(89 days)
Both the Pneumatic API system and the Battery API system are designed to provide controlled pulsatile irrigation to a joint during arthroscopic surgical procedures. The pulsatile action of the pump irrigation and mechanical debridement of tip brush help to remove blood, tissue debris, loose bodies, and foreign matter from the joint cavity. When connected to a suction source the device's can be used to aspirate fluids and debris from the joint cavity. The device's will be provided as sterile single patient use devices.
The Pneumatic API System, Battery API System, Simpulse Plus Suction Irrigator System and the Simpulse SOLO Suction Irrigator System are jet lavage devices intended to provide controlled powered pulsatile irrigation for the cleansing and debridement of surgical sites (the Simpulse Plus and Simpulse SOLO also have the extended indication of providing irrigation to wound/burns). When connected to a suction source, the devices can be used to aspirate fluids and debris from the surgical site.
The API Irrigation/Brush tip and the Davol Femoral Canal Irrigation Brush Tip are both intended to provide pulsatile irrigation for the cleansing and debridement of orthopaedic surgical sites. In addition ,both of these tips and the Acufex Microsurgical Rasp are intended to provide mechanical debridement of surfaces during orthopaedic surgical procedures.
The API Suction Tip and the Davol Arthroscopic Outflow Cannula are intended to allow for the outflow of fluid and debris from the joint space during arthroscopic surgical procedures.
Both the Pneumatic API system and the Battery API system are designed to provide controlled pulsatile irrigation to a joint during arthroscopic surgical procedures. The pulsatile action of the pump irrigation and mechanical debridement of tip brush help to remove blood, tissue debris, loose bodies, and foreign matter from the joint cavity. When connected to a suction source the device's can be used to aspirate fluids and debris from the joint cavity. The device's will be provided as sterile single patient use devices. The major components of the systems are as follows:
Pneumatic Arthroscopy Pulsed Irrigator System: The Pneumatic Arthroscopy Pulsed Irrigator (API) system consists of the Davol Simpulse Plus Handle with the API Irrigation/Brush Tip and the API Suction Tip. The Pneumatic API System functions by means of a pneumatically activated pump membrane (diaphragm) contained within the pump assembly to generated the pulsating fluid output. The pump membrane is activated by pressure from an air/nitrogen source.
Battery Arthroscopy Pulsed Irrigator System: The Battery Arthroscopy Pulsed Irrigator System consists of the Davol Simpulse SOLO Handle with the API Irrigation/Brush Tip and the API Suction Tip. The Battery API system uses a mechanical pumping system to generate the pulsating fluid output. It is powered with four (4) standard AA alkaline batteries with an output amperage of approximately 1.8 amperes, with a voltage of 6 volts, dc (direct current). The batteries power a motor which activates movement of a bellows pump. The pumping system and power source are housed in the device's handle which will be manufactured from cyrolite (acrylic polymer). The batteries are contained in a battery enclosure within the device's handle.
The provided text describes a 510(k) summary for the Davol Arthroscopy Pulsed Irrigator Systems, which is a medical device. This type of document is a premarket submission made to the FDA to demonstrate that the device to be marketed is at least as safe and effective, that is, substantially equivalent, to a legally marketed predicate device.
The acceptance criteria are not explicitly stated in a quantifiable manner (e.g., "flow rate must be > X L/min"), but rather the study aims to show equivalence to predicate devices in terms of performance characteristics. The conclusion states that the devices compare favorably based on the testing performed.
Here's the breakdown of the information requested, based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| Equivalence in Irrigation Flow Rate: The API Irrigation/Brush Tip should have comparable irrigation flow rates to the Davol Femoral Canal Irrigation Brush Tip when connected to both Pneumatic and Battery API handles. | Compares favorably to the Davol Femoral Canal Irrigation Brush Tip, indicating similar hydraulic performance. Specific quantitative results (e.g., actual flow rates in L/min) are not provided in this summary. |
| Equivalence in Suction Flow Rate: The API Suction Tip should have comparable suction flow rates to the Davol Arthroscopy Outflow Cannula. | Compares favorably to the Davol Arthroscopy Outflow Cannula. Specific quantitative results (e.g., actual flow rates in L/min) are not provided in this summary. |
| Equivalence in Pulse Frequency and Impact Pressure: The API Irrigation/Brush Tip should have comparable pulse frequency and impact pressure to the Davol Femoral Canal Irrigation Brush Tip when connected to both Pneumatic and Battery API handles. | Compares favorably to the Davol Femoral Canal Irrigation Brush Tip. Specific quantitative results (e.g., pulse rate, pressure values) are not provided in this summary. |
| Equivalence in Static Pressure (Simulated Distended Joint Cavity): The API Irrigation/Brush Tip should maintain comparable static pressure in a simulated joint cavity to the Davol Femoral Canal Irrigation Brush Tip, with and without an outflow cannula open. | Compares favorably to the Davol Femoral Canal Irrigation Brush Tip. Specific quantitative results (e.g., pressure values) are not provided in this summary. |
| Biocompatibility: All patient-contacting and fluid-path materials should be biocompatible. | Results show that the materials of the API Systems are suitable for a limited contact, externally communicating device. Specific test results (e.g., cytotoxicity, sensitization) are not provided in this summary. |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size: The document refers to "laboratory bench testing" and "all materials" for biocompatibility. Specific sample sizes (N per test) for each type of bench testing are not provided.
- Data Provenance: The testing was conducted as "Laboratory bench testing". The country of origin is not specified, but it's implied to be within the manufacturer's (Davol Inc.) R&D or contracted labs. The data is prospective as it was generated specifically for this 510(k) submission.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications
- Not Applicable. This study is for a medical device (irrigator systems) and involves bench testing of physical performance characteristics and biocompatibility. It does not involve human interpretation of medical images or patient data that would require experts to establish a "ground truth" in the diagnostic sense. The comparison is against established performance of predicate devices.
4. Adjudication Method for the Test Set
- Not Applicable. As mentioned above, this is laboratory bench testing of physical performance, not diagnostic evaluation requiring adjudication. The assessment is based on direct measurement and comparison of physical parameters.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done
- No. This is a bench study of a physical medical device. MRMC studies are typically used for diagnostic imaging devices or algorithms where human readers interpret medical cases.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
- Not Applicable. This is not an algorithm or AI device. The "standalone" performance refers to the device's inherent mechanical and material performance. The conducted tests (flow rate, pressure, biocompatibility) can be considered the "standalone" performance of the device components.
7. The Type of Ground Truth Used
- Predicate Device Performance and Industry Standards: The "ground truth" for this study is essentially the established and accepted performance characteristics of the legally marketed predicate devices (Davol Simpulse Plus Suction Irrigator, Davol Simpulse SOLO Suction Irrigator, Davol Femoral Canal Irrigation Brush Tip, Davol Arthroscopy Outflow Cannula, Acufex Microsurgical Rasp) and adherence to biocompatibility standards (General Program memorandum #G95-1). The new device is deemed acceptable if its performance "compares favorably" to these established benchmarks.
8. The Sample Size for the Training Set
- Not Applicable. This is a medical device bench study, not a machine learning model, so there is no training set in that context.
9. How the Ground Truth for the Training Set Was Established
- Not Applicable. As there is no training set for a machine learning model, this question is not relevant to the provided text.
§ 888.1100 Arthroscope.
(a)
Identification. An arthroscope is an electrically powered endoscope intended to make visible the interior of a joint. The arthroscope and accessories also is intended to perform surgery within a joint.(b)
Classification. (1) Class II (performance standards).(2) Class I for the following manual arthroscopic instruments: cannulas, currettes, drill guides, forceps, gouges, graspers, knives, obturators, osteotomes, probes, punches, rasps, retractors, rongeurs, suture passers, suture knotpushers, suture punches, switching rods, and trocars. The devices subject to this paragraph (b)(2) are exempt from the premarket notification procedures in subpart E of part 807 of this chapter, subject to the limitations in § 888.9.