(57 days)
Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows: Intra-operative (Specify), Extra Corporeal/ Other (specify)
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.
The provided document is a 510(k) premarket notification for accessories (Sled, Finger, Handle) for an ultrasound transducer. It focuses on demonstrating substantial equivalence to predicate devices, material biocompatibility, and sterilization methods. This type of submission typically does not involve a study to prove device performance against acceptance criteria in the way that an AI/software device would, as it's for physical accessories with a different regulatory pathway and different types of "performance" to demonstrate.
Therefore, I cannot extract the information you requested regarding acceptance criteria and a study proving device performance in the context of an AI/software device. The document describes:
- Device Function: The accessories "function with the AU4 ultrasound system's intraoperative probe" and allow the surgeon to "position the probe more easily inside the body."
- Performance Evaluation: The "performance" in this context is primarily related to material biocompatibility and effective sterilization, rather than diagnostic accuracy or clinical outcomes.
Here's how I can address your request based on the provided document, interpreting "acceptance criteria" and "study" in the context of this specific type of device (physical accessories):
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Biocompatibility: Meet ISO 10993 / EN 30993 for External Communicating Device (Class A - limited, ≤ 24 hours). Specific tests: Cytotoxicity, Sensitization, Irritation. | Passed: Material (polyurethane resin 6090 black) tested by Biolab in accordance with ISO10993. |
| Sterilization: Compatibility with recommended sterilizing solution and ability to be properly sterilized. | Compatible: Instructions provided for use with Cidex Activated Dialdehyde Solution (Johnson & Johnson). |
| Functionality: Function with the AU4 ultrasound system's intraoperative probe to facilitate probe positioning. | Claimed: "The three intraoperative probe accessories... function with the AU4 ultrasound system's intraoperative probe," and "the surgeon is able to position the probe more easily inside the body." (Note: this is a functional claim, not an explicit performance metric like sensitivity/specificity). |
| Dimensions: Adherence to specified dimensions for Sled, Finger, and Handle. | Provided: Dimensions listed for Sled (47.43 mm X 22.70 mm), Finger (Irregular), and Handle (104.96 mm X 13.78 mm). (Implied to meet intended design, no explicit "testing" details provided for this.) |
2. Sample Size Used for the Test Set and Data Provenance
Not applicable in the context of AI/software performance studies. The "testing" referred to for this device is physical material testing.
- For Biocompatibility, the "sample" would refer to the material itself (polyurethane resin 6090 black). The tests were performed by Biolab, an Italian laboratory. This is a retrospective assessment of the material's properties.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Their Qualifications
Not applicable for this type of device. Ground truth, in the AI/software context, typically refers to expert labels or definitive diagnoses. Here, "ground truth" for biocompatibility is established by international standards (ISO 10993 / EN 30993) and laboratory testing protocols.
4. Adjudication Method for the Test Set
Not applicable. Adjudication methods like 2+1 or 3+1 are used for resolving disagreements among multiple human readers on diagnostic tasks, which is not relevant here.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done
No, an MRMC study was not done. These studies are conducted to compare human reader performance with and without AI assistance, which is outside the scope of physical ultrasound probe accessories.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
No, a standalone performance assessment was not done. This concept applies to AI algorithms operating independently, which is not relevant for physical accessories.
7. The Type of Ground Truth Used
The "ground truth" used related to the device's safety is based on international standards and laboratory test results for biocompatibility (ISO 10993 / EN 30993 testing for cytotoxicity, sensitization, irritation) and compatibility with sterilization solutions.
8. The Sample Size for the Training Set
Not applicable. This device is a physical accessory, not an AI algorithm, so there is no "training set."
9. How the Ground Truth for the Training Set Was Established
Not applicable, as there is no training set for this device.
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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: (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)
| 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.
{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
| 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 +39-2-250715-1 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 (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
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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)
§ 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.