(75 days)
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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Nov 26 1996
2590 Walsh Ave. Santa Clara, CA 95051
SUMMARY SAFETY AND EFFICACY
Device Name
Current Classification Name:
Vacuum-powered Body Fluid Suction Apparatus CFR 21 Class II 880.6740 Gynecologic Laparoscope and Accessories CFR 21 Class II 884.1720 Gastroenterology-urology Evacuator CFR 21 Class II 876.4370 Laparoscope General and Plastic Surgery CFR 21 Class II 878.4400 Arthroscopic Accessories CFR 21 Class II 888.1100 Cardiopulmonary Bypass Intracardiac Suction Control CFR 21 Class II 870.4430
| Common and Usual Name: | Suction Regulator or SSR |
|---|---|
| Proprietary Name: | Stryker Suction Regulator |
| Device Sponsor | Stryker Endoscopy |
|---|---|
| 2590 Walsh Ave. | |
| Santa Clara, CA 95051 |
This summary of 510(k) safety and effectiveness is being submitted in accordance with requirements of SMDA 1990.
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 SSR is constructed of materials which are tested for biocompatibility per ISO 10993 and are safe, effective, and durable for their intended purposes. The SIGF ETO sterilization processes are validated per AAMI standard ST 27, to a SAL of 10°. Gamma irradiation validation is per AAMI standard ST 32, method 1, section 5.2.3.1. The minimum dose for an SAL of 10° is 1.66 Mrads.
The SSR is equivalent in safety and effectiveness to the Arthrex Suction Regulator. It is intended for uses in any procedure in which the control of suction force is desired.
This device does not raise new issues when compared to its predicate devices or uses. Therefore, it is considered substantially equivalent to those devices.
Ata
Tony Lee Senior Design Engineer
§ 880.6740 Vacuum-powered body fluid suction apparatus.
(a)
Identification. A vacuum-powered body fluid suction apparatus is a device used to aspirate, remove, or sample body fluids. The device is powered by an external source of vacuum. This generic type of device includes vacuum regulators, vacuum collection bottles, suction catheters and tips, connecting flexible aspirating tubes, rigid suction tips, specimen traps, noninvasive tubing, and suction regulators (with gauge).(b)
Classification. Class II (special controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to § 880.9.