Synthetic polyisoprene probe covers are indicated for use during diagnostic ultrasound procedures in cases where patient sensitivity to natural rubber latex is speculative.

Device Description

The Sheathing Technologies, Inc CIS-Isoprene Ultrasound Transducer Cover provides a thin, conformal covering to fit various and specific ultrasound transducer shapes. The cover is made by dipping to form a general cylindrical shape. It is closed at the proximal end and open at the distal end for insertion of the ultrasound transducer. This device is an accessory used on diagnostic probes to help minimize cross contamination. The cover material is a Cis-1,4-polyisoprene, a synthetic version of natural rubber latex made without using natural rubber latex in the formulation. Various sizes and shapes of covers are offered to address the variations in Ultrasound Transducer configurations. Product categories/models include General Purpose SheathesISO Ultrasound Transducer Covers (sterile and non-sterile). Covers are packaged in both sterile and nonsterile, individually wrapped or in bag/box quantities, as well as in "procedure kit" form for single patient/procedure, disposable use. The "procedure kit" may include elastic fasteners, with or without coupling gel packets. Transducer covers are also combined with disposable needle guide devices into kits.

AI/ML Overview

This document is a 510(k) premarket notification for a Synthetic Polyisoprene Ultrasound Transducer Cover. The information provided does not describe a study involving AI or complex statistical analysis for diagnostic accuracy. Instead, it focuses on demonstrating substantial equivalence to a predicate device through non-clinical bench testing and biocompatibility assessments. Therefore, many of the requested categories related to AI performance, expert ground truth, and comparative effectiveness studies are not applicable.

Here's an analysis of the provided text based on your request:

Acceptance Criteria and Reported Device Performance

The document describes the device's characteristics and the non-clinical tests performed to demonstrate its safety and effectiveness relative to predicate devices. The "acceptance criteria" here are implied by successful completion of these tests in comparison to established standards and the predicate device's performance.

Acceptance Criteria	Reported Device Performance
Material Composition and Design: Synthetic polyisoprene, thin, conformal covering, general cylindrical shape, closed at proximal end, open at distal end for transducer insertion.	The cover material is "Cis-1,4-polyisoprene, a synthetic version of natural rubber latex made without using natural rubber latex in the formulation." It provides "a thin, conformal covering to fit various and specific ultrasound transducer shapes. It is closed at the proximal end and open at the distal end for insertion of the ultrasound transducer."
Intended Use: Accessory used on diagnostic probes to help minimize cross-contamination, indicated for use during diagnostic ultrasound procedures where patient sensitivity to natural rubber latex is speculative.	"This device is an accessory used on diagnostic probes to help minimize cross contamination." Indication for Use: "Synthetic polyisoprene probe covers are indicated for use during diagnostic ultrasound procedures in cases where patient sensitivity to natural rubber latex is speculative."
Viral Penetration: Prevent viral penetration.	Successfully passed "Viral Penetration Testing."
Stretch Testing: Possess sufficient strength and elasticity for intended application.	Successfully passed "Stretch testing."
Pinhole Testing: Prevent pinholes.	Successfully passed "Pinhole testing."
Gel Compatibility: Compatible with ultrasound gel.	Successfully passed "Gel Compatibility" testing. "Sheathing Technologies's CIS-Polyisoprene ultrasound transducer cover is compatible with ultrasound gel."
Biocompatibility (ISO 10993-1:2003 for surface-contacting device < 24 hours): - Material Mediated Pyrogen - Cytotoxicity - Systemic Toxicity - Hemolysis - Irritation - Sensitization	"is biocompatible according to the ISO 10993-1:2003 biocompatibility standard for a surface-contacting device that is in contact with the body for less than 24 hours." - Material Mediated Pyrogen (Passed) - Cytotoxicity (Passed) - Systemic Toxicity (Passed) - Hemolysis (Passed) - Irritation (Passed) - Sensitization (Passed)
Substantial Equivalence: Equivalent to predicate devices (CIVCO's current, legally marketed NeoFlex™ Ultrasound Transducer Covers and CIVCO's Synthetic Polyisoprene Ultrasound Transducer Cover).	"The Sheathing Technologies, Inc. CIS-Polyisoprene Ultrasound transducer cover is identified as substantially equivalent to CIVCO's current, legally marketed NeoFlex™ Ultrasound Transducer Covers and CIVCO's Synthetic Polyisoprene Ultrasound Transducer Cover."

Non-AI Specific Study Information

This submission is for a medical device (ultrasound transducer cover), not an AI algorithm. Therefore, many of the requested AI-centric points are not applicable to the provided text.

Sample size used for the Test Set and the data provenance:
- Not applicable. This is a physical device, and testing involved bench tests and biocompatibility, not a "test set" of data for an algorithm. The "samples" would be units of the transducer cover subjected to physical and chemical tests. The document doesn't specify the exact number of units tested for each non-clinical test (e.g., how many covers were used for viral penetration testing).
Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not applicable. There's no "ground truth" establishment in the context of an AI algorithm's performance. The results of the bench tests and biocompatibility tests are assessed against established industry standards (e.g., ISO 10993-1:2003) and internal specifications.
Adjudication method (e.g. 2+1, 3+1, none) for the test set:
- Not applicable. This is for an AI algorithm performance evaluation, not for physical device testing.
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 for an AI algorithm, not a physical medical device.
If a standalone (i.e. algorithm only without human-in-the loop performance) was done:
- Not applicable. This is for an AI algorithm, not a physical medical device.
The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- Not applicable in the AI sense. For the physical device, the "ground truth" for compliance relied on:
  - Standardized Test Methods: e.g., viral penetration tests, stretch tests, pinhole tests, gel compatibility tests.
  - Biocompatibility Standards: ISO 10993-1:2003.
  - Comparison to Predicate Device: Implicitly, the performance of the predicate devices in these categories served as a benchmark for substantial equivalence.
The sample size for the training set:
- Not applicable. This is not an AI algorithm requiring a training set.
How the ground truth for the training set was established:
- Not applicable. This is not an AI algorithm.

Summary

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10091828

Section 5: 510(K) Summarv

(As required by 21 CFR 807.92)

Synthetic Polyisoprene Ultrasound Transducer Cover

September 25, 2009 (updated)

SEP 2 8 2009

Food and Drug Administration Center for Devices and Radiological Health Document Mail Center (WO66-0609) 10903 New Hampshire Avenue Silver Spring, MD 20993-0002

To Whom it may Concern:

This letter, along with the attached materials is to notify your office of the intention of Sheathing Technologies to market the following revice starting on or after (90) days from this date.

Device/Specification Developer:

Sheathing Technologies, Inc. 18431 Technology Drive Morgan Hill, CA 95037

Establishment Registration No.: 2950776

Contact Persons:

Richard Stevens Director of Product Development 1-408-782-2720

Jennifer Downing Manager of Quality & Research 1-408-782-2720

Trade Name:

Common Name:

Ultrasound Transducer Cover/Sheath/Drape

SheathesISO Ultrasound Transducer Covers

Classification Name:

Ultrasonic Diagnostic Transducer Accessories

5-1

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Equivalence:

510(K) K013721, Synthetic Polvisoprene Ultrasound Transducer Cover, Civco Medical Instruments

510(K) K991236, NeoFlex™ Ultrasound Transducer Cover, Civco Medical Instruments

Labeling and Usage:

The following information will be found on each box/bag . (See Attachment E):

Proprietary name 1 ..
Quantity of sheathes packed 2.
Name and Location of Manufacturer 3.
1. Sterile/NS (if applicable)
1. Expiration date
1. Size of probe cover
1. Caution statements: Follow manufacturer's instructions for cleaning and disinfecting the transducer.
Prescription Statement: "Caution: 8. Federal law restricts this device to sale by or on the order of a physician or a practitioner trained in its use."

The cover material is a Cis-1,4-polyisoprene, a synthetic version of natural rubber latex made without using natural rubber latex in the formulation. Various sizes and shapes of covers are offered to address the variations in Ultrasound Transducer configurations.

Product categories/models include

Device Description:

5-2

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1. General Purpose SheathesISO Ultrasound Transducer Covers (sterile and non-sterile)
  Covers are packaged in both sterile and nonsterile, individually wrapped or in bag/box quantities, as well as in "procedure kit" form for single patient/procedure, disposable use. The "procedure kit" may include elastic fasteners, with or without coupling gel packets. Transducer covers are also combined with disposable needle guide devices into kits.

Substantial Equivalence:

Non-Clinical Tests:

The Sheathing Technologies, Inc. CIS-Polyisoprene Ultrasound transducer cover is identified as substantially equivalent to CIVCO's current, legally marketed NeoFlex™ Ultrasound Transducer Covers and CIVCO's Synthetic Polyisoprene Ultrasound Transducer Cover.

1. Bench Testing:
- a. Viral Penetration Testing
- b. Stretch testing
- c. Pinhole testina
- d. Gel Compatibility
1. Biocompatibility
- a. Material Mediated Pyrogen
- b. Cytotoxicity
- c. Systemic Toxicity
- d. Hemolysis
- e. Irritation
- Sensitization f.

Conclusions from Non-Clinical Tests: Sheathing Technologies's CIS-Polyisoprene ultrasound transducer cover is compatible with ultrasound gel, has sufficient strength and elasticity for the intended application, and is biocompatible according to

the ISO 10993-1:2003 biocompatibility standard for a surface-contacting device that is in contact with the body for less than 24 hours.

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Image /page/3/Picture/0 description: The image shows the seal of the Department of Health & Human Services - USA. The seal features an abstract design with three upward-pointing lines that resemble stylized flames or ribbons. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the design.

DEPARTMENT OF HEALTH & HUMAN SERVICES

Public Health Service

Food and Drug Administration 10903 New Hampshire Avenue Document Control Room - WO66-G609 Silver Spring, MD 20993-0002

Ms. Jennifer Downing Manager of Quality & Research Sheathing Technologies, Inc. 18431 Technology Drive MORGAN HILL CA 95037

SEP 2 8 2009

Re: K091828

Trade/Device Name: SheathesISO Ultrasound Transducer Covers Regulation Number: 21 CFR 892.1570 Regulation Name: Diagnostic ultrasound transducer Regulatory Class: II Product Code: ITX Dated: August 28, 2009 Received: September 1, 2009

Dear Ms. Downing:

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, 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.

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

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Page 2 -

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.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.

Sincerely yours,

Janine M. Morris

Acting Director, Division of Reproductive, Abdominal, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Section 4: Indications for Use Statement

510(k) Number (if known):

K091828

Device Name: SheathesISO Ultrasound Transducer Covers

Indication For Use: Synthetic polyisoprene probe covers are indicated for use during diagnostic ultrasound procedures in cases where patient sensitivity to natural rubber latex is speculative.

Prescription Use X (21 CFR Part 801 Subpart D) Subpart C)

And/Or

Over the Counter Use (21 CFR Part 801

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

Concurrence of CDRH, Office of In Vitro Diagnostic Device Evaluation and Safety (OIVD)

Division Sign-Off Office of In Vitro Diagnostic Device Evaluation and Safety

510(k) K0911828

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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.