TRANSTRACHEAL DEMAND OXYGEN CONTROLLER (DOC-2000) by TRANSTRACHEAL SYSTEMS

This FDA letter is a 510(k) clearance for the Transtracheal Systems, Inc. DOC 2000 Demand Oxygen Controller. It does not describe a study with acceptance criteria and device performance in the way a clinical trial or AI/ML study would.

Instead, the letter confirms that the device is "substantially equivalent" to legally marketed predicate devices, meaning it has similar intended use and technological characteristics and raises no new questions of safety or effectiveness. For a device like a demand oxygen controller, substantial equivalence is typically demonstrated through bench testing and potentially limited human factors testing, rather than large-scale clinical performance studies as seen in drug approvals or advanced diagnostic devices.

Therefore, many of the requested points are not applicable in this context. However, I can extract the relevant information where possible and explain why other points are not present.

1. A table of acceptance criteria and the reported device performance

This document does not contain a table of acceptance criteria or reported device performance in the format typical for AI/ML or clinical efficacy studies. The FDA 510(k) clearance process for devices like this typically relies on demonstration of compliance with recognized standards and comparison to predicate devices, rather than establishing new, specific performance metrics for the approval itself. Performance metrics would have been evaluated during the design and testing phases by the manufacturer (Transtracheal Systems, Inc.) to ensure the device met its functional specifications and standards for oxygen delivery and conservation, which the FDA reviewed as part of the 510(k) submission.

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

Not applicable. This is a 510(k) clearance letter confirming substantial equivalence to a predicate device. It does not involve a "test set" of patient data for performance evaluation in the context of diagnostic accuracy or clinical outcomes. The "testing" involved would have been engineering and bench tests, possibly human factors testing, to ensure the device met its specifications and performed as intended in a controlled environment.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

Not applicable. There is no mention of "ground truth" established by experts in this context. Device safety and efficacy for a demand oxygen controller are evaluated based on engineering specifications, adherence to standards, and comparison to existing, already approved devices.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

Not applicable. As there is no "test set" requiring expert review for ground truth establishment, no adjudication method is 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

Not applicable. The DOC 2000 is a demand oxygen controller, a medical device for oxygen delivery, not a diagnostic imaging device utilizing AI. Therefore, an MRMC study and AI assistance are irrelevant to this product's clearance.

6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done

Not applicable. The DOC 2000 is a hardware device for oxygen delivery, not an algorithm.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)

Not applicable in the conventional sense of diagnostic or clinical outcome studies. For this type of device, "ground truth" would relate to its functional performance (e.g., accurate oxygen delivery, oxygen conservation rate, proper trigger sensitivity) measured against engineering specifications and industry standards, perhaps through bench testing or simulated use.

8. The sample size for the training set

Not applicable. This is not an AI/ML device that requires a training set.

9. How the ground truth for the training set was established

Not applicable. This is not an AI/ML device that requires a training set.

Summary of what can be inferred from the document:

Device: Transtracheal Systems, Inc. DOC 2000 Demand Oxygen Controller
Purpose of clearance: Substantial Equivalence (510(k)) to a predicate device.
Indications for Use (from Enclosure):
- 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
Regulatory Class: II (two)
Product Code: 73 NFB
Regulation Number: 868.5905 (Noncontinuous Ventilator)

The FDA's finding of "substantial equivalence" means they reviewed the manufacturer's submission which would have included:

A description of the device and its intended use.
Comparison to a predicate device already legally on the market.
Data from non-clinical (bench) testing to demonstrate that the device performs as intended and is as safe and effective as the predicate device. This would include testing related to oxygen delivery accuracy, conservation efficiency, alarm functions, and biocompatibility if applicable.
Verification that the device meets relevant recognized standards.

The acceptance criteria for such a device are typically defined by these standards and the performance of the predicate device, which the manufacturer would have provided data to demonstrate compliance with. The FDA clearance letter itself does not detail these specific criteria or the exact performance data.

Summary

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DEPARTMENT OF HEALTH & HUMAN SERVICES	Public Health Service
	Food and Drug Administration9200 Corporate BoulevardRockville MD 20850
	FEB 2 6 2002
Mr. Lewis WardTranstracheal Systems, Inc.c/o L.W. Ward and Associates, Inc.4655 Kirkwood CourtBoulder, 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 DemandOxygen Controller, DOC-2000. Our letter identified the product code as 73 BZD. This is inerror; the correct product code is 73 NFB as indicated above.
	We have reviewed your Section 510(k) premarket notification of intent to market the devicereferenced above and have determined the device is substantially equivalent (for the indicationsfor use stated in the enclosure) to legally marketed predicate devices marketed in interstatecommerce 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.

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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

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Indications for Use

Device name: Transtracheal Systems, Inc. DOC 2000 Demand Oxygen Controller

Indications for Use:

1. Conserve the flow of oxygen
1. Deliver oxygen during the inspiration cycle
1. Maintain adequate oxygen saturation of a patient
1. Adjustable time for delayed inspiration alarm
1. 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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Regulation Number and Section

§ 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).