The DS-7000 Series Telemetry Monitoring System is intended to be used as central station monitoring system for the evaluation of the cardiovascular system. It is intended to be used by or on the order of a physician or similarly qualified healthcare professional. The DS-7000 Series Telemetry Monitoring System is intended to be used in hospital environments: ER, ICU, a clinic or similar settings. The DS-7000 Series Telemetry Monitoring System is intended to be used in those situations where the patient is being monitored by a Fukuda Denshi DS-5000-7000 Series bedside monitor, or patient worn telemetry transmitter where remote, central station monitoring is desired. This system is not intended for home use.

Device Description

The Fukuda Denshi model LX-7230KM/7230N is a patient worn Transmitter that transmits physiological data such as ECG, respirogram, arterial oxygen saturation (SpO2), plethysmograph, and pulse rate from a patient to a Fukuda Denshi Central Monitor. The front LCD display information such as ECG, heart rate, respirogram, respiration rate, SpO2, plethysmograph, pulse rate, pulse amplitude level, battery level, and the conditions of the ECG electrodes and SpO2 sensor. For the SpO2 measurement, the LX-7230N utilizes Nellcor SpO2 module technology (K060576) and the LX-7230KM utilizes Konica-Minolta SpO2 module technology (K053419). Both transmitters can only be used as an interface device of the previously cleared Fukuda Denshi Central Monitor (K970585, K000746, K020084) utilizing the central telemetry receiver (K980728). Both transmitters utilize digital FSK (frequency shift keying) technology and operate in the WMTS 608 to 614 MHz transmission frequencies. One or two channel ECG waveforms are selectable with lead selection available using the two buttons (Enter and down arrow) on the front panel. (In case of using a 3-electrode lead cable or a 5-electrode chest lead cable). Both transmitters are battery powered using 2 AA alkaline batteries with available continuous operation for 6 days (LX-7230KM) or 3 days (LX-7230N). The LX-7230KM/7230N is small and lightweight at 190 grams including batteries. The physical dimensions of the device are 72 mm (W) x 98 mm (H) x 24.8(D) mm.

AI/ML Overview

This is a summary of the acceptance criteria and study information based on the provided text.

This submission describes a telemetry transmitter (Fukuda Denshi Model LX-7230KM/7230N) which is an interface device that transmits physiological data (ECG, respirogram, arterial oxygen saturation (SpO2), plethysmograph, and pulse rate) from a patient to a central monitor. The core technology (ECG and Respiration measurement) is the same as the predicate device (LX-5630, [K033711](https://510k.innolitics.com/device/K033711)). The SpO2 measurement function integrates OEM modules from Konica Minolta (PULSOX-300/300i, [K053419](https://510k.innolitics.com/device/K053419)) and Nellcor (N-600x Pulse Oximeter, [K060576](https://510k.innolitics.com/device/K060576)), without modification to these modules or their sensors. The submission focuses on demonstrating substantial equivalence to the predicate device and the previously cleared OEM SpO₂ modules rather than presenting new clinical study data with specific performance metrics.

Acceptance Criteria and Device Performance

The provided document does not specify quantitative acceptance criteria (e.g., sensitivity, specificity, accuracy targets) for the Fukuda Denshi Model LX-7230KM/7230N Transmitter. Instead, the claim for substantial equivalence is based on the device incorporating identical fundamental technology for ECG and Respiration measurement as a predicate device and utilizing pre-cleared, unmodified SpO₂ modules whose performance has already been established and accepted by the FDA.

The "reported device performance" indicated is that the device "demonstrates that this device is as safe and effective as and performs as well as the legally marketed predicate device, the Fukuda Denshi model LX-5630 Transmitter 510(k) #K033711." This implies that the device meets the performance standards already established for the predicate device and the incorporated OEM SpO₂ modules.

Acceptance Criteria (Implied)	Reported Device Performance
Safety and Efficacy (equivalent to predicate device)	"demonstrates that this device is as safe and effective as...the legally marketed predicate device, the Fukuda Denshi model LX-5630 Transmitter 510(k) #K033711."
Functional Performance (equivalent to predicate device)	"performs as well as the legally marketed predicate device, the Fukuda Denshi model LX-5630 Transmitter 510(k) #K033711."
SpO₂ Measurement Performance (equivalent to OEM modules)	The device utilizes unmodified Konica Minolta SpO₂ module technology (cleared under K053419) and unmodified Nellcor SpO₂ module technology (cleared under K060576). Performance is inherently linked to these previously cleared modules. "host tested at the previously noted OEM engineering test facility to insure that performance and functional specifications for their supplied module were met."
ECG and Respiration Measurement Performance (equivalent to predicate device)	"The new modified device, LX-7230KM, utilizes the same fundamental technology of ECG and Respiration measurement as the current patient worn transmitter LX-5630 (K033711)." "The new modified device, LX-7230N, utilizes the same fundamental technology of ECG and Respiration measurement as the current transmitter LX-5630 (K033711)."
Compliance with Safety, Environmental, and Performance Standards	"The Fukuda Denshi model LX-7230KM/7230N Transmitter has been subjected to extensive safety, environmental and performance testing. Final testing for the device included various performance tests for the device designed to insure that all functional and performance specifications were met."

Study Details

The provided text describes a 510(k) submission seeking substantial equivalence for a medical device by demonstrating that its core technology is the same as a predicate device and that its SpO2 components are pre-cleared, unmodified OEM modules. Therefore, the "study" described is not a new clinical trial with specific performance endpoints, but rather a set of tests to confirm the new device's functionality and safety consistent with its predicate and incorporated components.

Sample size used for the test set and the data provenance:
- Test Set Sample Size: Not explicitly stated as a patient-based sample size. The document mentions "extensive safety, environmental and performance testing" and "various performance tests." For the SpO2 modules, it states they were "host tested at the previously noted OEM engineering test facility."
- Data Provenance: Not specified in terms of country of origin or whether it was retrospective or prospective. The testing appears to be internal validation ("laboratory testing, validation and risk Analysis") and OEM engineering testing.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. The submission relies on technical equivalence to established, cleared devices and modules rather than new ground truth establishment by experts for a new dataset.
Adjudication method for the test set: Not applicable. There is no mention of an adjudication process for expert consensus on a test set.
If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance: Not applicable. This device is a telemetry transmitter and does not involve AI or human interpretation of medical images or data requiring an MRMC study.
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not explicitly detailed as a "standalone" performance study in the context of an algorithm. The device itself is a standalone transmitter. Its performance is demonstrated through its hardware and software functionality as an interface for physiological data, relying on the established performance of its component parts (ECG/Respiration from predicate, SpO2 from OEM modules).
The type of ground truth used: The "ground truth" for this submission is based on the performance established for:
- The predicate device (Fukuda Denshi model LX-5630 Transmitter, K033711) for ECG and Respiration measurement.
- The pre-cleared OEM SpO₂ modules (Konica Minolta "Pulsox-300/300i" K053419 and Nellcor "OxiMax N-600x Pulse Oximeter" K060576).
  The ground truth is implicit in the regulatory clearance of these prior devices and modules.
The sample size for the training set: Not applicable. This is not an AI/machine learning device that would typically involve a "training set" for an algorithm. The device's functionality uses established physiological measurement technologies.
How the ground truth for the training set was established: Not applicable, as there is no training set for an AI algorithm.

Summary

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REVISED 510(k) Summary 1-30-2011

MAR 1 1 2011

Fukuda Denshi Model LX-7230KM/7230N Transmitter

This summary of 510(k) safety and effectiveness information is being submitted in accordance with the requirements of SMDA 1990 and 21 CFR part 870.92.

The assigned 510(k) number is: K103134.

Submitter: Fukuda Denshi USA, Inc. 17725 NE 65th St. Building C Redmond WA, 98052 Tel: 425-881-7737 Fax: 425-869-2018
- Contact Person: Doug Blakely . Director- Regulatory Affairs -Fukuda Denshi USA, Inc. 17725 NE 65th St. Building C Redmond WA, 98052 Tel: 210-240-4521 Fax: 408-547-4521 Email: DBlakely(@fukuda.com
- Date Prepared: October 8, 2010 .

Device Name:

Proprietary Name : Fukuda Denshi Model LX-7230KM/7230N Transmitter .
. Common Name: Telemetry Transmitter
Product Code: MHX ●
Regulation Number: 21 CFR Part 870.1025 .

Class: .
. Review Panel: Cardiovascular

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REVISED 510(k) Summary 1-30-2011

Fukuda Denshi Model LX-7230KM/7230N Transmitter

Legally Marketed Device:

Fukuda Denshi model LX-5630 Transmitter, #K033711

In addition, the SpO2 measurement function of the LX-7230KM/7230N Transmitter utilizes technology incorporated into previously cleared devices and several OEM manufactured modules that have received separate clearance from the FDA as follows:

The SpO2 measurement technology used in the LX-7230KM is the same as that used in the Konica Minolta model "Pulsox-300/300i" cleared under 510(k) # K053419. We have made no modifications to Konica Minolta SpO2 module or sensors under K053419.

The SpO2 measurement technology used in the LX-7230N is the same as that used in the Nellcor Puritan Bennett model "OxiMax N-600x Pulse Oximeter" cleared under 510(k) # K060576. We have made no modifications to the Nellcor SpO2 module or sensors under K060576.

Description:

The Fukuda Denshi model LX-7230KM/7230N is a patient worn Transmitter that transmits physiological data such as ECG, respirogram, arterial oxygen saturation (SpO2), plethysmograph, and pulse rate from a patient to a Fukuda Denshi Central Monitor. The front LCD display information such as ECG, heart rate, respirogram, respiration rate, SpO2, plethysmograph, pulse rate, pulse amplitude level, battery level, and the conditions of the ECG electrodes and SpO2 sensor. For the SpO2 measurement, the LX-7230N utilizes Nellcor SpO2 module technology (K060576) and the LX-7230KM utilizes Konica-Minolta SpO2 module technology (K053419). Both transmitters can only be used as an interface device of the previously cleared Fukuda Denshi Central Monitor (K970585, K000746, K020084) utilizing the central telemetry receiver (K980728). Both transmitters utilize digital FSK (frequency shift keying) technology and operate in the WMTS 608 to 614 MHz transmission frequencies. One or two channel ECG waveforms are selectable with lead selection available using the two buttons (Enter and ▽) on the front panel. (In case of using a 3-electrode lead cable or a 5electrode chest lead cable). Both transmitters are battery powered using 2 AA alkaline batteries with available continuous operation for 6 days (LX-7230KM) or 3 days (LX-7230N). The LX-7230KM/7230N is small and lightweight at 190 grams including batteries. The physical dimensions of the device are 72 mm (W) x 98 mm (H) x 24.8(D) mm.

Additional details regarding the device description can be found in the device's Operation Manual (Exhibit # 3) and Section 10, "Device Information (Modified Device) for Fukuda Denshi model LX-7230KM/7230N Transmitter*. Also included in Section 10 are the subject device's Engineering Drawings, such as external appearance.

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3/4

REVISED 510(k) Summary 1-30-2011

Fukuda Denshi Model LX-7230KM/7230N Transmitter

The modifications to the Fukuda Denshi model LX-5630 Transmitter include the replacement of a later version of Konica Minolta SpO2 module, adding an optional SpO2 module from Nellcor, changes to the overall dimensions of the device, and changes to the ECG lead wire set.

The new modified device, LX-7230KM, utilizes the same fundamental technology of ECG and Respiration measurement as the current patient worn transmitter LX-5630 (K033711) and, for SpO2 measurement, utilizes the latest version SpO2 module built and manufactured by Konica-Minolta and cleared as the PULSOX-300/300i Oximeter (K053419). We have made no modifications to Konica Minolta SpO2 module or sensors under K053419.

The new modified device, LX-7230N, utilizes the same fundamental technology of ECG and Respiration measurement as the current transmitter LX-5630 (K033711) and, for SpO2 measurement, utilizes the SpO2 module built and manufactured by Nellcor and cleared as the N-600x Pulse Oximeter (K060576). We have made no modifications to Nellcor SpO2 module or sensors under K060576

The LX-7230KM/7230N Transmitter weighs 190 grams including batteries and has dimensions of 72(W) x 98(H) x 24.8(D) mm. The modified device is also powered by two (2) AA size batteries as before.

The LX-7230KM/7230N Transmitter is a WMTS compliant device and operates only preprogrammed channels in the 608 to 614 MHz bandwidth as before.

Statement of Intended Use:

The intended use of the modified device as described in the labeling has not changed as a result of the modifications.

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REVISED 510(k) Summary 1-30-2011

Fukuda Denshi Model LX-7230KM/7230N Transmitter

Technological Characteristics:

The Fukuda Denshi model LX-7230KM/7230N Transmitter incorporates the identical technology as the predicate devices. The device provides a means with interfacing with a patient, transmitting specific physiological data to a Fukuda Denshi Central Monitor (K970585, K000746, K020084) utilizing the central telemetry receiver (K980728). and processing the data for display of numeric values and waveforms on the front LCD.

The technology characteristics of the LX-7230KM/7230N Transmitter do not affect the safety or efficacy of the device. Any safety issues raised by a software control medical device are either the same issues already addressed by the predicate devices or are addressed the system hazard analysis. or in the system validation.

Testing:

The Fukuda Denshi model LX-7230KM/7230N Transmitter has been subjected to extensive safety, environmental and performance testing. Final testing for the device included various performance tests for the device designed to insure that all functional and performance specifications were met. We have made no modifications to Konica Minolta SpO2 module or sensors under K053419 or to Nellcor SpO2 module or sensors under K060576. Additionally the device was host tested at the previously noted OEM engineering test facility to insure that performance and functional specifications for their supplied module were met.

Conclusion:

In conclusion, drawing from laboratory testing, validation and risk Analysis, the Fukuda Denshi model LX-7230KM/7230N Transmitter demonstrates that this device is as safe and effective as and performs as well as the legally marketed predicate device, the Fukuda Denshi model LX-5630 Transmitter 510(k) #K033711.

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Image /page/4/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle with three stripes forming its wing, and the words "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" arranged in a circular pattern around the eagle. The eagle is facing left, and the stripes are angled upwards. The text is in all capital letters.

Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002

Fukuda Denshi USA, Inc. c/o Doug Blakely Regulatory Director 17725 NE 65th Street, Bldg. C Redmond, WA 98052

MAR 1 1 2011

Re: K103134

Trade/Device Name: Fukuda Denshi Model LX-7230KM/7230N Transmitter Regulation Number: 21 CFR 870.1025 Regulation Name: Telemetry Transmitters Regulatory Class: Class II (two) Product Code: MHX Dated: February 25, 2011 Received: March 3, 2011

Dear Mr. Blakely,

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.

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 or any I odoral battle and step including, but not limited to: registration and listing (21

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Page 2 – Mr. Doug Blakely

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/CDRH0ffices/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,

R. Kirchner

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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Indications for Use

510(k) Number (if known): K103134 Device Name: _ Fukuda Denshi Model LX-7230KM/7230N Transmitter Indications For Use:

The DS-7000 Series Telemetry Monitoring System is intended to be used as central station monitoring system for the evaluation of the cardiovascular system. It is intended to be used by or on the order of a physician or similarly qualified healthcare professional. The DS-7000 Series Telemetry Monitoring System is intended to be used in hospital environments: ER, ICU, a clinic or similar settings. The DS-7000 Series Telemetry Monitoring System is intended to be used in those situations where the patient is being monitored by a Fukuda Denshi DS-5000-7000 Series bedside monitor, or patient worn telemetry transmitter where remote. central station monitoring is desired. This system is not intended for home use.

Prescription Use X AND/OR Over-The-Counter Use (Part 21 CFR 801 Subpart D)

(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)

sumar R.V.limes

Page 1 of

(Division Sign-Off) (Division Sign-Off)
Division of Cardiovascular Devices
Division of Cardiovascular

510(k) Number للكتروما كل

Regulation Number and Section

§ 870.1025 Arrhythmia detector and alarm (including ST-segment measurement and alarm).

(a)
Identification. The arrhythmia detector and alarm device monitors an electrocardiogram and is designed to produce a visible or audible signal or alarm when atrial or ventricular arrhythmia, such as premature contraction or ventricular fibrillation, occurs.(b)
Classification. Class II (special controls). The guidance document entitled “Class II Special Controls Guidance Document: Arrhythmia Detector and Alarm” will serve as the special control. See § 870.1 for the availability of this guidance document.