TRANS VAGINAL NEEDLE GUIDE

K971722 · Protek Medical Products, Inc. · ITX · Jul 10, 1997 · Radiology

Device Facts

• Record ID: K971722
• Device Name: TRANS VAGINAL NEEDLE GUIDE
• Applicant: Protek Medical Products, Inc.
• Product Code: ITX · Radiology
• Decision Date: Jul 10, 1997
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 892.1570
• Device Class: Class 2

Intended Use

Accessory-Needle Guides used for Vaginal Ultrasound Transducers for performing Vaginal Biopsies.

Device Story

Device is a disposable, sterile, single-use tube or cannula accessory that attaches to an ultrasound transducer. It functions as a mechanical guide to direct needles, biopsy instruments, or catheters toward a target during vaginal ultrasound-guided procedures. Used in hospitals and clinics by physicians. The guide improves needle placement accuracy compared to manual guidance. It does not contain electrical components. The device is provided sterile via ETO sterilization.

Clinical Evidence

Bench testing only. No clinical data provided. Equivalence established through design comparison, material safety, and mechanical testing.

Technological Characteristics

Stainless steel cannula or medical-grade plastic tube with injection-molded clips/brackets. Mechanical attachment to ultrasound transducer. ETO sterilization. No electrical components. Packaging: TYVEK chevron peel pouch.

Indications for Use

Indicated for use by physicians as an accessory to vaginal ultrasound transducers to guide needles, biopsies, or catheters during vaginal biopsy procedures.

Regulatory Classification

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.

Predicate Devices

• Civco Medical Instruments Needle Guide (K875240/A)

Reference Devices

• Amedic needle guide
• GE Medical needle guide

Submission Summary (Full Text)

{0}------------------------------------------------

Document # 9-926-0006 Rev. 1 FDA 510(k) Notification-Vaginal Ultrasound Needle Guide

JUL 10 1997

# L PRODUCTS INC.

May 1, 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 TRANSVAGINAL NEEDLE GUIDE an ULTRASOUND TRANSDUCER ACCESSORY

SUBMITTER: COMPANY: ADDRESS: CITY: STATE: COUNTRY: CONTACT: PHONE: FAX:

Rick L. Pruter PROTEK Medical Products Inc. 221 East Market Street Iowa City lowa USA Rick L. Pruter [phone] [phone]

May 1. 1997 DATE SUMMARY PREPARED:

Trade Name:

Trans vaginal Needle/Biopsy Guide for Ultrasound Transducers Common Name:

Needle Guide, Puncher guide, Biopsy guide, Needle Guide system, Endocavity Needle Guide

Classification Name:

Not Known

6-1

{1}------------------------------------------------

6-2

### SUMMARY

## COMMERCIALLY PRODUCED PRODUCTS OF EQUIVALENCE:

### Substantial Equivalence Comparison:

These new devices are the same as devices being legally marketed by several companies.

The new devices design, manufacturing, labeling and its intended uses are the same as many existing devices currently being marketed by Civco Medical Instruments, and Amedic among others. The only deviation is in the size and shape. Owner of this new company is co-inventor of these products and was an officer at Civco, one of the companies we are claiming substantial equivalence.

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

#### New Device

PROTEK Medical Inc 1-535-0003 Guide 1-535-0004 Guide

Civco 677-027 6000-0022-1 A Civco's 510(k) K875240/A K875240/A

*Other part numbers vary only in size and shape

#### Commercially Produced Products of Equivalence:

There are several products of equivalence legally marketed by companies including the following:

Civco Medical from Iowa, USA Amedic of Sweden, . GE Medical Wis. USA.

#### Other known companies that legally market this device:

ATL Bothell Washington Siemens Medical Systems Isaque Washington Diasonics San Jose Calif. Toshiba Tustin, California among others

#### Comparison: (see Comparison Chart Appendix D-1)

These devices are similar to several predicate devices legally marketed in respect to the materials, packaging, distribution and intended use. There are several hundred different configurations that Civco and Amedic are currently legally marketing for the (OEM)original equipment manufacturers. The original equipment manufacturers also legally markets these devices. This notification compares our product with Civco,s and Amedic and GE Medical.

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.

{2}------------------------------------------------

#### SUMMARY

#### DEVICE DESCRIPTION:

#### Narrative Description:

A tube, a cannula that is an accessory that snaps or rests(depending on configuration) onto an ultrasound transducer(884.2960)

A disposable, single use, sterile tube that helps direct a needle, biopsy or catheter to a target working in conjunction with an ultrasound transducer and system

#### Device Physical Specifications:

A stainless steel cannula or plastic tube with a small clip or bracket for locating and securing. Dimensions and designs vary and are specified with the original equipment manufacturer of ultrasound systems and transducers

#### Intended use:

1. Used to assist doctors when performing a vaginal biopsy

2. Used to guide a needle, biopsy or catheter into the vaginal gland.

3. Used as an accessory in conjunction with an ultrasound transducer (884.2960)

4. Used as an accessory in conjunction with Ultrasound systems (892.1560)

5. Used to improve needle placement vs. guiding needle with the finger

#### TECHNOLOGICAL CHARACTERISTICS COMPARED TO PREDICATE DEVICE:

(SEE ATTACHED CHART - APPENDIX D)

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

... .. ...

{3}------------------------------------------------

Document # 9-926-0006 Rev. 1 FDA 510(k) Notification-Vaginal Ultrasound Needle Guide

6-4

#### Appendix D in SUMMARY

### Substantially Equivalence Comparison Chart With Civco Medical 510(k) #K875240/A

| Description | PROTEK Medical Products Inc. | Civco Medical |
|----------------------|-------------------------------------------------------|-------------------------------------------------------|
| Indications for use | Ultrasound transducer<br>needle guide (accessory) | Ultrasound transducer<br>needle guide |
| Target Population | Doctor's | Doctor's |
| Designed by | OEM. Doctor. PROTEK | OEM. Doctor. Civco |
| Design | Sizes & Shapes Varies | Sizes & Shapes Varies |
| Materials | Stainless steel<br>Medical grade plastic | Stainless steel<br>Medical grade plastic |
| Performance | Target fixtures<br>Mil Std 105E | Target Fixtures<br>Mil Std 105E |
| Sterility | ETO | ETO |
| Mechanical Safety | end product tests | end products tests |
| Chemical Safety | No Hazardous Components<br>29CFR 1910.1200 | No Hazardous Components<br>29CFR 1910.1200 |
| Anatomical Sites | Where Ultrasound is Used | Where Ultrasound is Used |
| Disposition | Disposable | Disposable |
| Where Used | Hospitals & Clinics | Hospitals & Clinics |
| Standards Met | Mil Std 105E on voluntary<br>standards | Mil Std 105E on voluntary<br>standards |
| Electrical Safety | No Electrical Components | No Electrical Components |
| Manufacturing Method | Injection molded clips and<br>purchased surgical tube | Injection molded clips and<br>purchased surgical tube |
| Packaging | TYVEK "Chevron Peel Pouch" | TYVEK "Chevron Peel Pouch" |
| Human Factor | No Known Adverse Effects | No Known Adverse Effects |

*OEM definition: Original Equipment manufacturer of Ultrasound Systems(892.1560) including Ultrasound Transducer manufacturers (884.2960)

{4}------------------------------------------------

Image /page/4/Picture/0 description: The image shows the text "DEPARTMENT OF HEALTH & HUMAN SERVICES". The text is in a bold, sans-serif font and is centered on the page. To the left of the text is a graphic of three diagonal lines.

Image /page/4/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized image of an eagle with three human profiles incorporated into its design. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the eagle.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

### JUL 1 0 1997

Re: K971722

Rick L. Pruter President / CEO PROTEK Medical Products, Inc. 221 E. Market, Suite 291 Iowa City, Iowa 52245-2166

1-535-0003 Transvaginal Needle Guide for Shimadzu and 1-535-0004 Transvaginal Needle Guide for Acoustic Imaging, Inc. Dated: May 5, 1997 Received: May 9, 1997 Regulatory Class: II 21 CFR 892.1570/Procode: 90 ITX

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 (for the indications for use stated in the enclosure) 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. You may, therefore, market the device, subject to the general controls provisions Act (Act). The general controls provisions of the Act include requirements for registration, listing of devices, good manufacturing practices, labeling, and prohibitions against misbranding and adulteration.

If your device is classified (see above) into either class II (Special Controls) or class III (Premarket Approval) it may be subject to such 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 requirement, as set forth in the Quality System Regulation (OS) for Medical Devices: General regulation (CFR Part 820) and that, through periodic OS inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, 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.

Please be advised that the determination above is based on the fact that no medical devices have been demonstrated to be safe and effective for in vitro fertilization or percutaneous umbilical blood sampling, nor have any devices been marketed for these uses in interstate commerce prior to May 28, 1976, or reclassified into class I (General Controls) or class II (Special Controls). FDA considers devices specifically intended for in vitro fertilization and percutaneous umbilical blood sameling to be investigational, and subject to the provision of the investigational device exemptions (IDE) regulations, 21 CFR, Part 812. Therefore, your product labeling must be consistent with FDA's position on this use.

This letter will allow you to begin marketing your device as described in your premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a c!assification for your device and thus permits your device to proceed to market.

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

Page 2 - Mr. Rick Pruter

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801 and additionally 809.10 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 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 at [phone] or at its Internet address "http://www.fda.gov/cdrh/dsmamain.html."

If you have any questions regarding the content of this letter, please contact Paul Gammell, Ph.D. at [phone].

Sincerely yours,

William Yin

Lillian Yin, Ph.D. Director, Division of Reproductive, Abdominal, Ear, Nose and Throat, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure(s)

{6}------------------------------------------------

Document # 9-926-0006 Rev. 1 FDA 510(k) Notification-Vaginal Ultrasound Needle Guide

| 510(k) Number (if known) | K971722 |
|--------------------------|---------|
|--------------------------|---------|

Device Name: Trans Vaginal Needle Guide ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------

Indication for Use:

Accessory-Needle Guides used for Vaginal Ultrasound Transducers for performing Vaginal Biopsies.

(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 Reproductive, Abdominal, ENT,

Radiological Devices
510(k) Number K971722

Prescription Use
(Per 21 CFR 801.109)

OR

Over The Counter Use

(Optional Format 1-2-96)

ત્ત્વન્ત્વ