(90 days)
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.
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.
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.
§ 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.