(43 days)
No
The device description focuses on mechanical surgical tools and does not mention any software, algorithms, or data processing capabilities indicative of AI/ML.
No.
The device is used for cutting, grasping, and dissecting tissue during surgical procedures, which are interventional actions rather than therapeutic ones. It aids in the surgical procedure rather than directly treating a disease or condition.
No
The device is described as surgical tips used for cutting, grasping, and dissecting tissue during endoscopic procedures, which indicates a therapeutic or interventional function, not a diagnostic one.
No
The device description explicitly states it consists of "Disposable Re-New Forceps Laparoscopic Surgical Tips" and "a series disposable tip configurations," which are physical components, not software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices used to perform tests on samples taken from the human body (like blood, urine, or tissue) to provide information about a person's health. These tests are performed outside of the body.
- Device Function: The description clearly states the device is used for "Cutting, Grasping, and Dissecting Various Abdominal Tissue during Endoscopic (inclusive of laparoscopic) Surgical Procedures." This is a surgical instrument used within the body during a procedure.
- Lack of Diagnostic Activity: There is no mention of analyzing samples, performing tests, or providing diagnostic information based on biological samples.
Therefore, this device falls under the category of a surgical instrument, not an In Vitro Diagnostic.
N/A
Intended Use / Indications for Use
Cutting, Grasping, and Dissecting Various Abdominal Tissue during Endoscopic (inclusive of laparoscopic) Surgical Procedures.
Product codes
GEI
Device Description
The Disposable Re-New Forceps Laparoscopic Surgical Tips are an extension of the Re-New Forceps Laparoscopic Instruments product line used to cut, grasp, and dissect various abdominal tissue during Endoscopic (inclusive of laparoscopic) surgical procedures.
The Disposable Re-New Forceps Laparoscopic Surgical Tips consist of a series disposable tip configurations. Tip configurations include: Grasper, Fenestreded Forceps, "Dolphin Nose" Dissector, "Babcock", and "Maryland" Dissector.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
abdominal tissue
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
§ 878.4400 Electrosurgical cutting and coagulation device and accessories.
(a)
Identification. An electrosurgical cutting and coagulation device and accessories is a device intended to remove tissue and control bleeding by use of high-frequency electrical current.(b)
Classification. Class II.
0
10. SMDA Summary of Safety and Effectiveness - "510(k) Summary"
A. Submittor Information
Microline, Inc. 1100 Cummings Center Suite 350-G Beverly, MA 01915
| Telephone: | (978) 922-9810 |
|---|---|
| Contact Person: | Mr. Hughes de Laforcade |
| President |
April 13, 1997 Date Prepared:
B. Device Identification
| Common/Usual Name: | Manual Detachable Surgical Instruments |
|---|---|
| Proprietary Name: | Disposable Re-New Forceps Laparoscopic Surgical Tips |
C. Identification of Predicate Device(s)
The Disposable Re-New Forceps Laparoscopic Surgical Tips are substantially equivalent to their predicate. Re-New Forceps (K974066), previously cleared and currently marketed.
D. Device Description
The Disposable Re-New Forceps Laparoscopic Surgical Tips are an extension of the Re-New Forceps Laparoscopic Instruments product line used to cut, grasp, and dissect various abdominal tissue during Endoscopic (inclusive of laparoscopic) surgical procedures.
The Disposable Re-New Forceps Laparoscopic Surgical Tips consist of a series disposable tip configurations. Tip configurations include: Grasper, Fenestreded Forceps, "Dolphin Nose" Dissector, "Babcock", and "Maryland" Dissector.
E. Substantial Equivalence
The technical characteristics of the Disposable Re-New Forceps Laparoscopic Surgical Tips are identical to those of the Microline Re-New Forceps (K974066). Differences that exist between these devices relating to technical specifications, materials, and physical appearance do not affect the relative safety or effectiveness of the Disposable Re-New Forceps relative to its predicate.
The Disposable Re-New Forceps Laparoscopic Surgical Tips are intended for use to cut, grasp, and dissect various abdominal tissue in endoscopic, including laparoscopic surgical procedures where instruments are introduced into the body through a cannula .
1
Image /page/1/Picture/2 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized depiction of an eagle or bird-like figure with three curved lines representing its wings or body. The bird is positioned to the right of a circular arrangement of text that reads "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA".
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
MAY 2 9 1998
Microline, Incorporated ·c/o Ms. Jacqueline E. Masse Senior Consultant Interactive Consulting 70 Walnut Street Wellesley, Massachusetts 02181
K981389 Re : Trade Name: Disposable Re-New Forceps Regulatory Class: II Product Code: GEI April 13, 1998 Dated: April 16, 1998 Received:
Dear Ms. Masse:
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 The general controls provisions of the Act 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 requlations affecting your device can be found in the Code of Federal Requlations, Title 21, Parts 800 to 895. प्र 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 In addition, FDA may publish further announcements action. 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 requlations.
2
Page 2 - Ms. Masse
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
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
510(k) Number (if known): ____________________________________________________________________________________________________________________________________________________
Device Name: Disposable Re-New Forceps Laparoscopic Surgical Tips
Indications For Use:
Cutting, Grasping, and Dissecting Various Abdominal Tissue during Endoscopic (inclusive of laparoscopic) Surgical Procedures.
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
coee
(Division Sign-Off)
Division of General Restorative Devices
510(k) Number. K981399
Prescription Use -(Per 21 CFR 801.109)
1
OR
Over-The-Counter Use
(Optional Format 1-2-96)