(89 days)
Not Found
None
No
The provided 510(k) summary does not mention AI, ML, or any related concepts. The device description and intended use focus on basic oxygen delivery control based on inspiration timing.
Yes
The device is used to deliver oxygen and maintain oxygen saturation, which are therapeutic actions aimed at treating or alleviating a medical condition.
No
The device's indications for use describe functions related to oxygen delivery and conservation, such as "Conserve the flow of oxygen" and "Deliver oxygen during the inspiration cycle." These are therapeutic or life-support functions, not diagnostic ones. Diagnostic devices are used to identify or detect medical conditions, diseases, or abnormalities.
No
The provided 510(k) summary describes a "Demand Oxygen Controller," which is inherently a hardware device designed to control oxygen flow. The summary lacks any information suggesting it is a software-only component or application.
Based on the provided information, the Transtracheal Systems, Inc. DOC 2000 Demand Oxygen Controller is not an IVD (In Vitro Diagnostic) device.
Here's why:
- IVD devices are used to examine specimens derived from the human body. The indications for use of the DOC 2000 clearly describe a device that delivers oxygen directly to a patient during the inspiration cycle to maintain oxygen saturation. This is a therapeutic and life-support function, not a diagnostic test performed on a sample.
- The description focuses on oxygen delivery and conservation. The functions listed (conserve oxygen, deliver during inspiration, maintain saturation, adjustable timing) are all related to the mechanics and control of oxygen delivery to a living patient.
- There is no mention of analyzing biological samples. The provided text does not mention any analysis of blood, urine, tissue, or any other bodily fluid or substance.
Therefore, the DOC 2000 is a medical device used for oxygen therapy, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
-
- Conserve the flow of oxygen
-
- Deliver oxygen during the inspiration cycle
-
- Maintain adequate oxygen saturation of a patient
-
- Adjustable time for delayed inspiration alarm
-
- Adjustable inspiration time
Product codes
73 NFB
Device Description
Not Found
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
Not Found
Intended User / Care Setting
Not Found
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.)
Not Found
Predicate Device(s)
Not Found
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 868.5905 Noncontinuous ventilator (IPPB).
(a)
Identification. A noncontinuous ventilator (intermittent positive pressure breathing-IPPB) is a device intended to deliver intermittently an aerosol to a patient's lungs or to assist a patient's breathing.(b)
Classification. Class II (performance standards).
0
| DEPARTMENT OF HEALTH & HUMAN SERVICES | Public Health Service |
|---|---|
| Food and Drug Administration | |
| 9200 Corporate Boulevard | |
| Rockville MD 20850 | |
| FEB 2 6 2002 | |
| Mr. Lewis Ward | |
| Transtracheal Systems, Inc. | |
| c/o L.W. Ward and Associates, Inc. | |
| 4655 Kirkwood Court | |
| Boulder, CO 80301 | |
| Re: | K962944 |
| Demand Oxygen Controller, DOC-2000 | |
| Regulation Number: 868.5905 | |
| Regulation Name: Noncontinuous Ventilator | |
| Regulatory Class: | II (two) |
| Product Code: | 73 NFB |
| Dear Mr. Ward: | |
| This letter corrects our substantially equivalent letter of October 23, 1996, regarding the Demand | |
| Oxygen Controller, DOC-2000. Our letter identified the product code as 73 BZD. This is in | |
| error; the correct product code is 73 NFB 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 |
commerce prior to May 28, 1970, the chacinene with the provisions of the Federal Food, Drug, devices that have been recassified in acceraanse val of a premarket approval application (PMA).).
and Cosmetic Act (Act) that do not require approval of a premaining of the A and Cosmetic Act (Act) that do not require approval controls provisions of the Act. The Act. The Act. The You may, merelore, market the device, seoject to use ments for annual registration, listing of the adjus and general controls provisions of the free 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
If your device is classified (SCC above) into entist on the major regulations affecting your device can
may be subject to such additional controls. Existing major regulation may be subject to such additional controlis. Existing may of 898. In addition, FDA may be found in the Ood of I passes oncerning your device in the Federal Register.
1
Page 2 - Mr. Lewis Ward
Please be advised that FDA's issuance of a substantial equivalence determination does not mean Please be advised that I Dri 3 issualled or our device complies with other requirements of the Act that I DA has made a decorminations administered by other Federal agencies. You must or any Federal statutes and regulations and limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set and Cr K Far 807), adomig (2) OF R Part 820); and if applicable, the electronic forul in the quality systems (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 marketing of substantial equivalence of your device to a legally premarket notheation. The FDF imaling of cation 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 additionally 21 CTTC Far 807.10 for ministry, for questions on the promotion and advertising of Compliance at (301) 597 - 1010. There of Compliance at (301) 594-4639. Also, please note the your de recess pread "Misbranding by reference to premarket notification" (21CFR Part 807.97). Ingulation chitined, Thisolanans oresponsibilities under the Act may be obtained from the Other general mionmation on your respontional 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,
for
Bram D. Zuckerman, M.D.
Acting Director
Division of Cardiovascular and
Respiratory Devices
Office of Device Evaluation
Center for Devices and
Radiological Health
Enclosure
2
Indications for Use
Device name: Transtracheal Systems, Inc. DOC 2000 Demand Oxygen Controller
Indications for Use:
-
- Conserve the flow of oxygen
-
- Deliver oxygen during the inspiration cycle
-
- Maintain adequate oxygen saturation of a patient
-
- Adjustable time for delayed inspiration alarm
-
- Adjustable inspiration time
/ Prescription Use
Per 21 CFR 801.109
Richard F. Nixon
(Division Sign-OM) Division of Cardiovascular, Re and Neurological Devices 96294 510(k) Numbe
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