(14 days)
Protective cover or sheath placed over diagnostic ultrasound transducer / probe / scanhead instruments. The cover allows use of the transducer in scanning and needle guided procedures for body surface, endocavity, central nervous system, and intra-operative diagnostic ultrasound, while helping to prevent transfer of microorqanisms, body fluids, and particulate material to the patient and healthcare worker during reuse of the transducer. The cover also provides a means for maintenance of a sterile field. The cover is single use patient / procedure, nonpyrogenic, and disposable.
The Non-Pyrogenic Ultrasound Transducer Cover provides a thin, conformal covering to fit a variety of ultrasound transducer geometries. The cover is made of polyurethane, polyethylene, and/or synthetic polyisoprene materials. The cover is manufactured as either a one-or two-piece design that helps prevent the transmission of pathogens as the ultrasound transducer is reused from one patient to another. The Non-Pyrogenic Ultrasound Transducer Cover is provided sterile and is single patient / procedure and disposable.
Ultrasound imaging is not impaired by use of the cover as it is intended. As adequate coupling between the cover and the transducer is required, the Non-Pvrogenic Ultrasound Transducer Cover is utilized by applying sterile saline or other non-pyrogenic coupling media onto the transducer face or into the closed end of cover, inserting the ultrasound transducer into the closed end of cover, and unrolling the cover over the length of the transducer as desired. The open end is secured with elastic bands and nylon clips as necessary. The removal process is accomplished by pulling the cover off the transducer in a reverse method from the application.
It seems there's a misunderstanding about the nature of the provided document. This document is a 510(k) Premarket Notification Summary for a medical device (Non-Pyrogenic Ultrasound Transducer Cover), not a study report demonstrating the performance of an AI algorithm or a diagnostic device that outputs specific measurements.
Therefore, the requested information about acceptance criteria for an AI device, sample sizes for test/training sets, expert ground truth, MRMC studies, or standalone algorithm performance, does not apply to this document.
This document is primarily concerned with demonstrating substantial equivalence of a physical medical device (transducer cover) to previously cleared predicate devices, and justifying an expanded indication for use (central nervous system and non-pyrogenic claim) through specific non-clinical tests.
However, I can extract the information that is relevant to the document concerning the device's safety and effectiveness for its intended use based on the non-pyrogenic and implantation claims.
Here's an interpretation based on the document's content, focusing on what could be considered acceptance criteria and how the device met them, with caveats that this is not an AI device:
1. A table of acceptance criteria and the reported device performance
| Acceptance Criteria (for expanded claims) | Reported Device Performance |
|---|---|
| Non-Pyrogenic: Pyrogen levels acceptable for medical devices. | Endotoxin testing per USP<85> Bacterial Endotoxins Test demonstrated that pyrogen levels are acceptable in accordance with USP<161> Transfusion and Infusion Assemblies and Similar Medical Devices. |
| Biocompatibility for CNS use: Non-reactive when implanted in muscle. | Implant testing per ISO 10993-06 Tests for Local Effects After Implantation demonstrated that the device materials are non-reactive when implanted in muscle for one week. |
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 testing: The document does not specify the exact sample size (number of units tested) for the endotoxin or implant testing. It states "test data" was used.
- Data Provenance: The tests were conducted to support a 510(k) submission to the US FDA, implying the data would adhere to relevant US regulatory standards. However, the country of origin of the actual testing facilities or samples is not specified in this summary. The testing appears to be prospective laboratory testing of the device itself.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
This concept is not applicable as this is a physical medical device undergoing non-clinical laboratory testing, not a diagnostic device requiring expert interpretation of results for ground truth.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable. The testing methods (USP<85> and ISO 10993-06) involve objective laboratory measurements, not subjective interpretation requiring adjudication among experts.
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 not an AI diagnostic device.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This is not an AI algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
The "ground truth" here would be the objective measurements obtained from standardized laboratory tests:
- For pyrogenicity: Detection of bacterial endotoxins below a specified limit as defined by USP<85> and USP<161>.
- For biocompatibility: Observation of local tissue reactions after implantation in muscle, evaluated against criteria defined by ISO 10993-06.
8. The sample size for the training set
Not applicable. This device does not have a "training set" as it is not an AI/machine learning model.
9. How the ground truth for the training set was established
Not applicable.
In summary: The provided document is a regulatory submission for a physical medical device. It details non-clinical testing to demonstrate the safety and effectiveness of a transducer cover for expanded indications, specifically regarding its non-pyrogenic nature and biocompatibility for central nervous system use. The "acceptance criteria" and "device performance" in this context refer to the successful completion and results of these specific laboratory tests against established standards.
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Image /page/0/Picture/0 description: The image shows the logo for CIVCO Medical Solutions. The logo features a stylized globe on the left, followed by the word "CIVCO" in a bold, sans-serif font. Below "CIVCO" are the words "MEDICAL SOLUTIONS" in a smaller, sans-serif font with wide spacing between the letters.
K131528
Page 1 of 3
JUN 1 1 2013
Section 5 - 510(k) Summary
A. Submitter Information
| Submitter Name & Address: | CIVCO Medical Instruments Co., Inc. d/b/a CIVCO MedicalSolutions102 First Street SouthKalona, Iowa 52247 |
|---|---|
| Contact Person: | Amanda Stahle, Regulatory Affairs SpecialistTelephone: 319-248-6628, Fax: 877-218-0324amanda.stahle@civco.com |
| Date Summary Prepared: | September 10, 2012 |
| Trade Name: | Non-Pyrogenic CIV-FlexTMNon-Pyrogenic NeoGuardTM SurgiTipTMNon-Pyrogenic NeoGuardTM |
| Common Name: | Non-Pyrogenic Ultrasound Transducer Cover |
| Classification Name: | Transducer, Ultrasonic, Diagnostic |
| Classification Number: | Class II under 21 CFR 892.1570 |
| Review Panel: | Radiology |
| Product Code: | ITX |
B. Predicate Device
The proposed Non-Pyrogenic Ultrasound Transducer Cover is substantially equivalent to the following predicate devices:
| Predicate Devices | Mfa. |
|---|---|
| K970513: General Purpose Transducer Cover | CIVCO Medical Instruments |
| Materials: Polyurethane and Polyethylene | Co., Inc. |
| K013721: Synthetic Polyisoprene Ultrasound Transducer Cover | CIVCO Medical Instruments |
| Materials: Synthetic Polyisoprene | Co., Inc. |
The proposed device and the predicate devices are comprised of equivalent materials and have the same design. The purpose of this 510(k) is to expand the indications for use of these predicate devices to include use in the central nervous system and add the claim of non-pyrogenic. These additional indications of use are supported by test data and this testing has demonstrated that the device is safe and effective for these additional intended uses.
C. Device Description
The Non-Pyrogenic Ultrasound Transducer Cover provides a thin, conformal covering to fit a variety of ultrasound transducer geometries. The cover is made of polyurethane,
| Corporate Headquarters | 102 First Street South | Kalona, IA 52247 | USA | 319.248.6757 | 319.248.6660 | ||
|---|---|---|---|---|---|---|---|
| Coralville Office | 2301 Jones Blvd. | Coralville, IA 52241 | USA | 319.248.6757 | 319.248.6660 | ||
| Europe Office | Pasteurstraat 6 | 2811 DX Reeuwijk | The Netherlands | +31(0) 182.394495 | +31(0) 182.395014 | ||
| Orange City Office | 1401 8th Street SE | Orange City, IA 51041 | USA | 712.737.8688 | 712.737.8654 |
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Image /page/1/Picture/0 description: The image shows the logo for CIVCO Medical Solutions. The logo features a stylized globe on the left, followed by the word "CIVCO" in bold, sans-serif font. Below "CIVCO" are the words "MEDICAL SOLUTIONS" in a smaller font size. The globe is made up of intersecting lines, giving it a three-dimensional appearance.
WWW.CIVCO.COM
polyethylene, and/or synthetic polyisoprene materials. The cover is manufactured as either a one-or two-piece design that helps prevent the transmission of pathogens as the ultrasound transducer is reused from one patient to another. The Non-Pyrogenic Ultrasound Transducer Cover is provided sterile and is single patient / procedure and disposable.
Ultrasound imaging is not impaired by use of the cover as it is intended. As adequate coupling between the cover and the transducer is required, the Non-Pvrogenic Ultrasound Transducer Cover is utilized by applying sterile saline or other non-pyrogenic coupling media onto the transducer face or into the closed end of cover, inserting the ultrasound transducer into the closed end of cover, and unrolling the cover over the length of the transducer as desired. The open end is secured with elastic bands and nylon clips as necessary. The removal process is accomplished by pulling the cover off the transducer in a reverse method from the application.
The following models of Non-Pyrogenic Ultrasound Transducer Covers are included in this submission:
| Non-Pyrogenic Ultrasound Transducer Cover | Accessories | |
|---|---|---|
| Product Name | Material(s) | |
| Non-Pyrogenic CIV-Flex™ (7.6 taperedto 4.1 x 147cm) | Polyurethane | Kraton elastic bands |
| Non-Pyrogenic CIV-Flex™ (10.2 x147cm) | Polyurethane | Kraton elastic bands |
| Non-Pyrogenic NeoGuard™ SurgiTip™(15.2 x 244cm with 3cm tip) | SyntheticPolyisoprene,Polyethylene | Kraton elasticbands, nylon clips |
| Non-Pyrogenic NeoGuard™ | SyntheticPolyisoprene | Kraton elastic bands |
D. Indications for Use/Intended Use
Protective cover or sheath placed over diagnostic ultrasound transducer / probe / scanhead instruments. The cover allows use of the transducer in scanning and needle guided procedures for body surface, endocavity, central nervous system, and intraoperative diagnostic ultrasound, while helping to prevent transfer of microorganisms, body fluids, and particulate material to the patient and healthcare worker during reuse of the transducer. The cover also provides a means for maintenance of a sterile field. The cover is single use patient / procedure, non-pvrogenic, and disposable,
| Corporate Headquarters | 102 First Street South | Kalona, IA 52247 | USA | 319.248.6757 | 319.248.6660 | ||
|---|---|---|---|---|---|---|---|
| Coralville Office | 2301 Jones Blvd. | Coralville, IA 52241 | USA | 319.248.6757 | 319.248.6660 | ||
| Europe Office | Pasteurstraat 6 | 2811 DX Reeuwijk | The Netherlands | +31(0) 182.394495 | +31(0) 182.395014 | ||
| Orange City Office | 1401 8th Street SE | Orange City, IA 51041 | USA | 712.737.8688 | 712.737.8654 |
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Image /page/2/Picture/0 description: The image shows the logo for CIVCO Medical Solutions. The logo features a stylized globe on the left, followed by the word "CIVCO" in a bold, sans-serif font. Below the word "CIVCO" are the words "MEDICAL SOLUTIONS" in a smaller, sans-serif font.
K131528
Page 3 of 3
WWW.CIVCO.COM
E. Technological Characteristics
No technological characteristics have changed between the proposed device and predicate devices. Both the predicates and the proposed device are comprised of equivalent materials (polyurethane, polyethylene, and/or synthetic polyisoprene). The predicate devices and the proposed device are identical in design.
F. Non-Clinical Testing
In order to support the expanded indications for use to include a non-pyrogenic claim and use in the central nervous system, non-clinical endotoxin testing per USP<85> Bacterial Endotoxins Test and implant testing per ISO 10993-06 Tests for Local Effects After Implantation was completed on the proposed device. The endotoxin testing demonstrated that pyrogen levels are acceptable in accordance with USP<161> Transfusion and Infusion Assemblies and Similar Medical Devices. The implant testing demonstrated that the device materials are non-reactive when implanted in muscle for one week.
Sterility, packaging, shelf life, biocompatibility, and performance testing completed on the predicate devices remains applicable for the proposed device and this testing is summarized in the submission.
G. Conclusion
This premarket submission for the Non-Pyrogenic Ultrasound Transducer Cover has demonstrated substantial equivalence as defined and understood in the Federal Food, Drug and Cosmetic act and various quidance documents issued by the Center for Devices and Radiological Health. Based on comparison against predicate devices, endotoxin testing, and implant testing, the Non-Pyrogenic Ultrasound Transducer Cover is safe and effective for its intended use.
| Corporate Headquarters | 102 First Street South | Kalona, IA 52247 | USA | P 319.248.6757 | F 319.248.6660 |
|---|---|---|---|---|---|
| Coralville Office | 2301 Jones Blvd. | Coralville, IA 52241 | USA | P 319.248.6757 | F 319.248.6660 |
| Europe Office | Pasteurstraat 6 | 2811 DX Reeuwijk | The Netherlands | P +31(0) 182.394495 | F +31(0) 182.395014 |
| Orange City Office | 1401 8th Street SE | Orange City, IA 51041 | USA | P 712.737.8688 | F 712.737.8654 |
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DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle-like symbol with three curved lines representing the body and wings. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the symbol.
Food and Drug Administration
Public Health Service
10903 New Hampshire Avenue Document Control Center - WO66-G60 Silver Spring, MD 20993-0002
June 11, 2013
CIVCO Medical Instruments Co., Inc. % Mr. Mark Job Responsible Third Party Official Regulatory Technology Services, LLC 1394 25th Street NW BUFFALO MN 55313
Re: K131528
· Trade/Device Name: Non-Pyrogenic Ultrasound Transducer Covers Regulation Number: 21 CFR 892.1570 Regulation Name: Diagnostic ultrasonic transducer (accessory) Regulatory Class: II Product Code: ITX Dated: May 24, 2013 Received: May 28, 2013
Dear Mr. Job:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The .general.controls.provisions.of.the.Act.include.requirements.for.annual.registration. Jisting.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 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.
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Page 2 - Mr. Job
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Small Manufacturers, International and Consumer Assistance at its tollfree number (800) 638 2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.hum. 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.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely yours,
Sm.p)
for
Janine M. Morris Director, Division of Radiological Health Office of In Vitro Diagnostics and Radiological Health Center for Devices and Radiological Health
Enclosure
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510(k) Number (if known): K131528
Device Name: Non-Pyrogenic Ultrasound Transducer Cover
Indications for Use: Protective cover or sheath placed over diagnostic ultrasound transducer / probe / scanhead instruments. The cover allows use of the transducer in scanning and needle guided procedures for body surface, endocavity, central nervous system, and intra-operative diagnostic ultrasound, while helping to prevent transfer of microorqanisms, body fluids, and particulate material to the patient and healthcare worker during reuse of the transducer. The cover also provides a means for maintenance of a sterile field. The cover is single use patient / procedure, nonpyrogenic, and disposable.
Over-The-Counter Use Prescription Use AND/OR AND/OR AND/OR × -------------------------------------------------------------------------------------------------------------------------------------------------------------------------------(Part-21-GFR-801-Subpart-D) --
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of In Vitro Diagnostics and Radiological Health (OIR)
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(Division Sign Oft) Division of Radiological Health Office of In Vitro Diagnostic and Radiological Health
K131528 510(k)
Page 1 of
§ 892.1570 Diagnostic ultrasonic transducer.
(a)
Identification. A diagnostic ultrasonic transducer is a device made of a piezoelectric material that converts electrical signals into acoustic signals and acoustic signals into electrical signals and intended for use in diagnostic ultrasonic medical devices. Accessories of this generic type of device may include transmission media for acoustically coupling the transducer to the body surface, such as acoustic gel, paste, or a flexible fluid container.(b)
Classification. Class II.