(75 days)
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No
The description details a purely mechanical device that controls suction by varying ambient air intake. There is no mention of software, algorithms, or any technology that would suggest AI/ML.
No
The device is described as controlling suction force in medical procedures. While it's used in a medical context, it does not directly treat or diagnose a disease or condition itself; rather, it regulates the function of another product.
No
The device controls suction force, which is a therapeutic or procedural function, not a diagnostic one. It does not gather or analyze data to identify a disease, condition, or provide a diagnosis.
No
The device description explicitly details physical components like an inlet tube, outlet tube, and handpiece, indicating it is a hardware device, not software-only.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is "for uses in any procedure in which the control of suction force is desired." This describes a device used during a medical procedure to manage suction, not a device used to test samples outside the body to diagnose or monitor a condition.
- Device Description: The description details a mechanical device that controls suction by regulating airflow. It does not mention any components or processes related to analyzing biological samples (blood, urine, tissue, etc.).
- Lack of IVD Indicators: There is no mention of analyzing samples, detecting analytes, providing diagnostic information, or any other characteristic typically associated with IVD devices.
Therefore, the Stryker Suction Regulator is a medical device used for procedural support, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
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.
Product codes
880.6740, 884.1720, 876.4370, 878.4400, 888.1100, 870.4430
Device Description
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
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Summary of Performance Studies
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Key Metrics
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Predicate Device(s)
Arthrex Suction Regulator
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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.
0
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