(300 days)
Indications for Use statement for the ERBECRYO 2 cryosurgical unit:
"The ERBECRYO 2 cryosurgical unit and accessories are intended for cryoadhesion and devitalization of tissue by the application of extreme cold."
Indications for Use statement for the Erbe Flexible Cryoprobes:
"The Erbe Flexible Cryoprobes are intended for palliative devitalization) of tissue during interventional procedures by the application of extreme cold and cryoadhesion for applications such as the removal of foreign bodies, mucus plugs, blood clots, necrotic tissue, tissue tumors (palliative recanalization) and tissue biopsies."
The ERBECRYO® 2 Unit and Accessories are manufactured with various metals, plastics, silicone, adhesive, etc. The system consists of connecting hoses, an adapter, a switching valve (optional for using two gas cylinders), the Unit, electrical cables, the footswitch, and the flexible cryoprobes. The ERBECRYO® 2 unit is a standalone unit that can be placed on a table top or secured on a cart. The Cryosurgical Unit has a monochromatic display that provides operational information. The display is surrounded by buttons allowing for user interface (e.g., set the effect, select a program, etc.). Default settings are also displayed per the cryoprobe that is attached. The Cryorugical Unit is connected to an electrical power source, a carbon dioxide (CO2) source, the footswitch and a flexible cryoprobe. The Cryosurgical Unit displays errors and/or emits audio alarms to alert users of malfunctions or user errors. Typically, a cryoprobe is placed down the working channel of an endoscope (e.g., bronchoscope, etc.) that can accommodate the dimensional attributes (i.e., outer diameter and length) of the probe. Upon activation via the pedal of the footswitch, the Unit delivers the regulated flow of the CO2 to the tip of the flexible cryoprobe. Through the Joule-Thomson Effect and in the presence of moisture, an ice is formed and surrounding tissue is cooled. The extreme cold is used for cryoadhesion and/or devitalization (i.e., the destruction) of target tissue (Note: The smaller 1.1mm single use cryoprobes have an oversheath so that tissue frozen to the tip can be removed through the endoscope without having to remove the scope from the patient.). The Unit and all of the Accessories, except for the single use flexible cryprobes, are supplied non-sterile and are reusable. The single use cryoprobes are provided sterile and are single patient use.
The provided text describes a 510(k) premarket notification for the ERBECRYO 2 Cryosurgical Unit and Accessories (K190651), comparing it to a legally marketed predicate device (K151041). The document primarily focuses on demonstrating substantial equivalence rather than a clinical study establishing acceptance criteria for a new AI/software device. There is no mention of an AI/software component in this submission.
Therefore, many of the requested categories are not applicable to the information provided. The document describes a medical device (cryosurgical unit and cryoprobes) and its physical and performance characteristics, along with various standard tests to ensure its safety and effectiveness relative to a predicate device.
However, I can extract the relevant information where applicable and indicate "Not applicable" for items that are not present or relevant to this type of medical device submission.
1. Table of Acceptance Criteria and Reported Device Performance
Since this is not an AI/software device and the submission focuses on substantial equivalence to a predicate, the "acceptance criteria" are generally compliance with recognized standards and demonstration that new features (like different cryoprobe dimensions or sterile single-use probes) do not raise new safety or effectiveness concerns. The performance reported relates to the cryosurgical function and material properties.
| Acceptance Criteria Category | Specific Acceptance Criteria (if quantifiable) | Reported Device Performance (if quantifiable) |
|---|---|---|
| Biocompatibility | No sensitizing, irritating, or cytotoxic properties. No acute systemic toxic characteristics. | Probes showed no sensitizing or irritating properties. No release of substances in cytotoxic concentration observed. No acute systemic toxic characteristics demonstrated. |
| Sterilization | Sterility Assurance Level (SAL) of 10^-6 for EO sterilization (per ISO 11135:2014). Residual EO and ECH gas levels within limits (per ISO 10993-7:2009). | SAL of 10^-6 achieved. Residual EO and ECH gas levels were within limits. |
| Shelf Life | Ability to maintain sterility and integrity for 3 years after accelerated aging and transport simulation (per ISO 11607). | Samples passed visual inspection, dye penetration, burst test, peel test, bubble emission test, microbial barrier test, and function test for 3 years. |
| Electrical Safety & EMC | Compliance with ANSI AAMI ES60601-1, IEC 60601-1-2. | Compliance with these standards is implied by their mention and the submission's purpose. (Specific performance values not detailed). |
| Risk Management | Implementation of risk management process per ANSI AAMI ISO 14971. | Implied compliance through mention of standard. |
| Software Life Cycle | Compliance with IEC 62304. | Implied compliance through mention of standard. |
| Usability | Compliance with IEC 62366-1 and IEC 60601-1-6. | Implied compliance through mention of standards. |
| Freezing Performance & Stability | Comparable to predicate device. | Comparative testing conducted to determine freezing performance and stability. (Specific quantitative results not detailed, but described as comparable). |
| Biopsy Weight (Ex-vivo) | Comparable to predicate device. | Comparative ex vivo tissue testing on bovine liver, porcine kidney, and porcine lung demonstrated comparability. (Specific quantitative results not detailed, but described as comparable). |
| In-vivo Performance | Comparable to predicate device. | Animal testing in an in vivo porcine lung model demonstrated comparability. (Specific quantitative results not detailed, but described as comparable). |
| Removal of Blood Clots | Device is safe and effective for this application. | Supported by peer-reviewed real-world evidence (literature and published case reports). |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Sample Size for Test Set: Not specified in terms of clinical trial patient numbers or image counts, as this is primarily a device safety and performance submission based on bench testing, ex-vivo, and in-vivo (animal) studies, and literature review.
- Biocompatibility: "Erbe Flexible cryoprobes" tested. Specific number of probes or samples not given.
- Sterilization Validation: "Mixed load sterilization cycle" validated. Specific number of samples not given.
- Shelf Life Validation: "Sterilized samples" tested. Specific number of samples not given.
- Performance Testing (Freezing, Biopsy Weight, In-vivo): "Comparative ex vivo tissue testing on three different tissues (bovine liver, porcine kidney and porcine lung)" and "animal testing in an in vivo porcine lung model" were conducted. Specific numbers of tissue samples or animals not given.
- Data Provenance:
- Biocompatibility, Sterilization, Shelf Life, and Performance Testing were conducted by Erbe Elektromedizin GmbH, based in Germany. The specific testing facilities are not mentioned.
- For the "removal of blood clots" indication, "peer-reviewed real world evidence (literature and published case reports)" were provided. This implies a retrospective review of existing published data globally.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
- This is not applicable as there is no "ground truth" established by experts in the context of an AI/software device. The data is physical measurements, biological evaluations, and performance characteristics compared to a predicate device and existing literature.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not applicable, as there is no expert review or adjudication method described for establishing ground truth for an AI/software output. The testing methodologies are based on laboratory measurements and comparisons.
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. This is a submission for a physical cryosurgical unit and cryoprobes, not an AI or software device. No human reader studies with or without AI assistance were performed.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Not applicable. This device does not involve an algorithm or AI.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
- The "ground truth" in this context refers to the established scientific and engineering principles for device performance, safety standards, and comparative data against a legally marketed predicate device.
- Benchmarking/Comparative Data: Performance as measured against the predicate device (e.g., freezing performance, biopsy weight).
- Standard Compliance: Adherence to international standards (e.g., ISO 10993 for biocompatibility, ISO 11135 for sterilization, ISO 11607 for shelf life, IEC 60601 series for electrical safety).
- Animal Model Data: In-vivo performance (porcine lung model).
- Literature Review: Real-world evidence from peer-reviewed literature and published case reports for specific indications (e.g., removal of blood clots).
- Laboratory Procedures: Sterility, shelf-life, and biocompatibility testing results.
8. The sample size for the training set
- Not applicable. This is not an AI/software device, so there is no training set.
9. How the ground truth for the training set was established
- Not applicable. As there is no training set for an AI/software device.
{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 & Human Services logo on the left and the FDA acronym and name on the right. The FDA acronym is in a blue square, and the full name "U.S. Food & Drug Administration" is written in blue letters next to it.
January 7, 2020
Erbe Elektromedizin GmbH Henry Kutz Specialist Regulatory Affairs Waldhoernlestrasse 17 Tuebingen. Germany 72072
Re: K190651
Trade/Device Name: ERBECRYO 2 Cryosurgical Unit and Accessories: ERBECRYO 2 cryosurgical unit; Erbe Flexible Cryoprobe Regulation Number: 21 CFR 878.4350 Regulation Name: Cryosurgical Unit and Accessories Regulatory Class: Class II Product Code: GEH Dated: December 4, 2019 Received: December 6, 2019
Dear Henry Kutz:
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.
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
{1}------------------------------------------------
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 medical devices and radiation-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.
Long Chen, Ph.D. 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) K190651
Device Name
ERBECRYO 2 Cryosurgical Unit and Accessories
Indications for Use (Describe)
Indications for Use statement for the ERBECRYO 2 cryosurgical unit:
"The ERBECRYO 2 cryosurgical unit and accessories are intended for cryoadhesion and devitalization of tissue by the application of extreme cold."
Indications for Use statement for the Erbe Flexible Cryoprobes:
"The Erbe Flexible Cryoprobes are intended for palliative devitalization) of tissue during interventional procedures by the application of extreme cold and cryoadhesion for applications such as the removal of foreign bodies, mucus plugs, blood clots, necrotic tissue, tissue tumors (palliative recanalization) and tissue biopsies."
| 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)
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}------------------------------------------------
K190651 510(k) SUMMARY [AS REQUIRED BY 21 CFR 807.92(C)]
| Submitted By: | Erbe Elektromedizin GmbHWaldhoernlestrasse 1772072 TuebingenGermanyTel: 0049-7071-755-0Fax: 0049-7071-755-179 |
|---|---|
| Contact Person: | Mr. Henry KutzSpecialist Regulatory Affairs |
| Date Prepared: | January 6th, 2020 |
| Trade/Proprietary Name: | ERBECRYO® 2 Cryosurgical Unit and Accessories |
| Common Name: | Cryosurgical Unit and Accessories |
| Classification Name and Code: | Cryosurgical Unit & Accessories (21 CFR 878.4350) |
| Regulatory Class: | II |
| Product Code: | GEH |
| Legally MarketedPredicate Device: | ERBE ERBECRYO 2 Cryosurgical Unit and Accessories- K151041 |
Device Description:
The ERBECRYO® 2 Unit and Accessories are manufactured with various metals, plastics, silicone, adhesive, etc. The system consists of connecting hoses, an adapter, a switching valve (optional for using two gas cylinders), the Unit, electrical cables, the footswitch, and the flexible cryoprobes. The ERBECRYO® 2 unit is a standalone unit that can be placed on a table top or secured on a cart. The Cryosurgical Unit has a monochromatic display that provides operational information. The display is surrounded by buttons allowing for user interface (e.g., set the effect, select a program, etc.). Default settings are also displayed per the cryoprobe that is attached. The Cryorugical Unit is connected to an electrical power source, a carbon dioxide (CO2) source, the footswitch and a flexible cryoprobe. The Cryosurgical Unit displays errors and/or emits audio alarms to alert users of malfunctions or user errors. Typically, a cryoprobe is placed down the working channel of an endoscope (e.g., bronchoscope, etc.) that can accommodate the dimensional attributes (i.e., outer diameter and length) of the probe. Upon activation via the pedal of the footswitch, the Unit delivers the regulated flow of the CO2 to the tip of the flexible cryoprobe. Through the Joule-Thomson Effect and in the presence of moisture, an ice is formed and surrounding tissue is cooled. The extreme cold is used for cryoadhesion and/or devitalization (i.e., the destruction) of target tissue (Note: The smaller 1.1mm single use cryoprobes have an oversheath so that tissue frozen to the tip can be removed through the endoscope without having to remove the scope from the patient.). The Unit and all of the Accessories, except for the single use flexible cryprobes, are supplied non-sterile and are reusable. The single use cryoprobes are provided sterile and are single patient use.
{4}------------------------------------------------
Erbe Elektromedizin GmbH Traditional 510(k) for ERBECRYO® 2 Cryosurgical Unit and Accessories
Intended Use / Indications for Use
Indications for Use statement for the ERBECRYO 2 cryosurgical unit:
"The ERBECRYO® 2 cryosurgical unit and accessories are intended for cryoadhesion and devitalization (destruction) of tissue by the application of extreme cold."
Indications for Use statement for the Erbe Flexible Cryoprobes:
The Erbe Flexible Cryoprobes are intended for palliative devitalization (destruction) of tissue during interventional procedures by the application of extreme cold and cryoadhesion for applications such as the removal of foreign bodies, mucus plugs, blood clots, necrotic tissue, tissue tumors (palliative recanalization) and tissue biopsies."
Similarities and Differences of the Modified Device to the Current Device (Predicate Comparison/Substantial Equivalence):
| Characteristics | K151041ERBECRYO 2 Cryosurgical Unitand Accessories | K190651ERBECRYO® 2 Cryosurgical Unitand Accessories |
|---|---|---|
| Manufacturer | Erbe Elektromedizin GmbH(Germany) | Same |
| Submitter | Erbe USA Inc. (USA) | Erbe Elektromedizin GmbH(Germany) |
| Trade/ ProprietaryName | ERBE ERBECRYO 2 CryosurgicalUnit and Accessories | ERBECRYO® 2 Cryosurgical Unitand Accessories |
| Characteristics | K151041ERBECRYO 2 Cryosurgical Unitand Accessories | K190651ERBECRYO® 2 Cryosurgical Unitand Accessories |
| Indications for UseStatement -ERBECRYO 2 unit | The ERBECRYO 2 CryosurgicalUnit and Accessories are intendedfor devitalization (destruction) oftissue during surgical procedures bythe application of extreme cold andfor removal of foreign bodies,mucous plugs, necrotic tissue, andtissue biopsy by cryoadhesion.Clinical Indications for Cryosurgery: | The ERBECRYO® 2 cryosurgicalunit and accessories are intendedfor cryoadhesion and devitalization(destruction) of tissue by theapplication of extreme cold. |
| Characteristics | K151041ERBECRYO 2 Cryosurgical Unitand Accessories | K190651ERBECRYO® 2 Cryosurgical Unitand Accessories |
| Indications for UseStatement -FlexibleCryoprobes | The ERBE Flexible Cryo Probeused with the ERBECRYO 2Cryosurgical Unit is intended fordevitalization (destruction) of tissueduring surgical procedures by theapplication of extreme cold and forremoval of foreign bodies, mucousplugs, necrotic tissue, and tissuebiopsy by cryoadhesion. Also seeClinical Indications in theERBECRYO 2 User Manual. | Intended Use / Indications for UseThe Erbe Flexible Cryoprobes areintended for palliative devitalization(destruction) of tissue duringinterventional procedures by theapplication of extreme cold andcryoadhesion for applications suchas the removal of foreign bodies,mucus plugs, blood clots, necrotictissue, tissue tumors (palliativerecanalization) and tissue biopsies. |
| Prescription orOTC | Prescription | Same |
| MaterialsERBECRYO 2 Unit | Metal sheet, aluminum, copperpipes, plastics and wiring, electroniccomponents | Same |
| MaterialsFootswitch | Plastics and wiring | Same |
| Materials FlexibleCryoprobes | Stainless steel, silicone, aluminum,plastics, brass (gold plated),adhesive | Stainless steel, silicone, plastics,platine, Tyvek, printing color,adhesive |
| Dimensions ofFlexibleCryoprobes | - Outer Diameter (OD) 1.9mm,Length (L) 900mm- OD 1.9mm, L1150mm- OD 2.4mm, L900mm | - OD 1.1mm; L1150mmw/ oversheath OD2.6mm, L817mm- OD 1.1mm; L1150mmw/ oversheath OD2.6mm, L757mm- OD 1.7mm, L1150mm- OD 2.4mm, L1150mm |
| Units Compatiblewith FlexibleCryoprobes | ERBECRYO 2 | Same |
{5}------------------------------------------------
{6}------------------------------------------------
{7}------------------------------------------------
| Characteristics | K151041ERBECRYO 2 Cryosurgical Unitand Accessories | K190651ERBECRYO® 2 Cryosurgical Unitand Accessories |
|---|---|---|
| Other CompatibleEquipment | ERBECRYO 2 Cart | ERBECRYO® 2 Cart, VIO Cart |
| Performance Dataof Unit | No. of effect levels: 1 - 5 (dependingon instrument) | Same |
| Activation: via footswitch | Same | |
| Cooling gas used: CO2 | Same | |
| Input Pressure:653 - 943psi (45 - 65bar) | Same | |
| Provided Condition | ERBECRYO 2 Unitnon-sterile, reusable | Same |
| Footswitchnon-sterile, reusable | Same | |
| Flexible Cryoprobesnon-sterile, reusable | Flexible Cryoprobessterile, single-use | |
| All other Accessoriesnon-sterile, reusable | Same | |
| SterilizationMethod Used | Steam sterilization for reprocessingreusable Flexible Cryoprobes | Ethylene Oxide (EO) sterilization ofsingle use Flexible Cryoprobes |
| Shelf Life | Not Applicable for reusable Unit andAccessories | Three (3) years for single useFlexible Cryoprobes |
The proposed flexible cyroprobes have comparable technological characteristics compared to the predicate device. The main differences are:
- Outer diameter (two of the proposed flexible cryoprobes have a smaller outer diameter, i.e. 1.1mm and 1.7mm compared to 1.9mm of the predicate probes).
- -The proposed 1.1mm cryoprobe has an additional oversheath compared to the predicate probes.
- -The proposed flexible cyroprobes are single-use compared to the re-usable predicate device
- -The materials of proposed flexible cyroprobes are slightly different compared to the predicate probes
Verification/validation activities from non-clinical testing as described below demonstrate that the differences do not raise any new issues of safety or effectiveness of the subject device compared to the predicate device.
Summary of Biocompatibility Testing
Biocompatibility Testing took place according to standard ISO 10993-1 Fourth edition and in compliance with the FDA guidance document "Use of International Standard ISO 10993-1, Biological evaluation of medical devices". Cytotoxicity Testing, Acute System Toxicity as well
as Sensitization Testing and Testing for Irritation or Intracutaneous Reactivity were carried out with the Erbe Flexible cryoprobes. The probes showed no sensitizing or irritating properties. No release of substances in cytotoxic concentration was observed. Furthermore, the products showed no acute systemic toxic characteristics.
{8}------------------------------------------------
Erbe Elektromedizin GmbH Traditional 510(k) for ERBECRYO® 2 Cryosurgical Unit and Accessories
Summary of Sterilization Validation
The Erbe Flexible Cryoprobes are provided sterile to the customer and are single use products. Sterilization testing for the flexible cyroprobes was conducted in accordance with the FDA's Guidance for Industry and Food and Drug Administration Staff. "Submission and Review of Sterility Information in Premarket Notification (510(k)) Submissions for Devices Labeled as Sterile". A mixed load sterilization cycle was validated in accordance with ISO 11135:2014. As requested by the standard a sterility assurance level (SAL) of 106 was achieved to validate the cycle. Furthermore, levels of residual EO and ECH gas were tested after the sterilization and were within the limits of standard ISO 10993-7:2009.
Summary of Shelf Life Validation
The shelf-life (3 years) of the packed cryoprobes was validated on sterilized samples affer transport simulation and accelerated aging and based on the requirements of standard ISO 11607. The samples passed the visual inspection, dye penetration testing, burst test, peel test, bubble emission test, microbial barrier test and the function test.
Standard Testing:
- · ANSI AAMI ISO 14971:2007/(R)2010 (Corrected 4 October 2007) Medical devices -Applications of risk management to medical devices
- . ANSI AAMI ES60601-1:2005/(R)2012 and A1:2012, C1:2009/(R)2012 and A2:2010/(R)2012 (Consolidated Text) Medical electrical equipment - Part 1: General requirements for basic safety and essential performance (IEC 60601-1:2005, MOD)
- . IEC 60601-1-2 Edition 4.0 2014-02 Medical electrical equipment - Part 1-2: General requirements for basic safety and essential performance - Collateral Standard: Electromagnetic disturbances - Requirements and tests
- EN 60529 Edition from October 1991 + A1 February 2000 + A2 October 2013 . Degrees of protection provided by enclosures (IP Code)
- · IEC 62304 Edition 1.1 2015-06 Medical device software Software life cycle processes
- IEC 62366-1 Edition 1.0 2015-02 Medical devices Part 1: Application of usability . engineering to medical devices [Including CORRIGENDUM 1 (2016)]
- IEC 62366:2007 + A1:2014 Medical Devices Application Of Usability Engineering To . Medical Devices
- IEC 60601-1-6 Edition 3.1 2013-10 Medical electrical equipment Part 1-6: General requirements for basic safety and essential performance - Collateral standard: Usability
- EN ISO 15223-1:2016 Medical devices Symbols to be used with medical device . labels, labelling and information to be supplied - Part 1: General requirements
- EN 1041:2008 + A1:2013 Information supplied by the manufacturer of medical devices .
- · ISO 11135 Second edition 2014-07-15 Sterilization of health-care products Ethylene oxide - Requirements for the development, validation and routine control of a sterilization process for medical devices
- · ISO 11737-1 Third edition 2018-01 Sterilization of health care products -Microbiological methods - Part 1: Determination of a population of microorganisms on product
- . ISO 11737-2 Second edition 2009-11-15 Sterilization of medical devices -Microbiological methods - Part 2: Tests of sterility performed in the definition, validation and maintenance of a sterilization process
- ISO 11607-1 First edition 2006-04-15 Packaging for terminally sterilized medical devices - Part 1: Requirements for materials, sterile barrier systems and packaging systems [Including: Amendment 1 (2014)]
- . ISO 11607-2 First edition 2006-04-15 Packaging for terminally sterilized medical devices - Part 2: Validation requirements for forming, sealing and assembly processes [Including: Amendment 1 (2014)]
{9}------------------------------------------------
Erbe Elektromedizin GmbH Traditional 510(k) for ERBECRYO® 2 Cryosurgical Unit and Accessories
- · DIN EN 556-1:2006 Sterilization of medical devices Requirements for medical devices to be designated "STERILE" - Part 1: Requirements for terminally sterilized medical devices
- · ISO 10993-1 Fourth edition 2009-10-15 Biological evaluation of medical devices -Part 1: Evaluation and testing within a risk manaqement process [Including: Technical Corrigendum 1 (2010)]
- ISTA 2A:2011 Partial Simulation Performance Test Packaged-Products 150 Ib (68 kg) or Less
Summary of Performance Testing
To demonstrate substantial equivalence (performance) testing of the subject device was conducted in accordance with applicable standards, guidance documents and internal design control procedures following 21 CFR 820.30 to ensure that the subject device performs as intended and meets design specifications.
Comparative testing was conducted to determine freezing performance and stability. In addition, comparative ex vivo tissue testing on three different tissues (bovine liver, porcine kidney and porcine lung) and animal testing in an in vivo porcine lung model was conducted to compare biopsy weight and in vivo performance, respectively.
To substantiate the indication "removal of blood clots", peer-reviewed real world evidence (literature and published case reports) were provided, demonstrating that flexible cryotechnology is a safe and effective method for the removal of airway-obstructing blood clots. Standard Testing, Biocompatibility Testing, (comparative) performance testing and comparative ex-vivo tissue testing demonstrated that the technological characteristics of the proposed device do not raise any new issues of safety or effectiveness. Since the application of the 1.1mm probe is slightly different due to the additional oversheath compared to the predicate device, a benefit-risk analysis was provided to demonstrate that the benefits outweigh the associated risks.
Conclusion:
The intended use/indications for use was simplified as well as clarified for the proposed ERBECRYO® 2 Cryosurgical Unit, but the proposed unit has the same intended use, principles of operation, technological characteristics, as well as performance characteristics as the predicate Cryosurgical Unit in the previously cleared 510(k).
The differences between the proposed and the predicate cryoprobes mentioned above do not raise different questions of safety and effectiveness and the functionality of both groups has been found to be comparable. The principles of operation and technological characteristics are equivalent. Validation and verification activities in design control that include testing/certification to designated standards and performance/bench testing of the proposed cryoprobes has demonstrated the subject device is substantially equivalent to the predicate device. The ERBECRYO® 2 Cryosurgical Unit and Accessories subject device is as safe and effective as the predicate device.
§ 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.