(91 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.
This document is a 510(k) summary for a medical device (OverStitch Endoscopic Suturing System) and thus does not contain the detailed study data, acceptance criteria, or ground truth establishment typically found in a full clinical study report or a premarket approval (PMA) application. A 510(k) submission primarily demonstrates substantial equivalence to a legally marketed predicate device, often relying on bench testing and comparisons of technological characteristics rather than extensive clinical trials for new functionality.
Based on the provided text, here's what can be extracted and what cannot:
1. A table of acceptance criteria and the reported device performance:
The document states: "Appropriate product testing was performed to evaluate conformance to USP requirements, product specifications, and equivalence to the predicate design. The device was evaluated against individual functional and reliability requirements, as well as OverStitch Endoscopic Suturing System compatibility."
Specific quantitative acceptance criteria are not explicitly listed in this summary. Instead, it refers to conformance with USP requirements and product specifications.
The performance reported is qualitative: "The results of all studies confirmed substantial equivalence between the subject and predicate designs, and that no new issues of safety or efficacy were raised."
Performance Testing Mentioned:
- Bench testing included:
- Needle passing reliability
- Suture Cinch deployment and pull-off strength
- Tensile strength per USP <881>
- Needle pull off strength per USP <871>
- Suture diameter measurements per USP <861>
- Packaging Integrity: Confirmed by repeating testing in accordance with ASTM F1929-15, ASTM DI69-16, and ASTM F1886/F1886M-16.
- Biocompatibility: Performed in accordance with ISO 10933-1, including extractable and leachable studies (ISO 10993-18: 2005) and toxicological risk assessment (ISO 10993-17: 2002).
2. Sample size used for the test set and the data provenance:
- Sample Size: Not specified in the provided summary.
- Data Provenance: The tests are "bench testing" and "packaging integrity" studies, which implies laboratory-based, non-clinical data. No specific country of origin is mentioned, but the FDA approval implies compliance with US standards. This is retrospective in the sense that the testing was completed prior to submission.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- This information is not applicable as the evaluation relies on a comparison to a predicate device and bench testing against established standards (USP, ASTM, ISO), rather than a clinical study requiring expert assessment of patient outcomes or images for ground truth.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:
- Not applicable. As this is primarily bench testing and comparison to a predicate device, there is no need for an adjudication method as would be used in a clinical study with human readers or assessments where consensus is required.
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 MRMC study was done. This device is a mechanical endosurgical suturing system, not an AI or imaging-based diagnostic tool. The concept of "human readers improving with AI assistance" is not relevant to this device. The document explicitly states: "Clinical testing was not required to demonstrate substantial equivalence."
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Not applicable. This is a mechanical device, not an algorithm. Its performance is assessed through bench testing of its mechanical properties and functionality.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- The "ground truth" for this submission is established through conformance to recognized standards (USP, ASTM, ISO) and comparison to the performance characteristics of the legally marketed predicate device (K181141 - OverStitch™ Endoscopic Suturing System). It is not based on clinical "outcomes data" or "expert consensus" in the traditional sense of a diagnostic or therapeutic clinical trial. The phrase "no new issues of safety or efficacy were raised" implies the performance is deemed equivalent to the previously cleared device, which serves as a benchmark.
8. The sample size for the training set:
- Not applicable. This refers to a mechanical device, not a machine learning algorithm that requires a "training set."
9. How the ground truth for the training set was established:
- Not applicable. See point 8.
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Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
August 29, 2019
Apollo Endosurgery David Hooper Director of Regulatory Affairs 1120 S. Capital of Texas Hwy Austin, Texas 78746
Re: K191439
Trade/Device Name: OverStitch Endoscopic Suturing System Regulation Number: 21 CFR 876.1500 Regulation Name: Endoscope And Accessories Regulatory Class: Class II Product Code: OCW Dated: May 29, 2019 Received: May 30, 2019
Dear David Hooper:
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); medical device 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,
Dr. Nina Mezu-Nwaba Acting Assistant Director DHT4B: Division of Infection Control and Plastic Surgery Devices OHT4: Office of Surgical and Infection Control Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known) K191439
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) |
|---|
| For testing Use in CFR 49, Subtitle B |
| For Training Use in CFR 49, Subtitle B |
|× | 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: | David HooperDirector, Regulatory AffairsPhone: (512)-618-4855Email : David.Hooper@apolloendo.com |
| Date: | August 29, 2019 |
| 510(k) Number: | K191439 |
| 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: | K181141 - 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 SutureAnchor Assembly devices. All devices are sterile packaged anddesigned for single use and are manufactured from variousthermoplastic, silicone, stainless steel and other medical gradematerials. |
OverStitch ESS
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 Suture-Anchor Assembly with the Anchor Exchange to perform 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.
The OverStitch Endoscopic Suturing System is intended for Indications for Use: endoscopic placement of suture(s) and approximation of soft tissue.
Modifications: The OverStitch Endoscopic Suturing System has been modified to add a new product code option for the OverStitch 2-0 Polypropylene Suture-Anchor Assembly. The remaining components of the system remain unchanged.
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Technological Characteristics:
| SUTURE-ANCHORASSEMBLY | OverStitch 2-0 Polypropylene Suture | |||||||||
|---|---|---|---|---|---|---|---|---|---|---|
| Single Use | Yes | |||||||||
| Shelf-Life Claim | 1-year | |||||||||
| Materials-Anchor | Stainless Steel 316L Cobalt Chromium MP35 | |||||||||
| Materials-Suture | USP 2-0 Polypropylene Chemical Formula: -(CH(CH3)-CH2)n Copper Phthalocyanine Blue (Below 0.5 WT %) in accordance with21CFR 74, 3045 | |||||||||
| Dimensions | 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 engagewith the Anchor Exchange, and a latch feature on the opposite enddesigned to engage with the Needle Body Assembly. The suture isswaged onto the center of the needle body to allow for the needlebody 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 to evaluate conformance to USP requirements, product specifications, and equivalence to the predicate design. The device was evaluated against individual functional and reliability requirements, as well as OverStitch Endoscopic Suturing System compatibility.
Performance Testing
Bench testing included needle passing reliability, Suture Cinch deployment and pull-off strength, tensile strength per USP <881>, needle pull off strength per USP <871> and suture diameter measuremnts per USP <861>.
Packaging Integrity Packaging Integrity was confirmed by repeating 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, and that no new issues of safety or efficacy were raised.
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
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| accordance with ISO 10993-18: 2005 and a toxicological riskassessment in accordance with ISO 10993-17: 2002 | |
|---|---|
| Clinical Performance Data: | Clinical testing was not required to demonstrate substantialequivalence. |
| Basis of Substantial Equivalence: | Based on a comparison of indications for use and technologicalcharacteristics, the proposed devices have demonstratedsubstantial equivalence to their 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.