(89 days)
No
The device description focuses on the mechanical and thermal aspects of cryoablation. The optional computer is explicitly stated as a redundant display and archival system that does not control or affect the operation of the cryoprobes. There is no mention of AI, ML, or any computational analysis of imaging or other data to guide or optimize the procedure.
Yes
The device is described as being used to "ablate" or "destroy" unwanted tissue and "freeze" tissue, which are direct interventions aimed at treating medical conditions.
No
The device is used for ablation (destruction) of tissue, which is a treatment, not a diagnosis. While it uses imaging for monitoring (e.g., ultrasound), it does not generate a diagnosis itself.
No
The device description explicitly states it consists of a console with a pumping mechanism and cryoprobes, which are hardware components used for tissue ablation. While it mentions an optional on-board computer, it clarifies that this computer does not control or affect the operation of the cryoprobes.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostic devices are used to examine specimens (like blood, urine, or tissue) taken from the human body to provide information for diagnosis, monitoring, or screening. This testing is performed outside of the body (in vitro).
- Device Function: The CMS AccuProbe® 800 Series is described as a system that uses cryoprobes to directly ablate or freeze tissue within the body. It is a therapeutic device used for the destruction of unwanted tissue.
- Intended Use: The intended uses listed all involve direct intervention on various tissues and organs within the body (prostate, skin, tumors, etc.) for therapeutic purposes (ablation, freezing, destruction, palliation).
- Device Description: The description details a console and cryoprobes that deliver extreme cold directly to the target tissue. While imaging (like ultrasound) is used for guidance, the device itself is not analyzing biological samples.
Therefore, the CMS AccuProbe® 800 Series is a therapeutic device, not an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The CMS AccuProbe® 800 Series (all models depicted as A) has the same indications for use as its predicate device, the AccuProbe® 600 Series [510(k) number K973190 cleared November 21, 1997].
Urology
- The (A) system may be used to ablate prostatic tissue.
- . The (A) system may be used for the ablation of prostate tissue in cases of prostate cancer and benign prostatic hyperplasia.
Oncology
- . system may be used for ablation of cancerous or The (A) malignant tissue.
- system may be used for ablation of benign tumors. . The (A)
- The . (A) system may be used for palliative intervention.
Dermatology
- system may be used for the ablation or freezing of The (A) . skin cancers and other cutaneous disorders.
Gynecology - system may be used for the ablation of malignant . The (A) neoplasia or benign dysplasia of the female genitalia.
Prescription Use
(Per 21 CFR 801.109)
General Surgery
- (A) system may be used for the ablation of The . leukoplakia of mouth, anaiomas, sebaceous hyperpalsia, basal cell tumors of the eyelid or canthus area, ulcerated basal cell tumors, dermatofibromas, small hemangiomas, mucocele cysts, multiple warts, plantar warts, hemorrhoids, anal fissures, perianal condylomata, pilonidal cysts, actinic and seborrheic keratoses , cavernous hemanaiomas recurrent cancerous lesions.
- . The (A) system may be used for the destruction of warts or lesions.
- . The (A) system may be used for the palliation of tumors of the oral cavity, rectum, and skin.
Thoracic Surgery
- The . (A) system may be used for the ablation of arrhythmic cardiac tissue.
- . The system may be used for the ablation of cancerous (A) lesions.
Proctology
- The (A) system may be used for the ablation of benign or malignant growths of the anus and rectum
- . systems may be used for the ablation of The (A) hemorrhoids.
Product codes (comma separated list FDA assigned to the subject device)
OCL, GEH
Device Description
The CMS AccuProbe® 800 Series consists of eight models, each of which has two components: i) a console with a pumping mechanism to compress and pressurize the cryogen and ii) one to eight (models 810 through 880) cryoprobes with tips extending from the console. The may include an optional on-board computer which is as redundant display system and archival system to store information about 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 which are used a necessary.
The AccuProbe® 800 Series is used to destroy unwanted tissue by the application of extreme cold to the selected site. Liquid nitrogen is forced through the cryoprobes under pressure. The cryoprobe, having been placed in the appropriate position through the used of utlrasound or other 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 cryoprobe will be heated using warming gas in order to facilitate thawing and removal of the cryoprobe from the frozen tissue.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
ultrasound or other imaging device
Anatomical Site
prostatic tissue, prostate, cancerous or malignant tissue, benign tumors, skin, skin cancers and other cutaneous disorders, malignant neoplasia or benign dysplasia of the female genitalia, leukoplakia of mouth, anaiomas, sebaceous hyperpalsia, basal cell tumors of the eyelid or canthus area, ulcerated basal cell tumors, dermatofibromas, small hemangiomas, mucocele cysts, multiple warts, plantar warts, hemorrhoids, anal fissures, perianal condylomata, pilonidal cysts, actinic and seborrheic keratoses , cavernous hemanaiomas recurrent cancerous lesions, warts or lesions, tumors of the oral cavity, rectum, and skin, arrhythmic cardiac tissue, cancerous lesions, benign or malignant growths of the anus and rectum, hemorrhoids.
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.
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
8 1998 SEb
510(k) SUMMARY
June 11, 1998 Submitted by:
ﻤﺼﻨﻌﺔ
Contact:
Richard J. Reinhart, Ph.D. President and CEO
Cryomedical Sciences, Inc. 1300 Piccard Drive Suite L105 Rockville, Maryland 20850 (301) 417-7070 Fax (301) 417-7077
Proprietary name: CMS AccuProbe® Models 810, 820, 830, 840, 850, 860, 870, and 880
Common name: Cryosurgical units and accessories
Cryosuraical units with Liquid Nitrogen, Nitrous Oxide, Carbon Classification: Dioxide, Class II, under CFR § 878.4350. Under CFR § 882.4250 a cryogenic surgical device also is classified in Class II.
The CMS AccuProbe® 800 Series consists of eight models, each of which has two components: i) a console with a pumping mechanism to compress and pressurize the cryogen and ii) one to eight (models 810 through 880) cryoprobes with tips extending from the console. The may include an optional on-board computer which is as redundant display system and archival system to store information about 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 which are used a necessary.
The AccuProbe® 800 Series is used to destroy unwanted tissue by the application of extreme cold to the selected site. Liquid nitrogen is forced through the cryoprobes under pressure. The cryoprobe, having been placed in the appropriate position through the used of utlrasound or other imaging device, then becomes cold and freezes the unwanted tissue. The procedure may be
1
monitored in real-time through the use of imaging modes such as ultrasound, ﻤﺴﺴﺴﺴﺴﺴﺴﺴ Once the freezing is completed (approximately 20 minutes), the cryoprobe will be heated using warming gas in order to facilitate thawing and removal of the cryoprobe from the frozen tissue.
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2
COMPARISON OF FEATURES BETWEEN THE AccuProbe® 600 Series [CLEARED 510(k) (K964336)] AND THE AccuProbe® 800 SERIES
| FEATURES | AccuProbe® 600 Series | AccuProbe® 800 SERIES |
|---|---|---|
| Liquid Nitrogen | ||
| Capacity | ||
| (Dewar size) | 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 | Model 810 25 liters | |
| Model 820 25 liters | ||
| Model 830 25 liters | ||
| Model 840 35 liters | ||
| Model 850 35 liters | ||
| Model 860 45 liters | ||
| Model 870 45 liters | ||
| Model 880 45 liters | ||
| Normal Operating | ||
| Pressure | 65psi | 65psi |
| Regen/recirculating | ||
| time | Two minutes | Less than 10 seconds |
| Regen mode | Depressurizes the supply | |
| dewar and pressurizes the | ||
| return dewar (this allows | ||
| capture of LN2 to flow from | ||
| the return dewar through the | ||
| cryoprobe and back to the | ||
| supply dewar) | The LN2 return line from the | |
| cryoprobe feeds directly into | ||
| the LN2 supply | ||
| Dimensions | Model 610 45"x24"x29" | |
| Model 620 49"x24"x29" | ||
| Model 630 52"x24"x29" | ||
| Model 640 52"x24"x29" | ||
| Model 650 54"x28"x32" | ||
| Model 660 54"x30"x34" | ||
| Model 670 54"x32"x34" | ||
| Model 680 54"x32"x34" | Model 810 38"x24"x24" | |
| Model 820 38"x24"x24" | ||
| Model 830 38"x24"x24" | ||
| Model 840 38"x24"x24" | ||
| Model 850 38"x26"x26" | ||
| Model 860 38"x26"x26" | ||
| Model 870 38"x26"x26" | ||
| Model 880 38"x26"x26" | ||
| Operation | Uses a three dewar system | Uses a one dewar system |
| Warming Gas | Nitrogen Gas | Nitrogen Gas |
3
DEPARTMENT OF HEALTH & HUMAN SERVICES
Public Health Service
Image /page/3/Picture/2 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle or bird-like figure with flowing lines, representing a sense of movement or progress. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the bird symbol.
FEB 2 1 2008
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Cryomedical Sciences, Inc. c/o Mr. Richard J. Reinhart, Ph.D President and CEO 1300 Piccard Drive, Suite L105 Rockville, MD 20850
Re: K982055
Trade Name: Accuprobe 800 Series Model Numbers: 810, 820, 830, 840, 850, 860, 870 and 880 Regulatory Class: II (two) Product Code: OCL. GEH Dated: June 11, 1998 Received: June 11, 1998
Dear Dr. Reinhart:
This letter corrects our substantially equivalent letter of September 8, 1998.
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 (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 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.
4
Page 2 - Mr. Richard J. Reinhart, Ph.D.
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 (OS) 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 continue 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 (240) 276-0120. 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 Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html
Sincerely vours.
eempe.
Bram D. Zuckerman, M.D. Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
5
Indications For Use
The CMS AccuProbe® 800 Series (all models depicted as A) has the same indications for use as its predicate device, the AccuProbe® 600 Series [510(k) number K973190 cleared November 21, 1997].
Urology
- The (A) system may be used to ablate prostatic tissue.
- . The (A) system may be used for the ablation of prostate tissue in cases of prostate cancer and benign prostatic hyperplasia.
Oncology
- . system may be used for ablation of cancerous or The (A) malignant tissue.
- system may be used for ablation of benign tumors. . The (A)
- The . (A) system may be used for palliative intervention.
Dermatology
- system may be used for the ablation or freezing of The (A) . skin cancers and other cutaneous disorders.
Gynecology
- system may be used for the ablation of malignant . The (A) neoplasia or benign dysplasia of the female genitalia.
ccer
Prescription Use
(Per 21 CFR 801.109)
(Division Sign-Off
Division of General Restorative Devices K982055
510(k) Number
6
Indications for Use
(continued for CMS AccuProbe® device family)
General Surgery
- (A) system may be used for the ablation of The . leukoplakia of mouth, anaiomas, sebaceous hyperpalsia, basal cell tumors of the eyelid or canthus area, ulcerated basal cell tumors, dermatofibromas, small hemangiomas, mucocele cysts, multiple warts, plantar warts, hemorrhoids, anal fissures, perianal condylomata, pilonidal cysts, actinic and seborrheic keratoses , cavernous hemanaiomas recurrent cancerous lesions.
- . The (A) system may be used for the destruction of warts or lesions.
- . The (A) system may be used for the palliation of tumors of the oral cavity, rectum, and skin.
Thoracic Surgery
- The . (A) system may be used for the ablation of arrhythmic cardiac tissue.
- . The system may be used for the ablation of cancerous (A) lesions.
Proctology
- The (A) system may be used for the ablation of benign or malignant growths of the anus and rectum
- . systems may be used for the ablation of The (A) hemorrhoids.
(Division Sign-Off)
Division of General Restorative Devices
510(k) Number K982655
Prescription Use
(Per 21 CFR 801.109)
6