(29 days)
Not Found
No
The summary describes a mechanical endoscopic suturing system and its accessories. There is no mention of AI, ML, image processing for analysis, or any data-driven decision-making components. The performance studies focus on mechanical and biocompatibility testing.
Yes
The device is used for endoscopic placement of sutures and approximation of soft tissue within the gastrointestinal tract, which directly involves treatment and repair of bodily tissues.
No
The device is described as a suturing system intended for "endoscopic placement of suture(s) and approximation of soft tissue," which is a therapeutic rather than a diagnostic function.
No
The device description explicitly details physical components made of thermoplastic, silicone, stainless steel, and other medical grade materials, and describes mechanical actions like squeezing a handle to actuate a needle body. This indicates a hardware-based medical device, not a software-only one.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is "for endoscopic placement of suture(s) and approximation of soft tissue." This describes a surgical procedure performed within the body, not a test performed on a sample taken from the body.
- Device Description: The description details a system for manipulating tissue and placing sutures endoscopically. This is a therapeutic/surgical device, not a diagnostic one.
- Lack of Diagnostic Elements: There is no mention of analyzing biological samples (blood, urine, tissue, etc.) or providing diagnostic information about a patient's health status.
- Performance Studies: The performance studies focus on mechanical properties, functional testing in an ex vivo model, packaging integrity, and biocompatibility. These are typical evaluations for a surgical device, not an IVD which would involve studies on diagnostic accuracy (sensitivity, specificity, etc.).
IVD devices are used to examine specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes. This device is used for a surgical intervention.
N/A
Intended Use / Indications for Use
The OverStitch Sx Endoscopic Suturing System is intended for endoscopic placement of suture(s) and approximation of soft tissue.
Product codes
OCW
Device Description
OverStitch™ Sx Endoscopic Suturing System and The accessories are intended for endoscopic placement of sutures and approximation of soft tissue within the gastrointestinal tract utilizing a 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 OverStitch Sx ESS is designed for compatibility with single channel endoscopes. The ESS is mounted onto the endoscope using thermoplastic polyurethane straps for the 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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
soft tissue within the gastrointestinal tract
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
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
Non-Clinical Performance Data: Appropriate product testing was performed on the subject device 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 written protocols, previously applied to the predicate device. All devices were evaluated to their individual functional and reliability requirements, as well as system compatibility.
Performance Testing
Bench testing included suture drag testing, tensile testing, endoscope compatibility, reliability and bond strength.
Functional Testing
An ex vivo model was utilized under the same test methods as the predicate to evaluate the device function and intended use.
Packaging Integrity
Packaging Integrity was confirmed by repeating testing in accordance with ASTM F2096-11, ASTM F1980-16, ASTM D4169-16 and ASTM F88/F88M-15.
Acceptance criteria were met in each of the studies listed above. The results confirmed equivalency between the subject and predicate devices, and that no new issues of safety or efficacy were raised.
Key Metrics
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
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.
0
Image /page/0/Picture/0 description: The image shows 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.
March 2, 2021
Apollo Endosurgery Inc. David Hooper VP Quality and Regulatory 1120 South Capital of Texas Hwy., Suite 300 Austin, Texas 78746
Re: K210266
Trade/Device Name: OverStitch Sx Endoscopic Suturing System Regulation Number: 21 CFR 876.1500 Regulation Name: Endoscope and Accessories Regulatory Class: Class II Product Code: OCW Dated: January 28, 2021 Received: February 1, 2021
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 Actinclude 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); 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 (QS) 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-devices/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device (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,
for Cindy Chowdhury, Ph.D., MBA 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) K210266
Device Name
OverStitch Sx Endoscopic Suturing System
Indications for Use (Describe)
The OverStitch Sx 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)
CONTINUE ON A SEPARATE PAGE IF NEEDED.
This section applies only to requirements of the Paperwork Reduction Act of 1995.
DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.
The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:
Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff@fda.hhs.gov
"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."
3
K210266 p. 1 of 3
Image /page/3/Picture/1 description: The image is a logo for Apollo Endosurgery. The logo features a stylized human figure on the left, with a blue circle representing the head and a curved line representing the body. To the right of the figure is the word "apollo" in blue, with the word "endosurgery" in a smaller font size below it, also in blue. The logo is simple and modern, and the use of blue gives it a clean and professional look.
1120 S. Capital of TX Hwy, Bldg. 1, Ste. 300 Austin, Texas 78746 USA Phone: 512.279.5100 FAX: 512.279.5105
510(k) Summary
Lisa Peterson
March 2, 2021
OCW
Kaedon Consulting, LLC
lpeterson@kaedonconsulting.com
OverStitch™ Sx Endoscopic Suturing System
Endoscopic Tissue Approximation Device
| Owner's Name & Address: | Apollo Endosurgery
1120 S. Capital of Texas Hwy
Building 1, Suite 300
Austin, TX 78746 |
| ------------------------- | ------------------------------------------------------------------------------------------------- |
|---|
Contact Person: David M. Hooper, PhD VP Quality and Regulatory 512-852-3757 david.hooper@apolloendo.com
Submission Compiled By:
Date:
Ow
Trade Name:
Common Name:
Product Code:
Classification:
Classification Name Endoscope and Accessories
Predicate Devices: K181141 - OverStitch™ Sx Endoscopic Suturing System
Class II (21 CFR 876.1500)
Device Description OverStitch™ Sx Endoscopic Suturing System and The accessories are intended for endoscopic placement of sutures and approximation of soft tissue within the gastrointestinal tract utilizing a 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 OverStitch Sx ESS is designed for compatibility with single channel endoscopes. The ESS is mounted onto the endoscope using thermoplastic polyurethane straps for the 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.
4
Image /page/4/Picture/0 description: The image shows the logo for Apollo Endosurgery. The logo features a stylized figure of a person with a circular head and a body made of a spiral line. The figure is positioned to the left of the word "apollo" in blue, with the word "endosurgery" in a smaller font below it. The logo is clean and modern, with a focus on the company's name and a visual representation of its services.
1120 S. Capital of TX Hwy, Bldg. 1, Ste. 300 Austin, Texas 78746 USA Phone: 512.279.5100 FAX: 512.279.5105
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.
Indications for Use: The OverStitch Sx Endoscopic Suturing System is intended for endoscopic placement of suture(s) and approximation of soft tissue.
Technological Characteristics: Modifications to design and materials as compared to the predicate device cleared via K181141 are as follows:
- Material Change: Endcap material changed to support change from machined component to plastic injection molded component. Adhesive changed for endcap glue joints to improve manufacturability.
- Dimensional Change: Minor geometry adjustments made to support injection molding requirements.
- . Biopsy Valve components provided and pre-installed on Handle
Non-Clinical Performance Data: Appropriate product testing was performed on the subject device 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 written protocols, previously applied to the predicate device. All devices were evaluated to their individual functional and reliability requirements, as well as system compatibility.
Performance Testing
Bench testing included suture drag testing, tensile testing, endoscope compatibility, reliability and bond strength.
Functional Testing
An ex vivo model was utilized under the same test methods as the predicate to evaluate the device function and intended use.
Packaging Integrity
Packaging Integrity was confirmed by repeating testing in accordance with ASTM F2096-11, ASTM F1980-16, ASTM D4169-16 and ASTM F88/F88M-15.
Acceptance criteria were met in each of the studies listed above. The results confirmed equivalency between the subject and predicate devices, and that no new issues of safety or efficacy were raised.
K210266 p. 2 of 3
5
Image /page/5/Picture/0 description: The image shows the logo for Apollo Endosurgery. The logo features a stylized figure of a person with a blue circle for a head and a blue spiral for a body. To the right of the figure is the word "apollo" in blue, with the word "endosurgery" in blue below it. The logo is simple and modern, and the use of blue gives it a clean and professional look.
| 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, irritation and skin sensitization, systemic
toxicity, 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 their predicates. |
Table 1 Summary Table of Equivalence
| Predicate OverStitch Sx ESS (K181141) | Modified Sx ESS Device | |
|---|---|---|
| Indications for Use | The OverStitch Sx Endoscopic Suturing System is intended for endoscopic placement of suture(s) and approximation of soft tissue. | Same |
| Endoscope Compatibility | Compatible with single channel endoscopes having an outer diameter range of 8.8 to 9.8 mm | Same |
| Working Length | Maximum working length of 110 cm | Same |
| Sterilization Method | EO | Same |
| Shelf Life | 3 years | Same |
| Usage | Single-use | Same |
| Biocompatibility | Tested per ISO 19993. | Same |
| MR Compatibility | Safe with 1.5 and 3 T MR scanners with spatial field gradient of 2000 Gauss/cm (extrapolated or less) and SAR of 2.0 W/kg for 15 minutes of continuous scanning | Same |