(356 days)
The Envoy is intended for use as a multiparameter monitoring system.
The Envoy can monitor ECG/heart rate, two invasive blood pressure channels, two temperature channels, pulse oximetry, respiration, non-invasive blood pressure, etCO2 and Spirometry. This effectively allows the Envoy to monitor a wide-range of adult, pediatric and neonatal patient conditions, in many different areas of the hospital.
The Envoy also includes a spirometer intended for continuous monitoring of adult and pediatric patients with tidal volumes greater than 100mL. Functions include display of multiparameter waveforms, vital signs, and status messages.
The Spirometry module is used to provide an objective measurement of lung function. The Spirometry module is intended for use in the hospital clinical environment only (e.g. in the RICU). The module is used for the continuous monitoring of mechanically ventilated adult and pediatric patients, or adult and pediatric patients able to breathe spontaneously. In both cases, the patient is connected to the module via an endotracheal tube or mask. The module is to be used only for patients with tidal volumes greater than 100 ml.
The Envoy is a multiparameter physiological patient monitor consisting of a main processing unit, a mountable color monitor, and a module rack housing the various Mennen Medical plug-in vital signs modules to monitor the patient's vital signs. Up to six internal modules can be plugged into a module rack. The Envoy can accommodate two module racks. Data presented from the modules by the Envoy are presented on the monitor as waveform and numeric displays.
The Envoy vital signs modules acquire vital signs data from the patient, and display their indications on the Envoy display unit. Vital signs and waveform information are displayed simultaneously on the Envoy Display Unit. Up to 8 traces can be displayed at any one time.
The Envoy is a reusable, software driven, patient monitor, intended for use as part of a physiological monitoring system in a hospital environment. As such, it is not a life supporting, nor is it implantable and therefore sterility is not a consideration.
The Envoy is not a kit and does not contain any drug or biological products. The Spirometry module of the Envoy patient monitor is not sold as a stand-alone spirometry device, but as part of a multiparameter physiological patient monitoring system (ENVOY).
The provided document is a 510(k) premarket notification for a new Spirometry module added to the Envoy Patient Monitor. The document indicates that the device has been subject to "extensive safety and performance testing" but does not contain the detailed study results needed to fully answer your request.
Here's a breakdown of what can be extracted and what information is missing:
1. Table of Acceptance Criteria and Reported Device Performance
The document provides some specifications for the OEM Airway Adapter/Flow sensor which can be considered performance criteria and reported performance:
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Flow Range | 2 - 180 lpm (33 - 3000 ml/s) |
| Accuracy | ± 5 % reading, or 0.5 lpm |
| Dead Space | 6.9 ml |
| Degree of protection against electrical shock | Type BF applied part |
| Sampling | 100 sps |
Missing Information for Table: The document states that the system included "various performance tests designed to ENSURE that the device complies to applicable requirements and performance specifications" but does not explicitly list the acceptance criteria or the full detailed results for all monitored parameters (Vt_e, PIP, PEEP, MAP, Plat, PF_i, PF_e, RR, Ve, I:E, COMP, RES, RSBI).
2. Sample size used for the test set and the data provenance
- Sample Size for Test Set: Not specified. The document mentions "extensive safety and performance testing" but does not provide details on the number of samples or cases used.
- Data Provenance: Not specified. It is not clear whether the testing involved retrospective or prospective data, or the geographical origin of any patient data, if used.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
- Not specified. The document does not describe a process for establishing ground truth using experts. The testing seems to be based on engineering performance specifications rather than clinical reads.
4. Adjudication method for the test set
- Not applicable/Not specified. Since expert ground truth establishment is not described, adjudication methods are also not mentioned.
5. 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
- No. This is not an AI/CAD device. It is a physiological patient monitor with a spirometry module. An MRMC study is not relevant to this type of device.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Yes, implicitly. The performance testing described refers to the device itself and its components. The document explicitly states, "The Spirometry module of the Envoy patient monitor is not sold as a stand-alone spirometry device, but as part of a multiparameter physiological patient monitoring system (ENVOY)." However, the performance specifications are for the module's technical capabilities (e.g., flow range, accuracy), which would be tested in a standalone capacity within the system.
7. The type of ground truth used
- Engineering Specifications/Reference Standards. The reported accuracy and flow range suggest comparison against known, calibrated inputs or reference standards rather than clinical consensus or pathology. Examples: "Accuracy: ± 5 % reading, or 0.5 lpm."
8. The sample size for the training set
- Not applicable/Not specified. This device is a hardware-based physiological monitor, not an AI/machine learning algorithm that requires a training set.
9. How the ground truth for the training set was established
- Not applicable. No training set is mentioned or implied for this type of device.
Study Proving Device Meets Acceptance Criteria:
The document states: "The Envoy Spirometry module has been subject to extensive safety and performance testing. The survey of the system included various performance tests designed to ensure that the device complies to applicable requirements and performance specifications. Safety testing and EMC testing were performed by an independent testing laboratory to ensure that the device complies to applicable industry and safety standards."
This is a general statement that indicates testing was done, but the document does not detail the specific study, methodology, or results of this "extensive safety and performance testing" beyond the specifications provided in the table above. It does not provide a formal "study" report within this 510(k) summary.
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Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an abstract symbol that resembles an eagle or a bird in flight, composed of three curved lines.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
MAR 1 2 2004
Mr. Asher Kassel Director of Regulatory Affairs Mennen Medical, Ltd. 4 Hayarden Street, Yavne 81228 P.O. Box 102 Rehovot 76100 ISRAEL
Re: K030722
Trade/Device Name: Envoy Patient Monitor Regulation Number: 21 CFR 870.1025 Regulation Name: Physiological Patient Monitor (with arrhythmia detection or alarms) Regulatory Class: III Product Code: MHX, BZK Dated: January 14, 2004 Received: February 2, 2004
Dear Mr. Kassel:
This letter corrects our substantially equivalent letter of February 26, 2004, regarding the Envoy Patient Monitor. Our letter identified the regulation name as Continuous Ventilator. This is in error; the correct regulation name is Physiological Patient Monitor (with arrhythmia detection or alarms) as indicated above.
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
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Page 2 - Mr. Asher Kassel
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 Eederal 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 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), 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). 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) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html.
Sincerely vours,
Qur
Shin-Lin Liu, Ph.D.
Chiu Lin. Ph.D. Director Division of Anesthesiology, General Hospital, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health
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Indications for Use
K030722 510(k) Number:
Envoy Patient Monitor Device Name:
Indications for Use:
The Envoy is intended for use as a multiparameter monitoring system.
The Envov can monitor ECG/heart rate, two invasive blood pressure channels, two temperature channels, pulse oximetry, respiration, non-invasive blood pressure, etCO2 and Spirometry. This effectively allows the Envoy to monitor a wide-range of adult, pediatric and neonatal patient conditions, in many different areas of the hospital.
The Envoy also includes a spirometer intended for continuous monitoring of adult and pediatric patients with tidal volumes greater than 100mL. Functions include display of multiparameter waveforms, vital signs, and status messages.
Prescription Use X (Part 21 CFR 801 Subpart D)
AND/OR Over-The-Counter Use (21 CFR 807 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Page 1 of 1
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Page 1 of 6
FEB 2 6 2004
Food and Drug Administration
ENVOY Patient Monitor - 510(k) for new Spirometry module
Image /page/3/Picture/13 description: The image shows the logo for Mennen Medical. The logo is in black and white, with the word "mennen" in a sans-serif font. The word "medical" is in a smaller font and is partially obscured by a circle. The circle is filled with a pattern of dots.
Mennen Medical Ltd., 4 Hayarden Street, Yavne 81228 PO Box 102, Rehovot 76100 Israel
Tel.: +972-8-9323333 Fax: +972-8-9328510
Date: 24 February, 2004
Topic: 510(k) Safety and Effectiveness Summary as per 21 CFR Section 807.92(c) Envoy Patient Monitor - new Spirometry module:
Establishment Name, Registration Number and Address:
| Name: | Mennen Medical Ltd. |
|---|---|
| Registration Number | 9611022 |
| Operator Number: | 9011766 |
| Address: | 4 Ha-yarden Street, Yavne, 81228, Israel |
| Postal Address: | PO Box 102,Rehovot, 76100, Israel |
| Tel: | +972-8-9323333 |
| Fax: | +972-8-9328510 |
| Contact person: | Asher Kassel, Director of Regulatory Affairs |
| To: | Food and Drug AdministrationCenter for Devices and Radiological HealthDocument Mail Center (HFZ-401)9200 Corporate BoulevardRockville MD, 20850 |
| Attn.: | Document Control Clerk |
| From: | Asher Kassel, Director of Regulatory Affairs |
| Product Name: | |
| Proprietary: | ENVOY |
| Common: | Physiological Patient Monitor |
| Mennen Medical Part Number: | 550-010-000 (full system) |
554-000-010 (CPU only)
551-137-000 P/N: New Envoy Spirometry module
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FDA Classification of Envoy Patient Monitor:
Arrhythmia Detector and Alarm Classification Name: Classification Number: 21 CFR 870.1025 Class III Classification: 74 DSI Product Code:
FDA Classification of new Spirometry module:
| Classification Name: | Monitoring spirometer |
|---|---|
| Classification Number: | 21 CFR 868.1850 |
| Classification: | Class II |
| Product Code: | BZK |
Performance Standards:
None promulgated
Voluntary Standards:
*IEC 60601-1: General Requirement for Safety for Medical Electrical Systems - part 1, (1988); Amendment 1 - 1991-11; Amendment 2 - 1995-03 *IEC 60601-1-2 (2001): General Requirement for Safety Collateral Standard: Electromagnetic compatibility - Requirements and tests.
Predicate Device:
METEOR Respiratory Mechanics Monitor(s) - K011784.
Device Description - Envoy Patient Monitor:
The Envoy is a multiparameter physiological patient monitor consisting of a main processing unit, a mountable color monitor, and a module rack housing the various Mennen Medical ulur-in vital signs modules monitor the patient's vital signs. Up to six internal modules can be plugged into a module rack. The Envoy can accommodate two module racks. modules can be presewad from the modules by the Envoy are presented on the monitor as waveform and numeric displays.
The Envoy vital signs modules acquire vital signs data from the patient, and display their The Envoy That Signs indications on the Envoy display unit. Vital signs and waveform information are displayed simultaneously on the Envoy Display Unit. Up to 8 traces can be displayed at any one time.
The Envoy is a reusable, software driven, patient monitor, intended for use as part of a r he Life's a reasaols, bestem in a hospital environment. As such, it is not a life supporting, priyalorogical monitoring - nor is it implantable and therefore sterility is not a consideration.
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Food and Drug Administration
ENVOY Patient Monitor - 510(k) for new Spirometry module
The Envoy is not a kit and does not contain any drug or biological products. The Spirometry module of the Envoy patient monitor is not sold as a stand-alone spirometry device, but as part of a multiparameter physiological patient monitoring system (ENVOY). In Chapter 1 of the Envoy Operating Manual, the following Prescription Notice appears: "Federal United States law restricts the sale and use of this instrument to qualified medical personnel only".
Intended Use and Functional Description and of the New Envoy Spirometry module:
Intended Use of the Spirometry module:
The Spirometry module is used to provide an objective measurement of lung function. rne Spirometry module is intended for use in the hospital clinical environment only (c.g. in the RICU). The module is used for the continuous monitoring of mechanically ventilated adult and reles). The module is as adult and pediatric patients able to breathe spontaneously. In both pearative patients, or let acheal tube or mask. The module is to be used only for patients with tidal volumes greater than 100 ml.
Functional Description:
The spiromctry module can measure the following:
a) Expiratory Vital Capacity (EVC): The maximum volume of gas which can be expired from the lungs during a relaxed expiration from a position of full inspiration.
b) Inspiratory Vital Capacity (IVC): The maximum volume of gas which can be inspired into the lungs during a relaxed inspiration from a position of full expiration. The expiratory phase is the one more commonly used to mcasure obstruction and restriction within the lungs.
Intended Use of the Envoy Patient Monitor:
The Envoy is intended for use as a multiparameter monitoring system.
The Envoy can monitor ECG/heart rate, two invasive blood pressure channels, two temperature The Entroy can moments , respiration, non-invasive blood pressure, etCO2 and Spirometry. enatinels, parec of the Envoy to monitor a wide-range of adult, pediatric and neonatal patient conditions, in many different areas of the hospital.
The Envoy also includes a spirometry module intended for continuous monitoring of adult and rne invoy alou moral tidal volumes greater than 100mL. Functions include display of multiparameter waveforms, vital signs, and status messages.
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Summary of the technological characteristics of the new Envoy Spirometry module (incorporating OEM technology for a Respiratory Mechanics System):
The following tables summarize data on the Mennen Medical new Envoy Spirometry module:
| Envoy Spirometry Module | |
|---|---|
| Part Number: | 551-137-000 |
| MonitoredParameters: | *Air Flow signal*Volume signal*Airway pressure |
| Module size: | Single slotHeight: 10.0cm (4.0 in)Width: 4.0 cm (1.6 in)Depth: 14.0 cm (5.5 in) |
| Monitored parameters | Envoy Spirometry module |
|---|---|
| Vt_e | Yes |
| PIP | Yes |
| PEEP | Yes |
| MAP | Yes |
| Plat | Yes |
| PF_i | Yes |
| PF_e | Yes |
| RR | Yes |
| Ve | Yes |
| I:E | Yes |
| COMP | Yes |
| RES | Yes |
| RSBI | Yes |
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Food and Drug Administration
:
ENVOY Patient Monitor - 510(k) for new Spirometry module
| Alarm Indications | EnvoySpirometry module |
|---|---|
| Clinical Alarms forderived parameters | Visual & Sound Alarms |
| Specifications | EnvoySpirometry module |
|---|---|
| Degree of protectionagainst electrical shock | Type BF applied part |
| Sampling | 100 sps |
| OEM Airway Adapter/Flow sensor | EnvoySpirometry module |
|---|---|
| Flow Range: | 2 - 180 lpm (33 - 3000 ml/s) |
| Accuracy: | ± 5 % reading, or 0.5 lpm |
| Dead Space: | 6.9 ml |
| Connections: | Airway - 15 mm ID/22 mmOD patient end by 15 mm IDventilator end (ISO 5356-1) Proprietary Smart connectorTri-Tubing - triple 0.055" inch ID lumen |
| Length: | 2.5 inches (adapter) - 6 feet (tubing) |
| Weight: | 6.3 grams (minus tubing) |
| Material: | Sensor - Polycarbonate (Makrolon).Tubing - Medical grade Polyvinyl Chloride |
:
:
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Food and Drug Administration
ENVOY Patient Monitor – 510(k) for new Spirometry module
Conclusion of comparison of technological characteristics:
We consider the Envoy Spirometry module to be substantially equivalent to the METEOR 200 Respiratory Mechanics Monitor; we submit that any differences between the two monitors do not raise any new issues of safety and effectiveness.
Testing
The Envoy Spirometry module has been subject to extensive safety and performance testing. The Larvey of the system included various performance tests designed to ensure that the device I mar county requirements and performance specifications. Safety testing and EMC testing were performed by an independent testing laboratory to ensure that the device complies to applicable industry and safety standards.
Signature: Asher Kassel
Asher Kassel Director of Regulatory Affairs Mennen Medical Ltd.
Tel: +972-8-9323311 (direct) Fax: +972-8-9328510 E-mail: asher(@mmi.co.il
§ 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.