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 for general cryosurgical procedures. The gaseous nitrogen, when dispensed, is at a temperature of -196°C.

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. 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.

AI/ML Overview

This appears to be a 510(k) premarket notification for a medical device, specifically a cryosurgical unit. In the context of a 510(k), the "acceptance criteria" and "study that proves the device meets the acceptance criteria" are not framed in the same way as they might be for a novel device or a clinical trial. Instead, the primary "acceptance criterion" for a 510(k) is demonstrating substantial equivalence to a predicate device. The "study" proving this is often a comparison of technical characteristics and intended use.

Here's an analysis based on your request, highlighting what is (and isn't) present in the provided document:

1. Table of Acceptance Criteria and Reported Device Performance

For a 510(k) submission, the "acceptance criteria" are essentially the characteristics and performance of the predicate devices that the new device must match or be equivalent to. The "reported device performance" is a comparison of the new device's characteristics against those predicate devices.

Acceptance Criteria (Predicate Device Characteristics)	Reported Device Performance (Premier Nitrospray Plus/Lite Plus)
Method of Operation: Finger Activated Valve	Finger Activated Valve
Cooling Media: Liquid Nitrogen	Liquid Nitrogen
Reservoir Volume: 0.55 L, 0.30 L (Wallach); 0.50 L, 0.30 L (Brymill); 0.5 L (CryoJet)	16 oz / 0.47 L (Nitrospray Plus); 10 oz / 0.30 L (Nitrospray Lite Plus)
Tip Locking Mechanism: Luer Lock Fitting (Wallach); Threaded Tip (Brymill); Special Design (CryoJet)	Luer Lock Fitting (for both Premier devices)
Reservoir Material: Stainless Steel (Wallach, Brymill)	Stainless Steel
Cap Material: Plastic Material (Wallach, CryoJet); Stainless Steel (Brymill)	Delrin (for both Premier devices)
Pressure Relief Setting: Operator Adjustable (Wallach); 7.5 psi (Brymill, CryoJet)	7.5 psi
Accessories: Spray Tips	Spray Tips
Intended Use: To provide a means for transporting liquid nitrogen to the patient and to dispense it as a cold gas for cryosurgical procedures.	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 for thermal cryosurgical procedures. (Consistent with predicate devices as described in the Kaflik article).

2. Sample Size Used for the Test Set and Data Provenance

No specific "test set" and associated sample size are explicitly mentioned for a performance study. The document relies on a comparison of technical specifications and the shared operating principles with legally marketed predicate devices.
Data Provenance: The data is primarily from the manufacturer's own specifications for their device and specifications (or general knowledge) of predicate devices from other manufacturers (Wallach Surgical Devices Inc., Galderma Laboratories/Brymill Corporation, Center Laboratories). This is essentially retrospective in the sense that it's based on existing device designs and specifications rather than a prospective study with a clinical cohort.
The document references an article by E. G. Kaflik, MD (December 1994, Journal of the American Academy of Dermatology) that "summarizes the intended use...and the complications...of this well established treatment modality." This article provides clinical evidence for the modality itself, not a specific performance study of the Premier device.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications

Not applicable in this context. For a 510(k) submission based on substantial equivalence to existing devices, a "ground truth" derived from expert consensus on a test set (as one might see in an AI algorithm validation) is not typically required or presented. The "ground truth" here is effectively the established performance and safety profile of the predicate devices.

4. Adjudication Method for the Test Set

Not applicable. There is no "test set" in the sense of a collection of cases requiring adjudication. The comparison is based on technical specifications and functional equivalence.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done

No, an MRMC comparative effectiveness study was not done. This type of study is typically used to evaluate the impact of a new diagnostic aid (like AI) on physician performance. The Premier Nitrospray Plus is a cryosurgical device used directly by clinicians, not a diagnostic tool requiring interpretation or a study of how it assists human readers.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done

Not applicable. This device is a physical cryosurgical unit, not an algorithm. Standalone performance studies are relevant for software or AI components. The device requires a human operator (a licensed clinician) for its intended function.

7. The Type of Ground Truth Used

The "ground truth" for this 510(k) submission is the established safety and effectiveness of the legally marketed predicate devices for cryosurgical procedures using liquid nitrogen. The Premier device aims to demonstrate it performs in a "substantially equivalent" manner to these established technologies. The Kaflik article supports the general effectiveness of the cryosurgical modality.

8. The Sample Size for the Training Set

Not applicable. There is no "training set" as this is not an AI/machine learning device.

9. How the Ground Truth for the Training Set was Established

Not applicable. As there is no training set mentioned, there is no ground truth established for it.

Summary

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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.

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Description of Product and Function -4.

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.

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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.

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E I COMPARISON OF PREMIER NITRUSPRAY PLUS TO PREDICATE DEVICES

MANUFACTURED BY	Premier DentalProducts Co	Premier DentalProducts Co	Wallach SurgicalDevices	Brymill Corp.	Not Known
MANUFACTURED FOR				Galderma Labs.	Center Laboratories
PROPRIETARY NAME	Nitrospray Plus	Nitrospray Plus Lite	UltraFreeze	CRY-AC andCRY-AC-3	CryoJet Model8300
510(k) NUMBER	To Be Assigned	To Be Assigned	Not Known	Not Known	Not Known
METHOD OFOPERATION	Finger ActivatedValve	Finger ActivatedValve	Finger ActivatedValve	Finger ActivatedValve	Finger ActivatedValve
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 LOCKINGMECHANISM	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

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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.

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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

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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)
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Regulation Number and Section

§ 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.