(51 days)
Multi-Link Cable and Lead Wire Systems are electrocardiograph cable systems used to transmit signals from patient surface electrodes to various electrocardiograph recorders/monitors for both diagnostic and monitoring purposes. Use is limited by the indications for use of the connected monitoring or diagnostic equipment. Multilink Cables and Lead Wire Systems are intended to be used by trained operators in a medical professional's environment.
The Multilink Cables and Leadwires are part of the GE Medical Systems Information Technologies line of supplies and accessories used to transmit patient ECG and RESP signals to diagnostic and monitoring equipment. The system is designed to provide a family of leadwires that will link the patient and patient cable system. Leadwires are available in multiple lengths and in multiple lead sets. Patient end terminations are available in Snap, Banana, Mactrode, or Grabber configurations. The multi-lead individual set design allows single leadwires to be individually removed and replaced as necessary. Mulilink leadwires are also available in a radiotranslucent version.
The provided document is a 510(k) Premarket Notification Submission for the GE Multilink Cable and Leadwire Systems. It describes the device, its intended use, and claims substantial equivalence to a predicate device.
However, the document states: "The subject of this premarket submission, Multilink Cable and Leadwire Systems, did not require clinical studies to support substantial equivalence."
Therefore, based on the provided text, there is no study provided that proves the device meets specific acceptance criteria based on performance. The submission relies on non-clinical tests (Risk Analysis, Requirements Reviews, Design Reviews, Testing on unit level, Integration testing, Final acceptance testing, Performance testing, Safety testing) and the claim that the device employs the same functional scientific technology as its predicate device. This implies that the acceptance criteria are met by virtue of being substantially equivalent to a previously approved device through engineering and quality assurance measures, rather than a clinical performance study.
Given this, I cannot provide the detailed information requested in points 1-9 as there is no performance study or specific acceptance criteria (e.g., sensitivity, specificity, accuracy) for a new clinical performance being evaluated. The submission focuses on safety, effectiveness, and substantial equivalence to the predicate device through non-clinical testing and shared technology.
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510(K) Premarket Notification Submission
510(k) Summary
| In accordance with 21 CFR 807.92 the following summary of information is provided: | ||||
|---|---|---|---|---|
| Date: | September 26, 2008 | |||
| Submitter: | GE Medical Systems Information Technologies9900 Innovation DriveWauwatosa, WI 53226 | |||
| Primary Contact Person: | Matthias BuergerDirector QA/RA - Diagnostic CardiologyGE Medical Systems Information TechnologiesRP-21229900 Innovation DriveWauwatosa, WI 53226Telephone: 414-721-1438Fax: 414-721-3863E-mail: Matthias.buerger@ge.com | |||
| Secondary Contacts: | Margaret MuchaRegulatory Affairs LeaderGE Medical Systems Information TechnologiesRP-21229900 Innovation DriveWauwatosa, WI 53226Telephone: 262-548-2514Fax: 414-721-3863E-mail: margaret.mucha@ge.com | |||
| Renee ThornboroughQA LeaderGE Medical Systems Information TechnologiesRP-21229900 Innovation DriveWauwatosa, WI 53226Telephone: 414-721-3954Fax: 414-721-3899E-mail: renee.thornborough@ge.com | ||||
| Device: | Trade Name: | Multilink Cable and Leadwire Systems | ||
| Common/Usual Name: | Multilink Cable and Leadwire Systems | |||
| Classification Names: | Patient transducer and electrode cable | |||
| Product Code: | 890.2900 | Patient transducer andelectrode cable | DSA | |
| Predicate Device(s): | Multilink Cable and Leadwire Systems (K980582) | |||
| Device Description: | The purpose and function of the device has not changedThe Multilink Cables and Leadwires are part of the GE Medical SystemsInformation Technologies line of supplies and accessories used to transmitpatient ECG and RESP signals to diagnostic and monitoring equipment. Thesystem is designed to provide a family of leadwires that will link the patient andpatient cable system.Leadwires are available in multiple lengths and in multiple lead sets. Patientend terminations are available in Snap, Banana, Mactrode, or Grabberconfigurations. The multi-lead individual set design allows single leadwires to |
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510(K) Premarket Notification Submission
| be individually removed and replaced as necessary. Mulilink leadwires are also available in a radiotranslucent version. | |
|---|---|
| Intended Use: | The Intended Use has been modified to include description of users and location of use |
| Multi-Link Cable and Lead Wire Systems are electrocardiograph cable systems used to transmit signals from patient surface electrodes to various electrocardiograph recorders/monitors for both diagnostic and monitoring purposes. Use is limited by the indications for use of the connected monitoring or diagnostic equipment. | |
| Multilink Cables and Lead Wire Systems are intended to be used by trained operators in a medical professional's environment |
| Technology: | The Multilink Cable and Leadwire Systems employs the same functionalscientific technology as its predicate device. |
|---|---|
| Determination ofSubstantial Equivalence: | Summary of Non-Clinical Tests:The Multilink Cable and Leadwire Systems and its applications comply withvoluntary standards as detailed in Section 9, 11 and 17 of this premarketsubmission. The following quality assurance measures were applied to thedevelopment of the system:Risk Analysis Requirements Reviews Design Reviews Testing on unit level (Module verification) Integration testing (System verification) Final acceptance testing (Validation) Performance testing (Verification) Safety testing (Verification) Summary of Clinical Tests:The subject of this premarket submission, Multilink Cable and LeadwireSystems, did not require clinical studies to support substantial equivalence. |
| Conclusion: | GE Healthcare considers the Multilink Cable and Leadwire Systems to be assafe, as effective, and performance is substantially equivalent to the predicatedevice(s). |
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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
NOV 1 9 2008
GE Medical Systems Information Technologies c/o Matthias Buerger Director QA/RA - Diagnostic Cardiology 9900 Innovation Drive Wauwatosa, WI 53226
Re: K082851
Multilink Cable and Leadwire Systems Regulation Number: 21 CFR 870.2900 Regulation Name: Transducer and Electrode Patient Cable (including connector) Regulatory Class: II Product Code: DSA Dated: September 26, 2008 Received: September 26, 2008
Dear Mr. Buerger:
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 such 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 statutes and regulations administered by other Federal agencies. You must
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comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); 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. This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Center for Devices and Radiological Health's (CDRH's) Office of Compliance at (240) 276-0120. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometric's (OSB's) Division of Postmarket Survcillance at 240-276-3474. For questions regarding the reporting of device adverse events (Mcdical Device Reporting (MDR)), please contact the Division of Surveillance Systems at 240-276-3464. 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 (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours,
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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KUOLOJI
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GE Healthcare 510(K) Premarket Notification Submission
510(k) Number (if known):
Device Name: Multilink Cable and Leadwire Systems
Indications for Use:
Multi-Link Cable and Lead Wire Systems are electrocardiograph cable systems used to transmit signals from patient surface electrodes to various electrocardiograph recorders/monitors for both diagnostic and monitoring purposes. Use is limited by the indications for use of the connected monitoring or diagnostic equipment.
.
Multilink Cables and Lead Wire Systems are intended to be used by trained operators in a medical professional's environment.
Prescription Use x (Part 21 CFR 801 Subpart D)
AND/OR
Over-The-Counter Use (Part 21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
| for Zuckerman | |
|---|---|
| -- | --------------- |
| (Division Sign-Off) | 11/19/08 |
|---|---|
| Division of Cardiovascular Devices |
KOBZAS I 510(k) Number_
§ 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).