(57 days)
This product is intended to be used by Dermatologists and/or Plastic Surgeons for the following procedures. Freeze destruction on epithelial arising cryoresponsive benign, premalignant and malignant tumors, such as skin tags, verrucae, cutaneous horns, actinic keratoses, and basal cell carcinoma.
The DELASCO Frigiderm FrigiSpray has engineered a 0.3L Vacuum Flask of stainless steel, brass and teflon for the dispensing of liquid nitrogen. The device assembly is also equipped with various size nozzles providing accessibility and a direct spray to different size lesions.
The provided document is a 510(k) premarket notification for the Frigiderm FrigiSpray, a cryosurgical unit. It states that "No performance data is required for this Class II device nor requested by the Food and Drug Administration (Office of Device Evaluation)." Therefore, the document does not contain information about acceptance criteria or a study proving the device meets them.
No performance data, and subsequently no acceptance criteria or study details regarding performance, are available in the provided text.
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Summary of Safety and Effectiveness
May 19, 1997
MAY 2 9 1997
Cryosurgical unit and accessories Device Submitted: I.
- Frigiderm FrigiSpray II. Proprietary Name: Common Usual Name: Cryogenic Spray
- III. Predicate Device:
Frigiderm FrigiSpray marketed by DELASCO is substantially equivalent to The Brymill Cryogun manufactured by Brymill Corporation, PO Box 2392, Vernon, Connecticut 06066.
IV. Device Description:
The DELASCO Frigiderm FrigiSpray has engineered a 0.3L Vacuum Flask of stainless steel, brass and teflon for the dispensing of liquid nitrogen. The device assembly is also equipped with various size nozzles providing accessibility and a direct spray to different size lesions.
V. Intended Use:
The DELASCO Frigiderm FrigiSpray is intended to be used by Dermatologists and/or Plastic Surgeons for the following procedures.
- Freeze destruction on evithelial arising cryoresponsive benign, premalignant and ● malignant tumors, such as skin tags, verrucae, cutaneous horns, actinic keratoses, and basal cell carcinoma.
- VI. Technological Characteristic Similarities:
The DELASCO Frigiderm FrigiSpray is similar in intended use and construction to the Brymill Cryogun. The Vacuum Canister composed of stainless steel is similar in design as well as the Nozzles for Liquid Nitrogen application.
VII. Performance Data;
No performance data is required for this Class II device nor requested by the Food and Drug Administration (Office of Device Evaluation). A data base search has been performed to evaluate any adverse effects of the device which is currently marketed.
No data submitted for section 807.92 6[(b)(1)(2)(3c)] See attached documentation for adverse effects.
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Image /page/1/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is circular and contains the words "DEPARTMENT OF HEALTH & HUM SERVICES USA" around the perimeter. Inside the circle is an image of an eagle.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
MAY 2 9 1997
Ms. Deborah Grafelman Director of Marketing Delasco ... ... ......... 608 13th Avenue Council Bluffs, Iowa 51501
Re: K971216 Trade Name: Frigiderm FrigiSpray Regulatory Class: II Product Code: GEH Dated: April 1, 1997 Received: April 2, 1997
Dear Ms. Grafelman:
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 Good Manufacturing Practice for Medical Devices: General (GMP) regulation (21 CFR Part 820) and that, through periodic GMP 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 - Ms. Deborah Grafelman
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,
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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510(k) Number: " K971216_ 『
Device Name: Frigiderm FrigiSpray
Indications for Use:
This product is intended to be used by Dermatologists and/or Plastic Surgeons for the following procedures.
Freeze destruction on epithelial arising cryoresponsive benign, premalignant and malignant tumors, such as skin tags, verrucae, cutaneous horns, actinic keratoses, and basal cell carcinoma.
(PLEASE DO NOT WRITE BELOW THIS LINE -- CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (OUE)
(Division Sign-Om
Division of General Restorative Devices
510(k) Number... 971216
Prescription Use
(Per 21 CFR 801.109)
§ 878.4350 Cryosurgical unit and accessories.
(a)
Identification —(1)Cryosurgical unit with a liquid nitrogen cooled cryoprobe and accessories. A cryosurgical unit with a liquid nitrogen cooled cryoprobe and accessories is a device intended to destroy tissue during surgical procedures by applying extreme cold.(2)
Cryosurgical unit with a nitrous oxide cooled cryoprobe and accessories. A cryosurgical unit with a nitrous oxide cooled cryoprobe and accessories is a device intended to destroy tissue during surgical procedures, including urological applications, by applying extreme cold.(3)
Cryosurgical unit with a carbon dioxide cooled cryoprobe or a carbon dioxide dry ice applicator and accessories. A cryosurgical unit with a carbon dioxide cooled cryoprobe or a carbon dioxide dry ice applicator and accessories is a device intended to destroy tissue during surgical procedures by applying extreme cold. The device is intended to treat disease conditions such as tumors, skin cancers, acne scars, or hemangiomas (benign tumors consisting of newly formed blood vessels) and various benign or malignant gynecological conditions affecting vulvar, vaginal, or cervical tissue. The device is not intended for urological applications.(b)
Classification. Class II.