Su2ura Approximation Device

K201744 · Anchora Medical, Ltd. · OCW · Jun 17, 2021 · Gastroenterology, Urology

Device Facts

• Record ID: K201744
• Device Name: Su2ura Approximation Device
• Applicant: Anchora Medical, Ltd.
• Product Code: OCW · Gastroenterology, Urology
• Decision Date: Jun 17, 2021
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 876.1500
• Device Class: Class 2
• Attributes: Therapeutic

Indications for Use

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

Device Story

Su2ura is a 5mm single-use endoscopic suturing device; used in OR by trained physicians. Device features plastic handle, 36-cm stainless steel shaft, and trigger mechanism. Input: manual trigger activation by operator. Transformation: trigger action deploys up to 19 stainless steel anchors through a 2.1mm needle into soft tissue; suture passes between anchors. Output: anchored suture configuration in tissue. After deployment of 2+ anchors, suture is tightened to approximate tissue. Benefits: enables endoscopic tissue approximation via U-shaped stitch profile. Device is MR Conditional.

Clinical Evidence

No clinical data. Evidence includes bench testing (dimensional verification, component compatibility, tissue anchoring pull-out, corrosion per ASTM F2129, deployment reliability, suture pull-out/tensile strength), MRI safety (ASTM F2052, F2213, F2182, F2119), packaging integrity, biocompatibility (ISO 10993-1, -6, -17, -18), HFE study (18 users), and a GLP animal study (8 pigs, 13-week follow-up) demonstrating successful incision closure and histopathological safety.

Technological Characteristics

Single-use endoscopic suturing device. Materials: medical-grade plastics, stainless steel 316 LVM (ASTM F138) anchors, UHMWPE suture (Teleflex Medical). Dimensions: 36cm shaft, 5.4mm outer diameter. Sensing/Actuation: manual trigger-based mechanical deployment. Connectivity: none. Sterilization: EtO (SAL 10^-6). MR Conditional.

Indications for Use

Indicated for use in endoscopic surgery for the placement of interrupted or running stitches in soft tissue by physicians trained in endoscopic techniques.

Regulatory Classification

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.

Special Controls

*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.

Predicate Devices

• Modified Endo Stitch (K082659)

Submission Summary (Full Text)

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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 ([e-mail]) or phone [phone] 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.<br>Leshem St., 1<br>Industrial Park<br>Caesarea, 3088900<br>Israel<br>Phone: [phone] |
|------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Contact Person | Esther Kott<br>Regulatory Consultant<br>Phone: [phone]<br>Email: [e-mail] |
| 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 sterile<br>single use device is indicated in endoscopic surgery for the<br>placement of interrupted or running stitches in soft tissue.<br>The device is a 5mm single-use endoscopic suturing device<br>loaded with threaded anchors. It is designed to deploy up to<br>19 anchors by a trigger action of the handle of the delivery<br>system. After deployment, each anchor is anchored within<br>the tissue in which it was deployed. After deployment of 2 or<br>more anchors, the suture that passes between the anchors<br>can be tightened to pull the anchors toward each other and<br>approximate the tissue.<br>The delivery system consists of a plastic handle and a 36-cm<br>stainless steel shaft. The handle includes a Trigger, a Knob,<br>and a Toggle Button. A Cap can be added at the distal edge<br>of the Shaft to advance extracorporeal suture knots.<br>The anchors can be deployed in single-stitch or running-<br>stitch configuration. The device deploys the anchors through<br>a 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<br>[predicate device] | Su2ura Approximation<br>Device [subject device] |
|-----------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| 510(k) number | K082659 | K201744 |
| Product Code | OCW | OCW |
| Intended Use/Indications for<br>Use | The Modified Endo Stitch™ 10 mm single- use suturing device<br>has 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 construction<br>and materials | Plastic handle, stainless steel shaft and needle | Similar |
| Implant materials | 4 sutures materials are<br>compatible with the Endo<br>Stitch:<br>• Surgidac™ (0 and 2-0)<br>• Polysorb™ (0,2-0,3-0 and 4-0)<br>• Bralon™ (0 and 2-0)<br>Sofsilk™ (0 and 2-0) | Suture:<br>Force Fiber® Polyethylene<br>Non-Absorbable Surgical<br>Sutures by Teleflex Medical,<br>non-absorbable surgical<br>thread, USP 0, cleared under<br>K172016, K150438, K100506,<br>K070673, K063778, K040472<br>and K033654<br><br>Anchors: |
| | | Stainless Steel 316 LVM, per<br>ASTM F138<br>Each device consists of 19<br>implants |
| Graduation on shaft | Yes - cm | Same |
| Handling | One-handed instrument,<br>dominant or non-dominant | Same |
| Suture placement | The device holds and passes a<br>needled suture between its two<br>jaws. The suture needle is<br>passed from one jaw to<br>another by squeezing the<br>opposing handles and<br>securing it in each jaw by<br>activating the toggle lever. The<br>device needs to approach the<br>two sides of the tissue being<br>sutured. | The device pushes and passes<br>an anchored suture through<br>the needle by squeezing the<br>handle's trigger lever. The<br>device features a retracting<br>shaft exposing a needle at its<br>distal end. The device needs<br>to approach one side of the<br>tissue deploying a T anchor. |
| Suture location | The suture is placed through<br>and into the tissue. | Same |
| Suturing type | Interrupted stiches and running<br>stitches | Same |
| Knot tying type | Intracorporeal and<br>extracorporeal square knots,<br>surgeons' knot and a variety of<br>slip knots | Same |
| Needle | Curved stainless steel,<br>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 of<br>10-6) | Same |
| Biocompatibility | All patient contact materials<br>have been evaluated in<br>accordance with ISO 10993-1 | Same |
| Performance Data | In-vitro and in-vivo testing has<br>been performed in support of<br>the intended use of this device | Same |
| | Bench testing included dimensional verification, component<br>compatibility, tissue anchoring pull-out, corrosion testing per<br>ASTM F2129, deployment reliability, suture pull-out strength,<br>and tensile strength per USP <881>. | |
| | MRI Safety and Compatibility<br>MRI safety and compatibility was verified per ASTM F2052,<br>ASTM F2213, ASTM F2182, and ASTM F2119. The device<br>was deemed MR Conditional. | |
| | Packaging Integrity<br>Packaging Integrity was confirmed by testing in accordance<br>with ASTM F1929-15, ASTM DI69-16 and ASTM<br>F1886/F1886M-16. | |
| | The results of all studies confirmed substantial equivalence<br>between the subject and predicate designs. | |
| Biocompatibility | Biocompatibility assessments were performed in accordance<br>with the appropriate risk category requirements, as defined<br>in ISO 10933-1. Testing included extractable and leachable<br>studies in accordance with ISO 10993-18 and a toxicological<br>risk assessment in accordance with ISO 10993-17. | |
| HFE Study | A Human Factors Engineering Study was performed to verify<br>the usability of the device. The study was performed with 18<br>representative users, and evaluated the usability of all tasks<br>needed to use the device. The study confirmed device<br>usability and demonstrated that the training provided to users<br>and the Instructions for Use of the device were clear and<br>accurate. These data support the safety and effectiveness of<br>the Su2ura Approximation Device for its intended use. | |
| Pre-Clinical Performance Data | An animal study was performed to assess the safety and<br>performance of the device, under GLP conditions and in<br>compliance with ISO 10993-6. The study included 8 pigs,<br>each subjected to a series a surgical incisions. Separate<br>animals were employed for the Test (N=5) and Control Items<br>(N=3). All incisions were closed with the Test or Control<br>Items, and the animals were monitored clinically for 13 weeks<br>before sacrifice. All incision sites were successfully closed by<br>either Test or Control Items, and histopathological data<br>indicated that long-term safety was similar between the Test<br>and Control Items. | |
| Clinical Performance Data | Clinical testing was not required to demonstrate substantial<br>equivalence. | |
| Substantial Equivalence | The Anchora Su2ura® has very similar indications for use<br>and technological features to the predicate device. The minor<br>differences in technological characteristics do not raise new<br>types of safety or effectiveness questions. Bench, animal anc<br> | |
| Conclusion | Based on the intended use, technological characteristics<br>performance testing and comparison to the predicate device<br>the subject device is substantially equivalent to the predicate<br>device and raises no different questions of safety o<br>effectiveness. | |

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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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