SLED, FINGER, HANDLE

K971942 · Biosound Esaote, Inc. · ITX · Jul 23, 1997 · Radiology

Device Facts

• Record ID: K971942
• Device Name: SLED, FINGER, HANDLE
• Applicant: Biosound Esaote, Inc.
• Product Code: ITX · Radiology
• Decision Date: Jul 23, 1997
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 892.1570
• Device Class: Class 2

Intended Use

The ultrasound system used with the Intraoperative Transducer provides imaging information. Through the accessory previously described, the surgeon is able to position the probe more easily inside the body during the surgical procedure. The probe and its various accessories may also be used in Vascular and Small Parts imaging applications. These applications were cleared via K944485/S3.

Device Story

Device consists of three plastic brackets (Sled, Finger, Handle) designed as accessories for the AU4 ultrasound system's intraoperative transducer. Accessories attach to the transducer to facilitate easier probe positioning within the body during surgical procedures. Operated by surgeons in clinical/surgical settings. Device does not perform imaging itself; it acts as a mechanical interface to improve ergonomics and probe manipulation. Benefits include enhanced maneuverability and configuration versatility for a single ultrasound probe. Sterilization is performed via cold sterilization using Cidex activated dialdehyde solution.

Clinical Evidence

Bench testing only. Biocompatibility testing performed in accordance with ISO 10993 / EN 30993, including cytotoxicity, sensitization, and irritation testing.

Technological Characteristics

Materials: Polyurethane resin 6090 black. Dimensions: Sled (47.43mm x 22.70mm), Finger (irregular), Handle (104.96mm x 13.78mm). Sensing/Actuation: None (mechanical accessory). Connectivity: None. Sterilization: Cold sterilization (Cidex activated dialdehyde solution). Biocompatibility: Class A-Limited (<= 24 hours) per ISO 10993.

Indications for Use

Indicated for diagnostic ultrasound imaging or fluid flow analysis of the human body, specifically for intra-operative and extra-corporeal/other applications, including vascular and small parts imaging.

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 INT 13 (K953819)
• Hitachi EUP-033J (K884644)

Submission Summary (Full Text)

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Safety and Effectiveness Summary INT13 Accessories Biosound Esaote

K971942
PAGE 1 of 4

## Safety and Effectiveness Summary

JUL 2 3 |997

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] [phone] Fax:

| Contact Person: | Gerald A. Richardson |
|-------------------------|---------------------------------------------|
| Date: | May 23, 1997 |
| 807.92(a)(2) | |
| Trade Name: | Sled, Finger, Handle |
| Common Name: | Accessory for ultrasound transducer |
| Classification Name(s): | Transducer, ultrasonic, diagnostic 892.1570 |

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

| Company | Article | 510 (k) |
|---------|----------|---------|
| Esaote | INT 13 | K953819 |
| Hitachi | EUP-033J | K884644 |

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

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K 971942 psec 2

Safety and Effectiveness Summary INT13 Accessories Biosound Esaote

807.92(a)(4)

## Device Description

The three intraoperative probe accessories, Sled, Finger and Handle function with the AU4 ultrasound system's intraoperative probe, cleared via K953819. The intraoperative accessories consist of three kinds of plastic brackets attached to the ultrasound intraoperative transducer. The material used in the brackets has been tested following ISO 10993 / EN 30993. The biocompatibility tests required are attached.

## Specifications

| ITEM | CHARACTERISTICS | DIMENSION |
|--------|-----------------|----------------------|
| Sled | Plastic | 47.43 mm X 22.70 mm |
| Finger | Plastic | Irregular |
| Handle | Plastic | 104.96 mm X 13.78 mm |

## Materials

The three accessories (Finger, Sled, Handle) have 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:

## ·CYTOTOXICITY ·SENSITIZATION ·IRRITATION

These tests where performed by Biolab the Italian Laboratory located in Milan at Vimodrone Via Buozzi 2 tel [phone] in accordance with ISO10993.

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K971942 pxe 3

Safety and Effectiveness Summary INT13 Accessories Biosound Esaote

## Sterilization

#### THE INSTRUCTIONS PROVIDED BY THE FOLLOW 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 damage.

807.92(a)(5)

## Intended Use(s)

The ultrasound system used with the Intraoperative Transducer provides imaging information. Through the accessory previously described, the surgeon is able to position the probe more easily inside the body during the surgical procedure. The probe and its various accessories may also be used in Vascular and Small Parts imaging applications. These applications were cleared via K944485/S3.

807.92(a)(6)

## Substantial Equivalence

Other manufacturers market separate dedicated ultrasound probes for each one of the configurations which are provided by the Esaote accessories. With these accessories, the user achieves a variety of different configurations with a single probe. The following table shows a comparison between the intraoperative probe and each accessory with a predicate ultrasound transducer, already on the market.

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# KIDULUMS SSSULANIJOSELLE PUD KIJINI

| MATERIALS | | | ACCESSORIES |
|--------------------|-------------------------------|-------------------------------|--------------------------|
| STERILIZATION | | | INTENDED USE |
| Plastic | Plastic | Plastic | Esaote INT13 Accessories |
| Cold Sterilization | Cold Sterilization with Cidex | Cold Sterilization with Cidex | Esaote INT13 |
| Hitachi EUP-033J | | | |
| Surgery/vascular | Abdominal, intraoperative | Abdominal, intraoperative | |
| Yes | No | Subject to this submission | |

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Image /page/4/Picture/0 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo features a stylized image of an eagle with three heads, representing the department's mission to protect the health of all Americans and provide essential human services. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" is arranged in a circular pattern around the eagle image. The logo is black and white.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

JUL 2 3 1997

Gerald A. Richardson Biosound Easote 8000 Castleway Drive Indianapolis, IN 46250 Re: K971942 Sled, Finger, Handle (Accessories for Ultrasound Transducer) Dated: May 23, 1997 Received: May 27, 1997 Regulatory class: II 21 CFR 892.1570/Procode: 90 ITX

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, subject to the general controls provisions of 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 (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 oblieation 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 vitro diagnostic devices), please contact the Office of Compliance at [phone]. Additionally, for question 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.

William Yu

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

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## 510K 971942 Intracterative Has

## Indications for Use Form Fill our one form for each ultrasound system and each transducer.

Clagnostic ultrasound imaging or fluid flow analysis of the Intended Use: human pody as follows:

| Clinical Application | A | M | PWC | CWC | Color Doppler | Power Amplitude Doppler | Color Velocity Imaging | Combined (specify) | Other (specify) |
|----------------------------------|---|---|-----|-----|---------------|-------------------------|------------------------|--------------------|-----------------|
| Ophthalmic | | | | | | | | | |
| Fetal | | | | | | | | | |
| Abdominal | | | | | | | | | |
| Intra-operative (Specify) | | X | | | X | | | | |
| Intra-operative Neuro.spinal | | | | | | | | | |
| Pediatric | | | | | | | | | |
| Small Organ (Specify) | | | | | | | | | |
| Neonatal Cephalic | | | | | | | | | |
| Adult Cephalic | | | | | | | | | |
| Cardiac | | | | | | | | | |
| Trans-esophageal | | | | | | | | | |
| Trans-Rectal | | | | | | | | | |
| Trans-Vaginal | | | | | | | | | |
| Trans-Urethral | | | | | | | | | |
| Intra-Luminal | | | | | | | | | |
| Pericerebral Vascular | | | | | | | | | |
| Laparoscopic | | | | | | | | | |
| Musculo-skeletal Conventional | | | | | | | | | |
| Musculo-skeletal Superficial | | | | | | | | | |
| Extra Corporeal/ Other (specify) | | X | | | X | | | | |

Addit 1058) Comments : INT 13 MOSC in

(PLEASE (X) NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Conservation of Oil, Office of Surface Mining Reclamation and Enforcement (OSM)

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

310(k) Number K971942

Prescription Use (Per 21 CFR 801.109)