GE MEDICAL-NEEDLE GUIDE FOR SV, TR ANDATF, ACUSON-NEEDLE GUIDE

K971115 · Protek Medical Products, Inc. · ITX · Jun 13, 1997 · Radiology

Device Facts

• Record ID: K971115
• Device Name: GE MEDICAL-NEEDLE GUIDE FOR SV, TR ANDATF, ACUSON-NEEDLE GUIDE
• Applicant: Protek Medical Products, Inc.
• Product Code: ITX · Radiology
• Decision Date: Jun 13, 1997
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 892.1570
• Device Class: Class 2

Intended Use

1. Used to assist doctors when performing a prostate biopsy 2. Used to guide a needle, biopsy or catheter into the prostate gland. 3. Used as an accessory in conjunction with an ultrasound transducer (892.1570) 4. Used to improve needle placement vs. guiding needle with the finger

Device Story

Device is a disposable, sterile, single-use cannula or tube accessory that attaches to an ultrasound transducer. It functions as a mechanical guide to direct needles, biopsy instruments, or catheters toward a target within the prostate gland during ultrasound-guided procedures. Used in hospitals and clinics by physicians; replaces manual needle guidance by finger to improve placement accuracy. Device does not contain electrical components; relies on physical alignment with the transducer. Benefits include improved precision and consistency in needle placement during prostate biopsies.

Clinical Evidence

Bench testing only. No clinical data provided. Equivalence established through comparison of materials, design, and adherence to established standards (Mil Std 105E, ISO-10993, 29CFR 1910.1200).

Technological Characteristics

Materials: stainless steel and medical-grade plastic. Form factor: tube/cannula with clip/bracket for transducer attachment. Energy source: none (mechanical accessory). Sterilization: ETO. Connectivity: none. Standards: Mil Std 105E, ISO-10993, 29CFR 1910.1200. No electrical components.

Indications for Use

Indicated for use by physicians as a needle guide for rectal ultrasound transducers during prostate biopsies to guide needles, biopsy instruments, or catheters into the prostate gland.

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 (K875128/A)

Reference Devices

• Amedic
• GE Medical
• ATL
• Siemens Medical Systems
• Diasonics
• Toshiba

Submission Summary (Full Text)

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K971115

JUN 13 1997

Document # 9-926-0005 Rev.3 FDA 510(k) Notification-Rectal Ultrasound Needle Guide

6-1


February 20, 1997

Document Mail Center (HFZ-401)
Center for Devices and Radiological Health
Food and Drug Administration
9200 Corporate Boulevard
Rockville, Maryland 20850 USA

# SUMMARY
## PREMARKET NOTIFICATION 510 (k)
## FOR TRANSRCTAL NEEDLE GUIDE
## an ULTRASOUND TRANSDUCER ACCESSORY

| 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:
Transrectal Needle/Biopsy Guide for Ultrasound Transducers

Common Name:
Needle Guide, Puncher guide, Biopsy guide, Needle Guide system

Classification Name:
Diagnostic Ultrasound Transducer Accessory
892.1570 ITX class 11

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

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Document # 9-926-0005 Rev.3 FDA 510(k) Notification-Rectal Ultrasound Needle Guide
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 | Civco | Civco’s 510(k) |
| --- | --- | --- | --- |
| | 1-535-0001 Guide | 612-045 | K875128/A |
| | 1-535-0002 Guide | 612-035 | K875128/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.

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

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Document # 9-926-0005 Rev.3 FDA 510(k) Notification-Rectal Ultrasound Needle Guide
6-3

# SUMMARY

## DEVICE DESCRIPTION:

### Narrative Description:

A tube, a cannula that is an accessory that snaps or rests (depending on configuration) onto an ultrasound transducer (892.1570)

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 prostate biopsy
2. Used to guide a needle, biopsy or catheter into the prostate gland.
3. Used as an accessory in conjunction with an ultrasound transducer (892.1570)
4. 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]

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Document # 9-926-0005 Rev.3 FDA 510(k) Notification-Rectal Ultrasound Needle Guide
6-4

# Appendix D in SUMMARY

## Substantially Equivalence Comparison Chart With Civco Medical 510(k) #K875128/A

| Description | PROTEK Medical Products Inc. | Civco Medical |
| --- | --- | --- |
| Indications for use | Ultrasound transducer needle guide | Ultrasound transducer 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
Medical grade plastic | Stainless steel
Medical grade plastic |
| Performance | Target fixtures
Mil Std 105E | Target Fixtures
Mil Std 105E |
| Sterility | ETO | ETO |
| Biocompatibility | ISO-10993 | ISO-10993 |
| Mechanical Safety | end product tests | end products tests |
| 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 | Mil Std 105E on voluntary standards | Mil Std 105E on voluntary standards |
| Electrical Safety | No Electrical Components | No Electrical Components |
| Manufacturing Method | Injection molded clips and purchased surgical tube | Injection molded clips and 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 Transducer 892.1570

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 20850
JUN 13 1997

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

Re: K971115
1-535-0001 Transrectal Needle Guide for GE Medical and 1-535-0002 Transrectal Needle guide for Acuson, Inc.
Dated: February 20, 1997
Received: February 27, 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 (Act). 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 (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 for Medical Devices: General (GMP) regulation (21 CFR Part 820) and that, through periodic GMP 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.

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 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at [phone] for Radiology devices, or 594-4613 for Ear, Nose and Throat devices. 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 [phone] or at its Internet address "http://www.fda.gov/cdrh/dsmamain.html".

Sincerely yours,


Enclosure

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Document # 9-926-0005 Rev.3 FDA 510(k) Notification-Rectal Ultrasound Needle Guide

510(k) Number K971115

# Statement
## Indication For Use

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

Needle Guides for Rectal Ultrasound Transducers used in prostate biopsies.


Rick L. Pruter, President/CEO
PROTEK Medical Products Inc.

6-11-97

(Division Sign-Off)
Division of Reproductive, Abdominal, ENT, and Radiological Devices
510(k) Number K971115

Prescription Use ☑
(Per 21 CFR 801.109)

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