Who is the manufacturer of Cryo 7?

Zimmer Medizinsysteme GmbH filed the 510(k) submission for Cryo 7 (K220020).

What is the FDA product code for Cryo 7?

GEX. It is classified under 21 CFR 878.4810 as a Class 2 device in the General, Plastic Surgery panel.

What is the regulatory pathway for Cryo 7?

510(k) clearance (submission type: Special).

Who can help prepare an FDA 510(k) submission like Cryo 7?

Innolitics — a medical-device software consultancy — provides regulatory and engineering support for FDA 510(k) submissions. See https://innolitics.com/services/510ks/ or contact https://innolitics.com/contact.

Cryo 7

K220020 · Zimmer Medizinsysteme GmbH · GEX · Feb 4, 2022 · General, Plastic Surgery

Device Facts

Record ID	K220020
Device Name	Cryo 7
Applicant	Zimmer Medizinsysteme GmbH
Product Code	GEX · General, Plastic Surgery
Decision Date	Feb 4, 2022
Decision	SESE
Submission Type	Special
Regulation	21 CFR 878.4810
Device Class	Class 2
Attributes	Therapeutic

Intended Use

The Cryo 7 is indicated to be used to: Minimize pain and thermal injury during laser and dermatological treatments and for temporary topical anesthetic relief for injections.

Device Story

Cryo 7 is a non-invasive, contactless cold air therapy device used in clinical settings (dermatology, plastic surgery). It utilizes a compressor, evaporator, and fan system to cool and dehumidify air, which is then directed onto the patient's skin to provide cooling via conduction, evaporation, and forced convection. The device is operated by a clinician via a 10.1-inch capacitive touchscreen interface. It provides localized skin cooling to minimize pain and thermal injury during procedures or as a topical anesthetic aid. The device is a stationary unit with a chassis, rollers, and shelf plate. It is essentially an updated version of the predicate Cryo V6.0, featuring updated hardware, mechanical layout, and display, while maintaining identical cooling parameters and operating principles.

Clinical Evidence

Bench testing only. No clinical data. Performance was verified through electrical/mechanical safety testing (ES60601-1), EMC testing (IEC 60601-1-2), and software verification (IEC 62304). Usability engineering was performed per IEC 62366-1. Biocompatibility was assessed per ISO 10993-1; no testing required as the device is contactless.

Technological Characteristics

Closed-loop cooling system using R452a refrigerant. Cooling principle: compressor-based refrigeration with forced air convection. Dimensions: 1060mm x 500mm x 560mm. Weight: 60kg. Interface: 10.1-inch capacitive touch display, USB 2.0, RS 232. Power: 100-120V, 50-60Hz. IP20 rating. Software developed per IEC 62304.

Indications for Use

Indicated for patients undergoing laser or dermatological treatments to minimize pain and thermal injury, and for temporary topical anesthetic relief for injections.

Regulatory Classification

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.

Predicate Devices

Cryo V6.0 (K060395)

Related Devices

K060395 — CRYO, MODEL V6.0 · Zimmer Elektromedizin GmbH · Feb 24, 2006
K080735 — CRYOMINI · Zimmer Elektromedizin GmbH · Apr 4, 2008
K233416 — Cryojet Plus (SHE-ACP001-1) · Beijing Sano Laser S&T Development Co.,Ltd · Feb 6, 2024
K242132 — FREDDO · Fabinject Lndustria E Comercio Lmportacao E Exportacao Ltda · Oct 18, 2024
K040727 — CRYO 5 · Zimmer Elektromedizin GmbH · Apr 23, 2004

Submission Summary (Full Text)

{0}------------------------------------------------ Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health and Human Services logo on the left and the FDA logo on the right. The FDA logo is a blue square with the letters "FDA" in white, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue. February 4, 2022 Zimmer MedizinSysteme GmbH % Scott Blood Principal Consultant Quality and Regulatory Services 151 Gleasondale Road Stow, Massachusetts 01775 Re: K220020 Trade/Device Name: Cryo 7 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 29, 2021 Received: January 5, 2022 Dear Scott Blood: 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 (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 located 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. 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. {1}------------------------------------------------ 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 803) for devices or postmarketing safety reporting (21 CFR 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 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 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). 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-device-advice-comprehensive-regulatoryassistance/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. Purva Pandya Assistant Director DHT4A: Division of General Surgery Devices OHT4: Office of Surgical and Infection Control Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health Enclosure {2}------------------------------------------------ # Indications for Use 510(k) Number (if known) K220020 Device Name Cryo 7 Indications for Use (Describe) The Cryo 7 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) | | |------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------| | <div style="display:flex; align-items:center;">☑ Prescription Use (Part 21 CFR 801 Subpart D)</div> | <div style="display:flex; align-items:center;">☐ Over-The-Counter Use (21 CFR 801 Subpart C)</div> | CONTINUE ON A SEPARATE PAGE IF NEEDED. This section applies only to requirements of the Paperwork Reduction Act of 1995. #### *DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.* The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to: > Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov "An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number." {3}------------------------------------------------ K220020 Image /page/3/Picture/1 description: The image shows the logo for Zimmer MedizinSysteme. The logo consists of the word "zimmer" in a bold, sans-serif font. Below the word "zimmer" is the word "MedizinSysteme" in a smaller, sans-serif font. The logo is simple and modern. # 510(k) SUMMARY This 510(k) summary of safety and effectiveness information is submitted in accordance with the requirements of SMDA 1990 and 21 CFR 807.92. | I. SUBMITTER: | Zimmer MedizinSysteme GmbH Junkersstrasse 9 89231 Neu-Ulm, Germany Establishment Registration: 8010720 Ms. Ute Killet Manager, Regulatory Affairs Phone: +49-731-9761-216 Fax: +49-731-9761-118 E-mail: u.klllet@zimmer.de | |------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | CONTACT: | Scott Blood Principal Consultant Phone: 978.729.5978 Fax: +49-731-9761-118 E-mail: scottqara@gmail.com | | DATE PREPARED: | December 29, 2021 | | TRADE NAME: | Cryo 7 | | COMMON NAME: | Laser surgical instrument for use in general and plastic surgery and in dermatology | | CLASSIFICATION NAME: | Powered Laser Surgical Instrument | | DEVICE CLASSIFICATION: | Class II, 21 CFR §878.4810 | | PRODUCT CODE: | GEX | | III. PREDICATE DEVICE: | Cryo V6.0 (K060395) | ## IV. DEVICE DESCRIPTION: The Cryo 7 is a non-invasive Therapeutic device. The cold air therapy device cools and dehumidifies the air, which can be used to minimize pain and thermal injury during laser and dermatological treatments and for temporary topical anesthetic relief for injections. The cold air therapy device is intended to cool the patient's skin locally and is intended to be used contactless. The subject Cryo 7 device is the same as the currently-cleared Cryo 6 {4}------------------------------------------------ Image /page/4/Picture/0 description: The image shows the logo for Zimmer MedizinSysteme. The logo consists of the word "zimmer" in a bold, sans-serif font, with a horizontal line above the "z". Below the word "zimmer" is the text "MedizinSysteme" in a smaller, lighter font. The logo is simple and modern, and the use of a bold font and horizontal line makes it easily recognizable. (K060395), except for branding and state-of-the-art updates. Both the subject device and predicate device are manufactured by Zimmer MedizinSysteme GmbH. The mechanical assembling consists of a housing, a chassis with 4 rotating rollers and a shelf plate. The chassis includes all technical components, like compressor, evaporator, condenser, fans and all electrical power components. On the upper front cover, the user interface control it operated via touchscreen. The software controls the device initialization, the hardware components for the cooling circuit as well as the user interface. The user interface can be controlled via capacitive touch display. The software controls the device initialization, the hardware components for the cooling circuit as well as the user interface. #### V. INDICATONS FOR USE: Cryo 7 is indicated to be used to: Minimize pain and thermal injury during laser and dermatological treatments and for temporary topical anesthetic relief for injections. #### VI. COMPARISON OF TECHNOLOGICAL CHARACTERISTICS WITH THE PREDICATE DEVICE: The technological characteristics and operating principle associated with the treatment this device delivers remain unchanged from the predicate device. The device produces cold air for blowing on patient's skin locally and is intended to be contactless. Updates were made to the predicate device (K060395) system hardware, mechanical layout and the display (new, 10.1 inch touch display). Also, the software was adapted according to the hardware modifications. Specifically, the cooling parameters remain unchanged. The technological similarities and differences between the subject device and the predicate device are described below in the comparison table. The differences do not raise any new questions regarding safety or effectiveness. {5}------------------------------------------------ Image /page/5/Picture/0 description: The image shows the logo for Zimmer MedizinSysteme. The logo consists of the word "zimmer" in a bold, sans-serif font, with a horizontal line above the "z" and "i". Below the word "zimmer" is the text "MedizinSysteme" in a smaller, sans-serif font. The logo is in grayscale. | Comparison with the Predicate Device | SUBJECT DEVICE Zimmer MedizinSysteme GmbH Cryo 7 (This Submission) | PREDICATE DEVICE Zimmer MedizinSysteme GmbH Cryo V6.0 (K060395) | Discussion | |-------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------| | 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 Cryo 7 Cold Air Device utilizes a compressor, evaporator and fan to cool the patient's skin locally and contactless. | The Zimmer Cryo V6.0 Cold Air Device utilizes a compressor, evaporator and fan to cool room air and then direct it onto skin. | Similar | | Intended Use | The Cryo 7 is intended to minimize pain and thermal injury during laser and dermatological treatments and for temporary topical anesthetic relief for injections. | The Cryo V6.0 Cold Air Device 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 | -30°C ± 3°C At an air speed of 210 ± 40 to 600 ± 100 liters/minute. | -30°C At an air speed of 100 to 1000 liters/minute. | Similar, not significantly different | | Cooling Method, Operation principle | Cooling agent-based condenser and evaporation system. Cold air is produced which is then directed onto the skin. Conduction, evaporation, and forced convection cool the skin. | Cooling agent-based condenser and evaporation system. Cold air is produced which is then directed onto the skin. Conduction, evaporation, and forced convection cool the skin. | Identical | | Cooling Material | Gas (Air) | Gas (Air) | Identical | | Mains Voltage | 100V - 120V / 50-60Hz | 100V - 120V / 50-60Hz | Identical | | Main Fuse | 16A circuit breaker in main switch | 16A circuit breaker in main switch | Identical | | Power Consumption | Max. 10A | Max. 9 - 11A | No impact | | IP classification | IP20 | IPX0 | Identical | | Design | Internal metal chassis covered by industrial designed plastic housing | Metal enclosure | Similar, not important for the device safety and effectiveness evaluation | | Materials | Environmentally approved R452a, closed loop cooling system | Environmentally approved R507, closed loop cooling system | Both environment- ally approved, no impact | | Cooling spot Size | Varies with distance from distal end of air hose to tissue - 10cm² @ 5cm distance | Varies with distance from distal end of air hose to tissue - 10cm² @ 5cm distance | Identical | | Fan speed settings | 1 - 9 | 1 - 9 | Identical | | Comparison with the Predicate Device | SUBJECT DEVICE Zimmer MedizinSysteme GmbH Cryo 7 (This Submission) | PREDICATE DEVICE Zimmer MedizinSysteme GmbH Cryo V6.0 (K060395) | Discussion | | Interface | USB 2.0, RS 232 | N/A | Product feature with no effect to safety or effectiveness evaluation | | Therapy time, treatment time | 1:00 - 100:00 min - user selectable | 1-99 minute timer - user selectable | Similar, not significantly different | | Time delay to operate | Immediate from pressing start button once unit achieves standby mode | Immediate from pressing start button once unit achieves standby mode | Identical | | Compatibility with the environment | R452a Ozone destruction level 0 | R507 Ozone destruction level 0 | Both environment- ally approved, no impact | | Display | 10.1 inch touch display | LCD display | Product feature with no effect to safety or effectiveness evaluation | | Weight without accessories | 60 kg | 60 kg | Identical | | Dimensions | H 1060 mm x W 500 mm x D 560 mm | H 645 mm x W 390 mm x D 680 mm | Different dimensions have no influence on the device safety and effectiveness evaluation | | Operating Ambient Temperature and Humidity | Temperature: 10 - 35°C Humidity: 20-80% relative humidity without condensation Air pressure: 900-1030 hPa | Temperature: 10 - 35°C Humidity: 20-80% relative humidity without condensation Air pressure: 900-1060 hPa | 30hPa lower air pressure has no impact | | Storage and Transport | Temperature: -10 - 50°C Humidity: 10-90% relative humidity without condensation Air pressure: 700-1060 hPa | Storage: Temperature: 0 - 40°C Humidity: 10-90% relative humidity without condensation Air pressure: 600-1060 hPa Transport: Temperature: -10 - 50°C Humidity: 10-90% relative humidity | 10°C higher storage temperature and 100 hPa higher air pressure has no influence | | Comparison with the Predicate Device | SUBJECT DEVICE Zimmer MedizinSysteme GmbH Cryo 7 (This Submission) | PREDICATE DEVICE Zimmer MedizinSysteme GmbH Cryo V6.0 (K060395) | Discussion | | | | without condensation Air pressure: 600-1060 hPa | on the device safety and effectiveness evaluation | | Environmental Specifications | For indoor use only | For indoor use only | Identical | {6}------------------------------------------------ Image /page/6/Picture/0 description: The image shows the logo for Zimmer MedizinSysteme. The word "zimmer" is in bold, lowercase letters. Below the word "zimmer" is the word "MedizinSysteme" in a smaller font size. The logo is in gray. {7}------------------------------------------------ Image /page/7/Picture/0 description: The image shows the logo for Zimmer MedizinSysteme. The logo consists of the word "zimmer" in a bold, sans-serif font, with a horizontal line above the "z" and "i". Below the word "zimmer" is the text "MedizinSysteme" in a smaller, lighter font. The logo is simple and modern, and the use of a bold font and horizontal line makes it easily recognizable. ## VII. PERFORMANCE DATA: The Cryo 7 has been investigated and tested against and complies with the following voluntary standards: | Standards | Standards Organization | Standards Title | |---------------------------------------------------------------------------------------------------------|---------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | ES60601-1:2005/(R)2012 and A1:2012, C1:2009/(R)2012 and A2:2010/(R)2012 (Consolidated Text) | ANSI AAMI | Medical electrical equipment - Part 1: General requirements for basic safety and essential performance | | 60601-1-2:2014 (Edition 4.0) | IEC | Medical electrical equipment - Part 1-2: General requirements for basic safety and essential performance - Collateral standard: Electromagnetic disturbances - Requirements and tests | | 60601-1-6:2013 (Edition 3.1) | IEC | Medical electrical equipment - Part 1-6: General requirements for basic safety and essential performance - Collateral standard: Usability | | 62366-1:2015 (Edition 1.0) | IEC | Medical devices - Part 1: Application of usability engineering to medical devices | | 62304:2015 (Edition 1.1) | IEC | Medical devices software -software life cycle processes | | 14971:2019-12 (Edition 3.0) | ISO | Medical devices - Application of risk management to medical devices | | 15223-1:2016 (Edition 3) | ISO | Medical devices - Symbols to be used with medical device labels, labeling, and information to be supplied - Part 1: General requirements | | 10993-1:2018 (Edition 5) | ISO | Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process | #### Software Verification and Validation Testing After evaluation of the specified use conditions, it could be demonstrated that the technical design including software flow and device usage of the Cryo 7 is suitable to fulfill the specified intended use. In both formative and summative testing performed, no application problems were identified that could lead to any risk for the user, patient or third. {8}------------------------------------------------ Image /page/8/Picture/0 description: The image shows the logo for Zimmer MedizinSysteme. The logo is in gray and features the word "zimmer" in a bold, sans-serif font. Below the word "zimmer" is the phrase "MedizinSysteme" in a smaller, lighter font. The logo is simple and modern. The verification of the software requirements was performed according 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 per ISO 10993-1. Since the device is not intended to contact the patient and the user contacts the device only through gloved hands, there are no additional biocompatibility requirements for the 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 ES60601-1:2005 + CORR: 1:2006 + CORR. 2:2007 + A1:2012 (Edition 3.1), and IEC 60601-1-2:2014 (Fourth Edition). #### VIII. CONCLUSION: The proposed indications for use for the Cryo 7 are the same as those cleared in K060395. The subject device described in this submission is essentially the same device cleared in K060395. The changes between the two devices have been conducted through the company's Design Controls process. The changes that have been made to the system's hardware, software, mechanical layout and the display, do not affect the intended use, performance or risk profile of the device. Other changes were cosmetic which included new housing for the unit and the new brand name: Cryo 7. The Cryo 7 is substantially equivalent to the predicate device.