(90 days)
No
The device description and performance studies focus on mechanical components and surgical technique, with no mention of AI/ML or related concepts like image processing, training data, or performance metrics typically associated with AI/ML algorithms.
No.
The device is used for endoscopic placement of sutures to approximate and fixate gastrointestinal soft tissue, which is a surgical procedure for tissue approximation, not a therapeutic treatment itself.
No
The device is described as a suturing system for endoscopic placement of sutures to approximate and fixate gastrointestinal soft tissue, which is a therapeutic rather than a diagnostic function.
No
The device description clearly outlines multiple hardware components (instrument, retractor, grasper, suture cartridge) made of various materials (polyurethane, stainless steel, nitinol, titanium, polypropylene, ePTFE). The procedural description also details the physical manipulation of these components within the patient.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostic devices are used to examine specimens taken from the human body (like blood, urine, or tissue) to provide information about a person's health. This testing is done outside of the body (in vitro).
- Plicator GSX Suturing System Function: The Plicator GSX Suturing System is a surgical device used inside the body (in vivo) to physically approximate and fixate gastrointestinal soft tissue. It is used for a therapeutic purpose (repairing tissue), not for diagnostic testing of specimens.
The description clearly outlines a device used for a surgical procedure within the gastrointestinal tract, which is the opposite of an in vitro diagnostic test.
N/A
Intended Use / Indications for Use
The Plicator GSX™ Suturing System is indicated for the endoscopic placement of sutures to approximate and fixate gastrointestinal soft tissue.
Product codes (comma separated list FDA assigned to the subject device)
OCW
Device Description
The Plicator GSX Suturing System (GSX) deploys a pledgeted, suture to approximate and secure tissue within the gastrointestinal tract. The GSX consists of four procedural components: the Plicator® instrument, the Plicator® tissue retractor, the Plicator® tissue grasper and the Plicator GSX™ suture cartridge. The Plicator instrument's shaft, which comes into contact with the patient, is made of polyurethane. The retractor is made of surgical grade stainless steel, with a polycarbonate sheath. The grasper is made of surgical grade stainless steel, with a nitinol connecting rod and arms. The pledgeted suture is comprised of two titanium retention bridges, 2.0 polypropylene suture and two ePTFE pledgets. The suture is housed in a disposable cartridge. Procedurally, the suture cartridge and either the retractor or the grasper are loaded onto the instrument and the instrument is then passed transorally into the gastrointestinal tract to deploy the suture and secure tissue. Once the Plicator instrument has been introduced transorally, the retractor or grasper is engaged into soft tissue in the gastrointestinal tract and the tissue is retracted into the arms of the instrument. The arms of the instrument are closed and the suture is deployed, creating a transmural fixation of soft tissue.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
gastrointestinal soft tissue within the gastrointestinal tract, gastric wall
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)
Bench and animal testing of the Plicator GSX™ Suturing System demonstrated that the system is able to safely and reliably deploy multiple pledgeted sutures. Bench testing confirmed that the GSX pledgeted suture meets USP requirements and testing in the porcine animal model demonstrated successful closure of gastric perforations, with normal results for the healing process. Biocompatibility testing per ISO 10993-1: Biological Evaluation of Medical Devices - Part 1: Evaluation and Testing confirmed acceptable biocompatibility profiles of patient contact materials used in the Plicator GSXTM Suturing System. Published clinical treatment outcomes demonstrate that placement of multiple, GSX pledgeted sutures safely and effectively closes gastric wall defects.
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.
K071533, K072125, K994290, K003956, K062875, K070151
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.
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.
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Image /page/0/Picture/1 description: The image is a black and white logo for the Department of Health & Human Services - USA. The logo consists of a circular border with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the circumference. Inside the circle is an abstract symbol that resembles a stylized human figure with outstretched arms, or possibly an eagle-like shape.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
NDO Surgical, Inc. Mr. John J. Vozella VP RA/Clinical/QA 125 High Street, Suite 7 Mansfield. MA 02048
JUL 2 7 2015
Re: K073671
Trade/Device Name: Plicator GSX™ Suturing System Regulation Number: 21 CFR 876.1500 Regulation Name: Endoscope and accessories Regulatory Class: II Product Code: OCW Dated (Date on orig SE ltr): December 21, 2007 Received (Date on orig SE ltr): December 27, 2007
Dear Mr. Vozella,
This letter corrects our substantially equivalent letter of March 26, 2008.
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
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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 (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); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Small Manufacturers. International and Consumer Assistance at its toll-free number (800) 638 2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR 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.
You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely yours,
Benjamin R. Fisher -S
Beniamin R. Fisher, Ph.D. Director Division of Reproductive, Gastro-Renal, and Urological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
2
INDICATIONS FOR USE STATEMENT
510(k) Number (if known):_KO Blo U
Device Name: Plicator GSX™ Suturing System
Indications for Use: The Plicator GSX™ Suturing System is indicated for the endoscopic placement of sutures to approximate and fixate gastrointestinal soft tissue.
Prescription Use X (Per 21 C.F.R. 801.109) OR
Over-The-Counter Use_
(PLEASE DO NOT WRITE BELOW THIS LINE -- CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use _ (Per 21 C.F.R. 801.109)
OR
Over-The-Counter Use
(Optional Format 1-2-96)
Nancy C. Brogdon
Division Ston-Off Division of Reproductive. Abdo and Radiological Devi 510(k) Number.
\\DC - 71403/600 - 0869482.01
3
KO72671 pg. 10+3
5. 510(K) SUMMARY
MAR 2 6 2008
1. SUBMITTER:
NDO Surgical, Inc. 125 High St. Mansfield, MA 02048 Telephone: 508-337-8881 Fax: 508-337-8882
Contact: John J. Vozella, V.P. Regulatory/Clinical/QA Date Prepared: December 21, 2007
2. DEVICE:
Trade Name: Plicator GSXTM Suturing System Common Name: Endoscope accessory Classification Name: Endoscope and accessories Class: II
3. PREDICATE DEVICE:
NDO Surgical Plicator™ Endoscopic Plication System (K071533; K072125) Bard® EndoCinch™ Suturing System (K994290; K003956) EndoGastric StomaphyX Device and Accessories (K062875) InScope Tissue Apposition System (K070151)
4. DEVICE DESCRIPTION:
The Plicator GSX Suturing System (GSX) deploys a pledgeted, suture to approximate and secure tissue within the gastrointestinal tract. The GSX consists of four procedural components: the Plicator® instrument, the Plicator® tissue retractor, the Plicator® tissue grasper and the Plicator GSX™ suture cartridge. The Plicator instrument's shaft, which comes into contact with the patient, is made of polyurethane. The retractor is made of surgical grade stainless steel, with a polycarbonate sheath. The grasper is made of surgical grade stainless steel, with a nitinol connecting rod and arms. The pledgeted suture is comprised of two titanium retention bridges, 2.0 polypropylene suture and two ePTFE pledgets. The suture is housed in a disposable cartridge. Procedurally, the suture cartridge and either the retractor or the grasper are loaded onto the instrument and the instrument is then passed transorally into the gastrointestinal tract to deploy the suture and secure tissue. Once the Plicator instrument has been introduced transorally, the retractor or grasper is engaged into soft tissue in the gastrointestinal tract and the tissue is retracted into the arms of the instrument. The arms of the instrument are closed and the suture is deployed, creating a transmural fixation of soft tissue.
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K073671 pa 2 of 3
5. INTENDED USE:
The Plicator GSX™ Suturing System is indicated for the endoscopic placement of sutures to approximate and fixate gastrointestinal soft tissue.
6. COMPARISON OF CHARACTERISTICS:
The proposed Plicator GSX™ Suturing System (GSX), is identical in design, materials and fundamental operating principles to the predicate Plicator Endoscopic Plication System (EPS) device (K023234, K032820, K071533), except that:
- . the Plicator GSX pre-tied, pledgeted suture will be offered in two different lengths (the EPS only offers one suture length),
- a tissue grasper is being offered as a procedural accessory component to . the GSX system (the predicate EPS does not include this accessory component) and
- . a cartridge release accessory (CRA) is being offered as a non-procedural accessory component to the GSX system (the predicate EPS does not include this accessory component).
The GSX System is also similar to the other listed predicate devices in that they are all designed to reach the desired suture location under endoscopic visualization, grasp tissue in some fashion and place sutures, clips or fasteners in a targeted soft tissue location. All devices share common features such as: singleuse sterile components and delivery of the soft tissue fixation component via manual actuation of a mechanism on the deployment system. Finally, the Plicator GSXTM Suturing System and the predicate devices have the same or similar intended use, which is to endoscopically place sutures, clips or fasteners to approximate soft tissue.
7. PERFORMANCE DATA:
Bench and animal testing of the Plicator GSX™ Suturing System demonstrated that the system is able to safely and reliably deploy multiple pledgeted sutures. Bench testing confirmed that the GSX pledgeted suture meets USP requirements and testing in the porcine animal model demonstrated successful closure of gastric perforations, with normal results for the healing process.
Biocompatibility testing per ISO 10993-1: Biological Evaluation of Medical Devices - Part 1: Evaluation and Testing confirmed acceptable biocompatibility profiles of patient contact materials used in the Plicator GSXTM Suturing System.
Published clinical treatment outcomes demonstrate that placement of multiple, GSX pledgeted sutures safely and effectively closes gastric wall defects.
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K07-3671 pg. 3 of 3
8. CONCLUSION:
Based on the intended use, descriptive information and performance evaluation provided in this submission, the Plicator GSX™ Suturing System has been shown to be equivalent in technology, method of operation and intended use to the currently marketed predicate devices.