(106 days)
Not Found
No
The description focuses on the mechanical and gas-based operation of the device for cryosurgery and does not mention any computational or learning capabilities.
Yes
The device is intended to destroy tissue during surgical procedures, which is a therapeutic action.
No
The device is described as a surgical instrument for destroying tissue, not for diagnosing conditions.
No
The device description clearly describes a physical, hand-held instrument that applies cold gas to tissue. It contains hardware components like a gas cylinder, guidance tube, safety valve, and microapplicators.
Based on the provided information, the CryoProbe™ is not an In Vitro Diagnostic (IVD) device.
Here's why:
- Intended Use: The intended use is "To destroy tissue during surgical procedures by applying extreme cold." This describes a therapeutic or surgical intervention performed directly on a patient's body, not a test performed on a sample taken from the body (which is the definition of an IVD).
- Device Description: The description details a hand-held instrument that applies cold gas directly to tissue. This aligns with a surgical tool, not a device used for analyzing biological samples.
- Lack of IVD Characteristics: The description does not mention any of the typical characteristics of an IVD, such as:
- Analyzing biological samples (blood, urine, tissue, etc.)
- Detecting or measuring substances in samples
- Providing diagnostic information based on sample analysis
The CryoProbe™ is a surgical device used for cryosurgery, a therapeutic procedure.
N/A
Intended Use / Indications for Use
To destroy tissue during surgical procedures by applying extreme cold.
Product codes
GEH
Device Description
The CryoProbe™ is a hand-held cryosurgical instrument for destroying tissue during surgical procedures by applying extreme cold gas (N2O). The device is based on direct application of nitrous oxide in the liquid phase to the selected area. The N2O gas is delivered to the treatment site at -89° C to effect cellular destruction.
The hand-held device is shaped like a pencil to afford maximum user control and comfort. An N2O gas cylinder, commercially available, is held within the pencil body. The gas cylinder is punctured at its intended nozzle by the CryoProbe™ gas guidance tube and retained by the safety valve (handle) until treatment begins. The gas flow is controlled by the microapplicators, high or low flow. This flow rate is selectable when a gas cylinder is installed by selecting the appropriate microapplicator for the assembly.
The CryoProbe™ is designed for safety, performance, and convenience for the user. The design is confirmed by Risk Analysis and actual market usage in the European market. Over 3,000 units are in distribution and use with no adverse effects reported.
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)
Wallach Surgical Ultra Freeze and Cold Soaker, Erbokryo CA Cryosurgical System
Reference Device(s)
Not Found
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
Trade Name: CryoProbe™
K024009
10F2
Common Name: Unit, Cryosurgical, Accessories
Classification: 878.4350 Cryosurgical Unit, Class II
MAR 2 0 2003
Predicate Devices:
- a) Wallach Surgical Ultra Freeze and Cold Soaker
- b) Erbokryo CA Cryosurgical System
Device Description:
The CryoProbe™ is a hand-held cryosurgical instrument for destroying tissue during surgical procedures by applying extreme cold gas (N2O). The device is based on direct application of nitrous oxide in the liquid phase to the selected area. The N2O gas is delivered to the treatment site at -89° C to effect cellular destruction.
The hand-held device is shaped like a pencil to afford maximum user control and comfort. An N2O gas cylinder, commercially available, is held within the pencil body. The gas cylinder is punctured at its intended nozzle by the CryoProbe™ gas guidance tube and retained by the safety valve (handle) until treatment begins. The gas flow is controlled by the microapplicators, high or low flow. This flow rate is selectable when a gas cylinder is installed by selecting the appropriate microapplicator for the assembly.
The CryoProbe™ is designed for safety, performance, and convenience for the user. The design is confirmed by Risk Analysis and actual market usage in the European market. Over 3,000 units are in distribution and use with no adverse effects reported.
Intended Use:
To destroy tissue during surgical procedures by applying extreme cold.
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510(k) Summary
H&O Equipments NV/SA Ninovesteenweg 198 9320 Aalst (Erembodegem) Belgium +32-53-76.17.40 Telephone +32-53-83.20.04 Fax
Contact Person: Mr. Lewis Ward L.W. Ward and Associates, Inc. 4655 Kirkwood Court Boulder, CO 80301 303-530-3279 Telephone 303-530-4774 Fax
2
Image /page/2/Picture/12 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular border with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the top half of the circle. Inside the circle is a stylized symbol that resembles an eagle or bird in flight, with three human profiles incorporated into the design of the bird's body.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
H & O Equipments NV/SA c/o Lewis Ward L. W. Ward and Associates, Inc. 4655 Kirkwood Court Boulder, Colorado 80301
MAR 2 0 2003
Re: K024009
Trade/Device Name: CryoProbeTM Regulation Number: 878.4350 Regulation Name: Cryosurgical unit and accessories Regulatory Class: Class II Product Code: GEH Dated: March 14, 2003 Received: March 17, 2003
Dear Mr. Ward:
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 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
3
Page 2 -- Mr. Lewis Ward
(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. 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 (301) 594-4659. 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 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.qov/cdrh/dsma/dsmamain.html
Sincerely yours,
Sincerely yours,
Mark N. Mulkeran
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
Initial 510(k): ______________________________________________________________________________________________________________________________________________________________
Device Name: CryoProbeTM
Indications for Use:
To destroy tissue during surgical procedures by applying extreme cold.
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
for Mark n Melkuse
(Division Sign-Off)
Division of General, Restorative
and Neurological Devices
K024009
10(k) Number__
Prescription Use
(Per 21 CFR 801.109)
X
OR Over-the-Counter Use__