(55 days)
Not Found
No
The summary describes a simple cryogenic device that dispenses gas and includes bench testing for gas flow and temperature, with no mention of AI or ML.
Yes
The device is intended for the surgical destruction of tissue to treat various conditions, which is a therapeutic purpose.
No
The device is intended for the "surgical destruction of tissue" using cryogenic gases, which is a therapeutic rather than diagnostic function.
No
The device description clearly states it is a physical device designed to dispense liquid nitrous oxide using cartridges, indicating it is a hardware device, not software-only.
Based on the provided information, the Freezpoint device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is "for the surgical destruction of tissue by applying cryogenic gases at extreme low temperatures." This describes a therapeutic procedure performed directly on a patient's body.
- Device Description: The device dispenses nitrous oxide for cryosurgery, which is a treatment method.
- Lack of In Vitro Activity: IVD devices are used to examine specimens (like blood, urine, or tissue samples) outside of the body to provide information about a patient's health. The Freezpoint device does not interact with or analyze such specimens.
The Freezpoint device is a therapeutic device used for cryosurgery, a medical procedure.
N/A
Intended Use / Indications for Use
The Freezpoint device is intended for the surgical destruction of tissue by applying cryogenic gases at extreme low temperatures.
The List below shows examples of the types of lesions that may be treated:
- Molluscum Contagiosum
- Skin Tags
- Actinic Keratosis
- Lentigo
- Verruca Plana
- Verruca Vulgaris
- Verruca Plantaris
- Genital Lesions
- Seborrheic Keratosis
Product codes
GEH
Device Description
The Freezpoint device is designed to dispense a continuous stream of liquid nitrous oxide when actuated. The device uses an 8g or 16g cartridge of nitrous oxide. Licensed Practitioners can then dispense the gas for use in procedures requiring the destruction of tissue using the extreme cold of nitrous oxide, N20 (-89ºC).
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Licensed Practitioners
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies
Bench testing: Replicate sprays of each device were performed, weighing the devices before and after a 5 second spray. The amount dispensed for the Freezpoint and CryOmega were calculated and found to be
§ 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
Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health and Human Services logo on the left and the FDA logo on the right. The FDA logo is in blue and includes the letters "FDA" and the words "U.S. Food & Drug Administration."
March 21, 2018
Bovie Medical Corp. % Sam Niedbala CEO CryoConcepts LP 205 Webster Street Bethlehem, Pennsylvania 18015
Re: K180211
Trade/Device Name: Freezpoint Regulation Number: 21 CFR 878.4350 Regulation Name: Cryosurgical Unit and Accessories Regulatory Class: Class II Product Code: GEH Dated: January 13, 2018 Received: January 25, 2018
Dear Sam Niedbala:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and 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, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). 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, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting of medical device-related adverse events) (21 CFR 803); good
1
manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely, Jennifer R. Stevenson -S. For Binita S. Ashar, M.D., M.B.A., F.A.C.S. Director Division of Surgical Devices
Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known) K180211
Device Name Freezpoint
Indications for Use (Describe)
The Freezpoint device is intended for the surgical destruction of tissue by applying cryogenic gases at extreme low temperatures.
The List below shows examples of the types of lesions that may be treated:
- Molluscum Contagiosum
- · Skin Tags
- Actinic Keratosis
- · Lentigo
- Verruca Plana
- · Verruca Vulgaris
- Verruca Plantaris
- · Genital Lesions
- · Seborrheic Keratosis
| Type of Use (Select one or both, as applicable) |
|---|
| ------------------------------------------------- |
| Research Use (Part 21 CFR 201.321, Subpart B) |
|---|
| Over-The-Counter Use (21 CFR 201.66, Subpart C) |
Prescription Use (Part 21 CFR 801 Subpart D)
| | Over-The-Counter Use (21 CFR 801 Subpart C)
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3
510(k) Summary
I. SUBMITTER
Bovie Medical Corp. 5115 Ulmerton Road Clearwater, Florida 33760 Prepared January 08, 2018
Send Correspondence To: Sam Niedbala, Ph.D. Phone: 855-355-2796 sam(@cryoconcepts.com
II. DEVICE
Name of Device: Freezpoint Usual Name – Cryosurgical unit and accessories Classification Name -General & Plastic Surgery (21CFR 878.4350) Regulatory Class: II Product Code: GEH
III. PREDICATE DEVICE
CryOmega-K102006
IV. DEVICE DESCRIPTION
The Freezpoint device is designed to dispense a continuous stream of liquid nitrous oxide when actuated. The device uses an 8g or 16g cartridge of nitrous oxide. Licensed Practitioners can then dispense the gas for use in procedures requiring the destruction of tissue using the extreme cold of nitrous oxide, N20 (-89ºC).
V. INDICATIONS FOR USE
The Freezpoint is intended for the surgical destruction of tissue of target tissue by applying cryogenic gases at extreme low temperatures.
The List below shows examples of the types of lesions that may be treated:
- Molluscum Contagiosum ●
- Skin Tags ●
- Actinic Keratosis ●
- Lentigo
- Verruca Plana ●
- Verruca Vulgaris ●
- Verruca Plantaris
4
- Genital Lesions .
- . Seborrheic Keratosis
VI. COMPARISON OF TECHNOLOGICAL CHARACTERISTICS WITH THE PREDICATE DEVICE
A summary of the technological characteristics for the Freezpoint versus the CryOmega predicate is provided in the following table.
| Technological | Freezpoint | Predicate |
|---|---|---|
| Characteristics | CryOmega-K102006 | |
| -Intended Use | ||
| Statement | Intended Use: The | |
| Freezepoint is a | ||
| disposable device with a | ||
| spray applicator intended | ||
| for the surgical | ||
| destruction of target | ||
| tissue by applying | ||
| cryogenic gases at | ||
| extreme low | ||
| temperatures | Intended Use: The | |
| CryOmega is a disposable | ||
| device with a spray | ||
| applicator intended for | ||
| the surgical destruction | ||
| of target tissue by | ||
| applying cryogenic gases | ||
| at extreme low | ||
| temperatures | ||
| -Cryogen | ||
| Characteristics | Nitrous Oxide, N2O at 50 | |
| bar pressure. 16g | ||
| cartridge | Nitrous Oxide, N2O at 50 | |
| bar pressure. 16g | ||
| cartridge | ||
| -Materials | Housing: Plastic | |
| Filter: Plastic | ||
| O-rings: Butadiene- | ||
| rubber | ||
| Gas Cartridge: Metal | Housing: Plastic | |
| Filter: Plastic | ||
| O-rings: Butadiene- | ||
| rubber | ||
| Gas Cartridge: Metal | ||
| -Mode of Use | Apply Spray Topically | Apply Spray Topically |
| -Mechanism of action | N2O gas is delivered to | |
| the treatment site at -89C | ||
| to effect cellular | ||
| destruction | N2O gas is delivered to | |
| the treatment site at -89C | ||
| to effect cellular | ||
| destruction | ||
| -Storage Conditions |