(50 days)
The SprayGenix™ Cryo Ablation System is intended to be used as a cryosurgical tool for destruction of unwanted tissue in the field of general surgery, specifically for endoscopic applications.
The SprayGenix™ Cryo Ablation System is a cryosurgical device. consisting of an electronic console, cryo-catheter, nasal/oral gastric tube and cryogen delivery system. The SprayGenix™ Cryo Ablation System is used to destroy unwanted tissue by application of extreme cold to a selected site. Liquid Nitrogen is stored in a tank and then propelled through a cryo-catheter to perform the cryo-ablation procedure. The catheter is placed in the appropriate position through the use of visual observation. The cryo-catheter applies the cryogen to a selected area 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 is a 510(k) safety summary for the SprayGenix™ Cryo Ablation System. It focuses on demonstrating substantial equivalence to predicate devices and does NOT contain information about specific acceptance criteria or a study proving the device meets them.
Therefore, I cannot fulfill your request as the necessary information is not present in the provided document. The document describes the device, its intended use, and lists predicate devices, but lacks details about performance metrics, study designs, sample sizes, ground truth establishment, or expert involvement for evaluating specific acceptance criteria.
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510(k) Safety Summary
KOGOSSS
February 2006 Submitted by:
CryMed Technologies, Inc. CryMed Technologies, Inc. Emerging Technology Center 3225 Ellerslie Ave., Third Floor - #6311 Baltimore, MD 21218 0: 443.921.8053 Contact Person: Tim Askew, President CryMed Technologies, Inc.
Name of Device
- SprayGenix™ Cryo Ablation System · Trade Name:
- · Common Name: Cryosurgical Unit, Cryogenic Surgical Device
- Classification: Cryosurgical unit with Liquid Nitrogen, Class II [21 CFR & 878.4350(a)].
- Establishment Registration Number: 9062377
Predicate Devices
| Device | Premarket Notification |
|---|---|
| CryMed Cryo-Ablator | K040809 |
| Wallach Surgical Devices WA1000 | K813024 |
| Figitronics Cryo-Plus ™ | K811390 |
| Figitronics Cryo-Surg™ System 5900 | K840536 |
| Wallach Surgical Devices UltraFreeze | K935010 |
| Cortex Technology's Cryopro Maxiand Cryopro Mini | K982280 |
| CMS Cryolite | K970995 |
Device Description
The SprayGenix™ Cryo Ablation System is a cryosurgical device. consisting of an electronic console, cryo-catheter, nasal/oral gastric tube and cryogen delivery system.
The SprayGenix™ Cryo Ablation System is used to destroy unwanted tissue by application of extreme cold to a selected site. Liquid Nitrogen is stored in a tank and then propelled through a cryo-catheter to perform the cryo-ablation procedure. The catheter is placed in the appropriate position through the use of visual observation. The cryo-catheter applies the cryogen to a selected area and freezes the unwanted tissue. Cryosurgical procedures are
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used when surgical resection is not indicated, and may also provide an alternative to typical resection in certain cases.
Indications for Use
The SprayGenix™ Cryo Ablation System is intended to be used as a cryosurgical tool for destruction of unwanted tissue in the field of general surgery, specifically for endoscopic applications.
Technical Characteristics
The technology used by CryMed Technologies, Inc. is substantially equivalent to those of the above listed predicate devices.
Summary
Based on the principles of operation, design, materials and intended use, the SprayGenix™ Cryo Ablation, design, matchans and in equillivant to devices currently marketed in the United States.
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Image /page/2/Picture/1 description: The image shows a logo with a stylized bird symbol on the right and a circular text element on the left. The bird symbol is composed of three curved lines that resemble the shape of a bird in flight. The text element is arranged in a circle around the bird symbol, and it appears to be a series of words or phrases. The logo has a simple and clean design, with a focus on conveying a sense of movement and progress.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
APR 2 1 2006
CryMed Technologies, Inc. c/o Mr. Tim Askew President Emerging Technology Center 3225 Ellerslie Avenue Third Floor - #B311 Baltimore, Maryland 21218
Re: K060555
Trade/Device Name: SprayGenix" Cryo Ablation Regulation Number: 21 CFR 878.4350 Regulation Name: Cryosurgical unit and accessories Regulatory Class: II Product Code: GEH Dated: February 24, 2006 Received: March 2. 2006
Dear Mr. Askew:
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 recicetions 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 Forte. Or to and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA), You may, therefore, market the device, subject to the general controls provisions of the TTT (The general controls provisions of the Act include requirements for annual registretiren. Until gol 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 such additional controls. Existing major regulations affecting your devise can be found in the Code of Federal Regulations. Title 21, Parts 800 to 898. In addition, 127 max publish further announcements concerning your device in the Federal Register.
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. Noumunst comply with all the Act's requirements, including, but not limited to: registrest and fitsting (21
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Page 2 - Mr. Tim Askew
CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set forth in the quality systems (QS) 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 begin 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) 276-0115. 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 (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsmamain.html
Sincerely yours.
elamae
Mar
Dir
Mark N. Melkerson Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known): ____________________________________________________________________________________________________________________________________________________
DEVICE NAME: SprayGenix™ Cryo Ablation
CryMed Technologies, Inc.
INDICATIONS FOR USE:
The SprayGenix™ Cryo Ablation System is intended to be used as a cryosurgical tool for destruction of unwanted tissue in the field of general surgery, specifically for endoscopic applications.
Concurrence of CDRH, Office of Device Evaluation (ODE)
or Prescrition Use X (per 21 CFR 801.109)
Over-The-Counter Use_
ell
(Division Sign-O Division of General, Restorative. and Neurological Devices
KOGOSS S 510(k) Number
§ 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.