(30 days)
Not Found
No
The description focuses on mechanical components and manual operation, with no mention of AI/ML terms or functionalities.
Yes
The device's intended use is for "endoscopic placement of suture(s) and approximation of soft tissue within the gastrointestinal tract", which is a therapeutic action aimed at treating or repairing tissue.
No
Explanation: The device is described as an "Endoscopic Suturing System" intended for "placement of suture(s) and approximation of soft tissue" within the gastrointestinal tract. This describes a therapeutic, procedural device, not one designed for diagnosis.
No
The device description explicitly details physical components like the Needle Driver Assembly, Anchor Exchange Device, Tissue Helix, Suture Cinch, and Suture-Anchor Assembly, made from various materials. It also 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 or procedural intervention, not a diagnostic test performed on samples taken from the body.
- Device Description: The description details a system for delivering sutures within the gastrointestinal tract using an endoscope. This is a medical device used for treatment or repair, not for analyzing biological samples to diagnose a condition.
- Lack of IVD Characteristics: The description does not mention any components or functions related to:
- Analyzing biological samples (blood, urine, tissue, etc.)
- Detecting or measuring substances in samples
- Providing information for diagnosis, monitoring, or screening
The OverStitch NXT Endoscopic Suturing System is a therapeutic medical device used for surgical procedures within the gastrointestinal tract.
N/A
Intended Use / Indications for Use
The OverStitch NXT Endoscopic Suturing System is intended for endoscopic placement of suture(s) and approximation of soft tissue.
Product codes (comma separated list FDA assigned to the subject device)
OCW
Device Description
The OverStitch NXT Endoscopic Suturing System (ESS) and 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 or NXT Tissue Helix Pro, 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 NXT ESS is designed for compatibility with single channel endoscopes. The ESS is mounted onto the endoscope using polyester medical tape 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 (study type, sample size, AUC, MRMC, standalone performance, key results)
Non-Clinical Performance Data: Appropriate product testing was performed on the subject device 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 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 of the ESS, Tissue Helix Pro (alone and in combination with anchor-sutures and cinch devices) included suture drag testing, tensile testing, torque testing, endoscope compatibility, sterility, 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 F1980-21, ASTM D4169-22 and ASTM F88/F88M-21. 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 with the new device.
Biocompatibility: Biocompatibility testing and toxicological assessments were performed on subject OverStitch NXT 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.
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.
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.
Not Found
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.
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.
June 29, 2023
Apollo Endosurgery Inc. James Shene Senior Regulatory Affairs Specialist 1120 South Capital of Texas Hwy., Suite 300 Austin, Texas 78746
Re: K231553
Trade/Device Name: OverStitch NXT Endoscopic Suturing System Regulation Number: 21 CFR 876.1500 Regulation Name: Endoscope And Accessories Regulatory Class: Class II Product Code: OCW Dated: May 26, 2023 Received: May 30, 2023
Dear James Shene:
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 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
1
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-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 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.
Cynthia Chang -S
for
Deborah Fellhauer 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
2
Indications for Use
510(k) Number (if known) K231553
Device Name
OverStitch NXT Endoscopic Suturing System
Indications for Use (Describe)
The OverStitch NXT 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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Image /page/3/Picture/0 description: The image shows the logo for Boston Scientific. The words "Boston" and "Scientific" are stacked on top of each other. The text is in a blue serif font.
Page 1 of 3 Boston Scientific Corporation
300 Boston Scientific Way
Marlborough, MA 01752 (508) 382-4000 www.bostonscientific.com
510(k) Summary
| Owner's Name & Address: | Boston Scientific Coporation
300 Boston Scientific Way
Marlborough, MA 01752 |
|-------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Contact Person: | James Shene
Senior Regulatory Affairs Specialist
(512) 852-3793
james.shene@apolloendo.com |
| Date: | June 26, 2023 |
| Trade Name: | OverStitch™ NXT 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: | K210266 - OverStitch™ Sx Endoscopic Suturing System |
| Device Description | The OverStitch NXT Endoscopic Suturing System (ESS) and
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 or NXT Tissue Helix Pro, 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 NXT ESS is designed for compatibility with single
channel endoscopes. The ESS is mounted onto the endoscope
using polyester medical tape 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. |
4
Image /page/4/Picture/0 description: The image shows the logo for Boston Scientific. The words "Boston Scientific" are written in a serif font. The color of the text is blue.
age 2 of 3
The OverStitch NXT Endoscopic Suturing System is intended for Indications for Use: 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 K210266 are as follows: . "MaxFlex" Feature: a new feature, integrated into the needle driver assembly, that incorporates the use of a "pull string" to provide physicians with the ability to further control the retroflexion capabilities of their endoscope. . Endoscope Attachment Method : the method and materials used to attach the needle driver to the endoscope were updated. . Design/Material Modifications: New materials and design modifications were implemented in order to improve product durability and the manufacturability of the device. Non-Clinical Performance Data: Appropriate product testing was performed on the subject device 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 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 of the ESS, Tissue Helix Pro (alone and in combination with anchor-sutures and cinch devices) included suture drag testing, tensile testing, torque testing, endoscope compatibility, sterility, 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 F1980-21, ASTM D4169-22 and ASTM F88/F88M-21. 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 with the new device.
5
Image /page/5/Picture/0 description: The image contains the logo for Boston Scientific. The logo is in blue and consists of the words "Boston" on the top line and "Scientific" on the bottom line. The font is a serif font, and the letters are bold.
| Biocompatibility: | Biocompatibility testing and toxicological assessments were
performed on subject OverStitch NXT 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.
| Predicate OverStitch Sx ESS (K210266) | OverStitch NXT Device | |
|---|---|---|
| Indications for Use | The OverStitch Sx Endoscopic Suturing | |
| System is intended for endoscopic | ||
| placement of suture(s) and approximation | ||
| of soft tissue. | Same, with the exception of the | |
| name. | ||
| 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 | 1 year |
| 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 2500 Gauss/cm | ||
| (extrapolated or less) and SAR of 2.0 W/kg | ||
| for 15 minutes of continuous scanning | Same |