(113 days)
To destroy tissue during surgical procedures by applying extreme cold.
The CRYOSUCCESS is a hand-held cryosurgical instrument for destroying tissue during surgical procedures by applying cold gas (nitrous oxide, N₂O). The device is based on direct application of nitrous oxide in the liquid phase to the selected treatment area. The N₂0 gas is delivered to the treatment site at -89° C to effect cellular destruction (necrosis). CRYOSUCCES functions by means of heat evaporation upon phase transition, where liquid nitrous oxide (N₂O, laughing gas) is applied to the treatment area by means of a capillary tube at a constant temperature of -89°C (cold performance) followed by evaporation. The treatment may be invasive.
The provided text describes a 510(k) summary for the device CRYOSUCCESS, a cryosurgery unit. This document focuses on demonstrating substantial equivalence to a predicate device, rather than presenting a standalone study with detailed performance metrics against specific acceptance criteria.
However, I can extract information related to the acceptance criteria and the study that proves the device meets them based on the submission's structure:
1. Table of Acceptance Criteria and Reported Device Performance:
The document states that the device was evaluated against:
- Standard: ASTM F 882-84 (2002) - Standard for Biocompatibility of Materials Used in Medical Devices (Note: The provided text identifies the standard as F 882-84, which typically refers to biocompatibility. However, the context of the device (cryosurgery unit) and the stated 'requirements' suggest it's likely referring to a broader set of performance/safety standards, or specific aspects of this standard were applied. Without further details on the specific requirements within this standard that were tested, a detailed performance table cannot be generated.)
- Additional requirements: "additional requirements specified by the manufacturer." These are not detailed in the provided text.
The reported device performance is a general statement: "The device has fulfilled the requirements detailed above." No specific numerical performance metrics are provided in this summary.
2. Sample Size Used for the Test Set and Data Provenance:
The document refers to "bench testing" and "V&V Plan & Report CRYOSUCCESS enclosed." However, the 510(k) summary itself does not provide details on:
- The sample size used for the test set.
- The data provenance (e.g., country of origin, retrospective or prospective).
3. Number of Experts and Their Qualifications for Establishing Ground Truth:
The provided text does not contain any information about experts used to establish ground truth or their qualifications. This summary relies on technical characteristics and performance against specified standards rather than clinical data requiring expert review for ground truth.
4. Adjudication Method:
The provided text does not contain any information about an adjudication method. This type of method is typically used in clinical studies with human interpretation, which is not described here.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:
The provided text does not describe or mention a multi-reader multi-case (MRMC) comparative effectiveness study, nor does it discuss human reader improvement with or without AI assistance. This device is a surgical instrument, not an AI-assisted diagnostic tool.
6. Standalone (Algorithm Only) Performance:
The provided text does not mention or describe any standalone (algorithm-only) performance, as the device is a physical cryosurgery unit, not an algorithm or software.
7. Type of Ground Truth Used:
For this device (a cryosurgery unit), the "ground truth" would likely be based on technical specifications and functional testing results (e.g., temperature achieved, flow rate, material integrity, sterility). The summary highlights that "The relevant requirements set forth in standard ASTM F 882-84 (2002) and the additional requirements specified by the manufacturer are sufficient to assure a safe and effective functioning of the CRYOSUCCESS cryosurgery device." This implies the ground truth for testing came from established engineering and safety standards. No pathology, outcomes data, or expert consensus on clinical outcomes are detailed in this summary.
8. Sample Size for the Training Set:
The provided text does not contain any information about a training set. Training sets are relevant for machine learning algorithms, which is not applicable to this physical medical device.
9. How the Ground Truth for the Training Set Was Established:
As there is no training set mentioned or implied, this information is not applicable and not provided in the document.
In summary, the 510(k) summary primarily focuses on demonstrating substantial equivalence through a comparison of technical characteristics to a predicate device and adherence to a recognized standard (ASTM F 882-84) and internal manufacturer requirements, rather than presenting a detailed clinical study with performance metrics against specific acceptance criteria for a diagnostic or AI-driven device.
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5 510(k) Summary
In accordance with 21 CFR 807.92, the following information provides sufficient detail to understand the basis for a determination of substantial equivalence.
Submitter Information / Official Correspondent:
| Submitter name: | New Medical Technologies GmbH | |
|---|---|---|
| Responsible person: | Adrian B. Joss | OCT - 2 2009 |
| Phone: | +41 31 348 46 20 | |
| Fax: | +41 31 348 46 23 | |
| Mailto: | joss@ump.ag |
US Agent:
| United Statescontact address: | Premier Dental Products, 1710 Romano Drive, Plymouth Meeting,PA 19462 U.S.A. |
|---|---|
| United Statescontact person: | Vince d'Alessandro |
| Phone: | +1 (610) 239 6015 |
| Fax: | +1 (610) 239 6171 |
| Mailto: | VDAlessandro@premusa.com |
| Date prepared: | May 27, 2009 |
Device Name:
| Proprietary name: | CRYOSUCCESS |
|---|---|
| 510(k) number: | K091721 |
| Common name: | cryosurgery unit |
| Classification name: | 878.4350 Unit, cryosurgery and accessories, Class II |
| Product code: | GEH |
Predicate Device:
Substantial Equivalence is claimed with the device, K024009 "CryoProbe", manufactured by H&O Equipments NV/SA on the basis of equivalent intended use / indications for use, technological characteristics and principle of operation.
Device Description:
The CRYOSUCCESS is a hand-held cryosurgical instrument for destroying tissue during surgical procedures by applying cold gas (nitrous oxide, N₂O). The device is based on direct application of nitrous oxide in the liquid phase to the selected treatment area. The N₂0 gas is delivered to the treatment site at -89° C to effect cellular destruction (necrosis).
CRYOSUCCES functions by means of heat evaporation upon phase transition, where liquid nitrous oxide (N₂O, laughing gas) is applied to the treatment area by means of a capillary tube at
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a constant temperature of -89°C (cold performance) followed by evaporation. The treatment may be invasive.
In general any person may be treated, irrespective of gender or age. The treatment must be performed by medically trained specialists.
Intended Use:
To destroy tissue during surgical procedures by applying extreme cold.
Comparison of Technological Characteristics:
Table 05-1 provides a comparison of the predominant technical characteristics of the new device and the legally marketed predicate device. A more detailed comparison of the devices is presented in section 12-A.
| Characteristic | Predicate Device | Device Under Evaluation |
|---|---|---|
| Device Name | CryoProbe | CRYOSUCCESS |
| Models | CryoProbe c, 1 micro-applicator(information not clear) | Standard tip ( $Ø$ = 1mm) |
| CryoProbe x, 3 micro-applicators | Standard tip ( $Ø$ = 2mm) | |
| Standard tip ( $Ø$ = 3mm) | ||
| Standard tip ( $Ø$ = 4mm) | ||
| Gynecology tip | ||
| 510(k) Number | K024009 | K091721 |
| Cryogen | Nitrous oxide (N2O, laughing gas),available in 8 g or 16 g cartridges | Nitrous oxide (N2O, laughing gas),available in 23,5 g cartridge |
| Cartridge Pressure: ~50 bar (725 psi) | Cartridge Pressure: 50 bar (725 psi) | |
| Shelf life: 2 years | Shelf life: 2 years | |
| Shelf life(device) | 2 years | 5 years (with 2 years warranty) |
| Treatmenttemperature | Temperature: Depending ondistance of device to lesion,minimum -89°C at contact to lesion | Temperature: constant temperatureof -89°C (-128° F) at contact to lesion |
| Materials | Housing: aluminum | Cryo unit (no housing): brass andstainless steel, gold plated |
| Micro-applicator: unknown | Cryotip: metal, gold plated, cryotip inborosilicate glass 3.3 (such asDURAN) | |
| Lock cap: unknown | Protective cap: thermoplastic rubber | |
| Filter: unknown | Filter: stainless steel | |
| O-rings: unknown | Seals: PTFE and acrylonitrile-butadiene-rubber | |
| Cartridge: metal | Cartridge: metal | |
| OperatingPrinciple | The patented principle of theCryoProbe™ is based upon the directflow of N₂O in liquid phase for thepurpose of freezing with resultingnecrosis of tissue in the practice ofmedicine. To achieve thisphenomena a economical gascartridge is used. The cartridge isfilled with liquid N₂O (83%) and therest with N₂O gas. The liquid N20 isthe refrigerant and the N₂O gas isthe propellant.The innovation of the CryoProbe™ isthe ability to achieve a constant flowof liquid N₂O out of the micro-applicator tip. This is made possibleby maintaining the pressure levelwithin the instrument until the liquidN₂O leaves the tip of the micro-applicator, whereupon it willimmediately expand. | CRYOSUCCESS functions by means ofheat evaporation upon phasetransition, where liquid nitrous oxide(N₂O, laughing gas) is applied to thetreatment area by means of acapillary tube at a constanttemperature of -89°C (coldperformance) followed byevaporation. This results in cellulardestruction (necrosis) in thetreatment area. The amount of gasdispensed is controlled by themedical specialist pressing the leverof the device. |
| Cleaning /Sterilization | All external parts can be wiped witha cloth soaked in any non-corrosivesterilization solution or alcohol /Whole CryoProbe may be autoclaved | The unit body and cryotips can beencleaned and disinfected with aalcohol-based disinfectant or alcohol/ Steam sterilize tips at 134° C(273° F), according to the instructionin the manual of your steam sterilizerand according to the country specificlaw |
| Storage | Store in a cool dry place and keepout of the reach of children | Protect the unit against heat andexposure to direct sunlight. Thestorage temperature is between-10° C and max. +45° C (14° F andmax. 113° F). |
| Maintenance | Change filter with each cartridge,exchange o-rings after frequentautoclaving | No maintenance required, repairsmay only be executed by a licensedwholesaler / representative |
Table 05-1: Comparison of Technological Characteristics
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Summary of Testing:
The relevant requirements set forth in standard ASTM F 882-84 (2002) and the additional requirements specified by the manufacturer are sufficient to assure a safe and effective functioning of the CRYOSUCCESS cryosurgery device. The device has fulfilled the requirements detailed above. The results of the bench testing are summarized in the V&V Plan & Report CRYOSUCCESS enclosed.
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Conclusion:
Based on equivalence of intended use / indications for use, technological characteristics and operational principle the applicant concludes, that substantial equivalence between the new and the predicate device has been demonstrated and that the new device, CRYOSUCCESS, is at least as safe and as effective as the legally marketed predicate device, CryoProbe (K024009).
Section 5: 510(k) Summary
.
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Food and Drug Administration 10903 New Hampshire Avenue Document Mail Center - WO66-G609 Silver Spring, MD 20993-0002
New Medical Technologies, GmbH % Premier Dental Products Mr. Vince D'Alessandro 1710 Romano Drive Plymouth Meeting, Pennsylvania 19462
OCT - 2 2009 -
Re: K091721
Trade/Device Name: Cryosuccess Regulation Number: 21 CFR 878.4350 Regulation Name: Cryosurgical unit and accessories Regulatory Class: Class II Product Code: GEH Dated: May 27, 2009 Received: June 11, 2009
Dear Mr. D'Alessandro:
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. 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 (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.
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 (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set
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Page 2 - Mr. Vince D'Alessandro
forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to http://www.fda.gov/cdrh/mdr/ for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours,
incerely yours.
Mark N. Melkerson Director Division of Surgical, Orthopedic and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Indications for Use Statement
510(k) Number (if known): K091721
Device Name:
CRYOSUCCESS
Indications for Use:
To destroy tissue during surgical procedures by applying extreme cold.
Prescription Use _ × (Part 21 CFR 801 Subpart D) AND/OR
Over-The-Counter Use (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Nilpeal for men
Division of Surgical, Orthopedic, and Restorative Devices
510(k) Number K091721
§ 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.