(110 days)
Not Found
No
The device description and intended use focus on a purely mechanical cryosurgical process using cryogens and probes, with no mention of AI/ML capabilities or data processing for decision-making or analysis.
Yes
The device is described as a "cryosurgical tool for destruction of unwanted tissue," which is a therapeutic intervention aimed at treating medical conditions.
No
The device is a cryosurgical tool intended for the destruction of unwanted tissue, which is a therapeutic rather than a diagnostic function.
No
The device description clearly states it is a "completely disposable hand-held cryosurgical device" consisting of a hand-held body, cryogen packet, and cryoprobe, indicating it is a hardware device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In vitro diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections.
- Device Function: The CMS Cryo-lite® System is a cryosurgical tool used to destroy unwanted tissue by applying extreme cold directly to the tissue. This is a surgical procedure performed in vivo (on the living body), not a diagnostic test performed in vitro (outside the body).
- Intended Use: The intended use clearly states it's a "cryosurgical tool for destruction of unwanted tissue."
- Mechanism of Action: The device works by freezing tissue directly, not by analyzing a sample taken from the body.
Therefore, the CMS Cryo-lite® System falls under the category of a surgical device, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
The Cryo-lite® System is used to destroy unwanted tissue by application of extreme cold to the selected site. The cryogen is forced through the cryoprobes under pressure. The cryoprobe, having been placed in the appropriate position through the use of ultrasound, another imaging device or visual observation then becomes cold and freezes the unwanted tissue. Cryosurgical procedures are used when surgical resection is not indicated, and may also provide an alternative to typical resection in certain cases. The CMS Cryo-lite® System has the same indications for use as its predicate devices, the Frigitronics Model 5900, Frigitronics Cryocare I and the Cryomedics Model MT700 . The Cryo-lite® System is intended to be used as a cryosurgical tool for destruction of unwanted tissue in the fields of dermatology, gynecology general surgery, etc. and veterinary medicine.
Product codes (comma separated list FDA assigned to the subject device)
GEH
Device Description
The CMS Cryo-lite® System is a completely disposable hand-held cryosurgical device. Both Crvo-lite® System Models 2001 and 2002 consist of hand-helo body, a physician-selected cryogen packet and single cryoprope of varying materials, sizes and shapes. Cryogens available with this system are liquid nitrogen, nitrous oxide, carbon dioxide and argon.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
ultrasound, another imaging device or visual observation
Anatomical Site
unwanted tissue
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Physician / 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 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
510(k) SUMMARY
JUL=7 1907
March 19, 1997
Submitted by:
Cryomedical Sciences, Inc. 1300 Piccard Drive Rockville, Maryland 20850 (301) 417-7070 Fax (310) 417-7077
Contact:
Richard J. Reinhart, Ph.D. President and CEO or Susan Hayes Administrative Manager Operations
Proprietary name: CMS Cryolite
Cryosurgical Unit, Cryogenic Surgical Device or Cryoprobe Common name:
Cryosurgical unit with Liquid Nitrogen, Nitrous Oxide, Carbon Classification: Dioxide, Class II [21 CFR § 878.4350(a).
The CMS Cryo-lite® System is a completely disposable hand-held cryosurgical device. Both Crvo-lite® System Models 2001 and 2002 consist of hand-helo body, a physician-selected cryogen packet and single cryoprope of varying materials, sizes and shapes. Cryogens available with this system are liquid nitrogen, nitrous oxide, carbon dioxide and argon.
The Crvo-lite® System is used to destroy unwanted tissue by application of extreme cold to the selected site. The cryogen is forced through the cryoprobes under pressure. The cryoprobe, having been placed in the appropriate position through the use of ultrasound, another imaging device or visual observation then becomes cold and freezes the unwanted tissue. Cryosurgical procedures are used when surgical resection is not indicated, and may also provide an alternative to typical resection in certain cases.
The CMS Cryo-lite® System is similar in form and function to the Frigitronics' Cryocare I System and its Cryo Surg Model 5900 (K840536) and Cabot Medical's Cryomedics MT700. Intended use for the CMS Cryo-lite® System is the same as those listed for the CMS Cryolite® System predicate devices.
1
COMPARISON OF FEATURES BETWEEN THE FRIGITRONICS MODEL 5900 SYSTEM AND THE CMS CRYO-LITE SYSTEM
| FEATURES | Frigitronics 5900 | Cryolite System |
|---|---|---|
| Cryoprobes | Spray and closed-tip | Spray and closed-tip |
| Cryoprobes | Various, interchangeable | Various, interchangeable |
| Power source | Non-electric | Non-electric |
| Cryogen | Liquid nitrogen | Choice of liquid nitrogen, |
| carbon dioxide, nitrous oxide | ||
| and argon | ||
| Flow control | Adjustable flow rates, trigger | |
| type | Dial with flow rate markings | |
| Size | Portable, hand-held | Portable, hand-held |
| Capacity | 500 ml cryogen container | 9 oz. cryogen packet and |
| different capacities depending | ||
| on commercial cryogen | ||
| containers used with transfer | ||
| line |
COMPARISON OF FEATURES BETWEEN THE CRYOMEDICS MT700 SYSTEM AND THE CMS CRYO-LITE SYSTEM
| FEATURES | Cryomedics MT700 | Cryolite System |
|---|---|---|
| Cryogen | Choice of nitrous oxide and | |
| carbon dioxide | Choice of liquid nitrogen, | |
| carbon dioxide, nitrous oxide | ||
| and argon | ||
| Flow control | Dial with flow rate control | Dial with flow rate markings |
| Size | Portable, hand-held | Portable, hand-held |
2
comparison of features between the frigitronics model cs-76/cryocare i system and the cms cryo-lite system
K9405%
:
f
| FEATURES | Frigitronics CS-76/Cryocare I | Cryolite System |
|---|---|---|
| Cryoprobes | Spray and closed-tip | Spray and closed-tip |
| Cryoprobes | Various sizes and materials , | |
| interchangeable | Various sizes and materials, | |
| interchangeable | ||
| Power source | Non-electric | Non-electric |
| Cryogen | Liquid nitrogen | Liquid nitrogen, carbon |
| dioxide, nitrous oxide and | ||
| argon | ||
| Flow control | Adjustable flow rates, trigger | |
| type | Dial with control markings | |
| Size | Portable, hand-held trigger with | |
| LN2 transfer line attached to | ||
| LN2 vacuum insulated | ||
| containers | Portable, hand-held, with | |
| cryogen packet or cryogen | ||
| transfer line to an external | ||
| cryogen source | ||
| Capacity | 1 liter | 9 oz. cryogen packet and |
| different sizes of commercial | ||
| cryogen containers used with | ||
| transfer line |
Page 3 of 3
3
Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular arrangement of text surrounding a stylized emblem. The text reads "DEPARTMENT OF HEALTH & HUMAN SERVICES · USA" in a circular fashion. The emblem in the center appears to be a stylized representation of a human figure or a symbol related to health and well-being.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Richard J. Reinhart, Ph.D. President and CEO .. ... ...... Cryomedical Sciences, Inc. 1300 Piccard Drive Rockville, Maryland 20850-4303
JUL - 7.1997
K970995 Re: Trade Name: CMS Cryolite Regulatory Class: II Product Code: GEH Dated: June 19, 1997 Received: June 20, 1997
Dear Dr. Reinhart:
We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to 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). 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 (Premarket Approval), 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 895. A substantially equivalent determination assumes compliance with the current Good Manufacturing Practice requirements , as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic (OS) inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.
4
Page 2 - Richard J. Reinhart, Ph.D.
.
This letter will allow you to begin marketing your device as described in your 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, permitsvour device to proceed to the market.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4595. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its internet address "http://www.fda.gov/cdrh/dsmamain.html".
Sincerely vours,
Stephen Rlurchis
Celia M. Witten, Ph.D., M.D. Director Division of General and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
5
Indications For Use
The CMS Cryo-lite® System has the same indications for use as its predicate devices, the Frigitronics Model 5900, Frigitronics Cryocare I and the Cryomedics Model MT700 . The Cryo-lite® System is intended to be used as a cryosurgical tool for destruction of unwanted tissue in the fields of dermatology, gynecology general surgery, etc. and veterinary medicine.
Hyt Purdy
(Division Sign-Of Division of General Restorative Devices 510(k) Number
Prescripti
(Per 21 CFR 801.109)
Y
Over-the-Counter Use
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