The TroClose1200™ bladeless trocar is intended for use in a variety of gynecologic, general and urologic endoscopic procedures to create and maintain a port of entry and to facilitate the delivery of absorbable sutures and anchors through soft tissues of the body during endoscopic/ laparoscopic surgery. The trocar may be used with or without visualization for primary and secondary insertions.

Device Description

The TroClose1200™ is a Trocar system comprised of an Obturator and a Cannula including preloaded sutures. It includes a bladeless Obturator, designed to allow penetration and positioning at the required site within the abdomen, and several single use Cannulas, which serve as working channels for the procedure. The Cannulas are pre-loaded with two absorbable PGLA sutures, each attached to an absorbable PLGA anchor. The deployment of the anchors and sutures ("closure device) is achieved by utilizing two pushers within the Obturator as a deployment mechanism.

The TroClose1200™, as one unit, consists of the following components:

. An Obturator, which is the part of a trocar that allows the insertion of the trocar (after routine scalpel-made incision). An Obturator is for single patient use. For this purpose, the Company's Obturator is bladeless, similar to the predicate Obturator. In addition, the Company's Obturator has a set of 2 pushers that deploy (the closure device's deployment mechanism) the anchors with sutures attached from the Cannula for later closure.
A Cannula, which is the part of a trocar that establishes the working channel through which the surgeon introduces surgical tools while keeping the CO2 in the abdominal lumen. The Cannula is for single use and is similar to the predicate trocar Cannula. In addition, the Company's Cannula has 2 absorbable anchors attached to absorbable threads, at 180° to each other, as the closure device, which is similar to the predicate closure device. The thread (suture) is made of absorbable PGLA and the anchors are made of absorbable PLGA and is designed to close the access port by suturing the abdominal wall's fascia.

GORDIAN 's TroClose1200™ is manufactured from routinely used medical device biocompatible materials.

Like its' predicates, this disposable device is provided sterile (by EtO) and intended for single patient (Obturator) and single use (Cannula) only.

AI/ML Overview

The document describes the TroClose1200™ Trocar System, a medical device intended for use in gynecologic, general, and urologic endoscopic/laparoscopic procedures to create and maintain a port of entry and facilitate the delivery of absorbable sutures and anchors. The document focuses on demonstrating the device's substantial equivalence to predicate devices, rather than establishing acceptance criteria or reporting performance metrics for classification as a diagnostic AI/ML device.

Therefore, the specific information requested about acceptance criteria, performance metrics, sample sizes for test/training sets, data provenance, ground truth establishment, expert adjudication, and comparative effectiveness studies (MRMC) for an AI/ML diagnostic device is largely not applicable to this document. The provided text describes a physical surgical device and its safety/performance testing for FDA clearance as "substantially equivalent" to existing predicate devices under 510(k).

Here's an analysis based on the available information, noting the missing elements due to the nature of the device:

1. Table of Acceptance Criteria and the Reported Device Performance:

The document does not explicitly state "acceptance criteria" in the format of a diagnostic performance target (e.g., sensitivity, specificity). Instead, it lists performance tests conducted to demonstrate the device meets its intended use and is comparable to predicate devices. The "reported device performance" is generally stated as "successfully achieving its intended use" or "comparable to the two functions provided by separate devices."

Test Category	Name of Test	Acceptance Criteria (Implicit)	Reported Device Performance
Sterilization & Shelf life	Shelf life testing (packaging sealing after shelf life)	Maintain sterility and package integrity over shelf life.	Successfully demonstrated.
	Sterilization validation including EtO residues (per ISO 11135)	Meet ISO 11135 standards for sterilization and residual EtO levels.	Successfully demonstrated.
	Packaging validation at time "0" (Per ISO 11607)	Meet ISO 11607 standards for packaging integrity.	Successfully demonstrated.
	Functionality Test	Device functions as intended.	Successfully demonstrated.
Bench study	Obturator and Cannula detachment force	Maintain appropriate forces for intended function. (Specific values not provided)	Successfully demonstrated.
	Instrument Drag Forces into and from the Cannula	Allow instruments to pass through with acceptable drag. (Specific values not provided)	Successfully demonstrated.
	Device marking durability	Markings remain legible.	Successfully demonstrated.
	Micro-laser welding Process Qualification	Welding meets specified quality standards.	Successfully demonstrated.
	Trocar Seal System Durability, demonstrated by Air Leak Performance	Maintain air seal integrity.	Successfully demonstrated.
Tests per USP for absorbable sutures	Knot pull tensile strength (test method as described in USP<881>)	Meet USP requirements for knot pull tensile strength. (Specific value provided: minimum and average 38.2N)	Achieved a minimum and average 38.2N.
	Needle attachment tensile strength (per USP<871> with the test method described in USP<881>)	Meet USP requirements for needle attachment tensile strength. (Specific value not provided)	Successfully demonstrated.
	Diameter (test method as described in USP<861>)	Meet USP requirements for suture diameter. (Specific value not provided)	Successfully demonstrated.
	Length (USP absorbable suture monograph)	Meet USP requirements for suture length. (Specific value not provided)	Successfully demonstrated.
	Degradation (per ASTM F1635-11)	Meet ASTM F1635-11 degradation profile.	Successfully demonstrated.
Anchors Strength	Degradation profile (per ASTM F1635-11)	Meet ASTM F1635-11 degradation profile.	Successfully demonstrated.
	Creep test	Resist deformation under sustained load. (Specific values not provided)	Successfully demonstrated.
	Cyclic test	Resist failure under repeated loading. (Specific values not provided)	Successfully demonstrated.
Biocompatibility	Cytotoxicity, Irritation, Sensitization, Acute systemic toxicity, Pyrogenicity	Meet ISO 10993 standards and blue book memorandum #G95-1 for biocompatibility. (All performed by NAMSA).	All tests successful.
	Sub-chronic toxicity, Genotoxicity, Implantation, Chronic toxicity, Carcinogenicity	Meet ISO 10993 and FDA Draft guidance rationale. (Some rationale based on predicate/suture manufacturer data).	Successful demonstration via rationale and/or testing.
	In-vitro Hemolysis Study (for sutures)	Meet acceptance criteria for hemolysis. (Performed by NAMSA).	Successful.
GLP Animal Studies	Acute GLP animal study	Device performs comparably to predicate devices and hand suturing in acute animal model.	Successful: Demonstrated substantial equivalence.
	Sub-Chronic GLP animal study	Closure device performs comparably to predicate closure device in sub-chronic animal model.	Successful: Demonstrated substantial equivalence.
Usability testing	Perform procedure after reading IFU, Device functionality, Device ease of use	Users can successfully and easily operate the device according to instructions, and the device functions as intended. (Subjective assessment)	Successful: Demonstrated intended use and ease of use.

2. Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective):

Test Set Sample Size: Not explicitly stated for each individual test. The document refers to "Performance data" and lists various tests, but doesn't quantify the number of devices or animals used for each.
Data Provenance: The document mentions "GLP animal studies," implying professional, controlled studies. It does not specify the country of origin for the studies, but the company is located in Israel. The studies are prospective in nature as they involve testing the device.

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

This is not applicable as the document describes a physical surgical device, not an AI/ML diagnostic system requiring expert-established ground truth on a dataset. The tests are primarily engineering, mechanical, material, and biological evaluations.

4. Adjudication method (e.g., 2+1, 3+1, none) for the test set:

This is not applicable for the reasons stated above. Adjudication methods are typically for subjective assessments of diagnostic output, which is not the case here.

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:

This is not applicable as the document describes a physical surgical device, not an AI-assisted diagnostic tool.

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

This is not applicable as the document describes a physical surgical device, not an AI algorithm.

7. The type of ground truth used (expert concensus, pathology, outcomes data, etc.):

For the animal studies, the "ground truth" would be physiological and histological observations of the tissue response, healing, and device functionality in vivo, as well as comparison to the performance of predicate devices and hand suturing. For the bench tests, the "ground truth" is established by adherence to recognized standards (e.g., USP, ASTM, ISO) and comparison to the specifications of predicate devices.

8. The sample size for the training set:

This is not applicable as the document describes a physical surgical device, not an AI/ML system that requires a training set.

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

This is not applicable for the reasons stated above.

Summary

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Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

November 17, 2016

Gordian Surgical Ltd. % Dr. Susan Alpert Regulatory Consultant and U.S. Agent 200 Park Avenue, Unit 111 Minneapolis, Minnesota 55415

Re: K160564

Trade/Device Name: TroClose1200™ Trocar System Regulation Number: 21 CFR 878.4493 Regulation Name: Absorbable Poly(Glycolide/L-Lactide) Surgical Suture Regulatory Class: Class II Product Code: GAM, GCJ Dated: October 10, 2016 Received: October 17, 2016

Dear Dr. Alpert:

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 CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical devicerelated adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

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If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education 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. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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 Industry and Consumer Education 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,

Jennifer R. Stevenson -A

For Binita S. Ashar, M.D., M.B.A., F.A.C.S. Director Division of Surgical Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known) K160564

Device Name TroClose1200TM

Indications for Use (Describe)

The trocar may be used with or without visualization for primary and secondary insertions.

Type of Use (Select one or both, as applicable)
✓ Prescription Use (Part 21 CFR 801 Subpart D)	Over-The-Counter Use (21 CFR 801 Subpart C)

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510(k) SUMMARY

(As required by 21 C.F.R. § 807.92)

TroClose1200™

Company:

GORDIAN SURGICAL Ltd. Misgav Industrial Park P.O.Box 499 Karmiel 2161401, ISRAEL. Fax: + 972 72 260 7200

Contact Person:

Dr. Susan Alpert, M.D. Mobile: 612 202 7019 E-MAIL: drsusanalpert@gmail.com

Date Prepared: October 10, 2016

Trade Name:	TroClose1200™
Common Name:	Trocar with Closure Device
Classification Name:	Absorbable poly(glycolide/l-lactide) surgical suture
Regulation Number:	21 CFR §878.4493
Product Code:	GAM (absorbable PGLA suture) , GCJ (Endoscope and accessories)

Predicate Devices

Primary Predicate Device- Closure Device- neoClose® (K123280) (21 CFR §876.1500, product code GCJ)

Secondary Predicate Device- Trocar- Versaport™ V2 Bladeless Trocar (K130435) (21 CFR §876.1500, product code GCJ).

Intended Use / Indications for Use

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Device Description

The TroClose1200™, as one unit, consists of the following components:

. An Obturator, which is the part of a trocar that allows the insertion of the trocar (after routine scalpel-made incision). An Obturator is for single patient use. For this purpose, the Company's Obturator is bladeless, similar to the predicate Obturator. In addition, the Company's Obturator has a set of 2 pushers that deploy (the closure device's deployment mechanism) the anchors with sutures attached from the Cannula for later closure.
A Cannula, which is the part of a trocar that establishes the working channel through which the surgeon introduces surgical tools while keeping the CO2 in the abdominal lumen. The Cannula is for single use and is similar to the predicate trocar Cannula. In addition, the Company's Cannula has 2 absorbable anchors attached to absorbable threads, at 180° to each other, as the closure device, which is similar to the predicate closure device. The thread (suture) is made of absorbable PGLA and the anchors are made of absorbable PLGA and is designed to close the access port by suturing the abdominal wall's fascia.

GORDIAN 's TroClose1200™ is manufactured from routinely used medical device biocompatible materials.

Like its' predicates, this disposable device is provided sterile (by EtO) and intended for single patient (Obturator) and single use (Cannula) only.

Technological Characteristics/ Principals of Operation

Gordian's Single Patient Use / Single Use TroClose1200™ has similar technological characteristics, and use the same principles of operation as the predicates. The only technological differences between the TroClose1200™ and its predicates are: (1) the Trocar predicate has a marketing feature for optics (2) the trocar predicate has a greater variety of sizes, (3) the closure device predicate's anchor is narrower and longer than the TroClose1200™ anchor and has a slightly different configuration design (4) the deployment timing of the anchors in the TroClose1200™ is at the beginning of the laparoscopic procedure as the TroClose1200™ has both the closure device and trocar in the same device while the predicate closure device deployment is at the end of the procedure, (5) the TroClose1200™ operation has two additional

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steps consisting of pulling and pushing an applicator for coking and deployment of the anchors and sutures, (6) the trocar predicate device has an additional indication of "thoracic", and (7) the TroClose1200™ uses more common PGLA sutures presenting knot-pull tensile strength with a minimum and average of 38.2N, while the neoClose® uses PGA sutures presenting knot-pull tensile strength with a minimum and average of 26.3N.

Performance Data

As for the predicate devices, both under 21 CFR 876.1500 and product code GCJ, no applicable performance standards have been promulgated under Section 514 of the Food, Drug and Cosmetic Act for the device and similar devices regulated under this regulatory number and product code.

For the TroClose1200™ regulation and product code (21 CFR878.4493 and product code GAM) performance tests were done also according to SUTURE and included mechanical tests and degradation testing according to ASTM F1635-11, knot-pull tensile strength (per absorbable sutures USP monograph instructions), needle attachment strength (per absorbable sutures USP monograph instructions), biocompatibility testing according to ISO 10993, sterilization according to ISO 11135, and a GLP animal studies. These tests demonstrated that the TroClose1200™ is substantially equivalent to its predicates, by successfully achieving its intended use, which is the same as the predicates.

No.	Category	Name of test
1.	Sterilization & Shelf life	Shelf life testing (packaging sealing after shelf life)
2.	including packaging,functionality and moisturelevel testing	Sterilization validation including EtO residues (per ISO 11135)
3.		Packaging validation at time "0" (Per ISO 11607)
4.		Functionality Test
5.	Bench study	Mechanical testing Obturator and Cannula detachment force Instrument Drag Forces into and from the Cannula Device marking durability Micro-laser welding Process Qualification Trocar Seal System Durability, demonstrated by Air Leak Performance
6.	Tests per USP forabsorbable sutures	Knot pull tensile strength (test method as described in USP<881>) Needle attachment tensile strength (per USP<871> with the test method described in USP<881>)) Diameter (test method as described in USP<861>) Length (USP absorbable suture monograph) Degradation (per ASTM F1635-11)
No.	Category	Name of test
7.	Anchors Strength	○ Degradation profile (per ASTM F1635-11)○ Creep test○ Cyclic test
8.	Biocompatibility (per ISO10993 and Blue BookMemorandum #G95-1) forthe entire final productincluding sutures andanchors unless otherwiseindicated	○ Cytotoxicity (performed by NAMSA)○ Irritation (performed by NAMSA)○ Sensitization (performed by NAMSA)○ Acute systemic toxicity (performed by NAMSA)○ Pyrogenicity (performed by NAMSA)○ Sub-chronic toxicity for sutures and anchors (viarationale allowed by ISO 10993-1 and FDA Draftguidance "Use of International Standard ISO -10993-1 "Biological Evaluation of Medical DevicesPart 1- Evaluation and testing" issued on 23 Apr2013).○ Genotoxicity for anchors (via rationale allowed byISO 10993-1 and FDA Draft guidance "Use ofInternational Standard ISO -10993-1 "BiologicalEvaluation of Medical Devices Part 1- Evaluationand testing" issued on 23 Apr 2013) and as testperformed by NAMSA (by the suture manufacturer)for the sutures.○ Implantation for anchors (via rationale allowed byISO 10993-1 and FDA Draft guidance "Use ofInternational Standard ISO -10993-1 "BiologicalEvaluation of Medical Devices Part 1- Evaluationand testing" issued on 23 Apr 2013) and as testperformed by NAMSA (by the suture manufacturer)for the sutures.○ Chronic toxicity for sutures and anchors (viarationale allowed by ISO 10993-1 and FDA Draftguidance "Use of International Standard ISO -10993-1 "Biological Evaluation of Medical DevicesPart 1- Evaluation and testing" issued on 23 Apr2013).
		○ Carcinogenicity for sutures and anchors (viarationale allowed by ISO 10993-1 and FDA Draftguidance "Use of International Standard ISO -10993-1 "Biological Evaluation of Medical DevicesPart 1- Evaluation and testing" issued on 23 Apr2013).
		○ In-vitro Hemolysis Study for the sutures as testperformed by NAMSA (by the suture manufacturer).
No.	Category	Name of test
9.	GLP Acute and sub-chronic animal studies	Acute GLP animal study testing TroClose1200™, neoClose®, Versaport™ V2 trocar and hand suturing. Sub-Chronic GLP animal study testing TroClose1200™ closure device vs. neoClose® closure devices used with Versaport™ V2 trocar.
10.	Usability testing	Perform procedure after reading the IFU Device functionality Device ease of use

The following table summarizes the non-clinical testing performed for the TroClose1200™ .

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Performance testing demonstrated that the functionality of the combined device to act as trocar and closure device is comparable to the two functions provided by separate devices.

Substantial Equivalence

Gordian's TroClose1200™ has the same intended use with minor modifications (excluding thoracic use) and similar technological characteristics as its predicate devices. Both the TroClose1200™ and the predicate Obturators are bladeless and provide an airtight cannula as a working channel. They are made of similar commonly used materials. Both the TroClose1200™ and predicate closure devices use anchors with sutures, and are made from similar bioabsorbable materials.

The TroClose1200™ principles of operation are the same as other trocars for the trocar function, and the same principle of operation as other cleared devices for the closure device function. The trocar has similar sizes and dimensions as other trocars, and uses the same approach to establish the port of entry. The closure device uses the same principle of operation as the predicate device, deploying anchors with attached sutures into the port of entry, on both sides of the cannula.

Performance testing confirms that the minor differences in technological features compared to the predicates do not adversely impact performance. Thus, the TroClose1200™ is substantially equivalence to the predicates.

These minor differences do not present any new issues of safety or effectiveness as confirmed by the company's bench testing and the GLP acute and sub-chronic animal testing and usability testing. Thus, the TroClose1200™ is substantially equivalent to neoClose closure device by NeoSurgical Ltd., K123280 and to the Versaport™ V2 Bladeless Trocar by Covidien, K130435.

Regulation Number and Section

§ 878.4493 Absorbable poly(glycolide/l-lactide) surgical suture.

(a)
Identification. An absorbable poly(glycolide/l-lactide) surgical suture (PGL suture) is an absorbable sterile, flexible strand as prepared and synthesized from homopolymers of glycolide and copolymers made from 90 percent glycolide and 10 percent l-lactide, and is indicated for use in soft tissue approximation. A PGL suture meets United States Pharmacopeia (U.S.P.) requirements as described in the U.S.P. “Monograph for Absorbable Surgical Sutures;” it may be monofilament or multifilament (braided) in form; it may be uncoated or coated; and it may be undyed or dyed with an FDA-approved 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.