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510(k) Data Aggregation
(216 days)
Plastic Surgery CFR 21 Class II 878.4400 Cardiopulmonary Bypass Cardiotomy Return Sucker CFR 21 Class II 870.4430
The Stryker Strykeflow Suction Irrigator Gravity Flow (SIGF) is an irrigation suction device which is provided sterile for single use disposable application. The SIGF accepts a variety of tips for laparoscopic and open general surgery, laparoscopic and open obstetric surgery, laparoscopic and open urologic surgery, endoscopic and open nasal surgery, open otolaryncologic surgery, and open plastic surgery.
The Stryker Strykeflow Suction Irrigator Gravity Flow (SIGF) is an irrigation suction device which is provided sterile for single use disposable application. The SIGF accepts a variety of tips for laparoscopic and open general surgery, laparoscopic and open obstetric surgery, laparoscopic and open urologic surgery, endoscopic and open nasal surgery, open otolaryncologic surgery, and open plastic surgery. The SIGF is validated per AAMI HF18 for electrocautery application. The tips may be sterile packaged and disposable (single-use only) or non-sterile packaged for reusable purposes. The SIGF is constructed of materials which are tested for biocompatibility per ISO 10993 and are safe, effective, and durable for their intended purposes. Gamma irradiation validation is per AAMI standard ST 32, method 1, section 5.2.3.1. The minimum dose for an SAL of 10to is 1.66 Mrads.
This document is a 510(k) summary for a medical device and does not contain the kind of detailed study information (acceptance criteria, specific performance metrics, sample sizes, ground truth establishment, expert qualifications, etc.) that would typically be found in a clinical study report or a more comprehensive efficacy submission.
Therefore, I cannot extract the requested information. The provided text is a regulatory summary focused on substantial equivalence to predicate devices, material safety, and sterilization validation, rather than a performance study with detailed acceptance criteria and results.
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(75 days)
Accessories CFR 21 Class II 888.1100 Cardiopulmonary Bypass Intracardiac Suction Control CFR 21 Class II 870.4430
It is intended for uses in any procedure in which the control of suction force is desired.
The Stryker Suction Regulator (SSR) controls the rate of suction from any product that requires suction control. It consists of an inlet tube with a suction adapter at the end, an outlet tube with a suction adapter at the end, and a handpiece. The handpiece controls suction by varying the amount of ambient air entering the tube set. As more air is let into the tube set, suction force at the inlet tube is reduced. As less air is let into the tube set, suction force is increased.
The provided text is a summary of safety and efficacy for a medical device (Stryker Suction Regulator) and does not contain information about acceptance criteria or a study proving that the device meets those criteria. Therefore, I cannot extract the requested information.
The document focuses on:
- Device Classification and Name: Listing various classifications and the proprietary name of the device.
- Device Description: Explaining how the suction regulator works.
- Material and Sterilization Standards: Mentioning biocompatibility testing (ISO 10993) and sterilization validation (AAMI ST 27, AAMI ST 32).
- Substantial Equivalence Claim: Stating that the device is equivalent to the "Arthrex Suction Regulator" and does not raise new issues.
There's no mention of specific performance metrics, acceptance thresholds, or a study that evaluates the device against such criteria.
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