(87 days)
The "Re-New Forceps" Laparoscopic Surgical Tips are intended to cut, grasp, and dissect various abdominal issue for use in endoscopic, including laparoscopic surgical procedures where instruments are introduced into the body through a cannula.
The "Re-New Forceps" Laparoscopic Surgical Tips are an extension of the "Re-New" Laparoscopic Instruments product line used to cut, grasp, and dissect various abdominal tissue during Endoscopic (inclusive of laparoscopic) surgical procedures.
The "Re-New Forceps" Laparoscopic Surgical Tips consist of a series reusable tip configurations. The tip assembly, designed with a double thread, permits simple and reliable attachment and detachment of the desired tip to the shaft of the handle/shaft component. Tip configurations include:
- · Grasper,
- · Fenestreded Forceps.
- · "Dolphin Nose" Dissector,
- · "Babcock", and
- · "Maryland" Dissector
The provided text describes a 510(k) premarket notification for "Re-New Forceps" Laparoscopic Surgical Tips and focuses on demonstrating substantial equivalence to a predicate device ("Re-New" K962119). It does not contain information about acceptance criteria, device performance metrics, or study designs (e.g., sample sizes, ground truth establishment, expert qualifications, MRMC studies) typically associated with direct studies proving a device meets specific performance criteria.
Therefore, I cannot provide a table of acceptance criteria and reported device performance, nor details about a study that proves the device meets those criteria, as this information is absent from the provided document.
The document is a 510(k) summary, which is primarily concerned with establishing substantial equivalence to a legally marketed predicate device, rather than detailed performance study results against specific acceptance criteria.
Here's what can be inferred or stated based on the provided text, addressing the points where information is available:
1. A table of acceptance criteria and the reported device performance
- Information Not Available: The document does not specify quantitative acceptance criteria or provide a table of reported device performance metrics (e.g., force measurements, dissection efficiency, tissue damage scores) against such criteria. The basis for clearance is "substantial equivalence" to a predicate device.
2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Information Not Available: No information regarding sample sizes for a test set, data provenance, or whether any studies were retrospective or prospective is provided. The submission focuses on device description and comparison to a predicate.
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)
- Information Not Available: There is no mention of experts, ground truth establishment for a test set, or their qualifications.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Information Not Available: No information regarding adjudication methods is provided.
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
- Information Not Available: This device is a surgical instrument, not an AI-assisted diagnostic tool. Therefore, an MRMC comparative effectiveness study involving human "readers" and AI assistance is not applicable and not mentioned.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
- Information Not Available / Not Applicable: This is a manual surgical instrument, not an algorithm. Standalone algorithm performance is not relevant.
7. The type of ground truth used (expert concensus, pathology, outcomes data, etc)
- Information Not Available: No ground truth data or its source is mentioned in relation to performance evaluation. Substantial equivalence relies on comparing the new device's technical characteristics and intended use to those of the predicate device.
8. The sample size for the training set
- Information Not Available: No training set or associated sample size is mentioned, as this is not an AI/machine learning device.
9. How the ground truth for the training set was established
- Information Not Available / Not Applicable: No training set or ground truth for such a set is relevant or discussed for this type of device.
{0}------------------------------------------------
974066
10. SMDA Summary of Safety and Effectiveness - "510(k) Summary"
JAN 2 2 1998
A. Submittor Information
Microline, Inc. 181 Elliott Street Suite 915 Beverly, MA 01915
Telephone: (508) 922-9810 Contact Person: Mr. Huges de Laforcade President
Date Prepared: October 24, 1997
- B. Device Identification
Common/Usual Name: Manual Detachable Surgical Instruments Proprietary Name: "Re-New Forceps" Laparoscopic Surgical Tips
C. Identification of Predicate Device(s)
The "Re-New Forceps" Laparoscopic Surgical Tips are substantially equivalent to their predicate, "Re-New" (K962119), previously cleared and currently marketed.
D. Device Description
The "Re-New Forceps" Laparoscopic Surgical Tips are an extension of the "Re-New" Laparoscopic Instruments product line used to cut, grasp, and dissect various abdominal tissue during Endoscopic (inclusive of laparoscopic) surgical procedures.
The "Re-New Forceps" Laparoscopic Surgical Tips consist of a series reusable tip configurations. The tip assembly, designed with a double thread, permits simple and reliable attachment and detachment of the desired tip to the shaft of the handle/shaft component. Tip configurations include:
- · Grasper,
- · Fenestreded Forceps.
- · "Dolphin Nose" Dissector,
- · "Babcock", and
- · "Maryland" Dissector
E. Substantial Equivalence
The technical characteristics of the "Re-New Forceps" Laparoscopic Surgical Tips are almost identical to those of the Microline "Re-New" (K962119). Differences that exist between these devices relating to technical specifications, materials, and physical appearance do not affect the relative safety or effectiveness of the "Re-New Forceps" relative to its predicate.
The "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 .
050007
{1}------------------------------------------------
Image /page/1/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is circular, with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the top half of the circle. Inside the circle is an abstract symbol that resembles an eagle or bird in flight, composed of three curved lines.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
JAN 222 1998
Mr. Hughes de Laforcade President Microline, Incorporated 181 Elliott Street, Suite 915 Beverly, Massachusetts 01915
Re: K974066
Trade Name: "RE-NEW FORCEPS" Laparoscopic Surgical Tips Regulatory Class: II Product Code: GEI Dated: October 24, 1997 Received: October 27, 1997
Dear Mr. de Laforcade:
We have reviewed your Section 510(k) notification of intent to market the devices referenced above and we have determined the devices are 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 devices, 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 devices are classified (see above) into either class II (Special Controls) or class III (Premarket Approval), they may be subject to such additional controls. Existing major regulations affecting your devices 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 (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. In addition, FDA may publish further announcements concerning your devices in the Federal Register. Please note: this response to your premarket notification submissions 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. de Laforcade
This letter will allow you to begin marketing your devices as described in your 510(k) premarket notification. The FDA finding of substantial equivalence of your devices to a legally marketed predicate device results in a classification for your devices and thus, permits your devices to proceed to the market.
If you desire specific advice for your devices 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 devices, 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.
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}------------------------------------------------
The generator manufacturers which are compatible with the "Re-New Forceps" Laparoscopic Surgical Tips are as follows:
-
- Bovie
-
- Valley Lab, Inc.
- CIRCOM ACMI 3.
-
- Elmed, inc.
-
- Leisegang Medical
6.5 Intended Use
The "Re-New Forceps" Laparoscopic Surgical Tips are intended to cut, grasp, and dissect various abdominal issue for use in endoscopic, including laparoscopic surgical procedures where instruments are introduced into the body through a cannula.
CAUTION: Federal Law (USA) restricts this device to use or sales by or on order of a physician.
7. Packaging
The "Re-New Forceps" stainless steel reusable laparoscopic surgical tips are packaged nonsterile in a plastic blister with 5 blisters in a carton. A copy of the labeling for this carton is located in Appendix A.
§ 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.