(62 days)
No
The summary does not mention AI, ML, or any related concepts. The device description focuses on mechanical components and basic software guidance.
No
The device is used for imaging and guiding a biopsy needle, which are diagnostic and procedural functions, not therapeutic ones.
No
Explanation: The device is an ultrasound system with a biopsy accessory used for guiding a needle to recover physiological material for analysis. It provides imaging information for guidance but does not diagnose conditions itself; it aids in obtaining samples for subsequent diagnostic analysis.
No
The device description explicitly states the device consists of a "metal and plastic bracket and needle guides that attach to the ultrasound transducer," indicating it includes physical hardware components in addition to software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states that the device is used to guide a biopsy needle to an anatomical site for the recovery of physiological material. The material is then subject to further analysis. This "further analysis" is where an IVD would typically come into play (e.g., analyzing the recovered sample for disease markers).
- Device Description: The device is described as an accessory attachment and handle for an ultrasound system. Its function is to guide the needle. It does not perform any analysis or testing on the physiological material itself.
- Lack of IVD Characteristics: There is no mention of the device performing any tests, measurements, or analysis on biological samples in vitro (outside the body). Its role is purely in the collection of the sample.
In summary, this device is a surgical accessory used in conjunction with an ultrasound system to facilitate the collection of a biological sample. The analysis of that sample, which would be the domain of an IVD, is a separate step that occurs after the sample is collected using this device.
N/A
Intended Use / Indications for 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.
Product codes
90 ITX
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Ultrasound
Anatomical Site
anatomical site where the sample of physiological material is recovered for further analysis.
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
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)
Reference Device(s)
Not Found
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
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.
1
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 |
2
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.
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.
3
Safety and Effectiveness Summary INT13 Biopsy Accessories Biosound Esaote
807.92(a)(5)
: w
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.
4
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Substantist Eppinvalence
| FEATURE | |||
|---|---|---|---|
| MATERIALS | Polyurethane Resin | ||
| Stainless Steel | Stailness steel | ||
| Medical Plastic | Stainless steel | ||
| Medical Plastic | |||
| NEEDLE GUIDE ANGLE | Fixed | 15° and 30° | 20° to 45° |
| STERILIZATION | Cold Sterilization with | ||
| 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 | |||
| for Intraoperative probe | Diasonics NewImage System Biopsy | ||
| Attachment | ESAOTE AU530 Biopsy Accessory | ||
| For Ultrasound Transducer K912088 |
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5
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
6
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 |
| to guide the biopsy needle through the accessory to the | |
| anatomical site where the sample of physiological material is | |
| 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