(51 days)
The Adagio™ Retracting ECG patient lead wires are used to connect electrodes and/or sensors placed at the appropriate sites on the patient to a monitoring device for general monitoring and/or diagnostic evaluation by a health care professional.
The Adagio™ Retracting ECG Lead Wires are standard five lead wire set that incorporate retractors to facilitate the handling of the lead wires and are:
• ANSI/AAMI EC 53: 1995 (R) 2001 Compliant
• AAMI EC 13: 2002 (R) 2007 Color Code compliant
The provided document K093657 describes the Adagio™ Retracting ECG Lead Wires. Here's an analysis of its acceptance criteria and the study that proves the device meets those criteria:
1. Table of Acceptance Criteria and Reported Device Performance:
| Acceptance Criteria Category | Specific Acceptance Criteria (Standards/Tests) | Reported Device Performance (Compliance/Results) |
|---|---|---|
| Electrical Safety | 21 CFR 898.12IEC 60601-1, Sub clause 56.3 (c)ANSI/AAMI EC 53: 1995 (R) 2001 | Tested and found to comply with all required patient safety testing, including the listed applicable standards. "Test results confirm that the Adagio is safe and effective for its intended use." |
| Performance - Bench | Established protocols for bench testing. | "Bench testing was conducted on the Adagio™ Retracting ECG Lead Wires according with established protocols and test results confirm that the final product met the requirements for the safety and performance standards and its intended use." |
| Biocompatibility | Based on patient contact. | Not Applicable: "The Adagio™ Retracting ECG Lead Wires do not have patient contact. Therefore they do not require biocompatibility testing." |
| Sterilization | Sterility requirements. | Not Applicable: "are not provided sterile." |
| Shelf Life | Expected lifespan/usability. | Not Applicable: "The Adagio™ Retracting ECG Lead Wires; are intended to be reusable." |
| Substantial Equivalence | Comparison to predicate device (K942321). | "The Adagio™ Retracting ECG Lead Wires has identical performance and technological characteristics of common non retractable ECG patient lead wires used extensively in the medical industry as well as the legally marketed predicate, cleared under 510(k) K942321." "The Adagio™ Retracting ECG Lead Wires are equivalent to the predicate lead wire devices cleared to market under 510(k) K942341." |
2. Sample Size Used for the Test Set and Data Provenance:
The document describes bench testing and electrical safety testing as the primary means to demonstrate safety and effectiveness.
- Sample Size for Test Set: The document does not specify a numerical sample size for the devices tested in electrical safety or bench testing. It generally states that the "Adagio™ Retracting ECG Lead Wires" (plural) were tested.
- Data Provenance: The data is from prospective testing conducted by the manufacturer (ACIST Medical Systems, Inc.) to evaluate the device against specified standards and internal protocols. No information is provided regarding the country of origin of the data beyond the manufacturer's location in Eden Prairie, MN, USA.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts:
- This question is not applicable in this context. The "ground truth" for the performance of an ECG lead wire is based on objective measurements against established engineering and safety standards, not on expert interpretation of medical images or clinical outcomes. The device's function is to transmit electrical signals reliably and safely, which is assessed through bench and electrical tests.
4. Adjudication Method for the Test Set:
- This question is not applicable. Adjudication methods like "2+1" are typically used in clinical studies where multiple experts evaluate ambiguous cases. For bench and electrical safety testing, results are typically objective measurements against pass/fail criteria from standards.
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:
- This question is not applicable. The device is an ECG lead wire, a hardware component for signal transmission, not an AI-powered diagnostic or assistive tool for human readers. Therefore, an MRMC study and AI assistance improvement are irrelevant to its evaluation.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done:
- This question is not applicable. This device is a passive hardware component (lead wire) and does not involve an algorithm or AI operating in a standalone capacity. Its performance is evaluated on its ability to meet electrical and mechanical standards.
7. The Type of Ground Truth Used:
The "ground truth" for this device's performance is established by:
- Objective measurements and compliance with recognized industry standards: Specifically, electrical safety standards (21 CFR 898.12, IEC 60601-1, ANSI/AAMI EC 53: 1995 (R) 2001) and internal bench testing protocols.
- Demonstration of "identical performance and technological characteristics" to a legally marketed predicate device (K942321). This establishes a comparative "ground truth" based on the predicate's known safe and effective performance.
There is no mention of expert consensus, pathology, or outcomes data being used to establish the ground truth for this type of device.
8. The Sample Size for the Training Set:
- This question is not applicable. There is no "training set" as this device is a hardware component and does not employ machine learning or AI that would require a training phase.
9. How the Ground Truth for the Training Set Was Established:
- This question is not applicable for the same reasons as above.
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Summary of Safety and Effectiveness الموقع الموقع الموقع الموقع الموقع الموقع الموقع الموقع الموقع الموقع الموقع الموقع الموقع الموقع الموقع الموقع الموقع الموقع الموقع الموقع الموقع الموقع الموقع الموقع الموق
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| Submission Date | November 25,2009 |
|---|---|
| Submitter | ACIST Medical Systems, Inc.7905 Fuller RoadEden Prairie, MN 55344 |
| Submitter Contact | Mr. Al SaalabiVice President of Regulatory Affairs and QualityAssuranceACIST Medical Systems, Inc.(952) 995–9315(952) 941-4648 (fax)al.saalabi@acistmedical.com |
| Manufacturing Site | ACIST Medical Systems, Inc.7905 Fuller RoadEden Prairie, MN 55344 USA |
| Official Contact | Mr. Al SaalabiVice President of Regulatory Affairs and QualityAssuranceACIST Medical Systems, Inc.(952) 995-9315(952) 941-4648 (fax)al.saalabi@acistmedical.com |
| Trade Name | Adagio™ Retracting ECG Lead Wires |
| Proprietary Name: | Adagio™ Retracting ECG Lead Wires |
| Common Name | ECG Lead Wires |
| Classification Name | Patient Transducer and Electrode Cable (includingconnector) 21CFR 870.2900, Product Code DSA |
| Classification Regulation | 21 CFR §870.2900 |
| Classification | II |
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DSA
Product Code
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K093657
i
15
| SubstantiallyEquivalentDevices | Company Name | Predicate510(k)Number | Predicate Manufacturer / Model |
|---|---|---|---|
| Merit CablesIncorporated | K942321 | Various Patient Monitoring Cables | |
| ProposedDeviceDescription | The Adagio™ Retracting ECG Lead Wires are standard five leadwire set that incorporate retractors to facilitate the handling ofthe lead wires and are:• ANSI/AAMI EC 53: 1995 (R) 2001 Compliant• AAMI EC 13: 2002 (R) 2007 Color Code compliant | ||
| Intended Use: | The Adagio™ Retracting ECG patient lead wires are used toconnect electrodes and/or sensors placed at the appropriatesites on the patient to a monitoring device for generalmonitoring and/or diagnostic evaluation by a health careprofessional. | ||
| CAUTION: Federal (USA) law restricts sale of the Adagio™Retracting ECG Lead Wires to or on the order of a physician. | |||
| TechnologyComparison: | The Adagio™ Retracting ECG Lead Wires has identicalperformance and technological characteristics of common nonretractable ECG patient lead wires used extensively in the medicalindustry as well as the legally marketed predicate, cleared under510(k) K942321. |
Summary of Performance Testing:
The Adagio™ Retracting ECG Lead Wires Sterilization Not Applicable: are not provided sterile. Validation:
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| Shelf Life Testing | Not Applicable: The Adagio™ Retracting ECG Lead Wires; are intended to be reusable. |
|---|---|
| BiocompatibilityTesting | Not Applicable: The Adagio™ Retracting ECG Lead Wires do not have patient contact. Therefore they do not require biocompatibility testing. |
| Electrical SafetyTesting | The Adagio™ Retracting ECG Lead Wires were tested and found to comply with all required patient safety testing including with the following applicable Standards:• 21 CFR 898.12• IEC 60601-1, Sub clause 56.3 (c )• ANSI/AAMI EC 53: 1995 (R ) 2001Test results confirm that the Adagio is safe and effective for its intended use. |
| PerformanceTesting - Bench | Bench testing was conducted on the Adagio™ Retracting ECG Lead Wires according with established protocols and test results confirm that the final product met the requirements for the safety and performance standards and its intended use. |
| PerformanceTesting - Animal | Animal performance testing is not required and was not performed to demonstrate safety and effectiveness of the Adagio. |
| PerformanceTesting - Clinical | Clinical performance testing is not required and was not performed to demonstrate safety and effectiveness of the Adagio. |
Conclusion
- · The Adagio™ Retracting ECG Lead Wires are equivalent to the predicate lead wire devices cleared to market under 510(k) K942341.
- Electrical safety and bench testing confirms the device performs as intended. .
- The proposed device does not raise new issues of safety and effectiveness. .
- The proposed device is deemed safe and effective for its intended use. 0
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Image /page/3/Picture/0 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an abstract symbol resembling an eagle or bird-like figure.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room W-066-0609 Silver Spring, MD 20993-0002
JAN 1 5 2010
Acist Medical Systems, Inc. c/o Mr. Al Saalabi Vice President of Regulatory Affairs and Quality Assurance 7905 Fuller Road Eden Prairie, MN 55344
Re: K093657
Trade/Device Name: Adagio™ Retracting ECG Lead Wires Regulatory Number: 21 CFR 870.2900 Regulation Name: Patient Transducer and Electrode Cable (Including Connector) Regulatory Class: II (two) Product Code: 74 DSA Dated: November 25, 2009 Received: November 25, 2009
Dear Mr. Saalabi:
We have reviewed your 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. 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.
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.
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Page 2 - Mr. Al Saalabi
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 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 (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to
http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely vours.
E. balmer
Bram D. Zuckerman, M.D. Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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510(k) Number (if known): Device Name:
Adagio™ Retracting ECG Lead Wires
Indications for Use:
The Adagio™ Retractable ECG patient lead wires are used to connect electrodes and/or sensors placed at the appropriate sites on the patient to a monitoring device for general monitoring and/or diagnostic evaluation by a health care professional.
CAUTION: Federal (USA) law restricts sale of the Adagio™ ECG Leads to or on the order of a physician.
AND/OR - Quiz
Prescription Use (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 IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE
Dumer R-Vahner
scular Devices
510(k) Number K093657
§ 870.2900 Patient transducer and electrode cable (including connector).
(a)
Identification. A patient transducer and electrode cable (including connector) is an electrical conductor used to transmit signals from, or power or excitation signals to, patient-connected electrodes or transducers.(b)
Classification. Class II (performance standards).