(122 days)
The Automatic Continuous Effusion Shunt (ACES) System is indicated for use in adult (>21 years of age) patients with • chylothorax • intractable aseptic pleural effusion
The ACES System is an implanted pleural-peritoneal shunt system intended to palliate symptoms of recurrent pleural effusion, an accumulation of fluid in the cavity around the lungs. The ACES System comprises a pump that is, generally, a resilient flexible bulb having an inlet and an outlet. The inlet is attached to a first fenestrated barium striped tube that extends from the inlet valve to the patient's pleural cavity. The outlet is connected to a second fenestrated barium striped tube that extends from the outlet valve to the patient's peritoneal cavity. Each one-way valve is connected to a single pump chamber with an internal automatic pump extension and external manual compression and an integrated implant securement flange for suture fixation in the muscular facia. Internal (intercostal) automatic (passive) pump extension is placed between adjacent ribs in the external (subdermal) manual compression (active) pump extension is positioned under the skin and external to the ribs. Using a patient's own respiration, the internal automatic pump extension operates by being successively compressed and decompressed between adjacent ribs, as the patient breathes, whereby pumping the fluid from the pleural cavity to the peritoneal cavity, where it is naturally reabsorbed by the external manual compression pump extension allows for intraprocedural priming of the pump chamber as well as manual compression by the patient, post procedurally, at will or as directed by their physician for movement of fluid from the pleural cavity to the peritoneal cavity.
Here's a breakdown of the acceptance criteria and study information for the Automatic Continuous Effusion Shunt (ACES) System, based on the provided FDA 510(k) summary:
This device is a Class II medical device (Peritoneo-venous shunt), product code KPM. Its primary function is to move fluid from the pleural cavity to the peritoneal cavity in adult patients with chylothorax or intractable aseptic pleural effusion.
1. Table of Acceptance Criteria and Reported Device Performance
The provided document primarily details non-clinical performance and biocompatibility testing. It doesn't present specific numerical acceptance criteria (e.g., "flow rate must be X mL/day") with corresponding numerical performance results. Instead, for most tests, the acceptance criterion is implied as "Pass" and the reported performance is simply "All samples passed the acceptance criteria."
| Test Category | Test Method Summary | Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|---|---|
| Simulated Use | Visual Inspection | Pass | All samples passed |
| Pressure Testing | Pass | All samples passed | |
| Chamber Pumping (Automatic) | Pass | All samples passed | |
| Bulb Pumping (Manual) | Pass | All samples passed | |
| Chamber Flowrate (Automatic) | Pass | All samples passed | |
| Bulb Flowrate (Manual) | Pass | All samples passed | |
| Destructive | Tensile | Pass | All samples passed |
| Burst | Pass | All samples passed | |
| Backflow | Backflow | Pass | All samples passed |
| Securement | Suture Pull Out Force | Pass | All samples passed |
| Coating | Vertical Pinch Test | Pass | All samples passed |
| Coating Length Verification | Pass | All samples passed | |
| Toluidine Blue & Finger Rub Test | Pass | All samples passed | |
| Packaging | Withstand ISTA 3A and ASTM D-4169; DC13; AL1 without loss of function, sterility, or legibility. | Pass | All samples passed |
| Shelf-Life | Withstand simulated storage conditions without loss of function, sterility, or legibility. | Pass | All samples passed |
| Sterilization | Validate a minimum SAL of 10-6 for Gamma radiation. | Pass | All samples passed |
| Biocompatibility | Cytotoxicity (MEM Elution Cytotoxicity Assay) | Non-cytotoxic | Non-cytotoxic |
| Sensitization (Guinea Pig Maximization Test) | Non-sensitizer | Non-sensitizer | |
| Irritation/Intracutaneous Reactivity (Intracutaneous Reactivity Test) | Non-irritant | Non-irritant | |
| Material Mediated Pyrogenicity (Material Mediated Pyrogenicity Test) | Non-pyrogenic | Non-pyrogenic | |
| Acute Systemic Toxicity (Acute Systemic Toxicity Test) | Non-toxic | Non-toxic | |
| Subacute/Subchronic Toxicity (31-Day Systemic Toxicity & Implant Evaluation in Rabbits) | No systemic toxic effects | No systemic toxic effects | |
| Implantation Effects (91-Day Systemic Toxicity & Implant Evaluation in Rabbits) | No systemic toxic effects, | No systemic toxic effects, | |
| Genotoxicity (Ames Bacterial Reverse Mutation Assay, Mouse Lymphoma Assay) | Non-mutagenic | Non-mutagenic |
Note: The document states that the biocompatibility evaluation supports an implant duration of 12 months, beyond which removal is recommended, and that chronic toxicity and carcinogenicity were "Not evaluated".
2. Sample Size Used for the Test Set and Data Provenance
The document does not explicitly state the numerical sample sizes for each test in the "Non-Clinical Performance Tests" or "Biocompatibility" sections. For most tests, it simply states "All samples passed the acceptance criteria."
- Test Set Sample Size: Not specified numerically for individual tests.
- Data Provenance: Not explicitly stated (e.g., country of origin, retrospective/prospective). However, given this is a 510(k) summary for a US FDA submission, the tests were likely conducted in accordance with recognized international standards (ISO, ASTM) and GLP (Good Laboratory Practice) guidelines, often performed by contract research organizations. The testing appears to be prospective bench and animal (biocompatibility) testing rather than human clinical data.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Their Qualifications
This information is not applicable as the studies described are non-clinical (bench and animal testing). There is no "ground truth" established by human experts in the context of diagnostic performance for these types of engineering and biological safety tests. The ground truth for these tests is defined by the objective measurement and standards outlined in the test methods.
4. Adjudication Method for the Test Set
This is not applicable for non-clinical performance and biocompatibility testing. Adjudication methods like 2+1 or 3+1 are used in clinical studies, especially for evaluating diagnostic performance where expert disagreement needs to be resolved.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done
No, a MRMC comparative effectiveness study was not done. The provided document details bench and biocompatibility testing for a medical device (a shunt system), not a diagnostic algorithm that requires human reader interpretation. No mention of AI assistance or human reader improvement appears in this summary.
6. If a Standalone Study Was Done (Algorithm Only Without Human-in-the-Loop Performance)
This is not applicable. The ACES System is a physical medical device, not a software algorithm or AI model.
7. The Type of Ground Truth Used
For the non-clinical performance tests, the "ground truth" is based on pre-defined engineering specifications, standard test methods (e.g., pressure thresholds, flow rates, tensile strength values), and visual inspection criteria.
For biocompatibility tests, the "ground truth" is based on established biological safety endpoints and accepted international standards (ISO, USP) for reactions in in-vitro assays and animal models. For example, "non-cytotoxic," "non-sensitizer," and "no systemic toxic effects" represent the ground truth for biological safety.
8. The Sample Size for the Training Set
This is not applicable. The ACES System is a physical medical device, not a machine learning model. There is no "training set."
9. How the Ground Truth for the Training Set Was Established
This is not applicable as there is no training set for a physical medical device.
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August 18, 2023
Pleural Dynamics, Inc. % Joseph Ostendorf Regulatory Affairs Consultant Ostendorf Consulting, LLC 23879 Blue Spruce Road Sauk Centre, Minnesota 56378
Re: K231096
Trade/Device Name: Automatic Continuous Effusion Shunt (ACES) System Regulation Number: 21 CFR 876.5955 Regulation Name: Peritoneo-Venous Shunt Regulatory Class: Class II Product Code: KPM Dated: July 27, 2023 Received: July 27, 2023
Dear Joseph Ostendorf:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal
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statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
Glenn B. Bell -S
for Gema Gonzalez Acting Assistant Director DHT3A: Division of Renal, Gastrointestinal, Obesity and Transplant Devices OHT3: Office of GastroRenal, ObGyn, General Hospital and Urology Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known) K231096
Device Name
Automatic Continuous Effusion Shunt (ACES) System
Indications for Use (Describe)
The Automatic Continuous Effusion Shunt (ACES) System is indicated for use in adult (>21 years of age) patients with • chylothorax
• intractable aseptic pleural effusion
| Type of Use (Select one or both, as applicable) |
|---|
| ------------------------------------------------- |
| Construction Use (Part 41 CFR 60-1 Subpart B) |
|---|
| On-Site Construction (41 CFR 60-4 Subpart A) |
|× | Prescription Use (Part 21 CFR 801 Subpart D)
| | Over-The-Counter Use (21 CFR 801 Subpart C)
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Pleural Dynamics, Inc. 510(k) Summary
This summary of 510(k) safety and effectiveness information is submitted in accordance with the requirements of SMDA 1990 and 21 CFR 807.92.
| 510(k) Number: | K231096 |
|---|---|
| Date Prepared: | August 17, 2023 |
| Applicant: | Pleural Dynamics, Inc.952 Medina RoadWayzata, MN 55391+1 (763) 501-7223 |
| Contact Person: | Joseph OstendorfRegulatory Affairs Consultant23879 Blue Spruce RoadSauk Centre, MN 56378 |
| SUBJECT DEVICE | |
| Trade/Device Name: | Automatic Continuous Effusion Shunt (ACES) System |
| Device Regulation Number: | 21 CFR § 876.5955 |
| Device / Regulation Name: | Peritoneo-venous shunt |
| Regulation Description /Common Name: | Shunt, Peritoneal |
| Product Code: | KPM |
Class II
Device Class / Regulation
Classification:
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DEVICE DESCRIPTION (For the Device Subject to this 510(k) Premarket Notification)
The ACES System is an implanted pleural-peritoneal shunt system intended to palliate symptoms of recurrent pleural effusion, an accumulation of fluid in the cavity around the lungs.
The ACES System comprises a pump that is, generally, a resilient flexible bulb having an inlet and an outlet. The inlet is attached to a first fenestrated barium striped tube that extends from the inlet valve to the patient's pleural cavity. The outlet is connected to a second fenestrated barium striped tube that extends from the outlet valve to the patient's peritoneal cavity. Each one-way valve is connected to a single pump chamber with an internal automatic pump extension and external manual compression and an integrated implant securement flange for suture fixation in the muscular facia. Internal (intercostal) automatic (passive) pump extension is placed between adjacent ribs in the external (subdermal) manual compression (active) pump extension is positioned under the skin and external to the ribs.
Using a patient's own respiration, the internal automatic pump extension operates by being successively compressed and decompressed between adjacent ribs, as the patient breathes, whereby pumping the fluid from the pleural cavity to the peritoneal cavity, where it is naturally reabsorbed by the external manual compression pump extension allows for intraprocedural priming of the pump chamber as well as manual compression by the patient, post procedurally, at will or as directed by their physician for movement of fluid from the pleural cavity to the peritoneal cavity.
INDICATIONS FOR USE (For the Device Subject to this 510(k) Premarket Notification)
The Automatic Continuous Effusion Shunt (ACES) System is indicated for use in adult (>21 years of age) patients with
- chylothorax
- intractable aseptic pleural effusion
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DEVICE CLASSIFICATION, INTENDED USE/INDICATIONS FOR USE, AND TECHNOLOGICAL AND PERFORMANCE CHARACTERISTICS COMPARISONS
The following tables provide a side-by-side comparison of the ACES System to the predicate and reference devices to support this pre-market notification.
| Device Classification Comparison | ||||
|---|---|---|---|---|
| Subject DeviceK231096 | Predicate DeviceK822686 | Reference DeviceK012235 | Reference DeviceK912645 | |
| Trade/DeviceName: | AutomaticContinuousEffusion Shunt(ACES) System | Denver Peritoneo-Venous Shunt | Denver PleuralEffusion Shunt andDenver PleuralEffusion Shunt withExternal PumpChamber | Atriums PDRThoracic Catheter |
| RegulationMedical Specialty | Gastroenterology /Urology | Gastroenterology /Urology | Gastroenterology /Urology | General & PlasticSurgery |
| Device RegulationNumber: | 21 CFR § 876.5955 | 21 CFR § 876.5955 | 21 CFR § 876.5955 | 21 CFR § 878.4200 |
| Device /Regulation Name: | Peritoneo-venousshunt | Peritoneo-venousshunt | Peritoneo-venousshunt | Introduction/drainagecatheter andaccessories |
| RegulationDescription /Common Name: | Shunt, Peritoneal | Shunt, Peritoneal | Shunt, Peritoneal | Catheter.Ventricular, General& Plastic Surgery |
| Product Code: | KPM | KPM | KPM | GBS |
| Device Class /RegulationClassification: | Class II | Class II | Class II | Class I |
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| Intended Use/Indications for Use Comparison | ||||
|---|---|---|---|---|
| Subject DeviceK231096 | Predicate DeviceK822686 | Reference DeviceK012235 | Reference DeviceK912645 | |
| IntendedUse | The AutomaticContinuous EffusionShunt (ACES)System is intended tomove fluid from onelocation in the bodyto another. | The DenverPeritoneo-VenousShunt is intended tomove fluid from onelocation in the bodyto another. | The Denver PleuralEffusion Shunt isintended to movefluid from onelocation in the bodyto another. | The Atriums PDRThoracic Catheter isintended to allowmovement of fluidfrom the body. |
| Indicationsfor Use | The AutomaticContinuous EffusionShunt (ACES) Systemis indicated for use inadult (>21 years ofage) patients withchylothorax intractableaseptic pleuraleffusion | Unknown | The Denver PleuralEffusion Shunt isindicated for use inpatients with chylothorax intractableaseptic pleuraleffusionThe Denver PleuralEffusion Shunt withExternal PumpChamber is indicatedfor adult, pediatric,and neonatal patientswith chylothorax intractableaseptic pleuraleffusion | Atrium thoraciccatheters are intendedto facilitate theevacuation of airand/or fluid from thechest cavity ormediastinum. |
| Technological and Performance Characteristics Comparison | |||||
|---|---|---|---|---|---|
| Subject DeviceK230196 | Predicate DeviceK822686 | Reference DeviceK012235 | Reference DeviceK912645 | ||
| Manufacturer | Pleural Dynamics,Inc. | BD(Becton, Dickinsonand Company) | BD(Becton, Dickinsonand Company) | Atrium MedicalCorporation(MAQUETCardiovascular,LLC) | |
| Construct | Single PumpChamber withDouble Valves andPleural andPeritoneal Limbs | Single PumpChamber withValves withPeritoneal andVenous Limbs | Single PumpChamber withDouble Valves andPleural andPeritoneal Limbs | Single Limb Tube | |
| Materials ofConstruction | Pump Chamber:SiliconeLimbs: Siliconewith BariumSulfate Stripe | Pump Chamber:SiliconeLimbs: Siliconewith BariumSulfate Stripe | Pump Chamber:SiliconeLimbs: Siliconewith BariumSulfate Stripe | Limb: Silicone orPolyvinyl Chloridewith RadiopaqueStripe | |
| Surface Treatment | Yes - CovalentlyBonded HeparinCoating | Yes - IonicallyBonded Heparin | None Known | Yes - CovalentlyBonded HeparinCoating | |
| Technological and Performance Characteristics Comparison | |||||
| Subject DeviceK230196 | Predicate DeviceK822686 | Reference DeviceK012235 | Reference DeviceK912645 | ||
| PlacementTechnique | SeldingerTechnique | SeldingerTechnique | SeldingerTechnique | Surgical Technique | |
| Design Intent | Placed internally,relative to the skin,with an extensionof the pumpchamber positionedbetween adjacentribs to managepleural effusion bymoving fluid fromthe pleural cavity tothe peritonealcavity. | Placed internally orexternally, relativeto the skin, with aportion of theperitoneal tubepositioned acrossthe abdominal wallto manage ascitesby moving fluidfrom the peritonealcavity to the venoussystem. | Placed internally orexternally, relativeto the skin, with aportion of thepleural tubepositioned betweenadjacent ribs tomanage pleuraleffusion by movingfluid from thepleural cavity to theperitoneal cavity. | Placed partiallyinternal andpartially external,relative to the skin.with a portion ofthe tube positionedbetween adjacentribs to drain thecavity by movingfluid or air from thepleural cavity toexterior of thebody. | |
| Principles ofOperation | Pleural effusionshunts arepermanently placeddrainagemanagementsystems designed tomove fluid from thepleural cavity to theperitoneal cavity. | Peritoneo-Venousshunts arepermanently placeddrainagemanagementsystems designed tomove fluid from theperitoneal cavity tothe venous system. | Pleural effusionshunts arepermanently placeddrainagemanagementsystems designed tomove fluid from thepleural cavity to theperitoneal cavity. | Thoracic cathetersare temporarilyplaced accessdevices designed tomove fluid from thethorax to theexterior of thebody. | |
| Tubing Length | 30 cm | Unknown | Unknown | Unknown | |
| Tubing InnerDiameter | 2.64 mm | Unknown | Unknown | Unknown | |
| Tubing OuterDiameter | 4.88 mm | Unknown | Unknown | Unknown | |
| Pump | Automatic | 250 – 750 mL/day | N/A | N/A | N/A |
| FluidFlowRate | Manual | Approximately2 mL per completepump compression | Unknown | Approximately2 mL per completepump compression | N/A |
| Implantable | Yes | Yes | Yes | Yes | |
| Single Patient Use | Yes | Yes | Yes | Yes | |
| Design PreventsBackflow | Yes | Yes | Yes | No | |
| Biocompatible | Yes | Yes | Yes | Yes | |
| Provided Sterile | Yes | Yes | Yes | Yes |
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SUMMARY OF PERFORMANCE TESTING AND STANDARDS
Performance testing was conducted to evaluate and characterize the performance of the device to support a determination of substantial equivalence to the predicate and reference devices, where applicable. A comparison was made against the predicate and reference devices, where data was available. The ACES System has undergone bench, biocompatibility, packaging, and sterilization testing to demonstrate the differences in technological characteristics do not raise different questions of safety and effectiveness.
| Non-Clinical Performance Tests | ||
|---|---|---|
| Test | Test Method Summary | Results and Conclusions |
| Simulated Use | Visual Inspection | Pass – All samples passed the acceptance criteria |
| Pressure Testing | Pass – All samples passed the acceptance criteria | |
| Chamber Pumping (Automatic) | Pass – All samples passed the acceptance criteria | |
| Bulb Pumping (Manual) | Pass – All samples passed the acceptance criteria | |
| Chamber Flowrate (Automatic) | Pass – All samples passed the acceptance criteria | |
| Bulb Flowrate (Manual) | Pass – All samples passed the acceptance criteria | |
| Destructive | Tensile | Pass – All samples passed the acceptance criteria |
| Burst | Pass – All samples passed the acceptance criteria | |
| Backflow | Backflow | Pass – All samples passed the acceptance criteria |
| Securement | Suture Pull Out Force | Pass – All samples passed the acceptance criteria |
| Coating | Vertical Pinch Test | Pass – All samples passed the acceptance criteria |
| Coating Length Verification | Pass – All samples passed the acceptance criteria | |
| Toluidine Blue & Finger Rub Test | Pass – All samples passed the acceptance criteria | |
| Packaging | The packaged device and labeling shall withstand the conditions of ISTA 3A and ASTM D-4169; DC13; AL1 without loss of function, sterility, or legibility. | Pass – All samples passed the acceptance criteria |
| Shelf-Life | The packaged device and labeling shall withstand simulated storage conditions without loss of function, sterility, or legibility. | Pass – All samples passed the acceptance criteria |
| Sterilization | The sterilization process shall be validated to demonstrate a minimum of SAL of 10-6 for the product using Gamma radiation. | Pass – All samples passed the acceptance criteria |
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| Biocompatibility | ||
|---|---|---|
| Test | Test Summary | Conclusions |
| Cytotoxicity | MEM Elution Cytotoxicity Assay(ISO)(GLP) | Pass - Non-cytotoxic |
| Sensitization | Guinea Pig Maximization Test(ISO) Sensitization(GLP - 2 Extracts) | Pass - Non-sensitizer |
| Irritation or IntracutaneousReactivity | Intracutaneous Reactivity Test(ISO)(GLP - 2 Extracts) | Pass - Non-irritant |
| Material Mediated Pyrogenicity | Material Mediated PyrogenicityTest (ISO/USP)(GLP) | Pass - Non-pyrogenic |
| Acute Systemic Toxicity | Acute Systemic Toxicity Test(ISO)(GLP - 2 Extracts) | Pass - Non-toxic |
| Subacute/Subchronic Toxicity | (31-Day) Systemic Toxicity(Implant Method) and ImplantEvaluation Test in Rabbits (ISO) | Pass - No systemic toxic effectswere observed |
| Implantation Effects | (91-Day) Systemic Toxicity(Implant Method) and ImplantEvaluation Test in Rabbits (ISO) | Pass - No systemic toxic effectswere observedPass - Slight reaction observed |
| Genotoxicity | Ames Bacterial Reverse MutationAssay (ISO)(GLP - 2 Extracts)Mouse Lymphoma Assay (ISO)(GLP - 2 Extracts) | Pass - Non-mutagenic |
| Chronic Toxicity | Not evaluated | The biocompatibility of theAutomatic Continuous EffusionShunt System has been evaluatedto support an implant duration of12 months, beyond which point itis recommended the device beremoved. |
| Carcinogenicity |
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BASIS FOR DETERMINATION OF SUBSTANTIAL EQUIVALENCE
The Device Classification. Intended Use, and elemental Scientific Technology for the ACES System are the same as those described for the Predicate Device (K822686). The Surface Treatment is the same as that of the Reference Device (K912645). The Indications for Use and Principle of Operation is the same as that of the Reference Device (K012235).
The ACES System does not raise different questions regarding safety and effectiveness when compared to the predicate and reference devices and has been determined by Pleural Dynamics, Inc. to be substantially equivalent.
In summary, the ACES System has the same or similar following characteristics to the predicate and reference devices, which have previously received 510(k) clearance:
- Has the same device classification (Predicate Device K822686) ●
- . Has the same intended use (Predicate Device K822686)
- Has the similar indications for use (Reference Device K012235)
- Uses similar technological and performance characteristics (Reference Device K012235) ●
- Uses the similar principles of operation (Reference Device K012235) ●
- Same special controls are met (Predicate Device K822686) ●
Therefore, the conclusions drawn from the non-clinical tests demonstrate the device is as safe, as effective, and performs as well as the legally marketed device predicate, and reference devices, where applicable, per 21 CFR 807.92(b)(3). The ACES System is substantially equivalent to the predicate device and reference devices, where applicable.
SUBSTANTIAL EQUIVALENCE CONCLUSIONS
Through the thorough comparison of technological and performance characteristics, the subject device is determined to be substantially equivalent to the predicate device.
§ 876.5955 Peritoneo-venous shunt.
(a)
Identification. A peritoneo-venous shunt is an implanted device that consists of a catheter and a pressure activated one-way valve. The catheter is implanted with one end in the peritoneal cavity and the other in a large vein. This device enables ascitic fluid in the peritoneal cavity to flow into the venous system for the treatment of intractable ascites.(b)
Classification. Class II. The special controls for this device are FDA's:(1) “Use of International Standard ISO 10993 ‘Biological Evaluation of Medical Devices—Part I: Evaluation and Testing,’ ”
(2) “510(k) Sterility Review Guidance of 2/12/90 (K90-1),” and
(3) Backflow specification and testing to prevent reflux of blood into the shunt.