(119 days)
No reference devices were used in this submission.
No
The device description and performance studies focus on standard medical device components and testing (electrical safety, EMC, software verification/validation) and do not mention any AI/ML components, algorithms, or related performance metrics.
Yes.
The device's intended use is to "Minimize pain and thermal injury during laser and dermatological treatments and for temporary topical anesthetic relief for injections," which directly relates to alleviating or treating symptoms.
No
The provided text describes the device's function as minimizing pain, thermal injury, and providing temporary topical anesthetic relief. It does not mention any diagnostic capabilities like detecting, identifying, or monitoring medical conditions.
No
The device description clearly lists multiple hardware components including a main body, power supply system, cooling system, supporting arm rod, wind tube, adapters, and casters. While it mentions a control system with an LCD screen and control board, the overall device is a physical apparatus with integrated software, not a standalone software product.
Based on the provided information, the Cryojet Plus device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states that the device is used to "Minimize pain and thermal injury during laser and dermatological treatments and for temporary topical anesthetic relief for injections." This is a therapeutic and pain management function applied directly to the patient's skin.
- Device Description: The description details a cooling system and components designed to deliver cold air to the skin. This aligns with a physical therapy or pain relief device, not a device that analyzes biological samples.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue, etc.), reagents, or any processes typically associated with in vitro diagnostics.
IVD devices are used to examine specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes. The Cryojet Plus does not perform any such analysis.
N/A
Intended Use / Indications for Use
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.
Product codes (comma separated list FDA assigned to the subject device)
GEX
Device Description
Cryojet Plus is intended to minimize pain and thermal injury during laser and dermatological treatments and for the temporary topical anesthetic relief for injections. And it shall be used by professionally trained medical operators.
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.
How It Works: Gaseous refrigerant is compressed into high-temperature and high-pressure gas by high-power compressor and sent to condenser for cooling. Refrigerant can produce cold air by condenser and evaporation system for skin cooling through conduction, evaporation and forced convection. Evaporator absorbs heat in air and vaporizes the heat, then heat is gaseous, then the gas is back to compressor and continue to be compressed. Thus cooling is done through such circulation. Defrosting system melts the frost inside evaporation system into liquid water and discharge the water through drain valve.
Software is used for system initialization, displaying user interface and cooling system control. Parameter setting (therapy time and wind level) can be done by touching LCD screen, thus START/STOP and defrosting of device can be controlled. The software can be used in conjunction with hardware system during treatment to minimize thermal damage to tissues and reduce pain.
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
professionally trained medical operators
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)
Non-clinical testing for Cryojet Plus included electrical safety testing according to IEC 60601-1, electromagnetic compatibility testing according to IEC 60601-1-2. The device has been assessed for the requirement of biocompatibility testing as per ISO 10993-1. Since the device is not intended to be in contact with the patient, and the user wears medical gloves when touching the device, there is no additional biocompatibility requirement for device. In addition, software verification and validation was completed.
No clinical testing is included in this 510(k).
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
No reference devices were used in this submission.
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 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.
0
Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue. The words "U.S. FOOD & DRUG" are on the top line, and the word "ADMINISTRATION" is on the bottom line.
February 6, 2024
Beijing Sano Laser S&T Development Co., Ltd % Zhao Huifang Correspondent Microkn Business Consulting (Shanghai) Co., Ltd. Room 1319, Block A, No 3699, Gonghexin Road Jingan District Shanghai, 200040 China
Re: K233416
Trade/Device Name: Cryojet Plus (SHE-ACP001-1) Regulation Number: 21 CFR 878.4810 Regulation Name: Laser Surgical Instrument For Use In General And Plastic Surgery And In Dermatology Regulatory Class: Class II Product Code: GEX Dated: December 26, 2023 Received: December 26, 2023
Dear Zhao Huifang:
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 indications 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 Food, Drug, and Cosmetic Act (the 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 Act. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database available at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
1
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device" (https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download).
Your device is also subject to, among other requirements, the Quality System (QS) regulation (21 CFR Part 820), which includes, but is not limited to. 21 CFR 820.30. Design controls: 21 CFR 820.90. Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review, the QS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.70) and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181).
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. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting of medical device-related adverse events) (21 CFR Part 803) for devices or postmarketing safety reporting (21 CFR Part 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn).
2
Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-devices/deviceadvice-comprehensive-regulatory-assistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely.
Tanisha L. Tanisha L.Hithe -S 2024.02.06 Hithe -S 17:09:18 -05'00'
Tanisha Hithe Assistant Director DHT4A: Division of General Surgery Devices OHT4: Office of Surgical & Infection Control Devices, Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
3
Indications for Use
510(k) Number (if known) K233416
Device Name Cryojet Plus (SHE-ACP001-1)
Indications for Use (Describe)
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.
| Type of Use (Select one or both, as applicable) | |
|---|---|
| ------------------------------------------------- | -- |
X Prescription Use (Part 21 CFR 801 Subpart D)
| Over-The-Counter Use (21 CFR 801 Subpart C)
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4
I. Contact Details
| Applicant Name: | Beijing Sano Laser S&T Development Co., Ltd. |
|---|---|
| Room 201, 2nd Floor, No.7 Building, Maohuagongchang, NO.1 | |
| CAIDA Third Street, Nancai Town, Shunyi District, Beijing, China | |
| TEL: 086-10-57150601 | |
| Contact: | Hongbo Zhang, CEO |
| 360349720@qq.com |
Date Prepared: Oct 06, 2023
II. Device Name
Device Name : Cryojet Plus (Model: SHE-ACP001-1)
Generic Name: Powered Laser Surgical Instrument
Classification Name: Laser surgical instrument for use in general and plastic surgery and in dermatology (21CFR 878.4810)
Regulatory Class: II
Product Code: GEX
III. Predicate Device
| 510(k) Number | Product Code | Trade Name | Applicant |
|---|---|---|---|
| K220020 | GEX | Cryo 7 | Zimmer MedizinSysteme GmbH |
This predicate has not been subject to a design-related recall.
No reference devices were used in this submission.
IV. Device Description
Cryojet Plus is intended to minimize pain and thermal injury during laser and dermatological treatments and for the temporary topical anesthetic relief for injections. And it shall be used by professionally trained medical operators.
5
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.
How It Works: Gaseous refrigerant is compressed into high-temperature and high-pressure gas by high-power compressor and sent to condenser for cooling. Refrigerant can produce cold air by condenser and evaporation system for skin cooling through conduction, evaporation and forced convection. Evaporator absorbs heat in air and vaporizes the heat, then heat is gaseous, then the gas is back to compressor and continue to be compressed. Thus cooling is done through such circulation. Defrosting system melts the frost inside evaporation system into liquid water and discharge the water through drain valve.
Software is used for system initialization, displaying user interface and cooling system control. Parameter setting (therapy time and wind level) can be done by touching LCD screen, thus START/STOP and defrosting of device can be controlled. The software can be used in conjunction with hardware system during treatment to minimize thermal damage to tissues and reduce pain.
V. Intended Use/Indications for use
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.
Main components of device are listed below:
| Components | Function Description |
|---|---|
| Air Switch | Control of Device Power ON/OFF |
Table 2 Main Components of Proposed Device
6
| Touch Screen | Display User Interface, Operation Control System, Treatment
Parameter Setting |
|--------------|--------------------------------------------------------------------------------------|
| Wind Tube | Deliver cold air from blower to adapter. |
| Adapter | Different sizes of adapters are applicable to different body parts to be
treated. |
VI. Substantial Equivalence Comparison / Comparison of technological characteristics with the predicate device
The predicate device for this submission is Cryo 7(K220020) from Zimmer MedizinSysteme GmbH that has been approved under K220020.
The submitted proposed device (Cryojet Plus) and predicate device (Cryo 7) are both classified as II. They are both for skin cooling by blowing cold wind to patient's local skin parts (the device is not intended to be in contact with patient). The indications of proposed device (Cryojet Plus) and predicate device (Cryo 7) are the same.
The submitted proposed device (Cryojet Plus) and predicate device (Cryo 7) are based on the same scientific theories:
- The working theories principles are identical. They both apply compressor cooling. Refrigerant is compressed into high-temperature and high-pressure gas (by high-power compressor) and sent to condenser for cooling and liquefaction. Refrigerant goes through expansion valve for throttle in evaporator and it absorbs heat in air and generate cold air surrounding it. Meanwhile, the fan blows natural air into evaporator for coldness and heat exchange, then the cold air is conducted to skin by wind tube. Forced convection makes skin cooling. Refrigerant absorbs heat in evaporator and becomes evaporated, then back to compressor to continue compression. Thus cooling is done through such circulation.
7
Defrosting system melts the frost inside evaporation system into liquid water and discharge the water through drain valve.
-
- While the wind current flow level range, lowest temperature of output wind, cooling spot coverage area at a distance of 5cm, therapy time and defrost for both devices are identical or similar to reach the indicated effect, they do differ in appearance, size (dimension), weight and the product code of control system. The whole device is supported and moved through casters.
- Product Components: The two devices are both substantially composed of compressor, 3. evaporator, condenser, DC brushless motor, fan, temperature sensor and wind tubes.
-
- Their energy sources are also identical.
The comparison of technical characteristics between proposed device (Cryojet Plus) and predicate device (Cryo 7) are as follows:
-
- For Cryojet Plus produced by SANO Laser, there are 3 sizes of adapters (listed below) for therapy on different body parts; for Cryo 7 produced by Zimmer, there is no adapter for choice, wind is blown out from end of wind tube directly. (Vary in cooling spot coverage area at a distance of 5cm).
| Item | Adapter Specifications | Size | Intended for use |
|---|---|---|---|
| 1 | Small Sized Round | ||
| Adapter | Image: Small Sized Round Adapter | For small area | |
| treatment and skin | |||
| cooling meanwhile | |||
| (e.g. eyebrow, | |||
| armpits, forehead.) | |||
| 2 | Medium Sized | ||
| Square Adapter | Image: Medium Sized Square Adapter | For medium area | |
| treatment and skin | |||
| cooling meanwhile | |||
| (especially used for | |||
| hair removal on arms, | |||
| armpits and legs, in | |||
| conjunction with hair |
8
| removal machine.) | |||
|---|---|---|---|
| 3 | Large Sized Square | ||
| Adapter | Image: Adapter | For large area | |
| treatment and skin | |||
| cooling meanwhile | |||
| (especially used for | |||
| hair removal on | |||
| thighs, abdomen, in | |||
| conjunction with hair |
-
- Different Display Screen Size: Proposed device (Cryojet Plus) screen size is 10.1 inch and predicate device (Cryo 7) screen size is 5 inch;
- IP Protection Level Difference: Proposed device (Cryojet Plus) is IPX0 and predicate 3. device (Cryo 7) is IP20;
- Weight Difference: Proposed device (Cryojet Plus) is 65kg and predicate device (Cryo 7) 4. is 60kg.
However, these differences do not affect the substantial equivalence; they are still based on the same technical characteristics to achieve the same purpose. For technical characteristics and operating principle associated with therapy, proposed device (Cryojet Plus) and predicate device (Cryo 7) are identical similarities and differences between the proposed device and the predicate device are described below in the comparison table. The differences do not raise any new issues of safety or effectiveness.
9
| Specification | PROPOSED DEVICE
Beijing Sano Laser S&T Development
Co., Ltd.
Cryojet Plus (This Submission) | PREDICATE DEVICE
Zimmer MedizinSysteme GmbH
Cryo 7 (K220020) | Discussion of
Similarities/
Differences |
|-------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Product Code and
Regulation | General & Plastic Surgery 21 CFR
878.4810 GEX – Powered Laser Surgical
Instrument | General & Plastic Surgery 21 CFR 878.4810
GEX - Powered Laser Surgical Instrument. | Identical |
| Device
Description | The Cryojet Plus Air Device consists of a
compressor, evaporator and fan to cool the
patient's skin locally without contact to
skin. | The Cryo 7 Cold Air Device consists of a
compressor, evaporator and fan to cool the
patient's skin locally without contact to skin. | Identical |
| Intended Use | The Cryojet Plus is intended to minimize
pain and thermal injury during laser and
dermatological treatments and for
temporary topical anesthetic relief for
injections. | The Cryo 7 is intended to minimize pain and
thermal injury during laser and dermatological
treatments and for temporary topical anesthetic
relief for injections. | Identical |
| Performance
Characteristics
Measurement at
device outlet | -25°C ± 3°C, At an air speed of 200 ± 50
to 620 ± 60 liters/minute. | -30°C ± 3°C, At an air speed of 210 ± 40 to
600 ± 100 liters/minute. | Similar, not
significantly
different |
| Cooling Method,
Operation
Principle | Cooling agent-based condenser and
evaporation system. Cold air is produced
which is then delivered to skin for skin
cooling by conduction, evaporation, and
forced convection. | Cooling agent-based condenser and evaporation
system. Cold air is produced which is then
delivered to skin for skin cooling by conduction,
evaporation, and forced convection. | Identical |
| Specification | PROPOSED DEVICE
Beijing Sano Laser S&T Development
Co., Ltd.
Cryojet Plus (This Submission) | PREDICATE DEVICE
Zimmer MedizinSysteme GmbH
Cryo 7 (K220020) | Discussion of
Similarities/
Differences |
| Cooling Material | Gas (Air) | Gas (Air) | Identical |
| Mains Voltage | 100V - 120V / 50-60Hz | 100V - 120V / 50-60Hz | Identical |
| Main Fuse | Without circuit breaker in main switch | 16A circuit breaker in main switch | No impact |
| Power
Consumption | Max. 8A | Max. 10A | No impact |
| IP Classification | IPX0 | IP20 | No impact |
| Design | Internal metal chassis and framework by
industrial designed ABS plastic shell,
adapter material is ABS+PC | Internal metal chassis covered by industrial
designed plastic shell | Similar, no
impact on
device safety
and
effectiveness
evaluation |
| Materials | Environmentally approved R404a, closed
loop cooling system | Environmentally approved R452a, closed loop
cooling system | No impact |
| Specification | PROPOSED DEVICE
Beijing Sano Laser S&T Development
Co., Ltd.
Cryojet Plus (This Submission) | PREDICATE DEVICE
Zimmer MedizinSysteme GmbH
Cryo 7 (K220020) | Discussion of
Similarities/
Differences |
| Cooling Spot Size | Varies in cooling spot size (coverage area)
with a distance of 5cm from wind outlet
part to skin - 10cm $^{2}$ | Varies in cooling spot size (coverage area) with
a distance of 5cm from wind outlet part to skin -
10cm $^{2}$ | The
difference of
adapter
quantity does
not raise
different
questions of
safety and
effectiveness:
SANO
Cryojet Plus
machine has 3
adapter sizes
for choice
according to
different body
parts to be
treated;
Zimmer
machine has
only one
adapter size. |
| Specification | PROPOSED DEVICE
Beijing Sano Laser S&T Development
Co., Ltd.
Cryojet Plus (This Submission) | PREDICATE DEVICE
Zimmer MedizinSysteme GmbH
Cryo 7 (K220020) | Discussion of
Similarities/
Differences |
| Fan Speed
Settings | 1-10 | 1-9 | Similar, not
significantly
different |
| Interface | TTL, PWM | USB 2.0, RS232 | Difference in
interfaces
doesn't affect
device safety
and
effectiveness
evaluation |
| Therapy time,
Treatment time | 1:00 - 100:00 min - adjustable for users | 1:00 - 100:00 min - adjustable for users | Identical |
| Time Delay to
Operate | Immediate from pressing START
button when system turns to standby mode | Immediate from pressing START
button when system turns to standby mode | Identical |
| Compatibility with
the environment | R404 Ozone destruction level 0 | R452a Ozone destruction level 0 | Both
environmenta
lly approved,
no impact |
| Specification | PROPOSED DEVICE
Beijing Sano Laser S&T Development
Co., Ltd.
Cryojet Plus (This Submission) | PREDICATE DEVICE
Zimmer MedizinSysteme GmbH
Cryo 7 (K220020) | Discussion of
Similarities/
Differences |
| Display | 5.0 inch touch screen display | 10.1 inch touch screen display | Different
screen sizes
have no
impact on the
device safety
and
effectiveness
evaluation |
| Net Weight
without
accessories | 65kg | 60kg | Similar, not
significantly
different |
| Dimensions | H810 mm x W400 mm x D845mm | H1060 mm x W500 mm x D560 mm | Different
dimensions
have no
impact on the
device safety
and
effectiveness
evaluation |
| Specification | PROPOSED DEVICE
Beijing Sano Laser S&T Development
Co., Ltd.
Cryojet Plus (This Submission) | PREDICATE DEVICE
Zimmer MedizinSysteme GmbH
Cryo 7 (K220020) | Discussion of
Similarities/
Differences |
| Working
Environment
Temperature and
Humidity | Temperature: 10 - 35°C | Temperature: 10 - 35°C | Identical |
| | Humidity: 20-80% relative humidity (no
condensation) | Humidity: 20-80% relative humidity (no
condensation) | |
| | Atmosphere Pressure: 900-1030 hPa | Atmosphere Pressure: 900-1030 hPa | |
| Storage and
Transport | Temperature: -10 - 50°C | Temperature: -10 - 50°C | Identical |
| | Humidity: 10-90% relative humidity (no
condensation) | Humidity: 10-90% relative humidity (no
condensation) | |
| | Atmosphere Pressure: 700-1060 hPa | Atmosphere Pressure: 700-1060 hPa | |
| Environmental
Specifications | For indoor use only | For indoor use only | Identical |
Table Summary of Similarities and Differences
10
11
12
13
14
15
Cryojet Plus 510(k) Notification K233416 Performance Data
By investigation and test, Cryojet Plus has been considered to comply with the following voluntary standards:
| Standards | Standards
Organization | Standards Title |
|------------------------------------------|---------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| IEC 60601-
1:2005;A1:2012;A
2:2020 | IEC | Medical electrical equipment-Part1:General
requirements for basic safety and essential
performance |
| IEC 60601-1-
2:2014 | IEC | Medical electrical equipment – Part 1-2: General
requirements for basic safety and essential
performance – Collateral standard: Electromagnetic
disturbances - Requirements and tests |
| IEC 60601-1-
6:2013 | IEC | Medical electrical equipment – Part 1-6: General
requirements for basic safety and essential
performance - Collateral standard: Usability |
| IEC 62366-1:2015 | IEC | Medical devices – Part 1: Application of usability
engineering to medical devices |
| IEC 62304:2015 | IEC | Medical devices software –software life cycle
processes |
| ISO 14971:2019-
12 | ISO | Medical devices – Application of risk management to
medical devices |
| ISO 15223-1:2016 | ISO | Medical devices - Symbols to be used with medical
device labels, labeling, and information to be
supplied - Part 1: General requirements |
| ISO 13485:2016 | ISO | Medical devices – Quality management systems-- |
| | | Requirements for regulatory purposes |
| ISO 10993-1:2018 | ISO | Biological evaluation of medical devices – Part 1:
Evaluation and testing within a risk management
process |
16
Software Verification and Validation Testing
After evaluation on specified use conditions, it could be proved that the technical design (including software flow and device application) of Cryojet Plus is suitable to fulfill the specified intended use. In both formative and summative testing performed, no application problems were found that could lead to any risk for the user, patient or the third parties.
The verification of software requirements was performed according to IEC 62304. All the tests were performed successfully and met their acceptance criteria.
Biocompatibility Testing
The device has been assessed for the requirement of biocompatibility testing as per ISO 10993-1. Since the device is not intended to be in contact with the patient, and the user wears medical gloves when touching the device, there is no additional biocompatibility requirement for device.
Electrical Safety and Electromagnetic Compatibility (EMC)
The device has undergone electrical and mechanical safety performance testing and electromagnetic compatibility testing as a result of the changes referenced. The system complies with IEC 60601-1:2005 + A1:2012+ A2:2020, and IEC 60601-1-2:2014+ A1:2020 .
Non-clinical Testing
Non-clinical testing for Cryojet Plus included electrical safety testing according to IEC 60601-1, electromagnetic compatibility testing according to IEC 60601-1-2. The device has been assessed for the requirement of biocompatibility testing as per ISO 10993-1. Since the device is not intended to be in contact with the patient, and the user wears medical gloves when touching the device, there is no additional biocompatibility requirement for device. In addition, software verification and validation was completed.
Clinical Testing
No clinical testing is included in this 510(k).
17
Summary / Conclusion
The Cryojet Plus are substantially equivalent to the Cryo 7 in intended use, device characteristics and application parameters.