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 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.

AI/ML Overview

The provided document is a 510(k) summary for the "Biopsy Accessory attachment and handle" by Biosound Esaote, dated April 27, 1997. It primarily focuses on demonstrating substantial equivalence to predicate devices for regulatory approval.

Based on the content, there is NO information about acceptance criteria or a study proving the device meets specific performance criteria as typically defined for AI/ML-based medical devices. This submission predates the widespread use of such devices and the regulatory framework for them.

The document discusses:

Device Description: A metal and plastic bracket and needle guides that attach to an ultrasound transducer.
Intended Use: To guide a biopsy needle to an anatomical site for sample recovery, using imaging information from an ultrasound system.
Materials and Biocompatibility: Polyurethane resin and stainless steel. Biocompatibility tests (cytotoxicity, sensitisation, irritation) were performed on the polyurethane resin according to ISO 10993.
Sterilization: Cold sterilization with CIDEX solution.
Substantial Equivalence Comparison: Compares features like materials, needle guide angle, sterilization method, removability, and compatibility with biopsy needles to predicate devices.

Therefore, I cannot provide the requested table or detailed study information because it is not present in the provided text. The document's purpose is to demonstrate substantial equivalence for a physical medical accessory, not to report on the performance of a software algorithm or AI.

If this were a typical AI/ML medical device submission, the requested information would look like this (but again, it's not present in the provided text):

1. Table of Acceptance Criteria and Reported Device Performance

Performance Metric	Acceptance Criteria	Reported Device Performance
*N/A*	*N/A*	*N/A*
(e.g., Sensitivity)	(e.g., ≥ 90%)	(e.g., 92.5%)
(e.g., Specificity)	(e.g., ≥ 85%)	(e.g., 88.1%)
(e.g., Accuracy)	(e.g., ≥ 88%)	(e.g., 90.3%)

2. Sample size used for the test set and data provenance

Test Set Size: Not provided.
Data Provenance: Not provided (not relevant for this type of device submission).

3. Number of experts used to establish the ground truth for the test set and their qualifications

Number of Experts: Not provided.
Qualifications: Not provided.

4. Adjudication method for the test set

Adjudication Method: Not provided.

5. Multi-Reader Multi-Case (MRMC) comparative effectiveness study

MRMC Study: No, an MRMC study was not conducted or reported. This type of study is typically for evaluating human performance with and without AI assistance for interpretation tasks, which is not applicable to a physical biopsy accessory.
Effect Size: Not applicable.

6. Standalone (algorithm only) performance study

Standalone Study: No, a standalone performance study for an algorithm was not conducted or reported. The device is a physical accessory, not a software algorithm.

7. Type of ground truth used

Ground Truth Type: Not applicable/Not provided. The "ground truth" mentioned in the document relates to biocompatibility testing against ISO 10993 standards and substantial equivalence to predicate devices, not clinical performance for diagnostic accuracy.

8. Sample size for the training set

Training Set Size: Not applicable/Not provided, as this is not a machine learning device.

9. How the ground truth for the training set was established

Ground Truth Establishment: Not applicable, as this is not a machine learning device.

Summary

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

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 +39-2-250715-1, in accordance ISO 10993.

Sterilization

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

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 ResinStainless Steel	Stailness steelMedical Plastic	Stainless steelMedical Plastic
NEEDLE GUIDE ANGLE	Fixed	15° and 30°	20° to 45°
STERILIZATION	Cold Sterilization withCIDEX	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 accessoryfor Intraoperative probe	Diasonics NewImage System BiopsyAttachment	ESAOTE AU530 Biopsy AccessoryFor Ultrasound Transducer K912088

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Image /page/5/Picture/0 description: The image shows the seal of the Department of Health & Human Services USA. The seal is circular, with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" arranged around the perimeter. In the center of the seal is a stylized image of an eagle, with three wavy lines extending from its head.

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 (301) 594-4613. Additionally, for questions on the promotion 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/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, usedto guide the biopsy needle through the accessory to theanatomical site where the sample of physiological material isrecovered 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

Over-The-Counter Use

Ra. Rege

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

510(k) Number K971700

Regulation Number and Section

§ 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.