(53 days)
Not Found
No
The device description focuses on the mechanical and physical aspects of cryo-ablation and does not mention any computational or algorithmic components that would suggest AI/ML. The "Mentions AI, DNN, or ML" field is also explicitly marked as "Not Found".
Yes
The device is described as a "cryosurgical tool" and "cryosurgical device" used to "destroy unwanted tissue by application of extreme cold," which aligns with the definition of a therapeutic device as it performs a medical treatment.
No
The device description states that the system is "used to destroy unwanted tissue by application of extreme cold," indicating a therapeutic rather than diagnostic function. It performs a procedure ("cryo-ablation") for treatment, not for identifying a condition or disease.
No
The device description explicitly states it consists of an electronic console, cryo-catheter, and cryogen tank, which are hardware components.
Based on the provided information, the CryMed Cryo-Ablator System is not an IVD (In Vitro Diagnostic) device.
Here's why:
- Intended Use: The intended use clearly states it's a "cryosurgical tool for use in dermatology, gynecology and general surgery." This describes a device used on a patient to treat tissue, not a device used to examine samples from a patient to diagnose a condition.
- Device Description: The description details a system that applies extreme cold to destroy unwanted tissue in situ (on the patient). It involves a console, catheter, and cryogen tank, all components of a surgical device.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue samples, etc.), performing tests on these samples, or providing diagnostic information based on such analysis.
IVD devices are specifically designed to examine specimens derived from the human body to provide information for the diagnosis, monitoring, or treatment of a disease or condition. The CryMed Cryo-Ablator System is a therapeutic device used for tissue destruction, which is a surgical procedure.
N/A
Intended Use / Indications for Use
The CryMed Cryo-Ablator System is intended to be used as a cryosurgical tool for the controlled destruction of unwanted tissue in the fields of dermatology, gynecology and general surgery.
Product codes
GEH
Device Description
The Cryo-Ablator System is a cryosurgical device, consisting of an electronic console, cryo-catheter and cryogen tank,
The Cryo-Ablator System is used to destroy unwanted tissue by application of extreme cold to a selected site. Liquid Nitrogen is stored in a tank and then propelled through a crvo-catheter to perform the cryo-ablation procedure. The catheter is placed in the appropriate position through the use of visual observation. The cryo-catheter applies the cryogen to a selected area and freezes the unwanted tissue. Cryosurgical procedures are used when surgical resection is not indicated, and may also provide an alternative to typical resection in certain cases.
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)
K813024, K811390, K840536, K935010, K982280, K970995
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
§ 878.4350 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
MAY 2 1 2004
510(k) Safety Summary
March 22, 2004 Submitted by:
CryMed Technologies, Inc. 319 W. Timonium Road Lutherville, MD 21093 Tel. 410-252-3313 Fax 410-252-9489 Frank Majerowicz, President CryMed Technologies, Inc. Contact Person:
Name of Device
- Trade Name: CryMed Cryo-Ablator �
- Common Name: Cryosurgical Unit, Cryogenic Surgical Device .
- · Classification: Cryosurgical unit with Liquid Nitrogen, Class II [21 CFR & 878.4350(a)].
K 040809
- Establishment Registration Number: t Applied for on 3/20/04
Predicate Devices
| Device | Premarket Notification |
|---|---|
| Wallach Surgical Devices WA1000 | K813024 |
| Figitronics Cryo-Plus ™ | K811390 |
| Figitronics Cryo-Surg™System 5900 | K840536 |
| Wallach Surgical Devices UltraFreeze | K935010 |
| Cortex Technology's Cryopro Maxi | |
| and Cryopro Mini | K982280 |
| CMS Cryolite | K970995 |
Device Description
The Cryo-Ablator System is a cryosurgical device, consisting of an electronic console, cryo-catheter and cryogen tank,
The Cryo-Ablator System is used to destroy unwanted tissue by application of extreme cold to a selected site. Liquid Nitrogen is stored in a tank and then propelled through a crvo-catheter to perform the cryo-ablation procedure. The catheter is placed in the appropriate position through the use of visual observation. The cryo-catheter applies the cryogen to a selected area and freezes the unwanted tissue. Cryosurgical procedures are used when surgical resection is not indicated, and may also provide an alternative to typical resection in certain cases.
1
Indications for Use
The CryMed Cryo-Ablator System is similar in form and function to the Cryomedical Sciences' CMS Cryolite, Wallach Surgical Devices WA1000 (K813024) and its UltraFreeze (K935010), Figitronics' Cryo-Plus ™ (K811390) and its Cryo-Surg™System 5900 (K840536), and the Cortex Technology's Cryopro Maxi and Cryopro Mini (K982280). The intended use for the CryMed Cryo-Ablator System is the same as those listed for the CryMed Cryo-Ablator System predicate devices.
Technical Characteristics
The technology used by CryMed Technologies, Inc. is substantially equivalent to those of the above listed predicate devices.
Summary
Based on the principles of operation, design, materials and intended use, the CryMed Cryo-Ablator System is substantially equilivant to devices currently marketed in the United States.
2
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is an abstract symbol resembling an eagle or bird in flight, composed of three curved lines.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
MAY 2 1 2004
Mr. Frank Majerowicz President CryMed Technologies, Inc. 319 W. Timonium Road Lutherville, Maryland 21093
Re: K040809
Trade/Device Name: CryMed Cryo-Ablator Regulation Number: 21 CFR 878.4350 Regulation Name: Cryosurgical unit and accessories Regulatory Class: II Product Code: GEH Dated: March 22, 2004 Received: March 29, 2004
Dear Mr. Majerowicz:
Wc have reviewed your Section 510(k) premarket notification of intent to market the device wo nave reviewed your betermined 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 encreations of 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). and Oosmette . fore, market the device, subject to the general controls provisions of the Act. The I ou may , aroney mass of the Act include requirements for annual registration, listing of general vehicle profitecturing practice, labeling, and prohibitions against misbranding and adulteration.
If your device is classified (see above) into either 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 complics 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.
3
Page 2 - Mr. Frank Majerowicz
This letter will allow you to begin marketing your device as described in your Section 510(k) Prins leter will and w you to over finding of substantial equivalence of your device to a legally promance noticated 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 n you dosir of Compliance at (301) 594-4659. 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 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
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
4
Indications for Use
510(k) Number (if known):_K040809
Device Name: CryMed Cryo-Ablator from CryMed Technologies, Inc.
Indications For Use:
The CryMed Cryo-Ablator System is intended to be used as a cryosurgical tool for The Cryined Cryo-Ablator Oystem is member to matology, gynecology and general surgery.
× 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)
Muriam C. Provost
(Division Sign-Off) Division of General, Restorative, and Neurological Devices
510(k) Number K040809