(41 days)
Not Found
Not Found
No
The description details a mechanical device for applying surgical clips and makes no mention of AI or ML.
No
The device is described as an applier for titanium clips to occlude vessels and tubular structures during laparoscopic procedures, which is a surgical tool, not a device that intrinsically provides therapy.
No
The device is a surgical tool used to ligate vessels, not to diagnose medical conditions.
No
The device description clearly details a physical, disposable laparoscopic clip applier made of stainless steel and polymers, containing titanium clips. It describes mechanical actions like handle actuation and jaw closure, indicating a hardware-based device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In vitro diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections. They are used outside of the body (in vitro).
- Device Function: The DeRoyal Disposable Laparoscopic Clip Applier is a surgical instrument used inside the body (in vivo) during laparoscopic procedures. Its purpose is to physically occlude vessels and tubular structures.
- Lack of Diagnostic Testing: The device does not perform any analysis or testing of biological samples to provide diagnostic information. It is a tool for surgical intervention.
Therefore, this device falls under the category of a surgical instrument rather than an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
The DeRoyal Industries Disposable Laparoscopic Clip Applier with Implantable Titanium Clips is intended for use in a variety of laparoscopic procedures to occlude tubular structures and vessels. The tissue being ligated should be consistent with the size of the clip.
Product codes
FZP, KOG
Device Description
The DeRoyal Disposable Laparoscopic Clip Applier with Implantable Titanium Clips is a disposable single patient use device fabricated from biocompatible stainless steels and biocompatible medical grade polymers. The Disposable Clip Applier contains up to 20 implantable titanium clips. The closed clip length is approximately 9 mm. The intended use of the device is to occlude vessels and other tubular structures during laparoscopic surgical procedures. The clip applier jaws, with the open clip in the jaws, is placed around the vessel or other tubular structure. Actuation/compression of the clip applier handle/trigger drives a mechanism within the device to close the jaws, thereby forming the clip securely around the vessel. Release/decompression of the clip applier handle/trigger allows the jaws to open and release the clip. The automatic feed feature releases the next clip into the jaws for another application.
The shaft of the applier is sized to fit through a 10 mm cannula. The overall shaft length is approximately 33 mm and consistent with other endoscopic instruments.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
vessels or other tubular structures
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)
United States Surgical Corporation, Ethicon, Pilling Weck
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 878.4300 Implantable clip.
(a)
Identification. An implantable clip is a clip-like device intended to connect internal tissues to aid healing. It is not absorbable.(b)
Classification. Class II.
0
MAY | 4 1998
510(k) SUMMARY: DeRoyal Industries, Inc. Disposable Laparoscopic Clip Applier with Implantable Titanium Clips
-
DeRoyal Industries, Inc. (1) 200 DeBusk Lane Powell, TN 37849
Contact Person: Telephone: Date Summary Prepared: -
Trade or Proprietary Name: (2)
Common Name:
Classified Name:
(3) Predicates: Camille Matlock (423) 938-7828 April 1, 1998
DeRoyal Industries Disposable Laparoscopic Clip Applier with Implantable Titanium Clips
Disposable Laparoscopic Clip Applier with Implantable Titanium Clips
Implantable Clip (74FZP, 21 CFR & 878.4300), Class II
Endoscope and accessories, (78KOG, 21 CFR & 878.1500). Class II
United States Surgical Corporation (! Ethicon . Pilling Weck (formerlv Edward Weck)/ ﺗﻤﺖ ﺍ
1
Description of Device: (4)
The DeRoyal Disposable Laparoscopic Clip Applier with Implantable Titanium Clips is a disposable single patient use device fabricated from biocompatible stainless steels and biocompatible medical grade polymers. The Disposable Clip Applier contains up to 20 implantable titanium clips. The closed clip length is approximately 9 mm. The intended use of the device is to occlude vessels and other tubular structures during laparoscopic surgical procedures. The clip applier jaws, with the open clip in the jaws, is placed around the vessel or other tubular structure. Actuation/compression of the clip applier handle/trigger drives a mechanism within the device to close the jaws, thereby forming the clip securely around the vessel. Release/decompression of the clip applier handle/trigger allows the jaws to open and release the clip. The automatic feed feature releases the next clip into the jaws for another application.
The shaft of the applier is sized to fit through a 10 mm cannula. The overall shaft length is approximately 33 mm and consistent with other endoscopic instruments.
- Intended Use: (5)
The DeRoval Disposable Clip Applier with Implantable Titanium Clips is intended for use during laparoscopic surgery to occlude a variety of vessels or other tubular structures.
| Characteristics | Predicate Devices | DeRoyal Industries |
|---|---|---|
| Intended Use | Endoscopic procedures to achieve occlusion of vessels and other tubular structures. | Same |
| Clip Surface | Textured | Same |
| Laparoscopic Intro. Size | $ \cong 10 $ MM | Same |
| Clip Dimensions | $ \cong 9 $ MM | Same |
| Sterility | Sterile | Same |
| Materials | Polymers, stainless steel, and black chrome coating. | Same |
(6) Technological Characteristics:
2
The DeRoyal Disposable Clip Applier with Implantable Titanium Clips has similar/same technological characteristics as the predicate devices in that they are comprised of similar design, similar materials, and are intended to be used to clip vessels or tubular structures during laparoscopic surgery.
Conclusion: (7)
The proposed device has the same intended use and the same basic technology as the legally marketed predicate devices identified in the premarket notification submission. The proposed device contains, in some combination, similar/same features, materials, and design as the predicate devices and does not pose any new questions concerning safety and effectiveness.
3
Image /page/3/Picture/1 description: The image shows the seal of the Department of Health & Human Services - USA. The seal features a stylized eagle with three stripes representing the three branches of government. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular pattern around the eagle.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
MAY | 4 1998
Ms. Camille Matlock ·Requlatory Affairs DeRoyal Industries, Incorporated 200 DeBusk Lane Powell, Tennessee 37849
K981239 Re: Trade Name: Disposable Laparoscopic Clip Applier with Implantable Titanium Clips Regulatory Class: II Product Code: FZP and KOG April 1, 1998 Dated: April 3, 1998 Received:
Dear Ms. Matlock:
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. ਜੋ substantially equivalent determination assumes compliance with the current Good Manufacturing Practice requirement, as set forth in the Quality System Requlation (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 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.
4
Page 2 - Ms. Matlock
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,
Colia M. Witten, Ph.D., M.
Cella M. Witten, Ph.D., M.D. Director Division of General and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
5
Page 1 of 1
510(k) Number (if known):
Disposable Laparoscopic Clip Applier with Implantable
Titanium Clips
Indications for Use:
Device Name:
The DeRoyal Industries Disposable Laparoscopic Clip Applier with Implantable Titanium Clips is intended for use in a variety of laparoscopic procedures to occlude tubular structures and vessels. The tissue being ligated should be consistent with the size of the clip.
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE) ીન્દ્ર nei Ji Restorative Devic Olk) Number Prescription Use OR Over-The-Counter Use (Per 21 CFR § 801.109)