ULTRASOUND TRANSDUCER DRAPE

K970889 · Protek Medical Products, Inc. · KKX · Oct 20, 1997 · General, Plastic Surgery

Device Facts

• Record ID: K970889
• Device Name: ULTRASOUND TRANSDUCER DRAPE
• Applicant: Protek Medical Products, Inc.
• Product Code: KKX · General, Plastic Surgery
• Decision Date: Oct 20, 1997
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 878.4370
• Device Class: Class 2

Intended Use

A polyethylene cover/drape kit used as an accessory to an ultrasound transducer. The sterile cover/drape acts as a barrier as 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

Disposable, sterile polyethylene film cover/drape kit for ultrasound transducers; includes conductivity gel, elastic bands, and plastic medical tape. Used in hospitals and clinics by sonographers, physicians, and technicians. The sterile bag is placed over a non-sterile ultrasound probe prior to contact with internal or external body surfaces; acts as a physical barrier to prevent microbial contamination of surgical sites. Benefits include maintaining a sterile field during ultrasound-guided procedures. No electrical components; device is purely mechanical/physical barrier.

Clinical Evidence

Bench testing only. Performance verified via ASTM F1671-95 (resistance to penetration by blood-borne pathogens), tensile strength testing (2400-3500 PSI), and ISO-10993 biocompatibility standards. No clinical data provided.

Technological Characteristics

Materials: Extruded polyethylene film (.001-.003 inches). Components: Conductivity gel, elastic bands, plastic medical tape. Sterilization: ETO. Packaging: Tyvek chevron peel pouch. Manufacturing: Vertrod heat sealer. No electrical components. Standards: ASTM F1671-95, ISO-10993.

Indications for Use

Indicated for use by sonographers, doctors, and technicians as a protective barrier on ultrasound transducers to isolate surgical incision sites from microbial and other contamination during internal and external ultrasound scanning procedures.

Regulatory Classification

Identification

A surgical drape and drape accessories is a device made of natural or synthetic materials intended to be used as a protective patient covering, such as to isolate a site of surgical incision from microbial and other contamination. The device includes a plastic wound protector that may adhere to the skin around a surgical incision or be placed in a wound to cover its exposed edges, and a latex drape with a self-retaining finger cot that is intended to allow repeated insertion of the surgeon's finger into the rectum during performance of a transurethral prostatectomy.

Special Controls

*Classification.* Class II (special controls). The device, when it is an ear, nose, and throat surgical drape, a latex sheet drape with self-retaining finger cot, a disposable urological drape, a Kelly pad, an ophthalmic patient drape, an ophthalmic microscope drape, an internal drape retention ring (wound protector), or a surgical drape that does not include an antimicrobial agent, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 878.9.

Predicate Devices

• Civco Medical (K844472)

Submission Summary (Full Text)

{0}

FROM : PROTEK MEDICAL PRODUCTS INC PHONE NO. :
Oct. 17 1997 09:38AM P1

Document # 9-926-0001 Rev.4 FDA 510(k) Notification-Polyethylene Surgical Drape Kit K970889

6-1


OCT 20 1997

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
### POLYETHYLENE 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 - POLYETHYLENE

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]

{1}

FROM : PROTEK MEDICAL PRODUCTS INC PHONE NO. :
Oct. 17 1997 09:39AM P2

Document # 9-926-0001 Rev.4 FDA 510(k) Notification-Polyethylene Surgical Drape Kit K970889

6-2

# SUMMARY

## COMMERCIALY 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.

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 | Predicate Device | Civco | Civco's 510(k) |
| --- | --- | --- | --- |
| PROTEK Medical Inc. | | | |
| 1-519-0122 | | 610-013 | K844472 |
| 1-519-0124 | | 610-015 | K844472 |
| 1-519-0126 | | 610-209 | 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 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]

{2}

FROM : PROTEK MEDICAL PRODUCTS INC PHONE NO. :
Oct. 17 1997 09:39AM P3
Document # 9-926-0001 Rev.4 FDA 510(k) Notification-Polyethylene Surgical Drape Kit K970889
6-3

# SUMMARY

## 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 Polyethylene film, with a thickness of .001 inches-.003 inches, Conductivity Gel, Elastic Bands, and Plastic Medical Tape.

## Intended use:

A polyethylene cover/drape kit used as an accessory to an ultrasound transducer. The sterile cover/drape acts as a barrier as 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)

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

{3}

Oct. 17 1997 09:39AM P4
FROM : PROTEK MEDICAL PRODUCTS INC PHONE NO. :
Document # 9-926-0001 Rev.4 FDA 510(k) Notification-Polyethylene Surgical Drape Kit K970889
6-4

# Appendix D in SUMMARY

## Substantially Equivalence Comparison Chart With Civco Medical K844472

| Description | PROTEK Medical Products Inc. | Civco Medical |
| --- | --- | --- |
| 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 | Polyethylene .001-.003inches | Polyethylene .001-.003inches |
| Additional Kit Components | Conductivity Gel
Elastic Bands
Plastic Medical Tape | Conductivity Gel
Elastic Bands |
| Performance | ASTM - F1671-95 | ASTM - F1671-95 |
| Sterility | ETO | ETO |
| Biocompatibility | ISO-10993 | ISO-10993 |
| Mechanical Safety | Tensile Strength
2400 - 3500 PSI | Tensile Strength
2400 - 3500 PSI |
| 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. Proter Phone [phone] Fax [phone]

{4}

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: K970889
Trade Name: Ultrasound Transducer Drape Kits, Polyurethane
Regulatory Class: II
Product Code: KKX
Dated: July 1, 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.

{5}

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

{6}

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

{7}

Document # 9-926-0001 Rev.2 FDA 510(k) Notification-Polyethylene Surgical Drape
4-3

# 510(k) Number K970889

## Statement
### Indication For Use

Device Name: Polyethylene 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.



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