(42 days)
No
The summary describes a mechanical ultrasonic surgical instrument and does not mention any AI or ML components or functionalities.
Yes
The device is described as having applications in various surgical procedures for the transection, dissection, and coagulation of tissue, indicating its direct involvement in treating medical conditions.
No
Explanation: The device is described as an ultrasonic hand instrument used for transection, dissection, and coagulation of tissues during surgery. Its intended use is therapeutic (surgical), not diagnostic.
No
The device description explicitly states it consists of "three endoscopic hand instruments which connected by an acoustic transducer to a generator," indicating physical hardware components.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly describes a surgical instrument used for "transection, dissection and coagulation of tissue(s)" during various surgical procedures. This is a direct interaction with the patient's body for therapeutic or diagnostic purposes in vivo.
- Device Description: The description confirms it's a surgical hand instrument connected to a generator, designed for physical manipulation of tissue.
- Lack of IVD Characteristics: There is no mention of analyzing samples (blood, urine, tissue, etc.) in vitro (outside the body) to provide diagnostic information.
IVD devices are specifically designed to examine specimens derived from the human body to provide information for the diagnosis, monitoring, or treatment of a disease or condition. This device does not fit that description.
N/A
Intended Use / 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.
Product codes
LFL
Device Description
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
abdominal, pediatric, gynecologic, thoracic, urologic and general
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
N/A
0
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 Corporation |
| 150 Glover Avenue | |
| Norwalk, CT 06856 | |
| JUL - 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 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. | |
| INTENDED USE: | The AUTO SUTURE* ultrasonic hand instruments have |
| application in abdominal, pediatric, gynecologic and other | |
| open and endoscopic procedures for the transection, | |
| dissection and coagulation of tissue(s). The instrument is | |
| available with a hook probe, with a shear probe and with a | |
| ball probe. | |
| MATERIALS: | The AUTO SUTURE* ultrasonic hand instruments are |
| composed entirely of biocompatible materials which are in | |
| compliance with ISO 10993-1 for their intended patient | |
| contact profile. |
1
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.
2
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
3
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)