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 - polv coextrusion pouch with appropriate labeling. The product will be sterilized using Ethylene Oxide gas.

AI/ML Overview

The provided text describes a medical device, the VascuLoop Two Tie Endoscopic Ligation System, and its substantial equivalence to a predicate device. However, it does not contain information about formal acceptance criteria or a study designed to prove the device meets specific performance metrics in the way that would typically be seen for a diagnostic AI/ML device.

Instead, the document focuses on demonstrating substantial equivalence to a previously cleared predicate device, which is a common pathway for medical device approval in the US. This means the primary "acceptance criterion" is that the new device is as safe and effective as the predicate device. The evidence provided is largely comparative.

Therefore, many of the requested categories (sample size, expert qualifications, adjudication, MRMC study, standalone performance, training set details) are not applicable or not explicitly stated in this type of submission.

Here's a breakdown based on the provided text:

1. Table of acceptance criteria and the reported device performance

Acceptance Criteria	Reported Device Performance
Overall Goal: Demonstrate substantial equivalence to the predicate device, Ethicon Inc.'s Pre-tied loop suture cannula (K925914, Ethicon EndoLoop™ with Ethibond™ Excel suture).	Functional performance testing conducted with the proposed device, simulated use cadaver study, and similarities in design, materials, and intended use demonstrate that the VascuLoop with PremiCron® Braided Polyester Suture is as safe and effective as the predicate device.
Specific Design/Material Equivalence:
Suture Type	Sorin: PremiCron® Braided Polyester Suture (FDA cleared by K012201). Predicate: Ethibond™ Excel suture. Both are size 0 polyester sutures. (Difference noted but considered equivalent based on prior clearance of PremiCron®).
Cannula	Nylon cannula with tapered ends for loop placement and closure.
Ligation Mechanism	Pre-tied Duncan loop for vessel ligation, user-tied loop for in-situ ligation.
Intended Use	For proximal and distal ligation of vessels during endoscopic vessel harvesting procedures.
Packaging	Different packaging configuration.
Manufacturer	Different manufacturer (B. Braun Medical Inc.).

2. Sample size used for the test set and the data provenance

Test Set Sample Size: Not explicitly stated as a numerical sample size. The text mentions "functional performance testing" and a "simulated use cadaver study." It does not specify how many cadavers or how many ligations were performed.
Data Provenance: The "simulated use cadaver study" implies a prospective, controlled experimental setting, likely in a laboratory rather than a clinical setting. The country of origin is not specified, but given the US submission, it's presumed to be within a regulatory framework compatible with the FDA.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

This information is not provided. For this type of device (a surgical tool), "ground truth" would likely be established through objective measurements of ligation integrity, ease of use, and mechanical strength in the cadaver study, rather than through expert consensus on diagnostic interpretations. The evaluators of the cadaver study are not described.

4. Adjudication method for the test set

Not applicable/not provided. Adjudication methods (like 2+1 or 3+1) are typically used when there's subjective interpretation involved, such as in diagnostic imaging studies to establish ground truth for ambiguous cases. For a mechanical device performance study, objective measurements are usually the primary evidence.

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

No, an MRMC study was not done. This type of study is relevant for AI-powered diagnostic devices where human interpretation is assisted by the AI. The VascuLoop is a surgical tool, not a diagnostic AI.

6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done

Not applicable. This device is a physical surgical tool and does not involve an algorithm or AI. Its performance is always "human-in-the-loop," as a surgeon uses it.

7. The type of ground truth used

For the "functional performance testing" and "simulated use cadaver study," the ground truth would likely be based on:
- Objective Measurements: Such as tensile strength of the ligated vessel, integrity of the knot, ease of deployment, and absence of damage to surrounding tissue, compared to established benchmarks or the predicate device.
- Observational Data: From the cadaver study regarding the practical application and outcome of using the device.

8. The sample size for the training set

Not applicable. This device is a surgical tool, not an AI/ML algorithm that requires a training set.

9. How the ground truth for the training set was established

Not applicable. No training set for an algorithm is involved.

Summary

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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

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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.

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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

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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

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VascuLoop Two Tie Endoscopic Ligation System Sorin Group USA, Inc.

Traditional 510(k)

INDICATIONS FOR USE STATEMENT

Page	1 of 1
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510(k) Number (if known):	K122735
Device Name:	VascuLoop Two Tie Endoscopic Ligation System made withPremiCron ® 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

・ ·

Regulation Number and Section

§ 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.