(43 days)
Not Found
Not Found
No
The device description focuses on mechanical components and actions (occluding vessels, automatic feeding, lock/release mechanism) and makes no mention of AI or ML. The "Mentions AI, DNN, or ML" field is explicitly marked as "Not Found".
No.
The device is used to occlude vessels or tubular structures during surgery, which is a surgical tool function, not an active therapeutic function to treat a disease or condition.
No
The device is described as an implantable clip intended to occlude vessels or other tubular structures during laparoscopic surgery, which is a therapeutic function, not a diagnostic one.
No
The device description clearly details a physical medical device consisting of a cartridge with implantable titanium clips made from stainless steels and polymers, designed to be used with a reusable clip applier. It is not software-only.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is to "occlude a variety of vessels or other tubular structures" during laparoscopic surgery. This is a surgical procedure performed in vivo (within the living body).
- Device Description: The device is a surgical instrument (clip cartridge and applier) designed to be used within the body to physically close off structures.
- Lack of IVD Characteristics: There is no mention of the device being used to examine specimens derived from the human body (like blood, urine, tissue, etc.) in vitro (outside the body) to provide information for diagnosis, monitoring, or compatibility testing.
IVD devices are used to perform tests on samples taken from the body, while this device is used directly on structures within the body during surgery.
N/A
Intended Use / Indications for Use
The PermaClip™ Cartridge with implantable titanium clips is intended for use during laparoscopic surgery to occlude a variety of vessels or other tubular structures.
Product codes
74FZP
Device Description
The Microsurge Laparoscopic PermaClip™ Cartridge with implantable titanium clips is a disposable single patient use device fabricated from biocompatible stainless steels and biocompatible medical grade polymers. The PermaClip ™ cartridge contains up to 12 implantable titanium clips. The closed clip length is approximately 9 mm. The device is designed to be used in conjunction with a separately supplied reusable PermaClip™ Multi-Use Clip Applier to occlude blood vessels and other tubular structures during laparoscopic surgical procedures. The clip cartridge is attached to the clip applier handle via a lock/release mechanism, and inserted through a trocar to gain laparoscopic access. The clip cartridge 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 cartridge to close the cartridge jaws, thereby forming the clip securely around the vessel. Release/decompression of the clip applier handle/trigger allows the iaws of the cartridge to open and releases the clip from the cartridge jaws. The automatic feeding cartridge releases the next clip into the jaws for another application. The cartridge is sized to fit through a 10 mm cannula. The overall shaft length of the cartridge plus the clip applier handle is approximately 33 mm, 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 (study type, sample size, AUC, MRMC, standalone performance, key results)
Not Found
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
United States Surgical Corporation, Ethicon Endosurgery, 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
Microsurge Permaclip 510(k) October 11, 1996
1996 ל 7 NOV 2 510 (k) SUMMARY: Microsurge Laparoscopic PermaClip™ Cartridge with Implantable Titanium Clips
- (1) Microsurge, Inc. 150 A Street Needham, MA 02194 (617) 444-2300
Contact Person: Richard Lariviere Date Summary Prepared: Oct. 11, 1996
| (2) | Trade or Proprietary Name: | Microsurge Laparoscopic
PermaClip™ Cartridge with
Implantable Titanium Clips |
|-----|----------------------------|------------------------------------------------------------------------------------|
| | Common Name: | Laparoscopic Clip Cartridge with
Implantable Titanium Clips |
| | Classified Name: | Implantable Clip (74FZP), 21 CFR
878.4300, Class II |
| (3) | Predicates: | United States Surgical Corporation |
| | | Ethicon Endosurgery
Pilling Weck |
(4) Description of Device:
The Microsurge Laparoscopic PermaClip™ Cartridge with implantable titanium clips is a disposable single patient use device fabricated from biocompatible stainless steels and biocompatible medical grade polymers. The PermaClip ™ cartridge contains up to 12 implantable titanium clips. The closed clip length is approximately 9 mm. The device is designed to be used in conjunction with a separately supplied 114
1
reusable PermaClip™ Multi-Use Clip Applier to occlude blood vessels and other tubular structures during laparoscopic surgical procedures. The clip cartridge is attached to the clip applier handle via a lock/release mechanism, and inserted through a trocar to gain laparoscopic access. The clip cartridge 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 cartridge to close the cartridge jaws, thereby forming the clip securely around the vessel. Release/decompression of the clip applier handle/trigger allows the iaws of the cartridge to open and releases the clip from the cartridge jaws. The automatic feeding cartridge releases the next clip into the jaws for another application.
The cartridge is sized to fit through a 10 mm cannula. The overall shaft length of the cartridge plus the clip applier handle is approximately 33 mm, consistent with other endoscopic instruments.
-
(5) Intended Use:
The PermaClip™ Cartridge with implantable titanium clips is intended for use during laparoscopic surgery to occlude a variety of vessels or other tubular structures. -
(6) Technological Characteristics:
The PermaClip™ Cartridge with implantable titanium clips has similar/same technological characteristics as the predicate devices in that they are comprised of similar design, materials, and are intended for use to clip vessels or tubular structures during laparoscopic surgery. -
(7) Conclusion:
The new device has the same intended use and the same basic technology as the predicates identified in the premarket notification submission. The new device contains in some combination similar/same features, materials, and design as the predicates and does not pose any new questions concerning safety and effectiveness. 115