The DHD Stealth Metered Dose Inhaler (MDI) Spacer (Without Integral Actuator) assists with the delivery of aerosolized medications when used in conjunction with commercially available Metered Dose Inhaler (MDI) canisters with their associated actuator elbows. In addition, for convenience, the MDI canister/elbow, may be stored inside of the Stealth when not in use (the spacer acts as the MDI canister/elbow holding chamber). Pilot is a one piece, silicone rubber face mask that may be attached to the Stealth MDI holding chamber as an interface between the Stealth MDI and the patient's face/mouth region.

Device Description

The Pilot device is a mask attachment for the Stealth Metered Dose Inhaler (MDI) Spacer. The Pilot mask fits directly onto the Stealth MDI Spacer. Pilot is a single piece, injection molded, silicone rubber piece. It is intended for single patient use and may be disassembled from the Stealth MDI for convenient cleaning the device, by hand, in warm soapy water. The Pilot mask will be available in several sizes. and large masks. The mask sizes are designed to fit comfortably to a users face. The masks also include a tapered fitting designed to mate with the Stealth mouthpiece. The tapered fitting includes a small ledge which serves as a stop, preventing the mask from being advanced too far onto the Stealth mouthpiece.

AI/ML Overview

The provided 510(k) summary for the "Stealth/Pilot (Final Name to Be Determined) MDI Spacer with Facemask" does not contain a study that proves the device meets specific acceptance criteria in the way a clinical trial or performance study would typically be described. Instead, the submission relies on demonstrating substantial equivalence to predicate devices and addressing technological characteristics with "no testing required" for most points.

Here's an analysis based on the information provided:

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria (Technological Information)	Reported Device Performance (Summary of Studies)
6.1 The mask must fit securely to the Stealth MDI spacer and be easily removed for cleaning. The tapered interface between the Pilot mask and Stealth mouthpiece meets this requirement.	Pilot meets this requirement. (No actual testing described; assertion made based on design.)
6.2 The mask shall be available in three sizes. As shown by the drawings in the device description, the Pilot mask will be available in small, medium and large sizes.	Pilot meets this requirement. (No actual testing described; assertion made based on design and availability.)
6.3 The mask must not interfere with MDI spacer performance. The mask system does not contain any valving, nor does the mask interface interfere with any of the functional areas of the Stealth spacer.	Pilot meets this requirement. (No actual testing described; assertion made based on design principles ["no valving," "no interference"]).
6.4 The mask shall be manufactured from a clear or translucent elastomer. The Bayer LSR 20 series of silicone rubber is clear/translucent.	Pilot meets this requirement. (No actual testing described; assertion made based on material specification.)

2. Sample size used for the test set and the data provenance

The document explicitly states: "There were no specific studies completed in association with this submission."

Therefore, there is no information on:

Sample size used for a test set.
Data provenance (e.g., country of origin, retrospective/prospective).

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

Not applicable, as no studies involving a test set and ground truth establishment were described.

4. Adjudication method for the test set

Not applicable, as no studies involving a test set were described.

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. This device is a mechanical medical device (MDI spacer with a facemask), not an AI-powered diagnostic or assistive technology.

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

Not applicable, as this is a mechanical device, not an algorithm.

7. The type of ground truth used

Not applicable, as no studies involving ground truth were described.

8. The sample size for the training set

Not applicable, as no training set was used (e.g., for an AI algorithm).

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

Not applicable, as no training set was used.

Summary of the Study and Device Acceptance:

The submission for the "Stealth/Pilot" facemask does not include any performance studies or clinical trials with acceptance criteria and measured device performance in the traditional sense. Instead, the device's acceptance is based on demonstrating substantial equivalence to existing predicate devices ("ACE" MDI Spacer and "Stealth" MDI Spacer) and confirming that its technological characteristics meet basic design requirements without interfering with the primary function of the MDI spacer.

The "Summary of Studies" section explicitly states, "There were no specific studies completed in association with this submission," and the "Conclusions Drawn from Studies" section states "None."

The acceptance criteria listed in Section 6 ("Technological Information") are essentially design requirements that the manufacturer asserts are met by the Pilot mask's design, materials, and intended function. The FDA's 510(k) clearance process often allows for substantial equivalence determinations without new clinical or performance data if the new device is sufficiently similar to legally marketed predicate devices. In this case, the Pilot mask is an accessory that interfaces with an already cleared MDI spacer, and the manufacturer argued successfully that its design characteristics inherently met the stated requirements, thus "no testing is required."

Summary

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KC981167

JUN 1 8 1998

ಿಗೆ

510(k) SUMMARY As Required by 807.92(c)

3-4-98

Stealth/Pilot (Final Name to Be Determined)

MDI Spacer with Facemask

Spacer - Class II - 868.5630

Oxygen Mask - Class 1 - 868.5580

DHD Healthcare 1. Submitter: 125 Rasbach Street Canastota, NY 13032
Phone: 315-697-2221 315-697-8083 Fax:

Contact:

Jean Wallace, Manager, Regulatory Affairs

2. Device Name

Trade Name ●
. Common name Classification name

3. Predicate Device:

1-"ACE" MDI Spacer 510(k)'s K913326A, K953206, K961973 DHD Canastota, NY 13032
"Stealth" MDI Spacer 2-510(k) K973532 DHD Canastota, NY 13032

The Pilot device is a mask attachment for the Stealth Metered Dose 4. Device Description: Inhaler (MDI) Spacer. The Pilot mask fits directly onto the Stealth MDI Spacer.

Pilot is a single piece, injection molded, silicone rubber piece. It is intended for single patient use and may be disassembled from the Stealth MDI for convenient cleaning the device, by hand, in warm soapy water.

The Pilot mask will be available in several sizes. and large masks. The mask sizes are designed to fit comfortably to a users face.

The masks also include a tapered fitting designed to mate with the Stealth mouthpiece. The tapered fitting includes a small ledge which serves as a stop, preventing the mask from being advanced too far onto the Stealth mouthpiece.

ഹ് Intended Use

ﻟﻤﺴﺘﻌﻤﻠﻬﺎ

Pilot is a one piece, silicone rubber face mask that may be attached to the Stealth MDI holding chamber as an interface between the Stealth MDI and the patient's face/mouth region. The DHD Stealth Metered Dose Inhaler (MDI) Spacer (Without Integral Actuator) assists with the delivery of aerosolized medications when used in conjunction with commercially available Metered Dose Inhaler (MDI) canisters with their associated actuator elbows. In addition, for convenience, the MDI canister/elbow, may be stored inside of the Stealth when not in use (the spacer acts as the MDI canister/elbow holding chamber).

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6. Technological Information

6.1 The mask must fit securely to the Stealth MDI spacer and be easily removed for cleaning. The tapered interface between the Pilot mask and Stealth mouthpiece meets this requirement. No testing is required. Pilot meets this requirement.
6.2 The mask shall be available in three sizes. As shown by the drawings in the device description, the Pilot mask will be available in small, medium and large sizes. No testing is required. Pilot meets this requirement.
6.3 The mask must not interfere with MDI spacer performance. The mask system does not contain any valving, nor does the mask interface interfere with any of the functional areas of the Stealth spacer. No additional testing is required. Pilot meets this requirement.
6.4 The mask shall be manufactured from a clear or translucent elastomer. The Bayer LSR 20 series of silicone rubber is clear/translucent. No additional testing is required. Pilot meets this requirement.

7. Summary of Studies

There were no specific studies completed in association with this submission.

Conclusions Drawn from Studies 8. None
ﺳﻨﺴﻪ

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Image /page/2/Picture/1 description: The image shows the seal of the Department of Health & Human Services USA. The seal is circular, with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" arranged around the perimeter. In the center of the seal is an abstract image of an eagle with three overlapping wings.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

JUN 18 1998

Mr. Jean Wallace Manager, Requlatory Affairs DHD Healthcare One Madison Street Wampsville, NY 13163

Re : K981167 Stealth Pilot Kit Requlatory Class: II (two) Product Code: 73 CAF Dated: March 23, 1998 April 1, 1998 Received:

Dear Mr. Wallace:

We have reviewed your Section 510(k) notification of intent to market the device referenced above and we 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, Druq, and Cosmetic Act (Act). You may, therefore, market the device, subject to the general controls provisions of the Act. However, you are responsible to determine that the medical devices you use as components in the kit have either been determined as substantially equivalent under the premarket notification process (Section 510(k) of the act), or were legally on the market prior to May 28, 1976, the enactment date of the Medical Device Amendments. Please note: If you purchase your device components in bulk (i.e., unfinished) and further process (e.g., sterilize) you must submit a new 510(k) before including these components in your kit. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, and labeling, and prohibitions against misbranding and adulteration.

If your device is classified (see above) into either class II (Special Controls) or class III (Premarket Approval) 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 895. A substantially equivalent determination assumes compliance with the Current Good Manufacturing Practice requirements, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic QS

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Page 2 - Mr. Jean Wallace

inspections, FDA will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, the Food and Drug Administration (FDA) may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal Laws or Regulations.

This letter will allow you to begin marketing your device as described in your 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 the labeling regulation (21 CFR Part 801 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4648. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers 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,

Woy Saparmem mma

Thomas J. Callahan, Ph Director Division of Cardiovascular, Respiratory, and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Page 1 of of 1_

... . . . . . . . . . . . . . . . . . . . . . . . . . . .

~10(k) Number (if known): ____________________________________________________________________________________________________________________________________________________

Stealth Metered Dose Inhaler Kit - Adding Pilot Face Mask Device Name:

Indications For Use:

1 Purpose:
The DHD Stealth Metered Dose Inhaler (MDI) Spacer (Without Integral Actuator) assists with the rns Bris Gount Medications when used in conjunction with commercially available Metered Dose Inhaler (MDI) canisters with their associated actuator elbows. In addition, for convenience, the MDI canister/elbow, may be stored inside of the Steath when not in use (the spacer acts as the MDI canister/elbow holding chamber). Pilot is a one piece, silicone rubber face mask that may be attached to the Stealth MDI holding chamber as an interface between the Stealth MDI and the patient's face/mouth region.
2 Claims:
- Use of the Stealth Spacer, without integral actuator, assists with the delivery of aerosolized 2.1 medications from Metered Dose Inhaler (MDI) canisters.
- Use of the Stealth Spacer reduces patient coordination and technique oriented problems 2.2 associated with MDI drug delivery.
- When used with the Stealth Spacer, the Pilot face mask reduces coordination and 2.3 technique problems associated with MDI drug delivery in lieu of the Stealth Mouthpiece.
3 Target Patient Population:
- Patients capable of following directions for hand held use of Metered Dose Inhaler (MDI) 3.1 Spacer therapy as determined by a physician.
  - Patients requiring mask interface. Pilot allows a clinical choice for use of the Stealth 3.2 MDI spacer with a mouthpiece and/or a mask .
4 Intended Environment For Use
- Labeling reflects the statement: "Federal (USA) Law restricts this device to sale by or on the 4.1 order of a physician."
- 4.2 May be used in hospital as well as the home.
5 Legally Marketed Predicate Devices:
- ACE® Aerosol Cloud Enhancer, manufactured by DHD Healthcare, Canastota, New 5.1 York.
- 5.2 Stealth Metered Dose Inhaler(MDI) Spacer, manufactured by DHD Healthcare, Canastota, NY 13032

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use	OR	Over-The-Counter Use
(Per 21 CFR 801.109)

Wolf Sapmka MD

(Division Sign-Off)

Division of Cardiovascular, Respiratory, and Neurological Devices

510(k) Number	K981167
---------------	---------

(Optional Format 1-2-96)

Regulation Number and Section

§ 868.5630 Nebulizer.

(a)
Identification. A nebulizer is a device intended to spray liquids in aerosol form into gases that are delivered directly to the patient for breathing. Heated, ultrasonic, gas, venturi, and refillable nebulizers are included in this generic type of device.(b)
Classification. Class II (performance standards).