(110 days)
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.
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 provided text describes a 510(k) premarket notification for the CMS Cryo-lite® System, a cryosurgical device. Crucially, this document does not contain details of an acceptance criteria study or performance data against specific criteria.
Instead, the submission focuses on demonstrating substantial equivalence to predicate devices already on the market by comparing features and intended use. This is a common regulatory pathway for medical devices that are similar in technology and purpose to existing cleared devices.
Therefore, I cannot provide the requested information about acceptance criteria, device performance, sample sizes, ground truth, or expert involvement because this type of study was not performed or detailed in the provided document.
Here's an explanation based on the available information:
- Acceptance Criteria and Reported Device Performance: Not applicable/not provided. The document focuses on demonstrating substantial equivalence to predicate devices, not on meeting specific, quantifiable performance metrics from a new study.
- Study Details (Sample Size, Data Provenance): Not applicable/not provided. No new clinical or performance study data is presented.
- Ground Truth Establishment (Number of Experts, Qualifications, Adjudication Method, Type of Ground Truth): Not applicable/not provided. Ground truth is not a concept typically applied to substantial equivalence demonstrations based on feature comparison.
- Multi Reader Multi Case (MRMC) Comparative Effectiveness Study: Not applicable/not provided. This type of study involves human readers interpreting data, usually images, with and without AI assistance, and is not relevant to a cryosurgical device's feature comparison.
- Standalone Performance (Algorithm Only): Not applicable/not provided. This device is a cryosurgical unit, not an AI algorithm.
- Training Set Details (Sample Size, Ground Truth Establishment): Not applicable/not provided. The document does not describe the development or training of an algorithm.
Summary of available information related to equivalence:
1. Comparison Tables (Features Demonstrating Substantial Equivalence):
| Feature/Criteria | Cryolite System Performance (as reported for equivalence) |
|---|---|
| Cryoprobes | Spray and closed-tip, various, interchangeable |
| Power source | Non-electric |
| Cryogen | Choice of liquid nitrogen, carbon dioxide, nitrous oxide, and argon |
| Flow control | Dial with flow rate markings/control |
| Size | Portable, hand-held |
| Capacity | 9 oz. cryogen packet and different capacities depending on commercial cryogen containers used with transfer line |
| Intended Use | Destruction of unwanted tissue in dermatology, gynecology, general surgery, etc., and veterinary medicine. |
Study Information (Based on Substantial Equivalence Argument):
- Sample size used for the test set and the data provenance: Not applicable. No test set as defined for a performance study was used. The demonstration relies on a comparison of features and intended use to predicate devices already cleared by the FDA.
- Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. Ground truth for a performance study was not established. The FDA reviewer (Celia M. Witten, Ph.D., M.D., Director, Division of General and Restorative Devices) made the determination of substantial equivalence based on the submitted documentation and comparison to predicate devices.
- Adjudication method for the test set: Not applicable. No test set requiring adjudication was used.
- If a multi reader multi case (MRMC) comparative effectiveness study was done: No. This type of study is not relevant for this device.
- Standalone (i.e. algorithm only without human-in-the loop performance) was done: No. This is a physical cryosurgical device, not an algorithm.
- The type of ground truth used: Not applicable in the context of a new performance study. The "ground truth" for this submission is the established safety and effectiveness of the predicate devices.
- The sample size for the training set: Not applicable. No algorithm training set was involved.
- How the ground truth for the training set was established: Not applicable. No training set was involved.
In essence, the provided document is a regulatory submission focused on equivalence rather than a new performance study with explicit acceptance criteria. The "proof" that the device meets "acceptance criteria" is the FDA's determination of substantial equivalence to already approved predicate devices.
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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.
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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 oxideand argon |
| Flow control | Adjustable flow rates, triggertype | Dial with flow rate markings |
| Size | Portable, hand-held | Portable, hand-held |
| Capacity | 500 ml cryogen container | 9 oz. cryogen packet anddifferent capacities dependingon commercial cryogencontainers used with transferline |
COMPARISON OF FEATURES BETWEEN THE CRYOMEDICS MT700 SYSTEM AND THE CMS CRYO-LITE SYSTEM
| FEATURES | Cryomedics MT700 | Cryolite System |
|---|---|---|
| Cryogen | Choice of nitrous oxide andcarbon dioxide | Choice of liquid nitrogen,carbon dioxide, nitrous oxideand argon |
| Flow control | Dial with flow rate control | Dial with flow rate markings |
| Size | Portable, hand-held | Portable, hand-held |
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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, carbondioxide, nitrous oxide andargon |
| Flow control | Adjustable flow rates, triggertype | Dial with control markings |
| Size | Portable, hand-held trigger withLN2 transfer line attached toLN2 vacuum insulatedcontainers | Portable, hand-held, withcryogen packet or cryogentransfer line to an externalcryogen source |
| Capacity | 1 liter | 9 oz. cryogen packet anddifferent sizes of commercialcryogen containers used withtransfer line |
Page 3 of 3
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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.
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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
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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
Page 7 of 7
§ 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.