(79 days)
The Aqua Spray is intended for use by Podiatric professionals as an accessory to a burr. The Aqua Spray provides an electric hand piece with an attachment that provides a fine mist of isopropyl alcohol and distilled water (50% concentration) to be dispensed over the burr. The purpose of this mist is to cool the burr and treatment area. In addition, the mist wets the treatment area, thus minimizing the amount of nail dust that becomes airborne during the nail debridement procedure.
The Aqua Spray is an electrically powered accessory to a burr. The Aqua Spray enables a burr to be attached to an electric hand piece capable of 30,000 rpm, in each direction. A small reservoir in which a 50% distilled water and isopropyl alcohol is placed is included in the unit. A small air pump sprays the water/alcohol liquid in a fine mist on the burr. The mist cools the area and prevents nail dust from the treatment area to become airborne.
This document is a 510(k) summary for a medical device (Aqua Spray). It explicitly states "Non-clinical tests: Not applicable" and "Clinical tests: Not applicable" and "Test summary: Not applicable".
Therefore, the study that proves the device meets acceptance criteria, and consequently, the acceptance criteria themselves, are not provided in the given text. This device was granted substantial equivalence ("K971941") without the need for clinical or non-clinical performance testing. The substantial equivalence was based on its similarity to a legally marketed predicate device (Podo Spray) in terms of intended use and technological characteristics.
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BOYD INDUSTRIES, INC.
12275 75th Sticet North•Fargo, Florida 33773 3031 813-336-3503+1-800-2-55-BOYD•EAX 813-330-5853
AUG 14 1997
971941
( 10) 510 (k) Summary
| Submitter's Name: | Boyd Industries, Inc.12275 75th Street NorthLargo, FL 33773 |
|---|---|
| Phone Number: | (813) 536-3592(800) 255-2693 |
| Fax Number: | (813) 530-5853 |
| Contact Person: | Mr. Bruce V. Livingston |
| Date of Summary: | May 23, 1997 |
| Trade Name: | Aqua Spray |
| Common Name: | Electric Hand piece |
| Classification Name: | Dermatome (Industry code 79) |
| Legally Marketed device of Equivalence: | Podo Spray |
| Device Descrption: | The Aqua Spray is an electrically powered accessory to a burr. The Aqua Spray enables a burr to be attached to an electric hand piece capable of 30,000 rpm, in each direction. A small reservoir in which a 50% distilled water and isopropyl alcohol is placed is included in the unit. A small air pump sprays the water/alcohol liquid in a fine mist on the burr. The mist cools the area and prevents nail dust from the treatment area to become airborne. |
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BOYD INDUSTRIES, INC. 12275 75th Street North•Largo, Horida 33773 3031 813-236-3292+1 800-233 BOND•EX 813-330-3853
| Device Use: | The Aqua Spray is intended for use in an office based environment. The target market of this device is podiatry. The Aqua Spray is an accessory to a manual burr. The Aqua spray provides an electrically powered hand piece that provides the burr a faster more efficient method of debriding fungus from the nails of the toe. |
|---|---|
| Technological characteristics: | The technological characteristics between the Aqua Spray and the Podo Spray are virtually identical. Both devices use an electric hand piece, air pump to create mist, PC board control of the unit, 110 volt AC power, foot control capability, variable flow of mist, master on/off switch, left/right rotation capability of hand piece (burr), on/off capablity of spray. A wiring schematic and component list is included for reference with the Podo Spray. |
| Non-clinical tests: | Not applicable |
| Clinical tests: | Not applicable |
| Test summary: | Not applicable |
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Image /page/2/Picture/1 description: The image is a black and white logo for the Department of Health & Human Services USA. The logo features a stylized caduceus symbol, which is a staff with two snakes coiled around it. The symbol is surrounded by the text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" in a circular arrangement. The text is written in a simple, sans-serif font.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Mr. Bruce V. Livingston Boyd Industries, Inc. 12275 75th Street North -Largo, Florida 33773-3031
AUG 1 4 1997
K971941 Re: Trade Name: Aqua Spray Regulatory Class: II Product Code: GEY Dated: May 23, 1997 Received: May 27, 1997
Dear Mr. Livingston:
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 (2) CFR Part 820) and that, through periodic (QS) inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in 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 - Mr. Bruce V. Livingston
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 regulation (21 CFR Part 801 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4595. 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.
Josee
Celia M. Witten, Ph.D., M.D. Director Division of General and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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BOYD INDUSTRIES, INC.
1227575th Sticet North®Largo Houda 33773 3031 813 336 350 3 9 1 800 2 5 3 800 2 5 3 80 58 33
510 (k) Indications For Use Statement
The Aqua Spray is intended for use by Podiatric professionals as an accessory to a burr. The Aqua Spray provides an electric hand piece with an attachment that provides a fine mist of isopropyl alcohol and distilled water (50% concentration) to be dispensed over the burr. The purpose of this mist is to cool the burr and treatment area. In addition, the mist wets the treatment area, thus minimizing the amount of nail dust that becomes airborne during the nail debridement procedure.
Prescription Use
(Per 21 CFR 801.109)
P. Cooper
(Division Sign-Off) sion of General Restorative Devi 510(k) Number
§ 878.4820 Surgical instrument motors and accessories/attachments.
(a)
Identification. Surgical instrument motors and accessories are AC-powered, battery-powered, or air-powered devices intended for use during surgical procedures to provide power to operate various accessories or attachments to cut hard tissue or bone and soft tissue. Accessories or attachments may include a bur, chisel (osteotome), dermabrasion brush, dermatome, drill bit, hammerhead, pin driver, and saw blade.(b)
Classification. Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to § 878.9.