BIOPSY ACCESSORY FOR ULTRASOUND TRANSDUCER

K971700 · Biosound, Inc. · ITX · Jul 9, 1997 · Radiology

Device Facts

• Record ID: K971700
• Device Name: BIOPSY ACCESSORY FOR ULTRASOUND TRANSDUCER
• Applicant: Biosound, Inc.
• Product Code: ITX · Radiology
• Decision Date: Jul 9, 1997
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 892.1570
• Device Class: Class 2

Intended Use

The ultrasound system provides imaging information, used to guide the biopsy needle through the accessory to the anatomical site where the sample of physiological material is recovered for further analysis.

Device Story

Biopsy accessory attachment and handle for ultrasound transducers; consists of metal/plastic bracket and needle guides. Attaches to ultrasound transducer to facilitate needle guidance during biopsy procedures. Operates with AU4 ultrasound system; system software provides visual guidance for needle path. Used in clinical settings by healthcare professionals. Device does not include needles. Benefits include precise needle placement for tissue sampling under ultrasound visualization.

Clinical Evidence

Bench testing only. Materials testing performed in accordance with ISO 10993, including cytotoxicity, sensitization, and irritation testing.

Technological Characteristics

Materials: Polyurethane resin (handle), stainless steel (bracket/needle guides). Needle guide sizes: 14-18-20-21-22 gauge. Sterilization: Cold sterilization via Cidex (activated dialdehyde solution). Mechanical attachment to ultrasound transducer.

Indications for Use

Indicated for patients requiring ultrasound-guided biopsy for the recovery of physiological material for analysis. Used in conjunction with ultrasound systems and transducers.

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

• Esaote ABS1, ABS2, ABS3 (K912088)
• Diasonics New Image (K831317)

Submission Summary (Full Text)

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971702

JUL - 9 1997

Safety and Effectiveness Summary INT13 Biopsy Accessories Biosound Esaote

# Safety and Effectiveness Summary

The following safety and effectiveness summary has been prepared pursuant to requirements for 510(k) summaries specified in 21 CFR 807.92.(a)

807.92(a)(1)

### Submitter Information

Gerald A. Richardson, Official Correspondent 8000 Castleway Drive Indianapolis, Indiana 46250 Phone: [phone] Fax: [phone]

| Contact Person: | Gerald A. Richardson |
|-----------------|----------------------|
|-----------------|----------------------|

Date:

807.92(a)(2)

Trade Name: Biopsy attachment and handle

April 27, 1997

Punch, biopsy Common Name:

Punch, biopsy 876.1075 Classification Name(s):

Predicate Device(s) 807.92(a)(3)

| Company | Article | 510 (k) |
|-----------|-------------------|---------|
| Esaote | ABS1, ABS2, ABS3, | K912088 |
| Diasonics | New Image | K831317 |

Additional Substantial Equivalence information is provided in the attached Substantial Equivalence Comparison Table.

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Safety and Effectiveness Summary INT13 Biopsy Accessories Biosound Esaote

807.92(a)(4)

### Device Description

The Biopsy accessory attachment and handle, function with the ESAOTE Ultrasound Transducer previously cleared via K953819, connected with the AU4 Ultrasound system cleared via K944485/S3.

The biopsy accessories consist of a metal and plastic bracket and needle guides that attach to the ultrasound transducer. The AU4 system software provides for the guidance of the biopsy needle through the biopsy accessory needle guide.

Information describing the device specifications is provided in the following substantial equivalence comparison table in Section 807.92(a)(6) Substantial Equivalence.

The Biopsy needles are not provided as part of the accessory.

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#### Specifications

| ITEM | CHARACTERISTICS | DIMENSION |
|-------------------|--------------------|----------------|
| Probe Handle | Polyurethane Resin | |
| Biopsy Attachment | Stainless Steel | |
| Needle Guide | Stainless Steel | 14-18-20-21-22 |

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Safety and Effectiveness Summary INT13 Biopsy Accessories Biosound Esaote

#### Materials

The Handle is one part of the Biopsy accessories. This component has been designed with polyurethane resin 6090 black: Resin Polyuretanica nera.

Following ISO 10993 or EN 30993 this material is classified as External Communicating Device Tissue Bone Dentin Communicating : Class A-Limited ( less or equal to 24 hours).

The Tests requested are:

ﺮ

#### ·CYTOTOXICITY ·SENSITISATION ·IRRITATION

These tests where performed by Biolab_the Italian Laboratory located in Milan at Vimodrone Via Buozzi 2 tel [phone], in accordance ISO 10993.

### Sterilization

PROVIDED BY THE INSTRUCTIONS FOLLOW THE MANUFACTURER OF THE CIDEX SOLUTION TO PERFORM PROPER STERILIZATION.

Recommended sterilizing solution.

Cidex Activated Dialdeyde Solution Johnson & Johnson. (P.O. Box 90130 Arlington, Texas 76004 - 3130)

#### Warning

Keep the probe connector clear of all solutions to avoid damages.

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Safety and Effectiveness Summary INT13 Biopsy Accessories Biosound Esaote

807.92(a)(5)

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## Intended Use(s)

The ultrasound system provides imaging information used to guide the biopsy needle, through the accessory, to the anatomical site where the sample of physiological material is recovered for further analysis.

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## Substantist Eppinvalence

| FEATURE | | | |
|----------------------------------------|-----------------------------------------------------|------------------------------------------------|--------------------------------------------------------------------|
| MATERIALS | Polyurethane Resin<br>Stainless Steel | Stailness steel<br>Medical Plastic | Stainless steel<br>Medical Plastic |
| NEEDLE GUIDE ANGLE | Fixed | 15° and 30° | 20° to 45° |
| STERILIZATION | Cold Sterilization with<br>CIDEX | Cold Sterilization with CIDEX | Cold Sterilization with CIDEX |
| REMOVABLE OPTIONS FOR ULTRASONIC PROBE | Yes | Yes | Yes |
| FOR USE WITH VARIETY OF BIOPSY NEEDLES | Yes, but needles are not supplied | Yes, needles are supplied in kit | Yes, but needles are not supplied |
| TENDED USE: | | | Fine needle aspiration |
| | ESAOTE Biopsy accessory<br>for Intraoperative probe | Diasonics NewImage System Biopsy<br>Attachment | ESAOTE AU530 Biopsy Accessory<br>For Ultrasound Transducer K912088 |

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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Gerald A. Richardson Official Correspondent Biosound Esaote Biosound, Inc. 8000 Castleway Drive Indianapolis, IN 46250

Re: K971700

Biopsy Accessories for Intraoperative Probe Dated: June 19, 1997 Received: June 20, 1997 Regulatory class: II 21 CFR 892.1570/Procode: 90 ITX

JUL - 9 1997

Dear Mr. Richardson:

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 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 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 Current Good Manufacturing Practice requirement, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic QS 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 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 yitro 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 [phone] or at its Internet address http://www.fda.gov/odth/dsmamain.html".

Sincerely yours,

William Yim, Ph.D.

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

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Attachment D

## INDICATIONS FOR USE

| 510(k) Number (if known): | 971700 |
|---------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Device Name: | Biopsy Accessories for Intraoperative Probe |
| Indications for Use: | The ultrasound system provides imaging information, used<br>to guide the biopsy needle through the accessory to the<br>anatomical site where the sample of physiological material is<br>recovered for further analysis. |

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use

X

Over-The-Counter Use

Ra. Rege

OR

(Division Sign-Off) Division of Reproductive, Abdominal, ENT, and Radiological Devices

510(k) Number K971700