(51 days)
Not Found
No
The description focuses on the physical characteristics and compliance of standard ECG lead wires with retractors, with no mention of AI or ML.
No.
The Adagio™ Retracting ECG patient lead wires are accessories used to connect electrodes to a monitoring device for diagnostic evaluation, not to provide therapy.
Yes
The "Intended Use / Indications for Use" states that the lead wires are used to connect to a monitoring device for "general monitoring and/or diagnostic evaluation by a health care professional." The lead wires themselves are not diagnostic, but they are an accessory used in the diagnostic process.
No
The device description explicitly states it is a "standard five lead wire set that incorporate retractors," which are physical hardware components.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is to connect electrodes/sensors on a patient to a monitoring device for general monitoring and/or diagnostic evaluation. This involves collecting physiological signals directly from the patient's body.
- Device Description: The device is described as ECG lead wires, which are external components used to transmit electrical signals from the patient's skin to a monitoring device.
- Lack of IVD Characteristics: An IVD device is typically used to examine specimens derived from the human body (like blood, urine, tissue) to provide information for diagnostic purposes. This device does not interact with or analyze such specimens.
The device is a component used in the process of in vivo (within the living body) monitoring and diagnosis, not in vitro (in glass, i.e., outside the body) diagnosis.
N/A
Intended Use / Indications for Use
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.
Product codes (comma separated list FDA assigned to the subject device)
DSA
Device Description
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
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
health care professional
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
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.
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
The Adagio™ Retracting ECG Lead Wires Sterilization Not Applicable: are not provided sterile.
Shelf Life Testing: Not Applicable: The Adagio™ Retracting ECG Lead Wires; are intended to be reusable.
Biocompatibility Testing: Not Applicable: The Adagio™ Retracting ECG Lead Wires do not have patient contact. Therefore they do not require biocompatibility testing.
Electrical Safety Testing: 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 ) 2001 Test results confirm that the Adagio is safe and effective for its intended use.
Performance Testing - 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.
Performance Testing - Animal: Animal performance testing is not required and was not performed to demonstrate safety and effectiveness of the Adagio.
Performance Testing - Clinical: Clinical performance testing is not required and was not performed to demonstrate safety and effectiveness of the Adagio.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 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).
0
် မြို့နယ်ရှိ ရွာများ ရခိုင်မြို့နယ်၊ မြို့နယ်၊ မြို့နယ်၊ မြို့နယ်၊ မြို့နယ်၊ မြို့နယ်၊ မြို့နယ်၊ မြို့နယ်၊ မြို့နယ်၊ မြို့နယ်၊ မြို့နယ်၊ မြို့နယ်၊ မြို့နယ်၊ မြို့နယ်၊ မြို့
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12 40 11
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
5
| Submission Date | November 25,2009 |
|---|---|
| Submitter | ACIST Medical Systems, Inc. |
| 7905 Fuller Road | |
| Eden Prairie, MN 55344 | |
| Submitter Contact | Mr. Al Saalabi |
| Vice President of Regulatory Affairs and Quality | |
| Assurance | |
| ACIST Medical Systems, Inc. | |
| (952) 995–9315 | |
| (952) 941-4648 (fax) | |
| al.saalabi@acistmedical.com | |
| Manufacturing Site | ACIST Medical Systems, Inc. |
| 7905 Fuller Road | |
| Eden Prairie, MN 55344 USA | |
| Official Contact | Mr. Al Saalabi |
| Vice President of Regulatory Affairs and Quality | |
| Assurance | |
| ACIST 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 (including |
| connector) 21CFR 870.2900, Product Code DSA | |
| Classification Regulation | 21 CFR §870.2900 |
| Classification | II |
Page 10=3
DSA
Product Code
1
K093657
i
15
| Substantially
Equivalent
Devices | Company Name | Predicate
510(k)
Number | Predicate Manufacturer / Model |
|----------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------|--------------------------------------------------------------------------------------------------------------------------|
| | Merit Cables
Incorporated | K942321 | Various Patient Monitoring Cables |
| Proposed
Device
Description | 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 | | |
| Intended Use: | 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. | | |
| | | | CAUTION: Federal (USA) law restricts sale of the Adagio™
Retracting ECG Lead Wires to or on the order of a physician. |
| Technology
Comparison: | 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. | | |
Summary of Performance Testing:
The Adagio™ Retracting ECG Lead Wires Sterilization Not Applicable: are not provided sterile. Validation:
Page 2 of 3
2
| Shelf Life Testing | Not Applicable: The Adagio™ Retracting ECG Lead Wires; are intended to be reusable. |
|---|---|
| Biocompatibility | |
| Testing | Not Applicable: The Adagio™ Retracting ECG Lead Wires do not have patient contact. Therefore they do not require biocompatibility testing. |
| Electrical Safety | |
| Testing | 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 ) 2001 | |
| Test results confirm that the Adagio is safe and effective for its intended use. | |
| Performance | |
| Testing - 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. |
| Performance | |
| Testing - Animal | Animal performance testing is not required and was not performed to demonstrate safety and effectiveness of the Adagio. |
| Performance | |
| Testing - 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
Page 3 of 3
3
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.
4
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
5
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