(140 days)
Not Found
No
The description explicitly states that the optional on-board computer "does not control or affect the operation of the cryoprobes in any fashion," indicating no AI/ML control or influence on the core function.
Yes
The device is used to destroy unwanted tissue, which is a direct therapeutic action on the body.
No
The device is used to destroy unwanted tissue by application of extreme cold, which is a therapeutic function rather than a diagnostic one.
No
The device description clearly outlines hardware components including a console, dewars, and cryoprobes, indicating it is not a software-only medical device. The optional computer is described as a redundant display and archival system, not the primary functional component.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is to "destroy unwanted tissue by application of extreme cold to the selected site." This describes a therapeutic procedure performed directly on a patient's body, not a test performed on a sample taken from the body to diagnose a condition.
- Device Description: The device description details a cryosurgical system with a console and cryoprobes. This is consistent with a device used for direct tissue treatment, not for analyzing biological samples.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue samples, etc.), reagents, or any other components typically associated with in vitro diagnostics.
In summary, the device's function and description clearly indicate it is a therapeutic device used for cryosurgery, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
The device is used to destroy unwanted tissue by application of extreme cold to the selected site. LN, is forced through the cryoprobes under pressure. The cryoprobe, having been placed in the appropriate position through the use of ultrasound or another imaging device, then becomes cold and freezes the unwanted tissue. The procedure may be monitored in real-time through the use of imaging modes such as ultrasound. Once the freezing is completed (approximately 20 minutes) the probe will be heated using warm nitrogen gas in order to facilitate thawing and removal of the cryoprobe from the frozen tissue. The cryosurgical procedure is available when surgical resection is not possible and may also provide an alternative to typical resection in certain cases.
Product codes
Not Found
Device Description
The CMS AccuProbe® 600 series consists of two components including: i) a console which holds three dewars of liguid nitrogen (LN-) (one dewar is filled at a time; one dewar is a receptacle for the circulating LN, and the third dewar contains the supercooling chamber); and ii) one to eight (models 610 through 680) cryoprobes with tips extending from the console. The console includes an optional on-board computer which is used as a redundant display system and an archival system to store information from the procedure. The computer does not control or affect the operation of the cryoprobes in any fashion. The cryoprobes consist of interchangeable tips of various materials, sizes and shapes to be utilized as necessary.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
ultrasound
Anatomical Site
unwanted tissue; selected site
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
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
October 31, 1996
Submitted by:
MAR 2 0 1997
Contact:
Cryomedical Sciences, Inc. 1300 Piccard Drive Rockville, Maryland 20850 (301) 417-7070 Fax (310) 417-7077
Richard J. Reinhart, Ph.D. President and CEO or Susan Hayes Administrative Manager Operations
Proprietary name: CMS AccuProbe® 610, 620, 630, 640, 650, 660, 670, 680
Cryosurgical Unit, Cryogenic Surgical Device or Cryoprobe Common name:
Classification:
Cryosurgical unit with Liquid Nitrogen, Class II [21 CFR § 878.4350(a)]
The CMS AccuProbe® 600 series consists of two components including: i) a console which holds three dewars of liguid nitrogen (LN-) (one dewar is filled at a time; one dewar is a receptacle for the circulating LN, and the third dewar contains the supercooling chamber); and ii) one to eight (models 610 through 680) cryoprobes with tips extending from the console. The console includes an optional on-board computer which is used as a redundant display system and an archival system to store information from the procedure. The computer does not control or affect the operation of the cryoprobes in any fashion. The cryoprobes consist of interchangeable tips of various materials, sizes and shapes to be utilized as necessary.
The device is used to destroy unwanted tissue by application of extreme cold to the selected site. LN, is forced through the cryoprobes under pressure. The cryoprobe, having been placed in the appropriate position through the use of ultrasound or another imaging device, then becomes cold and freezes the unwanted tissue. The procedure may be monitored in real-time through the use of imaging modes such as ultrasound. Once the freezing is completed (approximately 20 minutes) the probe will be heated using warm nitrogen gas in order to facilitate thawing and removal of the cryoprobe from the frozen tissue. The cryosurgical procedure is available when surgical resection is not possible and may also provide an alternative to typical resection in certain cases.
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1
The CMS AccuProbe® 600 series is similar in form and function to the 550/530 AccuProbe®, being modified models of that device. The CMS AccuProbe® 550/530 was cleared for marketing in November 20, 1995. The intended use and principal of operation are the same.
COMPARISON OF FEATURES BETWEEN THE AccuProbe® 550/530 [CLEARED 510(k) (K953637)] AND THE AccuProbe® 600 SERIES
| FEATURES | AccuProbe® 550/530 | AccuProbe® 600 SERIES |
|---|---|---|
| Liquid Nitrogen | ||
| Capacity | ||
| (Dewar size) | 85 liters | Model 610 15 liters |
| Model 620 25 liters | ||
| Model 630 40 liters | ||
| Model 640 55 liters | ||
| Model 650 70 liters | ||
| Model 660 85 liters | ||
| Model 670 100 liters | ||
| Model 680 115 liters | ||
| Normal Operating | ||
| Pressure | 55psi | 65psi |
| Regen time | four minutes | two minutes |
| Regen mode | Transfers the LN2 from the | |
| upper dewar to the lower | ||
| (supply) dewar | Depressurizes the supply | |
| dewar and pressurizes the | ||
| return dewar (this allows the | ||
| capture of LN2 to flow from | ||
| the return dewar through the | ||
| cryoprobe back to the supply | ||
| dewar) | ||
| Dimensions | 54"x 29"x 47" | Model 610 45"x 24"x 29" |
| Model 620 49"x 24"x 29" | ||
| Model 630 52"x 24"x 29" | ||
| Model 640 52"x 24"x 29" | ||
| Model 650 54"x 28"x 32" | ||
| Model 660 54"x 30"x 34" | ||
| Model 670 54"x 32"x 34" | ||
| Model 680 54"x 32"x 34" | ||
| Nitrogen Gas Supply | External Supply | Internally Generated |