The ATS 5000 Tourniquet System is intended to be used by qualified medical professionals to temporarily occlude blood flow in a patient's extremities during surgical procedures on those extremities. Tourniquets have been found useful in producing a bloodless operation field in surgical procedures involving the extremities including: Reduction of certain fractures Kirschner wire removal Tumor and cyst excisions Subcutaneous fasciotomy Nerve injuries Tendon repair Bone grafts Total wrist joint replacement Replacement of joints in the fingers Knee joint replacements Amputations Replantations.

Device Description

The ATS 5000 is a non-sterile dual-port microprocessor controlled pneumatic tourniquet instrument intended to be used by qualified medical professionals to temporarily occlude blood flow in a patient's extremities during surgical procedures on those extremities. The ATS 5000 instrument is used in conjunction with available dual port tourniquet cuffs and hoses distributed/supplied by Zimmer Biomet Inc. A cuff is applied to a patient prior to the beginning of a procedure. Connective tubing is then attached to the cuff and then plugged into the ATS 5000 connector ports. The instrument is controlled via a touchscreen user interface.

AI/ML Overview

The provided document is a 510(k) summary for the ATS 5000 Automatic Tourniquet Instrument. It details the device's indications for use, its substantial equivalence to a predicate device (Zimmer ® A.T.S. ® 4000 Automatic Tourniquet System, K123553), and includes non-clinical performance data.

However, the document explicitly states that clinical performance data was not needed for this device. This means there was no study conducted to assess device performance against specific clinical acceptance criteria. Instead, the submission relies on non-clinical testing and the established safety and performance of the base technology and predicate device.

Therefore, I cannot provide information on acceptance criteria and a study proving the device meets those criteria from the given text in the way you've requested for typical AI/ML medical devices, as this device (a pneumatic tourniquet) underwent a different regulatory pathway that did not require such a clinical study.

I can, however, extract details about the non-clinical performance data and the rationale for not requiring clinical data, as well as the overall conclusion regarding the device's safety and performance from the provided text.

Here's a breakdown of the information that can be extracted:

1. A table of acceptance criteria and the reported device performance:

Acceptance Criteria: The document mentions that "All tests passed according to predetermined acceptance criteria" for the non-clinical testing. However, the specific quantitative acceptance criteria for each test are not listed in this summary.
Reported Device Performance:

Test Category	Standards Adhered To / Description	Performance Outcome
Electrical Safety & Environmental	IEC 60601-1, 60601-1-2, 60601-1-8	All tests passed according to predetermined criteria.
Software & Device Development	IEC 62304:2006, AAMI/ANSI HE-75:2009/(R)2018	All tests passed according to predetermined criteria.
Device Usability	IEC 60601-1-6, IEC 62366-1:2015	All tests passed according to predetermined criteria.
Hardware & Software Testing/Validation	Not explicitly listed, but implied as part of the development process and validation.	All tests passed according to predetermined criteria.

2. Sample size used for the test set and the data provenance:

Not applicable as no clinical study was performed. The non-clinical tests would have their own sample sizes (e.g., number of units tested), but these are not provided in the summary.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

Not applicable as no clinical study was performed and thus no "ground truth" was established with experts in a clinical context.

4. Adjudication method for the test set:

Not applicable as no clinical study was performed.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:

Not applicable. This device is a pneumatic tourniquet, not an AI/ML diagnostic tool.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:

Not applicable. This device is a pneumatic tourniquet; it's an instrument, not an algorithm. Its operation involves human interaction (qualified medical professionals).

7. The type of ground truth used:

Not applicable since no clinical study was conducted. For the non-clinical tests, "ground truth" would be defined by the technical specifications and standards (e.g., a pressure reading is accurate if it matches a calibrated reference).

8. The sample size for the training set:

Not applicable. This device did not involve machine learning with a training set.

9. How the ground truth for the training set was established:

Not applicable. This device did not involve machine learning with a training set.

Summary of why clinical data was not required:
The document states: "Clinical Performance – Clinical data was not needed for this device. Expanded functionality which falls outside the 510(k) exemption classification, does not require additional clinical data as the base technology safety and performance is well established. Existing literature, alongside the non-clinical performance data support the safety and performance of the proposed device."

This indicates that because the device is largely a modification or update to an existing, well-understood technology (pneumatic tourniquets), and the new features (Deflation Protocols, Cuff ID, EZ Method to measure LOP) were either considered minor enhancements or had their safety and performance supported by non-clinical testing and existing literature, a clinical study was not deemed necessary for substantial equivalence.

Summary

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May 20, 2021

McEwen and Associates Consulting Ltd. Julie Kerr Consultant 207-1099 West 8th Avenue Vancouver, BC V6H 1C3 Canada

Re: K202919

Trade/Device Name: ATS 5000 Automatic Tourniquet Instrument Regulation Number: 21 CFR 878.5910 Regulation Name: Pneumatic Tourniquet Regulatory Class: Class I Product Code: KCY Dated: September 25, 2020 Received: September 29, 2020

Dear Julie Kerr:

We have reviewed vour Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976. the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies.combination product submissions. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, 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 does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal

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statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801): medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531 -542 of the Act); 21 CFR 1000-1050.

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.

For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).

Sincerely,

Long Chen, Ph.D. Assistant Director DHT4A: Division of General Surgery Devices OHT4: Office of Surgical and Infection Control Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known) K202919

Device Name

ATS 5000 Automatic Tourniquet Instrument

Indications for Use (Describe)

Reduction of certain fractures Kirschner wire removal Tumor and cyst excisions Subcutaneous fasciotomy Nerve injuries Tendon repair Bone grafts Total wrist joint replacement Replacement of joints in the fingers Knee joint replacements Amputations Replantations

Type of Use (Select one or both, as applicable)
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X Prescription Use (Part 21 CFR 801 Subpart D)

Over-The-Counter Use (21 CFR 801 Subpart C)

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McEwen and Associates Consulting Ltd.

Suite 207, 1099 West 8th Avenue Vancouver BC Canada V6H 1C3

K202919 - 510(k) Summary

Sponsor:	McEwen & Associates Consulting Ltd.1099 West 8th AvenueVancouver, BC, V6H 1C3
Contact Person:	Julie KerrProject ManagerTelephone: (604) 742-0600
Submission Date:	September 25, 2020
Trade Name:	ATS 5000 Automatic Tourniquet System
Common Name:	Tourniquet device
Product Code / Device:	KCY - Pneumatic Tourniquet. The applicable regulation is§878.5910 under the limitation defined by §878.9. We believethe proposed device requires 510(k) clearance as the deflationprotocols, Cuff ID, and EZ LOP features falls outside theexemption classification.
Predicate Device:	Zimmer ® A.T.S. ® 4000 Automatic Tourniquet System,K123553, cleared 08/09/2013
Device Description:	The ATS 5000 is a non-sterile dual-port microprocessorcontrolled pneumatic tourniquet instrument intended to beused by qualified medical professionals to temporarily occludeblood flow in a patient's extremities during surgicalprocedures on those extremities.
	The ATS 5000 instrument is used in conjunction with availabledual port tourniquet cuffs and hoses distributed/supplied byZimmer Biomet Inc. A cuff is applied to a patient prior to thebeginning of a procedure. Connective tubing is then attachedto the cuff and then plugged into the ATS 5000 connectorports. The instrument is controlled via a touchscreen userinterface.
Indications for Use:	The ATS 5000 Tourniquet System is intended to be used byperioperative nurses, surgeons, and anesthesiologists, totemporarily occlude blood flow in a patient's extremitiesduring surgical procedures on those extremities. Tourniquetshave been found useful in producing a bloodless operationfield in surgical procedures involving the extremities including:Reduction of certain fractures, Kirschner wire removal, tumor

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McEwen and Associates Consulting Ltd.

Suite 207, 1099 West 8th Avenue Vancouver BC Canada V6H 1C3

and cyst excisions, subcutaneous fasciotomy, nerve injuries, tendon repair, bone grafts, total wrist joint replacement, replacement of joints in the fingers, knee joint replacements, amputations, replantations.

Comparison to Predicate Device: The ATS 5000 instrument is substantially equivalent to other legally marketing tourniquet systems, specifically the Zimmer ATS 4000 Automatic Tourniquet System, in that the devices are similar in design, materials, and indications for use. A complete discussion of technological characteristics of the ATS 5000 compared to the predicate device may be found in Section 12. The below table highlights the primary technological differences that we believe

Technological Characteristics:

Feature	Discussion
DeflationProtocols	Two user-selectable deflation protocols allow the user to vary from the standardrapid deflation near the end of surgery.Cyclic Deflation: enables rapid detection and intervention for cauterization ofbleeding vessels immediately prior to wound closure.Step Deflation: enables gradual cuff deflation to allow for gradual return of arterialflow.Both types of deflation protocols are achievable through manual changes to thepressure (same between the proposed and predicate devices). Automatic protocols,if selected, can simplify the perioperative workflow, and may simplify andstandardize the detection and management of bleeding vessels.
Cuff ID	Barcode reader module in the instrument to scan cuff packing labels. If it is abarcode identified by the device the instrument will recognize the cuff as being oneof the cuffs listed in the Instructions for Use and will display cuff details for the userto view (EZ Method enabled, dual ports, limb circumference range).New feature to further personalize tourniquet usage by taking into account specificdetails of recognized cuffs. Barcode reader module will scan any label, but will onlydisplay cuff details of recognized cuffs.
EZ Methodto measureLOP	The EZ Method measures LOP by employing a tourniquet cuff recognized by Cuff IDto monitor arterial pulsations in an underlying limb by sensing pneumatic pressurepulsations in the cuff associated with volume changes in the limb as the cuffpressure is gradually increased. LOP is determined to be the cuff pressure at whichthe monitored arterial pulsations reach a certain threshold. The EZ Method is onlyenabled for cuffs recognized by Cuff ID.The EZ Method is a supplementary method to measure LOP, in addition to theDistal Method. The EZ Method enables the LOP measurement to be completedwithout the need for a Distal Sensor, thereby increasing convenience and speed andreducing disruptions of the perioperative workflow. Both methods monitor arterialpulsations to determine LOP as a cuff is gradually inflated. EZ Method and DistalMethod provide equivalent measurements of LOP.

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McEwen and Associates Consulting Ltd.

Suite 207, 1099 West 8th Avenue Vancouver BC Canada V6H 1C3

Performance Data:

Non-Clinical Performance:

During the development process of the ATS 5000, the following testing was completed: Electrical safety and Environmental testing in accordance with IEC 60601-1, 60601-1-2 and 60601-1-8; Software and device development was conducted in accordance with requirements of IEC 62304:2006 and AAMI/ANSI HE-75:2009/(R)2018; Device Usability testing was conducted in accordance with requirements of IEC 60601-1-6 and IEC 62366-1:2015; and Hardware and Software testing including validation. All tests passed according to predetermined acceptance criteria.

Clinical Performance – Clinical data was not needed for this device.

Conclusions:

Expanded functionality which falls outside the 510(k)exemption classification, does not require additional clinical data as the base technology safety and performance is well established. Existing literature, alongside the non-clinical performance data support the safety and performance of the proposed device.

Regulation Number and Section

§ 878.5910 Pneumatic tourniquet.

(a)
Identification. A pneumatic tourniquet is an air-powered device consisting of a pressure-regulating unit, connecting tubing, and an inflatable cuff. The cuff is intended to be wrapped around a patient's limb and inflated to reduce or totally occlude circulation during surgery.(b)
Classification. Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter, subject to the limitations in § 878.9.