(233 days)
No
The summary describes a microprocessor-controlled pneumatic tourniquet system with a touchscreen interface. There is no mention of AI, ML, image processing, or any data-driven algorithms for decision making or control. The performance studies focus on electrical safety, software development standards, usability, and hardware/software validation, not on the performance of an AI/ML model.
No
The device is described as an instrument used to temporarily occlude blood flow, not to treat or cure a disease or condition. Its purpose is to create a bloodless surgical field, which is a supportive function during surgery, not a therapeutic one.
No
The device is a pneumatic tourniquet system used to temporarily occlude blood flow during surgical procedures, which is a therapeutic function, not a diagnostic one.
No
The device description explicitly states it is a "non-sterile dual-port microprocessor controlled pneumatic tourniquet instrument" and mentions hardware testing and validation, indicating it is a physical device with integrated software, not a software-only medical device.
Based on the provided information, the ATS 5000 Tourniquet System is not an IVD (In Vitro Diagnostic) device.
Here's why:
- Intended Use: The intended use clearly states that the device is used to "temporarily occlude blood flow in a patient's extremities during surgical procedures." This is a direct intervention on the patient's body, not a test performed on a sample taken from the body.
- Device Description: The description details a "non-sterile dual-port microprocessor controlled pneumatic tourniquet instrument" used in conjunction with cuffs and hoses. This describes a physical device that applies pressure to a limb, not a device that analyzes biological samples.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue, etc.), detecting specific analytes, or providing diagnostic information based on laboratory testing.
IVD devices are specifically designed to perform tests on samples taken from the human body to provide information for the diagnosis, monitoring, or treatment of diseases or conditions. The ATS 5000 does not fit this description.
N/A
Intended Use / Indications for Use
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
Product codes
KCY
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
patient's extremities
Indicated Patient Age Range
Not Found
Intended User / Care Setting
qualified medical professionals, perioperative nurses, surgeons, and anesthesiologists / during surgical procedures
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)
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.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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.
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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
1
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)
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
| Type of Use (Select one or both, as applicable) |
|---|
| ------------------------------------------------- |
X Prescription Use (Part 21 CFR 801 Subpart D)
Over-The-Counter Use (21 CFR 801 Subpart C)
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3
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 Avenue
Vancouver, BC, V6H 1C3 |
|------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Contact Person: | Julie Kerr
Project Manager
Telephone: (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 believe
the proposed device requires 510(k) clearance as the deflation
protocols, Cuff ID, and EZ LOP features falls outside the
exemption 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 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. |
| Indications for Use: | The ATS 5000 Tourniquet System is intended to be used by
perioperative nurses, surgeons, and anesthesiologists, 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 |
4
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 |
|---|---|
| Deflation | |
| Protocols | Two user-selectable deflation protocols allow the user to vary from the standard |
| rapid deflation near the end of surgery. | |
| Cyclic Deflation: enables rapid detection and intervention for cauterization of | |
| bleeding vessels immediately prior to wound closure. | |
| Step Deflation: enables gradual cuff deflation to allow for gradual return of arterial | |
| flow. | |
| Both types of deflation protocols are achievable through manual changes to the | |
| pressure (same between the proposed and predicate devices). Automatic protocols, | |
| if selected, can simplify the perioperative workflow, and may simplify and | |
| standardize the detection and management of bleeding vessels. | |
| Cuff ID | Barcode reader module in the instrument to scan cuff packing labels. If it is a |
| barcode identified by the device the instrument will recognize the cuff as being one | |
| of the cuffs listed in the Instructions for Use and will display cuff details for the user | |
| to view (EZ Method enabled, dual ports, limb circumference range). | |
| New feature to further personalize tourniquet usage by taking into account specific | |
| details of recognized cuffs. Barcode reader module will scan any label, but will only | |
| display cuff details of recognized cuffs. | |
| EZ Method | |
| to measure | |
| LOP | The EZ Method measures LOP by employing a tourniquet cuff recognized by Cuff ID |
| to monitor arterial pulsations in an underlying limb by sensing pneumatic pressure | |
| pulsations in the cuff associated with volume changes in the limb as the cuff | |
| pressure is gradually increased. LOP is determined to be the cuff pressure at which | |
| the monitored arterial pulsations reach a certain threshold. The EZ Method is only | |
| enabled for cuffs recognized by Cuff ID. | |
| The EZ Method is a supplementary method to measure LOP, in addition to the | |
| Distal Method. The EZ Method enables the LOP measurement to be completed | |
| without the need for a Distal Sensor, thereby increasing convenience and speed and | |
| reducing disruptions of the perioperative workflow. Both methods monitor arterial | |
| pulsations to determine LOP as a cuff is gradually inflated. EZ Method and Distal | |
| Method provide equivalent measurements of LOP. |
5
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.