DRAPE, SURGICAL-LATEX

K970891 · Protek Medical Products, Inc. · KKX · Aug 22, 1997 · General, Plastic Surgery

Device Facts

• Record ID: K970891
• Device Name: DRAPE, SURGICAL-LATEX
• Applicant: Protek Medical Products, Inc.
• Product Code: KKX · General, Plastic Surgery
• Decision Date: Aug 22, 1997
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 878.4370
• Device Class: Class 2

Intended Use

A surgical drape and drape accessories used as a protective covering between an instrument and the patient to isolate a site of surgical incision from microbial and other contaminants

Device Story

Device is a sterile, disposable, dip-molded natural latex rubber bag; functions as a physical barrier between non-sterile ultrasound transducer probes and patients. Used in hospitals and clinics by sonographers, physicians, and technicians during general, intra-operative, rectal, and vaginal ultrasound procedures. Prevents cross-contamination of bacteria between the probe and the patient's internal or external surfaces. Device is supplied sterile via ETO sterilization in Tyvek pouches.

Clinical Evidence

No clinical data. Substantial equivalence is based on bench testing, including tensile strength (2400-3500 PSI), biocompatibility (ISO-10993), and resistance to microbial penetration (ASTM ES-22).

Technological Characteristics

Material: Dip-molded natural latex rubber (thickness 0.001-0.007 inches). Sterilization: ETO. Packaging: Tyvek chevron peel pouch. Performance standards: ASTM ES-22, ISO-10993. Mechanical properties: Tensile strength 2400-3500 PSI. Form factor: Disposable sterile bags/covers in various sizes (1.5cm x 10cm to 8.0cm x 30cm).

Indications for Use

Indicated for use as a sterile barrier on ultrasound transducers during general purpose ultrasound scanning, intra-operative procedures, and rectal or vaginal scanning to protect patients from cross-contamination.

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 (K895614)
• Civco Medical (K844472)
• Civco Medical (K943393)
• MicroTek Probe Drape (K882724)
• 3M #1071 Drape

Submission Summary (Full Text)

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DEPARTMENT OF HEALTH & HUMAN SERVICES
Public Health Service
Food and Drug Administration
9200 Corporate Boulevard
Rockville MD 20850

OCT 26 2004

Mr. Rick L. Pruter
PROTEK Medical Products, Incorporated
221 East Market Street, Suite 291
Iowa City, Iowa 52245-2166

Re: K970891
Trade/Device Name: Latex Ultrasound Transducer Surgical Drape
Regulation Number: 21 CFR 878.4370
Regulation Name: Surgical Drape and Drape Accessories
Regulatory Class: II
Product Code: KKX
Dated: July 12, 1997
Received: July 23, 1997

Dear Mr. Pruter:

This letter corrects our substantially equivalent letter of August 22, 1997 regarding the product code.

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 (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.

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Page 2 - Mr. Pruter

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); 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.

This letter will allow you to continue marketing your device as described in your Section 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), please contact the Office of Compliance at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). 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 [phone] or [phone] or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html

Sincerely yours,


Chiu Lin, Ph.D.
Director
Division of Anesthesiology, General Hospital,
Infection Control and Dental Devices
Office of Device Evaluation
Center for Devices and
Radiological Health

Enclosure

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Document #9-926-0003 Rev. 1 FDA 510(k) Notification-Latex Surgical Drape
6-1
K970891

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

February 20, 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
##### LATEX
###### ULTRASOUND TRANSDUCER SURGICAL DRAPE

| 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-LATEX
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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Document #9-926-0003 Rev. 1 FDA 510(k) Notification-Latex Surgical Drape
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# SUMMARY

## 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 | | Predicate Device | |
| --- | --- | --- | --- |
| PROTEK Medical Products Inc. | | Civco’s | Civco’s 510(k) |
| 1-519-0350 | 5 X 30 | 610-043 | K895614 |
| 1-519-0380 | 8 X 30 | 610-044 | K895614 |
| 1-519-0399 | 10 X 30 | 610-046 | K895614 |
| 1-519-0320 | 2 X 20 | 610-075 | K895614 |
| 1-519-0326 | 2.6 X 20 | 610-213 | K895614 |
| 1-519-0335 | 3.5 X 20 | 610-214 | K895614 |
| 1-519-0336 | 3.5 X 20 | 610-010 | K895614 |

*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 people that tested and processed Civco’s legally marketed devices. Other 510(k) numbers that have the same intended use are K844472 and K943393 under Civco Medical, K882724 MicroTek Probe Drape and 3m #1071 Drape

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

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Document #9-926-0003 Rev. 1 FDA 510(k) Notification-Latex Surgical Drape
6-3

# SUMMARY

## DEVICE DESCRIPTION:

### Narrative Description:

A sterile bag to contain a non-sterile ultrasound transducer probe during a sterile procedure.

A disposable, single use, sterile instrument cover/drape to protect the patients from cross contamination from bacteria’s of a non-sterile ultrasound transducer probe.

A sterile barrier between patient and ultrasound transducer probe.

### Device Physical Specifications:

Dip molded natural latex rubber
Thickness-.001-.007
Sizes-Sizes range from 1.5cm X 10cm thru 8.0cm x 30cm

## Intended use:

A cover/drape or sterile barrier placed on an ultrasound transducer 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. Intro-operative procedure that use non-sterile ultrasound transducers and require an extra sterile barrier. This would include invasive procedures where blood path indirect contact may occur.
3. Rectal and vaginal scanning.

## TECHNOLOGICAL CHARACTERISTICS COMPARED TO PREDICATE DEVICE:

(SEE ATTACHED CHART - APPENDIX D)

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

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Document #9-926-0003 Rev. 1 FDA 510(k) Notification-Latex Surgical Drape
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# Appendix D in SUMMARY

## Substantially Equivalence Comparison Chart With Civco Medical

| 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 | LATEX.001-.007 | LATEX .001-.007 |
| Vendors | Kent Latex, Ohio
Killian Latex, Ohio | Kent Latex, Ohio
Killian Latex, Ohio |
| Performance | ASTM - ES - 22 | ASTM - ES - 22 |
| 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 |
| Manufacturing Method | Dipped Latex
Vertrod Heat Scaler | |
| Packaging | TYVEK “Chevron Peel Pouch” | TYVEK “Chevron Peel Pouch” |
| Human Factor | Labels identify this product as Latex | Labels identify this product as Latex |

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

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Document #9-926-0003 Rev. 2 FDA 510(k) Notification-Latex Surgical Drape
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510(k) Number (if known) K970891

Device Name: Latex Ultrasound Transducer Drape

Indication for Use:

Latex Drapes for Ultrasound Transducers.
A surgical drape and drape accessories used as a protective covering between an instrument and the patient to isolate a site of surgical incision from microbial and other contaminants

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

(Division Sign-Off)
Division of Dental, Infection Control, and General Hospital Devices
510(k) Number K970891

Prescription Use
(Per 21 CFR 801.109)
OR
Over The Counter Use ☑
(Optional Format 1-2-96)

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