The Anchora Su2ura® Approximation Device is a sterile single use device is indicated in endoscopic surgery for the placement of interrupted or running stitches in soft tissue. The device is a 5mm single-use endoscopic suturing device loaded with threaded anchors. It is designed to deploy up to 19 anchors by a trigger action of the handle of the delivery system. After deployment, each anchor is anchored within the tissue in which it was deployed. After deployment of 2 or more anchors, the suture that passes between the anchors can be tightened to pull the anchors toward each other and approximate the tissue. The delivery system consists of a plastic handle and a 36-cm stainless steel shaft. The handle includes a Trigger, a Knob, and a Toggle Button. A Cap can be added at the distal edge of the Shaft to advance extracorporeal suture knots. The anchors can be deployed in single-stitch or running- stitch configuration. The device deploys the anchors through a needle with an outer diameter of 2.1 mm, available in two lengths: 5 mm and 9 mm protrusion. The Anchor is advanced outside of the needle by a Pushrod. Each anchor, made of stainless steel, is threaded with an off-the-shelf UHMWPE suture manufactured by Teleflex Medical. The device provides the anchors already threaded on this suture. The device is sterile packaged and designed for single use only. The device is manufactured from medical grade materials (mainly plastics and stainless steels).

AI/ML Overview

The Su2ura Approximation Device is a sterile, single-use endoscopic suturing device with the following acceptance criteria and reported performances:

1. Acceptance Criteria and Device Performance

Characteristic	Acceptance Criteria	Reported Device Performance
Biocompatibility	Evaluate all patient contact materials in accordance with ISO 10993-1.	Biocompatibility assessments were performed in accordance with ISO 10933-1. Testing included extractable and leachable studies (ISO 10993-18) and a toxicological risk assessment (ISO 10993-17). Implied that the device met the criteria.
Human Factors	Verify the usability of the device with representative users. Training provided and Instructions for Use (IFU) must be clear and accurate.	A Human Factors Engineering (HFE) Study was performed with 18 representative users, evaluating the usability of all tasks. The study confirmed device usability and demonstrated that the training and IFU were clear and accurate. Implied that the device met the criteria.
Pre-Clinical Safety & Performance	Assess safety and performance under GLP conditions, in compliance with ISO 10993-6. Incision sites should be successfully closed, and long-term safety should be similar between test and control items.	An animal study (8 pigs) was performed under GLP conditions and in compliance with ISO 10993-6. 5 pigs for the test item and 3 for control. All incisions were successfully closed, and histopathological data indicated long-term safety was similar between Test and Control Items. Implied that the device met the criteria.
Mechanical Performance	Conform to USP requirements, applicable standards, product specifications (e.g., dimensional verification, component compatibility, tissue anchoring pull-out, corrosion, deployment reliability, suture pull-out strength, tensile strength).	Bench testing included dimensional verification, component compatibility, tissue anchoring pull-out, corrosion testing per ASTM F2129, deployment reliability, suture pull-out strength, and tensile strength per USP <881>. The results of all studies confirmed substantial equivalence between the subject and predicate designs, implying these criteria were met.
MRI Safety & Compatibility	Verified per ASTM F2052, ASTM F2213, ASTM F2182, and ASTM F2119.	MRI safety and compatibility was verified per the specified ASTM standards. The device was deemed MR Conditional. Implied that the device met the criteria.
Packaging Integrity	Confirmed by testing in accordance with ASTM F1929-15, ASTM DI69-16, and ASTM F1886/F1886M-16.	Packaging integrity was confirmed by testing in accordance with the specified ASTM standards. Implied that the device met the criteria.

2. Sample Size Used for the Test Set and Data Provenance

Biocompatibility: Not explicitly stated as a test set with a specific sample size of biological samples, but rather a set of material characterization studies (extractables and leachables) and toxicological risk assessments. The input does not provide information on the number of samples for these tests.
Human Factors: 18 representative users. The provenance of the users (e.g., country of origin, whether they were clinicians or laypersons, etc.) is not specified. The study appears to be prospective.
Pre-Clinical Performance (Animal Study): 8 pigs (5 for test items, 3 for control items). The provenance of the data is a GLP animal study. It is a prospective study.
Mechanical Performance, MRI Safety, Packaging Integrity: These involved various bench tests. The sample sizes for each specific test (e.g., number of devices tested for tensile strength or deployment reliability) are not explicitly stated in the provided text. The data provenance is from laboratory/bench testing.

3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications

Biocompatibility: No explicit external experts are mentioned for establishing ground truth. Compliance was based on ISO standards.
Human Factors: The "representative users" assessed usability. It's not stated whether these were "experts" in the sense of clinicians or if their feedback constituted a "ground truth" to be adjudicated. Their feedback was used to confirm usability.
Pre-Clinical Performance (Animal Study): Not explicitly stated how many experts were involved in evaluating the histopathological data, but it would typically involve veterinary pathologists. Their specific qualifications are not detailed.
Mechanical Performance, MRI Safety, Packaging Integrity: Ground truth for these studies relies on recognized ASTM and USP standards and internal engineering measurements. No external "experts" were mentioned for ground truth establishment beyond standard scientific and engineering practices.

4. Adjudication Method for the Test Set

The document does not specify any formal adjudication method (like 2+1 or 3+1) for the various studies conducted as part of the regulatory submission.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

No, a multi-reader multi-case (MRMC) comparative effectiveness study was not done. The device is a surgical tool, and its effectiveness is not assessed through human reader interpretation of images, but rather through direct use in surgery, performance in bench tests, and pre-clinical animal studies. Clinical testing was expressly stated as "not required to demonstrate substantial equivalence."

6. Standalone Performance Study

The studies described (bench testing, animal study, human factors) are essentially "standalone" in the sense that they evaluate the device itself. However, the term "standalone performance" often refers to the algorithm-only performance of AI devices without human-in-the-loop. This device is a mechanical surgical tool, not an AI or imaging diagnostic device, so this concept does not directly apply.

7. Type of Ground Truth Used

Biocompatibility: Compliance with ISO 10993 standards (e.g., acceptable levels of extractables/leachables, lack of toxicological risk).
Human Factors: User feedback and observed usability were used to confirm clarity of training and IFU, and the overall usability of the device. This is a form of self-reported or observed performance against predetermined usability goals.
Pre-Clinical Performance (Animal Study): Histopathological data (from tissue analysis) and clinical monitoring of animals provided the ground truth for safety and performance (e.g., successful closure, similar long-term safety profile to controls).
Mechanical Performance, MRI Safety, Packaging Integrity: These rely on objective measurements and adherence to established industry standards (ASTM, USP) and predefined product specifications.

8. Sample Size for the Training Set

This question is not applicable. The Su2ura® Approximation Device is a mechanical surgical device, not a machine learning or AI model, so there is no "training set" in the context of algorithm development.

9. How the Ground Truth for the Training Set Was Established

This question is not applicable, as there is no training set for this type of device.

Summary

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June 17, 2021

Anchora Medical, Ltd. % Esther Kott RA Consultant Duet-Medical Consulting Ltd. 10 HaAnafa Street POB536 Zur Moshe, 42810 Israel

Re: K201744

Trade/Device Name: Su2ura Approximation Device Regulation Number: 21 CFR 876.1500 Regulation Name: Endoscope And Accessories Regulatory Class: Class II Product Code: OCW Dated: June 25, 2020 Received: June 25, 2020

Dear Esther Kott:

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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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

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requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801 and Part 809); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

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 https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.

For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).

Sincerely,

Cindy Chowdhury, Ph.D., M.B.A. Assistant Director DHT4B: Division of Infection Control and Plastic Surgery Devices OHT4: Office of Surgical and Infection Control Devices Office of Product Evaluation and Ouality Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known) K201744

Device Name Su2ura® Approximation Device

Indications for Use (Describe)

The Su2ura® Approximation Device is indicated in endoscopic surgery for the placement of interrupted or running stitches in soft tissue.

Prescription Use (Part 21 CFR 801 Subpart D)

| Over-The-Counter Use (21 CFR 801 Subpart C)

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510(K) SUMMARY

K201744

Owner's Name & Address	Anchora Medical, Ltd.Leshem St., 1Industrial ParkCaesarea, 3088900IsraelPhone: +972-54-777-6615
Contact Person	Esther KottRegulatory ConsultantPhone: +972-58-488-7454Email: esther@ldp-consulting.com
Date	June 15, 2021
Trade Name	Su2ura® Approximation Device
Common / Classification Name	Endoscopic tissue approximation device
Product Code	OCW
Classification	21 CFR 876.1500
Predicate Device	K082659, Modified Endo Stitch
Device Description	The Anchora Su2ura® Approximation Device is a sterilesingle use device is indicated in endoscopic surgery for theplacement of interrupted or running stitches in soft tissue.The device is a 5mm single-use endoscopic suturing deviceloaded with threaded anchors. It is designed to deploy up to19 anchors by a trigger action of the handle of the deliverysystem. After deployment, each anchor is anchored withinthe tissue in which it was deployed. After deployment of 2 ormore anchors, the suture that passes between the anchorscan be tightened to pull the anchors toward each other andapproximate the tissue.The delivery system consists of a plastic handle and a 36-cmstainless steel shaft. The handle includes a Trigger, a Knob,and a Toggle Button. A Cap can be added at the distal edgeof the Shaft to advance extracorporeal suture knots.The anchors can be deployed in single-stitch or running-stitch configuration. The device deploys the anchors througha needle with an outer diameter of 2.1 mm, available in two

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lengths: 5 mm and 9 mm protrusion. The Anchor is advanced outside of the needle by a Pushrod. Each anchor, made of stainless steel, is threaded with an off-the-shelf UHMWPE suture manufactured by Teleflex Medical. The device provides the anchors already threaded on this suture.

The device is sterile packaged and designed for single use only. The device is manufactured from medical grade materials (mainly plastics and stainless steels).

The Su2ura® single-use suturing device is indicated in Indications for Use endoscopic surgery for the placement of interrupted or running stitches in soft tissue.

Technological Characteristics and Substantial Equivalence Comparison with the Predicate

Characteristic	Modified Endo Stitch[predicate device]	Su2ura ApproximationDevice [subject device]
510(k) number	K082659	K201744
Product Code	OCW	OCW
Intended Use/Indications forUse	The Modified Endo Stitch™ 10 mm single- use suturing devicehas application in endoscopic surgery for the placement of interrupted or running stitches in soft tissue.	The Su2ura® single-use suturing device is indicated in endoscopic surgery for the placement of interrupted or running stitches in soft tissue.
Number of uses	Single use only	Same
Use Environment	Operating room	Same
Intended user	Physicians having adequate training and familiarity with endoscopic techniques	Same
Working length	Working length: 38 cm	Similar (36 cm)
Shaft diameter	Outer diameter: 10 mm	Outer diameter: 5.4 mm
Port size	10mm	5mm
Delivery System constructionand materials	Plastic handle, stainless steel shaft and needle	Similar
Implant materials	4 sutures materials arecompatible with the EndoStitch:• Surgidac™ (0 and 2-0)• Polysorb™ (0,2-0,3-0 and 4-0)• Bralon™ (0 and 2-0)Sofsilk™ (0 and 2-0)	Suture:Force Fiber® PolyethyleneNon-Absorbable SurgicalSutures by Teleflex Medical,non-absorbable surgicalthread, USP 0, cleared underK172016, K150438, K100506,K070673, K063778, K040472and K033654Anchors:
		Stainless Steel 316 LVM, perASTM F138Each device consists of 19implants
Graduation on shaft	Yes - cm	Same
Handling	One-handed instrument,dominant or non-dominant	Same
Suture placement	The device holds and passes aneedled suture between its twojaws. The suture needle ispassed from one jaw toanother by squeezing theopposing handles andsecuring it in each jaw byactivating the toggle lever. Thedevice needs to approach thetwo sides of the tissue beingsutured.	The device pushes and passesan anchored suture throughthe needle by squeezing thehandle's trigger lever. Thedevice features a retractingshaft exposing a needle at itsdistal end. The device needsto approach one side of thetissue deploying a T anchor.
Suture location	The suture is placed throughand into the tissue.	Same
Suturing type	Interrupted stiches and runningstitches	Same
Knot tying type	Intracorporeal andextracorporeal square knots,surgeons' knot and a variety ofslip knots	Same
Needle	Curved stainless steel,exposed	Straight stainless steel, hidden
Stitch profile	O-shaped stitch	U-shaped stitch
Stitch/Anchor Depth	Up to 19mm	Up to 13 mm
Sterilization	Supplied sterile by EtO (SAL of10-6)	Same
Biocompatibility	All patient contact materialshave been evaluated inaccordance with ISO 10993-1	Same
Performance Data	In-vitro and in-vivo testing hasbeen performed in support ofthe intended use of this device	Same
	Bench testing included dimensional verification, componentcompatibility, tissue anchoring pull-out, corrosion testing perASTM F2129, deployment reliability, suture pull-out strength,and tensile strength per USP <881>.
	MRI Safety and CompatibilityMRI safety and compatibility was verified per ASTM F2052,ASTM F2213, ASTM F2182, and ASTM F2119. The devicewas deemed MR Conditional.
	Packaging IntegrityPackaging Integrity was confirmed by testing in accordancewith ASTM F1929-15, ASTM DI69-16 and ASTMF1886/F1886M-16.
	The results of all studies confirmed substantial equivalencebetween the subject and predicate designs.
Biocompatibility	Biocompatibility assessments were performed in accordancewith the appropriate risk category requirements, as definedin ISO 10933-1. Testing included extractable and leachablestudies in accordance with ISO 10993-18 and a toxicologicalrisk assessment in accordance with ISO 10993-17.
HFE Study	A Human Factors Engineering Study was performed to verifythe usability of the device. The study was performed with 18representative users, and evaluated the usability of all tasksneeded to use the device. The study confirmed deviceusability and demonstrated that the training provided to usersand the Instructions for Use of the device were clear andaccurate. These data support the safety and effectiveness ofthe Su2ura Approximation Device for its intended use.
Pre-Clinical Performance Data	An animal study was performed to assess the safety andperformance of the device, under GLP conditions and incompliance with ISO 10993-6. The study included 8 pigs,each subjected to a series a surgical incisions. Separateanimals were employed for the Test (N=5) and Control Items(N=3). All incisions were closed with the Test or ControlItems, and the animals were monitored clinically for 13 weeksbefore sacrifice. All incision sites were successfully closed byeither Test or Control Items, and histopathological dataindicated that long-term safety was similar between the Testand Control Items.
Clinical Performance Data	Clinical testing was not required to demonstrate substantialequivalence.
Substantial Equivalence	The Anchora Su2ura® has very similar indications for useand technological features to the predicate device. The minordifferences in technological characteristics do not raise newtypes of safety or effectiveness questions. Bench, animal anc
Conclusion	Based on the intended use, technological characteristicsperformance testing and comparison to the predicate devicethe subject device is substantially equivalent to the predicatedevice and raises no different questions of safety oeffectiveness.

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Non-Clinical Performance Data

Appropriate product testing was performed to evaluate conformance to USP requirements, applicable standards, product specifications, and equivalence to the predicate design. The device was evaluated against individual functional and reliability requirements.

Performance Testing

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Regulation Number and Section

§ 876.1500 Endoscope and accessories.

(a)
Identification. An endoscope and accessories is a device used to provide access, illumination, and allow observation or manipulation of body cavities, hollow organs, and canals. The device consists of various rigid or flexible instruments that are inserted into body spaces and may include an optical system for conveying an image to the user's eye and their accessories may assist in gaining access or increase the versatility and augment the capabilities of the devices. Examples of devices that are within this generic type of device include cleaning accessories for endoscopes, photographic accessories for endoscopes, nonpowered anoscopes, binolcular attachments for endoscopes, pocket battery boxes, flexible or rigid choledochoscopes, colonoscopes, diagnostic cystoscopes, cystourethroscopes, enteroscopes, esophagogastroduodenoscopes, rigid esophagoscopes, fiberoptic illuminators for endoscopes, incandescent endoscope lamps, biliary pancreatoscopes, proctoscopes, resectoscopes, nephroscopes, sigmoidoscopes, ureteroscopes, urethroscopes, endomagnetic retrievers, cytology brushes for endoscopes, and lubricating jelly for transurethral surgical instruments. This section does not apply to endoscopes that have specialized uses in other medical specialty areas and that are covered by classification regulations in other parts of the device classification regulations.(b)
Classification —(1)Class II (special controls). The device, when it is an endoscope disinfectant basin, which consists solely of a container that holds disinfectant and endoscopes and accessories; an endoscopic magnetic retriever intended for single use; sterile scissors for cystoscope intended for single use; a disposable, non-powered endoscopic grasping/cutting instrument intended for single use; a diagnostic incandescent light source; a fiberoptic photographic light source; a routine fiberoptic light source; an endoscopic sponge carrier; a xenon arc endoscope light source; an endoscope transformer; an LED light source; or a gastroenterology-urology endoscopic guidewire, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 876.9.(2) Class I for the photographic accessories for endoscope, miscellaneous bulb adapter for endoscope, binocular attachment for endoscope, eyepiece attachment for prescription lens, teaching attachment, inflation bulb, measuring device for panendoscope, photographic equipment for physiologic function monitor, special lens instrument for endoscope, smoke removal tube, rechargeable battery box, pocket battery box, bite block for endoscope, and cleaning brush for endoscope. The devices subject to this paragraph (b)(2) are exempt from the premarket notification procedures in subpart E of part 807of this chapter, subject to the limitations in § 876.9.