(90 days)
['Not Found']
K #872796
No
The device description details a mechanical system for dispensing liquid nitrogen, with no mention of computational analysis, learning, or adaptive capabilities.
Yes
The device is intended for "general cryosurgical procedures" and dispenses liquid nitrogen for controlled application to target tissue, indicating its direct therapeutic use.
No
The device is described as a cryosurgical device used to dispense liquid nitrogen as a cold gas for general cryosurgical procedures, which are forms of treatment, not diagnosis. It does not mention any function for identifying or analyzing medical conditions.
No
The device description clearly outlines physical components like a stainless steel vacuum bottle, screw-on cap, control valve, handle assembly, and pressure relief valve. It is a hardware device for dispensing liquid nitrogen.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for cryosurgical procedures on a patient's tissue. This is a direct treatment application, not a diagnostic test performed on a sample taken from the body.
- Device Description: The device is designed to deliver liquid nitrogen as a cold gas to a target tissue. This is a physical intervention, not a method for analyzing a biological sample.
- Lack of IVD Characteristics: The description does not mention any of the typical characteristics of an IVD, such as:
- Analyzing biological samples (blood, urine, tissue, etc.)
- Detecting or measuring substances in a sample
- Providing information for diagnosis, monitoring, or screening
The device is clearly intended for a therapeutic procedure (cryosurgery) performed directly on the patient.
N/A
Intended Use / Indications for Use
The intended use of the Premier Nitrospray Plus cryosurgical device is to provide a means for transporting liquid nitrogen to the patient and to dispense the liquid nitrogen as a cold gas in a controlled manner. The gaseous nitrogen when dispensed is at a temperature of -196°C.
To provide a means for transporting liquid nitrogen to the patient and to dispense the liquid nitrogen as a cold gas in a controlled manner outputting a general thermal cryosurgical procedure. The gaseous nitrogen, when dispensed, is at a temperature of -196°C.
Product codes
GEH
Device Description
The Premier Nitrospray Plus consists of a stainless steel vacuum bottle reservoir in various volumes, a screw-on cap with control valve and handle assembly and a pressure relief valve mounted thereon. After filling the reservoir with liquid nitrogen the cap/valve assembly is screwed onto the reservoir to a snug fit. Complete directions for use can be found in Appendix 3.1.
To use the device the professional first attaches an accessory tip to the spray tube luer fitting and points the tip towards the treatment area. Pulling on the handle activates the device by opening the control valve which allows the cold nitrogen gas to be expelled through the tip and onto the target tissue. The length of time and area of exposure is controlled by the professional through the use of the control valve handle and the direction in which the tip is pointed.
The cap/ valve assembly has a safety relief valve mounted thereon to vent the gaseous nitrogen when the internal pressure exceeds the valves preset limit of 7.5 p.s.i.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
licensed clinicians
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)
Not Found
Reference Device(s)
K #872796
Predetermined Change Control Plan (PCCP) - All Relevant Information
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
1970992
JUN 17 1997
SUMMARY OF SAFETY AND EFFECTIVENESS INFORMATION
Submitter's Information -1.
Name and Address:
Premier Dental Products Co. 3600 Horizon Drive Box 61574 King of Prussia, PA 19406-0974
Telephone Number (215) 676-9090
Contact Person Mr. William J. Frezel
Date Prepared March 15, 1997
2. Names for the Device -
Classification Name: Cryosurgical Unit and Accessories (79GEH)
Common Name: Cryosurgical Unit
Proprietary Name: Premier Nitrospray Plus and Premier Nitrospray Lite Plus
- Legally Marketed Devices -3.
The Premier Nitrospray Plus cryosurgical device is substantively equivalent to those offer by:
Wallach Surgical Devices Inc.
Galderma Laboratories/ Brymill Corporation
Center Laboratories
Table 1 compares the Premier Nitrospray device to the predicate devices.
1
Description of Product and Function -4.
The Premier Nitrospray Plus consists of a stainless steel vacuum bottle reservoir in various volumes, a screw-on cap with control valve and handle assembly and a pressure relief valve mounted thereon. After filling the reservoir with liquid nitrogen the cap/valve assembly is screwed onto the reservoir to a snug fit. Complete directions for use can be found in Appendix 3.1.
To use the device the professional first attaches an accessory tip to the spray tube luer fitting and points the tip towards the treatment area. Pulling on the handle activates the device by opening the control valve which allows the cold nitrogen gas to be expelled through the tip and onto the target tissue. The length of time and area of exposure is controlled by the professional through the use of the control valve handle and the direction in which the tip is pointed.
The legally marketed predicate devices listed in section 3 utilize the substantively equivalent method for accomplishing the same basic treatment procedure. The directions for use of these devices can be found in Appendices 3.3 and 3.4.
The cap/ valve assembly has a safety relief valve mounted thereon to vent the gaseous nitrogen when the internal pressure exceeds the valves preset limit of 7.5 p.s.i.
Another similar cryosurgical device also utilizing liquid nitrogen is currently marketed by Premier. This device based on an open system design is activated by closing a finger port to the atmosphere thereby allowing pressure to build in the reservoir resulting in the expulsion of nitrogen gas through a spray tip. This device was originally designed and manufactured by Tower Manufacturing Co. San Antonio ,TX. In 1995 Premier purchased from Tower the rights to manufacture and distribute the device. The Tower open system design received 510(k) marketing clearance through K #872796.
Intended Use -રું.
The intended use of the Premier Nitrospray Plus cryosurgical device is to provide a means for transporting liquid nitrogen to the patient and to dispense the liquid nitrogen as a cold gas in a controlled manner. The gaseous nitrogen when dispensed is at a temperature of -196°C.
An article written by E. G. Kaflik, MD in the December 1994 issue of Journal of the American Academy of Dermatology summarizes the intended use (page 928) and the complications (page 931) of this well established treatment modality. The article also includes descriptions of the conditions which can be treated (pages 928 - 938). Techniques of treatment are described as well as cure rates for various conditions. A copy of the article is found in Appendix 3.5.
This cryosugical device is to be used only by licensed clinicians and is so labeled.
2
6. Technical Characteristics -
A comparison summary of the Premier Nitrospray Plus cryosurgical device to the predicate devices is given in Table 1.
An assembly drawing of the Premier Nitrospray is contained in Appendix 3.2.
3
E I COMPARISON OF PREMIER NITRUSPRAY PLUS TO PREDICATE DEVICES
| MANUFACTURED BY | Premier Dental
Products Co | Premier Dental
Products Co | Wallach Surgical
Devices | Brymill Corp. | Not Known |
|--------------------------|-------------------------------|-------------------------------|-----------------------------|---------------------------|---------------------------|
| MANUFACTURED FOR | | | | Galderma Labs. | Center Laboratories |
| PROPRIETARY NAME | Nitrospray Plus | Nitrospray Plus Lite | UltraFreeze | CRY-AC and
CRY-AC-3 | CryoJet Model
8300 |
| 510(k) NUMBER | To Be Assigned | To Be Assigned | Not Known | Not Known | Not Known |
| METHOD OF
OPERATION | Finger Activated
Valve | Finger Activated
Valve | Finger Activated
Valve | Finger Activated
Valve | Finger Activated
Valve |
| COOLING MEDIA | Liquid Nitrogen | Liquid Nitrogen | Liquid Nitrogen | Liquid Nitrogen | Liquid Nitrogen |
| RESERVIOR VOLUME | 16 oz / 0.47 1 | 10 oz. / 0.30 l | 0.55 1 and 0.30 1 | 0.50 1 and 0.30 1 | 0.5 l |
| TIP LOCKING
MECHANISM | Luer Lock Fitting | Luer Lock Fitting | Luer Lock Fitting | Threaded Tip | Special Design |
| RESERVIOR MATERIAL | Stainless Steel | Stainless Steel | Stainless Steel | Stainless Steel | Plastic Material |
| CAP MATERIAL | Delrin | Delrin | Plastic Material | Stainless Steel | Plastic Material |
| PRESSURE RELIEF SETTING | 7.5 psi | 7.5 psi | Operator Adjustable | 7.5 psi | 7.5 psi |
| ACCESSORIES | Spray Tips | Spray Tips | Spray Tips | Spray Tips | Spray Tips |
4
Image /page/4/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized caduceus, which is a symbol often associated with healthcare. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular pattern around the caduceus.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Mr. William J. Frezel Executive Vice President Premier Dental Products Company 10090 Sandmeyer Lane Philadelphia, Pennsylvania 19116-3502
JUN 17 1997
Re: K970992 Trade Name: Premier Nitrospray Plus and Premier Nitrospray Lite Plus Regulatory Class: II Product Code: GEH Dated: March 15, 1997 Received: March 19, 1997
Dear Mr. Frezel:
参
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 Good Manufacturing Practice for Medical Devices: General (GMP) regulation (21 CFR Part 820) and that, through periodic GMP 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.
5
Page 2 - Mr. William J. Frezel
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
6
Page 1 of of __ 1 __ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _
510(k) Number (if known):
Device Name: __ Premier Nitrospray_Plus_and_Premier_Nitrospray_Lite_Plus
Indications For Use:
To provide a means for transporting liquid nitrogen to the To provide a means for cranspociile itsgoen as a cold gas patient and to dispense the frigure hermal cryosurgical in a controlled manner outping general of the below of the are a
procedures. The gaseous nitrogen, when dispensed, is at a
nd a more of a controll processure of -1960.
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
| (Division Sign-Off) | |
|---|---|
| Division of General Restorative Devices | K970992 |
| 510(k) Number |
| Prescription Use
(Per 21 CFR 801.109) | OR | Over-The-Counter Use
(Optional Format 1-2-96) |
| ------------------------------------------ | ---- | -------------------------------------------------- |
|---|