(107 days)
Helix NGM Compact Surgical Kit Cases are indicated for organization of surgical and/or prosthetic instruments during sterilization, storage and transport. The use of this product facilitates storage and organization of instruments during and after surgical procedures.
Neodent Instrument Kit Cases are intended to allow sterilization of the enclosed medical devices. Neodent Instrument Kit Cases require the use of FDA cleared wrap to maintain the sterility of the enclosed devices.
The kits are to be enclosed in a sterilization wrap that is FDA-cleared for the indicated cycles, and moist heat (steam) sterilized using one of the following cycles:
Fractionated vacuum (pre-vacuum)- Exposure at 132 °C for 4 minutes, 20-minute dry time.
Gravity displacement - Exposure at 132 °C for 15 minutes, 20-minute dry time.
Neodent Instrument Kit Cases are intended for sterilization of non-porous loads.
The combined weight of the GM Surgical Kit Case and the associated instruments is 268.0 g. The weight of the empty Kit Case is 208.15 grams. Neodent Instrument Kit Cases should not be stacked during sterilization.
The subject device kit cases are reusable rigid containers, comprising a case bottom (or base), a removable inner tray, and tray lid (lid). The subject device kits are to be used to organize and protect instruments and accessories that are to be sterilized by the healthcare provider. The subject kit cases are manufactured in autoclavable polymer. The design of the subject devices include grommets manufactured from medical grade silicone that retain the instruments within the tray. They also presents markings that guide instrument use during procedures. The subject device kit cases are provided nonsterile to the end-user.
The provided document is a 510(k) Premarket Notification for a medical device (Neodent Implant System - Helix NGM Compact Surgical Kit Cases). This type of submission aims to demonstrate substantial equivalence to a legally marketed predicate device, rather than proving the device's efficacy through a clinical study with primary and secondary endpoints often seen in drug trials or some Class III device PMAs.
Therefore, the "acceptance criteria" here refer to the performance standards the device must meet to demonstrate substantial equivalence to its predicate for its stated indications for use, primarily regarding sterilization and reusability. The "study that proves the device meets the acceptance criteria" refers to the non-clinical performance testing conducted.
Here's the breakdown based on your request, using the information available in the provided FDA document:
1. Table of Acceptance Criteria and Reported Device Performance
| Standard or Test Method | Purpose of the Testing | Acceptance Criteria | Reported Device Performance |
|---|---|---|---|
| Custom | Manual cleaning validation (Test Soil: Blood Soil (BLSO) Cleaning Method: Manual Residuals Tested: Hemoglobin and Protein) | Visual Inspection: No Visible SoilHemoglobin Test: <2.2 µg/cm²Protein Test: <6.4 µg/cm² | Passed |
| ANSI/AAMI/ISO 17665-1ANSI/AAMI/ISO 17665-2 | Sterilization validation, including sterilant penetration and drying time | All Biological Indicators must be incubated for at least 7 days at 55-60°C. All positive controls for SAL testing must show characteristic growth of the indicator organism. | Passed |
| Reprocessing Medical Devices in Health Care Settings: Validation Methods and Labeling Guidance for Industry and Food and Drug Administration Staff | Life cycle (simulate usage) testing | The tested samples must withstand 100 cycles of use (cleaning, sterilization, and functional tests) without compromising their functionalities. | Passed |
| ANSI/AAMI/ISO 10993-5 (Cytotoxicity) | Cytotoxicity testing | Less than 30% cell proliferation inhibition | Passed |
2. Sample Size Used for the Test Set and Data Provenance
The document does not specify the precise sample sizes used for each of the non-clinical tests (e.g., how many units were tested for cleaning validation, sterilization, life cycle, or biocompatibility). It only states that the testing was performed and "Passed" the acceptance criteria.
Data Provenance: The testing appears to be non-clinical performance testing, likely conducted in a lab setting by the manufacturer or a third-party lab on units of the device. The document does not specify the country of origin of the data beyond the manufacturer's location in Brazil. This is an application for a medical device, and the data is prospective testing to support the 510(k) submission.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications of Experts
This type of submission (510(k) for sterilization trays) relies on objective engineering and microbiological testing standards, rather than expert human interpretation of images or clinical outcomes that would require a "ground truth" established by experts in the typical sense of a diagnostic AI study. The "ground truth" for these tests are the established scientific and engineering principles outlined in the referenced ISO, AAMI standards, and FDA guidance documents, which define what constitutes effective cleaning, sterilization, durability, and biocompatibility.
4. Adjudication Method for the Test Set
Not applicable for this type of non-clinical, objective performance testing. Adjudication methods (like 2+1, 3+1) are typically used in clinical studies involving human interpretation or subjective assessments to establish a consensus "ground truth."
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was Done
No, an MRMC comparative effectiveness study was not done. This device is a sterilization and instrument organization kit, not a diagnostic imaging AI algorithm.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was Done
Not applicable. This is not an AI algorithm. The performance evaluation is of the physical device's ability to be cleaned, sterilized, and resist wear over time.
7. The Type of Ground Truth Used
The "ground truth" for this device's performance testing is based on:
- Objective Measurement and Standards: This includes quantifiable measures for residual proteins/hemoglobin after cleaning, demonstration of sterility assurance level (SAL) of 10⁻⁶ using biological indicators, and quantifiable measures of cell proliferation inhibition for biocompatibility.
- Functional Longevity: The ability of the device to withstand 100 cleaning and sterilization cycles without compromising functionality.
- Compliance with Recognized Standards: The tests are performed according to established industry and regulatory standards (e.g., ANSI/AAMI/ISO 17665, AAMI/ANSI/ISO 10993-5, and FDA guidance on reprocessing). These standards define the acceptable performance metrics.
8. The Sample Size for the Training Set
Not applicable. This is not an AI/machine learning device. There is no training set.
9. How the Ground Truth for the Training Set Was Established
Not applicable. As noted above, this is not an AI/machine learning device.
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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: a symbol on the left and the FDA name and title on the right. The symbol on the left is a stylized representation of a human figure, while the text on the right reads "FDA U.S. FOOD & DRUG ADMINISTRATION" in blue letters.
April 13, 2022
JJGC Indústria e Comércio de Materiais Dentários S.A. % Jennifer Jackson Director of Regulatory Affairs Straumann USA, LLC 60 Minuteman Road Andover, Massachusetts 01810
Re: K214051
Trade/Device Name: Neodent Implant System-Helix NGM Compact Surgical Kit Cases Regulation Number: 21 CFR 880.6850 Regulation Name: Sterilization wrap Regulatory Class: Class II Product Code: KCT Dated: March 18, 2022 Received: March 23, 2022
Dear Jennifer Jackson:
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
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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,
Clarence W. Murray, III, PhD Assistant Director DHT4B: Division of Infection Control and Plastic Surgery Devices OHT4: Office of Surgical and Infection Control Devices Office of Product Evaluation and Ouality Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known) K214051
Device Name
Neodent Implant System - Helix NGM Compact Surgical Kit Cases
Indications for Use (Describe)
Helix NGM Compact Surgical Kit Cases are indicated for organization of surgical and/or prosthetic instruments during sterilization, storage and transport. The use of this product facilitates storage and organization of instruments during and after surgical procedures.
Neodent Instrument Kit Cases are intended to allow sterilization of the enclosed medical devices. Neodent Instrument Kit Cases require the use of FDA cleared wrap to maintain the sterility of the enclosed devices.
The kits are to be enclosed in a sterilization wrap that is FDA-cleared for the indicated cycles, and moist heat (steam) sterilized using one of the following cycles:
Fractionated vacuum (pre-vacuum)- Exposure at 132 °C for 4 minutes, 20-minute dry time.
Gravity displacement - Exposure at 132 °C for 15 minutes, 20-minute dry time.
Neodent Instrument Kit Cases are intended for sterilization of non-porous loads.
The combined weight of the GM Surgical Kit Case and the associated instruments is 268.0 g. The weight of the empty Kit Case is 208.15 grams. Neodent Instrument Kit Cases should not be stacked during sterilization.
| Type of Use (Select one or both, as applicable) | |
|---|---|
| ☑ Prescription Use (Part 21 CFR 801 Subpart D) | ☐ Over-The-Counter Use (21 CFR 801 Subpart C) |
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510(K) Summary
ADMINISTRATIVE INFORMATION
| Sponsor | JJGC Indústria e Comércio de Materiais Dentários SA(dba Neodent)Av. Juscelino Kubitschek de Oliveira, 3291Curitiba, Parana, Brazil 81270-200Registration No.: 3008261720Owner/Operator No.: 10031702 |
|---|---|
| Contact Person | Jennifer M. Jackson, MSDirector of Regulatory Affairs,Straumann USAE-mail: jennifer.jackson@straumann.comTelephone (978) 747-2509 |
| Date Prepared | 5/Apr/2022 |
| Preparer / Alternate Contact | Mariana HartmannRegulatory Affairs AnalystJJGC Indústria e Comércio de Materiais Dentários SAE-mail: mariana.hartmann@neodent.com |
DEVICE NAME AND CLASSIFICATION
| Trade/ Proprietary Name | Neodent Implant System – Helix NGM Compact Surgical Kit Cases |
|---|---|
| Common Name | Instrument Sterilization Trays |
| Classification Name | Sterilization Wrap Containers, Trays, Cassettes & Other |
| Classification Regulations | 21 CFR 880.6850, Class II |
| Product Code | KCT |
| Classification Panel | General Hospital |
| Reviewing Branch | Infection Control Devices Branch |
| PREDICATE DEVICE INFORMATION | |
| Primary Predicate Device | K192670 - Neodent Instrument Kit Cases, JJGC Indústria eComércio de Materiais Dentários S.A |
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INDICATIONS FOR USE
Indications for Use for Helix NGM Compact Surgical Kit Case and Pre-Mounted Helix NGM Compact Surgical Kit Case:
Helix NGM Compact Surgical Kit Cases are indicated for organization of surgical and/or prosthetic instruments during sterilization, storage and transport. The use of this product facilitates storage and organization of instruments during and after surgical procedures.
Neodent Instrument Kit Cases are intended to allow sterilization of the enclosed medical devices. Neodent Instrument Kit Cases require the use of FDA cleared wrap to maintain the sterility of the enclosed devices.
The kits are to be enclosed in a sterilization wrap that is FDA-cleared for the indicated cycles, and moist heat (steam) sterilized using one of the following cycles:
Fractionated vacuum (pre-vacuum) – Exposure at 132 °C for 4 minutes, 20-minute dry time.
Gravity displacement – Exposure at 132 °C for 15 minutes, 20-minute dry time.
Neodent Instrument Kit Cases are intended for sterilization of non-porous loads.
The combined weight of the GM Surgical Kit Case and the associated instruments is 268.0 g. The weight of the empty Kit Case is 208.15 grams. Neodent Instrument Kit Cases should not be stacked during sterilization.
SUBJECT DEVICE DESCRIPTION
The subject device kit cases are reusable rigid containers, comprising a case bottom (or base), a removable inner tray, and tray lid (lid). The subject device kits are to be used to organize and protect instruments and accessories that are to be sterilized by the healthcare provider. The subject kit cases are manufactured in autoclavable polymer. The design of the subject devices include grommets manufactured from medical grade silicone that retain the instruments within the tray. They also presents markings that guide instrument use during procedures. The subject device kit cases are provided nonsterile to the end-user.
The dimensions for each part of the model and the overall dimensions are presented in the table below:
| AssembledKit Case | Description | AssembledKit CaseDimension(L x W x H) | ComponentNumber | Component Dimension(L x W x H) |
|---|---|---|---|---|
| 110.315 | Helix NGM CompactSurgical Kit Case | 195 x 90 x54 mm | 212.293 (Lid) | 195 x 90 x 36 mm |
| 704346 (Tray) | 180 x 76 x 16.5 mm | |||
| 704345 (Base) | 188 x 84 x 32 mm | |||
| 110.316 | Pre-Mounted Helix NGMCompact Surgical Kit Case | 195 x 90 x54 mm | 212.293 (Lid) | 195 x 90 x 36 mm |
| 704346 (Tray) | 180 x 76 x 16.5 mm | |||
| 704345 (Base) | 188 x 84 x 32 mm |
Note: The instrument and accessory devices that are sterilized and stored within the subject Kit Cases are not themselves subject devices of this submission.
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TECHNOLOGICAL CHARACTERISTIC COMPARISON TABLE
| SUBJECT DEVICE | PRIMARY PREDICATE DEVICE | ||
|---|---|---|---|
| Helix NGM Compact Surgical Kit CasesJJGC Indústria e Comércio de MateriaisDentários S.A. | K192670Neodent Instrument Kit CasesJJGC Indústria e Comércio de MateriaisDentários S.A. | COMPARISON | |
| Indications forUse Statement | Indications for Use for Helix NGM CompactSurgical Kit CaseHelix NGM Compact Surgical Kit Cases areindicated for organization of surgical and/orprosthetic instruments during sterilization,storage and transport. The use of thisproduct facilitates storage and organizationof instruments during and after surgicalprocedures.Neodent Instrument Kit Cases are intendedto allow sterilization of the enclosed medicaldevices. Neodent Instrument Kit Casesrequire the use of FDA cleared wrap tomaintain the sterility of the enclosed devices.The kits are to be enclosed in a sterilizationwrap that is FDA-cleared for the indicatedcycles, and moist heat (steam) sterilizedusing one of the following cycles:Fractionated vacuum (pre-vacuum)Exposure at 132 °C for 4 minutes, 20-minutedry time.Gravity displacement — Exposure at 132 °Cfor 15 minutes, 20-minute dry time.Neodent Instrument Kit Cases are intendedfor sterilization of non-porous loads.The combined weight of the GM Surgical KitCase and the associated instruments is 268.0g. The weight of the empty Kit Case is 208.15grams. Neodent Instrument Kit Cases shouldnot be stacked during sterilization.Indications for Use for Pre-Mounted HelixNGM Compact Surgical Kit CaseProduct indicated for conditioning and safefastening surgical and/or prostheticinstruments during their use andsterilization. The use of this productfacilitates storage and organization ofinstruments during and after surgicalprocedures.Neodent Instrument Kit Cases are intendedto allow sterilization of the enclosed medicaldevices. Neodent Instrument Kit Casesrequire the use of FDA cleared wrap tomaintain the sterility of the enclosed devices.The kits are to be enclosed in a sterilizationwrap that is FDA-cleared for the indicatedcycles, and moist heat (steam) sterilizedusing one of the following cycles:Fractionated vacuum (pre-vacuum)Exposure at 132 °C for 4 minutes, 20-minutedry time.Gravity displacement — Exposure at 132 °Cfor 15 minutes, 20-minute dry time.Neodent Instrument Kit Cases are intendedfor sterilization of non-porous loads.The combined weight of the GM Surgical KitCase and the associated instruments is 268.0g. The weight of the empty Kit Case is 208.15grams. Neodent Instrument Kit Cases should | Indications for Use for GM Surgical Kit Case:Neodent Instrument Kit Cases are intended tobe used to enclose other medical devices thatare to be sterilized by a health care provider.Neodent Instrument Kit Cases are intended toallow sterilization of the enclosed medicaldevices. Neodent Instrument Kit Cases requirethe use of FDA cleared wrap to maintain thesterility of the enclosed devices.The kits are to be enclosed in a sterilizationwrap that is FDA-cleared for the indicatedcycles, and moist heat (steam) sterilized usingone of the following cycles:Fractionated vacuum (pre-vacuum) — Exposureat 132 °C for 4 minutes, 20-minute dry time.Gravity displacement — Exposure at 132 °C for15 minutes, 40-minute dry time.Neodent Instrument Kit Cases are intended forsterilization of non-porous loads.The combined weight of the GM Surgical KitCase and the associated instruments is 613.1 g.The weight of the empty Kit Case is 510 grams.Neodent Instrument Kit Cases should not to bestacked during sterilization.Indications for Use for GM Helix CompactSurgical Kit Case:Neodent Instrument Kit Cases are intended tobe used to enclose other medical devices thatare to be sterilized by a health care provider.Neodent Instrument Kit Cases are intended toallow sterilization of the enclosed medicaldevices. Neodent Instrument Kit Cases requirethe use of FDA cleared wrap to maintain thesterility of the enclosed devices.The kits are to be enclosed in a sterilizationwrap that is FDA-cleared for the indicatedcycles, and moist heat (steam) sterilized usingone of the following cycles:Fractionated vacuum (pre-vacuum) — Exposureat 132 °C for 4 minutes, 20-minute dry timeGravity displacement — Exposure at 132 °C for15 minutes, 20-minute dry time.Neodent Instrument Kit Cases are intended forsterilization of non-porous loads.The combined weight of the GM Helix CompactSurgical Kit Case and the associatedinstruments is 308.2 g. The weight of the emptyKit Case is 231 grams. Neodent Instrument KitCases should not to be stacked duringsterilization. | Similar |
| not be stacked during sterilization. | |||
| SUBJECT DEVICE | PRIMARY PREDICATE DEVICE | ||
| Helix NGM Compact Surgical Kit CasesJJGC Indústria e Comércio de MateriaisDentários S.A. | K192670Neodent Instrument Kit CasesJJGC Indústria e Comércio de MateriaisDentários S.A. | COMPARISON | |
| Intended Use | The Helix Narrow GM Compact SurgicalKit Cases is suitable for safe storage ofsurgical and prosthetic instruments,organizing the instruments in thesequence in which they will be used, aswell as for sterilization of suchinstruments. | The GM Helix Compact Surgical Kit Case issuitable for safe storage of surgical andprosthetic instruments, organizing theinstruments in the sequence in which theywill be used, as well as for sterilization ofsuch instruments. | Same |
| Design | Rigid polysulfone polymer base andremovable inner tray with apolyphenylsulfone lid.Retention grommets of medical gradesilicone. | Rigid polysulfone polymer base andremovable inner tray with apolyphenylsulfone lid.Retention grommets of medical gradesilicone. | Identical |
| Perforated | Yes; allows moist heat (steam)penetration to achieve sterilization | Yes; allows moist heat (steam)penetration to achieve sterilization | Identical |
| Reusable | Yes | Yes | Identical |
| Overalldimensions | 110.315: 195 L x 90 W x 54 H, mm110.316: 195 L x 90 W x 54 H, mm | 110.288: 264 L x 163 W x 54 H, mm110.297: 195 L x 90 W x 64 H, mm | Similar |
| Volume to VentRatio | 110.315: 52.3 cm³/cm² (20.59 in³/in²)110.316: 52.3 cm³/cm² (20.59 in³/in²) | 110.288: 98.04 cm³/cm² (38.6 in³/in²)110.297: 63.5 cm³/cm² (25.0 in³/in²) | Similar |
| Useful Life | Yes, reusable up to 100 cycles | Yes, reusable up to 100 cycles | Identical |
| Biocompatibility | The assessment to Biocompatibilitywas performed per ISO 10993-1 andtesting was performed using methodsdescribed in AAMI/ANSI/ISO 10993-5.The results indicate that the subjectdevices are biocompatible. | The assessment to Biocompatibility wasperformed per ISO 10993-1 and testingwas performed using methods describedin AAMI/ANSI/ISO 10993-5. The resultsindicate that the subject devices arebiocompatible. | Same |
| SterilizationMethod | Moist heat (steam) to a SAL of 10-6 | Moist heat (steam) to a SAL of 10-6 | Identical |
| Cycles | Gravity displacementFractionated vacuum (pre-vacuum) | Gravity displacementFractionated vacuum (pre-vacuum) | Same |
| Parameters | GravitySterilization temperature: 132 °CSterilization time: 15 minutes;Drying time: 20 minutes | GravitySterilization temperature: 132 °CSterilization time: 15 minutes;Drying time: 40 minutes (model number110.288) or 20 minutes (model number110.297) | Similar |
| Pre-VacuumSterilization temperature: 132 °CSterilization time: 4 minutes;Drying time: 20 minutes. | Pre-VacuumSterilization temperature: 132 °CSterilization time: 4 minutes;Drying time: 20 minutes. | ||
| Sterile Barrier | Sterilization wrap, FDA-cleared forindicated method and cycles | Sterilization pouch, FDA-cleared forindicated method and cycles | Identical |
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The subject devices and the primary predicate device per K192670 have same intended use and similar Indications for Use Statements. The subject devices and the primary predicate devices are reusable rigid containers used to organize and protect dental surgical instruments that are sterilized by the healthcare provider. The subject device and the primary predicate device components are perforated
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to allow for penetration of the moist heat (steam) sterilant and require the use of an FDA-cleared wrap or pouch to maintain sterility.
The subject devices and the primary predicate devices include components manufactured from polyphenylsulfone and polysulfone. The subject devices have the same size, whereas the primary predicate device is provided in two different size and configurations. The overall dimensions of the subject device are similar to the range of overall dimensions cleared for the predicate devices.
| Standard or Test Method | Purpose of the Testing | Acceptance Criteria | Results |
|---|---|---|---|
| Custom | Manual cleaning validation Test Soil: Blood Soil (BLSO) Cleaning Method: Manual Residuals Tested: Hemoglobin and Protein | Visual Inspection: No Visible Soil Hemoglobin Test: <2.2 µg/cm2 Protein Test: <6.4 µg/cm2 | Passed |
| ANSI/AAMI/ISO 17665-1ANSI/AAMI/ISO 17665-2 | Sterilization validation,including sterilantpenetration and drying time | All BiologicalIndicators must beincubated for at least7 days at 55-60°C. Allpositive controls forSAL testing must showcharacteristic growthof the indicatororganism. | Passed |
| Reprocessing Medical Devicesin Health Care Settings:Validation Methods andLabeling Guidance forIndustry and Food and DrugAdministration Staff | Life cycle (simulate usage)testing | The tested samplesmust withstand 100cycles of use(cleaning, sterilization,and functional tests)without compromisingtheir functionalities | Passed |
| ANSI/AAMI/ISO 10993-5(Cytotoxicity) | Cytotoxicity testing | Less than 30% cellproliferation inhibition | Passed |
NON-CLINICAL PERFORMANCE DATA
CONCLUSION
The conclusions drawn from the nonclinical tests demonstrate that the device in K214051, is as safe, as effective, and performs as well as or better than the legally marketed device (K192670).
§ 880.6850 Sterilization wrap.
(a)
Identification. A sterilization wrap (pack, sterilization wrapper, bag, or accessories, is a device intended to be used to enclose another medical device that is to be sterilized by a health care provider. It is intended to allow sterilization of the enclosed medical device and also to maintain sterility of the enclosed device until used.(b)
Classification. Class II (performance standards).