ULTRASOUND TRANSDUCER DRAPE

K970893 · Protek Medical Products, Inc. · FYA · Oct 20, 1997 · General, Plastic Surgery

Device Facts

• Record ID: K970893
• Device Name: ULTRASOUND TRANSDUCER DRAPE
• Applicant: Protek Medical Products, Inc.
• Product Code: FYA · General, Plastic Surgery
• Decision Date: Oct 20, 1997
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 878.4040
• Device Class: Class 2

Intended Use

A polyurethane cover/drape kit used as an accessory to an ultrasound transducer. The sterile cover/drape acts as a barrier as it is placed on the instrument prior to coming in contact with the human bodies internal and external services. The following is an abbreviated list of known uses: 1. General Purpose: Ultrasound scanning. 2. Cord cover for an extended sterile field on ultrasound transducer cords. 3. Rectal and vaginal scanning. 4. Drapes on Ultrasound Transducers used as protective coverings to isolate a site of surgical incisions from microbial and other contamination.

Device Story

Device is a sterile, single-use kit containing a polyurethane film cover/drape, conductivity gel, elastic bands, and plastic medical tape. The drape acts as a physical barrier between a non-sterile ultrasound transducer probe and the patient's internal or external body surfaces during surgical or diagnostic procedures. Used in hospitals and clinics by sonographers, physicians, and technicians. The drape is placed over the transducer and cord to maintain a sterile field and prevent microbial contamination of the surgical site. Benefits include infection control and protection of the transducer during procedures.

Clinical Evidence

Bench testing only. Evidence includes microbial challenge testing to verify barrier effectiveness against contamination and mechanical safety testing (tensile strength of 6250 PSI at break). Biocompatibility testing performed per ISO-10993 standards. No clinical data provided.

Technological Characteristics

Materials: Extruded polyurethane film (.001-.003" thickness). Components: Conductivity gel, elastic bands, plastic medical tape. Sterilization: Ethylene Oxide (ETO). Packaging: TYVEK chevron peel pouch. Manufacturing: Vertrod heat sealer. No electrical components. Biocompatibility: ISO-10993 compliant.

Indications for Use

Indicated for use as a protective covering for ultrasound transducers to isolate surgical incision sites from microbial and other contamination during ultrasound scanning procedures, including rectal and vaginal scanning. Intended for use by sonographers, doctors, and technicians in hospitals and clinics.

Regulatory Classification

Identification

Surgical apparel are devices that are intended to be worn by operating room personnel during surgical procedures to protect both the surgical patient and the operating room personnel from transfer of microorganisms, body fluids, and particulate material. Examples include surgical caps, hoods, masks, gowns, operating room shoes and shoe covers, and isolation masks and gowns. Surgical suits and dresses, commonly known as scrub suits, are excluded.

Special Controls

*Classification.* (1) Class II (special controls) for surgical gowns and surgical masks. A surgical N95 respirator or N95 filtering facepiece respirator is not exempt if it is intended to prevent specific diseases or infections, or it is labeled or otherwise represented as filtering surgical smoke or plumes, filtering specific amounts of viruses or bacteria, reducing the amount of and/or killing viruses, bacteria, or fungi, or affecting allergenicity, or it contains coating technologies unrelated to filtration (e.g., to reduce and or kill microorganisms). Surgical N95 respirators and N95 filtering facepiece respirators are exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to § 878.9, and the following conditions for exemption:(i) The user contacting components of the device must be demonstrated to be biocompatible. (ii) Analysis and nonclinical testing must: (A) Characterize flammability and be demonstrated to be appropriate for the intended environment of use; and (B) Demonstrate the ability of the device to resist penetration by fluids, such as blood and body fluids, at a velocity consistent with the intended use of the device. (iii) NIOSH approved under its regulation. (2) Class I (general controls) for surgical apparel other than surgical gowns and surgical masks. The class I device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to § 878.9.

Predicate Devices

• Civco Medical (K844472)

Submission Summary (Full Text)

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FROM : PROTEK MEDICAL PRODUCTS INC PHONE NO. :
Oct. 17 1997 12:51PM P1
Document #9-926-0002 Rev. 4 FDA 510 (k) Notification-Polyurethane Surgical Drape Kit K970093
OCT 20 1997 6-1

PROTEK
MEDICAL PRODUCTS INC.
211 E. MARKET SUITE 291 IOWA CITY IA
319-358-8080 FAX [phone]
USA 52245-2166

October 17, 1997

Document Mail Center
Center for Devices and Radiological Health
Food and Drug Administration
9200 Corporate Boulevard
Rockville, Maryland 20850 USA

SUMMARY
PREMARKET NOTIFICATION 510 (k)
FOR
POLYURETHANE ULTRASOUND TRANSDUCER
SURGICAL DRAPE KIT

SUBMITTER: Rick L. Pruter
COMPANY: PROTEK Medical Products Inc.
ADDRESS: 221 East Market Street
CITY: Iowa City
STATE: Iowa
COUNTRY: USA
CONTACT: Rick L. Pruter
PHONE: [phone]
FAX: [phone]

DATE SUMMARY PREPARED: January 21, 1997

TRADE NAME: ULTRASOUND TRANSDUCER DRAPE KIT - POLYURETHANE

COMMON NAME: TRANSDUCER COVER, PROBE COVER, SURGICAL DRAPE, INSTRUMENT COVER

CLASSIFICATION NAME: SURGICAL DRAPE (per 21 CFR Section 878.4370)

PROTEK Medical Products Inc. Contact: Rick L. Pruter Phone [phone] Fax [phone]

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FROM : PROTEK MEDICAL PRODUCTS INC
PHONE NO. :
Oct. 17 1997 12:51PM P2
Document #9-926-0002 Rev. 4 FDA 510 (k) Notification-Polyurethane Surgical Drape Kit K970893

# SUMMARY

6-2

## COMMERCIALLY PRODUCED PRODUCTS OF EQUIVALENCE:

There are several products of equivalence legally marketed including the following: Amedic of Sweden, Microtek of Mississippi, USA and Civco Medical from Iowa, USA, (details in body of this submission appendix).

These devices are similar to the predicate devices in respect to the materials, packaging, distribution and intended use.

## Substantial Equivalence Comparison:

The following is a cross reference of products that will be identical:

New Device

| PROTEK Medical Products Inc. | Civco | Civco’s 510(k) |
| --- | --- | --- |
| 1-519-0223 | 610-001 | K844472 |
| 1-519-0227 | 610-004 | K844472 |
| 1-519-0229 | 610-005 | K844472 |

*Other part numbers vary only on size and shape

These new products have the same intended use as legally marketed devices. The same end users. The same material manufactures and the same tests and processes as Civco’s legally marketed devices under 510(k) K844472.

PROTEK Medical Products Inc. Contact: Rick L. Pruter Phone [phone] Fax [phone]

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FROM : PROTEK MEDICAL PRODUCTS INC PHONE NO. :
Oct. 17 1997 12:52PM P3
Document #9-926-0002 Rev. 4 FDA 510 (k) Notification-Polyurethane Surgical Drape Kit K970893

# SUMMARY

6-3

## DEVICE DESCRIPTION:

### Narrative Description:

A variety of kits, ranging in sizes, containing a disposable, single use, sterile instrument cover/drape, gel, bands and tape. The sterile bag is placed over a non-sterile ultrasound transducer probe during a sterile procedure, acting as a barrier between the patient and the ultrasound probe.

### Device Physical Specifications:

Each kit contains one cover/drape, ranging in sizes from 2"x24" to 5"x100", made from extruded Polyurethane film, with a thickness of .001-.003 inches, Conductivity Gel, Elastic Bands, and Plastic Medical Tape.

## Intended use:

A polyurethane cover/drape kit used as an accessory to an ultrasound transducer. The sterile cover/drape acts as a barrier as it is placed on the instrument prior to coming in contact with the human bodies internal and external services. The following is an abbreviated list of known uses:

1. General Purpose: Ultrasound scanning.
2. Cord cover for an extended sterile field on ultrasound transducer cords.
3. Rectal and vaginal scanning.
4. Drapes on Ultrasound Transducers used as protective coverings to isolate a site of surgical incisions from microbial and other contamination.

## TECHNOLOGICAL CHARACTERISTICS COMPARED TO PREDICATE DEVICE:

(SEE ATTACHED CHART - APPENDIX D)

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PROTEK Medical Products Inc. Contact: Rick L. Pruter Phone [phone] Fax [phone]

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FROM : PROTEK MEDICAL PRODUCTS INC PHONE NO. :
Oct. 17 1997 12:52PM P4
Document #9-926-0002 Rev. 4 FDA 510 (k) Notification-Polyurethane Surgical Drape Kit K970893

# Appendix D in SUMMARY

## Substantially Equivalence Comparison Chart With Civco Medical K844472

| Description | PROTEK Medical Products Inc. | Civco Medical |
| --- | --- | --- |
| Comment | | |
| Indications for use | Ultrasound transducer covers | Ultrasound transducer covers |
| Target Population | Sonographers, Doctor's and Technicians | Sonographers, Doctor's and Technicians |
| Design | Sizes & Shapes Varies | Sizes & Shapes Varies |
| Materials | Polyurethane .001"-.003" | Polyurethane .001"-.003" |
| Additional Kit Components | Conductivity Gel
Elastic Bands
Plastic Medical Tape | Conductivity Gel
Elastic Bands |
| Performance | Microbial Challenge | Microbial Challenge |
| Sterility | ETO | ETO |
| Biocompatibility | ISO-10993 | ISO-10993 |
| Mechanical Safety | Tensile Strength
6250 PSI @ Break | Tensile Strength
6250 PSI @ Break |
| Chemical Safety | No Hazardous Components
29CFR 1910,1200 | No Hazardous Components
29CFR 1910,1200 |
| Anatomical Sites | Where Ultrasound is Used | Where Ultrasound is Used |
| Disposition | Disposable | Disposable |
| Where Used | Hospitals & Clinics | Hospitals & Clinics |
| Standards Met | Global Test Methods for Resistance to Penetration | Global Test Methods for Resistance to Penetration |
| Electrical Safety | No Electrical Components | No Electrical Components |
| Manufacturing Method | Vertrod Heat Sealer | Vertrod Heat Sealer |
| Packaging | TYVEK "Chevron Peel Pouch" | TYVEK "Chevron Peel Pouch" |
| Human Factor | No Known Adverse Effects | No Known Adverse Effects |

PROTEK Medical Products Inc. Contact: Rick L. Pruter Phone [phone] Fax [phone]

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DEPARTMENT OF HEALTH & HUMAN SERVICES
Public Health Service
Food and Drug Administration
9200 Corporate Boulevard
Rockville MD 20856

Mr. Rick L. Pruter
President/CEO
PROTEK Medical Products Incorporated
221 E. Market Street, Suite 291
Iowa City, Iowa 52245

OCT 20 1997

Re: K970893
Trade Name: Ultrasound Transducer Drape Kits, Polyurethane
Regulatory Class: II
Product Code: KKX
Dated: June 30, 1997
Received: July 23, 1997

Dear Mr. Pruter:

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 to 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 (the Act). You may, therefore, market the device, subject to the general controls provisions of Act. However, you are responsible to determine that the medical devices you use as components in the kit have either been determined as substantially equivalent under the premarket notification process (Section 510(k) of the act), or were on the market prior to May 28, 1976, the enactment date of the Medical Device Amendments. Please note: If you purchase your device components in bulk (i.e., unfinished) and further process (e.g., sterilize) you must submit a new 510(k) before including these components in your kit. 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.

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Page 2 - Mr. Pruter

If your device is classified (see above) into either class II (Special Controls) or class III (Premarket Approval) 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 895. A substantially equivalent determination assumes compliance with the Good Manufacturing Practice for Medical Devices: General (GMP) regulation (21 CFR Part 820) and that, through periodic GMP inspections, FDA will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, the Food and Drug Administration (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.

In addition, we have determined that your device kit contains Ultra/Phonic Conductivity Gel which are subject to regulation as drug.

Our substantially equivalent determination does not apply to the drug component[s] of your device. We recommend you first contact the Center for Drug Evaluation and Research before marketing your device with the drug component[s]. For information on applicable Agency requirements for marketing this [these] drug[s], we suggest you contact:

Director, Division of Drug Labeling Compliance (HFD-310)
Center for Drug Evaluation and Research
Food and Drug Administration
5600 Fishers Lane
Rockville, Maryland 20857
[phone]

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 for in vitro diagnostic devices), please contact the Office of Compliance at [phone]. Additionally, for questions on the promotion and advertising of your device, please contact the

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Page 3 - Mr. Pruter

Office of Compliance at [phone]. 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 [phone] or [phone], or at its internet address "[e-mail]".

Sincerely yours,


Timothy A. Ulatowski
Director
Division of Dental, Infection Control and General Hospital Devices
Office of Device Evaluation
Center for Devices and Radiological Health

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Document #9-926-0002 Rev. 3 FDA 510 (k) Notification-Polyurethane Surgical Drapes K970893

510(k) Number K970893

# Statement

# Indication For Use

Device Name: Polyurethane Ultrasound Transducer Drape Kit

I, Rick L. Pruter, President/CEO of PROTEK Medical Products Inc., certify that the devices in this notification are used for:

Drapes on Ultrasound Transducers used as protective coverings to isolate a site of surgical incisions from microbial and other contaminations.


Rick L. Pruter, President/CEO

PROTEK Medical Products Inc.

7-18-97


(Division Sign-Off)

Division of Dental, Infection Control,

and General Hospital Devices

510(k) Number 970893

PROTEK Medical Products Inc. Contact: Rick L. Pruter Phone [phone] Fax [phone]