(357 days)
No
The device description and performance studies focus on mechanical function and material properties, with no mention of AI or ML.
Yes.
The device is used in endoscopic surgery for placement of interrupted or running stitches in soft tissue, which directly contributes to the treatment or management of a medical condition by approximating tissue.
No
Explanation: The device is indicated for "placement of interrupted or running stitches in soft tissue," which is a therapeutic, not a diagnostic, function.
No
The device description clearly outlines a physical, sterile, single-use endoscopic suturing device made of plastic and stainless steel, with a handle, shaft, trigger, knob, toggle button, cap, needle, pushrod, anchors, and suture. It is a hardware device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for "placement of interrupted or running stitches in soft tissue" during endoscopic surgery. This is a surgical procedure performed on the body, not a test performed on a sample taken from the body.
- Device Description: The device is a surgical tool designed to deploy anchors and suture for tissue approximation. It is used directly in the surgical field.
- Lack of IVD Characteristics: There is no mention of the device being used to analyze biological samples (blood, urine, tissue, etc.) or to provide diagnostic information about a patient's health status.
IVD devices are used to examine specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes. This device clearly falls outside of that definition.
N/A
Intended Use / Indications for Use
The Su2ura® Approximation Device is indicated in endoscopic surgery for the placement of interrupted or running stitches in soft tissue.
Product codes (comma separated list FDA assigned to the subject device)
OCW
Device Description
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).
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Soft tissue
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Physicians having adequate training and familiarity with endoscopic techniques / Operating room
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)
Performance Data: In-vitro and in-vivo testing has been performed in support of the intended use of this device. 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. MRI Safety and Compatibility verified per ASTM F2052, ASTM F2213, ASTM F2182, and ASTM F2119. The device was deemed MR Conditional. Packaging Integrity confirmed by testing in accordance with ASTM F1929-15, ASTM DI69-16 and ASTM F1886/F1886M-16. The results of all studies confirmed substantial equivalence between the subject and predicate designs.
Biocompatibility: Biocompatibility assessments were performed in accordance with the appropriate risk category requirements, as defined in ISO 10933-1. Testing included extractable and leachable studies in accordance with ISO 10993-18 and a toxicological risk assessment in accordance with ISO 10993-17.
HFE Study: A Human Factors Engineering Study was performed to verify the usability of the device. The study was performed with 18 representative users, and evaluated the usability of all tasks needed to use the device. The study confirmed device usability and demonstrated that the training provided to users and the Instructions for Use of the device were clear and accurate. These data support the safety and effectiveness of the Su2ura Approximation Device for its intended use.
Pre-Clinical Performance Data: An animal study was performed to assess the safety and performance of the device, under GLP conditions and in compliance with ISO 10993-6. The study included 8 pigs, each subjected to a series a surgical incisions. Separate animals were employed for the Test (N=5) and Control Items (N=3). All incisions were closed with the Test or Control Items, and the animals were monitored clinically for 13 weeks before sacrifice. All incision sites were successfully closed by either Test or Control Items, and histopathological data indicated that long-term safety was similar between the Test and Control Items.
Clinical Performance Data: Clinical testing was not required to demonstrate substantial equivalence.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
K082659, Modified Endo Stitch
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
K172016, K150438, K100506, K070673, K063778, K040472, K033654
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 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.
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Image /page/0/Picture/0 description: The image contains two logos. On the left is the Department of Health & Human Services logo. On the right is the FDA logo, which includes the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue text.
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
1
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
2
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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3
510(K) SUMMARY
K201744
| Owner's Name & Address | Anchora Medical, Ltd.
Leshem St., 1
Industrial Park
Caesarea, 3088900
Israel
Phone: +972-54-777-6615 |
|------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Contact Person | Esther Kott
Regulatory Consultant
Phone: +972-58-488-7454
Email: 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 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 |
4
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 Approximation
Device [subject device] |
|-----------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| 510(k) number | K082659 | K201744 |
| Product Code | OCW | OCW |
| Intended Use/Indications for
Use | The Modified Endo Stitch™ 10 mm single- use suturing device
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
and materials | Plastic handle, stainless steel shaft and needle | Similar |
| Implant materials | 4 sutures materials are
compatible with the Endo
Stitch:
• 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® Polyethylene
Non-Absorbable Surgical
Sutures by Teleflex Medical,
non-absorbable surgical
thread, USP 0, cleared under
K172016, K150438, K100506,
K070673, K063778, K040472
and K033654
Anchors: |
| | | Stainless Steel 316 LVM, per
ASTM F138
Each device consists of 19
implants |
| Graduation on shaft | Yes - cm | Same |
| Handling | One-handed instrument,
dominant or non-dominant | Same |
| Suture placement | The device holds and passes a
needled suture between its two
jaws. The suture needle is
passed from one jaw to
another by squeezing the
opposing handles and
securing it in each jaw by
activating the toggle lever. The
device needs to approach the
two sides of the tissue being
sutured. | The device pushes and passes
an anchored suture through
the needle by squeezing the
handle's trigger lever. The
device features a retracting
shaft exposing a needle at its
distal end. The device needs
to approach one side of the
tissue deploying a T anchor. |
| Suture location | The suture is placed through
and into the tissue. | Same |
| Suturing type | Interrupted stiches and running
stitches | Same |
| Knot tying type | Intracorporeal and
extracorporeal square knots,
surgeons' knot and a variety of
slip 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 of
10-6) | Same |
| Biocompatibility | All patient contact materials
have been evaluated in
accordance with ISO 10993-1 | Same |
| Performance Data | In-vitro and in-vivo testing has
been performed in support of
the intended use of this device | Same |
| | 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 . | |
| | MRI Safety and Compatibility
MRI safety and compatibility was verified per ASTM F2052,
ASTM F2213, ASTM F2182, and ASTM F2119. The device
was deemed MR Conditional. | |
| | Packaging Integrity
Packaging Integrity was confirmed by testing in accordance
with ASTM F1929-15, ASTM DI69-16 and ASTM
F1886/F1886M-16. | |
| | The results of all studies confirmed substantial equivalence
between the subject and predicate designs. | |
| Biocompatibility | Biocompatibility assessments were performed in accordance
with the appropriate risk category requirements, as defined
in ISO 10933-1. Testing included extractable and leachable
studies in accordance with ISO 10993-18 and a toxicological
risk assessment in accordance with ISO 10993-17. | |
| HFE Study | A Human Factors Engineering Study was performed to verify
the usability of the device. The study was performed with 18
representative users, and evaluated the usability of all tasks
needed to use the device. The study confirmed device
usability and demonstrated that the training provided to users
and the Instructions for Use of the device were clear and
accurate. These data support the safety and effectiveness of
the Su2ura Approximation Device for its intended use. | |
| Pre-Clinical Performance Data | An animal study was performed to assess the safety and
performance of the device, under GLP conditions and in
compliance with ISO 10993-6. The study included 8 pigs,
each subjected to a series a surgical incisions. Separate
animals were employed for the Test (N=5) and Control Items
(N=3). All incisions were closed with the Test or Control
Items, and the animals were monitored clinically for 13 weeks
before sacrifice. All incision sites were successfully closed by
either Test or Control Items, and histopathological data
indicated that long-term safety was similar between the Test
and Control Items. | |
| Clinical Performance Data | Clinical testing was not required to demonstrate substantial
equivalence. | |
| Substantial Equivalence | The Anchora Su2ura® has very similar indications for use
and technological features to the predicate device. The minor
differences in technological characteristics do not raise new
types of safety or effectiveness questions. Bench, animal anc
| |
| Conclusion | Based on the intended use, technological characteristics
performance testing and comparison to the predicate device
the subject device is substantially equivalent to the predicate
device and raises no different questions of safety o
effectiveness. | |
5
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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