(203 days)
Not Found
No
The summary describes a refrigeration unit and air hose for cooling the skin, with no mention of AI or ML in the device description, intended use, or other sections.
No.
The device is intended to minimize pain and thermal injury and provide temporary topical anesthetic relief, which are symptomatic relief and adjuncts to other treatments, rather than directly treating a disease or condition.
No
The device is intended to minimize pain and provide temporary topical anesthetic relief, which are therapeutic and palliative functions, not diagnostic. It does not identify a disease, condition, or state of health.
No
The device description explicitly states it consists of a "refrigeration unit" and an "air hose," which are hardware components.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is to minimize pain and thermal injury during laser and dermatological treatments and for temporary topical anesthetic relief for injections. This is a therapeutic and pain management function applied directly to the patient's skin.
- Device Description: The device description clearly states it's a refrigeration unit that blows cold air onto the skin. This is a physical therapy/treatment device.
- Lack of IVD Characteristics: IVD devices are used to examine specimens (like blood, urine, tissue) in vitro (outside the body) to provide information for diagnosis, monitoring, or screening. This device does not interact with any specimens or provide diagnostic information.
Therefore, the Cryoflow 700 and Cryoflow 1000 fall under the category of a therapeutic or physical medicine device, not an IVD.
N/A
Intended Use / Indications for Use
The Cryoflow 700 and Cryoflow 1000 are intended to minimize pain and thermal injury during laser and dermatological treatments and for temporary topical anesthetic relief for injections.
Product codes (comma separated list FDA assigned to the subject device)
GEX
Device Description
The Cryoflow 700 and Cryoflow 1000 consists of a refrigeration unit that creates cold air. The cold air is blown onto the skin using an air hose.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Skin
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
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 (study type, sample size, AUC, MRMC, standalone performance, key results)
Not Found
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 878.4810 Laser surgical instrument for use in general and plastic surgery and in dermatology.
(a)
Identification. (1) A carbon dioxide laser for use in general surgery and in dermatology is a laser device intended to cut, destroy, or remove tissue by light energy emitted by carbon dioxide.(2) An argon laser for use in dermatology is a laser device intended to destroy or coagulate tissue by light energy emitted by argon.
(b)
Classification. (1) Class II.(2) Class I for special laser gas mixtures used as a lasing medium for this class of lasers. The devices subject to this paragraph (b)(2) are exempt from the premarket notification procedures in subpart E of part 807 of this chapter, subject to the limitations in § 878.9.
0
Image /page/0/Picture/0 description: The image contains the logo for a company called "uniphy Elektromedizin". The logo consists of a stylized wave-like graphic above the word "uniphy", with the word "Elektromedizin" appearing below. The text is in a simple, sans-serif font and the overall design is clean and modern.
MAR 1 5 2006
Abbreviated 510(k) submission for cryflow 700 and cryflow 1000.
510(k) Summary
KOS2310
| Date prepared: | August 19, 2005 |
|---|---|
| Submitter: | Uniphy Elektromedizin GmbH & Co. KG |
| 19B Neuendorferstraße | |
| 16761 Hennigsdorf | |
| Germany | |
| Contact Name: Reiner Tostmann, Doc-Eng | |
| Phone Number: 11-49-3302-50440 | |
| FAX Number: 11-49-3302-504499 | |
| E-mail: Reiner.Tostmann@uniphy-elmed.com | |
| Device trade name: | Cryoflow 700, Cryflow 1000 |
| Common name: | Skin Refrigerant |
| Classification name: | Class 2 (21CFR 878.4810) 78 GEX |
| Laser surgery instrument for use in general and plastic | |
| surgery and dermatology. | |
| Description of device: | The Cryoflow 700 and Cryoflow 1000 consists of a refrigeration unit |
| that creates cold air. The cold air is blown onto the skin | |
| using an air hose. | |
| Performance Standards: | None established (as a medical device) under section 514. |
| Intended use of the device: | The Cryoflow 700 and Cryoflow 1000 are intended to minimize |
| pain and thermal injury during laser and dermatological | |
| treatments and for temporary topical anesthetic relief for | |
| injections. |
Substantial equivalence claim to the following legally marketed device: Cryo 5 (Zimmer). K040727
Summary of substantial equivalence:
The Uniphy Cryoflow 700 and Cryflow 1000 are substantially equivalent to the compared device on the basis of similarities in operating principles, intended use and functional performance.
1
Image /page/1/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo features a stylized caduceus symbol, which is a staff with two snakes entwined around it. The symbol is surrounded by the text "DEPARTMENT OF HEALTH AND HUMAN SERVICES - USA" in a circular arrangement. The logo is black and white.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
MAR 1 5 2006
Gymnauniphy N.V. c/o Nico Beun Uniphy Elektromedizin GmbH & Co. KG Pasweg 6A Belzen 3740 Belgium
Re: K052310 Trade/Device Name: Cryoflow 700, Cryflow 1000 Regulation Number: 21 CFR 878.4810 Regulation Name: Laser surgical instrument for use in general and plastic surgery and in dermatology Regulatory Class: II Product Code: GEX Dated: August 22, 2005 Received: August 24, 2005
Dear Nico Beun:
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 practice, labeling, and prohibitions against misbranding and adulteration.
If your device is classified (see above) into cither class II (Special Controls) or class III (PMA), 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 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); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
2
This letter will allow you to begin marketing your device as described in your Section 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), please contact the Office of Compliance at (240) 276-0115. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html
Sincerely vours.
emall
Mark N. Melkerson Acting Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
3
Image /page/3/Picture/1 description: The image shows the logo for Uniphy Elektromedizin. The logo consists of a stylized wave-like graphic to the left of the word "uniphy" in a sans-serif font. Below "uniphy" is the word "Elektromedizin", also in a sans-serif font, but slightly smaller than "uniphy".
Uniphy Elektromedizin GmbH & Co. KG Neuendorfstraße 19 b D-16761 Hennigsdorf Germany
Indications for Use
510(k) Number (if known): K052310
Device Name: Cryoflow 700, Cryoflow 1000
-
Indications for Use:
. -
The Cryoflow 700 and Cryoflow 1000 are intended to minimize pain and thermal injury during laser and dermatological treatments and for temporary topical anesthetic relief for injections.
Prescription Use (Part 21 CFR 801 Subpart D)
AND/OR
Over-The-Counter Use No____________________________________________________________________________________________________________________________________________________________________________ (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
(Division Sign-Off)
Division of General, Restorative,
and Neurological Devices
| 510(k) Number | K052310 |
|---|---|
| --------------- | --------- |
Pagege loof l
(Posted November 13, 2003)