(57 days)
The OverStitch Endoscopic Suturing System is intended for endoscopic placement of suture(s) and approximation of soft tissue.
The OverStitch™ Endoscopic Suturing System and accessories are intended for endoscopic placement of sutures and approximation of soft tissue within the gastrointestinal tract utilizing either a dual channel or single-channel endoscope. The system is comprised of the Needle Driver Assembly and Anchor Exchange Device (collectively referred to as ESS), and accessories such as the Tissue Helix, Suture Cinch and Suture-Anchor Assembly devices. All devices are sterile packaged and designed for single use and are manufactured from various thermoplastic, silicone, stainless steel and other medical grade materials.
The provided text is a 510(k) summary for the OverStitch™ Endoscopic Suturing System and Accessories. It outlines the device's technical specifications and the non-clinical performance data used to demonstrate substantial equivalence to a predicate device. However, it explicitly states that clinical performance data was not required for this submission.
Therefore, I cannot provide information on acceptance criteria and a study proving the device meets those criteria from this document, as the document focuses on non-clinical testing for substantial equivalence, not on establishing device performance against clinical acceptance criteria through a clinical study.
Here's a breakdown of what can be and cannot be extracted from the provided text based on your request:
1. A table of acceptance criteria and the reported device performance
- Cannot be provided. The document details non-clinical performance testing (e.g., needle passing reliability, pull-off strength) to show equivalence to a predicate device, but it does not specify explicit "acceptance criteria" for these performance metrics or report quantitative results against such criteria in a manner suitable for a table. It only states that the testing "confirmed conformance to product specifications" and "equivalency between the subject and predicate devices."
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Cannot be provided. The document mentions "product testing" and "bench testing" but does not detail the sample sizes used for these tests. Data provenance (country of origin, retrospective/prospective) is also not mentioned for the non-clinical tests.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
- Not applicable. This document describes non-clinical bench testing and verification/validation activities for a physical medical device. The concept of "ground truth" established by experts, as would be relevant for diagnostic AI/imaging devices, does not apply to the type of testing described here.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not applicable. As above, the testing described is non-clinical performance testing of a physical device, not an interpretation-based study where adjudication would be relevant.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
- No. The document explicitly states: "Clinical Performance Data: Clinical testing was not required to demonstrate substantial equivalence." An MRMC study is a type of clinical study, typically for diagnostic devices or AI applications, which was not performed or submitted here.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- No. This device is a mechanical endoscopic suturing system; it is not an algorithm or AI system.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- Not applicable. "Ground truth" in the context of expert consensus, pathology, or outcomes data is relevant for clinical studies, particularly for diagnostic devices or AI. The testing described here is non-clinical performance testing against product specifications.
8. The sample size for the training set
- Not applicable. This device is a physical medical instrument, not a machine learning model, so there is no "training set."
9. How the ground truth for the training set was established
- Not applicable. As above, this is not a machine learning model.
In summary, the provided FDA 510(k) summary focuses on demonstrating substantial equivalence for a physical medical device through non-clinical performance, materials, and sterilization testing, rather than presenting clinical study data with acceptance criteria for device performance.
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June 27, 2018
Apollo Endosurgery % Ms. Maritza Ward Manager of Regulatory Affairs 1120 S. Capital of Texas Hwy Ste. 300 Austin, Texas 78746
Re: K181141
Trade/Device Name: OverStitch™ Endoscopic Suturing System and Accessories Regulation Number: 21 CFR 876.1500 Regulation Name: Endoscope and Accessories Regulatory Class: Class II Product Code: OCW Dated: April 27, 2018 Received: May 1, 2018
Dear Ms. Ward:
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 of medical device-related 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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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 comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). 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 (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
David Krause -S
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) K181141
Device Name
Overstitch Endoscopic Suturing System
Indications for Use (Describe)
The OverStitch Endoscopic Suturing System is intended for endoscopic placement of suture(s) and approximation of soft tissue.
| Type of Use (Select one or both, as applicable) |
|---|
| ------------------------------------------------- |
X Prescription Use (Part 21 CFR 801 Subpart D)
| Over-The-Counter Use (21 CFR 801 Subpart C)
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510(k) Summary
| Owner's Name & Address: | Apollo Endosurgery1120 S. Capital of Texas Hwy.Building 1, Suite 300Austin, TX 78746 |
|---|---|
| Contact Person: | Maritza WardManager, Regulatory AffairsPhone: (512)-279-5114Email: Maritza.Ward@apolloendo.com |
| Date: | June 22, 2018 |
| Trade Name: | OverStitch™ Endoscopic Suturing System |
| Common Name: | Endoscopic Tissue Approximation Device |
| Product Code: | OCW |
| Classification: | Class II (21 CFR 876.1500) |
| Classification Name | Endoscope and Accessories |
| Predicate Devices: | K171886 – OverStitch™ Endoscopic Suturing System |
| Device Description | The OverStitch™ Endoscopic Suturing System and accessoriesare intended for endoscopic placement of sutures andapproximation of soft tissue within the gastrointestinal tractutilizing either a dual channel or single-channel endoscope. Thesystem is comprised of the Needle Driver Assembly and AnchorExchange Device (collectively referred to as ESS), andaccessories such as the Tissue Helix, Suture Cinch and Suture-Anchor Assembly devices. All devices are sterile packaged anddesigned for single use and are manufactured from variousthermoplastic, silicone, stainless steel and other medical gradematerials. |
| OverStitch ESSThe OverStitch ESS is designed for compatibility with dualchannel endoscopes. The endcap of the Needle Driver Assemblyattaches to the distal end of the endoscope, and the handleattaches to the proximal end. The handle of the Needle DriverAssembly is squeezed to actuate the needle body and exchangethe Suture-Anchor Assembly with the Anchor Exchange toperform stitching operations. |
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OverStitch Sx ESS
The OverStitch Sx ESS is designed for compatibility with single channel endoscopes. The ESS is mounted onto the endoscope using silicone straps distributed along the length of the catheter and endcap assembly. The external catheter sheath has two working channels through which the Anchor Exchange and OverStitch accessories can operate, independent of the endoscope channel. The handle of the Needle Driver Assembly is squeezed to actuate the needle body and exchange the proprietary Suture-Anchor Assembly with the Anchor Exchange to perform stitching operations.
OverStitch Tissue Helix
The OverStitch Helix is an optional device that is designed to acquire tissue by rotating the device handle into targeted area until tissue is gathered into the exposed helix coil. The acquired tissue is then pulled into proximity of the needle body to complete the stitching operation.
OverStitch Suture-Anchor Assembly
The OverStitch Suture-Anchor Assembly is comprised of a 510(k) cleared suture product, manufactured from either polydioxanone or polypropylene materials attached to an implantable anchor manufactured from cobalt chrome and stainless steel. The Anchor component is intended to function with the OverStitch ESS devices to perform stitching operations and serves as an anchor to secure suture placement.
OverStitch Suture Cinch
The Overstitch Suture Cinch device is comprised of thermoplastic and stainless steel materials and includes an implantable PEEK Cinch component designed to secure the placement of suture as a final step of an OverStitch procedure. The device functions by squeezing the handle and deploying the PEEK components that press-fit onto the tail end of the suture to maintain suture position in situ.
Indications for Use: The OverStitch Endoscopic Suturing System is intended for endoscopic placement of suture(s) and approximation of soft tissue.
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Technological Characteristics:
| NEEDLE DRIVER ASSEMBLY | Gen 2 Needle Driver Assembly | Sx Needle Driver Assembly | |
|---|---|---|---|
| 510(k) Clearance | K171886 | ||
| Single Use | Yes | ||
| Shelf-Life Claim | 3-years | 1-year | |
| General Materials | Stainless Steel ABS | Stainless Steel ABS Silicone | |
| Dimensions | Length: 130cmO.D.: 2mm (distal end) | Length: 117cmO.D.: 2mm (distal end) | |
| Suture Mechanism | The handle of the Needle Driver Assembly is squeezed to actuate the needle body and exchange the proprietary suture assembly with the Anchor Exchange to perform stitching operations. | ||
| Compatible Scopes | Olympus GIF-2TH180 GIF-2T160 | Single Channel Endoscopes that are 8.8 - 9.8 mm in diameter and up to 110cm in working length | |
| Endcap + Scope | Position | Seats on distal scope face | Side mount to distal end in any rotational orientation |
| Attachment | Interference fit | Two straps | |
| Sterilization | Terminally sterilized to SAL 10-6 using a validated EO method |
| ANCHOR EXCHANGE | Gen 2 Anchor Exchange | |
|---|---|---|
| 510(k) Clearance | K171886 | |
| Single Use | Yes | |
| Shelf-Life Claim | 3-years (when packaged as ESS-G02-160)1-year (when packaged as ESS-G02-Sx1) | |
| General Materials | • Stainless Steel• ABS | |
| Dimensions | O.D.: 3.2mm (distal end) | |
| Compatible Scopes | Dual ChannelOlympus• GIF-2TH180• GIF-2T160Single ChannelEndoscopes that are 8.8 - 9.8mm in diameter and up to 110cm in working length | |
| Method of Actuation | Button on top of handle | |
| Integrated With NeedleDriver Assembly | No | |
| Sterilization | Terminally sterilized to SAL 10-6 using a validated EO method |
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| SUTURE CINCH | Gen 2 Suture Cinch |
|---|---|
| 510(k) Clearance | K171886 |
| Single Use | Yes |
| Shelf-Life Claim | 3-years |
| Materials | Stainless Steel ABS VESTAKEEP PEEK |
| Cinch design | PEEK Plug and collar components designed to press-fit together onto suture and hold construct in place. |
| Dimensions | Suture Cinch Assembly:Length: 152cmO.D.: 2.4mm (distal end)Deployed Cinch:Length: 8mmO.D. 2.4mm |
| User Sequence | Helix, Device Handle, Anchor Exchange, Cinch per DFU |
| Compatible Scopes | Dual ChannelOlympus GIF-2TH180 GIF-2T160 Single ChannelEndoscopes that are 8.8 - 9.8mm in diameter and up to 110cm in working length |
| Method of Actuation | Squeezing of Handle |
| Sterilization | Terminally sterilized to SAL $10^{-6}$ using a validated EO method |
| TISSUE HELIX | Gen 2 Tissue Helix | |
|---|---|---|
| 510(k) Clearance | K171886 | |
| Single Use | Yes | |
| Shelf-Life Claim | 3-years | |
| Materials | Stainless Steel | |
| Nitinol | ||
| PTFE | ||
| ABS | ||
| Dimensions | Length: 165cm | |
| O.D.: 2.4mm (distal end) | ||
| Compatible Scopes | Dual Channel | |
| Olympus | ||
| • | GIF-2TH180 | |
| • | GIF-2T160 | |
| Single Channel | ||
| Endoscopes that are 8.8 - 9.8mm in diameter and up to 110cm inworking length | ||
| Outer SheathProtecting Coil | Yes | |
| Sterilization | Terminally sterilized to SAL 10-6 using a validated EO method |
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| SUTURE-ANCHOR ASSEMBLY | Gen 2 Anchor | |||||||||
|---|---|---|---|---|---|---|---|---|---|---|
| 510(k) Clearance | K171886 | |||||||||
| Single Use | Yes | |||||||||
| Shelf-Life Claim | 3-years | |||||||||
| Materials | Stainless Steel 316LCobalt Chromium MP35 | |||||||||
| Dimensions | AnchorSutureLength:6.6 mm185 cmO.D.:1.0 mm2.0 mm | Anchor | Suture | Length: | 6.6 mm | 185 cm | O.D.: | 1.0 mm | 2.0 mm | |
| Anchor | Suture | |||||||||
| Length: | 6.6 mm | 185 cm | ||||||||
| O.D.: | 1.0 mm | 2.0 mm | ||||||||
| Suture Anchor Design | Suture-Anchor has a recessed feature on one end designed to engage with the Anchor Exchange, and a latch feature on the opposite end designed to engage with the Needle Body Assembly. The suture is swaged onto the center of the needle body to allow for the needle body to double as an anchor for the suture construct | |||||||||
| Sterilization | Terminally sterilized to SAL 10-6 using a validated EO method |
Non-Clinical Performance Data: Appropriate product testing was performed on all subject devices evaluate conformance to product specifications and to equivalence to the predicate designs. Verification and validation for the proposed system of devices was conducted in accordance with protocol. All devices were evaluated to their individual functional and reliability requirements, as well as system compatibility.
Performance Testing
Bench testing included needle passing reliability, needle pull off strength, Suture Cinch deployment and pull-off strength, Tissue Helix acquisition reliability and bond strength.
Packaging Integrity
Packaging Integrity was confirmed by repeating testing in accordance with ASTM F2096-11, ASTM DI69-16 and ASTM F88/F88M-15.
The results of all studies confirmed equivalency between the subject and predicate devices, and that no new issues of safety or efficacy were raised.
-
Biocompatibility: Biocompatibility testing and toxicological assessments were performed on subject OverStitch devices in accordance with their risk category requirements, as defined in ISO 10933-1. Testing included cytotoxicity and material mediated pyrogenicity.
Clinical Performance Data: Clinical testing was not required to demonstrate substantial equivalence. -
Basis of Substantial Equivalence: Based on a comparison of indications for use and technological characteristics, the proposed devices have demonstrated substantial equivalence to the predicate device.
§ 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.