reported is related to an increased flow rate.

Study Information (Based on 510(k) Context)

1. Sample size used for the test set and the data provenance:

   • Not applicable / Not provided. A formal "test set" in the sense of a clinical study or performance study with a specific sample size is not described. The basis for safety and effectiveness relies on comparison to predicate devices and general medical literature.

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

   • Not applicable / Not provided. Ground truth establishment for a test set is not detailed as there isn't a described performance study with a test set. The "ground truth" for the device's utility and safety is implicitly drawn from established medical literature and the long history of laparoscopic procedures and insufflators.

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

   • Not applicable / None. No formal adjudication method is mentioned as there isn't a described test set needing ground truth adjudication.

4. 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:

   • No. This is a medical device for laparoscopic insufflation, not an AI or imaging diagnostic device. Therefore, an MRMC study is not relevant or described.

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

   • Not applicable. This device is a physical medical instrument (an insufflator), not an algorithm or AI.

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

   • The "ground truth" for the device's safety and effectiveness relies on a combination of historical clinical experience and established medical literature regarding laparoscopic techniques and the use of high-flow insufflators. The document cites several medical textbooks to support the general safety and utility of such devices.

7. The sample size for the training set:

   • Not applicable / Not provided. This is not an AI/ML device where a "training set" would be used.

8. How the ground truth for the training set was established:

   • Not applicable / Not provided. As above, no training set is relevant to this device submission.

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The Surgiflator-20 PIM is a laparoscopic high flow insufflator intended to fill the abdominal cavity with CO2 to enable laparoscopic procedures.

The Surgiflator-20 PIM is a laparoscopic high flow insufflator intended to fill the abdominal cavity with CO2 to enable laparoscopic procedures. The Surgiflator-20 PIM described in this notification is similar in design and construction to the W.O.M. Surgiflator 20, K950035 and the Snowden-Pencer High Flow Insufflator, Model 89-8600 and Model SP 88-9700, distributed in the United States by Snowden-Pencer, Inc. The Surgiflator-20 PIM incorporates the same design features as the W.O.M. Surgiflator 20. The differences lie in the following features: Low pressure insufflation mode - fills the abdomen more gently; Fluid sensor: shows the user when the device is contaminated by backflow; Simultaneous pressure monitoring: monitoring of the pressure directly in the abdomen.

The provided text describes a medical device, the Surgiflator-20 PIM, which is a laparoscopic high-flow insufflator. However, the text does not contain the information requested in your bulleted list regarding acceptance criteria and the specifics of a study proving device performance.

Specifically, the document is a 510(k) Summary, which typically focuses on demonstrating substantial equivalence to a predicate device, rather than presenting detailed study results with acceptance criteria.

Here's a breakdown of why the information is missing from the provided text:

• Acceptance Criteria and Reported Device Performance: This information is entirely absent. The document states the device is "similar in design and construction" to predicate devices and highlights some differences, but it does not provide any quantitative or qualitative performance metrics, let alone specific acceptance criteria for those metrics.
• Sample size, data provenance, number of experts, adjudication method, MRMC study, standalone performance, type of ground truth, training set size, ground truth for training set: All of these points relate to specific details of a clinical or performance study that are not included in this 510(k) summary. The document makes general statements about the utility and safety being "thoroughly reported in the literature" and refers to books on "Operative Laparoscopy" and "Minimal Invasive Surgery" as background information, but these are general references to the field, not specific studies on the Surgiflator-20 PIM with the requested data.

Therefore, I cannot populate the requested table or answer the specific questions about the study from the provided text. The text primarily focuses on establishing similarity to predicate devices and referencing general literature about laparoscopic techniques and insufflators.

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The Arthro-Surgimat is a high flow arthroscopic pump classified under 21 C.F.R. § 888.1100 intended to distend joint cavities during arthroscopic procedures.

The Arthro-Surgimat is a high flow arthroscopic pump designed to react very quickly to various influences, thereby maintaining constant intraarticular pressure. It has pressure measurement through multiple sensors at the pump head, 3 optional preselectable pressure levels (to be programmed by end-user), a max. flow rate of 1500 ml/min, and a foot pedal for temporary increase of preselected flow level for rinsing of joint after/during shaver use.

The provided text does not contain information about acceptance criteria for a medical device or a study detailing its performance against such criteria. Instead, it describes a 510(k) Summary for the Arthro-Surgimat, a high-flow arthroscopic pump.

The document discusses:

• Device Description: The Arthro-Surgimat is an arthroscopic pump for distending joint cavities.
• Substantial Equivalence: It claims substantial equivalence to two predicate devices: Linvatec Apex Universal Irrigation System (K933873) and Smith & Nephew InteliJET Fluid Management System (K912453).
• Key Differences from Predicate Devices: These include pressure measurement points, preselectable pressure levels, max flow rate, and foot pedal features.
• Safety and Utility References: It cites two books (Hempfling, 1995 and McGinty, 1995) to generally discuss the utility and safety of arthroscopic techniques and high-flow pumps, mentioning the importance of effective instrumentation.

Therefore, I cannot populate the requested table and answer the specific questions about acceptance criteria and a study proving device performance because this information is not present in the provided text.

The text focuses on establishing substantial equivalence for a 510(k) submission, which typically relies on demonstrating that a new device is as safe and effective as a legally marketed predicate device, rather than providing detailed performance study results against specific acceptance criteria.

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