(217 days)
No
The document describes a standard telemetry system for monitoring ECG and SpO2. There is no mention of AI, ML, or any related technologies in the device description, intended use, or performance studies. The modifications described are related to sterilization and battery life, not advanced data processing.
No.
The device's stated physiological purpose is "To monitor the ECG or SpO2 of patients," indicating it is a diagnostic/monitoring device, not a therapeutic one that treats or prevents a disease/condition.
No
The device is intended to monitor ECG and SpO2 parameters, which is a monitoring function, not a diagnostic one. It tracks physiological data rather than identifying or classifying a disease or condition.
No
The device description explicitly states it consists of a pocket-sized digital synthesized transmitter, a receiver, and a central station device, all of which are hardware components. The modification described relates to a sterilization process for the device, further indicating it is a physical device.
Based on the provided information, this device is not an In Vitro Diagnostic (IVD).
Here's why:
- IVDs analyze samples taken from the body. The definition of an IVD involves examining specimens such as blood, urine, or tissue outside of the body to provide information about a person's health.
- This device monitors physiological parameters on the body. The Viridia Telemetry System obtains ECG and SpO2 signals directly from the patient's skin using electrodes and sensors. It is a monitoring device that interacts with the patient's body in real-time.
The intended use and device description clearly indicate that this system is for monitoring vital signs directly from the patient, not for analyzing samples in a laboratory setting.
N/A
Intended Use / Indications for Use
The device is intended to provide ambulatory and nonambulatory monitoring of ECG and SpO2 parameters of adult, and pediatric patients in a professional health care facility. It is intended to be used by trained health care personnel. It is not intended for home use. The intended use is unaffected by the modification.
The indications for use of the Viridia Telemetry System are:
- Condition: the licensed clinician decides that the Viridia Telemetry System should be used to monitor the patient.
- Prescription versus over-the-counter: Viridia Telemetry System is a prescription device.
- Part of body or type of tissue interacted with: The ECG signal is obtained from accessory electrodes in contact with the patient's skin. The SpO2 signal is obtained from an accessory sensor in contact with the patient's skin.
- Frequency of use: As prescribed by licensed clinician.
- Physiological purpose: To monitor the ECG or SpO2 of patients on the order of a licensed clinician.
- Patient population: Adult and pediatric patients.
Product codes
74DSI
Device Description
The Hewlett-Packard HP M2600A Viridia Telemetry System consists of a pocket sized digital synthesized transmitter, synthesized that a and receiver, accommodates up to eight receiver channels. Patient physiological parameter information is displayed on HP M2350A/60A, a central station device.
The modification allows the user to utilize an EtO Sterilization process for the purpose of cross-infection prevention and changes the labeling to reflect a change in battery life specification and in the device name.
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
Adult and pediatric patients.
Intended User / Care Setting
trained health care personnel in a professional health care facility. It is not intended for home use.
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)
The device was thoroughly tested to verify that performance claims in the labeling are met. A qualified independent laboratory performed tests related to the EtO sterilization process. Verification testing was done to show that performance of the M2601A was not changed due to exposure to the EtO sterilization process. The purpose was to verify that the device continued to perform to its specification and is that safety was not degraded. The test results support that purpose.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
K894277, K911139, K913533, K920429
Reference Device(s)
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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.
0
CHAPTER 14: 1510(K)] Summar
- This submission notifies the FDA of our SEP d 1998 intention to modify the HP M2600A Viridia Telemetry System.
1.0 Manufacturer/Submitter
1.1 Name and Address
Hewlett-Packard Company Patient Monitoring Division Medical Products Group 3000 Minuteman Road Andover, MA 01810-1099
1.2 Establishment Registration Number
1218950
- 1.3 Hewlett-Packard Manufacturing Site Address Hewlett-Packard Company Patient Monitoring Division Medical Products Group 3000 Minuteman Road Andover, MA 01810-1099
- 1.4 Sterilization Site
Does not apply.
1.5 Contact Persons
You may contact Ray Stelting at (978) 659-3445. or Mike Hudon at (978) 659-3173, or Chas Burr at (978) 659-2529.
- 1.6 Date
February 2, 1998
2.0 Regulatory Information
2.1 References
510(k) Notifications:
2.2 Device Name, Trade Name
Proprietary: HP M2600A Viridia Telemetry System Common Name: HP Viridia Telemetry System.
Classification name: Radio frequency physiological signal transmitter and receiver (per CFR 870.2910)
2.3 Predicate Device(s) Predicate device information is tabulated below.
Table 3: Predicate Device Information
| MFG | Device | Models | K# |
|---|---|---|---|
| Hewlett-Packard | Telemetry Monitoring System | M1403A System | K894277 |
| Hewlett-Packard | Telemetry Monitoring System, Revision 1.2 | M1403A System | K911139 |
| Hewlett-Packard | Telemetry Monitoring System, added Analog Output | M1403A System | K913533 |
| Hewlett-Packard | Telemetry Monitoring System, added ST monitoring | M1403A System | K920429 |
2.4 Products (Components) Included as Part of This Device:
No accessories or additional components are affected by this modification of the HP M2600A Viridia Telemetry System device.
- 2.5 Device Classification
74DRG
2.6 Performance Standard:
None established under section 514.
3.0 Description
The Hewlett-Packard HP M2600A Viridia Telemetry System consists of a pocket sized
1
digital synthesized transmitter, synthesized that a and receiver, accommodates up to eight receiver channels. Patient physiological parameter information is displayed on HP M2350A/60A, a central station device.
The modification allows the user to utilize an EtO Sterilization process for the purpose of cross-infection prevention and changes the labeling to reflect a change in battery life specification and in the device name.
4.0 Intended Use
device is intended to provide The ambulatory and nonambulatory monitoring of ECG and SpO, parameters of adult, and pediatric patients in a professional health care facility. It is intended to be used by trained health care personnel. It is not intended for home use. The intended use is unaffected by the modification.
5.0 Indications for Use
An indications for use statement is included in
this notification but was not part of the earlier notification, K961165.
The indications for use of the Viridia Telemetry System are:
- Condition: The licensed clinician 비 Viridia Telemetry decides that the System should be used to monitor the patient.
- Prescription versus over-the-counter: li System Viridia Telemetry is ਕ prescription device.
- I Part of body or type of tissue interacted with: The ECG signal is obtained from accessory electrodes in contact with the patient's skin. The SpO, signal is obtained from an accessory sensor in contact with the patient's skin.
- 트 Frequency of use: As prescribed by licensed clinician.
- Physiological purpose: To monitor the ECG or SpO, of patients on the order of a licensed clinician.
- D Patient population: Adult and pediatric patients.
Substantial Equivalence 6.0
Comparison of technological 6.1 characteristics
HP M2600A Viridia Telemetry System is now substantially equivalent to the M1403A regarding cross-infection prevention in that both transmitters now utilize similar EtO sterilization processes. The comparison shows the device to be substantially equivalent in safety, effectiveness, and intended use to a legally marketed device.
Verification and Validation 6.2
The device was thoroughly tested to verify that performance claims in the labeling are met. A qualified independent laboratory performed tests related to the EtO sterilization process. Verification testing was done to show that performance of the M2601A was not changed due to exposure to the EtO sterilization process. The purpose was to verify that the device continued to perform to its specification and is that safety was not degraded. The test results support that purpose.
6.3 SE Conclusion
Based on comparison to the predicated device and on the test results, the Viridia Telemetry System is substantially equivalent to the HP M 1403A.
7.0 Conclusion:
The logic of the SE Decision Tree leads to a determination of SE. We agree with that logic. The modified device is very similar to the predicate device. The modified device was thoroughly validated. We conclude, therefore, that it is safe and effective when used as intended and indicated.
2
Image /page/2/Picture/2 description: The image shows a partial view of a logo or emblem, likely from a government or organizational entity. The visible portion includes a stylized symbol consisting of three curved, parallel lines, which could represent a flag or a stylized representation of movement or progress. To the left of the symbol, there's a partial inscription of text, with the words 'DEPARTMENT OF' visible, suggesting that the logo belongs to a department or agency.
વે નિર્ઝિક
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Ms. Elisabeth George Hewlett-Packard Company 3000 Minuteman Road Andover, MA 01810
K980429 Re: HP M2600A Viridia Telemetry System Mofication Regulatory Class: III (three) Product Code: 74 DSI Dated: May 28, 1998 Received: June 8, 1998
Dear Ms. George:
We have reviewed your Section 510(k) notification of intent to market the device referenced above and we 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). 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 reqistration, 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 (Premarket Approval), 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 895. A substantially equivalent determination assumes compliance with the Current Good Manufacturing Practice requirements, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic QS inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP requlation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.
3
Page 2 - Ms. Elisabeth George
This letter will allow you to begin marketing your device as described in your 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 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4648. 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" (21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers 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,
Thomas J. Callahan
Thomas J. allahan, Ph.D. Director Division of Cardiovascular, Respiratory, and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
510(k) Number (if known):
Device Name: HP M2600A Viridia Telemetry System
Indications for Use:
The indications for use of the Viridia Telemetry System are:
- · Condition: the licensed clinician decides that the Viridia Telemetry System should be used to monitor the patient.
- · Prescription versus over-the-counter: Viridia Telemetry System is a prescription device.
- Part of body or type of tissue interacted with: The ECG signal is obtained from accessory electrodes in r art of bouy of type of tissue meeraces innal is obtained from an accessory sensor in contact with the patient's skin.
- · Frequency of use: As prescribed by licensed clinician.
- · Physiological purpose: To monitor the ECG or SpO2 of patients on the order of a licensed clinician.
- · Patient population: Adult and pediatric patients.
PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEEDED)
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asd
Concurrence of CDRH, Office of Device Evaluation (ODE)
Kon
(Division Sign-Off)
Division of Cardiovascular, Respiratory,
and Neurological Devices
510(k) Number __
Prescription Use ✓ OR Over-The
Over-The-Counter Use
(Per 21 CFR 801.1109)
(Optional Format 1-2-96)