These ultrasound probe drape devices are intended for use by or as directed by a licensed medical practitioner during a medical ultrasound imaging procedure involving limited-duration unbroken-skin patient contact, to provide for maintenance of a sterile field (sterile covers only), to help protect the patient and healthcare worker from transfer of contaminants and biological risk agents (sterile and non-sterile covers), and to protect the ultrasound probe from contamination that could adversely affect its functionality or create downtime and require cleaning procedures (sterile and non-sterile covers). These single patient/procedure, disposable devices are furnished sterile, in most cases as an element of a kit-product that also includes a foil packet of ultrasound coupling gel, which always is pre-sterilized.

Device Description

Contour Fabricators, Inc. Ultrasound Probe Drapes provide an efficient flexible covering to fit various specific ultrasound probes. These ultrasound probe drapes are constructed primarily of polyurethane film, a customary ultrasound probe drape material. Some drape designs additionally utilize an inner layer of polyethylene film to provide an extended cable cover. This extended cable cover has no patient contact and, at most, incidental user contact. Most product versions include a pre-sterilized foil packet of ultrasound coupling gel and two sterile synthetic elastomer (non-latex) bands that are customarily used to control extra "bulk" of drape material in the vicinity of the application procedure. Each Ultrasound Probe Drape is roll- or telescope-folded during its manufacturing to facilitate user application to the ultrasound probe. Each folded Ultrasound Probe Drape then is wrapped with a suitable piece of "CSR-wrap" (medical paper customarily used for this purpose). The wrapped, folded Ultrasound Probe Drape is then placed, along with the pre-sterilized foil packet of ultrasound coupling gel and the synthetic elastomer bands if provided, into a medical device pouch for terminal sterilization and distribution.

AI/ML Overview

The provided 510(k) summary describes the acceptance criteria and the study that indicates the Contour Fabricators, Inc. (CFI) Ultrasound Probe Drape meets these criteria, primarily through demonstrating substantial equivalence to a predicate device and compliance with recognized consensus standards.

Here's the breakdown of the information requested:

1. Table of Acceptance Criteria and Reported Device Performance

This product is a medical device (ultrasound probe drape) rather than an AI/software device. Hence, the "acceptance criteria" here relate to safety, effectiveness, and substantial equivalence to a predicate device, rather than performance metrics like sensitivity/specificity.

Acceptance Criterion (CFI Device)	Reported Device Performance (CFI Device)
Intended Use: For use during medical ultrasound imaging procedures involving limited-duration unbroken-skin patient contact, to maintain a sterile field (sterile covers only), protect patient/healthcare worker from contaminants, and protect the ultrasound probe.	Substantially equivalent to predicate device: provides a thin, conformal protective cover/drape system for ultrasound transducer/probe usage in body-surface patient environments, maintaining a sterile field, protecting from contaminants, and protecting the probe. Single patient/procedure, disposable, furnished sterile or non-sterile, can include coupling gel.
Material Composition: Primarily polyurethane film; some designs also use polyethylene film. Can include pre-sterilized ultrasound coupling gel and synthetic elastomer bands.	Constructed primarily of polyurethane film. Some designs utilize polyethylene film. Typically includes pre-sterilized foil packet of ultrasound coupling gel and two sterile synthetic elastomer (non-latex) bands. These are customary materials used effectively and safely for many years in medical devices.
Design: Tubular bags or loose "socks," open on one end and closed on the other, to accommodate various ultrasound transducer/probe geometries. Applied over the transducer/probe with open end along the cable and closed end against the working face.	Configured as tubular bags or loose "socks," open on one end and closed on the other, with dimensional configurations to accommodate differences in ultrasound transducer/probe geometries. Designed identical to predicate device for application.
Manufacturing: Validated heat-seal fabrication processes, operations in certified ISO 14644-1:1999(E) Class 8 cleanrooms. Sterile barrier packaging validated per ISO 11607. EtO sterilization (if applicable) by certified subcontractor validated per ISO 11135.	CFI's device group is made using validated heat-seal fabrication processes, with specification-compliance-controlling operations conducted in certified, validated ISO 14644-1:1999(E) Class 8 cleanrooms. Sterile barrier packaging (when applicable) is validated per ISO 11607. EtO sterilization (when applicable) is conducted by an appropriately certified, audited sterilization subcontractor utilizing processes validated per ISO 11135. All operations are subject to the CFI quality management system. The predicate device uses similar manufacturing processes.
Safety (Biocompatibility): No adverse effects to healthcare worker and patient for limited contact (<24 hours) and surface contact with unbroken skin. Must meet "Pass" requirements. Studies conducted per ISO 10993 and FDA GLP.	Cytotoxicity: Evaluated per ISO 10993-5:1999 (Fluid Extract/L929 Mouse Fibroblast). Result: Best achievable score (exceeds "Pass").Primary Skin Irritation: Evaluated per ANSI/AAMI/ISO 10993-10:2002. Result: Best achievable score (exceeds "Pass").Dermal Sensitization: Evaluated per ISO 10993-10:2002 (0.9% NaCl Extract and Cottonseed Oil Extract). Result: Best achievable score (exceeds "Pass").Conducted in accordance with FDA Good Laboratory Practice.
Effectiveness (Barrier Performance): Adequate physical and mechanical properties (material strength, elasticity) to prevent tearing/pinholing during use. Must conform to at least Level 1 of ANSI/AAMI PB70:2003 for the entire surgical drape.	Materials and heat-seals were in-house-laboratory-evaluated per ANSI/AAMI PB70:2003 and determined to conform to Section 5.2.1.2 Level 1. This satisfies the 4.2.3.2 requirement for drapes (Product Code KKX) that "the entire surgical drape shall have a barrier performance of at least Level 1."

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

The document does not specify a "test set" in the context of an AI/ML algorithm evaluation. Instead, testing involves:

Biocompatibility Testing: Representative post-sterilization samples from CFI's device group were tested. The exact number of samples is not stated. This was likely performed in a controlled laboratory environment. The provenance of the "data" itself would be the test results from the certified laboratory.
Barrier Performance Testing: The CFI device group's materials and heat-seals were "in-house-laboratory-evaluated." The exact number of samples is not stated. This indicates testing performed within the manufacturer's or an affiliated lab.

The context is a 510(k) submission, which focuses on demonstrating substantial equivalence to a legally marketed predicate device rather than clinical trial data on patient outcomes, especially for a low-risk device like a probe drape.

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)

Not applicable. This is not an AI/ML diagnostic or prognostic device that requires expert ground truth labeling. The "ground truth" for this device relates to established standards for materials (biocompatibility) and barrier performance, assessed through laboratory tests.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

Not applicable, as this is not an AI/ML diagnostic or prognostic device involving interpretation adjudicated by 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 a physical medical device (ultrasound probe drape), not an AI system or software.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

Not applicable. This is a physical medical device, not an algorithm.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

The "ground truth" for this device's performance is based on:

Recognized Consensus Standards:
- Biocompatibility: ISO 10993 (various parts), FDA Blue Book Memorandum #G95-1.
- Barrier Performance: ANSI/AAMI PB70:2003.
Predicate Device Equivalence: The legally marketed Civco Medical Instruments Company, Inc. ultrasound probe drapes (K9705513).
Good Laboratory Practice (GLP): For safety testing.

8. The sample size for the training set

Not applicable. This is a physical medical device; there is no "training set" in the AI/ML sense.

9. How the ground truth for the training set was established

Not applicable. There is no training set for an AI/ML algorithm.

Summary

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Sep 18 2009

510(k) Summary

510(k) Owner

Address Voice Number Fax Number Name of Contact Person

Contour Fabricators, Inc. ("CFI") 14241 Fenton Road, Fenton, MI 48430 (810) 750-5300 . (810) 750-5310

John W. Schaefer, Regulatory Manager

Establishment Registration Number 1825560 Contour Fabricators, Inc. is FDA registered as a medical device manufacturer,

Device Trade or Proprietary Name Device Common or Usual Name Device Classification Name Classification Classification Panel Classification Product Code

CFI Ultrasound Probe Drape Ultrasound Probe Drape System, Imaging, Pulsed Echo, Ultrasonic Class II under 21 CFR 892.1560 90 Radiology IYO

Description of Devices Submitted for Premarket Notification:

Some drape designs additionally utilize an inner layer of polyethylene film to provide an extended cable cover. This extended cable cover has no patient contact and, at most, incidental user contact.

Phone 810.750.5300 Fax 810.750.5310

CFI Medical Solutions 14241 Fenton Road Fenton, MI 48430

sales(a)cfimedical.com

www.cfimedical.com

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Most product versions include a pre-sterilized foil packet of ultrasound coupling gel and two sterile synthetic elastomer (non-latex) bands that are customarily used to control extra "bulk" of drape material in the vicinity of the application procedure.

Each Ultrasound Probe Drape is roll- or telescope-folded during its manufacturing to facilitate user application to the ultrasound probe. Each folded Ultrasound Probe Drape then is wrapped with a suitable piece of "CSR-wrap" (medical paper customarily used for this purpose). The wrapped, folded Ultrasound Probe Drape is then placed, along with the pre-sterilized foil packet of ultrasound coupling gel and the synthetic elastomer bands if provided, into a medical device pouch for terminal sterilization and distribution.

When the Ultrasound Probe Drape is used as intended, ultrasound imaging is not impaired. Adequate coupling between the Drape and the probe normally is accomplished by applying an appropriate amount of ultrasound coupling gel to the ultrasound probe before application of the Drape. Once the Drape is fully applied, any excess Drape material covering the probe cable is gathered by means of elastic bands for neatness and convenience and to hold the Drane in place. The removal process for the Ultrasound Probe Drape is accomplished by removing the elastic bands, pulling off the Drape, disposing of those materials, and appropriately cleaning any remaining gel from the ultrasound probe, in a reverse method from the application.

Evidence of compliance with ANSI/AAMI PB70, a Recognized Consensus Standard for barrier performance of Product Code KKX Surgical Drapes, and of independent-certifiedlaboratory determination of biocompatibility per Recognized Consensus Standard ISO 10993, is provided to demonstrate further equivalency to the predicate devices.

Description of Predicate Devices

The bundled Contour Fabricators, Inc. Ultrasound Probe Drape designs are based on, and are equivalent in dimensions, technology, materials, and intended use to selected ultrasound probe drapes that are manufactured by Civco Medical Instruments Company, Inc. and legally marketed per premarket notification K970513. A listing of specific equivalencies is provided in the Device Description section. Contour Fabricators, Inc. does not make equivalent models to all

PHONE (810) 750-5300 Fax (810) 750-5310

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models made by Civco, including Civco models made for certain applications that involve contact with broken skin, mucous membranes, and external blood paths. Therefore the scope of this premarket notification is less broad than that of the Civco 510(k) cited as the Predicate.

Intended Use / Indications for Use:

Comparison of Submitted Devices to Substantially Equivalent, Legally Marketed Devices

Intended Use:	Both device groups provide a thin, conformal protective cover / drape systemfor ultrasound transducer / probe usage in body-surface patient environments.Both help to provide for maintenance of a sterile field (sterile covers only), tohelp protect the patient and healthcare worker from transfer of contaminantsand biological risk agents (sterile and non-sterile covers), and to protect theultrasound probe from contamination that could adversely affect itsfunctionality or create downtime and require cleaning procedures (sterile andnon-sterile covers). Both are single patient/procedure, disposable devices,furnished sterile or non-sterile, in most cases as an element of a kit-productthat also includes a foil packet of ultrasound coupling gel, which always ispre-sterilized.
	one end and closed on the other end, with various dimensional configurationsas necessary to accommodate differences in ultrasound transducer / probegeometries. Both are designed to be applied over the transducer / probe withthe open end of the ultrasound probe drape extending along the connectingcable, and the closed end of the drape arranged against the working face of the
	transducer / probe.
Materials:	Both device groups are constructed primarily of polyurethane film, acustomary ultrasound probe drape material. Polyurethane film has beeneffectively and safely used in ultrasound probe drapes for approximatelytwenty years. Some designs of both device groups additionally utilizepolyethylene film, a customary material in medical-device drapes and covers,other medical disposables, pharmaceutical packaging and food containers andpackaging. Polyethylene film has been effectively and safely used in medical-device, pharmaceutical and food applications for approximately thirty-fiveyears.
	Most product versions include a pre-sterilized foil packet of ultrasoundcoupling gel and two sterile synthetic elastomer (non-latex) bands that arecustomarily used to control extra "bulk" of drape material in the vicinity ofthe application procedure.These devices normally are colorless-transparent; which is the natural(unpigmented) color of the polyurethane film and (if present) the polyethylenefilm. Ancillary components such as elastic bands (which normally do not havepatient contact) may have other colors.
Manufacturing:	CFI's device group is made using validated heat-seal fabrication processes,with specification-compliance-controlling operations conducted in certified,validated ISO 14644-1:1999(E) Class 8 cleanrooms. Sterile barrier packaging(when applicable) is validated per ISO 11607. EtO sterilization (whenapplicable) is conducted by an appropriately certified, audited sterilization
	subcontractor utilizing processes validated per ISO 11135. All operations aresubject to the CFI quality management system.
	The predicate device group is made using "impulse heat-seal coverfabrication, packaging (in class 10,000 cleanroom), and EtO sterilization(when applicable)".
Safety:	Both device groups have been evaluated for potential adverse effects to thehealthcare worker and patient by means of biological testing by anappropriately certified test laboratory. Representative post-sterilizationsamples from CFI's device group were tested per Cytotoxicity Evaluation(ISO 10993-5:1999) per Fluid Extract/L929 Mouse Fibroblast; Primary SkinIrritation (ANSI/AAMI/ISO 10993-10:2002); Dermal SensitizationMaximization (ISO 10993-10:2002 (0.9% NaCl Extract); and DermalSensitization Maximization (ISO 10993-10:2002 (Cottonseed Oil Extract), forsafe use under conditions of limited contact (<24 hours) and surface contactwith unbroken skin, as appropriate for clinical applications of the CFI devices.This testing was conducted in accordance with FDA Good LaboratoryPractice. Test results indicated best achievable scores for cytotoxicity,irritation and sensitization per these standards, which exceeds the "Pass"requirements for such testing.The broader range of predicate devices, with device models that havedifferent clinical applications including invasive applications as indicated intheir broader Intended Use, were evaluated for safe use under "ISO 10993-Part 1 Biological Evaluation of Medical Devices, FDA Blue BookMemorandum #G95-1, and FDA-Good Laboratory Practices (GLP)". Theirsimilar materials were found to be non-toxic, non-sensitizing, non-irritating,non-hemolytic and non-pyrogenic.
Effectiveness:	Both device groups have essentially equal physical and mechanical properties,including material strength and elasticity that is adequate to allow use withouttearing or pinholing the Ultrasound Probe Drape during the drape's

Design:

Both device groups are configured as tubular bags or loose "socks", open on

PHONE (810) 750-5300 FAX (810) 750-5310

sales@contourfab.com www.contourfab.com

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, PHONE (810) 750-5300
FAX (810) 750-5310

{5}------------------------------------------------

application to or removal from the probe / transducer, or during scanning per Intended Use.

Ultrasound-related Product Codes ITX (the Predicate Device Group) and IYO (the Subject Device Group) do not specifically address effectiveness requirements for transducer / probe drapes. However, the functional requirements for these devices are related to those for Product Code KKX Surgical Drapes and MMP Protective Barrier Covers. ANSI/AAMI PB70:2003 "Liquid Barrier Performance and Classification of Protective Apparel and Drapes Intended for Use in Health Care Facilities" is a Recognized Consensus Standard for Product Codes KKX Surgical Drapes and MMP Protective Barrier Covers.

The CFI device group's materials and heat-seals (the subject device group) were in-house-laboratory-evaluated per ANSI/AAMI PB70:2003 and determined to conform to Section 5.2.1.2 Level 1. This satisfies the 4.2.3.2 requirement that "the entire surgical drape shall have a barrier performance of at least Level 1."

The predicate device group was laboratory tested under an unspecified "protocol adapted from that used to evaluate the barrier properties/resistance of surgeons glove materials to penetration by bloodborne pathogens using viral penetration as a test system."

In both cases, the testing showed that the device groups were an effective barrier as required per their respective Intended Use.

Contour Fabricators Inc. 14241 Fenton Road Fenton, MI 48430

PHONE (810) 750-5300 FAX (810) 750-5310

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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

SEP 1 8 2009

Mr. John W. Schaefer Regulatory Manager Contour Fabricators, Inc. 14241 Fenton Road FENTON MI 48430

Re: K090773

Trade/Device Name: Various Ultrasound Probe Drapes Regulation Number: 21 CFR 892.1560 Regulation Name: Image-intensified fluoroscopic x-ray system Regulatory Class: II Product Code: IYO Dated: July 24, 2009 Received: August 12, 2009

Dear Mr. Schaefer:

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 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

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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Indications for Use

510(k) Number: K090773

Device Name: Various Ultrasound Probe Drapes

Indications for Use:

Prescription Use -- YES AND/OR (Part 21 CFR 801 Subpart D)

Over-The-Counter Use -- NO (Part 21 CFR 801 Subpart C)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Hojue Karting

(Division Sign-Off) (Division Sign-On)
Division of Reproductive, Abdominal, Divisionogical Devices 9772 510(k) Number

Contour Fabricators Inc. 14241 Fenton Road Fenton, MI 48430

Phone 810.750.5300 Fax 810.750.5310

sales(@contourfab.com www.contourfab.com

1 REVISED PAGE FOR SECTION "INDICATIONS FOR USE", TO BE SUBSTITUTED FOR
EXISTING PAGE OF ORIGINAL SUBMISSION.

Regulation Number and Section

§ 892.1560 Ultrasonic pulsed echo imaging system.

(a)
Identification. An ultrasonic pulsed echo imaging system is a device intended to project a pulsed sound beam into body tissue to determine the depth or location of the tissue interfaces and to measure the duration of an acoustic pulse from the transmitter to the tissue interface and back to the receiver. This generic type of device may include signal analysis and display equipment, patient and equipment supports, component parts, and accessories.(b)
Classification. Class II (special controls). A biopsy needle guide kit intended for use with an ultrasonic pulsed echo imaging system only is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 892.9.