(257 days)
No
The device description and performance studies focus on mechanical ligation and comparison to a predicate device without mentioning any AI/ML components or functionalities.
No
This device is used for ligation during surgical procedures and does not directly provide therapy or treatment for a disease.
No
This device is used for ligation of vessels during surgical procedures, which is a therapeutic function, not a diagnostic one. It does not identify or analyze a condition or disease.
No
The device description clearly outlines physical components like a nylon cannula, braided polyester suture, paper envelope, and pouch, indicating it is a hardware device.
Based on the provided information, the Sorin VascuLoop is not an IVD (In Vitro Diagnostic) device.
Here's why:
- Intended Use: The intended use is for "proximal and distal ligation of vessels during endoscopic vessel harvesting procedures." This describes a surgical procedure performed on a patient's body, not a test performed on a sample taken from a patient's body.
- Device Description: The device is a physical tool (cannula and suture) used to tie off blood vessels during surgery. It does not involve analyzing biological samples.
- Lack of IVD Characteristics: The description does not mention any of the typical characteristics of an IVD, such as:
- Analyzing biological samples (blood, urine, tissue, etc.)
- Detecting or measuring substances in samples
- Providing information for diagnosis, monitoring, or screening of diseases or conditions
The Sorin VascuLoop is a surgical device used for a specific procedural step during surgery.
N/A
Intended Use / Indications for Use
The Sorin VascuLoop is used for proximal and distal ligation of vessels during endoscopic vessel harvesting procedures.
Product codes
GAT, GCJ
Device Description
The VascuLoop Two Tie Endoscopic Ligation System is used during endoscopic vessel harvesting to ligate both ends of the vessel being harvested at the sites where it is to be cut. The cannula allows the ligation loops to be placed and tightened from a single central incision.
The product consists of a nylon cannula, tapered at both ends, with a braided polyester suture (B. Braun/Aesculap PremiCron®, 510(k) cleared by K012201) that has a closable loop tied in one end with the free end through the cannula.
This assembly is packaged in a paper envelope and sealed in a Tyvek - poly coextrusion pouch with appropriate labeling. The product will be sterilized using Ethylene Oxide gas.
The Sorin VascuLoop product will be assembled, packaged, and sterilized by B. Braun Medical Inc. The instructions for use for both the VascuLoop and the PremiCron® suture are included in the packaged product.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
vessels
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)
Functional performance testing conducted with the proposed device, simulated use cadaver study, and the similarities between the Sorin VascuLoop and Ethicon Inc.'s Pre-tied suture cannula (EndoLoop") in design, materials, and intended use demonstrate that the VascuLoop with PremiCron® Braided Polyester Suture is as safe and effective as the predicate device and can be considered substantially equivalent.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 878.5000 Nonabsorbable poly(ethylene terephthalate) surgical suture.
(a)
Identification. Nonabsorbable poly(ethylene terephthalate) surgical suture is a multifilament, nonabsorbable, sterile, flexible thread prepared from fibers of high molecular weight, long-chain, linear polyesters having recurrent aromatic rings as an integral component and is indicated for use in soft tissue approximation. The poly(ethylene terephthalate) surgical suture meets U.S.P. requirements as described in the U.S.P. Monograph for Nonabsorbable Surgical Sutures; it may be provided uncoated or coated; and it may be undyed or dyed with an appropriate FDA listed color additive. Also, the suture may be provided with or without a standard needle attached.(b)
Classification. Class II (special controls). The special control for this device is FDA's “Class II Special Controls Guidance Document: Surgical Sutures; Guidance for Industry and FDA.” See § 878.1(e) for the availability of this guidance document.
0
K122735 page 1 of 2
VascuLoop Two Tie Endoscopic Ligation System Sorin Group USA, Inc.
Traditional 510(k)
510(k) SUMMARY
DATE:
November 13, 2012
SUBMITTER:
Sorin Group USA. Inc. 14401 West 6510 Way Arvada, Colorado 80004-3599 Device Establishment Registration Number: 1718850
- CONTACT PERSON: Scott Light (303) 467-6313 Phone: Fax: (303) 467-6502 scott.light@sorin.com E-mail:
DEVICE Suture component: Class II per 21 CFR §878.5000, CLASSIFICATION: Product Code: GAT
Cannula component: Class II, per 21 CFR §876.1500, Product Code: GCJ
- PREDICATE DEVICES: Pre-tied loop suture cannula, Ethicon Inc., K925914, Class II, GCJ, 21 CFR §876.1500
CONTRACT B. Braun Medical Inc. Allentown, PA 18109-9341 MANUFACTURER: (610) 266-0500 Device Establishment Registration Number: 2523676
DEVICE DESCRIPTION:
The VascuLoop Two Tie Endoscopic Ligation System is used during endoscopic vessel harvesting to ligate both ends of the vessel being harvested at the sites where it is to be The cannula allows the ligation loops to be placed and tightened from a single cut. central incision.
The product consists of a nylon cannula, tapered at both ends, with a braided polyester suture (B. Braun/Aesculap PremiCron®, 510(k) cleared by K012201) that has a closable loop tied in one end with the free end through the cannula.
This assembly is packaged in a paper envelope and sealed in a Tyvek - polv coextrusion pouch with appropriate labeling. The product will be sterilized using Ethylene Oxide gas.
MAY 2-1-2013
1
Traditional 510(k)
The Sorin VascuLoop product will be assembled, packaged, and sterilized by B. Braun Medical Inc. The instructions for use for both the VascuLoop and the PremiCron® suture are included in the packaged product.
INTENDED USE:
The VascuLoop is used for proximal and distal ligation of vessels during endoscopic vessel harvesting procedures.
SUBSTANTIAL EQUIVALENCE:
Ethicon Inc.'s Pre-tied loop suture cannula, FDA cleared by K925914, is the predicate device used for substantial equivalence comparison. The Ethicon product brand
chosen for this comparison was the Ethicon EndoLoop" with Ethibond" Excel suture. The Sorin VascuLoop has the same intended use as Ethicon's EndoLoop
Both the Sorin and Ethicon devices provide:
- A size 0 polyester suture with a pre-tied Duncan loop to perform the intended . vessel ligation action
- A nylon cannula with tapered ends to use for loop placement and closure .
- The same recommendations for the user-tied loop for in-situ vessel ligation. .
The only differences between the proposed and predicate devices include a different suture used (PremiCron®), a different packaging configuration for the finished device, and a different manufacturer assembling, packaging, and sterilizing the device.
CONCLUSION:
Functional performance testing conducted with the proposed device, simulated use cadaver study, and the similarities between the Sorin VascuLoop and Ethicon Inc.'s Pre-tied suture cannula (EndoLoop") in design, materials, and intended use demonstrate that the VascuLoop with PremiCron® Braided Polyester Suture is as safe and effective as the predicate device and can be considered substantially equivalent.
2
DEPARTMENT OF HEALTH & HUMAN SERVICES :
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-002
May 21, 2013
Sorin Group USA, Inc. % Mr. Scott Light Regulatory Affairs Manager 14401 West 65th Way Arvada, Colorado 80004-3599
Re: K122735
Trade/Device Name: VascuLoop Two Tie Endoscopic Ligation System Regulation Number: 21 CFR 878.5000 Regulation Name: Nonabsorbable poly(ethylene terephthalate) surgical suture Regulatory Class: Class II Product Code: GAT, GCJ Dated: May 15, 2013 Received: May 16, 2013
Dear Mr. Light:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate 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) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, 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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you; however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21
3
Page 2 - Mr. Scott Light
CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled. "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to
http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely yours, For
Peter D示取umm -S
Mark N. Melkerson Acting Director Division of Surgical Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
VascuLoop Two Tie Endoscopic Ligation System Sorin Group USA, Inc.
Traditional 510(k)
INDICATIONS FOR USE STATEMENT
| Page | 1 of 1 |
|---|---|
| ------ | -------- |
| 510(k) Number (if known): | K122735 |
|---|---|
| Device Name: | VascuLoop Two Tie Endoscopic Ligation System made with |
| PremiCron ® Braided Polyester Suture | |
| Indications For Use: | The Sorin VascuLoop is used for proximal and distal ligation of vessels during endoscopic vessel harvesting procedures. |
| Prescription Use | X OR Over-The-Counter Use |
(Per 21 CFR 801.109)
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE, IF NEEDED)
David Krause -S
(Division Sign-Off)
(Division Sign-Off) Division of Surgical Devices 510(k) Number: K122735
・ ·
・ ·