SYNTHETIC POLYSIOPRENE ULTRASOUND TRANSDUCER COVER

K013721 · CIVCO Medical Instruments Co., Inc. · ITX · Dec 28, 2001 · Radiology

Device Facts

• Record ID: K013721
• Device Name: SYNTHETIC POLYSIOPRENE ULTRASOUND TRANSDUCER COVER
• Applicant: CIVCO Medical Instruments Co., Inc.
• Product Code: ITX · Radiology
• Decision Date: Dec 28, 2001
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 892.1570
• Device Class: Class 2

Intended Use

The Synthetic Polyisoprene Ultrasound Transducer Cover is a protective cover or sheath placed over an ultrasound transducer / probe / scanhead instruments. The cover is used with the transducer in scanning and needle guide procedures for body surface, endocavity, and intra-operative ultrasound. The cover also helps 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). Synthetic Polyisoprene is latex-free and therefore beneficial when treating a patient with known type I hypersensitivity. Transducer covers are furnished sterile & non-sterile; single use patient / procedure, disposable.

Device Story

The device is a thin, conformal synthetic polyisoprene rubber cover designed to fit various ultrasound transducer geometries. It acts as a physical barrier to prevent cross-contamination between patients and healthcare workers by blocking microorganisms, body fluids, and particulates. It is used in clinical settings (body surface, endocavity, intra-operative) by healthcare professionals. The cover is disposable, single-use, and available in sterile or non-sterile versions. Some models include a polyethylene cord cover or are packaged with needle guides. By maintaining a sterile field and preventing pathogen transfer, the device protects both the patient and the clinician. It is latex-free, providing a safe alternative for patients with latex allergies.

Clinical Evidence

Bench testing only. Biocompatibility testing (cytotoxicity, acute systemic toxicity, irritation, sensitization, hemolysis, material-mediated pyrogen, and EtO residuals) confirmed the material is non-toxic, non-sensitizing, non-irritating, non-hemolytic, and non-pyrogenic. Barrier effectiveness was validated using a protocol adapted from surgical glove and endoscope sheath testing, utilizing viral penetration as a system to evaluate resistance to bloodborne pathogens.

Technological Characteristics

Material: Synthetic polyisoprene rubber (meets 21 CFR 177.2600 and 182.5991). Design: One or two-piece, closed-end, rolled or polyethylene-attached configurations. Thickness: 0.010 inches. Sterilization: 100% EtO (for sterile versions) per ANSI/AAMI/ISO 11135 (SAL 10^-6). Packaging: ANSI/AAMI/ISO 11607. Non-latex, powder-free.

Indications for Use

Indicated for use as a protective sheath for ultrasound transducers during body surface, endocavity, and intra-operative diagnostic and interventional ultrasound procedures. Intended for use on intact skin, mucosal membranes, or breached surfaces for limited contact duration (< 24 hours). Suitable for patients with type I latex hypersensitivity.

Regulatory Classification

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.

Predicate Devices

• NeoFlex™ Ultrasound Transducer Cover (K991236)

Submission Summary (Full Text)

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#### DEC 2 8 2001

K013721

## 510(k) SUMMARY OF SAFETY & EFFECTIVENESS

(As required by 21 CFR 807.92)

## Synthetic Polyisoprene Ultrasound Transducer Cover

#### A. General Information

| Submitter's Name: | CIVCO Medical Instruments Co., Inc. |
|-------------------|-----------------------------------------------|
| Address: | 102 First Street South, Kalona, IA 52247 |
| Telephone No.: | phone [phone] fax: [phone] |
| Contact Person: | Theresa Leinen, Quality Systems Administrator |

Establishment Registration Number: 1937223 CIVCO Medical Instruments Co., Inc. is registered as a medical device manufacturer.

| Device Trade: | Synthetic Polyisoprene Ultrasound Transducer<br>Cover |
|-----------------------------|-------------------------------------------------------|
| Device Common: | Ultrasound Transducer Cover / Sheath / Drape |
| Device Classification Name: | Ultrasonic Diagnostic Transducer Accessories |
| Classification: | Class II under 21 CFR 892.1570 |
| Classification Panel: | Radiology |
| Classification Procode: | 90 ITX |

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

#### B. Device Description

Classification Procode:

The Synthetic Polyisoprene Ultrasound Transducer Cover provides a thin, conformal covering to fit various and specific ultrasound transducer geometries. The cover is manufactured as either a one-or two-piece design that provides a covering that helps prevent the transmission of pathogens as the ultrasound transducer is reused from one patient to another.

The cover material is polyisoprene synthetic rubber similar to that of non-latex medical examination / surgical gloves. Various sizes and shapes of covers are offered in order to customize the fit to specific transducer geometries. Product categories / models include:

General Purpose Synthetic Polyisoprene Transducer Covers (sterile and non-sterile)

Endocavity Synthetic Polyisoprene Transducer Covers (sterile and non-sterile)

Surgi-Tip™ Intraoperative* Synthetic Polyisoprene Transducer Covers (sterile) *Polyethylene cord cover w/ Synthetic Polyisoprene tip

Covers are packaged in both sterile and non-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.

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K0/3721
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### C. Intended Use / Indications for Use

The Synthetic Polyisoprene Ultrasound Transducer Cover is a protective cover or sheath The Synthetic I virylsoprene Offransducer / probe / scanhead instruments. The cover is used with placed over an ultrasound transduor 7 probe Foody surface, endocavily, and the transdicer in Scanning and necule galadu procedured to rasound. The cover also helps to intra-operative ulagnostic, interventional; of the patient and healthcare in prevent transfer of the transducer (both sterile and non-sterile covers). The cover also
worker during reuse of the transducer (both sterile and non-sterile cover also worker dunny rease of the transadoes (secrile field (sterile covers only). Synthetic provides a means for maintenantes of a stonio ficial when treating a patient with known type I Polylsoprene is facex-free and therefore benoments. I sensitized. Transducer hypers are furnished sterile & non-sterile; single use patient / procedure, disposable.

The intended use and indications for use place Synthetic Polyisoprene Ultrasound The Intondou aso an in device body contact categories as follows:

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

#### D. Predicate Device

The Synthetic Polyisoprene Ultrasound Transducer Cover is identified as substantially The Oynlinetic Torylooprono Shiracolly marketed NeoFlex™ Ultrasound Transducer Covers:

| Predicate Device(s) | 510(k) Reference | Manufacturer |
|--------------------------------------|------------------|--------------|
| NeoFlex™ Ultrasound Transducer Cover | K991236 | CIVCO |

### E. Substantial Equivalence Summary

The Synthetic Polyisoprene Ultrasound Transducer Cover is substantially equivalent in The bynthetto I offectiveness to the CIVCO NeoFlex™ Ultrasound Transducer Cover. The salely and Shoutronooo following page demonstrates this substantial equivalence.

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K 013721
3/5

## Comparison of Device to Substantially Equivalent, Legally Marketed Device

| Parameter | Synthetic Polyisoprene<br>Ultrasound Transducer Cover | Predicate Device<br>CIVCO NeoFlex™ Ultrasound<br>Transducer Cover (K991236) |
|------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Intended Use /<br>Indications for<br>Use | Same. | Provides a thin, conformal protective<br>cover system for ultrasound transducer<br>usage in body surface, endocavity, and<br>intra-operative patient environments;<br>helps to prevent transfer of<br>microorganisms, body fluids, and<br>particulate material to the patient and<br>healthcare worker during reuse of the<br>transducer, and helps to maintain the<br>sterile field where applicable;<br>disposable device - for single patient /<br>procedure use. |
| Design | Same. | One-piece, closed end, rolled (condom<br>style) or a two-piece , closed end<br>cover, (synthetic rubber attached to<br>polyethylene) with various dimensional<br>configurations necessary to<br>accommodate differences in ultrasound<br>transducer geometries. |
| Material | Polyisoprene, synthetic rubber Materials used in compounding meet<br>the recommended safe levels as<br>specified in the US Food and Drugs<br>Administration CFR, Title 21, Section<br>177.2600 and 182.5991. USP Absorbable Dusting Powder. Synthetic rubber does not contain<br>the natural protein allergen residuals<br>present in latex. | Polychloroprene, synthetic<br>rubber Materials used in compounding<br>meet the recommended safe levels<br>as specified in the US Food and<br>Drugs Administration CFR, Title 21,<br>Section 177.2600 and 182.5991. USP Absorbable Dusting Powder. Synthetic rubber does not contain<br>the natural protein allergen<br>residuals present in latex. |
| Manufacturing | Same. | dip-molding / rubber vulcanization. packaged in class 10,000<br>cleanroom per Federal Std 209e. packaging system per<br>ANSI / AAMI / ISO 11607. |
| Parameter | Synthetic Polyisoprene<br>Ultrasound Transducer Cover | Predicate Device<br>CIVCO NeoFlex™ Ultrasound<br>Transducer Cover (K991236) |
| Quality Systems | Same. | FDA/QSR cGMP 21CFR Part 820. ISO 9001 / EN46001 / ISO 13485. |
| Sterility | Same. | sterilization (when applicable) by<br>100% EtO method; validated ANSI / AAMI / ISO 11135. SAL 10-6. |
| Device Body<br>Contact Category | Same. | surface devices, intact skin /<br>mucosal membranes / breached<br>surfaces;<br>limited contact duration (< 24 hours) External communicating devices,<br>tissue communicating;<br>limited contact duration (< 24 hours) |
| Safety | Biocompatibility tests for cytotoxicity,<br>acute systemic toxicity, irritation,<br>sensitization, hemolysis, material<br>mediated pyrogen, and ethylene oxide<br>sterilization residuals have demonstrated<br>the Synthetic Polyisoprene material /<br>cover device is: non-toxic. non-sensitizing. non-irritating. non-hemolytic. non-pyrogenic. Testing is in accordance with -<br>ISO 10993-Part 1 Biological Evaluation<br>of Medical Devices, FDA Blue Book<br>Memorandum #G95-1, and FDA-Good<br>Laboratory Practices (GLP). | Biocompatibility tests for acute systemic<br>toxicity, irritation, sensitization,<br>hemolysis, material mediated pyrogen,<br>and ethylene oxide sterilization<br>residuals have demonstrated the<br>NeoFlex™ material / cover device is: non-toxic. non-sensitizing. non-irritating. non-hemolytic. non-pyrogenic. Testing is in accordance with -<br>ISO 10993-Part 1 Biological Evaluation<br>of Medical Devices, FDA Blue Book<br>Memorandum #G95-1, and FDA-Good<br>Laboratory Practices (GLP). |
| Parameter | Synthetic Polyisoprene<br>Ultrasound Transducer Cover | Predicate Device<br>CIVCO NeoFlex™ Ultrasound<br>Transducer Cover (K991236) |
| Effectiveness | Testing for Synthetic Polyisoprene<br>covers has shown that the material is<br>adequate for the intended use:<br>Strength and elastic characteristics<br>are effectively similar to that of<br>NeoFlex™ and allows use without<br>tearing or pinholing the cover - a)<br>during application and removal of<br>cover from transducer, b) during<br>scanning under intended uses, and<br>c) attaching / removing a disposable<br>needle guide to the transducer<br>bracket over the cover. Nominal thickness of .010". Ultrasound imaging is not impaired. Synthetic Polyisoprene transducer<br>cover provides an effective barrier to<br>the prevention of microbial migration<br>- tested under protocol adapted from<br>that used to evaluate the barrier<br>properties / resistance of surgical<br>gloves and endoscope sheaths to<br>penetration by bloodborne<br>pathogens using viral penetration as<br>a test system. Synthetic Polyisoprene material is<br>used for medical examination /<br>surgical gloves. | Experience and testing has shown that<br>polychloroprene (neoprene) covers:<br>Neoprene has sufficient strength<br>and elasticity for the intended<br>application. Nominal thickness is .010". Does not impair ultrasound imaging. Are an effective barrier to the<br>prevention of microbial migration. |

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K013721
4/5

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

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K0/3721

5/5

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

#### F. Conclusions

This premarket submission for the Synthetic Polyisoprene 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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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

DEC 2 8 2001

Ms. Theresa Leinen Quality Systems Administrator CIVCO Medical Instruments Co., Inc. 102 First Street South KALONA IA 52247

Re: K013721

Trade/Device Name: Synthetic Polyisoprene Ultrasound Transducer Cover Regulation Number: 21 CFR 892.1570 Regulation Name: Diagnostic ultrasound transducer Regulatory Class: II Product Code: 90 ITX Dated: November 2, 2001 Received: November 9, 2001

Dear Ms. Leinen:

We have reviewed your Section 510(k) premarket notification of intent to market the device we nave reviewed your becament of the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate for use stated in the encreaty to the enactment date of the Medical Device Amendments, or to conninered pror to that 20, 1977, in accordance with the provisions of the Federal Food, Drug, de necs that have boon require approval of a premarket approval application (PMA). and Costience Act (110) that do novice, subject to the general controls provisions of the Act. The Tou may, moreloro, manot and work include requirements for annual registration, listing of general controls provisions of the revelop, and prohibitions against misbranding and adulteration.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it your device is classified (200 a00 a00 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 r teast of advised that I Driv institution that your device complies with other requirements of the Act that I Dr Hoss Intacted and regulations administered by other Federal agencies. You must or any I vathal beth steppirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set (21 Or It I at 007), acoming (OS) regulation (21 CFR Part 820); and if applicable, the electronic rordly in the quality by oversions (sections 531-542 of the Act); 21 CFR 1000-1050.

Image /page/5/Picture/11 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is a stylized symbol that resembles an abstract caduceus or a bird in flight, composed of three curved lines.

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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 nredicate 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), please contact the Office of Compliance at one of the following numbers, based on the regulation number at the top of this letter:

| 8xx.1xxx | [phone] |
|----------------------------------|----------------|
| 876.2xxx, 3xxx, 4xxx, 5xxx | [phone] |
| 884.2xxx, 3xxx, 4xxx, 5xxx, 6xxx | [phone] |
| 892.2xxx, 3xxx, 4xxx, 5xxx | [phone] |
| Other | [phone] |

Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number [phone] or [phone] or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html.

Sincerely yours,

Nancy C. Brogdon

Nancy C. Brogdor Director, Division of Reproductive, Abdominal, 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

and the same of the same of the same of the same of the same of

| 510(k) Number (if known): | K013721 |
|---------------------------|---------|
|---------------------------|---------|

Device Name: _________________________________________________________________________________________________________________________________________________________________

Indications For Use:

Protective cover or sheath is placed over an ultrasound transducer / probes / scanbead instruments. The Protective cover of sheath is placed over an unasounts in pocedures for body surface, endocarity, cover allows use of the transdacer in Naming and transfer of microorganisms, body fluids, and and intra-operative uitesound, while helping to proven during rease of the tearile and non-sterile covers). The cover also provides a means for maintenance of a sterile fold (sterile covers only). non-sterile covers). The cover also provides a modis for manished sterile and non-sterile, single use patient / procedure, disposable.

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

| | <i>Nancy Brogdon</i> |
|---------------------------------------------------------------|----------------------|
| (Division Sign-Off) | |
| Division of Reproductive, Abdominal, and Radiological Devices | |
| 510(k) Number | K013721 |

| Prescription Use<br>(Per 21 CFR 801.109) | OR | Over-the-Counter Use<br>(Optional Format 1-2-96) |
|------------------------------------------|----|--------------------------------------------------|
| ✓ | | |

Synthetic Polyisoprene

CIVCO Medical Instruments CO., Inc 02 November 2001

Synthetic Polyisoprene Ultrasound Transducer Cover