(261 days)
Not Found
No
The document describes a surgical tray for sterilization and does not mention any AI or ML components or functionalities.
No.
The device description clearly states its purpose is to "enclose other medical devices that are to be sterilized" and "organize and protect the instruments that are sterilized". It does not describe any direct therapeutic action on a patient.
No.
The device is a surgical tray intended for sterilizing medical devices, not for diagnosing any medical condition.
No
The device is a surgical tray, which is a physical hardware component used for sterilization, not a software-only device.
Based on the provided text, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is to enclose other medical devices for sterilization by a healthcare provider. This is a function related to the preparation and handling of medical instruments, not the diagnosis of diseases or conditions using in vitro methods.
- Device Description: The device is described as reusable rigid containers for organizing and protecting instruments during sterilization. This aligns with a device used in the sterilization process, not for analyzing samples from the human body.
- Lack of IVD Characteristics: The description does not mention any components or functions related to analyzing biological samples (blood, urine, tissue, etc.), detecting analytes, or providing diagnostic information.
Therefore, the ST-Z5 surgical trays are considered a medical device used in the sterilization process, not an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
ST-Z5 surgical trays are intended to be used to enclose other medical devices that are to be sterilized by a health care provider. ST-Z5 surgical trays are intended to allow sterilization of the enclosed medical devices.
ST-Z5 surgical trays require the use of an FDA cleared wrap to maintain the sterility of the enclosed devices.
The trays are to be enclosed in a sterilization wrap that is FDA cleared for the indicated cycle, and moist heat (steam) sterilized using the following cycle:
Pre-vacuum steam: 132 ℃ (270 ℃) for 4 minutes with 20 minutes drying time.
ST-Z5 surgical trays are intended for sterilization of non-porous loads. ST-Z5 surgical trays are recommended not to be stacked during sterilization.
The combined weight of the ST-Z5 c m c(t) m(t) tray and the associated instruments is 441 grams. The weight of the empty ST-Z5 c m c(t) m(t) tray is 361 grams.
The combined weight of the Z5-BL/TL tray and the associated instruments is 427 grams. The weight of the empty Z5-BL/TL tray is 363 grams.
Product codes
KCT
Device Description
The subject device trays are reusable rigid containers, comprising a base (bottom), a removable inner tray, and a lid (cover). The subject device trays are to be used to organize and protect the instruments that are sterilized in the trays by the healthcare provider. The base, inner tray, and lid components are designed to be integrated into a single unit which contains and protects the interior contents during sterilization. The trays are perforated to allow for penetration of the sterilant, are to be used with moist heat (steam), and require the use of an FDA cleared wrap to maintain sterility. The subject device components are manufactured from injection molded polyphenylsulfone (PPSU), and holders of various geometries to position instruments in the trays are manufactured from silicone. The subject device includes two instrument trays that have the same size (same lid, base, and enclosed volume) and two inner tray configurations.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
health care provider
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Summary of Nonclinical Testing:
Test Methodology: Automated Cleaning Validation
Purpose: To validate that the cleaning instructions provided in the Instructions for Use appropriately clean the tray, and to ensure the sterilization cycle will be effective.
Acceptance Criteria: Protein assay – Micro BCA Protein Assay Acceptance criterion: less than 6.4 µg/cm2 Assay quantitation limits: 2.0 µg/mL; Hemoglobin assay Acceptance criterion: less than 2.2 µg/cm2 Assay quantitation limits: 10.0 µg/mL
Results: Pass
Test Methodology: Sterilization Validation including sterilant penetration and dry time validation ANSI/AAMI/ISO 17665-1 ANSI/AAMI/ISO 17665-2
Purpose: To validate that the sterilization instructions listed in the Instructions for Use appropriately sterilize the tray and contents.
Acceptance Criteria: 3 consecutive half-cycles performed for each of the two sizes of trays will demonstrate complete inactivation of all biologic indicators; A minimum SAL of 10-6 is achieved if the Instructions for Use are followed
Results: Pass
Test Methodology: Dry time
Purpose: To validate that the sterilization instructions listed in the Instructions for Use appropriately dry the wrapped tray for storage.
Acceptance Criteria: Using pre-cycle and post-cycle weights, the weight gain after drying will not exceed ± 3%
Results: Pass
Test Methodology: Life Cycle / Simulated Use Life Validation FDA Guidance Reprocessing Medical Devices in Health Care Settings: Validation Methods and Labeling (issued March 2015)
Purpose: To validate the service life of the trays as stated in the Instructions for Use.
Acceptance Criteria: Visual inspection, component dimensional fit verification, functional closure/latch verification for 101 use cycles
Results: Pass
Test Methodology: Biocompatibility of Subject Device (by cytotoxicity testing) ANSI/AAMI/ISO 10993-5 ANSI/AAMI/ISO 10993-12
Purpose: To evaluate the cytotoxicity potential of the test article using an in vitro cell culture assay.
Acceptance Criteria: Non-cytotoxic if ≤ 30% reduction of L-929 cell viability after exposure to extract of the device
Results: Pass
Key Results: The nonclinical testing provided for these devices met the acceptance criteria for each standard and test methodology used to evaluate the devices. No clinical data were included.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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).
0
Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the FDA logo is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
March 25, 2021
Z-Systems AG % Kevin Thomas Vice President and Director of Regulatory Affairs PaxMed International, LLC 12264 El Camino Real. Suite 400 San Diego, California 92130
Re: K201878
Trade/Device Name: St-z5 Regulation Number: 21 CFR 880.6850 Regulation Name: Sterilization Wrap Regulatory Class: Class II Product Code: KCT Dated: February 25, 2021 Received: February 26, 2021
Dear Kevin Thomas:
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 statutes and regulations administered by other Federal agencies. You must comply with all the Act's
1
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 (OS) 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,
Clarence W. Murray III, Ph.D. Acting Assistant Director DHT4B: Division of Infection Control and Plastic 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) K201878
Device Name
ST-Z5
Indications for Use (Describe)
ST-Z5 surgical trays are intended to be used to enclose other medical devices that are to be sterilized by a health care provider. ST-Z5 surgical trays are intended to allow sterilization of the enclosed medical devices.
ST-Z5 surgical trays require the use of an FDA cleared wrap to maintain the sterility of the enclosed devices.
The trays are to be enclosed in a sterilization wrap that is FDA cleared for the indicated cycle, and moist heat (steam) sterilized using the following cycle:
Pre-vacuum steam: 132 ℃ (270 ℃) for 4 minutes with 20 minutes drying time.
ST-Z5 surgical trays are intended for sterilization of non-porous loads. ST-Z5 surgical trays are recommended not to be stacked during sterilization.
ST-25 surgical trays are recommended not to be stacked during sterilization.
The combined weight of the ST-Z5 c m c(t) m(t) tray and the associated instruments is 441 grams. The weight of the empty ST-Z5 c m c(t) m(t) tray is 361 grams.
The combined weight of the Z5-BL/TL tray and the associated instruments is 427 grams. The weight of the empty Z5-BL/TL tray is 363 grams.
| Type of Use (Select one or both, as applicable) | |
|---|---|
| 区 Prescription Use (Part 21 CFR 801 Subpart D) | │ Over-The-Counter Use (21 CFR 801 Subpart C) |
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3
510(k) Summary
K201878
ST-Z5
Z-Systems AG
March 23, 2021
ADMINISTRATIVE INFORMATION
| Manufacturer Name | Z-Systems AG
Werkhofstrasse 5
CH-4702 Oensingen
Switzerland |
|-------------------|----------------------------------------------------------------------|
| Telephone | +41 62 388 69 69 |
| Official Contact | Rubino DiGirolamo, CEO |
Representative/Consultant
Kevin A. Thomas, PhD Floyd G. Larson, MS, MBA PaxMed International, LLC 12264 El Camino Real, Suite 400 San Diego, CA 92130 Telephone +1 858-792-1235 +1 858-792-1236 Fax Email kthomas@paxmed.com flarson@paxmed.com
DEVICE NAME AND CLASSIFICATION
| Trade/Proprietary Name | ST-Z5 |
|---|---|
| Common Name | Instrument sterilization trays |
| Regulation Number | 21 CFR 880.6850 |
| Regulation Name | Sterilization Wrap Containers, Trays, Cassettes & Other Accessories |
| Regulatory Class | Class II |
| Product Code | KCT |
| Classification Panel | General Hospital |
| Reviewing Office | Office of Surgical and Infection Control Devices (OHT4) |
| Reviewing Division | Division of Infection Control and Plastic Surgery Devices (DHT4B) |
PREDICATE DEVICE INFORMATION The primary predicate device is: K171713, Neodent Instrument Kits, JJGC Indústria e Comércio de Materiais Dentários S.A.
4
INDICATIONS FOR USE
ST-Z5 surgical trays are intended to be used to enclose other medical devices that are to be sterilized by a health care provider. ST-Z5 surgical trays are intended to allow sterilization of the enclosed medical devices.
ST-Z5 surgical trays require the use of an FDA cleared wrap to maintain the sterility of the enclosed devices.
The trays are to be enclosed in a sterilization wrap that is FDA cleared for the indicated cycle, and moist heat (steam) sterilized using the following cycle:
Pre-vacuum steam: 132 ℃ (270 ℃) for 4 minutes with 20 minutes drying time.
ST-Z5 surgical trays are intended for sterilization of non-porous loads. ST-Z5 surgical trays are recommended not to be stacked during sterilization.
The combined weight of the ST-Z5 c m c(t) m(t) tray and the associated instruments is 441 grams. The weight of the empty ST-Z5 c m c(t) m(t) tray is 361 grams.
The combined weight of the Z5-BL/TL tray and the associated instruments is 427 grams. The weight of the empty Z5-BL/TL tray is 363 grams.
SUBJECT DEVICE DESCRIPTION
The subject device trays are reusable rigid containers, comprising a base (bottom), a removable inner tray, and a lid (cover). The subject device trays are to be used to organize and protect the instruments that are sterilized in the trays by the healthcare provider. The base, inner tray, and lid components are designed to be integrated into a single unit which contains and protects the interior contents during sterilization. The trays are perforated to allow for penetration of the sterilant, are to be used with moist heat (steam), and require the use of an FDA cleared wrap to maintain sterility. The subject device components are manufactured from injection molded polyphenylsulfone (PPSU), and holders of various geometries to position instruments in the trays are manufactured from silicone. The subject device includes two instrument trays that have the same size (same lid, base, and enclosed volume) and two inner tray configurations.
SUMMARY OF NON-CLINICAL TESTING
Provided below is a summary of the non-clinical performance testing included in this submission, including the test methods, purpose, acceptance criteria, and results.
5
Summary of Nonclinical Testing
| Test Methodology | Purpose | Acceptance Criteria | Results |
|---|---|---|---|
| Automated Cleaning Validation | |||
| FDA Guidance Reprocessing | |||
| Medical Devices in Health Care | |||
| Settings: Validation Methods | |||
| and Labeling | |||
| (issued March 2015) | The purpose of this test is to | ||
| validate that the cleaning | |||
| instructions provided in the | |||
| Instructions for Use | |||
| appropriately clean the tray, | |||
| and to ensure the | |||
| sterilization cycle will be | |||
| effective. | Protein assay – Micro BCA Protein Assay | ||
| Acceptance criterion: less than 6.4 µg/cm2 | |||
| Assay quantitation limits: 2.0 µg/mL |
Hemoglobin assay
Acceptance criterion: less than 2.2 µg/cm2
Assay quantitation limits: 10.0 µg/mL | Pass |
| Sterilization Validation
including sterilant penetration
and dry time validation
ANSI/AAMI/ISO 17665-1
ANSI/AAMI/ISO 17665-2 | The purpose of this test is to
validate that the sterilization
instructions listed in the
Instructions for Use
appropriately sterilize the
tray and contents. | Acceptance criterion:
3 consecutive half-cycles performed for
each of the two sizes of trays will
demonstrate complete inactivation of all
biologic indicators;
A minimum SAL of 10-6 is achieved if the
Instructions for Use are followed | Pass |
| Dry time | The purpose of this test is to
validate that the sterilization
instructions listed in the
Instructions for Use
appropriately dry the
wrapped tray for storage. | Acceptance criterion:
Using pre-cycle and post-cycle weights,
the weight gain after drying will not
exceed ± 3% | Pass |
| Life Cycle / Simulated Use Life
Validation
FDA Guidance Reprocessing
Medical Devices in Health Care
Settings: Validation Methods
and Labeling
(issued March 2015) | The purpose of this test is to
validate the service life of
the trays as stated in the
Instructions for Use. | Acceptance criteria:
Visual inspection, component dimensional
fit verification, functional closure/latch
verification for 101 use cycles | Pass |
| Biocompatibility of Subject
Device (by cytotoxicity testing)
ANSI/AAMI/ISO 10993-5
ANSI/AAMI/ISO 10993-12 | The purpose of this test is to
evaluate the cytotoxicity
potential of the test article
using an in vitro cell culture
assay. | Acceptance criterion:
Non-cytotoxic if ≤ 30% reduction of L-929
cell viability after exposure to extract of
the device | Pass |
In summary, the nonclinical testing provided for these devices met the acceptance criteria for each standard and test methodology used to evaluate the devices as shown in the table above.
No clinical data were included in this submission.
6
COMPARISON TO MARKETED PREDICATE DEVICE
The subject device is similar in indications and design principles to the predicate device. Provided at the end of this summary is a table comparing the Indications for Use Statements and the technological characteristics of the subject device and the predicate device.
The subject device and the predicate device K171713 have the same intended use, the same product classification and product code (KCT), and have similar Indications for Use statements.
Except for the names of the devices and details concerning the weights of the empty and loaded trays, the Indications for Use (IFU) statement for the subject device is identical to that of the predicate device K171713. Minor differences in the wording of the IFU do not change the intended use.
The subject device and the predicate device K171713 are reusable rigid sterilization trays used to organize and protect the instruments that are sterilized by the healthcare provider. Components of the subject device and the predicate device K171713 are perforated to allow for penetration of the sterilant, are to be used with the same moist heat (steam) sterilization cycle and require the use of an FDA cleared wrap to maintain sterility.
The subject device and the predicate device K171713 include components manufactured from polyphenylsulfone and silicone, and both devices are provided in one overall size and two configurations. The overall dimensions of the subject device are similar to the overall dimensions for the predicate devices K171713. The vent to volume ratio of the subject device is similar to the vent to volume ratio of the predicate device K171713.
The subject device was subjected to use life testing for 101 cycles, and the predicate device K171713 was subjected to use life testing for 60 cycles.
Minor differences in the dimensions, sizes, or designs between the subject device and the predicate device K171713 do not create different questions of safety and effectiveness relative to the predicate device because these differences are related to the specific designs features and system components, and are supported by the cleaning validation, sterilization validation, and use life testing performed.
7
Comparison of Technological Characteristics
| Subject Device | Primary Predicate Device | Comparison | |
|---|---|---|---|
| Attribute | K201878 | K171713 | |
| ST-Z5 | Neodent Instrument Kits | ||
| Z-Systems AG | JJGC Indústria e Comércio de Materiais Dentários S.A. | ||
| Indications for Use Statement | ST-Z5 surgical trays are intended to be used to enclose other medical devices that are to be sterilized | ||
| by a health care provider. ST-Z5 surgical trays are intended to allow sterilization of the enclosed | |||
| medical devices. | |||
| ST-Z5 surgical trays require the use of an FDA cleared wrap to maintain the sterility of the enclosed | |||
| devices. | |||
| The trays are to be enclosed in a sterilization wrap that is FDA cleared for the indicated cycle, and | |||
| moist heat (steam) sterilized using the following cycle: | |||
| Pre-vacuum steam: 132 °C (270 °F) for 4 minutes with 20 minutes drying time. | |||
| ST-Z5 surgical trays are intended for sterilization of non-porous loads. | |||
| ST-Z5 surgical trays are recommended not to be stacked during sterilization. | |||
| The combined weight of the ST-Z5 c m c(t) m(t) tray and the associated instruments is 441 grams. | |||
| The weight of the empty ST-Z5 c m c(t) m(t) tray is 361 grams. | Neodent Instrument Kits are intended to be used to enclose other medical devices that are to be | ||
| sterilized by a health care provider. Neodent Instrument Kits are intended to allow sterilization of the | |||
| enclosed medical devices. Neodent Instrument Kits 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 Kits are intended for sterilization of non-porous loads. | |||
| The GM/WS Surgical Kit Case maximum load weight is 125 grams. | |||
| The GM Surgical Kit Case maximum load weight is 113 grams. | |||
| Neodent Instrument Kits are recommended not to be stacked during sterilization. | Similar | ||
| The combined weight of the Z5-BL/TL tray and the associated instruments is 427 grams. | |||
| The weight of the empty Z5-BL/TL tray is 363 grams. | |||
| Product Code | KCT | KCT | Same |
| Design | Rigid polymer base, lid, and removable inner tray | Rigid polymer base, lid, and removable inner tray | Same |
| Materials | Polyphenylsulfone (Radel® R-5000) [lid, base, tray] | ||
| Medical grade silicone [grommets/holders] | Polyphenylsulfone (Radel® R5000) [lid] | ||
| Polysulfone [base, tray] | |||
| Medical grade silicone | Similar | ||
| Materials compatible with Sterilization | |||
| Method | Yes | Yes | Same |
| Perforated | Yes; allows moist heat (steam) penetration to achieve sterilization | Yes; allows moist heat (steam) penetration to achieve sterilization | Same |
| Reusable | Yes | Yes | Same |
| Number of Overall Sizes | 1 | 1 | Same |
| Number of Configurations | 2 | 2 | Same |
| Number of uses | 101 | Not stated in 510(k) Summary | n/a |
| Overall Dimensions | 185.1 mm Length x 133.6 mm Width x 61.5 mm Height | 264 mm Width x 163 mm Length x 54 mm Height | Similar |
| Vent to Volume Ratio | 0.01596 $cm^2 / cm^3$ (0.0405 $in^2 / in^3$ ) | 0.0102 $cm^2 / cm^3$ (0.0259 $in^2 / in^3$ ) | Similar |
| Reusable | Yes | Yes | Same |
| Use Life Testing | Reusable up to 101 cycles | ||
| Assembled, sterilized | |||
| Visual inspection | |||
| Component dimensional fit verification | |||
| Functional closure (lid-base latch) verification | Reusable up to 60 times; number not stated in 510(k) Summary, but in publicly available labeling | ||
| Assembled/disassembled, cleaned, sterilized | |||
| Visual inspection | |||
| Component dimensional fit verification | |||
| Functional closure (lid-base latch) verification | Similar | ||
| Sterilization Method | |||
| Sterilant | Moist heat (steam) | Moist heat (steam) | Same |
| Cycles | Fractionated vacuum (pre-vacuum) | ||
| Exposure at 132 °C (270 °F) for 4 minutes with 20 minutes drying time. | Gravity displacement and fractionated vacuum (pre-vacuum) | ||
| Cycle parameters not in 510(k) Summary | Similar | ||
| Sterile Barrier | Sterilization wrap, FDA cleared for indicated method and cycle | Sterilization wrap, FDA cleared for indicated method and cycle | Same |
CONCLUSION
The conclusions drawn the nocelnical tests cenonstrate that the suffective, and performs as will as or better than the legally markets predicate device.