(153 days)
No
The summary describes a pump system for joint distension and irrigation, focusing on mechanical and electrical equivalence to existing devices. There is no mention of AI or ML in the intended use, device description, or specific sections for AI/ML details.
No.
The device facilitates surgical visualization and irrigation, which are supportive functions during surgery, not directly therapeutic interventions that treat or cure a disease or condition.
No
The device is intended to distend joints for better viewing and irrigation during orthopedic surgery, which are therapeutic and facilitative functions, not diagnostic.
No
The device description explicitly states the system consists of a "Pump Console which powers disposable Tube Set, and Pressure Sensing Cannula," indicating it includes hardware components beyond just software.
Based on the provided text, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is to distend and irrigate orthopedic joints during surgery. This is a procedure performed on the patient's body, not on samples taken from the patient's body.
- Device Description: The device is a pump system used to circulate saline within a joint. This is a mechanical device for surgical assistance, not a device for analyzing biological samples.
- Lack of IVD Characteristics: The description does not mention any analysis of biological samples (blood, urine, tissue, etc.), diagnostic testing, or providing information about a patient's health status based on in vitro analysis.
IVD devices are specifically designed to examine specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes. The Stryker Tempest Orthopedic Pump does not fit this description.
N/A
Intended Use / Indications for Use
The Stryker Tempest Orthopedic Pump is intended to be used by surgeons in Orthopedic joints, including the knee, shoulder, ankle, elbow, wrist, and temporomandibular joints. It will be used to distend joints.
The distension and saline circulation allow better viewing of the joint and tissues, as well as, irrigation of loose debris. The Tempest Orthopedic Pump replaces currently used manual infusion systems, utilizing either a build syringe or gravity flow. The Stryker Orthopedic Pump is to be used with Stryker Arthroscopes, and Pressure Sensing Cannula, found substantially equivalent under 510(k) number K771200, Arthroscopes, and K944593, Pressure Sensing Cannula, respectively.
Product codes
Not Found
Device Description
The Stryker Tempest Orthopedic Pump System, consisting of Pump Console which powers disposable Tube Set, and Pressure Sensing Cannula, 510(k) # K944583, during orthopedic surgery is equivalent in intended use, safety and offectiveness to existing Stryker Infusion Pump, 510(k) # K910858, used in similar applications, by Stryker Corporation.
The disposable tube set utilized in Stryker Tempest Orthopedic Pump, will be provided sterile for single applications. The material of constructions, maximum pressure and flow rate are equivalent to currently marketed products. As proven in Orthopedic applications, these design offer the required precision for controlling the joints distension.
The Tempest Orthopedic Pump technology utilized in equivalent to existing marketed products. Power modality, intended use, methods of sterliization and safety risks are substantially equivalent. The Stryker Tempest Orthopedic Purno is electrically powered and is designed to meet CSA Electromedical Standard Number C22.2 Number 125, and UL 544 Standards.
The disposable tube set ETO sterilization processes are validated per AAM standard ST 27, to a S.A.L. of 10 . Gamma irradiation validation is per AAM standard ST 32, method 1, section 5,2,3,1,, for sterile packaged, single use disposable tube set. The minimum dose for an S.A.L. of 10 is 1.66 Mrade. The biocompatibility testing will Include USP Intracutaneous, USP Systemic Toxicity Test, Maximization, USP MEM Elution, and Hemolysis. These validation are equivalent to the existing marketed products.
The Tempest Orthopedic Pump is designed with appropriate safety features for over pressure controls and alarm. First, under normal Run/Stop mode, the pump prevents the pressure sensed at the joint or body cavity from exceeding 150 mmHg. The pump motor will stop, a red light emitting diode illuminates, and outflow solencid valve opens to relieve excess pressure. Under Lavage mode, any pressure above 150 mmHg for 3 seconds will trigger an uninterrupted audible alarm. Second, if the pump will not function if the pressure does not detect a change in actual pressure within four seconds, the pump motor will stop, followed by an audible alarm. The ONLY way to re-activate the pump is to depress the RUNSTOP switch. Third, the Lavage feature has an over pressure allerm. When using Lavage feature, and joint pressure go above 150 mmHg for 3 seconds, the uninterrupted audible alarm will sound.
A reusable hand control will be offered to allow surgeons to perform surgery in the sterile field.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Orthopedic joints, including the knee, shoulder, ankle, elbow, wrist, and temporomandibular joints.
Indicated Patient Age Range
Not Found
Intended User / Care Setting
surgeons in Orthopedic joints
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
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Not Found
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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.
0
Image /page/0/Picture/0 description: The image shows the Stryker Endoscopy logo. The word "Stryker" is in a bold, stylized font, with the letters connected. Below "Stryker" is the word "ENDOSCOPY" in a smaller, sans-serif font. The logo is black and white.
JAN 22 1997
K96 3304
2590 Walsh Avenue, Santa Clara, CA 95051
(408)567-9100 FAX (408)567-2507
SUMMARY OF SAFETY AND EFF-STIVENESS - 510(K) # K963304
Device Name :
| Current Classification Name : | Arthroscope and accessories CFR 888.1100 Class II |
|---|---|
| Common and Usual Name : | Arthroscopy Pump |
| Propriety Name : | Stryker Tempest Orthopedic Pump |
| Device Sponsor : | Stryker Endoscopy |
| 2590 Walsh Avenue, Santa Clara, CA 95051 | |
| FDA Registration # 2936485 | |
| Regulatory Classification : | Class II |
This summary of 510(k) safety and effectiveness being submitted in accordance with requirements of SMDA 1990 and 21 CFR 807.92.
The Stryker Tempest Orthopedic Pump System, consisting of Pump Console which powers disposable Tube Set, and Pressure Sensing Cannula, 510(k) # K944583, during orthopedic surgery is equivalent in intended use, safety and offectiveness to existing Stryker Infusion Pump, 510(k) # K910858, used in similar applications, by Stryker Corporation.
The disposable tube set utilized in Stryker Tempest Orthopedic Pump, will be provided sterile for single applications. The material of constructions, maximum pressure and flow rate are equivalent to currently marketed products. As proven in Orthopedic applications, these design offer the required precision for controlling the joints distension.
The Tempest Orthopedic Pump technology utilized in equivalent to existing marketed products. Power modality, intended use, methods of sterliization and safety risks are substantially equivalent. The Stryker Tempest Orthopedic Purno is electrically powered and is designed to meet CSA Electromedical Standard Number C22.2 Number 125, and UL 544 Standards.
The disposable tube set ETO sterilization processes are validated per AAM standard ST 27, to a S.A.L. of 10 . Gamma irradiation validation is per AAM standard ST 32, method 1, section 5,2,3,1,, for sterile packaged, single use disposable tube set. The minimum dose for an S.A.L. of 10 is 1.66 Mrade. The biocompatibility testing will Include USP Intracutaneous, USP Systemic Toxicity Test, Maximization, USP MEM Elution, and Hemolysis. These validation are equivalent to the existing marketed products.
The Tempest Orthopedic Pump is designed with appropriate safety features for over pressure controls and alarm. First, under normal Run/Stop mode, the pump prevents the pressure sensed at the joint or body cavity from exceeding 150 mmHg. The pump motor will stop, a red light emitting diode illuminates, and outflow solencid valve opens to relieve excess pressure. Under Lavage mode, any pressure above 150 mmHg for 3 seconds will trigger an uninterrupted audible alarm. Second, if the pump will not function if the pressure does not detect a change in actual pressure within four seconds, the pump motor will stop, followed by an audible alarm. The ONLY way to re-activate the pump is to depress the RUNSTOP switch. Third, the Lavage feature has an over pressure allerm. When using Lavage feature, and joint pressure go above 150 mmHg for 3 seconds, the uninterrupted audible alarm will sound.
A reusable hand control will be offered to allow surgeons to perform surgery in the sterile field.
Overall, the Stryker Tempest Orthopedic Pump System does not raise any new safety and officacy concerns when compared to Infusion pump. Therefore, the Stryker Pump System is substantially equivalent to Stryker Infusion Pump System.
1
Indications For Use : The Stryker Tempest Orthopedic Pump is intended to be used by surgeons in Orthopedic joints, including the knee, shoulder, ankle, elbow, wrist, and temporomandibular joints. It will be used to distend joints.
The distension and saline circulation allow better viewing of the joint and tissues, as well as, irrigation of loose debris. The Tempest Orthopedic Pump replaces currently used manual infusion systems, utilizing either a build syringe or gravity flow. The Stryker Orthopedic Pump is to be used with Stryker Arthroscopes, and Pressure Sensing Cannula, found substantially equivalent under 510(k) number K771200, Arthroscopes, and K944593, Pressure Sensing Cannula, respectively.
Roy his 1/16/97
Roy S. Chin Associate Project Engineer