S-SCORT (2500)

K964997 · Sscor · BTA · Mar 5, 1997 · General, Plastic Surgery

Device Facts

• Record ID: K964997
• Device Name: S-SCORT (2500)
• Applicant: Sscor
• Product Code: BTA · General, Plastic Surgery
• Decision Date: Mar 5, 1997
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 878.4780
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

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.

Device Story

Portable suction pump; provides constant suction for aspiration. Components: pump, regulator, battery, canister, suction tubing, suction tip with vent control, carrying case. Operated by professional personnel in clinical, transport, and home care environments. Device generates negative pressure to clear airways or surgical sites; assists healthcare providers in maintaining patient airway patency or removing fluids. Benefits: portable, battery-powered suction capability for emergency and routine clinical use.

Clinical Evidence

No clinical data provided; substantial equivalence based on technological characteristics and design similarity to predicate.

Technological Characteristics

Powered portable suction apparatus. Components: pump, regulator, battery, canister, suction tubing, suction tip with vent control. Operates via electrical input/output to generate negative pressure and airflow. Portable form factor with carrying case.

Indications for Use

Indicated for professional personnel requiring constant suctioning in hospital, transport, surgi-center, emergency medical service, and home health/nursing home settings.

Regulatory Classification

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.

Predicate Devices

• SSCOR S-SCORT® Jr. Model 90024B

Submission Summary (Full Text)

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SSCOR, Inc.
S-SCORT Model 2500
510(k) Notification
K964997

# SUMMARY OF SAFETY AND EFFECTIVENESS

# S-SCORT® MODEL 2500 PORTABLE SUCTION PUMP

MAR - 5 1997

This 510(k) summary of safety and effectiveness information is being submitted in accordance with the requirements of SMDA 1990.

1. **510(k) Submitter, Contact Person and Date Summary Prepared:**

Sam Say
SSCOR, Inc.
11064 Randall Street
Sun Valley, CA 91352
[phone]

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

4. **Device Description and Indications:**

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, and negative pressure.