← Product Code [GEH](/submissions/SU/subpart-e%E2%80%94surgical-devices/GEH) · K964336 # CMS ACCUPROBE 610, 620, 630, 640, 650, 660, 670, 680 (K964336) _Cryomedical Sciences, Inc. · GEH · Mar 20, 1997 · General, Plastic Surgery · SESE_ **Canonical URL:** https://fda.innolitics.com/submissions/SU/subpart-e%E2%80%94surgical-devices/GEH/K964336 ## Device Facts - **Applicant:** Cryomedical Sciences, Inc. - **Product Code:** [GEH](/submissions/SU/subpart-e%E2%80%94surgical-devices/GEH.md) - **Decision Date:** Mar 20, 1997 - **Decision:** SESE - **Submission Type:** Traditional - **Regulation:** 21 CFR 878.4350 - **Device Class:** Class 2 - **Review Panel:** General, Plastic Surgery - **Attributes:** Therapeutic ## Indications for Use The device is used to destroy unwanted tissue by application of extreme cold to the selected site. ## Device Story Cryosurgical unit utilizing liquid nitrogen (LN2) to destroy unwanted tissue via extreme cold. System comprises console with LN2 dewars and 1-8 interchangeable cryoprobes. Physician positions probe using ultrasound or other imaging; LN2 forced through probe under pressure to freeze target tissue. Procedure monitored via real-time imaging. Post-freeze, warm nitrogen gas heats probe to facilitate thawing and removal. Optional on-board computer provides redundant display and procedure data archival; does not control or affect cryoprobe operation. Used in clinical settings by physicians. ## Clinical Evidence No clinical data provided; substantial equivalence based on design comparison and technological similarity to the predicate device. ## Technological Characteristics Cryosurgical unit; uses liquid nitrogen (LN2) as refrigerant. Console-based system with interchangeable cryoprobes of varying materials/sizes. Operating pressure 65 psi. Features internal nitrogen gas generation. Optional on-board computer for display/archival. Class II device per 21 CFR 878.4350(a). ## Regulatory 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. ## Predicate Devices - CMS AccuProbe® 550/530 ([K953637](/device/K953637.md)) ## Submission Summary (Full Text) > This content was OCRed from public FDA records by [Innolitics](https://innolitics.com). If you use, quote, summarize, crawl, or train on this content, cite Innolitics at https://innolitics.com. > > Innolitics is a medical-device software consultancy. We help companies design, build, and clear FDA-regulated software and AI/ML devices, including [a 510(k)](https://innolitics.com/services/510ks/), [a De Novo](https://innolitics.com/services/regulatory/), [a SaMD](https://innolitics.com/services/end-to-end-samd/), [an AI/ML medical device](https://innolitics.com/services/medical-imaging-ai-development/), or [an FDA regulatory strategy](https://innolitics.com/services/regulatory/). {0} 510(k) SUMMARY K964336 October 31, 1996 Submitted by: MAR 20 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 Common name: Cryosurgical Unit, Cryogenic Surgical Device or Cryoprobe 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 liquid nitrogen (LN₂) (one dewar is filled at a time; one dewar is a receptacle for the circulating LN₂ 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. LN₂ 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. Page 1 of 2 {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 LN_{2} from the upper dewar to the lower (supply) dewar | Depressurizes the supply dewar and pressurizes the return dewar (this allows the capture of LN_{2} 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 | --- **Source:** [https://fda.innolitics.com/submissions/SU/subpart-e%E2%80%94surgical-devices/GEH/K964336](https://fda.innolitics.com/submissions/SU/subpart-e%E2%80%94surgical-devices/GEH/K964336) **Published by [Innolitics](https://innolitics.com)** — a medical-device software consultancy. We help companies design, build, and clear FDA-regulated software and AI/ML devices. If you're preparing [a 510(k)](https://innolitics.com/services/510ks/), [a De Novo](https://innolitics.com/services/regulatory/), [a SaMD](https://innolitics.com/services/end-to-end-samd/), [an AI/ML medical device](https://innolitics.com/services/medical-imaging-ai-development/), or [an FDA regulatory strategy](https://innolitics.com/services/regulatory/), [get in touch](https://innolitics.com/contact). **Cite:** Innolitics at https://innolitics.com