K Number
K971942
Device Name
SLED, FINGER, HANDLE
Date Cleared
1997-07-23

(57 days)

Product Code
Regulation Number
892.1570
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows: Intra-operative (Specify), Extra Corporeal/ Other (specify)
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.
More Information

No
The summary describes passive accessories (plastic brackets) for an existing ultrasound system and makes no mention of AI, ML, or advanced image processing.

No
The device is described as being for "Diagnostic ultrasound imaging or fluid flow analysis," which indicates a diagnostic rather than a therapeutic purpose.

Yes
The "Intended Use / Indications for Use" states "Diagnostic ultrasound imaging or fluid flow analysis of the human body."

No

The device description explicitly states it consists of "three kinds of plastic brackets attached to the ultrasound intraoperative transducer," indicating it includes physical hardware components.

No, this device is not an IVD (In Vitro Diagnostic).

Here's why:

  • IVD Definition: In vitro diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections. They are used to provide information for diagnosis, monitoring, or screening.
  • Device Function: The provided description clearly states the device is for "Diagnostic ultrasound imaging or fluid flow analysis of the human body." This is an in vivo diagnostic method, meaning it involves examining the body directly, not a sample taken from the body.
  • Device Components: The device consists of "intraoperative probe accessories" that function with an ultrasound system's intraoperative probe. These are physical components used to facilitate the ultrasound imaging process within the body during surgery.

Therefore, based on the intended use and device description, this device falls under the category of medical imaging equipment used for in vivo diagnosis, not in vitro diagnostics.

N/A

Intended Use / Indications for 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.

Intended Use: Cagnostic ultrasound imaging or fluid flow analysis of the human pody as follows:
Clinical Application: Intra-operative (Specify), Extra Corporeal/ Other (specify)
A: Intra-operative, Extra Corporeal/ Other (specify)
Color Doppler: Intra-operative, Extra Corporeal/ Other (specify)

Product codes

90 ITX

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

ITEMCHARACTERISTICSDIMENSION
SledPlastic47.43 mm X 22.70 mm
FingerPlasticIrregular
HandlePlastic104.96 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 +39-2-250715-1 in accordance with ISO10993.

Mentions image processing

Not Found

Mentions AI, DNN, or ML

Not Found

Input Imaging Modality

ultrasound

Anatomical Site

human pody, Vascular, Small Parts, Intra-operative, Extra Corporeal

Indicated Patient Age Range

Not Found

Intended User / Care Setting

surgeon

Description of the training set, sample size, data source, and annotation protocol

Not Found

Description of the test set, sample size, data source, and annotation protocol

Not Found

Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)

Not Found

Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)

Not Found

Predicate Device(s)

K953819, K884644

Reference Device(s)

K944485/S3

Predetermined Change Control Plan (PCCP) - All Relevant Information

Not Found

§ 892.1570 Diagnostic ultrasonic transducer.

(a)
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.(b)
Classification. Class II.

0

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: (317) 849-1793 (317) 841-8616 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)

CompanyArticle510 (k)
EsaoteINT 13K953819
HitachiEUP-033JK884644

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

1

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

ITEMCHARACTERISTICSDIMENSION
SledPlastic47.43 mm X 22.70 mm
FingerPlasticIrregular
HandlePlastic104.96 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 +39-2-250715-1 in accordance with ISO10993.

2

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.

3

KIDULUMS SSSULANIJOSELLE PUD KIJINI

MATERIALSACCESSORIES
STERILIZATIONINTENDED USE
PlasticPlasticPlasticEsaote INT13 Accessories
Cold SterilizationCold Sterilization with CidexCold Sterilization with CidexEsaote INT13
Hitachi EUP-033J
Surgery/vascularAbdominal, intraoperativeAbdominal, intraoperative
YesNoSubject to this submission

4

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 (301) 594-4613. Additionally, for question and advertising of your device, please contact the Office of Compliance at (301) 594-4639. 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 (800) 638-2041 or (301) 443-6597 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

5

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 ApplicationAMPWCCWCColor DopplerPower Amplitude DopplerColor Velocity ImagingCombined (specify)Other (specify)
Ophthalmic
Fetal
Abdominal
Intra-operative (Specify)XX
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)XX

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)