(216 days)
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No
The description focuses on the mechanical and material aspects of a suction irrigator, with no mention of software, algorithms, or data processing that would indicate AI/ML.
No
The device is described as an irrigation suction device used during surgical procedures, not as a device that treats or diagnoses a disease or condition. Its function is to facilitate surgery, not provide therapy.
No
The device description clearly states it is an "irrigation suction device" used during various surgical procedures. There is no mention of it being used to diagnose conditions.
No
The device description clearly indicates it is a physical irrigation suction device constructed of materials, provided sterile, and accepting physical tips. It also mentions validation for electrocautery application and biocompatibility testing, all indicative of a hardware device.
Based on the provided information, the Stryker Strykeflow Suction Irrigator Gravity Flow (SIGF) is not an IVD (In Vitro Diagnostic) device.
Here's why:
- Intended Use: The intended use describes the device as an "irrigation suction device" used in various surgical procedures (laparoscopic and open general, obstetric, urologic, nasal, otolaryngologic, and plastic surgery). This involves direct interaction with the patient's body during surgery.
- Device Description: The description reinforces its use as a surgical tool for irrigation and suction. It mentions biocompatibility testing and sterilization, which are typical for surgical instruments.
- Lack of IVD Characteristics: IVD devices are used to examine specimens (like blood, urine, tissue) taken from the human body to provide information about a physiological state, health, or disease. The SIGF does not perform this function. It is used on the body during a procedure.
Therefore, the SIGF is a surgical device, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
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Product codes
880.6740, 880.6960, 884.1720, 876.4370, 878.4400, 870.4430, 874.4420
Device Description
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.
Mentions image processing
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Mentions AI, DNN, or ML
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Input Imaging Modality
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Anatomical Site
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Indicated Patient Age Range
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Intended User / Care Setting
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Description of the training set, sample size, data source, and annotation protocol
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Description of the test set, sample size, data source, and annotation protocol
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Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
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Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
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Predicate Device(s)
Nezhat-Dorsey device, Stryker Strykeflow Suction Irrigator, equivalent gravity flow and bulb/syringe devices
Reference Device(s)
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Predetermined Change Control Plan (PCCP) - All Relevant Information
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§ 878.4400 Electrosurgical cutting and coagulation device and accessories.
(a)
Identification. An electrosurgical cutting and coagulation device and accessories is a device intended to remove tissue and control bleeding by use of high-frequency electrical current.(b)
Classification. Class II.
0
APR 1 6 1997
2590 Walsh Ave. Santa Clara, CA 95051
SUMMARY SAFETY AND EFFICACY
Device Name
Current Classification Name(s):
Vacuum-powered Body Fluid Suction Apparatus CFR 21 Class II 880.6740 Irrigation Device CFR 21 Class I 880.6960 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 Cardiopulmonary Bypass Cardiotomy Return Sucker CFR 21 Class II 870.4430 Ear, Nose, and Throat Manual Surgical Instrument CFR 21 Class II 874.4420
Common and Usual Name: Suction Irrigator GF or SIGF Stryker Strykeflow Suction Irrigator Gravity Flow Proprietary Name:
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 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.
The SIGF is equivalent in safety and effectiveness to a variety of devices currently marketed (the Nezhat-Dorsey device, the Stryker Strykeflow Suction Irrigator, and equivalent gravity flow and bulb/syringe devices) which are used in the applications noted above for general suction or irrigation purposes. Additionally, the suction/irrigator tips may serve as a cannula to the laparoscopic surgeon to provide a portal to the operation site similar to the function of the trocar cannula.
This device does not raise new issues when compared to its predicate devices or uses. Therefore, it is considered substantially equivalent to those devices.
Tony Lee Senior Design Enginee
eer