(42 days)
The AUTO SUTURE* ultrasonic hand instruments have application in abdominal, pediatric, gynecologic, thoracic, urologic and general open and endoscopic procedures for the transection, dissection and coagulation of tissue(s). The instrument is available with a hook probe, with a shear and with a ball probe.
The subject instruments consists of three endoscopic hand instruments which connected by an acoustic transducer to a generator. The hand instruments consist of an ultrasonic shear, ultrasonic hook probe and ultrasonic ball probe.
The provided text is a 510(k) Premarket Notification for a medical device and therefore does not contain the detailed study information typically found in a clinical trial report or a performance study to assess acceptance criteria. The 510(k) summary focuses on demonstrating substantial equivalence to a predicate device rather than presenting extensive performance studies against pre-defined acceptance criteria for a novel technology.
However, I can extract the information provided and note where details are missing based on your request.
1. A table of acceptance criteria and the reported device performance
Based on the provided 510(k) summary, explicit acceptance criteria and corresponding reported device performance against those criteria are not available. The submission primarily focuses on demonstrating substantial equivalence to a predicate device (Ethicon Ultracision ultrasonic hand instruments, K961104). The "device description" and "intended use" sections describe the device's function, but no quantitative performance metrics or acceptance thresholds are listed.
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
This information is not provided in the 510(k) summary. The document does not describe any specific test set or data provenance from a performance study.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
This information is not provided in the 510(k) summary. Given that it's a 510(k) for an ultrasonic surgical instrument, the "ground truth" would likely relate to objective measurements of tissue transection, dissection, and coagulation capabilities, rather than expert interpretation of images. However, no such studies are detailed.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
This information is not provided in the 510(k) summary.
5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
A multi-reader multi-case (MRMC) comparative effectiveness study is not mentioned and is not applicable to this type of device (an ultrasonic surgical instrument for transection, dissection, and coagulation of tissue). This type of study is typically used for diagnostic devices involving human interpretation of data, often with AI assistance, which is not the function of this surgical tool.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
This concept is not applicable to the AUTO SUTURE* Ultrasonic Hand Instrument system. This is a physical surgical tool operated by a human, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
This information is not provided in the 510(k) summary. For a surgical instrument, "ground truth" related to its performance would likely involve objective measures of tissue effect (e.g., precise cutting, effective coagulation, minimal thermal spread), which would typically be assessed in preclinical (e.g., animal or benchtop) studies. However, the details of such studies are not included in this summary.
8. The sample size for the training set
This information is not applicable as this is a physical medical device, not an AI/ML algorithm that requires a training set.
9. How the ground truth for the training set was established
This information is not applicable for the same reason as point 8.
In summary, the provided 510(k) Premarket Notification primarily serves to demonstrate substantial equivalence to a predicate device rather than detailing comprehensive performance studies with explicit acceptance criteria, sample sizes, expert involvement, or adjudication methods as requested. These types of detailed studies would likely have been performed during the development and verification/validation phases but are not included in this summary document.
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United States Surgical Corporation 510(k) Premarket Notification AUTO SUTURE* Ultrasonic Hand Instrument** system
| IX. 510(k)_Summary of Safety and Effectiveness | |
|---|---|
| SUBMITTER: | United States Surgical Corporation150 Glover AvenueNorwalk, CT 06856JUL - 1 199 |
| CONTACT PERSON: | Victor Clavelli |
| DATE PREPARED: | May 19, 1997 |
| CLASSIFICATION NAME: | Ultrasonic Surgical Instrument |
| COMMON NAME: | Ultrasonic hand instruments |
| PROPRIETARY NAME: | Not yet determined |
| PREDICATE DEVICES: | Ethicon Ultracision ultrasonic hand instruments, K961104 |
| DEVICE DESCRIPTION: | The subject instruments consists of three endoscopic handinstruments which connected by an acoustic transducer to agenerator. The hand instruments consist of an ultrasonicshear, ultrasonic hook probe and ultrasonic ball probe. |
| INTENDED USE: | The AUTO SUTURE* ultrasonic hand instruments haveapplication in abdominal, pediatric, gynecologic and otheropen and endoscopic procedures for the transection,dissection and coagulation of tissue(s). The instrument isavailable with a hook probe, with a shear probe and with aball probe. |
| MATERIALS: | The AUTO SUTURE* ultrasonic hand instruments arecomposed entirely of biocompatible materials which are incompliance with ISO 10993-1 for their intended patientcontact profile. |
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Image /page/1/Picture/1 description: The image shows the logo for the Department of Health & Human Services - USA. The logo features a stylized eagle with its wings spread, and the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular pattern around the eagle. The eagle is black, and the text is also black.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
JUL * 1 1997
Mr. Victor Clavelli United States Surgical Corporation 150 Glover Avenue Norwalk, Connecticut 06856
Re: K971861
Trade Name: AUTO SUTURE* Ultrasonic Surgical Instrument Regulatory Class: II Product Code: LFL Dated: May 20, 1997 Received: May 20, 1997
Dear Mr. Clavelli:
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 Device Amendments, or to 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 II (Special Controls) or 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 requirements , as set forth in the Quality System Regulation (OS) 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 the Electronic Product Radiation Control provisions, or other Federal laws or regulations.
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Page 2 - Mr. Victor Clavelli
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) 594-4595. 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/cdrh/dsmamain.html".
Sincerely yours,
Celia M. Witten, Ph.D., M.D. Director Division of General and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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ENCLOSURE II Indications For Use:
510(k) Number (if known): K971861
Device Name: AUTO SUTURE* Ultrasonic Surgical Instrument
Indications For Use:
The AUTO SUTURE* ultrasonic hand instruments have application in abdominal, pediatric, gynecologic, thoracic, urologic and general open and endoscopic procedures for the transection, dissection and coagulation of tissue(s). The instrument is available with a hook probe, with a shear and with a ball probe.
Prescription Use
(Per 21 CFR 801.109)
N/A