(142 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 and Suture Cinch devices. All devices are sterile packaged and designed for single use and are manufactured from various thermoplastic, silicone and stainless steel materials.
The OverStitch ESS is designed for compatibility with dual channel endoscopes. The endcap of the Needle Driver Assembly attaches to the distal end of the endoscope, and the handle attaches to the proximal end. 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.
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.
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 pull into proximity of the needle body to complete the stitching operation.
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 device to perform stitching operations and serves as an anchor to secure suture placement, once released from the ESS.
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.
The Apollo Endosurgery OverStitch Endoscopic Suturing System is a Class II medical device intended for endoscopic placement of suture(s) and approximation of soft tissue. The 510(k) summary provides information on the device's technological characteristics and non-clinical performance data to demonstrate substantial equivalence to its predicate device (K081853).
1. Table of Acceptance Criteria and Reported Device Performance:
The document does not explicitly present a table of acceptance criteria with corresponding performance results in a structured format. However, it states that "Appropriate product testing was performed on all subject devices to evaluate conformance to product specifications and 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 with various endoscopes."
The performance tests mentioned are:
| Test | Reported Performance |
|---|---|
| Needle Passing Reliability | Confirmed (part of "results of all studies confirmed equivalency") |
| Needle Pull-off Strength | Confirmed (part of "results of all studies confirmed equivalency") |
| Suture Cinch Deployment | Confirmed (part of "results of all studies confirmed equivalency") |
| Suture Cinch Pull-off Strength | Confirmed (part of "results of all studies confirmed equivalency") |
| Tissue Helix Acquisition Reliability | Confirmed (part of "results of all studies confirmed equivalency") |
| Tissue Helix Bond Strength | Confirmed (part of "results of all studies confirmed equivalency") |
| Sterility (SAL 10-6) | Confirmed in accordance with ISO 11135:2014 |
| Shelf-Life (1 and 3 years, depending on component) | Confirmed by repeating sterility and functional testing on aged product |
| Biocompatibility | Performed in accordance with ISO 10933-1 (cytotoxicity, sensitization, irritation, acute systemic toxicity, material mediated pyrogenicity, subacute/subchronic toxicity, implantation, and genotoxicity) |
| System Compatibility with various endoscopes | Confirmed |
The overall conclusion is that "The results of all studies confirmed equivalency between the subject and predicate devices, and that no new issues of safety or efficacy were raised." This implies that the device met its defined performance specifications, which serve as the acceptance criteria for each test.
2. Sample Size Used for the Test Set and Data Provenance:
The document does not explicitly state the specific sample sizes used for each performance test (e.g., number of needles tested, number of suture cinches). It indicates that "Appropriate product testing was performed on all subject devices."
The data provenance is retrospective, as the tests were conducted as part of a 510(k) submission to demonstrate substantial equivalence to an already marketed predicate device. The country of origin of the data is not specified.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts:
This information is not applicable as the document describes an evaluation of a physical medical device (suturing system) through engineering and bench testing, not an AI/software device that requires expert-established ground truth for image or data interpretation.
4. Adjudication Method for the Test Set:
This information is not applicable for the same reasons as point 3. Adjudication methods are typically used in clinical studies or AI evaluations where there might be disagreement among reviewers or interpreters.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:
This information is not applicable. The device is a suturing system, not an AI or imaging diagnostic device that would involve human readers or AI assistance for interpretation.
6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) was done:
This information is not applicable. The device is a physical medical device, not an algorithm.
7. The Type of Ground Truth Used:
For the performance testing, the "ground truth" refers to the established engineering specifications, physical measurements, and regulatory standards for device functionality, sterility, shelf-life, and biocompatibility.
- Bench Testing: Engineering specifications and physical measurements (e.g., strength measurements, deployment mechanisms).
- Sterility: Conformance to ISO 11135:2014.
- Shelf-Life: Functional and sterility testing results on aged products.
- Biocompatibility: Conformance to ISO 10933-1.
8. The Sample Size for the Training Set:
This information is not applicable as the document describes the evaluation of a physical medical device, not an AI/machine learning model that requires a training set.
9. How the Ground Truth for the Training Set Was Established:
This information is not applicable for the same reasons as point 8.
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November 15, 2017
Apollo Endosurgery Ms. Maritza Ward Manager, Regulatory Affairs 1120 S. Capital of Texas Hwy. Building 1, Suite 300 Austin, Texas 78746
Re: K171886
Trade/Device Name: OverStitch Endoscopic Suturing System Regulation Number: 21 CFR 876.1500 Regulation Name: Endoscope And Accessories Regulatory Class: Class II Product Code: HCF Dated: October 12, 2017 Received: October 16, 2017
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 (QS) regulation (21 CFR Part 820);
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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 http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
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
Binita S. Ashar, M.D., M.B.A., F.A.C.S. for 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) K171886
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) | |
|---|---|
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: | November 9, 2017 |
| Trade Name: | OverStitch™ Endoscopic Suturing System |
| Common Name: | Endoscopic Tissue Approximation Device |
| Product Code: | HCF |
| Classification: | Class II (21 CFR 876.1500) |
| Classification Name | Endoscope and Accessories |
| Predicate Devices: | K081853 – 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 and Suture Cinch devices.All devices are sterile packaged and designed for single use andare manufactured from various thermoplastic, silicone andstainless steel materials. |
The OverStitch ESS is designed for compatibility with dual channel endoscopes. The endcap of the Needle Driver Assembly attaches to the distal end of the endoscope, and the handle attaches to the proximal end. 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.
OverStitch Sx ESS
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Image /page/4/Picture/0 description: The image shows the logo for Apollo Endosurgery. The logo features a stylized human figure with a circular head and a swirling, ribbon-like body. To the right of the figure is the word "apollo" in blue, sans-serif font. Below "apollo" is the word "endosurgery" in a smaller, similar font, also in blue.
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 pull 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 device to perform stitching operations and serves as an anchor to secure suture placement, once released from the ESS.
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 DRIVERASSEMBLY | Gen 0 Needle DriverAssembly | Gen 2 Needle DriverAssembly | Sx Needle DriverAssembly | |
|---|---|---|---|---|
| 510(k) Clearance | K081853 | Proposed | Proposed | |
| Single Use | Yes | |||
| Shelf-Life Claim | 1-year | 3-years | 1-year | |
| Materials | Stainless Steel Delrin/ABS | 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 bodyand exchange the proprietary suture assembly with the Anchor Exchange to performstitching operations. | |||
| Compatible Scopes | Dual channel OD between 12.8 mm and 14.0 mm <170 cm length | 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 | Seats on distal scope face | Side mount to distal end in any rotational orientation |
| Attachment | Back-loaded wire | Interference fit | Two straps | |
| Sterilization | Terminally sterilized to SAL 10-6 using a validated EO method |
| ANCHOR EXCHANGE | Gen 0 Anchor Exchange | Gen 2 Anchor Exchange |
|---|---|---|
| 510(k) Clearance | K081853 | Proposed |
| Single Use | Yes | |
| Shelf-Life Claim | 1-year | 3-years(when packaged as ESS-G02-160)1-year(when packaged as ESS-G02-Sx1) |
| Materials | Stainless Steel Delrin/ABS | Stainless Steel ABS |
| Dimensions | Length: 130cmO.D.: 3.2mm (distal end) | |
| Compatible Scopes | Dual channel OD between 12.8 mm and 14.0 mm <170 cm length | Dual ChannelOlympus GIF-2TH180 GIF-2T160Single Channel |
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Image /page/6/Picture/0 description: The image shows the logo for Apollo Endosurgery. The logo features a stylized human figure with a blue circle for a head and a swirling blue line representing the body. To the right of the figure is the word "apollo" in blue, followed by the word "endosurgery" in a smaller font size and also in blue. The logo is clean and modern, with a focus on the company's name and area of expertise.
| ANCHOR EXCHANGE | Gen 0 Anchor Exchange | Gen 2 Anchor Exchange |
|---|---|---|
| Endoscopes that are 8.8 - 9.8mm indiameter and up to 110cm in workinglength | ||
| Method of Actuation | Sliding Lever | Button on top of handle |
| Integrated With NeedleDriver Assembly | Yes | No |
| Sterilization | Terminally sterilized to SAL 10-6 using a validated EO method |
| SUTURE CINCH | Gen 0 Suture Cinch | Gen 2 Suture Cinch |
|---|---|---|
| 510(k) Clearance | K081853 | Proposed |
| Single Use | Yes | |
| Shelf-Life Claim | 1-year | 3-years |
| Materials | Stainless Steel ABS Medical grade metallic or plastic materials | Stainless Steel ABS VESTAKEE PEEK |
| Cinch design | PEEK or Stainless Plug and collar components designed to press-fit together onto suture and hold construct in place. | PEEK Plug and collar components designed to press-fit together onto suture and hold construct in place. |
| Dimensions | Suture Cinch Assembly:Length: 182cmO.D.: 2.4mm (distal end) | Suture Cinch Assembly:Length: 152cmO.D.: 2.4mm (distal end) |
| Deployed Cinch:Length: 8mmO.D. 2.4mm | Deployed Cinch:Length: 8mmO.D. 2.4mm | |
| User Sequence | Helix, Device Handle, Anchor Exchange, Cinch per DFU | |
| Compatible Scopes | Dual channel OD between 12.8 mm and 14.0 mm <170 cm length | 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 0 Tissue Helix | Gen 2 Tissue Helix |
|---|---|---|
| 510(k) Clearance | K081853 | Proposed |
| Single Use | Yes | |
| Shelf-Life Claim | 1-Year | 3-years |
| Materials | • Stainless Steel• Derlin/ABS | • Stainless Steel• Nitinol• PTFE• ABS |
| Dimensions | Length: 165cmO.D.: 2.0 mm (distal end) | Length: 165cmO.D.: 2.4mm (distal end) |
| Compatible Scopes | • Dual channel | Dual Channel |
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Image /page/7/Picture/0 description: The image shows the logo for Apollo Endosurgery. The logo features a stylized human figure with a spiral design for the body, and a blue circle for the head. To the right of the figure is the word "apollo" in blue, with the word "endosurgery" underneath in a smaller font, also in blue.
| • OD between 12.8 mm and 14.0 mm• <170 cm length | Olympus· GIF-2TH180· GIF-2T160Single ChannelEndoscopes that are 8.8 - 9.8mm indiameter and up to 110cm in workinglength | |
|---|---|---|
| Outer SheathProtecting Coil | No | Yes |
| Sterilization | Terminally sterilized to SAL 10-6 using a validated EO method |
| ANCHOR-SUTUREASSEMBLY | Gen 0 Anchor | Gen 2 Anchor |
|---|---|---|
| 510(k) Clearance | K081853 | Proposed |
| Single Use | Yes | |
| Shelf-Life Claim | 1-year | 3-years |
| Materials | • Stainless Steel• Medical Grade Plastic | • Stainless Steel 316L• Cobalt Chromium MP35 |
| Dimensions | AnchorLength: 8.4 mmO.D.: 1.3 mmSutureLength: 185 cmO.D.: 2.0 mm | AnchorLength: 6.6 mmO.D.: 1.0 mmSutureLength: 185 cmO.D.: 2.0 mm |
| Suture Anchor Design | Suture-Anchor has recessed features onboth ends of the component designed toengage with the Needle Body Assemblyand the Anchor Exchange. The suture isswaged onto the center of the needlebody to allow for the needle body todouble as an anchor for the sutureconstruct | Suture-Anchor has a recessed featureon one end designed to engage withthe Anchor Exchange, and a latchfeature on the opposite end designedto engage with the Needle BodyAssembly. The suture is swaged ontothe center of the needle body to allowfor the needle body to double as ananchor 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 to evaluate conformance to product specifications and 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 with various endoscopes.
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.
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Image /page/8/Picture/0 description: The image shows the logo for Apollo Endosurgery. The logo features a stylized human figure with a spiral design in place of the body, colored in blue. To the right of the figure is the word "apollo" in a bold, sans-serif font, also in blue. Below "apollo" is the word "endosurgery" in a smaller, lighter blue font.
Sterility
Sterility claims (SAL 10-6) were confirmed by executing a sterilization validation in accordance with ISO 11135:2014.
Shelf-Life Shelf-life claims were confirmed by repeating sterility and functional testing on aged product.
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 all OverStitch devices in accordance with their risk category requirements, as defined in ISO 10933-1. Testing included cytotoxicity, sensitization, irritation, acute systemic toxicity, material mediated pyrogenicity, subacute/subchronic toxicity, implantation, and genotoxicity.
- 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 their predicates.
§ 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.