(56 days)
No
The summary describes a mechanical surgical instrument and makes no mention of AI, ML, image processing, or any data-driven capabilities.
No
The device is described as a surgical instrument used for cutting and dissecting tissue during endoscopic procedures, not for treating a disease or condition with therapeutic effect.
No
Explanation: The device is described as a surgical instrument for cutting and dissecting tissue during endoscopic procedures, and it is used with electrosurgical generators. Its function is to perform a surgical action, not to diagnose a condition or disease.
No
The device description explicitly states it is a line of "nonsterile, reusable 5 mm diameter instruments," which are 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 is "Cutting and Dissecting Various Abdominal Tissue during Endoscopic (inclusive of laparoscopic) Surgical Procedures". This describes a surgical instrument used on the body, not a device used to examine specimens from the body.
- Device Description: The description details a surgical instrument used with electrosurgical generators for cutting and dissecting tissue during surgery. This aligns with a surgical tool, not an IVD.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue samples, etc.), performing tests on these samples, or providing diagnostic information based on such analysis.
IVDs are devices used to examine specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes. This device's function is purely surgical.
N/A
Intended Use / Indications for Use
Cutting and Dissecting Various Abdominal Tissue during Endoscopic (inclusive of laparoscopic) Surgical Procedures where instruments are introduced into the body through a cannula.
Product codes
GEI
Device Description
The Microline ACCUSHEAR Laparoscopic Surgical Instruments are a line of nonsterile, reusable 5 mm diameter instruments used to cut and dissect various abdominal tissue for use in endoscopic, including laparoscopic surgical procedures where instruments are introduced into the body through a cannula. The device is used with monopolar electrosurgical generators.
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
Not Found
Key Metrics
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
OCT 21 1998
10. SMDA Summary of Safety and Effectiveness - "510(k) Summary"
- A. Submittor Information
Microline, Inc. 100 Cummings Center Suite 350-G Beverly, MA 01915
| Telephone: | (978) 922-9810 |
|---|---|
| Contact Person: | Mr. Huges de Laforce |
| President |
Date Prepared: August 24, 1998
B. Device Identification
| Common/Usual Name: | Manual Detachable Surgical Instruments |
|---|---|
| Proprietary Name: | ACCUSHEAR Laparoscopic Surgical Instrument |
C. Identification of Predicate Device(s)
The Microline ACCUSHEAR Laparoscopic Surgical Scissors Instruments are substantially equivalent to their predicates offered by Microline Inc. "Re-New" (K962119) and "Selec-Tip" (K980758) previously cleared and currently marketed.
D. Device Description
The Microline ACCUSHEAR Laparoscopic Surgical Instruments are a line of nonsterile, reusable 5 mm diameter instruments used to cut and dissect various abdominal tissue for use in endoscopic, including laparoscopic surgical procedures where instruments are introduced into the body through a cannula. The device is used with monopolar electrosurgical generators.
E. Substantial Equivalence
The Microline ACCUSHEAR Laparoscopic Surgical Scissors Instruments are a modified version of the predicate Microline "Re-New" (K962119) with a minor device modification related to the shaft and handpiece connection and does not affect the relative safety or effectiveness of the Microline ACCUSHEAR Laparoscopic Surgical Scissors Instruments relative to their predicate.
The Microline ACCUSHEAR Laparoscopic Surgical Instruments are intended to delivery energy from an independent monopolar electrosurgical generator to cut and dissect various abdominal tissue for use during laparoscopic, inclusive of endoscopic surgical procedures where instruments are introduced into the body through a cannula.
1
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
OCT 21 1998
Microline, Inc. Ms. Jacqueline E. Masse Senior Consultant c/o Interactive Consulting, Inc. 70 Walnut Street Wellesley, Massachusetts 02481
K982984 Re: Trade Name: ACCUSHEAR Laparoscopic Surgical Instruments Requlatory Class: II Product Code: GEI Dated: Auqust 24, 1998 Received: August 26, 1998
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 regulations 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 General regulation (21 CFR Part 820) and that, Devices: through periodic (QS) inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP requlation 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
2
Page 2 - Ms. Jacqueline E. Masse
Product Radiation Control provisions, or other Federal laws or requlations.
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 labelinq 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,
CeNia M. Witten, Ph.D., M.D.
Director
Division of General and
Division of General and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
3
510(k) Number (if known): ___ K982984
Device Name: ACCUSHEAR Laparoscopic Surgical Scissors Instruments
Indications For Use:
Cutting and Dissecting Various Abdominal Tissue during Endoscopic (inclusive of laparoscopic) Surgical Procedures where instruments are introduced into the body through a cannula.
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use V (Per 21 CFR 801 109)
OR
Over-The-Counter Use
(Optional Format 1-2-96)
(Division Sign-Off)
Division of General Restorative Devices
510(k) Number. L982904
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