(16 days)
Not Found
No
The document does not mention AI, ML, deep learning, or any related terms, and the description focuses on standard physiological monitoring parameters and functions.
No.
The device is a monitoring system intended for remote monitoring and recording of patient information, not for providing therapy.
No
The device monitors physiological parameters and displays vital signs and waveforms, which are inputs for diagnosis, but it does not perform the diagnosis itself.
No
The device description explicitly lists multiple physiological parameters it monitors (ECG, blood pressure, temperature, pulse oximetry, respiration, EtCO2), which are typically acquired through hardware sensors and components, indicating it is not solely software.
Based on the provided information, the Enguard device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices used to examine specimens taken from the human body (like blood, urine, tissue) to provide information about a person's health. This information is used for diagnosis, monitoring, or screening.
- Enguard's Function: The Enguard is described as a "remote patient multiparameter monitoring system." It directly monitors physiological parameters from the patient's body (ECG, blood pressure, temperature, pulse oximetry, respiration, EtCO2). It does not analyze specimens taken from the patient.
- Intended Use: The intended use clearly states it's for "remote patient monitoring and recording patient information" and "in-hospital application requiring remote patient monitoring." This aligns with monitoring vital signs directly from a living patient.
Therefore, the Enguard falls under the category of a patient monitoring device, not an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
Enguard is intended for use as a remote patient multiparameter monitoring system.
The Enguard can monitor ECG/heart rate, two invasive blood pressure channels, two temperature channels, pulse oximetry, respiration, non-invasive blood pressure and EtCO2. This effectively allows the Enguard to monitor a wide-range of adult, pediatric and neonatal patient conditions, in many different areas of the hospital.
Functions include display of multiparameter waveforms, vital signs, alarm & status messages.
The Mennen Medical Enguard is intended for sale as a system for remote monitoring and recording patient information or any in-hospital application requiring remote patient monitoring.
The following are examples of intended clinical applications:
- Critical Care Patients
- Cardiac Step-down/Telemetry Units
- Emergency Departments
- Intra-operative (Anesthesia) Monitoring
- Post Anesthesia Care
Product codes (comma separated list FDA assigned to the subject device)
OYX, DSI
Device Description
The Envoy is a multiparameter physiological patient monitor, capable of monitoring:
- ECG/Heart Rate
- invasive blood pressure
- non-invasive blood pressure
- respiration
- pulse oximetry
- two temperature channels
- cardiac output
- eTCO2
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, pediatric and neonatal
Intended User / Care Setting
in-hospital application
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)
Not Found
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
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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.
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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
§ 870.1025 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
Image /page/0/Picture/0 description: The image shows 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 in blue, with the words "U.S. FOOD & DRUG" stacked on top of the word "ADMINISTRATION". The FDA is a federal agency responsible for regulating and supervising the safety of food, drugs, and other products.
November 15, 2023
Mennen Medical Ltd. Erez Nimrod Managing Director Kirvat Weizmann Science Park P.O. Box 102 Rehovot, 76100 Israel
Re: K020632
Trade/Device Name: Enguard Remote Patient Monitor Regulation Number: 21 CFR 870.1025 Regulation Name: Arrhythmia detector and alarm (including ST-segment measurement and alarm) Regulatory Class: Class II Product Code: OYX, DSI
Dear Erez Nimrod:
The Food and Drug Administration (FDA) is sending this letter to notify you of an administrative change related to your previous substantial equivalence (SE) determination letter dated March 15, 2002. Specifically, FDA is updating this SE Letter because FDA has created a new product code to better categorize your device technology.
Please note that the 510(k) submission was not re-reviewed. For questions regarding this letter please contact Jennifer Kozen, OHT2: Office of Cardiovascular Devices, 301-796-5813, Jennifer.Kozen(@fda.hhs.gov.
Sincerely.
Jennifer W.Shih -S
Jennifer 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
1
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/1/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular border with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" written around it. Inside the circle is a stylized image of an eagle or bird with its wings spread, symbolizing the department's mission to protect and promote the health and well-being of the nation.
Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
MAR 1 5 2002
Mr. Asher Kassel Regulatory Affairs Mennen Medical Ltd. Kiryat Weizmann Science Park P.O.B. 102 Rehovot 76100 ISRAEL
Re: K020632
Trade Name: Enguard Remote Patient Monitor Regulation Number: 21 CFR 870.1025 Regulation Name: Arrhythmia Detector and Alarm Regulatory Class: Class III (three) Product Code: DSI Dated: February 24, 2002 Received: February 27, 2002
Dear Mr. Kassel:
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 10 more casses of 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.
2
Page 2 - Mr. Asher Kassel
Please be advised that FDA's issuance of a substantial equivalence determination does not mean Please be advised that FDA 3 issuation of a bevice complies with other requirements of the Act that FDA has made a decemination administered by other Federal agencies. You must of any Federal Statures and regulations administered of registration and listing (21 comply with an the Act 3 requirements, mercaining practice requirements as set CFR Part 807), labeling (21 CFR Part 820); and 1f applicable, the electronic forth in the quality systems (Sections (Sections 531-542 of the Act); 21 CFR 1000-1050.
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) I his letter will anow you to begin manoming your manoming of your device to a legally premarket notification. THC PDA maing of backansal 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 II you desire specific advice for your acviso diagnostic devices), please contact the Office of additionally 21 CFN Far 807.10 for nations on the promotion and advertising of Compliance at (301) 591 1016. There of Compliance at (301) 594-4639. Also, please note the your de roo, prease oversions by reference to premarket notification" (21CFR Part 807.97). regulation chitities, "Miseranange ogesponsibilities under the Act may be obtained from the Other general information on your respational 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,
signature
Bram. D. Zuckerman, M.D. Acting Director Division of Cardiovascular and Respiratory Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
3
Food and Drug Administration
K020633
14 February 2002
24 February, 2002
Food and Drug Admillishation: Special 510 (k) for Enguard Remote Patient Monitor
INDICATIONS FOR USE
Enguard is intended for use as a remote patient multiparameter monitoring system.
The Enguard can monitor ECG/heart rate, two invasive blood pressure channels, two
nessure and The Enguard can monitor ECGInean rate, two invasive blood pressure and
temperature channels, pulse oximetry, respiration, non-invasive blood pressure and temperature channels, pulse oximetry, respiration, indianton of adult, pediatric
EtCO2. This effectively allows the Enguard to monitor a wide-range of adult, pediatric
e in EtCO2. This effectively allows the Enguard to monton of the hospital.
and neonatal patient conditions, in many different areas of the hospital.
Functions include display of multiparameter waveforms, vital signs, alarm & status messages.
The Mennen Medical Enguard is intended for sale as a system for remote monitoring The Mennen Medical Enguard is intended for Sale as a System for Frina.
and recording patient information or any in-hospital application requiring remote patient monitoring.
The following are examples of intended clinical applications:
- · Critical Care Patients
- · Cardiac Step-down/Telemetry Units
- · Emergency Departments
- · Intra-operative (Anesthesia) Monitoring
- · Post Anesthesia Care
Division of Cardiovasc & Respiratory Devices
510(k) Number: K020632
4
Food and Drug Administration
K020632
24 February, 2002 page 1 of 1
ENVOY Patient Monitor - Device Modification: Special 510 (k) for Enguard Remote Patient Monitor
Image /page/4/Picture/3 description: The image shows the logo for "mennenmedical". The logo consists of a stylized lowercase "m" inside of a solid black circle. The word "mennen" is written in bold black letters, and the word "medical" is written in a lighter, non-bold font.
MAR 1 5 2002
MENNEN MEDICAL LTD.
Kiryat Weizmann Science Park P.O.B. 102 Rehovot 76100 Israel Tel: 972-8-9383030 Fax: 972-8-9406519
Date prepared: 24 February 2002
Topic: 510(k) Safety and Effectiveness Summary as per 21 CFR Section 807.92 Envoy Patient Monitor - Device Modification Special 510k for Enguard Remote Patient Monitor
Establishment Name, Registration Number and Address
Name: Registration Number Operator Number: Address:
Mennen Medical Ltd. 9611022 9011766 Kiryat Weizmann Science Park Rehovot, 76100 Israel Tel: 972-8-938-3030 Fax: 972-8-940-6519
Contact person:
Asher Kassel, Director of Regulatory Affairs
To: Food and Drug Administration Center for Devices and Radiological Health Document Mail Center (HFZ-401) 9200 Corporate Boulevard Rockville MD, 20850
Attn.: Document Control Clerk From: Asher Kassel, Director of Regulatory Affairs
Product Name
ENVOY Proprietary: Common: Physiological Patient Monitor Mennen Medical Part Number: 550-010-000 (full system) 554-000-010 (CPU only)
Proprietary: ENGUARD Common: Remote Patient Monitor Mennen Medical Part Number: 555-000-090
5
Food and Drug Administration
24 February, 2002
ENVOY Patient Monitor – Device Modification: Special 510 (k) for Enguard Remote Patient Monitor
age 242
FDA Classification
| Classification Name: | Arrhythmia Detector and Alarm |
|---|---|
| Classification Number: | 21 CFR 870.1025 |
| Classification: | Class III |
| Product Code: | 74 DSI |
Performance Standards
None promulgated
Voluntary Standards
UL 2601-1, IEC 60601-1 for electrical safety for medical equipment AAMI/ EC 11 - Diagnostic electrocardiograph devices (1991) AAMI/ EC 13 - Cardiac monitors, heart-rate meters, alarms (1992) AAMI/ ES 1 - Safe current limits for electromedical apparatus (1993) IEC 60601-1: General Requirement for Safety for Medical Electrical Systems - part 1, (1988); Amendment 1 - 1991-11 Amendment 2 - 1995-03 IEC 60602-2-27: Medical electrical equipment, Part 2, (1994) Requirements for safety of electrocardiograph monitoring equipment.
Predicate Device
MENNEN MEDICAL ENVOY PATIENT MONITOR (K001120).
Device Description: Envoy Patient Monitor
The Envoy is a multiparameter physiological patient monitor, capable of monitoring:
- · ECG/Heart Rate
- · invasive blood pressure
- · non-invasive blood pressure
- · respiration
- · pulse oximetry
- · two temperature channels
- · cardiac output
- · eTCO2