(119 days)
Cryojet Plus is indicated to be used to: Minimize pain and thermal injury during laser and dermatological treatments and for temporary topical anesthetic relief for injections.
Cryojet Plus is composed of main body (including power supply system, cooling system), power cable, supporting arm rod (a group of supporting rod, two support clips), wind tube, adapters, casters and other accessories. Control system consists of LCD screen display and control board, etc; Cooling system includes compressor, evaporator, radiator, fan, water tank; Power supply system is composed of power cable, filter and ON/OFF switch power.
The provided text describes a medical device called "Cryojet Plus" and its substantial equivalence to a predicate device "Cryo 7". However, it does not contain a study comparing the device's performance against specific acceptance criteria in a comparative effectiveness study involving human readers or standalone AI performance.
Therefore, many of the requested sections cannot be filled from the provided document.
Here's a breakdown of what information is available and what is not:
1. A table of acceptance criteria and the reported device performance
The document provides a comparison of technical specifications between the proposed device (Cryojet Plus) and the predicate device (Cryo 7). While these are performance characteristics, they are not explicitly presented as "acceptance criteria" met by a study designed to prove them. Instead, they are presented as part of a substantial equivalence comparison.
| Specification | Predicate Device (Cryo 7) Performance | Proposed Device (Cryojet Plus) Performance | Discussion of Similarities/Differences (Acceptance/Conformance) |
|---|---|---|---|
| Product Code and Regulation | GEX – Powered Laser Surgical Instrument | GEX – Powered Laser Surgical Instrument | Identical |
| Device Description | Compressor, evaporator, fan to cool skin | Compressor, evaporator, fan to cool skin | Identical |
| Intended Use | Minimize pain & thermal injury; temporary topical anesthetic relief | Minimize pain & thermal injury; temporary topical anesthetic relief | Identical |
| Outlet Temperature | -30°C ± 3°C | -25°C ± 3°C | Similar, not significantly different |
| Outlet Air Speed | 210 ± 40 to 600 ± 100 liters/minute | 200 ± 50 to 620 ± 60 liters/minute | Similar, not significantly different |
| Cooling Method, Operation Principle | Cooling agent-based condenser, evaporation system | Cooling agent-based condenser, evaporation system | Identical |
| Cooling Material | Gas (Air) | Gas (Air) | Identical |
| Mains Voltage | 100V - 120V / 50-60Hz | 100V - 120V / 50-60Hz | Identical |
| Main Fuse | 16A circuit breaker | Without circuit breaker | No impact |
| Power Consumption | Max. 10A | Max. 8A | No impact (Lower consumption is generally seen as positive/neutral) |
| IP Classification | IP20 | IPX0 | No impact |
| Design | Internal metal chassis, plastic shell | Internal metal chassis, industrial designed ABS plastic shell, adapter ABS+PC | Similar, no impact on safety/effectiveness |
| Materials | R452a, closed loop cooling system | R404a, closed loop cooling system | No impact (Both environmentally approved) |
| Cooling Spot Size | Varies, 10cm² at 5cm distance | Varies, 10cm² at 5cm distance (with 3 adapter sizes) | Difference in adapter quantity does not raise different safety/effectiveness questions |
| Fan Speed Settings | 1-9 | 1-10 | Similar, not significantly different |
| Interface | USB 2.0, RS232 | TTL, PWM | Difference doesn't affect safety/effectiveness |
| Therapy Time | 1:00 - 100:00 min - adjustable | 1:00 - 100:00 min - adjustable | Identical |
| Time Delay to Operate | Immediate from pressing START button | Immediate from pressing START button | Identical |
| Compatibility with Environment | R452a Ozone destruction level 0 | R404 Ozone destruction level 0 | Both environmentally approved, no impact |
| Display | 5.0 inch touch screen | 10.1 inch touch screen | Different screen sizes have no impact on safety/effectiveness |
| Net Weight | 60kg | 65kg | Similar, not significantly different |
| Dimensions | H1060 mm x W500 mm x D560 mm | H810 mm x W400 mm x D845mm | Different dimensions have no impact on safety/effectiveness |
| Working Environment Temperature | 10 - 35°C | 10 - 35°C | Identical |
| Working Environment Humidity | 20-80% RH (no condensation) | 20-80% RH (no condensation) | Identical |
| Working Environment Pressure | 900-1030 hPa | 900-1030 hPa | Identical |
| Storage & Transport Temperature | -10 - 50°C | -10 - 50°C | Identical |
| Storage & Transport Humidity | 10-90% RH (no condensation) | 10-90% RH (no condensation) | Identical |
| Storage & Transport Pressure | 700-1060 hPa | 700-1060 hPa | Identical |
| Environmental Specifications | For indoor use only | For indoor use only | Identical |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
Not applicable. This device is not an AI/ML diagnostic or image analysis device, and no clinical testing was performed or reported. The submission focuses on substantial equivalence based on technical characteristics and non-clinical testing.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
Not applicable. No clinical test set with ground truth established by experts was used.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable. No clinical test set was used.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
Not applicable. No MRMC comparative effectiveness study was done. The device is a non-AI therapeutic cooling device.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This is not an AI/ML algorithm.
7. The type of ground truth used (expert concensus, pathology, outcomes data, etc)
Not applicable. No clinical ground truth was established or used for the purpose of this 510(k) submission. The "ground truth" for the device's technical performance would be engineering measurements as per the standards listed.
8. The sample size for the training set
Not applicable. This is not an AI/ML algorithm and therefore does not have a training set.
9. How the ground truth for the training set was established
Not applicable. This is not an AI/ML algorithm and therefore does not have a training set.
Study/Evidence that Proves the Device Meets Acceptance Criteria:
The document states that the Cryojet Plus has been considered to comply with several voluntary standards through investigation and test. These standards cover aspects like electrical safety, electromagnetic compatibility, usability, software lifecycle processes, risk management, biocompatibility assessment (lack of direct patient contact negates further testing), and quality management systems.
Specifically mentioned are:
- IEC 60601-1:2005;A1:2012;A2:2020 (Medical electrical equipment - General requirements for basic safety and essential performance)
- IEC 60601-1-2:2014 (Medical electrical equipment – Electromagnetic disturbances - Requirements and tests)
- IEC 60601-1-6:2013 (Medical electrical equipment – Usability)
- IEC 62366-1:2015 (Medical devices – Application of usability engineering to medical devices)
- IEC 62304:2015 (Medical devices software – software life cycle processes) - Software verification and validation tests were performed successfully and met acceptance criteria.
- ISO 14971:2019-12 (Medical devices – Application of risk management to medical devices)
- ISO 15223-1:2016 (Medical devices - Symbols to be used with medical device labels, labeling, and information to be supplied - Part 1: General requirements)
- ISO 13485:2016 (Medical devices – Quality management systems--Requirements for regulatory purposes)
- ISO 10993-1:2018 (Biological evaluation of medical devices – Part 1: Evaluation and testing within a risk management process) - Biocompatibility was assessed, and no additional testing was deemed necessary due to no direct patient contact.
Non-clinical testing for Cryojet Plus included:
- Electrical safety testing according to IEC 60601-1.
- Electromagnetic compatibility testing according to IEC 60601-1-2.
- Software verification and validation.
The conclusion is that the Cryojet Plus is substantially equivalent to the predicate device (Cryo 7) in intended use, device characteristics, and application parameters, based on these technical comparisons and non-clinical testing. No clinical testing was included in this 510(k).
§ 878.4810 Laser surgical instrument for use in general and plastic surgery and in dermatology.
(a)
Identification. (1) A carbon dioxide laser for use in general surgery and in dermatology is a laser device intended to cut, destroy, or remove tissue by light energy emitted by carbon dioxide.(2) An argon laser for use in dermatology is a laser device intended to destroy or coagulate tissue by light energy emitted by argon.
(b)
Classification. (1) Class II.(2) Class I for special laser gas mixtures used as a lasing medium for this class of lasers. The devices subject to this paragraph (b)(2) are exempt from the premarket notification procedures in subpart E of part 807 of this chapter, subject to the limitations in § 878.9.