(32 days)
K 013864, K 014253
Not Found
No
The device description and intended use focus solely on a refrigeration unit producing cold air for topical cooling. There is no mention of AI, ML, image processing, or data analysis that would indicate the use of such technologies.
No
The device minimizes pain and thermal injury, which is a supportive rather than therapeutic function.
No
The device minimizes pain and thermal injury and provides temporary topical anesthetic relief, which are therapeutic functions, not diagnostic.
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, the Cryo 5 Cold Air Device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states that the device is used to minimize pain and thermal injury during laser and dermatological treatments and for temporary topical anesthetic relief for injections. This involves direct interaction with the patient's skin.
- Device Description: The device description explains that it creates and blows cold air onto the skin. This is a physical intervention applied externally to the body.
- IVD Definition: In Vitro Diagnostics (IVDs) are medical devices used to perform tests on samples taken from the human body, such as blood, urine, or tissue, to provide information about a person's health. The Cryo 5 does not perform any such tests on biological samples.
The Cryo 5 is a therapeutic device used for pain management and skin protection during other procedures, not a diagnostic device.
N/A
Intended Use / Indications for Use
The Cryo 5 Cold Air Device is intended to minimize pain and thermal injury during laser and dermatological treatments and for temporary topical anesthetic relief for injections.
Product codes
GEX
Device Description
The Cryo 5 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
Not Found
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)
K 013864, K 014253
Reference Device(s)
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
APR 2 3 2004
Circaner MedizinSysteme
Konzepta für Zukuntt
510(k) SUMMARY
| Date Prepared: | 19/1/2004 |
|---|---|
| Submitter: | Zimmer Elektromedizin GmbH |
| Junkersstrasse 9 | |
| D - 89231 Neu-Ulm | |
| Germany | |
| Contact Person: Mr. Stefan Leinweber | |
| Phone: +49-731-9761-162 | |
| Fax: +49-731-9761-118 | |
| E-mail: s.leinweber@zimmer.de | |
| Device Trade Name: | Cryo 5 |
| Common Name: | Skin Refrigerant |
| Classification: | Class II (21CFR 878.4810) |
| Laser surgery instrument for use in general and plastic | |
| surgery and dermatology. | |
| Performance Standards: | None established (as a medical device) under section 514. |
| Description of Device: | The Cryo 5 consists of a refrigeration unit |
| that creates cold air. The cold air is blown onto the skin | |
| using an air hose. | |
| Intended use of the Device: | The Cryo 5 Cold Air Device is 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 devices: | 1. Cryo 5 (Nidek) K 013864 |
- Paradigm Trex K 014253 |
Summary of Substantial Equivalence:
The Zimmer Cryo 5 is substantially equivalent to the compared devices on the basis of similarities in operating principles, intended use and functional performance.
Junkersstr.
D-89231 N
Postfach 2
D-89212 N
Deutsche Bank
BLZ 630 700 BB
Konto-Nr. 204 750
Geschältslührer Bernd Zimmer
HR Memmingen Nr. B
Aulsichtsrats-Vorsitzen Peter Zimmer
Id.Nr.: DE 130856191 Steuemr .: 151 / 116 / 9
10-1 Telefon 07 31 / 97 61-0
Telefax 07 31 / 97 61-118
e-mail: info@zimmer.de
www.zimmer.de
e
Zimmer
Elektromedizin GrabH
Junktornedizin Medizin Banklasse B
Postfact Newsload
D-892112 Neu-Ulm
Dresdner Bank
BLZ 630 800 15
Konto-Nr. 8 055 105 00
1
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/1/Picture/1 description: The image shows the seal of the Department of Health & Human Services - USA. The seal is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. In the center of the seal is an abstract image of an eagle.
Public Health Service
APR 2 3 2004
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Zimmer Elektromedizin GmbH c/o Mr. Stefan Preiss TÜV America, Inc. 1775 Old Highway 8 New Brighton, Minnesota 55112
Re: K040727 Trade/Device Name: Cryo 5 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: April 16, 2004 Received: April 19, 2004
Dear Mr. Preiss:
We have reviewed your Section 510(k) premarket notification of intent to market the device we nave reviewed your Section of the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate for use stated in the encrosure) to regally the enactment date of the Medical Device Amendments, or to commence price to May 20, 1978, the encordance with the provisions of the Federal Food. Drug, devices may been rocussimou in assee approval of a premarket approval application (PMA). and Costient Act (1101) that to not require appear al controls provisions of the Act. The You may, increfore, market the act include requirements for annual registration, listing of general controls provisions of uabeling, and prohibitions against misbranding and adulteration.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it If your device is onestined (600 ac 970) als. Existing major regulations affecting your device can inay be subject to such additions, Title 21, Parts 800 to 898. In addition, FDA may be found in the Ovac ucements concerning your device in the Federal Register.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean I least of advised that I Dris issuanthat your device complies with other requirements of the Act that IDA has made a colerimations administered by other Federal agencies. You must or ally receial statutes and regulations annuding, but not limited to: registration and listing (21 comply with an the 11et s requirements, 01); good manufacturing practice requirements as set CFN i at 607), mocing (21 CFR Part 820); and if applicable, the electronic forth in the quality systems (Sections 531-542 of the Act); 21 CFR 1000-1050.
2
Page 2 - Mr. Stefan Preiss
This letter will allow you to begin marketing your device as described in your Section 510(k) I ms letter will anow you to begin manceing your antial equivalence of your device to a legally prematication: The PDF Intellig of cassification 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 If you desire specific davice in 1984 - 301) 594-4659. Also, please note the regulation entitled, Connact the Office of Compilaremarket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the Division of Small other general 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/dsma/dsmamain.html
Sincerely yours,
Miriam C. Provost
W Celia M. Witten, Ph.D., M.D. Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
3
Ko40727
Indications for Use
| 510(k) Number (if known): | (none) |
|---|---|
| Device Name: | Cryo 5 - |
| Indications for Use: | The Cryo 5 Cold Air Device is intended, to minimize |
| pain and thermal injury during laser and | |
| dermatological treatments and for temporary topical | |
| anesthetic relief for injections. |
网 Prescription Use (Part 21 CFR 801 Subpart D) AND/OR
Over-The-Counter Use (21 CFR 807 Subpart C)
(Please Do Not WRITE BELOW THIS LINE – CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Miriam C. Provost.
(Division Sign-Off) Division of General, Restorative, and Neurological Devices
K040727 510(k) Number_
Page 1 of 1