(63 days)
Pre-Tied Loop Suture Cannula
Not Found
No
The description focuses on mechanical components and conventional sutures, with no mention of AI/ML terms or functionalities.
No
The device introduces sutures and facilitates knot tying during surgical procedures; it does not directly treat or cure a disease or condition itself.
No
The device is described as an instrument for introducing sutures and facilitating knot tying during surgical procedures. There is no mention of it being used to diagnose a medical condition or disease.
No
The device description explicitly details physical components (stainless steel device, sutures, plastic passer, slide component) and mentions sterilization and benchtop testing of physical characteristics, indicating it is a hardware device with associated consumables.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is to "Introduce sutures and facilitates knot tying of surgical sutures in endoscopic (videoscopic) procedures." This describes a surgical tool used during a procedure on a patient.
- Device Description: The description details a surgical instrument (ENDO-HOLDER) and surgical sutures. These are used directly on tissue within the body.
- Lack of IVD Characteristics: There is no mention of analyzing samples (blood, urine, tissue, etc.) in vitro (outside the body) to diagnose a condition, monitor treatment, or screen for diseases.
IVD devices are specifically designed to perform tests on samples taken from the human body to provide information about a person's health. This device is a surgical tool used for manipulation and repair within the body.
N/A
Intended Use / Indications for Use
Introduces sutures and facilitates knot tying of surgical sutures in endoscopic (videoscopic) procedures.
Product codes
Not Found
Device Description
ETHICON ENDOSUTURE System is comprised of two (2) parts, the ENDOSUTURE System ENDO-HOLDER Cannula Knot Pusher and the ENDOSUTURE System suture. Each is available separately for assembly at the surgical site. The ENDOSUTURE System ENDO-HOLDER is a one-piece stainless steel device designed to accept the ENDOSUTURE System suture. The ENDOSUTURE System ENDO-HOLDER is provided non-sterile for sterilization before initial use and is reusable. ENDOSUTURE System sutures are conventional sutures, the same suture materials available by ETHICON, Inc. allowed to be marketed by FDA. The ENDOSUTURE System suture is configured in either a loop or pre-tied with needle or a suture strand with needle. Pre-threaded to each ENDOSUTURE System suture is a plastic passer and slide component that is designed for loading the suture in the ENDOSUTURE System ENDO-HOLDER.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
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)
Benchtop evaluations were conducted on the sutures used in the ENDOSUTURE System to assess USP characteristics (diameter, knot tensile strength and needle pull-off). Comparative benchtop functionality testing was conducted to assess knot security following knot placement. Nonclinical laboratory testing was conducted to determine breaking strength retention.
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.
ENDOLOOP Ligature with Introducer, Pre-Tied Loop Suture Cannula.
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
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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SECTION 7
SUMMARY OF SAFETY AND EFFECTIVENESS
510(k) Summary of Information supporting claims of substantial equivalence as Safety and Effectiveness defined under the Federal Food. Drug and Cosmetic Act. respecting safety and effectiveness is summarized below. For the convenience of the Reviewer, this summary is formatted in accordance with the Agency's final rule " ... 510(k) Summaries and 510(k) Statements ... " (21 CFR 807) and can be used to provide a substantial equivalence summary to anyone requesting it from the Agency. NEW DEVICE NAME: ETHICON ENDOSUTURE System PREDICATE DEVICE NAME(S): ENDOLOOP Ligature with Introducer, Pre-Tied Loop Suture Cannula. 510(K) SUMMARY ETHICON ENDOSUTURE System is comprised of two (2) Device Description parts, the ENDOSUTURE System ENDO-HOLDER Cannula Knot Pusher and the ENDOSUTURE System suture. Each is available separately for assembly at the surgical site. The ENDOSUTURE System ENDO-HOLDER is a one-piece stainless steel device designed to accept the ENDOSUTURE System suture. The ENDOSUTURE System ENDO-HOLDER is provided non-sterile for sterilization before initial use and is reusable. ENDOSUTURE System sutures are conventional sutures, the same suture materials available by ETHICON, Inc. allowed to be marketed by FDA. The ENDOSUTURE System suture is configured in either a loop or pre-tied with needle or a suture strand with needle. Pre-threaded to each ENDOSUTURE System suture is a plastic passer and slide component that is designed for loading the suture in the ENDOSUTURE System ENDO-HOLDER.
Continued on next page
1
SUMMARY OF SAFETY AND EFFECTIVENESS (Continued)
| Intended Use | Introduces sutures and facilitates knot tying of surgical sutures in
endoscopic (videoscopic) procedures. |
|----------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Indications Statement | Introduces sutures and facilitates knot tying of surgical sutures in
endoscopic (videoscopic) procedures. |
| Technological
Characteristics | The new device is technologically like the predicate
device (except, i.e., a cannula with a surgical suture).
Differences do not raise new questions of safety and
effectiveness. |
| Performance Data | Benchtop evaluations were conducted on the sutures used in the
ENDOSUTURE System to assess USP characteristics (diameter,
knot tensile strength and needle pull-off). Comparative benchtop
functionality testing was conducted to assess knot security
following knot placement. Nonclinical laboratory testing was
conducted to determine breaking strength retention. |
| Conclusions | Based on the 510(k) summaries and 510(k) statements (21 CFR
807) and the information provided herein, we conclude that the
new device is substantially equivalent to the Predicate Device
under the Federal Food, Drug and Cosmetic Act. |
| Contact | John D. Paulson, Ph.D.
Vice President, Regulatory Affairs
ETHICON, Inc.
Rt. #22 West
Somerville, NJ 08876-0151 |
| Date | August 21. 1996 |
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