(29 days)
The PatientNet™ System is intended to collect and analyze patient data from ECG ambulatory The Pational - Syctorn - Jeading manufacturers' bedside monitors and ventilators anywhere in a healthcare facility and distributes the data to locations throughout the facility.
Monitoring of Recognized Conditions:
-An environmentally controlled clinical setting that has multiple patients using any combination of ECG leads, bedside monitors, or ventilators.
-Hospital areas that have the capability of installing hardwire paths to the Central Monitoring Station from the rooms or areas where bedside monitors or ventilators operate.
-Clinical areas that have the capability of installing 174-216 MHz radio systems (or alternate frequency bands approved by the FCC) to communicate via RF. The information from the ECG leads, bedside monitors or ventilators is transferred via an RF transmitter to the Central Monitoring Station.
Target Population:
Those patients who are connected through PatientNet™ Monitoring System via ambulatory ECG transmitters, bedside monitors, or ventilators.
The modified PatientNet™ Monitoring System performs patient monitoring using PatientNet™ rne moulhou Patient for radio transmitters connected directly to bedside monitors or athbuittory fudio transmitors with similar physiological parameters, and to ventilators that have digital outputs.
The provided documentation does not contain detailed acceptance criteria or a study that specifically proves the device meets such criteria in terms of performance metrics like sensitivity, specificity, accuracy, or any other quantitative measure typically associated with medical device performance studies.
Instead, the submission focuses on demonstrating substantial equivalence to a predicate device (VitalCom Networked Monitoring System K962473) through "risk analysis and verification and validation testing." The document states that "Test results demonstrated that the functionality and safety characteristics of the modified PatientNet™ Monitoring System are to the predicate device," implying that the acceptance criterion was likely meeting the functional and safety profile of the predicate device.
Here's an breakdown of the information that can be extracted from the provided text, while also explicitly stating what is not present:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| Functionality: Equivalent to predicate device (K962473) | "Test results demonstrated that the functionality... of the modified PatientNet™ Monitoring System are to the predicate device." |
| Safety: Equivalent to predicate device (K962473) | "Test results demonstrated that the... safety characteristics of the modified PatientNet™ Monitoring System are to the predicate device." |
| Risk Profile: Acceptable via risk analysis | "The safety and effectiveness... have been demonstrated through risk analysis..." |
| Verification and Validation: Successful completion | "...and verification and validation testing." |
| Intended Use: Capability to collect and analyze patient data | "The PatientNet™ System is intended to collect and analyze patient data from... bedside monitors and ventilators... and distributes the data..." |
Missing Information:
- Specific numerical performance metrics (e.g., accuracy, reliability, latency, data integrity rates).
- Quantitative thresholds for acceptance (e.g., "data transfer success rate must be >99%").
2. Sample Size Used for the Test Set and Data Provenance
This information is not provided in the document. The submission mentions "verification and validation testing" but does not specify the sample size of the test set, the type of data used (e.g., simulated, real patient data), or its provenance (country of origin, retrospective/prospective).
3. Number of Experts Used to Establish Ground Truth and Qualifications
This information is not provided. The type of testing described (risk analysis, verification and validation) for a network monitoring system typically doesn't involve the establishment of "ground truth" by clinical experts in the same way an AI diagnostic device would. It's more about technical verification of functionality and safety.
4. Adjudication Method for the Test Set
This information is not provided. Since the nature of the "test set" and "ground truth" for a network monitoring system validation is not clinical expert-based, an adjudication method like 2+1 or 3+1 would not apply.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
A MRMC comparative effectiveness study was not done and would not be applicable for this type of device. An MRMC study is relevant for devices, especially AI-driven ones, where human readers interpret medical images or data, and the study aims to assess how the AI assistance impacts their diagnostic performance. The PatientNet™ Monitoring System is a data collection and distribution system, not a diagnostic interpretation tool.
6. Standalone (Algorithm Only) Performance Study
A standalone performance study, as typically understood for an AI algorithm (i.e., algorithm only without human-in-the-loop performance), was not done or at least not described in this document. The assessment described ("risk analysis and verification and validation testing") focuses on the system's ability to perform its intended functions and meet safety requirements, rather than an "algorithm-only" performance for diagnostic accuracy.
7. Type of Ground Truth Used
The concept of "ground truth" (expert consensus, pathology, outcomes data) as it applies to diagnostic accuracy studies is not relevant or specified here. For a network monitoring system, "ground truth" would likely relate to the system correctly acquiring, transmitting, and displaying physiological data as intended, which would be verified through technical means against known inputs or reference standards rather than clinical outcomes.
8. Sample Size for the Training Set
This information is not provided. This device is a data collection and distribution system, not an AI/ML device that requires a "training set" in the conventional sense for learning patterns or making predictions.
9. How the Ground Truth for the Training Set Was Established
This information is not provided. As noted above, the concept of a training set and its associated ground truth is not applicable to the description of this device.
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MAR 2 0 2002
510(k) Summary
This 510(k) Summary is submitted in accordance with 21 CFR 807.92.
| Submitter's Name:Submitter's Address: | GE Medical Systems Information Technologies15222 Del Amo AvenueTustin, CA 92780 |
|---|---|
| Telephone :Fax:Contact Person:Date Prepared: | (800) 888-0777(714) 247-4155Diana M. ThorsonJanuary 14, 2002 |
| Device Trade Name: | PatientNet™ Monitoring System |
| Device Classification Name: | System, Network and Communication, Physiological Monitors |
| Device Classification: | Class II |
| Predicate Device(s): | VitalCom Networked Monitoring SystemK962473 |
Device Description:
The modified PatientNet™ Monitoring System performs patient monitoring using PatientNet™ rne moulhou Patient for radio transmitters connected directly to bedside monitors or athbuittory fudio transmitors with similar physiological parameters, and to ventilators that have digital outputs.
Intended Use:
The PatientNet™ System is intended to collect and analyze patient data from ECG ambulatory The Pational - Syctorn - Jeading manufacturers' bedside monitors and ventilators anywhere in a healthcare facility and distributes the data to locations throughout the facility.
Performance Data:
The safety and effectiveness of the modified PatientNet™ Monitoring System described in this r roo salety and been demonstrated through risk analysis and verification and validation testing. Test results demonstrated that the functionality and safety characteristics of the modified PatientNet™ Monitoring System are to the predicate device.
Conclusions:
Based on the information provided in this submission, the modified PatientNet™ Monitoring System is substantially equivalent to the predicate device and does not raise new issues of safety and effectiveness.
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DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/1/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo is a circular emblem with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized image of an eagle with its wings spread, symbolizing the department's mission to protect the health of all Americans.
Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
MAR 2 0 2002
Ms. Diana M. Thorson Regulatory Affairs Manager GE Medical Systems Information Technology General Electric Company 15222 Del Amo Avenue Tustin, CA 92780
Re: K020524
Trade Name: PatientNet™ Monitoring System Regulation Name: Arrhythmia Detector and Alarm Regulation Number: 21 CFR 870.1025 Regulatory Class: Class III (three) Product Code: MHX Dated: February 15, 2002 Received: February 19, 2002
Dear Ms. Thorson:
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.
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Page 2 - Ms. Diana M. Thorson
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); 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 and additionally 21 CFR Part 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4646. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html
Sincerely yours,
Dala Tulla
Bram D. Zuckerman, M.D. Acting Director Division of Cardiovascular and Respiratory Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Page 1 of 1
INDICATIONS FOR USE STATEMENT
| - | :44 | ----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------- | . | ----- | ----- |
|---|---|---|---|---|---|
Device Name: Patient Net
Monitoring System
Indications for Use:
Monitoring of Recognized Conditions:
-An environmentally controlled clinical setting that has multiple patients using any combination of ECG leads, bedside monitors, or ventilators.
-Hospital areas that have the capability of installing hardwire paths to the Central Monitoring Station from the rooms or areas where bedside monitors or ventilators operate.
-Clinical areas that have the capability of installing 174-216 MHz radio systems (or alternate frequency bands approved by the FCC) to communicate via RF. The information from the ECG leads, bedside monitors or ventilators is transferred via an RF transmitter to the Central Monitoring Station.
Target Population:
Those patients who are connected through PatientNet™ Monitoring System via ambulatory ECG transmitters, bedside monitors, or ventilators.
(PLEASE DO NOT WRITE BELOW THIS LINE – CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Division of Cardiovascular & Respiratory Devices
510(k) Number K020504
Prescription Use
(Per 21 CFR 801.109)
OR
Over-The-Counter Use
0000257
§ 870.2300 Cardiac monitor (including cardiotachometer and rate alarm).
(a)
Identification. A cardiac monitor (including cardiotachometer and rate alarm) is a device used to measure the heart rate from an analog signal produced by an electrocardiograph, vectorcardiograph, or blood pressure monitor. This device may sound an alarm when the heart rate falls outside preset upper and lower limits.(b)
Classification. Class II (performance standards).