(440 days)
Not Found
No
The device description explicitly states the cables have "no additional non-electrical conducting or processing functionality" and the document does not mention AI, ML, or related terms.
No.
The device is described as cables used to connect sensors/electrodes to monitoring devices for general monitoring and diagnostic evaluation. It transmits electrical power and/or signal but does not generate them, nor does it have therapeutic functionality.
Yes
The "Intended Use / Indications for Use" section explicitly states that the cables are used "for general monitoring and/or diagnostic evaluation by health care professionals."
No
The device description explicitly states it is comprised of insulated, electrical cables with connectors, which are hardware components.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In vitro diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections. They are used to provide information for diagnosis, monitoring, or screening.
- Device Function: The description clearly states that the Patient Monitoring Cables are used to connect medical devices (like sensors, transducers, and monitors) to the patient or to other monitoring devices. They transmit electrical signals and power.
- Lack of Sample Analysis: The device does not analyze any samples taken from the patient's body. It facilitates the connection of devices that might collect data from the patient, but the cable itself is not performing an in vitro diagnostic test.
- Intended Use: The intended use is for "general monitoring and/or diagnostic evaluation by health care professionals" using connected devices, not for performing diagnostic tests on patient samples.
Therefore, the Patient Monitoring Cables fall under the category of medical devices used for patient monitoring and signal transmission, not in vitro diagnostics.
N/A
Intended Use / Indications for Use
The Patient Monitoring Cables are intended to be used with SpO2, Temperature, BP, ECG, Cardiac Output, and related monitoring devices. The Patient Monitoring Cables are used to connect electrodes, catheters, and/or sensors placed at appropriate sites on the patient to a monitoring devices, or between monitoring devices, for general monitoring and/or diagnostic evaluation by health care professionals.
Product codes
DSA
Device Description
The Patient Monitoring Cables are replacements for similar accessory cables manufactured or specified by Original Equipment Manufacturers (OEM) for their respective transducers, monitors, and peripheral equipment. These are non-patient-contact, insulated, electrical cables with a connector (plug or receptacle) at each end, designed to transmit electrical power and/or signal (data) between medical devices (e.g., to connect SpO2 sensor, IBP transducer to a patient monitor). They are not intended to connect to the mains (i.e., not mains power cables), do not generate any type of power and/or signal, and have no additional non-electrical conducting or processing functionality.
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 professionals.
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
Performance testing and analyses were performed on worst case representative cable assemblies and cable material to support substantial equivalence to the predicate device. Testing and analysis included the following:
- . Cable assembly resistance and continuity testing
- Cable material signal integrity testing
- Electromagnetic interference and safety analysis
The Fogg System Patient Monitoring Cables met all acceptance criteria from the testing and analyses and concluded to be in conformance to applicable sections of standards IEC 60601 and AAMI/ANSI BP22.
Key Metrics
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
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
Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
November 22, 2023
Fogg System Company, Inc. Jared Walkenhorst Novare Medical Consulting LLC. 1765 Dusty Boot Dr Lafayette, Colorado 80026
Re: K222712
Trade/Device Name: Fogg System Patient Monitoring Cables Regulation Number: 21 CFR 870.2900 Regulation Name: Patient Transducer And Electrode Cable (Including Connector) Regulatory Class: Class II Product Code: DSA Dated: September 8, 2022 Received: September 8, 2022
Dear Jared Walkenhorst:
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 (the 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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database available at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
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.
Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device" (https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download).
U.S. Food & Drug Administration 10903 New Hampshire Avenue Silver Spring, MD 20993 www.fda.gov
1
Your device is also subject to, among other requirements, the Quality System (QS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30, Design controls; 21 CFR 820.90, Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review. the OS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181).
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 of medical device-related adverse events) (21 CFR Part 803) for devices or postmarketing safety reporting (21 CFR Part 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
Jennifer W. Shih -S
Jennifer Shih Kozen Assistant Director Division of Cardiac Electrophysiology, Diagnostics and Monitoring Devices Office of Cardiovascular Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
2
DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration
Indications for Use
510(k) Number (if known) K222712
Device Name
Fogg System Patient Monitoring Cables
Indications for Use (Describe)
The Patient Monitoring Cables are intended to be used with SpO2, Temperature, BP, ECG, Cardiac Output, and related monitoring devices. The Patient Monitoring Cables are used to connect electrodes, catheters, and/or sensors placed at appropriate sites on the patient to a monitoring devices, or between monitoring devices, for general monitoring and/or diagnostic evaluation by health care professionals.
| Type of Use (Select one or both, as applicable) | |
|---|---|
| Prescription Use (Part 21 CFR 801 Subpart D) | Over-The-Counter Use (21 CFR 801 Subpart C) |
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3
510(K) SUMMARY
| Submitter's Name: | Fogg System Company, Inc. |
|---|---|
| Submitter's Address: | 15592 East Batavia Drive |
| Aurora, CO 80011 | |
| United States | |
| Contact Person: | Jared Walkenhorst |
| Novare Medical Consulting | |
| 720.215.9244 | |
| novaremedllc@gmail.com | |
| Date Summary was Prepared: | 16 Nov 2023 |
| Trade or Proprietary Name: | Fogg System Patient Monitoring Cables |
| Common or Usual Name: | Patient transducer and electrode cable (including connector) |
| Classification: | Class II per 21 CFR §870.2900 |
| Product Code: | DSA |
DESCRIPTION OF THE DEVICE SUBJECT TO PREMARKET NOTIFICATION:
The Patient Monitoring Cables are replacements for similar accessory cables manufactured or specified by Original Equipment Manufacturers (OEM) for their respective transducers, monitors, and peripheral equipment. These are non-patient-contact, insulated, electrical cables with a connector (plug or receptacle) at each end, designed to transmit electrical power and/or signal (data) between medical devices (e.g., to connect SpO2 sensor, IBP transducer to a patient monitor). They are not intended to connect to the mains (i.e., not mains power cables), do not generate any type of power and/or signal, and have no additional non-electrical conducting or processing functionality.
INDICATIONS FOR USE
The Patient Monitoring Cables are intended to be used with SpO2, Temperature, BP, ECG, Cardiac Output, and related monitoring devices. The Patient Monitoring Cables are used to connect electrodes, catheters, and/or sensors placed at appropriate sites on the patient to a monitoring device, or between monitoring devices, for general monitoring and/or diagnostic evaluation by health care professionals.
TECHNOLOGICAL CHARACTERISTICS
The Fogg System Patient Monitoring Cables are identical in intended use and similar in basic shape, material, and performance characteristics to the predicate device. There are no differences in the fundamental scientific technology shared by both the subject and predicate devices.
| Description | Subject Device | Predicate Device (K203635) |
|---|---|---|
| Device Name | Patient Monitoring Cables | Patient Monitoring Cables |
| Indications | ||
| for Use | The Patient Monitoring Cables are | |
| intended to be used with SpO2, | ||
| Temperature, BP, ECG, Cardiac Output, | ||
| and related monitoring devices. The | The Patient Monitoring Cables are | |
| intended to be used with ECG, EKG, Spo2 | ||
| and BP monitoring devices. The Patient | ||
| Monitoring Cables are used to connect |
Table 1 Substantial Equivalence Table
4
| | Patient Monitoring Cables are used to
connect electrodes, catheters, and/or
sensors placed at appropriate sites on the
patient to a monitoring device, or
between monitoring devices, for general
monitoring and/or diagnostic evaluation
by health care professionals. | electrodes, catheters, and/or sensors
placed at appropriate sites on the patient
to a monitoring device for general
monitoring and/or diagnostic evaluation
by health care professional. |
|-----------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Design/
Appearance | Cables with various connectors
(please see the table below) | Cables with various connectors |
| Length | Various specified standard lengths
(please see the table below) | Various specified standard lengths |
| Material | Tin copper, PVC, Santoprene,
Thermoplastics | Tin copper, PA66, PVC, ABS |
| Usage | Reusable, non-patient-contacting | Reusable and disposable, patient-
contacting and non-patient-contacting |
| Sterilization | Non-Sterile | Non-Sterile |
NONCLINICAL TEST DATA
Performance testing and analyses were performed on worst case representative cable assemblies and cable material to support substantial equivalence to the predicate device. Testing and analysis included the following:
- . Cable assembly resistance and continuity testing
- Cable material signal integrity testing
- Electromagnetic interference and safety analysis
CONCLUSION FROM NONCLINICAL TEST DATA
The Fogg System Patient Monitoring Cables met all acceptance criteria from the testing and analyses and concluded to be in conformance to applicable sections of standards IEC 60601 and AAMI/ANSI BP22.
SUBSTANTIAL EQUIVALENCE CONCLUSION
The Fogg System Patient Monitoring Cables have intended use and indications for use as the predicate device. The subject devices use the same operating principle, incorporate the same basic design, configurations, and labeling as the predicate devices. Performance testing and analysis indicates conformance to the applicable sections of standards, the same as the predicate devices.
As such, the Fogg System Patient Monitoring Cables have been determined to be as safe and effective as the predicate device and no new or different questions were raised regarding the safety and effectiveness when compared to the predicate device. Therefore, the devices have been found to be substantially equivalent.
| Production Code | Description |
|---|---|
| 7162-0XXX | Interface Cable - Connects specified Transducer Simulators to Compatible |
| Monitors |
5
| - | តចេច |
|---|
| 7204-0XXX | Interface Cable - Connects specified Transducers to Compatible Monitors |
|---|---|
| 7206-0XXX | Interface Cable - Connects specified Transducer Simulators to Compatible Monitors |
| 7213-0XXX | Interface Cable - Connects specified Transducers to Compatible Monitors |
| 7216-0XXX | Interface Cable - Connects specified Transducers to Compatible Monitors |
| 7228-0XXX | Interface Cable - Connects specified Transducers to Compatible Monitors |
| 7229-0XXX | Interface Cable - Connects specified Transducers to Compatible Monitors |
| 7233-0XXX | Interface Cable - Connects specified Simulators to Compatible Monitors |
| 7238-0XXX | Interface Cable - Connects specified Transducers to Compatible Monitors |
| 7245-0XXX | Interface Cable - Connects specified Transducers to Compatible Monitors |
| 7251-0XXX | Interface Cable - Connects specified Transducers to Compatible Monitors |
| 7254-0XXX | Interface Cable - Connects specified Transducers to Compatible Monitors |
| 7268-0XXX | Interface Cable - Connects specified Transducer Control Unit to Compatible Monitors |
| 7279-0XXX | Interface Cable - Connects specified Transducers to Compatible Monitors |
| 7286-0XXX | Interface Cable - Connects specified Simulators to Compatible Monitors |
| 7287-0XXX | Interface Cable - Connects specified Transducers to Compatible Monitors |
| 7295-0XXX | Interface Cable - Connects specified Pressure Wire Interfaces to Compatible Monitors |
| 7297-0XXX | Interface Cable - Connects specified Simulators to Compatible Monitors |
| 7303-0XXX | Interface Cable - Connects specified Transducers to Compatible Monitors |
| 7304-0XXX | Interface Cable - Connects specified Transducers to Compatible Monitors |
| 7305-0XXX | Interface Cable - Connects specified Transducers to Compatible Monitors |
| 7307-0XXX | Interface Cable - Connects specified Transducers to Compatible Monitors |
| 7310-0XXX | Interface Cable - Connects specified Transducer / Monitor Systems to Compatible Monitors |
| 7316-0XXX | Interface Cable - Connects specified Transducers to Compatible Monitors |
| 7330-0XXX | Interface Cable - Connects specified Transducer / Monitor Systems to Compatible Monitors |
| 7339-0XXX | Interface Cable - Connects specified Transducers to Compatible Monitors |
| 7340-0XXX | Interface Cable - Connects specified Transducer / Monitor Systems to Compatible Monitors |
| 7342-0XXX | Interface Cable - Connects specified Transducers to Compatible Monitors |
| 7343-0XXX | Interface Cable - Connects specified Simulators to Compatible Monitors |
| 7353-0XXX | Interface Cable - Connects specified Transducers to Compatible Monitors |
| 7354-0XXX | Interface Cable - Connects specified Transducers to Compatible Monitors |
| 7360-0XXX | Interface Cable - Connects specified Transducer / Monitor Systems to Compatible Monitors |
| 7364-0XXX | Interface Cable - Connects specified Transducer / Monitor Systems to Compatible Monitors |
| 7367-0XXX | Interface Cable - Connects specified Transducer / Monitor Systems to Compatible Monitors |
| 7368-0XXX | Interface Cable - Connects specified Transducer / Monitor Systems to Compatible Monitors |
6
| ר | 7 | |
|---|---|---|
| - | ||
| 1 | - | |
| S | S | |
| 7378-0XXX | Interface Cable - Connects specified Transducers to Compatible Monitors |
|---|---|
| 7379-0XXX | Interface Cable - Connects specified Transducers to Compatible Monitors |
| 7380-0XXX | Interface Cable - Connects specified Transducers to Compatible Monitors |
| 7381-0XXX | Interface Cable - Connects specified Transducers to Compatible Monitors |
| 7383-0XXX | Interface Cable - Connects specified Transducer / Monitor Systems to Compatible |
| Monitors | |
| 7389-0XXX | Interface Cable - Connects specified Transducers to Compatible Monitors |
| 7161-0XXX-0XXX | Adapter Cable - Adapts Compatible Transducer with Interface Cable to a |
| Compatible Monitor | |
| 7185-0756 | Analog Cable - Cable for Pressure. |
| 7185-0805 | Analog Cable - Cable for Pressure. |
| 7185-0809 | Analog Cable - Cable for Pressure. |
| 7242-0001 | Analog Cable - Cable for Temperature Probe Simulator. |
| 7242-0002 | Analog Cable - Cable for Temperature Probe Simulator. |
| 7242-0004 | Analog Cable - Cable for Temperature Probe Simulator. |
| 7242-0006 | Analog Cable - Cable for Temperature Probe Simulator. |
| 7242-0009 | Analog Cable - Cable for Temperature Probe Simulator. |
| 7335-0007 | Analog Cable - Cable for ECG. |
| 7335-0008 | Analog Cable - Cable for ECG. |
| 7349-0001 | Analog Cable - Cable for ECG & Pressure. |
| 7349-0002 | Analog Cable - Cable for ECG & Pressure. |
| 7349-0003 | Analog Cable - Cable for ECG & Pressure. |
| 7349-0005 | Analog Cable - Cable for ECG & Pressure. |
| 7349-0006 | Analog Cable - Cable for ECG & Pressure. |
| 7349-0008 | Analog Cable - Cable for ECG & Pressure. |
| 7349-0009 | Analog Cable - Cable for ECG & Pressure. |
| 7350-0001 | Analog Cable - Cable for Pressure. |
| 7350-0002 | Analog Cable - Cable for Pressure. |
| 7356-0001 | Analog Cable - Cable for ECG & Pressure. |
| 7356-0002 | Analog Cable - Cable for ECG & Pressure. |
| 7356-0003 | Analog Cable - Cable for ECG & Pressure. |
| 7356-0004 | Analog Cable - Cable for Pressure. |
| 7356-0005 | Analog Cable - Cable for Pressure. |
| 7356-0006 | Analog Cable - Cable for ECG. |
| 7356-0007 | Analog Cable - Cable for ECG. |
| 7356-0008 | Analog Cable - Cable for Pressure. |
| 7356-0014 | Analog Cable - Cable for Pressure. |
| 7356-0016 | Analog Cable - Cable for ECG & Pressure. |
| 7358-0012 | Analog Cable - Cable for Pressure. |
| 7382-0001 | Analog Cable - Cable for Pressure. |
| 7382-0002 | Analog Cable - Cable for Pressure. |
| 7382-0003 | Analog Cable - Cable for Pressure. |
7
| K222712 - Traditional 510(k): Fogg System Patient Monitoring Cables | ||
|---|---|---|
| 7382-0004 | Analog Cable - Cable for Pressure. |
|---|---|
| 7382-0005 | Analog Cable - Cable for Pressure. |
| 7382-0006 | Analog Cable - Cable for Pressure. |
| 7382-0007 | Analog Cable - Cable for Pressure. |
| 7382-0008 | Analog Cable - Cable for Pressure. |
| 7382-0009 | Analog Cable - Cable for Pressure. |
| 7382-0010 | Analog Cable - Cable for Pressure. |
| 7390-0002 | Analog Cable - Cable for Pressure. |
| 7390-0004 | Analog Cable - Cable for Pressure. |