(90 days)
Not Found
Not Found
No
The provided text describes a cryotherapy device and does not mention any AI or ML components or functionalities.
Yes
The device is indicated for the treatment of various medical conditions, such as Actinic Keratosis, Genital Warts, and Molluscum Contagiosum. "Treatment" directly implies a therapeutic use.
No
The "Intended Use / Indications for Use" section lists various conditions that the device is used to treat (e.g., Actinic Keratosis, Genital Warts), not to diagnose them.
No
The 510(k) summary describes a "Histofreezer® device" and its intended use for treating various skin conditions. The description of the device itself is "Not Found," but the name "Histofreezer® device" strongly implies a physical device used for cryotherapy, not a software-only solution. The lack of any mention of software, algorithms, or digital processing further supports this conclusion.
Based on the provided information, the Histofreezer® device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use describes the treatment of various skin conditions (Actinic Keratosis, Genital Warts, etc.). This is a therapeutic use, not a diagnostic one.
- Lack of Diagnostic Information: There is no mention of the device being used to analyze samples (like blood, urine, or tissue) to diagnose a condition. IVDs are used to perform tests on such samples.
- Device Description (Not Found): While the description is missing, the intended use is the primary indicator here.
IVDs are devices used to examine specimens taken from the human body to provide information for the diagnosis, monitoring, or treatment of a disease or condition. The Histofreezer® device is used to treat conditions directly on the skin, not to analyze samples for diagnostic purposes.
N/A
Intended Use / Indications for Use
The Histofreezer® device is indicated for use in the treatment of the following: Actinic Keratosis Genital Warts Lentigo Molluscum Contagiosum -Seborrhoeic Keratosis_ Skin Tags Verruca Plantaris -Verruca Vulgaris
§ 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.
0
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
JUN 1 4 1999
R. Sam Niedbala, Ph.D., BCFE Chief Science Officer STC Technologies, Inc. 1745 Eaton Avenue Bethlehem, Pennsylvania 18018
K990877 Re: Trade Name: Histofreezer® Device Regulatory Class: II Product Code: GEH Dated: March 12, 1999 Received: March 16, 1999
Dear Dr. Niedbala:
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 requirement, 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 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 - R. Sam Niedbala, Ph.D., BCFE
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,
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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STATEMENT OF INDICATIONS FOR USE
510(k) Number (if known):
. . . . . . .
Device Name: Histofreezer® Device
Indications For Use: The Histofreezer® device is indicated for use in the treatment of the following:
Actinic Keratosis Genital Warts Lentigo Molluscum Contagiosum -Seborrhoeic Keratosis_ Skin Tags Verruca Plantaris -Verruca Vulgaris