Protective cover or sheath placed over diagnostic ultrasound transducer / probe / scanhead instruments. The cover allows use of the transducer in scanning and needle quided procedures for body surface, endocavity, and intra-operative 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 (both sterile and non-sterile covers). The cover also provides a means for maintenance of a sterile field (sterile covers only). CIVCO NeoFlex™ Ultrasound Transducer Covers are furnished sterile & non-sterile: single use patient / procedure, disposable.

Device Description

The NeoFlex™ Ultrasound Transducer Cover device provides a thin, conformal covering to fit various & specific ultrasound transducer geometries. Device is manufactured as a one-piece design that provides a covering that helps prevent the transmission of pathogens as the ultrasound transducer is reused from one patient to another.

Cover material is polychloroprene (neoprene) synthetic rubber similar to that of nonlatex medical examination / surgical gloves. Type I natural latex allergy does not occur in response to polychloroprene synthetic rubber since the synthetic rubber does not contain the natural protein allergen residuals present in latex.

Various sizes and shapes of covers are offered in order to customize the fit to specific transducer geometries. Product categories / models include:

General Purpose NeoFlex™ Transducer Covers (sterile and non-sterile)

Endocavity NeoFlex™ Transducer Covers (sterile and non-sterile)

Surgi-Tip™ Intraoperative* Transducer Covers (sterile) *polyethylene cord cover w/ NeoFlex ™ tip

Covers are packaged in both sterile "procedure kit" form for single patient / procedure, disposable use. Cover kits are supplied with fasteners, and with or without coupling gel packet. Transducer covers are also combined with disposable needle guide devices into custom kits that CIVCO builds for ultrasound OEMs and end users.

AI/ML Overview

The provided document, a 510(k) summary for the NeoFlex™ Ultrasound Transducer Cover, describes the device's characteristics and its substantial equivalence to a legally marketed predicate device (CIVCO Latex Ultrasound Transducer Cover K970515). This document is a regulatory submission for device clearance, not a peer-reviewed study, and therefore the "study" referred to in the prompt is a series of tests conducted to demonstrate equivalence rather than a clinical trial with human subjects.

Here's a breakdown of the requested information based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

Parameter / Acceptance Criteria	Reported Device Performance (NeoFlex™ Ultrasound Transducer Cover)
Material Biocompatibility (non-toxic, non-sensitizing, non-irritating, non-hemolytic, non-pyrogenic, compliant with ISO 10993-Part 1, FDA Blue Book Memorandum #G95-1, FDA-GLP)	The NeoFlex™ polychloroprene material/cover device is demonstrated to be non-toxic, non-sensitizing, non-irritating, non-hemolytic, and non-pyrogenic. Type I natural latex allergy does not occur due to polychloroprene. Testing was in accordance with ISO 10993-Part 1, FDA Blue Book Memorandum #G95-1, and FDA-Good Laboratory Practices (GLP).
Strength and Elastic Characteristics (adequate for intended use without tearing or pinholing during application/removal, scanning, or attaching/removing needle guide)	Strength and elastic characteristics of the polychloroprene material are effectively similar to that of latex and allow use without tearing or pinholing the cover: a) during application and removal from transducer, b) during scanning under intended uses, and c) when attaching/removing a disposable needle guide to the transducer bracket over the cover. The nominal thickness is .0065", same as the predicate.
Ultrasound Imaging Impairment (does not impair ultrasound imaging)	Ultrasound imaging is not impaired.
Microbial Migration Barrier Effectiveness (provides an effective barrier to the prevention of microbial migration)	NeoFlex™ polychloroprene transducer cover provides an effective barrier to the prevention of microbial migration. Tested under a protocol adapted from that used to evaluate barrier properties/resistance of surgical gloves and endoscope sheaths to penetration by bloodborne pathogens using viral penetration as a test system. Polychloroprene (neoprene) material is used for medical examination/surgical gloves.
Material Safety (polychloroprene materials meet recommended safe levels as specified in US FDA CFR, Title 21, Section 177.2600 and 182.5991, and USP Absorbable Dusting Powder; synthetic rubber does not contain natural protein allergen residuals present in latex)	Polychloroprene synthetic rubber materials used in compounding meet the recommended safe levels as specified in the US Food and Drugs Administration CFR, Title 21, Section 177.2600 and 182.5991. USP Absorbable Dusting Powder is used. The synthetic rubber does not contain the natural protein allergen residuals present in latex, addressing the benefit for Type I hypersensitivity or sensitized healthcare workers.
Sterility (when applicable, sterilization by 100% EtO method, validated ANSI/AAMI/ISO 11135, SAL 10-6)	Same as predicate. Sterilization (when applicable) by 100% EtO method; validated ANSI/AAMI/ISO 11135. SAL 10-6.

2. Sample Size Used for the Test Set and Data Provenance

The document does not explicitly state the sample sizes (e.g., number of covers, number of tests) for each specific test conducted to demonstrate performance. The provenance of the data is internal to CIVCO Medical Instruments Company, Inc., as these are tests performed by the manufacturer to support their 510(k) submission. The document implies these are prospective tests conducted specifically for the NeoFlex™ device. No country of origin for the data is specified beyond the manufacturer's location in Kalona, IA, USA.

3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications

This information is not applicable and not provided. The "ground truth" here is not established by human expert consensus on images or clinical cases, but rather by standardized laboratory testing methods and accepted regulatory guidelines for medical device materials and performance.

4. Adjudication Method for the Test Set

This is not applicable. Adjudication methods like 2+1 or 3+1 typically refer to resolving disagreements among multiple human readers in clinical studies. The tests described are laboratory-based and do not involve human reader adjudication.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

No, a multi-reader multi-case (MRMC) comparative effectiveness study was not done. The document is for a medical device (an ultrasound transducer cover), not an AI algorithm or diagnostic imaging interpretation system. Therefore, there is no discussion of human readers improving with or without AI assistance.

6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study

No, a standalone performance study (in the context of an AI algorithm) was not done, as the device is not an AI algorithm. The performance described is the physical and biological characteristics of the transducer cover itself.

7. Type of Ground Truth Used

The "ground truth" for the performance evaluation is based on established laboratory testing standards and regulatory compliance criteria. This includes:

Biocompatibility standards (e.g., ISO 10993-Part 1, FDA Blue Book Memorandum #G95-1, FDA-GLP)
Material safety regulations (e.g., 21 CFR 177.2600 and 182.5991)
Sterilization validation standards (e.g., ANSI/AAMI/ISO 11135)
Performance characteristics evaluated against the known performance of the predicate device (e.g., strength, elasticity, barrier properties, non-impairment of ultrasound imaging). For instance, the microbial barrier test likely uses a quantifiable endpoint (e.g., absence of viral penetration), and strength tests would have specific breakage points or elongation metrics as acceptance criteria.

8. Sample Size for the Training Set

This is not applicable. The device is a physical product (ultrasound transducer cover), not a machine learning or AI model, so there is no concept of a "training set" for an algorithm.

9. How the Ground Truth for the Training Set Was Established

This is not applicable for the reasons stated above.

Summary

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JUN 2 1999

CIVCO
MEDICAL INSTRUMENTS

K991236 (5 pages)

510(k) SUMMARY OF SAFETY & EFFECTIVENESS

(As required by 21 CFR 807.92)

NeoFlex™ Ultrasound Transducer Cover

A. General Information

Submitter's Name:	CIVCO Medical Instruments Company, Inc.
Address:	102 First Street South, Kalona, IA 52247
Telephone No.:	phone (319) 656-4447 fax: (319) 656-4451
Contact Person:	J. William Jones, Manager - Regulatory Affairs

1937223 Establishment Reqistration Number: CIVCO Medical Instruments is registered as a medical device manufacturer.

Device Trade:	NeoFlex™ Ultrasound Transducer Cover
Device Common:	Ultrasound Transducer Cover / Sheath / Drape
Device Classification Name:	Ultrasonic Diagnostic Transducer Accessories

Classification: Classification Panel: Classification Procode: Class II under 21 CFR 892.1570 Radiology 90 ITX

Performance Standards: No applicable performance standards have been issued under Section 514 of the Food, Drug and Cosmetic Act.

B. Device Description

Page II - 1

CIVCO North America

02 First Street South Kalona, IA 52247-9589 USA Phone: 319.656.4447 Fax: 319.656.4451 www.civcomedical.com

Image /page/0/Picture/18 description: The image contains two logos. The logo on the left is a circle with the text "QUALITY ASSURED FIRM" around the top half of the circle. Inside the circle is the text "ISO 9001" with a checkmark below it. The text "SGS" is below the checkmark. The logo on the right is a square with a crown on top. Inside the square is a checkmark and the text "NATIONAL ACCREDITATION OF CERTIFICATION BODIES".

Image /page/0/Picture/19 description: The image is a black and white logo for a company that is quality assured. The logo is circular in shape, with the words "QUALITY ASSURED FIRM" written around the top half of the circle. The letters "EN" are written above the number "46001" in the center of the circle. A check mark is below the number, and the letters "SGS" are at the bottom of the circle.

IV CO Europe

Avenue Louise 65, box 11 1050 Brussels Belgium Phone: +32(02)535.7881 Fax: +32(02)535.7700 www.civcomedical.com

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Various sizes and shapes of covers are offered in order to customize the fit to specific transducer geometries. Product categories / models include:

General Purpose NeoFlex™ Transducer Covers (sterile and non-sterile)

Endocavity NeoFlex™ Transducer Covers (sterile and non-sterile)

Surgi-Tip™ Intraoperative* Transducer Covers (sterile) *polyethylene cord cover w/ NeoFlex ™ tip

C. Intended Use / Indications for Use

The NeoFlex™ Ultrasound Transducer Cover is a 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, and intra-operative diagnostic ultrasound, while helping to prevent transfer of microorganisms, body fluids, and material to the patient and healthcare worker during reuse of the transducer (both sterile and non-sterile covers). The cover also provides a means for maintenance of a sterile field (sterile covers only). NeoFlex™ is latex-free and therefore beneficial when treating a patient with known type I hypersensitivity, or for the healthcare worker who has become type I sensitized. Transducer covers are furnished sterile & non-sterile; single use patient / procedure, disposable.

The intended use and indications for use place NeoFlex™ Ultrasound Transducer Covers in device body contact categories as follows:

a) surface devices, intact skin / mucosal membranes / breached surfaces, limited contact duration (< 24 hours)
external communicating devices, tissue communicating, b) limited contact duration (< 24 hours)

D. Predicate Device

The NeoFlex™ Ultrasound Transducer Cover device is identified as substantially equivalent to CIVCO Medical's currently, legally marketed Latex Ultrasound Transducer Covers:

Predicate Device(s)	510(k) Reference	Manufacturer	Parameter	NeoFlex™ Ultrasound TransducerCover	Predicate DeviceCIVCO Latex UltrasoundTransducer Cover (K970515)
and and the program and the management of the commended to the first of the first of the first of the first of the first of the first of the first of the first and	and and and the property of the commended to the controlled in the contrôleant of the complex of the complex of	and and the first for the mannel of the program and any first and and on	Intended Use /Indications forUse	Same.Additionally,NeoFlex™ is non-latex andtherefore beneficial when treating apatient with known type Ihypersensitivity, or for the healthcareworker who has become type Isensitized.	Provides a thin, conformal protectivecover system for diagnostic ultrasoundtransducer usage in body surface,endocavity, and intra-operative patientenvironments; helps to prevent transferof microorganisms, body fluids, andparticulate material to the patient andhealthcare worker during reuse of thetransducer, and helps to maintain thesterile field where applicable;disposable device - for single patient /procedure use.
Latex Ultrasound Transducer Cover	K970515	CIVCO Medical	Design	Same.	One-piece, closed end, rolled (condomstyle) with various dimensionalconfigurations necessary toaccommodate differences in ultrasoundtransducer geometries.
Material	Polychloroprene, synthetic rubber materials used in compounding meet the recommended safe levels as specified in the US Food and Drugs Administration CFR, Title 21, Section 177.2600 and 182.5991. USP Absorbable Dusting Powder. synthetic rubber does not contain the natural protein allergen residuals present in latex.	Latex, natural rubber materials used in compounding meet the recommended safe levels as specified in the US Food and Drugs Administration CFR, Title 21, Section 177.2600 and 182.5991. USP Absorbable Dusting Powder.
Manufacturing	Same.	dip-molding / rubber vulcanization. packaged in class 10,000 cleanroom per Federal Std 209e. packaging system per ANSI / AAMI / ISO 11607.

E. Substantial Equivalence Summary

The NeoFlex™ Ultrasound Transducer Cover is substantially equivalent in safety and effectiveness to the CIVCO Latex Ultrasound Transducer Cover. The comparison table on the following page demonstrates this substantial equivalence.

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Comparison of Device to Substantially Equivalent, Legally Marketed Device

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Comparison of Device to Substantially Equivalent, Legally Marketed Device cont.

Parameter	NeoFlex™ Ultrasound Transducer Cover	Predicate DeviceCIVCO Latex Ultrasound Transducer Cover (K970515)
Quality Systems	Same.	FDA/QSR cGMP 21CFR Part 820. ISO 9001 / EN46001 / ISO 13485.
Sterility	Same.	sterilization (when applicable) by 100% EtO method; validated ANSI / AAMI / ISO 11135. SAL 10-6.
Device Body Contact Category	Same.	surface devices, intact skin / mucosal membranes / breached surfaces; limited contact duration (< 24 hours) External communicating devices, tissue communicating; limited contact duration (< 24 hours)
Safety	Biocompatibility tests for acute systemic toxicity, irritation, sensitization, hemolysis, material mediated pyrogen, and ethylene oxide sterilization residuals have demonstrated the NeoFlex™ polychloroprene material / cover device is: non-toxic. non-sensitizing. non-irritating. non-hemolytic. non-pyrogenic. Testing is in accordance with - ISO 10993-Part 1 Biological Evaluation of Medical Devices, FDA Blue Book Memorandum #G95-1, and FDA-Good Laboratory Practices (GLP).Type I natural latex allergy does not occur in response to polychloroprene synthetic rubber.	Biocompatibility tests for acute systemic toxicity, irritation, sensitization, hemolysis, material mediated pyrogen, and ethylene oxide sterilization residuals have demonstrated the latex material / cover device is: non-toxic. non-sensitizing. non-irritating. non-hemolytic. non-pyrogenic. Testing is in accordance with - ISO 10993-Part 1 Biological Evaluation of Medical Devices, FDA Blue Book Memorandum #G95-1, and FDA-Good Laboratory Practices (GLP).
Parameter	NeoFlex™ Ultrasound TransducerCover	Predicate DeviceCIVCO Latex UltrasoundTransducer Cover (K970515)
Effectiveness	Testing for NeoFlex™ polychloroprenecovers has shown that the material isadequate for the intended use:strength and elastic characteristicsare effectively similar to that of latexand allows use without tearing orpinholing the cover - a) duringapplication and removal of coverfrom transducer, b) during scanningunder intended uses, and c)attaching / removing a disposableneedle guide to the transducerbracket over the cover. same nominal thickness of .0065". ultrasound imaging is not impaired. NeoFlex™ polychloroprenetransducer cover provides aneffective barrier to the prevention ofmicrobial migration - tested underprotocol adapted from that used toevaluate the barrier properties /resistance of surgical gloves andendoscope sheaths to penetration bybloodborne pathogens using viralpenetration as a test system. polychloroprene (neoprene)material is used for medicalexamination / surgical gloves.	Experience and testing has shown thatlatex natural rubber covers:latex has sufficient strength andelasticity for the intendedapplication. nominal thickness is .0065". do not impair ultrasound imaging. are an effective barrier to theprevention of microbial migration.

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Comparison of Device to Substantially Equivalent, Legally Marketed Device

cont.

F. Conclusions

This promarket submission for the NeoFlex™ Ultrasound Transducer Cover has demonstrated Substantial Equivalence as defined and understood in the Federal Food, Drug and Cosmetic act and various guidance documents issued by the Center for Devices and Radiological Health.

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Public Health Service

Image /page/5/Picture/2 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle or bird-like figure with three curved lines representing its body and wings. The bird is facing to the right. Encircling the bird is the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" in a circular arrangement.

J. William Jones Regulatory Affairs Manager Civco Medical Instruments Company, Inc. 102 Fist Street South Kalona, Iowa 55247

RE:

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

K991236 NeoFlex Ultrasound Transducer Cover Dated: April 8, 1999 Received: April 12, 1999 Regulatory Class: II 21 CFR 892.892.1570/Procode: 90 ITX

Dear Mr. Jones:

We have reviewed your Section 510(k) notification of intent to market the device referenced above and we 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 redassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act). 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 (Premarket Approval), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 895. A substantially equivalent determination assumes compliance with the Current Good Manufacturing Practice requirements, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic QS inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.

This letter will allow you to begin marketing your device as described in your 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4613. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification"(21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number (800) 638-2041 or (301) 443-6597, or at its internet address "http://www.fda.gov/cdrh/dsma/dsmamain.html".

Sincerely yours,

CAPT Daniel G. Schultz, M.D. Acting Director, Division of Reproductive. Abdominal, Ear, Nose and Throat, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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INDICATIONS FOR USE STATEMENT

Page 1 of 1

K991236 510(k) Number (if known):

NeoFlex™ Ultrasound Transducer Cover Device Name:

Indications For Use:

(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

(Division Sign-Off)
Division of Reproductive, Abdominal, ENT, and Radiological Devices
510(k) Number	K991236

Prescription Use
(Per 21 CFR 801.109)

Over-The-Counter Use (Optional Format 1-2-96)

Regulation Number and Section

§ 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.