(118 days)
No
The device description and performance studies focus on the mechanical function of applying a clip and substantial equivalence to a predicate device, with no mention of AI or ML.
Yes
The device is used for the closure of arteriotomies and venotomies, and for the approximation of prosthetic grafts and dural tissue, which are procedures aimed at treating or alleviating a condition.
No
The device is described as an "Applier" for closing arteriotomies and venotomies, creating vascular prostheses, and approximating tissues, indicating a therapeutic or surgical function rather than a diagnostic one.
No
The device description clearly describes a physical clip applier made of bioapproved materials, designed to apply a titanium clip. There is no mention of software as the primary or sole component of the device.
Based on the provided text, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use describes the device's application in surgical procedures involving the closure of blood vessels, attachment of prosthetic grafts, and approximation of soft tissues. These are all in vivo (within a living organism) applications.
- Device Description: The description focuses on the mechanical function of applying a clip to soft tissues.
- 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 samples) to provide information for diagnosis, monitoring, or screening.
IVD devices are used to perform tests outside of the body on biological samples. This device is clearly designed for use inside the body during surgical procedures.
N/A
Intended Use / Indications for Use
The AUTO SUTURE* Modified VCS* Clip ** Applier is available in multiple sizes and has application in the closure of arteriotomies and venotomies and sizes and bas application in cacular prosthesis, the creation of everting the actacument of Syleacer values provential tubular structures, and for the approximation of prosthetic grafts and dural tissue.
Product codes
FZP, HBT
Device Description
The AUTO SUTURE* Modified VCS* Clip** device is identical in safety and effectiveness to its currently marketed predicate - U.S. Surgical Corp.'s Vascular Anastomosis Clip** applier - 510(k) #K933887. This clip applier has been marketed for the closure of arteriotomics and venotomies, the attachment of synthetic vascular prosthesis, and the creation of everting anastomoses in blood vessels and other small tubular structures. The performance evaluation of this clip applier by USSC's PreQuality Assurance Laboratory and an independently contracted research laboratory have determined that the clip has additional utility for the approximation of soft tissues such. The information included in this notification demonstrates that the device is substantially equivalent to its predicate in respect to design, function, performance, labeling and sterilization.
- . Both the subject and predicate devices are designed to apply a single titanium clip to soft tissues.
- Both the subject and predicate device share indications. In addition, the ● subject device is additionally indicated for the approximation of soft tissues outside of the vascular arena.
- Both the subject devices and other currently marketed United States Surgical ● Corporation devices are manufactured in the same facilities, using similar processes . and controls.
- Both the subject devices and other currently marketed United States Surgical Corporation devices are packaged in the same facilities using similar processes and controls.
- . Both the subject and predicate devices perform the exact same function in the same way.
- Both the subject and predicate devices are manufactured from the exact same bioapproved materials
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
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
§ 878.4300 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
United States Surgical Corporation 510(k) Premarket Notification AUTO SUTURE* Modified VCS* Clip** Applier
SED 2 3 1996
SUMMARY OF INFORMATION SUPPORTING X 962043 SAFETY AND EFFECTIVENESS:
The AUTO SUTURE* Modified VCS* Clip** device is identical in safety and effectiveness to its currently marketed predicate - U.S. Surgical Corp.'s Vascular Anastomosis Clip** applier - 510(k) #K933887. This clip applier has been marketed for the closure of arteriotomics and venotomies, the attachment of synthetic vascular prosthesis, and the creation of everting anastomoses in blood vessels and other small tubular structures. The performance evaluation of this clip applier by USSC's PreQuality Assurance Laboratory and an independently contracted research laboratory have determined that the clip has additional utility for the approximation of soft tissues such. The information included in this notification demonstrates that the device is substantially equivalent to its predicate in respect to design, function, performance, labeling and sterilization.
- . Both the subject and predicate devices are designed to apply a single titanium clip to soft tissues.
- Both the subject and predicate device share indications. In addition, the ● subject device is additionally indicated for the approximation of soft tissues outside of the vascular arena.
- Both the subject devices and other currently marketed United States Surgical ● Corporation devices are manufactured in the same facilities, using similar processes . and controls.
- Both the subject devices and other currently marketed United States Surgical Corporation devices are packaged in the same facilities using similar processes and controls.
- . Both the subject and predicate devices perform the exact same function in the same way.
- Both the subject and predicate devices are manufactured from the exact same bioapproved materials
.
1
DEPARTMENT OF HEALTH & HUMAN SERVICES
Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
DEPARTMENT OF HEALTH & HUMAN SERVICES-USA
SEP 2 3 1998
Mr. Victor Clavelli Mr. Victor Regulatory Affairs Associate, Regulatory Mredded 150 Glover Avenue ୦୧୫୧୧ Norwalk, Connecticut
Auto Suture™ Modified VCS™ Clip™ Applier K962043 Re : Trade Name: Regulatory Class : II FZP and HBT Product Code: August 13, 1996 Dated: August 14, 1996 Received:
Dear Mr. Clavelli:
Deal Mr. Saat on Section 510 (k) notification of intent to We have reviewed your Section 510 (K) notification on the decident to the market the formers of market the device referenced above and we nations for device is substantially equivalent (for the enacteers).
use stated in the enclosure) to devices marketed in finers commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have the have the mayer the may Medical Device Amendments, or to devices cince new commender the Rederal, Food, Drug, and Cosmetic Act (Act). You may therefore, Food, Drug, and Cosmetic Act (Act). Controls general controls provisions
market the device, subject to the general controls provisions
market for a The general controls provi The general controls provisions of the Act
The general controls provisions of the Act include requirements for annual registration, listing of
include requirements for annual registration, listing of include requirements for annual regaractice, labeling, and devices, good manufacturing practice, but the beginn
If your device is classified (see above) into either class II If your device is classified (see above) it may a (Special Controls) or class III (Premarkos controls. Existing major
be subject to such additional controls. Existing major (Special Sections affecting your device can be found in the Code of regulations affecting, Title 21, Parts 800 to 895.
Federal Regulations, Title 21, Parts 800 to 895. substantially equivalent determination assumes conliance with
substantially equivalent determination assumes consisted on rederal Negly equivalent determination assimes Gevices: Gevices: Gevices: Gevices: Gevices: Gevices: Gericeral subscribed Manufacturing Practice for Medical Development.
(GMP) regulation (21 CFR Part 820) and that , through will (GMP) regulation (21 CPR Part 820) and Chack , Chros Juda Marker , Che MP
GMP inspections , the Food and Drug Administration , RD and Drug Aumomply with the GMP GMP inspections. verify such in i In addition, FDA verify such assumpt.ons . Farlate or action.
regulation may result in regulatory action. vertly have result in regulatory accrion. Threaded on the intentional of the in
may publish further announcements concerning your device in Please note: this response to your the Federal Register . premarket not ification submission does not affective any cremarkeon you might have under sections 531 through 542 of obligation you might have under the Electronic Product Radiation
the Act for devices under the Electronic Product Radiations. Che Act for devices under the Electronic Frederal laws or regulations
2
Page 2 - Mr. Victor Clavelli
This letter will allow you to begin marketing your device as the FDA This letter will allow you co begin mailtoung of the FDA.
described in your 510(k) premarket notification. The described in your 510(K) bremarker nocrricassem.
finding of substantial equivalence of your device to a Legally marketed predicate device results in a classification for your marketed predicate device results in a craosisco. In a crail.
device and thus, permits your device to proceed to the market.
If you desire specific advice for your device on our labeling
and and and and Box 801 and additionally 809.10 for in If you desire specific advice for your and additionally 809.10 for in
regulation (21 CFR Part 801 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of yitro diagnostic devices), please contact the original on
Compliance at (301) 594-4595. Additionally, for questions on
tact (301) 594-4593 odyoxtising of your device, please Compliance at (301) 594-4595. Additionariy, 1994-999.
the promotion and advertising of your device, please no the office of Compliance at (301) 594-4639. Also, please note
the Office of Compliance at (301) 594-4639. planes and the Office of Compliance at (50%) ding by reference to Other general the regulation encification" (21 CFR 807.97). premarket notification" (2) CFR 807.977. Cothe Act may be information on your responsibilities and or acturers Assistance
obtained from the Division of Small Manufacturers Assistance obtained from the Division of Smarl Manufacoursed on 1988
at its toll-free number (800) 638-2041 or at (301) 443-6597.
Sincerely yours.
-Mark n Milham
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
Page | of |
5 1 O(k) Number (if known): K962043
Device Name: Modified VCS* Clip** Applier
Indications For Use:
ﮯ۔
The AUTO SUTURE* Modified VCS* Clip ** Applier is available in multiple sizes and has application in the closure of arteriotomies and venotomies and sizes and bas application in cacular prosthesis, the creation of everting the actacument of Syleacer values provential tubular structures, and for the approximation of prosthetic grafts and dural tissue.
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Mark n Milkus
| (Division Sign-Off) | |
|---|---|
| Division of General Restorative Devices | |
| 510(k) Number | K962043 |
| Prescription Use (Per 21 CFR 801.109) | X | OR | Over-The-Counter Use (Optional Format 1-2-96) |
|---|---|---|---|
| --------------------------------------- | --- | ---- | ----------------------------------------------- |