(79 days)
SSCOR S-SCORT® Jr. Model 90024B
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No
The summary describes a standard portable suction pump with no mention of AI or ML features.
No
The device is a suction pump designed for constant suctioning, primarily used to remove fluids or air from a patient during medical procedures or emergencies. While it supports medical care, it does not directly treat a disease or condition but rather aids in patient management by maintaining a clear airway or field.
No
The device is described as a portable suction pump for constant suctioning, which is a therapeutic function, not a diagnostic one. It is used to remove fluids, not to diagnose a condition.
No
The device description explicitly lists hardware components such as a pump, regulator, battery, canister, tubing, and tip, indicating it is a physical medical device, not software-only.
Based on the provided information, the S-SCORT® Model 2500 is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use describes the device as a portable suction pump for constant suctioning of patients. This is a therapeutic or procedural use, not a diagnostic one.
- Device Description: The description details the components of a suction pump, which are used for removing fluids from the body. This aligns with a therapeutic/procedural device.
- Lack of Diagnostic Elements: There is no mention of analyzing samples (like blood, urine, tissue), detecting biomarkers, or providing diagnostic information about a patient's condition.
IVD devices are specifically designed to examine specimens taken from the human body to provide information for diagnostic, monitoring, or compatibility purposes. The S-SCORT® Model 2500's function is to physically remove substances from the body, which falls outside the scope of an IVD.
N/A
Intended Use / Indications for Use
The S-SCORT® Model 2500 is a portable suction pump to be used by professional personnel for constant suctioning. It can be used in hospital crash cart suction; patient transport; surgi-center back-up suction; emergency medical service; and home health care/nursing homes.
Product codes
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Device Description
The S-SCORT® Model 2500 is a portable suction pump to be used by professional personnel for constant suctioning. The unit comes equipped with a pump, regulator, battery, canister, suction tubing, suction tip with vent control, and carrying case.
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
professional personnel for constant suctioning. It can be used in hospital crash cart suction; patient transport; surgi-center back-up suction; emergency medical service; and home health care/nursing homes.
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): 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.
SSCOR S-SCORT® Jr. Model 90024B
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.
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Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
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§ 878.4780 Powered suction pump.
(a)
Identification. A powered suction pump is a portable, AC-powered or compressed air-powered device intended to be used to remove infectious materials from wounds or fluids from a patient's airway or respiratory support system. The device may be used during surgery in the operating room or at the patient's bedside. The device may include a microbial filter.(b)
Classification. Class II.
0
510(k) Notification
K964997
SUMMARY OF SAFETY AND EFFECTIVENESS MAR - 5 1997 S-SCORT® MODEL 2500 PORTABLE SUCTION PUMP
summary of safety and effectiveness information is 510 (k) This being submitted in accordance with the requirements of SMDA 1990.
510(k) Submitter, Contact Person and Date Summary Prepared: 1.
Summary Prepared On: December 16, 1996 Sam Say SSCOR, Inc. 11064 Randall Street Sun Valley, CA 91352 (818) 504-4054
2. Device Name:
| Trade/Proprietary Name: | S-SCORT® Model 2500 Portable
Suction Pump |
|-------------------------|------------------------------------------------------------------------|
| Common/Usual Names: | Powered Portable Aspiration Pump
Powered Portable Suction Apparatus |
Classification Name: Powered Suction Pump
3. Substantial Equivalence Information:
Predicate devices of the same type which the S-SCORT® Model 2500 Portable Suction Pump is substantially equivalent for purposes of Section 510 (k) of the Food, Drug and Cosmetic Act: SSCOR S-SCORT® Jr. Model 90024B
Device Description and Indications: 4 .
The S-SCORT® Model 2500 is a portable suction pump to be used by professional personnel for constant suctioning. The unit comes equipped with a pump, regulator, battery, canister, suction tubing, suction tip with vent control, and carrying case. It can be used in hospital crash cart suction; patient transport; surgi-center back-up suction; emergency medical service; and home health care/nursing homes .
5. Comparison of Technological Characteristics with Predicate Devices :
The S-SCORT® Model 2500 is technologically similar in design and operation to the predicate devices with respect to pump, battery, regulator, electrical input & output, airflow, negative and pressure.