(51 days)
Not Found
No
The device description and intended use clearly define the device as a passive cable and lead wire system for transmitting electrical signals. There is no mention of any processing, analysis, or interpretation of these signals using AI or ML. The performance studies focus on compliance with standards and safety, not on algorithmic performance.
No
The device is an electrocardiograph cable system used to transmit signals for diagnostic and monitoring purposes, not for treatment.
Yes
The "Intended Use / Indications for Use" states that the device is used "to transmit signals from patient surface electrodes to various electrocardiograph recorders/monitors for both diagnostic and monitoring purposes." The "Device Description" also mentions it is used to transmit signals to "diagnostic and monitoring equipment."
No
The device description explicitly states it is a system of cables and leadwires, which are physical hardware components used to transmit electrical signals. It does not describe software as the primary or sole component.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states that the device is used to "transmit signals from patient surface electrodes to various electrocardiograph recorders/monitors". This involves collecting electrical signals from the patient's body, not analyzing samples taken from the body (like blood, urine, or tissue).
- Device Description: The description reinforces this by explaining that the cables and leadwires transmit "patient ECG and RESP signals". These are physiological signals, not in vitro samples.
- Lack of IVD Characteristics: The description and intended use do not mention any analysis of biological samples, reagents, or any other components typically associated with in vitro diagnostics.
IVD devices are specifically designed to examine specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes. This device is a component used in the process of collecting physiological data from the patient's body.
N/A
Intended Use / 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.
Product codes (comma separated list FDA assigned to the subject device)
DSA
Device Description
The purpose and function of the device has not changed
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.
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
trained operators in a medical professional's environment
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)
Summary of Non-Clinical Tests:
The Multilink Cable and Leadwire Systems and its applications comply with voluntary standards as detailed in Section 9, 11 and 17 of this premarket submission. The following quality assurance measures were applied to the development 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 Leadwire Systems, did not require clinical studies to support substantial equivalence.
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
Page 1 of 2
NOV 1 9 2008
Image /page/0/Picture/2 description: The image shows the General Electric (GE) logo. The logo consists of the letters 'GE' in a stylized, cursive font, enclosed within a circular frame. The frame has four decorative elements resembling small, stylized leaves or petals, positioned symmetrically around the circle. The logo is black and white.
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 Technologies | |||
| 9900 Innovation Drive | ||||
| Wauwatosa, WI 53226 | ||||
| Primary Contact Person: | Matthias Buerger | |||
| Director QA/RA - Diagnostic Cardiology | ||||
| GE Medical Systems Information Technologies | ||||
| RP-2122 | ||||
| 9900 Innovation Drive | ||||
| Wauwatosa, WI 53226 | ||||
| Telephone: 414-721-1438 | ||||
| Fax: 414-721-3863 | ||||
| E-mail: Matthias.buerger@ge.com | ||||
| Secondary Contacts: | Margaret Mucha | |||
| Regulatory Affairs Leader | ||||
| GE Medical Systems Information Technologies | ||||
| RP-2122 | ||||
| 9900 Innovation Drive | ||||
| Wauwatosa, WI 53226 | ||||
| Telephone: 262-548-2514 | ||||
| Fax: 414-721-3863 | ||||
| E-mail: margaret.mucha@ge.com | ||||
| Renee Thornborough | ||||
| QA Leader | ||||
| GE Medical Systems Information Technologies | ||||
| RP-2122 | ||||
| 9900 Innovation Drive | ||||
| Wauwatosa, WI 53226 | ||||
| Telephone: 414-721-3954 | ||||
| Fax: 414-721-3899 | ||||
| E-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 and | ||
| electrode cable | DSA | |||
| Predicate Device(s): | Multilink Cable and Leadwire Systems (K980582) | |||
| Device Description: | The purpose and function of the device has not changed |
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 | | |
1
Image /page/1/Picture/0 description: The image shows the text "K0822851 Page 2 of 2" written in black ink on a white background. The text appears to be handwritten and has a slightly rough or uneven quality. The top line contains a series of numbers and letters, while the bottom line indicates that it is page 2 of 2.
Image /page/1/Picture/1 description: The image shows the General Electric (GE) logo. The logo consists of the letters 'G' and 'E' intertwined in a stylized, cursive font. The letters are enclosed within a circular border that has a decorative, swirling pattern around the edges.
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 functional
scientific technology as its predicate device. |
|----------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Determination of
Substantial Equivalence: | Summary of Non-Clinical Tests:
The Multilink Cable and Leadwire Systems and its applications comply with
voluntary standards as detailed in Section 9, 11 and 17 of this premarket
submission. The following quality assurance measures were applied to the
development 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 Leadwire
Systems, did not require clinical studies to support substantial equivalence. |
| Conclusion: | GE Healthcare considers the Multilink Cable and Leadwire Systems to be as
safe, as effective, and performance is substantially equivalent to the predicate
device(s). |
.
2
Image /page/2/Picture/1 description: The image shows the seal of the Department of Health & Human Services (HHS). The seal features a stylized eagle with three stripes forming its body and wings. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" are arranged in a circular pattern around the eagle.
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
3
Page 2 - Mr. Matthias Buerger
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
4
KUOLOJI
Page 1 of 1
Image /page/4/Picture/1 description: The image shows a black and white logo of General Electric (GE). The logo consists of the letters 'GE' intertwined within a circular border. The letters are stylized with curved lines and flourishes, giving the logo a classic and recognizable appearance. The logo is simple, yet distinctive, representing the brand identity of General Electric.
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_