(284 days)
No
The device description focuses on the mechanical and electrical components for cryoablation and does not mention any computational or data-driven features indicative of AI/ML.
Yes
The device is a cryosurgical unit intended for ablative surgical techniques on various tissues, including diseased and malignant tissue, which is a therapeutic purpose.
No
The device is described as a cryosurgical unit used for ablative type surgical techniques, which is a treatment method, not a diagnostic one.
No
The device description clearly outlines hardware components including hand-held freezing modules, a refrigeration unit, and disposable tips, indicating it is not a software-only device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is "Cryosurgical unit used for ablative type surgical technique." This describes a device used on the patient's tissue for treatment (ablation), not a device used to examine samples from the patient to diagnose a condition.
- Device Description: The description details a system for freezing tissue directly, not for analyzing biological samples.
- Lack of IVD Characteristics: There is no mention of analyzing blood, urine, tissue samples, or any other biological material in vitro (outside the body) for diagnostic purposes.
IVD devices are specifically designed to perform tests on samples taken from the human body to provide information for the diagnosis, monitoring, or treatment of diseases or conditions. This device's function is direct surgical intervention.
N/A
Intended Use / Indications for Use
The CryoPen is intended to be used as a Cryosurgical unit for ablative type surgical technique.
The CryoPen is indicated for use on multiple organ systems, including a wide range of disease (i.e. viral, benign, pre-malignant and malignant tissue).
Product codes
GEH
Device Description
The CryoPen system provides a means of freezing tissue without the use of cryogenic liquids or gases. The system consists of three hand-held freezing modules, a refrigeration unit, and disposable tips. When used properly, the system will deliver effective temperature for tissue ablation.
The refrigeration component is the largest unit, and is used to lower the temperature of the CryoPen units to temperature of -100 C. It operates on 115 VAC obtained from conventional convenience outlets. The supporting housed in the refrigerator cabinet include a DC power source to indicate the temperature of the CryoPen units during cool down, and all other necessary control and electrical safety features.
There are currently three different sizes of the hand-held modules: a 0.4 inch diameter unit, a 0.25 inch diameter unit, and a 0.19 inch diameter unit.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Multiple organ systems
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)
Reference Device(s)
Predetermined Change Control Plan (PCCP) - All Relevant Information
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
K012214 112 510(k) SUMMARY OF SAFETY and EFFECTIVENESS
A. General Information
| Submitter's Name | Cimex BioTech, L.C. |
|---|---|
| Address: | 72385 Industry Park |
| Covington, LA 70435 | |
| Telephone: | |
| Contact Person | Michael Haas, M.D. |
| Date Prepared: | July 10, 2001 |
| Registration Number | 2320472 |
B. Device
6:
| 1. | Name: | CryoPen (Model CP-010 and Accessories) |
|---|---|---|
| 2. | Trade name: | CryoPen and Accessories |
| 3. | Common Name: | Cryosurgical Unit and Accessories |
Classification Name: Unit, Cryosurgical, Accessories
II
-
-
- Product Code:
GEH
- Product Code:
-
-
Class: 6.
Regulation Number: 878.4350 7.
Description of the Device
The CryoPen system provides a means of freezing tissue without the use of cryogenic liquids or gases. The system consists of three hand-held freezing modules, a refrigeration unit, and disposable tips. When used properly, the system will deliver effective temperature for tissue ablation.
The refrigeration component is the largest unit, and is used to lower the temperature of the CryoPen units to temperature of -100 C. It operates on 115 VAC obtained from conventional convenience outlets. The supporting housed in the refrigerator cabinet include a DC power source to indicate the temperature of the CryoPen units during cool down, and all other necessary control and electrical safety features.
There are currently three different sizes of the hand-held modules: a 0.4 inch diameter unit, a 0.25 inch diameter unit, and a 0.19 inch diameter unit.
C. Intended Use Statement
1
KOI 2214 2/2
The CryoPen is intended to be used as a Cryosurgical unit for ablative type surgical technique.
The CryoPen is indicated for use on multiple organ systems, including a wide range of disease (i.e. viral, benign, pre-malignant and malignant tissue).
Components D.
CONTENTS:
PART NUMBER:
(1) CryoPen Cooling System Assembly
(2) CrvoPen Module Assembly (0.4 in)
(3) CryoPen Module Assembly (0.25 in)
(4) CryoPen Module Assembly (0.19 in)
(5) Disposable tips (0.4 in)
(6) Disposable tips (0.25 in)
(7) Disposable tips (0.19)
(8) CryoPen Cool-Down Fixture Plug
CP-001100-01 CP-004300-01 CP-004200-01 CP-004100-01 CP-004302-01 CP-004202-01 CP-004102-01 CP-006001-01
Substantial Equivalence E.
The CryoPen System is Substantially Equivalent to the Wallach LL100 Predicate Device, approved on February 04, 1981, (reference K803311). The CryoPen and the Wallach LL100 destroy tissue using cryogenic temperatures. The contacting metal incorporated in the cryotips used with the CryoPen™, are made of pure silver, which differs from the predicate contact material of stainless steel. A predicate device using silver is K981299 Silverlon™ Contact Wound Dressing. Appropriate biocompatibility testing was performed on this predicate device.
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 stylized eagle or bird symbol, with three curved lines representing its body and wings. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the bird symbol.
APR 26 2002
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Michael J. Haas, M.D. Vice President of Research and Development Cimex Bio-Tech 72385 Industry Park Covington, LA 70435
Re: K012214
Trade/Device Name: CryoPen and Accessories Regulation Number: 21 CFR 878.4350 Regulation Name: Cryosurgical unit and accessories Regulatory Class: Class II Product Code: GEH Dated: February 22, 2002 Received: February 28, 2002
Dear Dr. Haas:
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 ass backed in also 1.076, the enactment date of the Medical Device Amendments, or to devices that provision in the provisions 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 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 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.
3
Page 2 - Michael J. Haas, M.D.
This letter will allow you to begin marketing your device as described in your Section 510(k) I mis letter will anow you to organ finding of substantial equivalence of your device to a legally premarket nothleation: "The PDF massification 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 If you desire specific ad roo for you in vitro diagnostic devices), please contact the Office of additionally 21 OF N Far 80510 reading for questions on the promotion and advertising of your Compliance at (301) 591-1095 conpliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small mormation on your responsional 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 vours,
Miriam C. Provost
for Celia Witten, Ph.D., M.D.
Celia 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
510(k) Number:
Device Name:
CryoPen System
Indications For Use:
- Intended Use: Cryosurgical unit used for ablative type surgical ● technique
- Indications for use: Multiple organ systems, wide range of . disease, viral, premalignant and malignant tissue.
PLEASE DO NOT WRITE BELOW THIS LINE. CONTINUE ON ANOTHER PAGE IF NEEDED.
Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription USE __ V or OVER - THE - COUNTER - USE (Optional Form 1-2-96)
Muriam C. Provost
(Division Sign-Off) Division of General, Restorative and Neurological Devices
510(k) Number K012214