(90 days)
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Not Found
No
The document describes a cryosurgical system and its modifications compared to a predicate device. There is no mention of AI, ML, or any related concepts in the intended use, device description, or performance studies. The software modifications mentioned are related to functional features ("Stick" option) and not indicative of AI/ML.
Yes
The device is used for "cryogenic destruction of tissues during surgical procedures" for the "ablation of tissue", which directly addresses a medical condition or performs a therapeutic function.
No
The device is described as a cryosurgical tool intended for the "destruction" and "ablation of tissue during surgical procedures", indicating a therapeutic rather than diagnostic purpose.
No
The device description clearly outlines multiple hardware components including the system itself, cryoprobes, gas cylinders, and an optional foot pedal. While software is mentioned as being modified, it is part of a larger hardware system.
Based on the provided information, the Cryo-Mono Cryogenic system is not an IVD (In Vitro Diagnostic) device.
Here's why:
- Intended Use: The intended use clearly states that the device is for "cryogenic destruction of tissues during surgical procedures" and is used as a "cryosurgical tool for the ablation of tissue." This describes a device used on the patient's body for treatment, not a device used to test samples from the body to diagnose a condition.
- Device Description: The description focuses on the physical characteristics and functionality of a surgical instrument used for freezing tissue. There is no mention of analyzing biological samples or providing diagnostic information.
- Lack of IVD Characteristics: The document does not mention any of the typical characteristics of an IVD, such as:
- Analyzing blood, urine, tissue samples, etc.
- Providing diagnostic results or measurements.
- Using reagents or assays.
- Being used in a laboratory setting for diagnostic purposes.
The Cryo-Mono is a therapeutic device used for surgical intervention.
N/A
Intended Use / Indications for Use
The Cryo-Mono Cryogenic system is intended for cryogenic destruction of tissues during surgical procedures. It is indicated for use as a cryosurgical tool in the fields of general surgery, dermatology, neurosurgery, thoracic surgery, ENT, gynecology, oncology, proctocology, and urology for the ablation of tissue, including liver metastases, skin lesions, warts, tonsils, turbinate reduction and prostate tissues. Cryo-Mono is specifically indicated for tonsil reduction in patients with blood dyscrasias or other bleeding problems and/or patients for whom general anesthesia presents an increased risk.
Product codes
GEH
Device Description
The Cryo-Mono is a modified version of Cryo-Hit. They have the same technological characteristics with several exceptions: (1) Cryo-Mono can support one cryoprobe only, while its predicate, Cryo-Hit, is capable of supporting up to 8 probes; (2) the Cryo-Mono is smaller than Cryo-Hit. (3) the Cryo-Mono has 4 gas cylinders compared to the Cryo-Hit' s six; (4) Cryo-Mono software has been modified, and does not have a "Stick" option for holding the probe to the tissue during freezing; (5) Cryo-Mono can accommodate needle shaped, tonsillectomy and turbinectomy specific probes; (6) Cryo-Mono has an optional foot pedal; (7) The Cryo-Mono does not have external thermosensors, which the Cryo-Hit has; and (8) The Cryo-Mono's single-use turbinectomy and tonsillectomy cryoprobes do not have built-in thermosensors, unlike the Cryo-Hit and Cryo-Mono' s multi-use probes. The Cryo-Mono's single-use probes are within the range of probes that can be used with the Cryo-Hit, i.e. one to eight probes.
Mentions image processing
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Mentions AI, DNN, or ML
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Input Imaging Modality
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Anatomical Site
liver, skin, tonsils, prostate
Indicated Patient Age Range
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Intended User / Care Setting
surgical procedures
Description of the training set, sample size, data source, and annotation protocol
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Description of the test set, sample size, data source, and annotation protocol
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Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
The biocompatibility of the Cryo-Mono is based on FDA premarket clearance of the Cryo-Hit. The only component of the Cryo-Mono that comes into contact with the patient's body is its cryoprobe. Its components are made of the same materials, as the Cryo-Hit's probes and Influence, Inc.'s In-Probe and In-Fast. Influence has certified to the Cryo-Mono's conformance with IEC 60601-1, IEC 60601-1-2 and ASTM F882-84. Influence has summarized representative articles in the published medical literature regarding cryotonsillectomies and cryoturbinectomies in a pre-510(k) submission concerning the device.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Galil Medical, Ltd.'s Cryo-Hit Cryogenic System.
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
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§ 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
JUL - 1 1999
510(k) Summary Influence, Inc.'s Cryo-Mono Cryogenic System 510(k) Number K991122
Submitter's Name:
Peter A. Bick. M.D., President and CEO, Influence, Inc. 71 Stevenson Street, Suite 1120 San Francisco, California 94105 Telephone: 415-546-7700 / Fax: 415-546-7744
Trade Name:
Cryo-Mono Cryogenic System
Classification Name:
Cryosurgical unit
Product Code:
GEH
Predicate Devices:
Galil Medical, Ltd.'s Cryo-Hit Cryogenic System.
Intended Use and Indication for Use:
The Cryo-Mono Cryogenic system is intended for cryogenic destruction of tissues during surgical procedures. It is indicated for use as a cryosurgical tool in the fields of general surgery, dermatology, neurosurgery, thoracic surgery, ENT, gynecology, oncology, proctocology, and urology for the ablation of tissue, including liver metastases, skin lesions, warts, tonsils, turbinate reduction and prostate tissues. Cryo-Mono is specifically indicated for tonsil reduction in patients with blood dyscrasias or other bleeding problems and/or patients for whom general anesthesia presents an increased risk.
Technological Characteriatics:
The Cryo-Mono is a modified version of Cryo-Hit. They have the same technological characteristics with several exceptions: (1) Cryo-Mono can support one cryoprobe only, while its predicate, Cryo-Hit, is capable of supporting up to 8 probes; (2) the Cryo-Mono is smaller than Cryo-Hit. (3) the Cryo-Mono has 4 gas cylinders compared to the Cryo-Hit' s six; (4) Cryo-Mono software has been modified, and does not have a "Stick" option for
:
1
six; (4) Cryo-Mono software has been modified, and does not have a "Stick" option for holding the probe to the tissue during freezing; (5) Cryo-Mono can accommodate needle shaped, tonsillectomy and turbinectomy specific probes; (6) Cryo-Mono has an optional foot pedal; (7) The Cryo-Mono does not have external thermosensors, which the Cryo-Hit has; and (8) The Cryo-Mono's single-use turbinectomy and tonsillectomy cryoprobes do not have built-in thermosensors, unlike the Cryo-Hit and Cryo-Mono' s multi-use probes.
The Cryo-Mono's single-use probes are within the range of probes that can be used with the Cryo-Hit, i.e. one to eight probes.
Performance Data:
The biocompatibility of the Cryo-Mono is based on FDA premarket clearance of the Cryo-Hit. The only component of the Cryo-Mono that comes into contact with the patient's body is its cryoprobe. Its components are made of the same materials, as the Cryo-Hit's probes and Influence, Inc.'s In-Probe and In-Fast. Influence has certified to the Cryo-Mono's conformance with IEC 60601-1, IEC 60601-1-2 and ASTM F882-84. Influence has summarized representative articles in the published medical literature regarding cryotonsillectomies and cryoturbinectomies in a pre-510(k) submission concerning the device.
Substantial Equivalence:
The Cryo-Mono has the same intended use and virtually identical technological characteristics as the 510(k) cleared Cryo-Hit. The minor technological differences between these devices, namely, the Cryo-Mono smaller size, use of fewer probes, lack of a "stick" option, foot pedal, modified software, fewer gas cylinders and acceptance of tonsillectomy and turbinectomy specific probes do not raise any new questions of safety and effectiveness. Thus, the Cryo-Mono is substantially equivalent to a legally marketed cryosurgical device.
2
Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized depiction of an eagle or bird-like figure with three wing-like strokes above a wavy line, symbolizing care and protection. Encircling the bird is the text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA", indicating the department's name and national affiliation. The logo is presented in black and white, giving it a clean and official appearance.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
JUL - 1 1999
Influence. Inc. c/o Mr. Jonathan S. Kahan, Esq. Hogan and Hartson, L.L.P. Columbia Square 555 Thirteenth St., NW Washington, D.C. 20004
Re: K991122
Trade Name: Cryo-Mono Cryogenic System Regulatory Class: II Product Code: GEH Dated: March 30, 1999 Received: April 2, 1999
Dear Mr. Kahan:
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 requirement, as set forth in the Quality System Regulation (OS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic (QS) 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.
3
Page 2 - Mr. Jonathan S. Kahan, Esq.
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, permits your 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 yours,
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 STATEMENT
510(k) Number (if known): 11991122
Device Name:
Cryo-Mono Cryogenic System.
Indications for Use:
The Cryo-Mono Cryogenic system is intended for cryogenic destruction of tissues during surgical procedures. It is indicated for use as a cryosurgical tool in the of general surgery, fields dermatology, neurosurgery, thoracic surgery, ENT, gynecology, oncology, proctocology, and urology for the ablation of tissue, including liver metastases, skin lesions, warts, tonsils, turbinate reduction and prostate tissues. Cryo-Mono is specifically indicated for tonsil reduction in patients with blood dyscrasias or other bleeding problems and/or patients for whom general anesthasia presents an increased risk.
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
| Concurrence of CDRH, Office of Device Evaluation (ODE) |
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| (Division Sign-off) |
| Division of General and Restorative Devices |
| 510(k) Number | K991122 |
|---|---|
| --------------- | --------- |
| Prescription Use (Per 21 CFR 801.109) | OR | Over-The-Counter-Use |
|---|---|---|
| --------------------------------------- | ---- | ---------------------- |
| (Division Sign-Off) |
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| Division of General Restorative Devices |
| 510(k) Number | K991122 |
|---|---|
| --------------- | --------- |