(79 days)
For use in converting collet terminal outputs of pacing devices equipped with "For use in converting concernment will connect to extension cables and terminals spaced "1:25" on connected pin connectors."
Models 4820 and 4825 Pacing Adapters
I apologize, but the provided text ({0}, {1}, {2}) does not contain information about the acceptance criteria or a study proving that a device meets such criteria.
The text is a Food and Drug Administration (FDA) 510(k) Premarket Notification letter for the PACE Medical, Inc. Models 4820 and 4825 Pacing Adapters. This letter:
- Identifies the device and its manufacturer.
- States that the device has been found substantially equivalent to a legally marketed predicate device. This means the FDA determined the new device is as safe and effective as a device already on the market, based on the information provided by the manufacturer.
- Outlines the regulatory class and product code.
- Lists the "Indications for Use" which describe what the device is intended to be used for.
- Provides general information regarding compliance with FDA regulations.
There is no mention of:
- Specific acceptance criteria (e.g., performance thresholds for accuracy, sensitivity, specificity, etc.).
- A study design, methodology, or results demonstrating the device meets any particular performance metrics.
- Details about test sets, training sets, ground truth establishment, expert qualifications, or comparative effectiveness studies.
Therefore, I cannot provide the requested table or answer the points about study details based on the given input.
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Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002
1 2011 JUN
PACE Medical, Inc. c/o Mr. Robert C. Mace Quality Assurance and Regulatory Affairs 391 Totten Pond Road Waltham, MA 02451
Re: K011980
Trade/Device Name: Models 4820 and 4825 Pacing Adapters Regulation Number: 21 CFR 870.3600 Regulation Name: External Pacemaker Pulse Generator Regulatory Class: III (three) Product Code: DTE Dated: June 20, 2001 Received: June 25, 2001
Dear Mr. Mace:
This letter corrects our substantially equivalent letter of September 12, 2001.
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 (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. Robert C. Mace
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/Resourcesfor You/Industry/default.htm.
Sincerely yours,
Bram D. Zuckerman, M.D. Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health
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Kolla80 510(k) Number:________________________________________________________________________________________________________________________________________________________________
Device Name: Models 4820 and 4825 Pacing Adapters
INDICATIONS FOR USE
"For use in converting collet terminal outputs of pacing devices equipped with "For use in converting concernment will connect to extension cables and terminals spaced "1:25" on connected pin connectors."
Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use (Per 21 CFR 801.109) Over-The-Counter-Use (Optional Format 1-2)
Division of Cardiovascular & Respiratory Devices
510(k) Number K011980
§ 870.3600 External pacemaker pulse generator.
(a)
Identification. An external pacemaker pulse generator (EPPG) is a prescription device that has a power supply and electronic circuits that produce a periodic electrical pulse to stimulate the heart. This device, which is used outside the body, is used as a temporary substitute for the heart's intrinsic pacing system until a permanent pacemaker can be implanted, or to control irregular heartbeats in patients following cardiac surgery or a myocardial infarction. The device may have adjustments for impulse strength, duration, R-wave sensitivity, and other pacing variables.(b)
Classification. Class II (special controls). The special controls for this device are:(1) Appropriate analysis/testing must validate electromagnetic compatibility (EMC) within a hospital environment.
(2) Electrical bench testing must demonstrate device safety during intended use. This must include testing with the specific power source (
i.e., battery power, AC mains connections, or both).(3) Non-clinical performance testing data must demonstrate the performance characteristics of the device. Testing must include the following:
(i) Testing must demonstrate the accuracy of monitoring functions, alarms, measurement features, therapeutic features, and all adjustable or programmable parameters as identified in labeling;
(ii) Mechanical bench testing of material strength must demonstrate that the device and connection cables will withstand forces or conditions encountered during use;
(iii) Simulated use analysis/testing must demonstrate adequate user interface for adjustable parameters, performance of alarms, display screens, interface with external devices (
e.g. data storage, printing), and indicator(s) functionality under intended use conditions; and(iv) Methods and instructions for cleaning the pulse generator and connection cables must be validated.
(4) Appropriate software verification, validation, and hazard analysis must be performed.
(5) Labeling must include the following:
(i) The labeling must clearly state that these devices are intended for use in a hospital environment and under the supervision of a clinician trained in their use;
(ii) Connector terminals should be clearly, unambiguously marked on the outside of the EPPG device. The markings should identify positive (+) and negative (−) polarities. Dual chamber devices should clearly identify atrial and ventricular terminals;
(iii) The labeling must list all pacing modes available in the device;
(iv) Labeling must include a detailed description of any special capabilities (
e.g., overdrive pacing or automatic mode switching); and(v) Appropriate electromagnetic compatibility information must be included.