(226 days)
The Gyrus ACMI Cyber Wand™ Sterilization Trays are intended to be used to enclose and protect only CyberWand™ transducers and accessories during sterilization. The trays are to be used in conjunction with an FDA cleared sterilization wrap. The trays are optional accessories to the CyberWand™ transducers and accessories for which they are designed.
The trays are indicated for ETO sterilization of only the following (maximum load) per tray: 2 CyberWand Transducers, 2 CyberWand Probe sets, 1 Wrench, 1 Cleaning stylet.
EtO Sterilization parameters: EtO Sterilize using 100% ethylene oxide: Temp 55 ℃, Vacuum 97mmHgV, Preconditioning time 60 minutes, EtO concentration 735-750 mg/L, Exposure time 60 minutes, Humidity 35%-80%, Aeration 12 hours @55°C.
The Gyrus ACMI® Cyber wand Sterilization trays are comprised of plastic lids and bottoms that contain numerous large holes (approximately 7mm in diameter) that permit ready ingress and egress of sterilization gases. The trays are designed to provide protection from physical damage to the transducer and accessories during EtO sterilization and storage. The trays are constructed of biocompatible RADEL-R. The trays do not contact the patient. Radel-R is a polyphenylsulfone plastic that is widely used in medical devices. Radel-R meets the requirements for biocompatibility pursuant to ISO-10993 and is compatible with E1O sterilization. The trays are locked shut with stainless steel clips on each end.
The provided text describes the acceptance criteria and study for the Gyrus ACMI CyberWand Transducer and Accessories Storage-Sterilization Trays.
Acceptance Criteria and Device Performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| EtO Sterilization Efficacy: Achieve a 6 log reduction in biological indicator organisms. | System was sterilized successfully by EtO, demonstrating 6 log reduction capabilities (SAL of 10⁻⁶). |
| EtO Residual Concentrations: Residual concentrations of EtO should be within acceptable limits after aeration, pursuant to ISO10993-7. | EtO residual testing was performed, with a 12 hour aeration time. Pursuant to ISO10993-7, residual concentrations were within acceptable limits. |
| Biocompatibility: Constructed from biocompatible materials meeting requirements of ISO-10993. | Trays are constructed of biocompatible RADEL-R, which meets the requirements for biocompatibility pursuant to ISO-10993. |
| Compatibility with Sterilization Modality: Compatible with EtO sterilization. | Radel-R is compatible with EtO sterilization. |
| Protection from Physical Damage: Designed to provide protection from physical damage to the transducer and accessories during EtO sterilization and storage. | The trays are designed to provide protection from physical damage to the transducer and accessories during EtO sterilization and storage. |
| Ingress and Egress of Sterilization Gases: Design to permit ready ingress and egress of sterilization gases. | Trays are comprised of plastic lids and bottoms containing numerous large holes (approximately 7mm in diameter) that permit ready ingress and egress of sterilization gases. |
| Intended Use Conditions (Maximum Load): Successfully sterilize a maximum load per tray: 2 CyberWand Transducers, 2 CyberWand Probe sets, 1 Wrench, 1 Cleaning stylet, using specified EtO parameters (Temp: 55 ℃, Vacuum 97mmHgV, Preconditioning time 60 minutes, EtO concentration 735-750 mg/L, Exposure time 60 minutes, Humidity 35%-80%, Aeration: 12 hours @55 ℃). | The maximum load was placed in the tray, inoculated with FDA cleared biological indicator organisms, and chemical indicators were placed. The system was sterilized successfully by EtO, demonstrating 6 log reduction capabilities (SAL of 10⁻⁶). |
Study Details
The provided document describes a performance study to demonstrate the effectiveness of the sterilization trays.
1. Sample size used for the test set and the data provenance:
- Sample Size: The document does not explicitly state a precise numerical sample size (e.g., number of trays or sterilization cycles tested). However, it mentions that "The maximum load was placed in the tray and inoculated with FDA cleared biological indicator organisms, and chemical indicators were placed. . The trays were wrapped with two layers of FDA approved sterilization wrap and placed into ethylene oxide sterilizer for processing." This implies testing was conducted on at least one tray with the maximum specified load.
- Data Provenance: Not explicitly stated, but the submission is to the FDA for a US market, suggesting the testing was likely conducted in a controlled laboratory setting. It is a retrospective study in the context of the 510(k) submission, meaning the data was collected prior to the submission for regulatory approval.
2. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- This information is not applicable as the study relates to terminal sterilization efficacy and chemical residual limits, not diagnostic interpretation or clinical decision-making that would require expert consensus. The "ground truth" for sterilization efficacy is objectively measured via biological indicators (6-log reduction) and chemical residual testing (ISO10993-7 compliance) by laboratory analysis.
3. Adjudication method for the test set:
- Not applicable. The performance evaluation involved objective laboratory tests (biological indicator growth via incubation, chemical residue analysis) rather than subjective assessments requiring adjudication among experts.
4. 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:
- No. This type of study is entirely irrelevant to the evaluation of a sterilization tray. MRMC studies are typically used for evaluating diagnostic imaging devices or AI algorithms in clinical settings.
5. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:
- Yes, in essence. The study evaluated the standalone performance of the sterilization tray system (tray + wrap + sterilization process) in achieving sterilization and managing residuals. There is no "algorithm" or "human-in-the-loop" aspect to the function of a sterilization tray itself; its performance is purely mechanical/chemical.
6. The type of ground truth used:
- Biological indicator log reduction: The primary ground truth for sterilization efficacy was the "6 log reduction capabilities (SAL of 10⁻⁶)" demonstrated by the FDA cleared biological indicator organisms.
- ISO10993-7 standard for residuals: The ground truth for EtO residual concentrations was compliance with the limits specified in the ISO10993-7 standard.
7. The sample size for the training set:
- Not applicable. This device is a passive sterilization tray, not an AI or machine learning algorithm. Therefore, there is no "training set."
8. How the ground truth for the training set was established:
- Not applicable. As there is no training set for this type of device, ground truth establishment for a training set is not relevant.
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Gyrus ACMI CyberWand Transducer and Accessories Storage-Sterilization Trays Traditional 510(k) Notification Gyrus ACMI Incorporated 136 Turnpike Road Southborough, MA 01772
MAY 2 0 2011
510(k) Summary of Safety and Effectiveness Gyrus ACMI Inc. Gyrus ACMI CyberWand™ Storage-Sterilization Trays
.
5108 # : K102970
General Information
Manufacturer:
Contact Person:
Gyrus ACMI Inc. 136 Turnpike Rd. Southborough, MA 01772-2104
Lorraine Calzetta Regulatory Affairs Tel. #: 508-804-2752 Fax #: 508-804-2624
Date Prepared:
Device Description
August 26, 2010
Classification Name: Sterilization, wrap, containers and trays (21CFR 880.6850), Class II
Gyrus ACMI Cyber Wand Transducer and
Accessories Sterilization Trays
Trade Name:
Generic/Common Name:
Sterilization trays
Predicate Devices
| Gyros ACMI Flexible Endoscope Storage Sterilization Trays | K092682 |
|---|---|
| Symmetry Medical PolyVac Instrument Delivery System | K040223 |
Intended Uses
The Gyrus ACMI® CyberWand™ Transducer and Accessories Storage-Sterilization Trays are intended to be used to enclose and protect only CyberWand transducers and accessories during steam or EO sterilization. The trays are to be used in conjunction with an FDA cleared sterilization wrap. The trays are optional accessories to the CyberWand transducers and accessories for which they are designed. The trays are indicated for steam or ETO sterilization of only the following maximum load per tray: 2 CyberWand Transducers, 2 CyberWand Probe sets. I Wrench, I Cleaning stylet
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Gyrus ACMI CyberWand Transducer and Accessories Storage-Sterilization Trays Traditional S10(k) Notification Gyrus ACMI Incorporated 136 Turnpike Road Southborough, MA 01772
EtO Sterilization parameters:
EtO Sterilize using 100% ethylene oxide
Temp: 55 ℃, Vacuum 97mmHgV, Preconditioning time 60 minutes, EtO concentration 735-750 mg/L, Exposure time 60 minutes, Humidity 35%-80%, Aeration: 12 hours @55 ℃
Product Description
The Gyrus ACMI® Cyber wand Sterilization trays are comprised of plastic lids and bottoms that contain numerous large holes (approximately 7mm in diameter) that permit ready ingress and egress of sterilization gases. The trays are designed to provide protection from physical damage to the transducer and accessories during EtO sterilization and storage. The trays are constructed of biocompatible RADEL-R. The trays do not contact the patient. Radel-R is a polyphenylsulfone plastic that is widely used in medical devices. Radel-R meets the requirements for biocompatibility pursuant to ISO-10993 and is compatible with E1O sterilization.
Performance Data
The maximum load was placed in the tray and inoculated with FDA cleared biological indicator organisms, and chemical indicators were placed. . The trays were wrapped with two layers of FDA approved sterilization wrap and placed into ethylene oxide sterilizer for processing. The system was sterilized successfully by EtO demonstrating 6 log reduction capabilities (SAL of 10°).
Test systems were exposed to full cycles for EtO. EtO residual testing was performed, with a 12 hour aeration time. Pursuant to ISO10993-7, residual concentrations were within acceptable limits.
Technological Characteristics and Substantial Equivalence
The Gyrus ACMI® CyberWand Transducer and Accessories Storage-Sterilization Tray s are composed of the same materials and utilize similar features as that of the predicates.
The Gyrus ACMI® CyberWand Sterilization trays are comprised of Radel-R plastic lids and bottoms that contain numerous large holes (approximately 7mm in diameter) that permit ready ingress and egress of sterilization gases The trays are constructed of biocompatible RADEL-R. The trays are locked shut with stainless steel clips on each end. The predicate trays have similar design features ( numerous large hole that permit ingress and egress of gases.
Like the predicates , the intended use of the trays to provide protection from physical damage to accessories during EtO sterilization and storage. The trays do not contact the patient. Radel-R is a polyphenylsulfone plastic that is widely used in medical devices. Radel-R meets the requirements for biocompatibility) pursuant to ISO-10993 and is compatible with EtO sterilization.
The predicates are also composed of Radel R and have the same design philosophy and construction and are compatible with the same sterilization modalities
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Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized blue eagle-like symbol with three curved lines representing wings or feathers. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" is arranged in a circular pattern around the symbol.
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002
NOV 29 2011
Mr. Graham A. L. Baillie Associate Manager, Regulatory Affairs Gyrus ACMI, Incorporated 136 Turnpike Road Southborough, Massachusetts 01772
Re: K102970
Trade/Device Name: ACMI CyberWand™ Transducer and Accessories Storage -Sterilization Trays Regulation Number: 21CFR 880.6850 Regulation Name: Sterilization Wrap Regulatory Class: II Product Code: KCT Dated: October 24, 2011 Received: October 25, 2011
Dear Mr. Baillie:
This letter corrects our substantially equivalent letter of May 20, 2011.
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 (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.
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Page 2 - Mr. Baillie
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 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/MedicalDevices/Safety/ReportaProblem/default.htm 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 (301) 796-7100 or at its Internet address http://www.fda.goy/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely yours.
Antara
Anthony D. Watson, B.S., M.S., M.B.A. Director Division of Anesthesiology, General Hospital, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Oct 21, 2011
Indications for Use
510(k) Number:
Device Name: Gyrus ACMI CyberWand™Transducer and Accessories Storage - Sterilization Trays
Indications for Use:
The Gyrus ACMI Cyber Wand™ Sterilization Trays are intended to be used to enclose and protect only CyberWand™ transducers and accessories during sterilization. The trays are to be used in conjunction with an FDA cleared sterilization wrap. The trays are optional accessories to the CyberWand™ transducers and accessories for which they are designed.
The trays are indicated for ETO sterilization of only the following (maximum load) per tray: 2 CyberWand Transducers, 2 CyberWand Probe sets, 1 Wrench, 1 Cleaning stylet.
EtO Sterilization parameters: EtO Sterilize using 100% ethylene oxide: Temp 55 ℃, Vacuum 97mmHgV, Preconditioning time 60 minutes, EtO concentration 735-750 mg/L, Exposure time 60 minutes, Humidity 35%-80%, Aeration 12 hours @55°C.
Prescription Use: (Per 21 CFR 801.109) OR Over-the-Counter Use: X
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Shula A. Murphy, MD, F.C. Lavine-Williams
(Division Sign-Off Division of Anesthesiology, General Hospital Infection Control, Dental Devices
510(k) Number: K102970
§ 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).