The S-SCORT...Jr® Quickdraw, Model 2400 portable battery powered suction pump is a nonsterile reusable device, with a non-sterile single use disposable canister and integrated suction tip, that is to be used by professional personnel trained in Emergency Care techniques of constant suctioning to clear the airway by removing bodily fluids and particulate matter.

Device Description

The S-SCORT ...Jr® Quickdraw device is a design with added Subject Device Desertifications: a battery power level indicator, a custom non-sterile single use Uchents of user Inchary voltaons, a suction tip, an equally effective suction pump. The S-SCORT ... Jr® Quickdraw performance is significantly equivalent as the legally marketed devices.

Components: The subject S-SCORT...Jr® Quickdraw consists of a high-specd diaphragm pump Componently "The bagger ed electric motor, an internal 12 VDC sealed lead acid rechargeable powered by an integrative circuit board with controls and signaling light-emitting diodes. All battery, and enoticolno of can o a molded plastic custom chassis. The 12 V battery and 12 V components are assemble to both operate and charge the device from any 12 VDC source. Charging may also take it possible to toing an external 110 VAC to 9 VDC power converter.

Collection Canister: The S-SCORT ... Jr® Quickdraw uses a non-sterile single use disposable Concection Camster . The o OCON 11 is blow molded in a transparent plastic of Rigid Polyvinyl Chloride (RPVC) material that has been determined biocompatible (the RPVC does not contain Childride (11) VC) material that the canister sidewall has graduation marks that indicate the the plastioner DEFF you in canister has an integrated hydrophobic filter, which votune of content in oached in one capable of bacterial filtration to 99.98% with pore size of 20 microns and .200" in thickness.

AI/ML Overview

Here's a breakdown of the acceptance criteria and study information for the S-SCORT...Jr® Quickdraw, Model 2400, based on the provided document:

Acceptance Criteria and Device Performance

The document describes the tests performed but does not explicitly state "acceptance criteria" as pass/fail thresholds with specific numerical ranges for each criterion. Instead, it describes general performance expectations and what the tests will measure. However, based on the context, we can infer the intended acceptance for these key performance indicators. The device performance is implied to meet these expectations for substantial equivalence.

Table of Acceptance Criteria (Inferred) and Reported Device Performance (Implied)

Performance Criterion (Inferred Acceptance)	Reported Device Performance (Implied)
Vacuum Levels (Expected: 300 - 500 mmHg)	Assumed to meet this range, as it's a "principle performance criterion."
Time to suction 200cc of vomitus (Expected: Adequate/Clinically acceptable)	Assumed to be adequate, as it's a "principle performance criterion."
Continuous operation from internal battery (Expected: Minimum of 20 minutes)	Assumed to meet or exceed 20 continuous minutes.

Note: The document states "Tests will be performed using industry standard protocols* to challenge the performance criteria that are typical for this type of medical product," and concludes that the device "will be substantially equivalent." This implies that the device did meet or is expected to meet these criteria, but specific numerical results are not provided in this summary.

Study Details

The provided document is a 510(k) summary, which focuses on demonstrating substantial equivalence to a legally marketed predicate device rather than presenting a detailed clinical study with human subjects. The "study" described herein is primarily a set of performance and safety tests.

2. Sample Size Used for the Test Set and Data Provenance

Sample Size: Not explicitly stated as a number of devices. The tests are described as being performed "using industry standard protocols." It's standard for medical device testing to involve a representative number of devices to demonstrate consistency, but a specific "sample size" like in a clinical trial isn't detailed here.
Data Provenance: The document does not specify the country of origin for the data or whether it was retrospective or prospective. Given it's a 510(k) submission, the performance testing would have been conducted prospectively in a lab environment.

3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications of Those Experts

This information is not applicable and not provided. The "ground truth" for these performance tests is defined by established engineering and medical device standards (e.g., specific vacuum levels, suction speed, battery life). The "experts" would be the engineers and technicians conducting the tests and interpreting the results against the defined standards.

4. Adjudication Method for the Test Set

This information is not applicable and not provided. Performance testing typically involves objective measurements against predefined specifications, rather than subjective adjudication by multiple experts.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done

No, an MRMC comparative effectiveness study was not done. The document is a 510(k) summary for a portable aspiration pump, focusing on demonstrating substantial equivalence through technical performance and safety testing, not on comparing human reader performance with or without AI assistance. AI is not mentioned as part of this device.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done

Not applicable. This device is a hardware product (a portable suction pump), not an algorithm or software-only device. Performance tests described are for the physical device itself.

7. The Type of Ground Truth Used

The "ground truth" for the performance tests (vacuum levels, suction time, battery life) is based on engineering specifications and established industry standards (ISO 10079-1, ISO 10993-1, IEC 60601-1, IEC 60601-1-2). For biocompatibility, it refers to material properties meeting ISO 10993-1.

8. The Sample Size for the Training Set

Not applicable. This device is a medical device, not an AI/machine learning model that requires a "training set."

9. How the Ground Truth for the Training Set Was Established

Not applicable. As above, there is no training set for this type of medical device.

Summary

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Image /page/0/Picture/0 description: The image shows the text "SSCOR, INC." in a bold, sans-serif font. The letters are black and appear to be slightly pixelated, giving them a textured look. The text is arranged horizontally, with the comma between "SSCOR" and "INC." being a distinct element.

11064 Randall Street, Sun Valley, CA 91352 Tel: 818-504-4054 Fax: 818-504-6032 Web Site: www.sscor.com

K041154
page 1/3

MAY 1 8 2004

Attachment 4

510(k) SUMMARY

Submitted by:	SSCOR, Incorporated11064 Randall StreetSun Valley, CA 91352-2621Tel: (818) 504-4054	Prepared: December 24, 2003Fax: (818) 504-6032
Contact persons:	Jesus Gasaway, Director Quality Assurance/Regulatory AffairsSam D. Say, PresidentScott D. Eamer, Project Manager
Device name:	S-SCORT...Jr® Quickdraw, Model 2400
Common name:	Battery Powered Portable Aspiration Pump
Classification name:	Powered Suction Pump (21 CFR, 878.4780)
Legally Marketed devices:	The SSCOR, Inc. S-SCORT® TEN Model 2100, 510(k) K952632cleared on June 16, 1995;The SSCOR, Inc. S-SCORT® Duet Model 2014, 510(k) K945929cleared on December 22, 1994;

Laerdal Medical Corp., Laerdal™ Suction Unit, 510(k) K840110, cleared on March 12, 1984.

Legally Marketed General Device Description: The S-SCORT® TEN battery powered portable aspirator was developed in 1995 (K952632). It consisted of functional components equivalent to most other portable battery-operated suction devices on the market, i.e., operational controls and circuits, suction pump and motor, and a disposable canister with tubing and suction tip. The S-SCORT® TEN is intended for portable emergency application environments, where conventional AC house current is typically unavailable. A rechargeable battery powers the S-SCORT® TEN. The entire device is housed on a steel base and lightweight plastic molded chassis with a built-in carrying handle. Although the other two legally marketed devices may look different in outward appearance, the general description is the equivalent.

Legally Marketed Device Configuration: The suction pump component assembly is connected to the collection canister component by means of collapse resistant suction tubing. A longer piece of patient tubing with suction tip is also connected to the canister so as to convey secretions from the patient to the collection canister. All cited legally marketed devices are constructed of components and assemblies arranged in the same fashion.

Operating and Scientific Principles of Legally Marketed Devices: When the assembled device is switched "On", the circuits direct electrical current from the battery to the pump/motor assembly. The pump/motor operates to evacuate air from the collection canister. The resulting sub-atmospheric condition causes air to flow upward from the distal end of the suction tip and into the collection canister. Thus, when called upon to do so, secretions can be carried through the suction tip and patient tubing and deposited into the canister. Additional feature changes to the S-SCORT® TEN were taken into its production efforts toward continuous improvement which are, decreased size and a custom designed molded chassis with integrated carrying handle and canister holder.

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K041154 page 2/3

Subject Device Description: The S-SCORT ...Jr® Quickdraw device is a design with added Subject Device Desertifications: a battery power level indicator, a custom non-sterile single use Uchents of user Inchary voltaons, a suction tip, an equally effective suction pump. The S-SCORT ... Jr® Quickdraw performance is significantly equivalent as the legally marketed devices.

Instructions for Use: Directions for use are virtually the same as for the Legally Marketed Suction devices. Users of a suction device should also be well trained in the safe and proper use of medical suction equipment.

Indications for use: Indications for use are very similar to those legally marketed devices cited; as well as more than 10 others sold in the U.S. market. The S-SCORT... Jr® Quickdraw is a nonas well as more than 10 others beference single use disposable canister with integrated suction tip, sterne reduced by professional personnel trained in Emergency Care techniques of constant suctioning to clear the airway by removing bodily fluids and particulate matter.

Preparation for Use: The S-SCORT ...Jr® Quickdraw will be provided fully assembled and ready for use. Operator/device self-orientation, and device charging as directed are prerequisites to use.

To Use: The user removes the canister from its storage position and installs it in the use position, pre-selects an initial (high/low) suction level, and then switches the device "On". The patient end of the integrated suction tip is ready to suction body fluids and/or particulate matter from a patient's mouth and airway.

Suctioning: The high velocity of the airflow will suction body fluids and/or particulate matter through the integrated suction tip and into the collection canister. In procedures where lower suction is desired, the regulator vent may be adjusted accordingly.

Preparation for Re-Use: After every use the S-SCORT ... Jr® Quickdraw exterior surfaces must be wiped clean, refitted with a new disposable canister and connected to a 12 VDC power source for recharging of the internal battery. This is the same procedure as for the legally marketed devices.

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K04 1154 page 3/.

Technological Comparison with Legally Marketed Devices:

Similarities - Materials are selected to provide a durable device with equivalent performance to the legally marketed devices. All SSCOR aspirators use a diaphragm vacuum pump. The device can be operated from its internal rechargeable battery, or from a 12 VDC power source. The 12 VDC Cigar lighter adapter, or 110 VAC to 9 VDC power converter, provide power to facilitate charging of the internal battery.

Differences - The S-SCORT...Jr® Quickdraw will use a custom canister and a sealed lead acid battery; the legally marketed devices use an aftermarket collection canister, and the Laerdal device uses a Nickel Cadmium (NiCad) battery and a piston pump. The S-SCORT Duet is capable of running from direct 110-230 VAC. The S-SCORT...Jr® Quickdraw uses a combination cabinet/carrying case of size, weight and design different from the legally marketed equivalents.

Test: Tests will be performed using industry standard protocols* to challenge the performance criteria that are typical for this type of medical product. A principle performance criterion are vacuum levels of 300 - 500 millimeters of mercury (mmHg), the time necessary to suction 200cc of vomitus and the ability to function for twenty (20) continuous minutes of operation from its internal battery power source.

Conclusion: The subject S-SCORT ...Jr® Quickdraw will be substantially equivalent to its legally marketed versions in construction, indications for use, operating characteristics and performance.

** Industry Standard Protocols:

ISO 10079-1: Medical Suction Equipment-Part 1: Electrically Powered Suction Equipment-Safety Requirements.

ISO 10993-1: Biological Evaluation of Medical Devices

IEC 60601-1: Medical Electrical Equipment- Part 1: General Requirements for Safety.

IEC 60601-1-2; Int'l Electromagnetic Safety

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Image /page/3/Picture/1 description: The image shows the seal of the Department of Health & Human Services (HHS). The seal is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an abstract image of an eagle with three stripes representing the feathers.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

MAY 1 8 2004

SSCOR, Inc. c/o Mr. Daniel W. Lehtonen Staff Engineer Intertek Testing Services 70 Codman Hill Road Boxborough, Massachusetts 01719

Re: K041154

Trade/Device Name: S-SCORT ....Ir® Quickdraw, Model 2400 Regulation Number: 21 CFR 878.4780 Regulation Name: Powered suction pump Regulatory Class: II Product Code: BTA Dated: April 29, 2004 Received: May 3, 2004

Dear Mr. Lehtonen:

We have reviewed your Section 510(k) premarket notification of intent to market the device wf nave reviewed your becamed the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate for use stated in the encreations of the enactment date of the Medical Device Amendments, or to conninered print to May 20, 1977, in accordance with the provisions of the Federal Food, Drug, devices mat have been results approval of a premarket approval application (PMA). and Costietle Treef the device, subject to the general controls provisions of the Act. The r ou may, mererere, mains of the Act include requirements for annual registration, listing of general voltarons profitive practice, labeling, and prohibitions against misbranding and adulteration.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it If your device is enabilied (600 as corrols. Existing major regulations affecting your device can may oc subject to sach additions, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

Please be advised that FDA's issuance of a substantial equivalence determination docs not mean I louse of a ribed alaw it that your device complies with other requirements of the Act that I Dr Has Intact and regulations administered by other Federal agencies. You must or any I edelin statuter and regisments, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic forth in the quarty by ovisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

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Page 2 - Mr. Daniel W. Lehtonen

This letter will allow you to begin marketing your device as described in your Section 510(k) I mis letter will and in your to FDA finding of substantial equivalence of your device to a legally premits of notication " results in a classification for your device and thus, permits your device to proceed to the market.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please 11 you desire spocific acrisoliance at (301) 594-4659. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the Division of Small other general micronational and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html

Sincercly yours,

Miriam C. Provost

Celia M. Witten, Ph.D., M.D. Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known): K041154

Device Name: S-SCORT ... Jr® Quickdraw, Model 2400

Indications for Use:

Prescription Use X (Part 21 CFR 801 Subpart D)

AND/OR

Over-The-Counter Use (21 CFR 807 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED) ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------

Concurrence of CDRH, Office of Device Evaluation (ODE)

Miriam C. Provost
(Division Sign Off)

and Neurological Devices

510(k) Number_________________________________________________________________________________________________________________________________________________________________

Regulation Number and Section

§ 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.