(182 days)
1 - Purpose: The DHD Steath Metered Dose Intraler (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 then 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). 2 - Claims: 2.1 Use of the Stealth Spacer, without integral actuator, assists with the delivery of aerosolized medications from Metered Dose Inhaler (MDI) canisters. 2.2 Use of the Stealth Spacer reduces patient coordination and technique oriented problems associated with MDI drug delivery.
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This document is a 510(k) clearance letter for the "Stealth, Metered Dose Inhaler (MDI) Spacer without Integral Actuator." It grants permission to market the device based on its substantial equivalence to previously marketed devices. However, it does not contain the information required to describe the acceptance criteria and the study that proves the device meets them.
Specifically, the document does not include:
- A table of acceptance criteria and reported device performance.
- Details about sample sizes, data provenance, or the number/qualifications of experts used for ground truth.
- Information on adjudication methods.
- Results from a multi-reader multi-case (MRMC) comparative effectiveness study or a standalone algorithm-only performance study.
- The type of ground truth used.
- Sample size or ground truth establishment methods for a training set.
The document primarily focuses on regulatory approval based on substantial equivalence, rather than a detailed performance study report.
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Image /page/0/Picture/1 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo features a stylized image of three human profiles facing right, stacked on top of each other. The profiles are simple and abstract, with only the outlines of the faces visible. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" is arranged in a circular pattern around the image.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
MAR 19 1998
Ms. Jean Wallace DHD Healthcare, Diemolding Corporation One Madison Street Wampsville, NY 13163
Re: K973532 Stealth, Metered Dose Inhaler (MDI) Spacer without Integral Actuator Regulatory Class: II (two) Product Code: 73 CAF Dated: January 13, 1998 Received: January 15, 1998
Dear Ms. 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 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). 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 (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) inspections, the Food and Drug Administration (FDA) will verify such Failure to comply with the GMP regulation may result in assumptions. regulatory action. In addition, 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.
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Page 2 - Ms. Jean Wallace
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 our labeling requlation (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/dsmamain.html".
Sincerely yours,
Thomas J. Callahan
Thomas J. Callahan, Ph.D. Director Division of Cardiovascular, Respiratory, and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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510(k) Number (it known): K973532
Device Name: Steally
Indications For Use:
1 - Purpose:
The DHD Steath Metered Dose Intraler (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 then 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).
2 - Claims:
.
:
2.1 Use of the Stealth Spacer, without integral actuator, assists with the delivery of aerosolized medications from Metered Dose Inhaler (MDI) canisters.
2.2 Use of the Stealth Spacer reduces patient coordination and technique oriented problems associated with MDI drug delivery.
3 - Target Patient Population:
Patients capable of following directions for hand held use of Metered Dose Inhaler (MDI) Spacer therapy as determined by a physician.
- 4 Intended Environment For Use
4.1 Labeling reflects the statement: "Federal (USA) Law restricts this device to sale by or on the order of a physician."
May be used in hospital as well as the home. 4.2
5 - Legally Marketed Predicate Devices:
- 5.1 ACE® - Aerosol Cloud Enhancer, manufactured by DHD Healthcare, Canastota, New York.
- 5.2 Aerochamber®, manufactured by Monaghan Medical Corporation, Plattsburgh, New York.
(Please DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use
(Per 21 CFR 801.109)
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Over-The-Counter Use _________________________________________________________________________________________________________________________________________________________
(Optional Formal 1-2-96)
Mr. Puye
(Division Sign-Off) ( Division of Cardiovascular, Respiratory, and Neurological Devices
510(k) Number .
§ 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).