(112 days)
Not Found
No
The device description and intended use focus on mechanical ventilation and CO2 detection via color comparison, with no mention of AI or ML technologies.
Yes
The device is used to provide ventilatory support to patients in need, directly impacting a physiological function to restore health.
Yes
The device can include an integrated CO2 detector which assists in the verification of tube placement by detecting approximate ranges of CO2 by color comparison, indicating it performs a diagnostic function.
No
The device description clearly outlines a physical bag-valve-mask device with optional integrated hardware (CO2 detector). There is no mention of software as the primary or sole component.
Based on the provided text, the Nellcor INdGO Manual Resuscitator is not an In Vitro Diagnostic (IVD) device.
Here's why:
- IVD Definition: In Vitro Diagnostics are devices intended for use in the examination of specimens derived from the human body (such as blood, urine, or tissue) to provide information for diagnostic, monitoring, or compatibility purposes.
- Nellcor INdGO Function: The Nellcor INdGO Manual Resuscitator is a device used for manual ventilatory support. It assists with breathing by delivering air or oxygen to the patient's lungs.
- CO2 Detection: While it has an integrated CO2 detector, this detector is used to assist the verification of tube placement during intubation by detecting approximate ranges of CO2 in exhaled breath. This is a functional check related to the mechanical process of ventilation, not an analysis of a bodily specimen for diagnostic purposes.
The device's primary function is mechanical ventilation, not the analysis of biological samples. The CO2 detection feature is a supplementary tool for confirming proper tube placement during the ventilation process.
N/A
Intended Use / Indications for Use
The Nellcor INdGO Manual Resuscitator is a portable, nonsterile, single-patient use device intended for use on patients requiring manual ventilatory support. During artificial ventilation, the resuscitator can be operated from ambient air or provide oxygen-enriched air using the oxygen accumulator and connecting the supply tubing to a metered oxygen source. The Nellcor INdGO Manual Resuscitator is available with or without an integrated CO2 detector. The integrated CO2 detector can be used to assist the verification of tube placement during endotracheal or nasotracheal intubation. The integrated CO2 detector detects approximate ranges of CO2 by color comparison.
The Nellcor INdGO Manual Resuscitator is available in two sizes and is for use on the following patient populations:
- Adult size is for use on adults > 30kg. .
- Child size is for use on children 10 30 kg. .
The Nellcor INdGO Manual Resuscitator is intended for use by qualified healthcare professionals in any environment where pulmonary support resuscitation is indicated, such as hospital, transport, mobile, and home. This device is for prescription use only.
Product codes
BTM
Device Description
Nellcor INdGO Manual Resuscitator is a bag-valve-mask device with the capability of delivering supplemental oxygen. During artificial ventilation, the resuscitator can be operated from ambient air or provide oxygen-enriched air by connecting the supply tubing to a metered oxygen source.
The Nellcor INdGO Manual Resuscitator is available with and without integrated breath-to-breath CO2 detection. The integrated CO2 detector model incorporates an integral CO2 detector cartridge called INdCAP™ attached to the expiratory port of the resuscitator.
The Nellcor INdGO Manual Resuscitator is single-patient use, non-sterile, latex-free, and available in two sizes: adult and child. It has a double-swivel elbow, three oxygen accumulator styles, and comes in a variety of configurations.
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 size is for use on adults > 30kg. .
Child size is for use on children 10 30 kg. .
Intended User / Care Setting
qualified healthcare professionals in any environment where pulmonary support resuscitation is indicated, such as hospital, transport, mobile, and home.
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)
Performance and testing are consistent with the requirements for this device type specified by ASTM F920 and ISO 8382.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 868.5915 Manual emergency ventilator.
(a)
Identification. A manual emergency ventilator is a device, usually incorporating a bag and valve, intended to provide emergency respiratory support by means of a face mask or a tube inserted into a patient's airway.(b)
Classification. Class II (performance standards).
0
easanton, CA 9
Tele: 925 463-4427
Fax: 925 463-4020
tuco Healthcare
Nellcor
510(k) Summary
FEB 0 7 2003
| Submitted by: | Nellcor Puritan Bennett, Incorporated
4280 Hacienda Drive
Pleasanton, CA 94588 |
|-------------------------------------------|------------------------------------------------------------------------------------------------------------------------------|
| Company Contact: | Gina To
Senior Regulatory Affairs Project Manager
(925) 463-4427
(925) 463-4020 - FAX |
| Date Summary
Prepared: | February 5, 2003 |
| Trade Name: | Nellcor INdGO Manual Resuscitator |
| Common/Usual Name: | Disposable Manual Resuscitator |
| Classification Name: | Manual Emergency Ventilator, BTM per
21CFR§868.5915 |
| Legally Marketed
(Unmodified) Devices: | DMR²Plus™ Disposable Manual Resuscitator with
Integrated CO2 Detection, Nellcor Puritan Bennett, Inc.
510(k) # K973419 |
Device Description
Nellcor INdGO Manual Resuscitator is a bag-valve-mask device with the capability of delivering supplemental oxygen. During artificial ventilation, the resuscitator can be operated from ambient air or provide oxygen-enriched air by connecting the supply tubing to a metered oxygen source.
The Nellcor INdGO Manual Resuscitator is available with and without integrated breath-to-breath CO2 detection. The integrated CO2 detector model incorporates an integral CO2 detector cartridge called INdCAP™ attached to the expiratory port of the resuscitator.
The Nellcor INdGO Manual Resuscitator is single-patient use, non-sterile, latex-free, and available in two sizes: adult and child. It has a double-swivel elbow, three oxygen accumulator styles, and comes in a variety of configurations.
Indications for Use
The Nellcor INdGO Manual Resuscitator is a portable, nonsterile, single-patient use device intended for use on patients requiring manual ventilatory support. During artificial ventilation, the resuscitator can be operated from ambient air or provide oxygen-enriched air using the oxygen accumulator and connecting the supply tubing to a metered oxygen source. The Nellcor INdGO Manual Resuscitator is available with or without an integrated CO2 detector. The
1
integrated CO2 detector can be used to assist the verification of tube placement during endotracheal or nasotracheal intubation. The integrated CO2 detector detects approximate ranges of CO2 by color comparison.
The Nellcor INdGO Manual Resuscitator is available in two sizes and is for use on the following patient populations:
- Adult size is for use on adults > 30kg. .
- Child size is for use on children 10 30 kg. .
The Nellcor INdGO Manual Resuscitator is intended for use by qualified healthcare professionals in any environment where pulmonary support resuscitation is indicated, such as hospital, transport, mobile, and home. This device is for prescription use only.
Summary of Technological Characteristics of the Device Compared to the Legally Marketed (Unmodified) Device
The method of operation, technological characteristics, and CO2 detector technology of the Nellcor INdGO Manual Resuscitator remain the same as the above referenced predicate device. The only modifications relate to the elbow, NRV housing, check valve cartridge, and canister in the CO2 cartridge.
Testing
Performance and testing are consistent with the requirements for this device type specified by ASTM F920 and ISO 8382.
Conclusions
The design modifications and results of testing do not raise new questions of safety or effectiveness when compared to the legally marketed predicate device.
2
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized image of an eagle with three lines representing its wings.
FEB 0 7 2003
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Ms. Gina To Nellcor Puritan Bennett, Incorporated 4280 Hacienda Drive Pleasanton, California 94588
Re: K023494
Trade/Device Name: Nellcor® INdGO™ Manual Resuscitator Regulation Number: 21 CFR 868.5915 Regulation Name: Manual Emergency Resuscitator Regulatory Class: II Product Code: BTM Dated: January 15, 2003 Received: January 16, 2003
Dear Ms. To:
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 vour 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 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
3
Page 2 -- Ms. Gina To
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) 594-4646. 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 yours,
Susan Runner
Susan Runner, DDS, MA Interim Director Division of Anesthesiology, General Hospital, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
510(k) Number (if known): K023494
Nellcor INdGO Manual Resuscitator Device Name:
Indications For Use:
The Nellcor INdGO Manual Resuscitator is a portable, nonsterile, single-patient use device intended for use on patients requiring manual ventilatory support. During artificial ventilation, the resuscitator can be operated from ambient air or provide oxygen-enriched air using the oxygen accumulator and connecting the supply tubing to a metered oxygen source. The Nellcor INdGO Manual Resuscitator is available with or without an integrated CO2 detector. The integrated CO2 detector can be used to assist the verification of tube placement during endotracheal or nasotracheal intubation. The integrated CO2 detector detects approximate ranges of CO2 by color comparison.
The Nellcor INdGO Manual Resuscitator is available in two sizes and is for use on the following patient populations:
- Adult size is for use on adults > 30kg. .
- Child size is for use on children 10 30 kg. .
The Nellcor INdGO Manual Resuscitator is intended for use by qualified healthcare professionals in any environment where pulmonary support resuscitation is indicated, such as hospital, transport, mobile, and home. This device is for prescription use only.
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
| (Division Sign-Off) | |
|---|---|
| Division of Anesthesiology, General Hospital, | |
| Infection Control, Dental Devices | |
| 510(k) Number: | K023494 |
(Optional Format 3-10-98)
Prescription Use _ (Per 21 CFR 801.109) ﺬ