(210 days)
Use of Dentsleeve Manometric Assemblies is indicated when measurements of gastrointestinal tract pressures are judged to be useful for determining management of adults, children & infants with proven or suspected gastrointestinal motor disorders.
Dentsleeve Manometric Assemblies are designed for the monitoring and analysis of gastrointestinal pressures. They are designed to be used in conjunction with a low compliance manometric perfusion pump. The major structures of the Manometric Assemblies is a multi-channeled, medical grade, silicone rubber extrusion.
The Assemblies are designed with variations in length and channel number (depending on the extrusion and application) to enable precise low compliance pressure measurement from most areas of the GI tract. When attached to a manometric perfusion pump, a constant flow of perfused into the assembly and into the GI tract of the patient provided the perfusion pump is correctly operated. When the pressure changes within the GI tract the pressure is transferred faithfully up the assembly and detected with external pressure transducers mounted on the manometric perfusion pump.
Here's an analysis of the provided text, focusing on the acceptance criteria and study information for the Dentsleeve Manometric Assemblies:
Unfortunately, the provided text does not contain the detailed information required to fill out a complete table of acceptance criteria and reported device performance, nor does it describe a specific study proving the device meets acceptance criteria in the way a typical medical device validation study report would.
The document is a 510(k) submission summary and an FDA clearance letter for a medical device (Dentsleeve Manometric Assemblies). These documents focus on establishing substantial equivalence to a predicate device rather than presenting a detailed, standalone study with specific performance metrics and statistical analyses against pre-defined acceptance criteria.
However, based on the provided text, we can infer some aspects and highlight what is missing:
Inferred Information and Missing Details
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (Inferred from product description) | Reported Device Performance (Inferred/Implicit) |
|---|---|
| Biocompatibility: Device materials are safe for patient contact. | "The Manometric assemblies have been tested for biocompatibility..." (Testing results compiled in Attachment A, not provided) |
| Functionality: Device can accurately measure gastrointestinal pressures when connected to a perfusion pump. | "...designed to enable precise low compliance pressure measurement from most areas of the GI tract." |
| Sterilization: Device can be safely sterilized (up to 50 times by autoclave) without degradation. | "...ability to be sterilized up to 50 times by autoclave." (Testing results compiled in Attachment C, not provided) |
| Minimization of discomfort: Device material contributes to patient comfort during intubation. | "The flexibility of silicone rubber aids patient comfort..." |
| Avoidance of pharyngeal water infusion: Suitable for air perfusion in pharyngeal manometry. | "Dentsleeve assemblies are suitable for use with air perfusion which is used only in pharyngeal manometry..." |
| Risk Mitigation: Risks of use are minimal when operated and maintained as described. | "A Risk assessment and Failure Mode Effects and Criticality Analysis, the results of which can be seen in attachment D." (Attachment D not provided) |
Missing Information for a Comprehensive Table:
- Specific quantitative performance metrics: What defines "precise" pressure measurement? What are the tolerance limits for accuracy, drift, or signal-to-noise ratio? How were these measured?
- Detailed results for biocompatibility and sterilization: The document states testing was done, but doesn't provide the actual results or how they were compared against specific acceptance thresholds (e.g., cytotoxicity index, material integrity post-sterilization).
- Clinical effectiveness measures: While the device measures pressure, the document doesn't detail how well these measurements aid in patient management or diagnosis compared to other methods. This is often the focus of performance studies.
2. Sample size used for the test set and the data provenance
- Sample Size for Test Set: Not specified. The document only states "The Manometric assemblies have been tested for biocompatibility, functionality and ability to be sterilized..." without detailing the sample size for these tests (e.g., number of catheters tested, number of sterilization cycles for each, number of in-vitro pressure tests).
- Data Provenance: Not explicitly stated regarding the tests themselves. The company, Dentsleeve Pty Ltd, is located in Parkside, South Australia, so testing was likely conducted in Australia or by a contract lab. The document does not specify if the testing involved human subjects (prospective clinical study) or was entirely bench/lab-based (retrospective on manufactured components). Given the nature of a 510(k) for this type of device, most of the "testing" would likely be bench testing for functionality, biocompatibility, and sterilization, rather than large-scale clinical trials.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
- Not Applicable / Not Mentioned: This type of information is typically relevant for studies involving "ground truth" established by human interpretation (e.g., radiology image interpretation). For a device that measures physical parameters like pressure, "ground truth" would be established by validated reference instruments or physical standards, not human experts. For example, pressure accuracy would be assessed against a calibrated pressure manometer.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not Applicable / Not Mentioned: Similar to point 3, adjudication methods are used to resolve disagreements among human experts when establishing ground truth. This is not pertinent to the type of bench testing described for the Dentsleeve Manometric Assemblies.
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 manometric assembly, a physical device for measuring pressure, not an AI or imaging-based diagnostic tool. Therefore, an MRMC study is not relevant to this product.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Not Applicable: This is not an algorithmic or AI device. It's a physical catheter. Standalone performance for this device would refer to its inherent physical properties and measurement capabilities, which are likely what the "functionality" testing aimed to assess.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
- Inferred: Bench Test Standards / Reference Devices: For functionality, the ground truth would have been established using calibrated pressure measurement equipment and physical standards. For biocompatibility, it would be based on ISO standards for medical device biocompatibility testing. For sterilization, it would involve microbiological testing against sterility assurance levels.
8. The sample size for the training set
- Not Applicable: This device does not have a "training set" in the context of machine learning or AI. It's a physical medical device.
9. How the ground truth for the training set was established
- Not Applicable: As above, there is no training set.
Summary of what the document focuses on:
The provided text from the 510(k) submission and FDA letter primarily focuses on:
- Describing the device and its intended use.
- Highlighting material properties (silicone for flexibility, reduced discomfort, heat tolerance for autoclaving).
- Stating that biocompatibility, functionality, and sterilization testing were done (referencing attachments that are not provided).
- Mentioning a Risk Assessment and FMECA (also referencing an attachment not provided).
- The FDA letter confirms "substantial equivalence" to a predicate device, which is the core of a 510(k) clearance, implying that prior testing demonstrated it meets the same safety and effectiveness standards as previously cleared devices.
To obtain the specific details requested, one would need to access the full 510(k) submission attachments (A, B, C, and D) which are referenced in the provided text.
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Dentsleeve Manometric Assemblies are designed for the monitoring and analysis of gastrointestinal pressures. They are designed to be used in conjunction with a low compliance manometric perfusion pump. The major structures of the Manometric Assemblies is a multi-channeled, medical grade, silicone rubber extrusion.
The Assemblies are designed with variations in length and channel number (depending on the extrusion and application) to enable precise low compliance pressure measurement from most areas of the GI tract. When attached to a manometric perfusion pump, a constant flow of perfused into the assembly and into the GI tract of the patient provided the perfusion pump is correctly operated. When the pressure changes within the GI tract the pressure is transferred faithfully up the assembly and detected with external pressure transducers mounted on the manometric perfusion pump.
Indications
Use of Dentsleeve Manometric Assemblies is indicated when measurements of gastrointestinal tract pressures are judged to be useful for determining management of patients with proven or suspected gastrointestinal motor disorders.
Technical Characteristics
Minimisation of discomfort of intubation
Dentsleeve assemblies are made of silicone rubber. The properties of silicone rubber used by Dentsleeve facilitate the manufacture of smaller diameter (lower compliance) channels. The flexibility of silicone rubber aids patient comfort and the heat tolerance of the material allows autoclaving.
Avoidance of pharyngeal water infusion
Dentsleeve assemblies are suitable for use with air perfusion which is used only in pharyngeal manometry to monitor swallowing.
Testing and safety
The Manometric assemblies have been tested for biocompatibility, functionality and ability to be sterilized up to 50 times by autoclave. All testing results are compiled in attachments A, B & C.
A Risk assessment and Failure Mode Effects and Criticality Analysis, the results of which can be seen in attachment D.
Benefit vs. Risk
The risks of use of a Dentsleeve Manometric Assembly are believed to be minimal, provided this device is operated and maintained as described in the product labelling. Any significant but still minor risks of the use of the device are essentially those associated with gastrointestinal intubation. Proper management of these risks requires the performance or supervision of measurements by individuals who have been adequately trained in methods of gastro-intestinal manometry, including the understandiing of methods that ensure safe passage of manometric assemblies safely. Operators of this device must be adequately alert to factors that increase either the risk of perforation during intubation, such as stenoses of the gastro-intestinal tract or other physical deformities, or pulmonary aspiration of refluxed or vomited gastro-intestinal contents
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Image /page/1/Picture/0 description: The image shows the text "DEPARTMENT OF HEALTH & HUMAN SERVICES". The text is in all caps and is in a bold, sans-serif font. The text is centered in the image and is the only element present.
Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
MAY 17 ી તેવડીય
Mr. Marcus Tippett Technical Consultant Dentsleeve Ptv Ltd 56 a/b Cnr St Annes Place & Glen Osmond Road Parkside, South Australia AUSTRALIA 5063
Re: K983665 Dentsleeve Manometric Assemblies Dated: February 9, 1999 Received: February 16, 1999 Regulatory Class: II 21 CFR 876.1725/Procode: 78 KLA
Dear Mr. Tippett:
We have reviewed vour Section 510(k) notification of intent to market the device referenced above and we 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, You may, therefore, market the device, subject to the general controls provisions of the Act. 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.
If your device is classified (see above) into either class II (Special Controls) or class III (Premarket Approval), it may be subject to such additional controls. Existing major requlations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 895. A substantially equivalent determination assumes compliance with the Current Good Manufacturing Practice requirements, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic QS inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in requlatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.
This letter will allow you to begin marketing your device as described in your 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4613. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification"(21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number (800) 638-2041 or (301) 443-6597, or at its internet address "http://www.fda.gov/cdrh/dsma/dsmamain.html".
Sincerely yours,
CAPT Daniel G. Schultz, M.D. Acting Director, Division of Reproductive, Abdominal, Ear, Nose and Throat, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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510(k) number (if known):
K983665
Device Name:
Dentsleeve Manometric Assemblies Product code: 78KLA
Indications For Use:
Use of Dentsleeve Manometric Assemblies is indicated when measurements of gastrointestinal tract pressures are judged to be useful for determining management of adults, children & infants with proven or suspected gastrointestinal motor disorders.
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use
(Per 21 CFR 801.109) OR
(Division Sign-Off) Division of Reproductive, Abdominal, ENT, and Radiological Devic 510(k) Number.
Over-The-Counter Use_
(Optional Format 1-2-96)
§ 876.1725 Gastrointestinal motility monitoring system.
(a)
Identification. A gastrointestinal motility monitoring system is a device used to measure peristalic activity or pressure in the stomach or esophagus by means of a probe with transducers that is introduced through the mouth into the gastrointestinal tract. The device may include signal conditioning, amplifying, and recording equipment. This generic type of device includes the esophageal motility monitor and tube, the gastrointestinal motility (electrical) system, and certain accessories, such as a pressure transducer, amplifier, and external recorder.(b)
Classification. Class II (performance standards).